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Dural Connection Internet Edition Volume 4 Number 4

Topic
RE: Aetna’s Coverage Policy Bulletins May 2003
Number: 0107
Subject: Chiropractic Services
“The following chiropractic patient management procedures are considered experimental and investigational and are not covered:… k.. Sacro-Occipital Technique…”

TABLE OF CONTENTS

Aetna’s Coverage Policy Bulletins May 2003
Number: 0107
Subject: Chiropractic Services

From: Charles Blum, DC
Sent: July 17, 2003
To: Michael Siegel, MD
Subject: Sacro Occipital Technique and Aetna

From: Aetna Response Michael Siegel, MD
Sent:    July 31, 2003
To:    Charles Blum, DC
Subject: Sacro Occipital Technique: Aetna

From: Charles Blum, DC
Sent: July 31, 2003
To: Michael Siegel, MD
Subject: Sacro Occipital Technique: Aetna

From: Aetna Response Michael Siegel, MD
Sent:    July 31, 2003
To:    Charles Blum, DC
Subject: Sacro Occipital Technique: Aetna Request for Denies?

From: Charles Blum, DC
Sent: Thursday, August 1, 2003 1:28 AM
To: Michael Siegel, MD
Subject: Sacro Occipital Technique: Aetna Request for Denies - Response

From: Aetna Response Michael Siegel, MD
Sent:    August 1, 2003
To:    Charles Blum, DC
Subject: Sacro Occipital Technique: Aetna

From: Charles Blum, DC - SOTO-USA
Sent: August 9, 2003
To: Aetna Chiropractic Reviews – Dr. Robert Frank
Subject: Sacro Occipital Technique Reply to Aetna’s Policy Statement

Introduction

SOT Evidence In The Peer-Reviewed Published Literature

SOT Related Research From Proceedings of Research Conferences

SOT A Chiropractic Technique and its Considered As A Standard Of Care For Chiropractic Treatment

Randomized Controlled Studies and Their Use as a Sole Qualification of Chiropractic By Aetna

Summary

Sacro Occipital Technique Related Peer Reviewed Articles Published Following The Year 2000

Aetna’s Coverage Policy Bulletins May 2003

Number: 0107
Subject: Chiropractic Services

Important Note

Even though the policy described below may conclude that a particular service or supply is considered covered, this conclusion is not based upon the terms of your particular benefit plan. Each benefit plan contains its own specific provisions for coverage and exclusions. Not all benefits that are determined to be medically necessary will be covered benefits under the terms of your benefit plan. You need to consult the terms of your own benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and your plan of benefits, the provisions of your benefits plan will govern. However, applicable state mandates will take precedence with respect to fully insured plans and self-funded non-ERISA (e.g., government, school boards, church) plans. Unless otherwise specifically excluded, Federal mandates will apply to all plans. With respect to Medicare and Medicaid members, this policy y will apply unless Medicare and Medicaid policies extend coverage beyond this Coverage Policy Bulletin. Medicare and Medicaid policies will only apply to benefits paid for under Medicare or Medicaid rules, and not to any other health benefit plan benefits. CMS's Coverage Issues Manual can be found on the following website: http://cms.hhs.gov/manuals/pub06pdf/pub06pdf.asp

Policy

Aetna covers chiropractic services, subject to any applicable benefit limitations and exclusions, when ALL of the following criteria are met:

1.. Chiropractic care is either a covered benefit under the plan, there is an optional rider that covers chiropractic care, or coverage of chiropractic care is mandated by state law; and
2.. The patient has a neuromusculoskeletal disorder; and
3.. The medical necessity for treatment is clearly documented; and
4.. Improvement is documented within the initial 2 weeks of chiropractic care.
If no improvement is documented within the initial 2 weeks, additional chiropractic treatment is not medically necessary and is not covered unless the chiropractic treatment is modified.

If no improvement is documented within 30 days despite modification of chiropractic treatment, continued chiropractic treatment is not considered medically necessary and is not covered.

Once the maximum therapeutic benefit has been achieved, continuing chiropractic care is not considered medically necessary and thus is not covered.

Chiropractic manipulation in asymptomatic patients or in patients without an identifiable clinical condition is considered not medically necessary and is not covered.

Chiropractic care in patients whose condition is neither regressing or improving, is considered not medically necessary and is not covered.

Manipulation is deemed ineffective and is not covered when it is rendered for non-neuromusculoskeletal conditions.

Chiropractic manipulation is not considered medically necessary and is not covered for treatment of idiopathic scoliosis or for treatment of scoliosis beyond early adolescence, unless the patient is exhibiting pain or spasm, or some other medically necessary indication for chiropractic manipulation is present.

The following chiropractic patient management procedures are considered experimental and investigational and are not covered:

a.. Applied Spinal Biomechanical Engineering
b.. BioEnergetic Synchronization Technique
c.. Cranial Manipulation
d.. Coccygeal Meningeal Stress Fixation Technique
e.. Directional Non-force Technique
f.. Manipulation for internal (non-neuromusculoskeletal) disorders (Applied Kinesiology)
g.. Manipulation under anesthesia (See CPB 204 - Spinal Manipulation Under Anesthesia)
h.. Moire Contourographic Analysis
i.. Network Technique
j.. Neural Organizational Technique
k.. Sacro-Occipital Technique
l.. Upledger Technique
The following diagnostic procedures are considered experimental and investigational and are not covered:

a.. Thermography - See CPB 29 - Thermography
b.. Paraspinal Electromyography (EMG)/Surface Scanning EMG - See CPB 112 - Surface Scanning and Macro Electromyography
c.. Spinoscopy - See CPB 112 - Surface Scanning and Macro Electromyography
d.. Neurocalometer/Nervoscope CPB 29 - Thermography.
Background

Chiropractic is a branch of the healing arts that is concerned with human health and prevention of disease, and the relationship between the neuroskeletal and musculoskeletal structures and functions of the body. The primary focus of chiropractic is the relationship of the spinal column and the nervous system, as it relates to the restoration and maintenance of health. A practitioner of chiropractic is referred to as Doctor of Chiropractic (D.C.), Chiropractic Physician or Chiropractor.

The primary focus of the profession is the vertebral column; however, all other peripheral articular structures and adjacent tissues may be treated, depending on state chiropractic scope of practice laws.

Neuromusculoskeletal conditions commonly treated by chiropractic physicians include:

a.. Spondylosis
b.. Osteoarthritis - Intervertebral disc disorders of the spine such as disc protrusion, bulging, degeneration, and displacement
c.. Peripheral joint trauma
d.. Degenerative conditions of the joints
e.. Repetitive motion injuries
f.. Contractures
g.. Sprains and strains
h.. Headaches (including tension headaches, migraines, and vertebrogenic-type headaches)
i.. Noninfectious inflammatory disorders of the joints, muscles, and ligaments of the spine and extremities
j.. Myalgia, myofibrositis and fibrositis
k.. Neuralgias and radiculopathies
l.. Spinal facet syndromes
m.. Spondylolisthesis
The chiropractor may treat multiple neuromusculoskeletal conditions during a single visit.

Chiropractors use broadly accepted diagnostic procedures to assess diseases and adverse health conditions.

The primary mode of chiropractic treatment is manipulation or adjustment. Chiropractic manipulation is the application of a controlled force to re-establish normal articular function. The objective of manipulation is to restore the normal mobility and range of motion within the joint.

The chiropractor affects the body's physiology and promotes healing by locating and correcting mechanical disorders of joints or joint subluxations. In chiropractic, the term "subluxation" is used interchangeably with the term "spinal subluxation complex" or "vertebral subluxation complex". A subluxation may also be called a joint dysfunction, joint fixation, functional joint lesion, somatic dysfunction, or biomechanical dysfunction. A subluxation has been defined as a fixation, lack of motion, or aberrant motion of an articular joint, resulting in physiological changes within the joint that may cause inflammation of the joint and its capsule, which may result in pain, swelling, muscle spasm, nerve irritation, damage to joint cartilage, and loss of normal range of motion. Nerve irritation may cause pain and spasm to radiate. Vascular, sensory, and motor changes may accompany a spinal subluxation complex.

Some non-neuromusculoskeletal conditions may be managed by chiropractors when practicing within the scope of their licenses. In assessing the need for chiropractic treatment, both neuromusculoskeletal conditions and any related coexisting non-neuromusculoskeletal disorders should be considered.

Chiropractors treat disease without the use of medications or surgery. When medication or surgery is indicated, the chiropractor should refer the patient to an allopathic or osteopathic physician, as appropriate. Patients may receive medical treatment from an allopathic or osteopathic physician simultaneously or in conjunction with a chiropractic physician.

Chiropractors may diagnose disease and prescribe office-based treatments and home exercises. Chiropractors do not commonly make house calls.

In addition to manipulation, chiropractors may employ adjunctive nutritional, hygienic, and environmental modalities, physiotherapeutic modalities, rehabilitation, and therapeutic massage for the treatment of subluxation and related conditions. The use of adjunctive modalities must be appropriate for the diagnosis and must augment or enhance the manipulative treatment. The type of therapy used should be consistent with the status of the patient's condition (e.g., acute, subacute, rehabilitative or chronic)..

Examples of adjunctive physiotherapeutic measures that have been used in chiropractic include:

a.. Acute phase: thermal (cold) therapy, electrotherapy, trigger point therapy;
b.. Subacute phase: thermal (heat), electrotherapy, ultrasound; and
c.. Rehabilitative phase: exercise.
Massage therapy and traction procedures are not considered to be manipulation.

Literature indicates that chiropractic treatment during pregnancy may be appropriate. Chiropractic therapy is often effective in reducing back pain and allowing the patient to function and perform her activities of daily living.

Experimental and Investigational Interventions:

Some diagnostic and therapeutic procedures are not considered medically necessary or essential to the treatment of an illness or injury and are not broadly accepted by the chiropractic profession.

Manipulation is deemed experimental and investigational and is not covered when it is rendered for non-neuromusculoskeletal conditions, because the effectiveness of chiropractic manipulation for this indication has not been proven by adequate scientific studies, published in peer-reviewed scientific journals. An example is the use of manipulation in lieu of antibiotics for treatment of suppurative otitis media. Manipulative procedures are not proven to be an effective substitute for childhood immunizations or for the treatment of infectious diseases, and are not covered for these indications.

Chiropractic/manipulative management of scoliosis has not been shown to substantially alter the idiopathic scoliotic curve or progression of the curve in late adolescence or adulthood. Therefore, chiropractic manipulation is not considered medically necessary and is not covered for treatment of idiopathic scoliosis or for treatment of scoliosis beyond early adolescence, unless the patient is exhibiting pain or spasm or if some other medically necessary indication for chiropractic manipulation is present.

Scoliotic deviations may be a result of functional adaptations to lumbo-pelvic lower extremity dysfunction for which chiropractic care is appropriate. Manipulative procedures, in conjunction with electrical muscle stimulation and exercise, can significantly reduce the associated muscle spasm and resultant pain of scoliosis during the acute exacerbations and/or injury, and improve spinal mobility prior to an active exercise regimen. Chiropractic/manipulative management of scoliosis, however, has not been shown to substantially alter the idiopathic scoliotic curve or progression of the curve in late adolescence or adulthood.

Preventive or maintenance chiropractic manipulation is defined by the American Chiropractic Association as:

Elective health care that is typically long-term, by definition not therapeutically necessary but is provided at preferably regular intervals to prevent disease, prolong life, promote health and enhance the quality of life. This care may be provided after maximum therapeutic improvement, without a trial of withdrawal of treatment, to prevent symptomatic deterioration or it may be initiated with patients without symptoms in order to promote health and to prevent future problems.

Preventive services may include patient education, home exercises, and ergonomic postural modification. The appropriateness and effectiveness of chiropractic manipulation as a preventive or maintenance therapy has not been established by clinical research and is not covered.

Supportive care is defined by the American Chiropractic Association as "treatment for patients who have reached maximum therapeutic benefit, but who fail to sustain benefit and progressively deteriorate when there are periodic trials of treatment withdrawal." Continuation of chiropractic care is considered medically necessary until maximum therapeutic benefit has been reached, when the patient fails to progress clinically between treatments, or when pre-injury/illness status has been reached. Once the maximum therapeutic benefit has been achieved, continuing chiropractic care is not considered medically necessary and thus is not covered.

Active corrective care is ongoing treatment, rendered after the patient has become symptomatically and objectively stable, to prevent a recurrence of a patient's condition by correcting underlying abnormal spinal biomechanics that appear to be the cause of the initial injury. The efficacy of active corrective care is not supported by scientific evidence and is not covered.

The above policy is based on the following references:

1.. Nelson CD, McMillin DL, Richards DG, et al. Manual healing diversity and other challenges to chiropractic integration. J Manipulative Physiol Ther. 2000;23(3):202-207.
2.. Lee AC, Li DH, Kemper KJ. Chiropractic care for children. Arch Pediatr Adolesc Med. 2000;154(4):401-407.
3.. Ernst E. Prevalence of use of complementary/alternative medicine: A systematic review. Bull World Health Organ. 2000;78(2):252-257.
4.. Pirotta MV, Cohen MM, Kotsirilos V, et al. Complementary therapies: Have they become accepted in general practice? Med J Aust. 2000;172(3):105-109.
5.. Pelletier KR, Astin JA, Haskell WL. Current trends in the integration and reimbursement of complementary and alternative medicine by managed care organizations (MCOs) and insurance providers: 1998 update and cohort analysis. Am J Health Promot. 1999;14(2):125-133.
6.. Meeker WC. Public demand and the integration of complementary and alternative medicine in the US health care system. J Manipulative Physiol Ther. 2000;23(2):123-126.
7.. Haldeman S. Neurological effects of the adjustment. J Manipulative Physiol Ther. 2000;23(2):112-114.
8.. Hadler NM. Chiropractic. Rheum Dis Clin North Am. 2000;26(1):97-102.
9.. Vickers A, Zollman C. ABC of complementary medicine. The manipulative therapies: Osteopathy and chiropractic. Br Med J. 1999;319(7218):1176-1179.
10.. Astin JA, Marie A, Pelletier KR, et al. A review of the incorporation of complementary and alternative medicine by mainstream physicians. Arch Intern Med. 1998;158(21):2303-2310.
11.. Kaptchuk TJ, Eisenberg DM. Chiropractic: origins, controversies, and contributions. Arch Intern Med. 1998;158(20):2215-2224.
12.. Shekelle PG. What role for chiropractic in health care? N Engl J Med. 1998;339(15):1074-1075.
13.. Berman BM, Singh BB, Hartnoll SM, et al. Primary care physicians and complementary-alternative medicine: Training, attitudes, and practice patterns. J Am Board Fam Pract. 1998;11(4):272-281.
14.. Bergmann TF, Jongeward BV. Manipulative therapy in lower back pain with leg pain and neurological deficit. J Manipulative Physiol Ther. 1998;21(4):288-294.
15.. Polkinghorn BS, Colloca CJ. Treatment of symptomatic lumbar disc herniation using activator methods chiropractic technique. J Manipulative Physiol Ther. 1998;21(3):187-196.
16.. Triano JJ, McGregor M, Skogsbergh DR. Use of chiropractic manipulation in lumbar rehabilitation. J Rehabil Res Dev. 1997;34(4):394-404.
17.. White AR, Resch KL, Ernst E. Complementary medicine: Use and attitudes among GPs. Fam Pract. 1997;14(4):302-306.
18.. Shekelle PG, Coulter I. Cervical spine manipulation: Summary report of a systematic review of the literature and a multidisciplinary expert panel. J Spinal Disord. 1997;10(3):223-228.
19.. Turow VD. Chiropractic for children. Arch Pediatr Adolesc Med. 1997;151(5):527-528.
20.. Koes BW, Assendelft WJ, van der Heijden GJ, et al. Spinal manipulation for low back pain. An updated systematic review of randomized clinical trials. Spine. 1996;21(24):2860-2873.
21.. Simpson CA. Integrating chiropractic in managed care. Manag Care Q. 1996;4(1):50-58.
22.. Gordon JS. Alternative medicine and the family physician. Am Fam Physician. 1996;54(7):2205-2212, 2218-2220.
23.. Nyiendo J, Haas M, Goodwin P. Patient characteristics, practice activities, and one-month outcomes for chronic, recurrent low-back pain treated by chiropractors and family medicine physicians: A practice-based feasibility study. J Manipulative Physiol Ther. 2000;23(4):239-245.
24.. Triano JJ, Hondras M. Differences in treatment history with manipulation for acute, subacute, chronic and recurrent spine pain. Proceedings World Federation of Chiropractic, Toronto, 1991. J Manipulative Physiol Ther.

Dural Connection Internet Edition Index TOP

From: Charles Blum, DC
Sent: July 17, 2003
To: Michael Siegel, MD
Subject: Sacro Occipital Technique and Aetna

Dear Dr. Siegel,

It was a pleasure to speak with you today. Attached you will find a copy of the letter written to appeal the decision of Aetna that sacro occipital technique is experimental and investigational and therefor not a covered in your policy.

Please contact me if you have any questions or if I can be of help in any way.

Sincerely,

Charles

Charles L. Blum, DC, CSCP
drcblum@aol.com
www.soto-usa.org

July 17, 2003

Dr. Michael Siegel
C/o Aetna
6303 Owensmouth Avenue
Woodland Hills, California 91367
Telephone: (818) 932-6462
Facsimile: (818) 932-6553
Email: michaels1@aetna.com

RE:    Coverage Policy Bulletins
Number: 0107
Subject: Chiropractic Services

Dear Dr. Siegel:

Thank you so much for taking the time to speak with me today and particularly for going out of your way to initiate contact. I wish to address the issue of a chiropractic technique, sacro occipital technique, which is listed in your 0107 Coverage Policy Bulletin under “chiropractic patient management procedures [which] are considered experimental and investigational and are not covered:”

I am president of the Sacro Occipital Technique Organization – USA and have taught sacro occipital technique (SOT) in the chiropractic colleges and postgraduate education programs for over 20 years. I invite you to please review our website at [www.soto-usa.org] and it would be particularly important to go to the SOT Literature section for appropriate information.

SOT is a method of chiropractic that was developed over 80 years ago and used to some degree by a high percentage of chiropractors nationally. The “Job Analysis of Chiropractic is published by the National Board of Chiropractic Examiners (NBCE). The Job Analysis was first published in 1993; in 1994, and the NBCE released a companion volume that included a state-by-state statistical report on chiropractic practice.” a The Job Analysis 2000, is considered the largest and most comprehensive of all prior volumes.

“The project director, author and editor of all three volumes has been Mark Christensen, PhD, director of testing for the NBCE. To gather the necessary information for Job Analysis 2000, 9,244 U.S. doctors of chiropractic were selected from the 59,820 licensed DCs in 1998. The selection process was designed to provide reliable data at the state and national level. “ a

With regard to section of the study entitled “the most utilized chiropractic adjustive techniques/ procedures adjustive” SOT fared as follows:

“% of DC's Utilizing SOT in 1991:        41.3%
% of DC's Utilizing SOT in 1998:        49.0%
% of Patients Receiving SOT in 1998:    16.5%” a

a.       Christensen M, NBCE's Job Analysis 2000, NBCE: 901 54th Avenue, Greeley, CO
80634 (970) 356-9100 nbce@nbce.org [http://www.chiroweb.com/archives/18/14/23.html]

Of the chiropractic methods used in chiropractic to date SOT is one of the most researched and substantiated chiropractic techniques. [see enclosure] While there will always be more research necessary to determine the efficacy of treatment methods as well as to improve patient care, SOT is one chiropractic method that is leading the way in the field of chiropractic.

Sacro Occipital Technique Organization (SOTO) – USA presents research and collaborates with chiropractic researchers at the various RAC, ICSM, and VSC conferences as well as has supported and published literature in the chiropractic peer review literature. Please see the attached list of articles, related to SOT, that have been published in peer-reviewed journals and in the proceedings of research conferences. All the abstracts of each article can be viewed on the www.soto-usa.org website and there are books compiled by SOTO-USA that have most of the articles in full text to the year 2000.

I would greatly appreciate a detailed explanation of how your company came to the determination that SOT is considered “experimental and investigational.” On what is this determination based and how is your position supported? How are chiropractic services allowed and SOT methods of chiropractic not?

I greatly appreciate your kind consideration of this matter and look forward to your response. If you need any further information or if I can be of help in any way please do not hesitate to contact me.

Sincerely,


Charles L. Blum, DC, CSCP

Enclosures

SOT Related Research Published in Peer Review Literature

Klingensmith RD, Blum CL, The Relationship Between Pelvic Block Placement and Radiographic Pelvic Analysis Journal of Chiropractic Medicine Summer 2003; 2(3): 102-6 .

Behrendt M, Insult, Interference and Infertility: An Overview of Chiropractic Research Journal of Vertebral Subluxation Research   May 2003 :1 .[ www.jvsr.com ]

Thompson DM, Vrugtman RP, Johnson KM, Dicks SK, Unger-Boyd M, Correlation of Lateral Pelvic Sway to Variances of Pain along the Inguinal Ligaments: A Pilot Study, Proceedings of the ACC Conference X, Journal of Chiropractic Education Spr 2003; 17(1): 76.

Blum CL, Esposito V, Esposito C, Orthopedic Block Placement and its Affect on the Lumbosacral Spine and Discs: Three Case Studies with Pre and Post MRIs , Proceedings of the ACC Conference X, Journal of Chiropractic Education Spr 2003; 17(1): 48.

Pfefer, MT, Rasmussen S, Uhl NS, Cooper S, Treatment of a lumbar disc herniation utilizing sacro occipital chiropractic technique Proceedings of the ACC Conference X, Journal of Chiropractic Education Spr 2003; 17(1): 72.

Cooperstein R, Lisi A, Correlation of Ankle Joint Complex Range of Motion, Leg Checks, PSIS Measurements, and Radiological Findings Proceedings of the ACC Conference X, Journal of Chiropractic Education Spr 2003; 17(1): 51.

Goeselin G, McKnight R, Sacroiliac Joint Stiffness in Sacro-Occipital Technique Category II Subjects: Poster Presentations - Diagnostic Sciences European Journal of Chiropractic 2002; 49: 210-1.

Gleberzon BJ, Chiropractic "Name Techniques": A Review of the Literature Poster Presentation - Special Interest   European Journal of Chiropractic 2002; 49: 242-3.

Gleberzon BJ, Chiropractic Name Techniques in Canada: A Continued Look at Demographic Trends and Their Impact on Issues of Jurisprudence J Can Chiropr Assoc 2002; 46(4): 241-56.

Blum CL, " Chiropractic Treatment of Mild Head Trauma: A Case History "Proceedings of the 2002 International Conference on Spinal Manipulation , Toronto Ontario, Canada, Oct 2002;:136-8.

Blum, CL, " Chiropractic and Pilates Therapy for the Treatment of Adult Scoliosis ", Journal of Manipulative and Physiological Therapeutics, May 2002.; 25(4.

Farmer, JA, Blum, CL, " Dural Port Therapy ", Journal of Chiropractic Medicine , Spr 2002; 1(2): 1-8.

Blum CL, " Incongruent sacro-occipital technique examination findings: Two unusual case histories ." Proceedings of the ACC Conference IX, Journal of Chiropractic Education Spr 2002; 16(1): 67.

Lisi AJ, Cooperstein R, Morschhauser E, " A pilot study of provacation testing with pelvic wedges: Can prone blocking demonstrate a directional preference ?" Proceedings of the ACC Conference IX, Journal of Chiropractic Education Spr 2002; 16(1): 30-1.

Hong S, Duray SM, Morter HB, Zhang Q, Examination of Variations in Dense Connective Tissue Attachments for the Rectus Capitis Posterior Minor to the Dura Mater . Proceedings of the ACC Conference IX, Journal of Chiropractic Education Spr 2002; 16(1): 19-20.

Blum, CL, " Role of Chiropractic and Sacro Occipital Technique in Asthma ", Journal of Chiropractic Medicine , Mar 2002; 1(1): 16-22. :

Oleski SL Smith GH, Crow WT. Radiographic Evidence of Cranial Bone Mobility Cranio: The Journal of Craniomandibular Practice ; Jan 2002; 20(1):34-8.

Pick MG, Beyond the Neuron Integrative Bodywork: Towards Unifying Principles International Conference, London: University of Westminster and Journal of Bodywork and Movement Therapies 16/18 Nov 2001.

Gatterman MI, Coopertein R, Lantz C, Perle SM, Schneider MJ, "Rating Specific Chiropractic Technique Procedures for Common Low Back Conditions" Journal of Manipulative and Physiological Therapeutics , Sep 2001;24(7):449-56.

Gleberzon BJ, Chiropractic "Name Techniques": A Review of the Literature J Can Chiropr Assoc   2000;45(2): 86-99.

Crisera PN, "The cytological implications of primary respiration" ,Medical Hypotheses , Jan 2001; 56 (1): 40-51

Holtrop DP, " Resolution of Suckling Intolerance in a 6-month-old Chiropractic Patient "Journal of Manipulative and Physiological Therapeutics, Nov/Dec 2000;23(9):615-18.

Coopertein R, " Padded Wedges for Lumbopelvic Mechanical Analysis "Journal of the American Chiropractic Association, Oct 2000: 24-6.

Hestœk L, Leboeuf-Yde C, " Are chiropractic tests for the lumbo-pelvic spine reliable and valid? A systematic critical literature review ", Journal of Manipulative and Physiological Therapeutics May 2000;23:258–75

Gleberzon BJ, Incorporating Named Techniques into a Chiropractic College Curriculum: A Compilation of Investigative Reports   The Journal of Chiropractic Education 2000;14(1): 33-4.

Pederick FO, " Developments in the Cranial Field ", Chiropractic Journal of Australia, Mar 2000;30(1):13-23.

Getzoff HI, Chinappi AS Possible Manifestation Of Temporomandibular Joint Dysfunction On Chiropractic Cervical X-Ray Studies [Letter; Comment] J Manip Physiol Ther 1999 Nov/Dec; 22(6): 421-422.

Blum, CL, " Role of Chiropractic and Sacro Occipital Technique in Asthma ", Chiropractic Technique , Nov 1999; 10(4): 174-180.

Getzoff, H, " Sacro Occipital Technique Categories: a System Method of Chiropractic ", Chiropractic Technique , May 1999; 11(2): 62-5.

Hewitt EG, Chiropractic Care For Infants with Dysfunctional Nursing: A Case Series Journal of Clinical Chiropractic Pediatrics . 1999 May ; 4(1): 241-4.

Blum, CL, " Cranial Therapeutic Treatment of Down’s Syndrome "Chiropractic Technique ", May 1999; 11(2): 66-76.

Schneider, MJ, Cox, JM, Polkinghorn BS, Blum, CL, Getzoff, H, Troyanovich, Sj. " Grand Rounds Discussion: Patient with Acute Low Back Pain: Harvey Getzoff, Discussant, "Chiropractic Technique , Jan 1999; 11(1): 2-4.

Schneider, MJ, Cox, JM, Polkinghorn BS, Blum, CL, Getzoff, H, Troyanovich, Sj. " Grand Rounds Discussion: Patient with Acute Low Back Pain: Charles Blum, Discussant, "Chiropractic Technique, Jan 1999; 11(1): 19-20.

Unger JF, Jr, " The Effects of a Pelvic Blocking Procedure upon Muscle Strength: a Pilot Study ," Chiropractic Technique , Nov 1998; 10(4): 50-5.

Blum, CL, " Spinal/Cranial Manipulative Therapy and Tinnitus: A Case History, "Chiropractic Technique , Nov 1998; 10(4): 163-8.

Bonci AS, Verni LJ The Effect of Cranial Adjusting on Hypertension: A Case Report [Letter; Comment] Chiropractic Technique 1998 Nov; 10(4): 179-80.

Getzoff, H, " The Step Out-Toe Out Procedure: A Therapeutic and Diagnostic Procedure ," Chiropractic Technique , Aug 1998; 10(3): 16-8.

Blum, CL, Curl, DD, " The Relationship Between Sacro-Occipital Technique and Sphenobasilar Balance. Part One: the Key Continuities, "Chiropractic Technique, Aug 1998, Vol. 10, No. 3, Pp. 95-100.

Blum, CL, Curl, DD, " The Relationship Between Sacro-Occipital Technique and Sphenobasilar Balance. Part Two: Sphenobasilar Strain Stacking," Chiropractic Technique , Aug 1998; 10(3): 101-107.

Van Loon, M; Colic With Projectile Vomiting: A Case Study Journal Of Clinical Chiropractic Pediatrics . 1998 Aug; 3(1): 207-10.

Connelly, DM, Rasmussen, SA, " The Effect of Cranial Adjusting on Hypertension: a Case Report ," Chiropractic Technique , May 1998; 10(2): 75-78.

Courtis G, Young M, Chiropractic management of idiopathic secondary amenorrhœa: a review of two cases British Journal of Chiropractic Apr 1998; 2(1):12-4.

Keating JC James F. McGinnis, D.C., N.D., C.P. (1873-1947): Spinographer, Educator, Marketer and Bloodless Surgeon Chiropractic History , 1998; 18(2): 63-79.

Pederick FO, " A Kaminski-type evaluation of cranial adjusting ", Chiropractic Technique , Feb 1997;9(1): 1-15.

Tabar, J, " Treatment of Sacroiliac Joint: A review of Procedures "Chiropractic Technique, Nov 1997; 9(4) : 185-92

Chinappi, AS, Getzoff, H, " Chiropractic/Dental Cotreatment of Lumbosacral Pain with Temporomandibular Joint Involvement ," Journal of Manipulative and Physiological Therapeutics, Nov/Dec 1996; 19(9): 607-12.

Conway, CM; Chiropractic Care Of A Pediatric Glaucoma Patient: A Case Study Journal of Clinical Chiropractic Pediatrics . 1997 Oct; 2(2): 155-6.

Fallon, JM; The Role of the Chiropractic Adjustment in the Care and Treatment of 332 Children with Otitis Media Journal of Clinical Chiropractic Pediatrics . 1997 Oct; 2(2) :167-83.

Bilgrai-Cohen K, Chiropractic Treatment of the Musculoskeletal System During Pregnancy Journal Of The American Chiropractic Association May 1997: 33-34, 90.

Fallon, JM; Vallone, S; Treatment Protocols for the Chiropractic Care of Common Pediatric Conditions: Otitis Media and Asthma Journal of Clinical Chiropractic Pediatrics. 1997 Jan ; 2(1): 113-5.

Fallon, JM; Fysh, PN; Chiropractic Care of the Newborn With Congenital Torticollis Journal of Clinical Chiropractic Pediatrics . 1997 Jan ; 2(1): 116-21.

Getzoff, H, " Cranial Mandibular Motion Technique ", Chiropractic Technique , Nov 1996; 8(4): 182-5.

Phillips CJ, Birth Trauma - Antibiotic Abuse - Vaccine Reaction: A Single Case Report .J Am Chiro Assoc Sep 1996; 9: 57-59, 61 .

Getzoff, H, Gregory, TM, " Chiropractic Sacro-Occipital Technique Treatment of Arthrogryposis Multiplex Congenita ," Chiropractic Technique , May 1996; 8(2); 83-7.

Phillips CJ, Meyer JJ, Chiropractic Care, Including Craniosacral Therapy, During Pregnancy: A Static-Group Comparison of Obstetric Interventions during Labor and Delivery Journal of Manipulative and Physiological Therap 1995 Oct ;18(8): 525-9.

Chinappi, AS, Getzoff, H, " The Dental-Chiropractic Cotreatment of Structural Disorders of the Jaw and Temporomandibular Joint Dysfunction ," Journal of Manipulative and Physiological Therapeutics, Sep 1995; 18(7): 476-81.

Pederick FO, A Preliminary Single Case Magnetic Resonance Imaging Investigation Into Maxillary Frontal-Parietal Manipulation And Its Short-Term Effect Upon The Intercranial Structures Of An Adult Human Brain [Letter] J Manip Physiol Ther 1995 Feb; 18(2): 116-17.

Pick, MG, " A Preliminary Single Case Magnetic Resonance Imaging Investigation into Maxillary Frontal-Parietal Manipulation and its Short-Term Effect upon the Intercranial Structures of an Adult Human Brain ," Journal of Manipulative and Physiological Therapeutics , Mar-Apr 1994; 17(3): 168-73.

Chinappi, AS, Getzoff, H, "A New Management Model for Treating Structural-based Disorders, Dental Orthopedic and Chiropractic Co-Treatment, "Journal of Manipulative and Physiological Therapeutics, 1994; 17: 614-9.

Bergmann TF, Various Forms of Chiropractic Technique ,Chiropractic Technique May 1993; 5(2):53-5.

Gregory, TM. " Temporomandibular Disorder Associated with Sacroiliac Sprain, "Journal of Manipulative and Physiological Therapeutics , May 1993; 16(4): 256-65.

Esposito, V, Leisman, G, " Neuromuscular Effects of Temporomandibular Joint Dysfunction, "International Journal of Neuroscience , 1993; 68: 3-4.

Pederick FO, " For Debate: Cranial Adjusting -- An Overview", Chiropractic Journal of Australia , Sept 1993; 23(3):106-12.

Hewitt, E.; Chiropractic Treatment Of A 7-Month-Old With Chronic Constipation: A Case Report Chiropractic Technique . 1993 Aug; 5(3) :101-3.

Cook K, Rasmussen S, " Visceral Manipulation and the Treatment of Uterine Fibroids: A Case Report" ACA Journal of Chiropractic , Dec 1992; 29(12) : 39-41.

Heese, N, " Major Bertrand de Jarnette: Six Decades of Sacro Occipital Research, 1924-1984. " Chiropractic History. Jun 1991;11(1): 13-5.

Hobbs, D.; Rasmussen, S.; Chronic Otitis Media: A Case Report ACA Journal of Chiropractic . 1991 Feb; 28(2): 67-68.

Lebeouf, C, " The Reliability of Specific Sacro-Occipital Technique Diagnostic Tests, "Journal of Manipulative and Physiological Therapeutics , 1991; 14: 3-4.

Blum, CL, Cranial "Therapeutic Approach to Cranial Nerve Entrapment Part II: Cranial Nerve VII, "ACA Journal of Chiropractic, Dec 1990; 27(12): 27-33.

Lebeouf, C, " The Sensitivity and Specificity of Seven Lumbo-Pelvic Orthopedic Tests and Arm Fossa Test, "Journal of Manipulative and Physiological Therapeutics, 1990; 13: 138-43.

Flanagan, MF, " The Relationship Between CSF and Fluid Dynamics in the Neural Canal, "Journal of Manipulative and Physiological Therapeutics , Dec 1988; 11(6): 489-92.

Howatt, J, " Chiropractic: The Cranial Sacral Complex ", the Journal of Orthopaedic Medicine , 1988; (1) : 13-20.

Blum, CL, "Cranial Therapeutic Approach to Cranial Nerve Entrapment Part I: Cranial Nerves III, IV, and VI, "ACA Journal of Chiropractic, July 1988; 22(7): 63-7.

Lebeouf, C, Jenkins, DJ, Smyth, RA, " Sacro-Occipital Technique: the So-called Arm Fossa Test: Interexaminaer Agreement and Post-treatment Changes ," Journal of the Australian Chiropractic Association, 1988; 18: 67-8.

Blum, CL, " The Effect of Movement, Stress and Mechanoelectric Activity Within the Cranial Matrix, "International Journal of Orthodontics , Spring 1987; 25(1-2): 6-14.

Leboeuf C, Patrick K " The use of major and minor therapy forms in Australian chiropractic practice" Journal of the Australian Chiropractic Association 1987;17:109-11.

Denton DG, " Craniopathy and dentistry "Basal Facts , 1986, 8:4, 181-202

Denton DG, " From head to foot ." Basal Facts, 19 86, 8:4, 203-10

Denton DG, " Biomechanics of the pelvis" Basal Facts, 1986, 8:4, 211-21

Otter R, Literature on the Sacroiliac Joint   European Journal of Chiropractic Dec 1985;33(4): 221-42.

Blum, CL, " Biodynamics of the Cranium: A Survey, "The Journal of Craniomandibular Practice, Mar/May 1985: 3(2):, 164-71 .

Maltezopoulos V, Armitage N, A comparison of four chiropractic systems in the diagnosis of sacroiliac malfunction, European Journal of Chiropractic, 1984;32:4-42.

Peterson, K.; A Review of Cranial Mobility, Sacral Mobility, and Cerebrospinal Fluid Journal of the Australian Chiropractic Association . 1982 Apr ; 12(3): 7-14.

DeJarnette MB, Shall Chiropractic Survive ?The Journal of the National Chiropractic Association Nov 1959; 29(11): 75.

SOT Related Research from Proceedings of Research Conferences

Klingensmith RD, Blum CL The relationship between pelvic block placement and radiographic pelvic analysis. 10th Annual Vertebral Subluxation Research Conference Hayward, CA, Dec 7-8, 2002

Pick MG, Beyond the Neuron Integrative Bodywork: Towards Unifying Principles International Conference, London: University of Westminster and Journal of Bodywork and Movement Therapies 16/18 Nov 2001.

Kenin S, Humphreys BK, Hubbard B, Cramer GD, Attachments from the Spinal Dura to the Ligamentum Nuchae: Incidence, MRI Appearance, and Strength of Attachment Proceedings of the 2000 International Conference of Spinal Manipulation 2000 Sep: 202-4.

Getzoff H, Ten Reasons Why I Like Sacro Occipital Technique 9th Annual Clinical Meeting of the American Academy of Pain Management , Las Vegas, NV, Sep 1998.

Pick MG, Spinal-cranial morphology and physiology: A review of the relationships between osseous, meningeal and neuronal structures and their role in the cranio-sacral respiratory rhythms Association of Swiss Chiropractors Conference: BŸrgenstock Hotels and Resorts : September 18, 1998.

Pick MG, Anatomy & physiology of cranial motion: A look into the various intercranial rhythmic motions and their effects upon the brain, meninges and cranial bones Association of Swiss Chiropractors Conference: BŸrgenstock Hotels and Resorts : September 18, 1998.

Pick MG, Cranial palpation: Hand utilization techniques & cranial rhythmic identification Association of Swiss Chiropractors Conference: BŸrgenstock Hotels and Resorts : September 18, 1998.

Pick MG, Morphology of the cranial vault sutures: A comprehensive description of the vault sutures interarticular unions and developing a working knowledge toward their manipulative strategies Association of Swiss Chiropractors Conference: BŸrgenstock Hotels and Resorts : September 18, 1998.

Remeta EM, Indicators for Disc Herniation Supported by Magnetic Resonance Imaging (MRI): Poster Presentation 9th Annual Clinical Meeting of the American Academy of Pain Management , Las Vegas, NV, Sep 1998.

Hack GD, The Anatomical Basis for the Effectiveness of Chiropractic Spinal Manipulation in Treating Headache Proceedings of the 1998 International Conference on Spinal Manipulation : Vancouver, British Columbia, Canada July 16-19, 1998: 114-15.

Sanders GE, Unger JF Cranial Distortion and Category II Pelvic Blocking – A Pilot Study: Poster Presentation (Diagnostic Sciences) Proceedings of the Scientific Symposium - 1997 World Chiropractic Congress : Tokyo, Japan Jun 6-8, 1997: 252 .

Unger JF Temporomandibular Joint Dysfunction (TMJD): Work Shop [In English and Japanese] Proceedings of the Scientific Symposium - 1997 World Chiropractic Congress : Tokyo, Japan Jun 6-8, 1997: 274.

Klingensmith RD, Chiropractic Evaluation and Care for Lumbosacral Pain American Academy of Pain Management Washington DC, Sep 1996.

Getzoff H, Sacro Occipital Technique (SOT): A Method of Chiropractic Proceedings of Pathways to Success – Credentialing and Technique Validity: Assessing the Comparative Validity of Chiropractic Techniques, 28 Jun 1996: 1-4.

Unger JF, The Legacy of a Chiropractor, Inventor and Researcher: Dr. Major Bertrand DeJarnette Conference Proceedings of the Chiropractic Centennial Foundation : Davenport, Iowa, Sep 14-16, 1995: 35-6.

Unger J, The Effects of a Pelvic Blocking Procedure Upon Muscle Strength: A Pilot Study Conference Proceedings of the Chiropractic Centennial 1995 Jul: 376-7.

Getzoff H, Sacro Occipital Technique Assessment ACA Council on Technic- Proceedings of the Third National Symposium on the Comparison of Chiropractic Procedures: "The Cervical Subluxation Complex"- Seattle Washington Feb 1995: 69-73.

Phillips CJ, Chiropractic and Pediatrics Cranial Compression and Distraction: a Possible Implication in Otitis Media Proceedings of the 1994 International conference on Spinal Manipulation : Palm Springs, California Jun 10-11, 1994: 136-39.

Unger J, Sweat S, Flanagan S, Chudkowski S , An Effect of Sacro Occipital Technique on Blood Pressure Proceeding of the International Conference on Spinal Manipulation . 1993 Oct : 87.

Arcadi V, Birth Induced TMJ Dysfunction: The Most Common Cause of Breastfeeding Difficulties Proceedings Of The National Conference On Chiropractic. 1993 Oct: 18-22.

Vail B, Evaluation and Cranial Treatment of the Pediatric Patient With Sagittal Suture Synostosis: A Case Report Proceedings Of The National Conference On Chiropractic 1993 Oct: 58-63.

Hewitt, E.; Chiropractic Treatment Of A 7-Month-Old With Chronic Constipation: A Case Report Proceedings Of The National Conference On Chiropractic. 1992 Nov : 16-23.

Blum CL, Cranial Therapeutic Treatment of Downs Syndrome : Poster Presentation, Proceedings of the 7th Annual Conference on Research and Education , Palm Springs, California, June 19-21, 1992: 279-81.

Hospers LA EEG and CEEG studies before and after upper cervical or SOT category 11 adjustment in children after head trauma, in epilepsy, and in “hyperactivity.” Proc of the Nat’l Conference on Chiropractic and Pediatrics (ICA) 1992;84-139.

Phillips C, Case Study: The Effect of Utilizing Spinal Manipulation and Craniosacral Therapy as the Treatment Approach for Attention Deficit-Hyperactivity Disorder Proceedings Of The National Conference On Chiropractic 1991 Nov: 57-74 .

Unger J, Short Lever Manual Force Mechanically Assisted Procedures in Sacro Occipital Technic (SOT) Transactions of the Consortium for Chiropractic Research 1991 Jun: 305-9.

Pick MG, Outline of SOT Presentation Transactions of the Consortium for Chiropractic Research 1991 Jun: 166-7.

Kinsinger FS, A Comparative Study of Activator Methods and Sacro Occipital Technique in Low Back Pain: Short Term Effects on Biomechanical Measures Proceedings of the 1991 International Conference of Spinal Manipulation 1991 Apr: 87-9.

Shambaugh P, Pearlman RC, Hauck K, Changes in Brain Stem Evoked Response as a Result of Chiropractic Treatment ,Proceeding of the 1991 International Conference on Spinal Manipulation , Apr 1991: 227-9.

Jansen RD, Nansel DD, Szlazak M, Four Quadrant Forceplate Analysis of Postural Sway: Frequency Domain Characteristics Transactions of the Pacific Consortium for Chiropractic Research: {Proceedings of the Third Annual Conference on Research and Education Jun 18-19, 1988; A3: 1 – 11.

Davis J, Hamilton A, Rouzer P, A Radiographic Definition of Sacroiliac Joints: Their Normal Anatomy and Sprain States Transactions of the Consortium for Chiropractic Research 1987 Jun.

Mootz R, Jameson S, Menke M, Inter and Intra-Rater Reliability of Occipital Fiber Palpation Proceedings of the Fifth Annual Conservative Health Science Research Conference Oct 1986: 37-9.

Blum CL, Biodynamics of the Cranium: A Survey Proceedings: Conference on Current Topics in Chiropractic: Reviews of the Literature 1984 May 19-20; F3: 1-15.

Wood J, Motion of the Sacroiliac Joint Proceedings: Conference on Current Topics in Chiropractic: Reviews of the Literature 1984 May 19-20; F2: 1-16.

Yoshihara H, Miller C, Abelew T, Cerebrospinal Fluid Flow Along Cranial Nerves Proceedings: Conference on Current Topics in Chiropractic: Reviews of the Literature 1984 May 19-20; F4: 1-6

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From: Aetna Response Michael Siegel, MD
Sent: July 31, 2003
To: Charles Blum, DC
Subject: Sacro Occipital Technique: Aetna

Dr. Blum,

This is the response that I received today from our tech assessment unit.

Aetna's policies are based on evidence in the peer-reviewed published medical literature. Abstracts and poster presentations are not considered peer-reviewed. There are no well-designed prospective randomized controlled clinical trials in the peer-reviewed published medical literature demonstrating the effectiveness of this technique.

We will not be able to cover this procedure.

Michael

Michael M. Siegel M.D.
Senior Medical Director
Southern California
Phone: 818-932-6462
Fax: 818-932-6553
Beeper: 888-371-4784

From: Charles Blum, DC
Sent: July 31, 2003
To: Michael Siegel, MD
Subject: Sacro Occipital Technique: Aetna

Dear Michael,

Thank you so much for forwarding this to me. The majority of the references were articles published in peer reviewed journals and the ones included as abstracts from research conferences were only to show that Sacro Occipital Technique (SOT) is an evolving, researched form of chiropractic. Is there anyway of me being able to contact the "tech assessment unit" directly instead of having to go through you?

The statement that, "well-designed prospective randomized controlled clinical trials in the peer-reviewed published medical literature demonstrating the effectiveness of this technique" are essential prior to having Aetna acknowledge effectiveness of a technique is a powerful statement. I believe that would preclude the majority of all chiropractic procedures, as well as most surgical and pharmaceutical interventions if this was the sole criteria.

For example in the policy statement it authorizes other chiropractic methods, implied by not being part of this list. [Coverage Policy Bulletins, Number: 0107, Subject: Chiropractic Services] Where are all the "well-designed prospective randomized controlled clinical trials in the peer-reviewed" literature to substantiate this position?

The large array of peer reviewed published articles relating to SOT, which is more than most of the technique methods approved by Aetna, makes the qualification of "well-designed prospective randomized controlled clinical trials" curious at best. SOT is a chiropractic technique based on human anatomy and physiology, used in the field of chiropractic for over 80 years, and the National Board of Chiropractic Examiner's Job Analysis study (which was discussed in the prior letter), also used by approximately 50% of the chiropractors nationally.

I would greatly appreciate a clear understanding of how some chiropractic methods have been approved by Aetna and
SOT not approved based on the necessity of "well-designed prospective randomized controlled clinical trials." Please review the prior articles and note that the bulk are peer review related articles concerning or related to SOT.

Sincerely,

Charles

Charles L. Blum, DC, CSCP
drcblum@aol.com
www.soto-usa.org

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From: Aetna Response Michael Siegel, MD
Sent:    July 31, 2003
To:    Charles Blum, DC
Subject: Sacro Occipital Technique: Aetna Request for Denies?

Dr. Blum,

Is there a specific member denial related to your request? If so, can you provide me with the member's name and Aetna ID number. I am asking you this because if a member is involved and you are appealing our decision, I will further process your request as a member appeal.

If this is not related to a member appeal, the only other additional piece of information I can offer you is that we did have chiropractic input on our position. Our coverage policy is set unless more information becomes available to consider changing it.

Michael

Michael M. Siegel M.D.
Senior Medical Director
Southern California
Phone: 818-932-6462
Fax: 818-932-6553
Beeper: 888-371-4784

From: Charles Blum, DC
Sent: Thursday, August 1, 2003 1:28 AM
To: Michael Siegel, MD
Subject: Sacro Occipital Technique: Aetna Request for Denies - Response

Dear Dr. Siegel,

Is there anyway I might have the name and contact information of the chiropractic consultant or whomever is in charge of making these decisions? The position is completely untenable and is without basis.

The "Guidelines for Chiropractic Quality Assurance and Practice Parameters" [1] also known as the Mercy Guidelines was for most of the 1990s considered the accepted guidelines for chiropractic healthcare. While the majority of the SOT related literature published in the peer review literature was published following the review of the authors they still came to specific determinations regarding SOT's major treatment modality, the pelvic blocks. Using Kaminsky's [2] method of analysis for chiropractic methods and techniques the Mercy review committee determined the following regarding SOT "Pelvic Blocks":

Pelvic Blocks: These paired wedges are used primarily for positioning the lumbosacral and sacroiliac joints to produce a sustained stretch. This procedure is in fairly common use, and there is reasonable rationale and expert opinion on its utility in certain situations. [1]

Rating: Promising for the care of patients with neuromusculoskeletal problems. [1]

Evidence: Class III - Evidence provided by expert legal opinion, descriptive studies or case reports. [1]

Consensus Level: 1 - Established: Accepted as appropriate by the practicing chiropractic community for the given indication in the specified patient population. [1]

There has been a great deal of literature published following the publication of the Mercy Guidelines as well as other SOT published literature that was not available at the time of review. Therefore while the consensus level could not possibly be any higher, the evidence level would be.

Please guide me to the appropriate channels so that I can have dialogue with someone in charge who would be reasonable and interested. I greatly appreciate your assistance in this matter.

1.    Haldeman S, Chapman-Smith D, Peterson DM, Guidelines for Chiropractic Quality Assurance and Practice Parameters: Proceedings of the Mercy Center Consensus Conference, Aspen Publisher, Inc.: Gaithersburg, Maryland; 1993: 106-8.

2.    Kaminski M, Validation of Chiropractic Methods, Journal of Manipulative and Physiological Therapeutics, 1987; 110(2): 61-4.

Sincerely,

Charles

Charles L. Blum, DC, CSCP
drcblum@aol.com
www.soto-usa.org

Dural Connection Internet Edition Index TOP

From: Aetna Response Michael Siegel, MD
Sent: August 1, 2003
To: Charles Blum, DC
Subject: Sacro Occipital Technique: Aetna

Response to August 1, 2003 email:

Dr. Blum,

I will inquire about this and let you know.

Michael

Michael M. Siegel M.D.
Senior Medical Director
Southern California
Phone: 818-932-6462
Fax: 818-932-6553
Beeper: 888-371-4784

From: Charles Blum, DC - SOTO-USA
Sent: August 9, 2003
To: Aetna Chiropractic Reviews – Dr. Robert Frank
Subject: Sacro Occipital Technique Reply to Aetna’s Policy Statement

Sacro Occipital Technique

RE: Coverage Policy Bulletin
Number: 0107
Subject: Chiropractic Services

Sacro Occipital Technique Organization - USA
PO Box 24936
Winston-Salem, NC 27114-4936
Telephone: (336) 760-1618
FAX: (336) 760-3438
E-Mail: sotousa@bellsouth.net
Website: www.SOTO-USA.org

Charles L. Blum, DC, CSCP
1752 Ocean Park Boulevard
Santa Monica, California 90405
(310) 392-9795

From: Charles Blum, DC - SOTO-USA
Sent: August 9, 2003
To: Aetna Chiropractic Reviews – Dr. Robert Frank
Subject: Sacro Occipital Technique Reply to Aetna’s Policy Statement
Introduction

August 9, 2003

Aetna Insurance Inc.
Chiropractic Department – MC1B
1000 Middle Street
Middletown, Connecticut 06457
(877) 234-2205 (Assistant: Anita)

RE: Coverage Policy Bulletins
Number: 0107
Subject: Chiropractic Services

To Whom It May Concern:

The enclosed is in response to your May 2003 Coverage Policy Bulletins, Number: 0107, Subject: Chiropractic Services. I have had contact with Dr. Michael Siegel, who referred me to Dr. Robert Frank, who then advised me to follow up the communications to your department in order to receive a proper reply. They were both very professional and helpful, and I am grateful for their help.

As president of Sacro Occipital Technique Organization (SOTO) – USA I am questioning your statement in the bulletin that “Sacro-Occipital Technique”… is “considered experimental and investigational and [is] not covered.”

When peer reviewed published literature was sent to illustrate that sacro occipital technique (SOT) is far from just “experimental and investigational” the only reply was, “Aetna's policies are based on evidence in the peer-reviewed published medical literature. Abstracts and poster presentations are not considered peer-reviewed. There are no well-designed prospective randomized controlled clinical trials in the peer-reviewed published medical literature demonstrating the effectiveness of this technique.”

Therefore the enclosed will discuss the issues of:

1. SOT evidence in the peer-reviewed published literature

2. SOT a chiropractic technique and its considered as a standard of care for chiropractic treatment

3. Randomized controlled studies and their use as a sole qualification of a chiropractic technique by Aetna

Peer reviewed research and published literature is greatly important to Sacro Occipital Technique Organization – USA and SOT. Accompanying the following list of references will include:

1. The book entitled the “Compendium of Sacro Occipital Technique 1984-2000.” This was our first attempt to gather all published peer review literature and many articles have been found since.

2. The book entitled the “SOT Collection: Supplement to the Year 2000.” This was an attempt to gather other related articles, which were missed in the Compendium. There is also a third book entitled “The SOT Collection to the Year 2000” however that is mostly publications in chiropractic “non-peer related” journals; if you are interested I will forward you a copy.

3. Photocopies of full text SOT related articles listed that were published following the year 2000.

Please note that all of the enclosed and more SOT related articles can be viewed on the website www.soto-usa.org by going to the SOT Literature page.

While there was comment that “Abstracts and poster presentations are not considered peer-reviewed,” abstracts and poster presentations do show due diligence on the part of SOTO-USA and SOT to be a part of the research process and work within an evidence based system. Many of the initial stages prior to publication involve presentations at research conferences and incorporating feedback from experts in the field. Lastly, articles submitted to the Research Agenda for Chiropractic / Association of Accredited Chiropractic Conferences (RAC/ACC) all go through a blinded peer review process before being accepted for presentation at their conference.

What other methods of chiropractic care have the same level of research as submitted in the following?

From: Charles Blum, DC - SOTO-USA
Sent: August 9, 2003
To: Aetna Chiropractic Reviews – Dr. Robert Frank
Subject: Sacro Occipital Technique Reply to Aetna’s Policy Statement
SOT Evidence In The Peer-Reviewed Published Literature

SOT EVIDENCE IN THE PEER-REVIEWED PUBLISHED LITERATURE

Klingensmith RD, Blum CL, The Relationship Between Pelvic Block Placement and Radiographic Pelvic Analysis Journal of Chiropractic Medicine Summer 2003; 2(3): 102-6 [in press].

Behrendt M, Insult, Interference and Infertility: An Overview of Chiropractic Research Journal of Vertebral Subluxation Research   May 2003 :1 .[ www.jvsr.com ]

Gleberzon BJ, Chiropractic "Name Techniques": A Review of the Literature Poster Presentation - Special Interest   European Journal of Chiropractic 2002; 49: 242-3.

Gleberzon BJ, Chiropractic Name Techniques in Canada: A Continued Look at Demographic Trends and Their Impact on Issues of Jurisprudence J Can Chiropr Assoc 2002; 46(4): 241-56.

Blum, CL, " Chiropractic and Pilates Therapy for the Treatment of Adult Scoliosis ", Journal of Manipulative and Physiological Therapeutics, May 2002.; 25(4.

Farmer, JA, Blum, CL, " Dural Port Therapy ", Journal of Chiropractic Medicine , Spr 2002; 1(2): 1-8.

Blum, CL, " Role of Chiropractic and Sacro Occipital Technique in Asthma ", Journal of Chiropractic Medicine , Mar 2002; 1(1): 16-22. :

Oleski SL Smith GH, Crow WT. Radiographic Evidence of Cranial Bone Mobility Cranio: The Journal of Craniomandibular Practice ; Jan 2002; 20(1):34-8.

Pick MG, Beyond the Neuron Integrative Bodywork: Towards Unifying Principles International Conference, London: University of Westminster and Journal of Bodywork and Movement Therapies 16/18 Nov 2001.

Gatterman MI, Coopertein R, Lantz C, Perle SM, Schneider MJ, "Rating Specific Chiropractic Technique Procedures for Common Low Back Conditions" Journal of Manipulative and Physiological Therapeutics , Sep 2001;24(7):449-56.

Gleberzon BJ, Chiropractic "Name Techniques": A Review of the Literature J Can Chiropr Assoc   2000;45(2): 86-99.

Crisera PN, "The cytological implications of primary respiration" ,Medical Hypotheses , Jan 2001; 56 (1): 40-51

Holtrop DP, " Resolution of Suckling Intolerance in a 6-month-old Chiropractic Patient "Journal of Manipulative and Physiological Therapeutics, Nov/Dec 2000;23(9):615-18.

Coopertein R, " Padded Wedges for Lumbopelvic Mechanical Analysis "Journal of the American Chiropractic Association, Oct 2000: 24-6.

Hestœk L, Leboeuf-Yde C, " Are chiropractic tests for the lumbo-pelvic spine reliable and valid? A systematic critical literature review ", Journal of Manipulative and Physiological Therapeutics May 2000;23:258–75

Gleberzon BJ, Incorporating Named Techniques into a Chiropractic College Curriculum: A Compilation of Investigative Reports   The Journal of Chiropractic Education 2000;14(1): 33-4.

Pederick FO, " Developments in the Cranial Field ", Chiropractic Journal of Australia, Mar 2000;30(1):13-23.

Getzoff HI, Chinappi AS Possible Manifestation Of Temporomandibular Joint Dysfunction On Chiropractic Cervical X-Ray Studies [Letter; Comment] J Manip Physiol Ther 1999 Nov/Dec; 22(6): 421-422.

Blum, CL, " Role of Chiropractic and Sacro Occipital Technique in Asthma ", Chiropractic Technique , Nov 1999; 10(4): 174-180.

Getzoff, H, " Sacro Occipital Technique Categories: a System Method of Chiropractic ", Chiropractic Technique , May 1999; 11(2): 62-5.

Hewitt EG, Chiropractic Care For Infants with Dysfunctional Nursing: A Case Series Journal of Clinical Chiropractic Pediatrics . 1999 May ; 4(1): 241-4.

Blum, CL, " Cranial Therapeutic Treatment of Down’s Syndrome "Chiropractic Technique ", May 1999; 11(2): 66-76.

Schneider, MJ, Cox, JM, Polkinghorn BS, Blum, CL, Getzoff, H, Troyanovich, SJ. " Grand Rounds Discussion: Patient with Acute Low Back Pain: Harvey Getzoff, Discussant, "Chiropractic Technique , Jan 1999; 11(1): 2-4.

Schneider, MJ, Cox, JM, Polkinghorn BS, Blum, CL, Getzoff, H, Troyanovich, SJ. " Grand Rounds Discussion: Patient with Acute Low Back Pain: Charles Blum, Discussant, "Chiropractic Technique, Jan 1999; 11(1): 19-20.

Unger JF, Jr, " The Effects of a Pelvic Blocking Procedure upon Muscle Strength: a Pilot Study ," Chiropractic Technique , Nov 1998; 10(4): 50-5.

Blum, CL, " Spinal/Cranial Manipulative Therapy and Tinnitus: A Case History, "Chiropractic Technique , Nov 1998; 10(4): 163-8.

Bonci AS, Verni LJ The Effect of Cranial Adjusting on Hypertension: A Case Report [Letter; Comment] Chiropractic Technique 1998 Nov; 10(4): 179-80.

Getzoff, H, " The Step Out-Toe Out Procedure: A Therapeutic and Diagnostic Procedure ," Chiropractic Technique , Aug 1998; 10(3): 16-8.

Blum, CL, Curl, DD, " The Relationship Between Sacro-Occipital Technique and Sphenobasilar Balance. Part One: the Key Continuities, "Chiropractic Technique, Aug 1998, Vol. 10, No. 3, Pp. 95-100.

Blum, CL, Curl, DD, " The Relationship Between Sacro-Occipital Technique and Sphenobasilar Balance. Part Two: Sphenobasilar Strain Stacking," Chiropractic Technique , Aug 1998; 10(3): 101-107.

Van Loon, M; Colic With Projectile Vomiting: A Case Study Journal Of Clinical Chiropractic Pediatrics . 1998 Aug; 3(1): 207-10.

Connelly, DM, Rasmussen, SA, " The Effect of Cranial Adjusting on Hypertension: a Case Report ," Chiropractic Technique , May 1998; 10(2): 75-78.

Courtis G, Young M, Chiropractic management of idiopathic secondary amenorrhœa: a review of two cases British Journal of Chiropractic Apr 1998; 2(1):12-4.

Keating JC James F. McGinnis, D.C., N.D., C.P. (1873-1947): Spinographer, Educator, Marketer and Bloodless Surgeon Chiropractic History , 1998; 18(2): 63-79.

Pederick FO, " A Kaminski-type evaluation of cranial adjusting ", Chiropractic Technique , Feb 1997;9(1): 1-15.

Tabar, J, " Treatment of Sacroiliac Joint: A review of Procedures "Chiropractic Technique, Nov 1997; 9(4) : 185-92

Chinappi, AS, Getzoff, H, " Chiropractic/Dental Cotreatment of Lumbosacral Pain with Temporomandibular Joint Involvement ," Journal of Manipulative and Physiological Therapeutics, Nov/Dec 1996; 19(9): 607-12.

Conway, CM; Chiropractic Care Of A Pediatric Glaucoma Patient: A Case Study Journal of Clinical Chiropractic Pediatrics . 1997 Oct; 2(2): 155-6.

Fallon, JM; The Role of the Chiropractic Adjustment in the Care and Treatment of 332 Children with Otitis Media Journal of Clinical Chiropractic Pediatrics . 1997 Oct; 2(2) :167-83.

Bilgrai-Cohen K, Chiropractic Treatment of the Musculoskeletal System During Pregnancy Journal Of The American Chiropractic Association May 1997: 33-34, 90.

Fallon, JM; Vallone, S; Treatment Protocols for the Chiropractic Care of Common Pediatric Conditions: Otitis Media and Asthma Journal of Clinical Chiropractic Pediatrics. 1997 Jan ; 2(1): 113-5.

Fallon, JM; Fysh, PN; Chiropractic Care of the Newborn With Congenital Torticollis Journal of Clinical Chiropractic Pediatrics . 1997 Jan ; 2(1): 116-21.

Getzoff, H, " Cranial Mandibular Motion Technique ", Chiropractic Technique , Nov 1996; 8(4): 182-5.

Phillips CJ, Birth Trauma - Antibiotic Abuse - Vaccine Reaction: A Single Case Report .J Am Chiro Assoc Sep 1996; 9: 57-59, 61 .

Getzoff, H, Gregory, TM, " Chiropractic Sacro-Occipital Technique Treatment of Arthrogryposis Multiplex Congenita ," Chiropractic Technique , May 1996; 8(2); 83-7.

Phillips CJ, Meyer JJ, Chiropractic Care, Including Craniosacral Therapy, During Pregnancy: A Static-Group Comparison of Obstetric Interventions during Labor and Delivery Journal of Manipulative and Physiological Therap 1995 Oct ;18(8): 525-9.

Chinappi, AS, Getzoff, H, " The Dental-Chiropractic Cotreatment of Structural Disorders of the Jaw and Temporomandibular Joint Dysfunction ," Journal of Manipulative and Physiological Therapeutics, Sep 1995; 18(7): 476-81.

Pederick FO, A Preliminary Single Case Magnetic Resonance Imaging Investigation Into Maxillary Frontal-Parietal Manipulation And Its Short-Term Effect Upon The Intercranial Structures Of An Adult Human Brain [Letter] J Manip Physiol Ther 1995 Feb; 18(2): 116-17.

Pick, MG, " A Preliminary Single Case Magnetic Resonance Imaging Investigation into Maxillary Frontal-Parietal Manipulation and its Short-Term Effect upon the Intercranial Structures of an Adult Human Brain ," Journal of Manipulative and Physiological Therapeutics , Mar-Apr 1994; 17(3): 168-73.

Chinappi, AS, Getzoff, H, "A New Management Model for Treating Structural-based Disorders, Dental Orthopedic and Chiropractic Co-Treatment, "Journal of Manipulative and Physiological Therapeutics, 1994; 17: 614-9.

Bergmann TF, Various Forms of Chiropractic Technique ,Chiropractic Technique May 1993; 5(2):53-5.

Gregory, TM. " Temporomandibular Disorder Associated with Sacroiliac Sprain, "Journal of Manipulative and Physiological Therapeutics , May 1993; 16(4): 256-65.

Esposito, V, Leisman, G, " Neuromuscular Effects of Temporomandibular Joint Dysfunction, "International Journal of Neuroscience , 1993; 68: 3-4.

Pederick FO, " For Debate: Cranial Adjusting -- An Overview", Chiropractic Journal of Australia , Sept 1993; 23(3):106-12.

Hewitt, E.; Chiropractic Treatment Of A 7-Month-Old With Chronic Constipation: A Case Report Chiropractic Technique . 1993 Aug; 5(3) :101-3.

Cook K, Rasmussen S, " Visceral Manipulation and the Treatment of Uterine Fibroids: A Case Report" ACA Journal of Chiropractic , Dec 1992; 29(12) : 39-41.

Heese, N, " Major Bertrand de Jarnette: Six Decades of Sacro Occipital Research, 1924-1984. " Chiropractic History. Jun 1991;11(1): 13-5.

Hobbs, D.; Rasmussen, S.; Chronic Otitis Media: A Case Report ACA Journal of Chiropractic . 1991 Feb; 28(2): 67-68.

Lebeouf, C, " The Reliability of Specific Sacro-Occipital Technique Diagnostic Tests, "Journal of Manipulative and Physiological Therapeutics , 1991; 14: 3-4.

Blum, CL, Cranial "Therapeutic Approach to Cranial Nerve Entrapment Part II: Cranial Nerve VII, "ACA Journal of Chiropractic, Dec 1990; 27(12): 27-33.

Lebeouf, C, " The Sensitivity and Specificity of Seven Lumbo-Pelvic Orthopedic Tests and Arm Fossa Test, "Journal of Manipulative and Physiological Therapeutics, 1990; 13: 138-43.

Flanagan, MF, " The Relationship Between CSF and Fluid Dynamics in the Neural Canal, "Journal of Manipulative and Physiological Therapeutics , Dec 1988; 11(6): 489-92.

Howatt, J, " Chiropractic: The Cranial Sacral Complex ", the Journal of Orthopaedic Medicine , 1988; (1) : 13-20.

Blum, CL, "Cranial Therapeutic Approach to Cranial Nerve Entrapment Part I: Cranial Nerves III, IV, and VI, "ACA Journal of Chiropractic, July 1988; 22(7): 63-7.

Lebeouf, C, Jenkins, DJ, Smyth, RA, " Sacro-Occipital Technique: the So-called Arm Fossa Test: Interexaminer Agreement and Post-treatment Changes ," Journal of the Australian Chiropractic Association, 1988; 18: 67-8.

Blum, CL, " The Effect of Movement, Stress and Mechanoelectric Activity Within the Cranial Matrix, "International Journal of Orthodontics , Spring 1987; 25(1-2): 6-14.

Leboeuf C, Patrick K " The use of major and minor therapy forms in Australian chiropractic practice" Journal of the Australian Chiropractic Association 1987;17:109-11.

Denton DG, " Craniopathy and dentistry "Basal Facts , 1986, 8:4, 181-202

Denton DG, " From head to foot ." Basal Facts, 19 86, 8:4, 203-10

Denton DG, " Biomechanics of the pelvis" Basal Facts, 1986, 8:4, 211-21

Otter R, Literature on the Sacroiliac Joint   European Journal of Chiropractic Dec 1985;33(4): 221-42.

Blum, CL, " Biodynamics of the Cranium: A Survey, "The Journal of Craniomandibular Practice, Mar/May 1985: 3(2):, 164-71 .

Maltezopoulos V, Armitage N, A comparison of four chiropractic systems in the diagnosis of sacroiliac malfunction, European Journal of Chiropractic, 1984;32:4-42.

Peterson, K.; A Review of Cranial Mobility, Sacral Mobility, and Cerebrospinal Fluid Journal of the Australian Chiropractic Association . 1982 Apr ; 12(3): 7-14.

DeJarnette MB, Shall Chiropractic Survive ?The Journal of the National Chiropractic Association Nov 1959; 29(11): 75.

From: Charles Blum, DC - SOTO-USA
Sent: August 9, 2003
To: Aetna Chiropractic Reviews – Dr. Robert Frank
Subject: Sacro Occipital Technique Reply to Aetna’s Policy Statement
SOT Related Research From Proceedings of Research Conferences

SOT RELATED RESEARCH FROM PROCEEDINGS OF RESEARCH CONFERENCES

Thompson DM, Vrugtman RP, Johnson KM, Dicks SK, Unger-Boyd M, Correlation of Lateral Pelvic Sway to Variances of Pain along the Inguinal Ligaments: A Pilot Study, Proceedings of the ACC Conference X, Journal of Chiropractic Education Spr 2003; 17(1): 76.

Blum CL, Esposito V, Esposito C, Orthopedic Block Placement and its Affect on the Lumbosacral Spine and Discs: Three Case Studies with Pre and Post MRIs, Proceedings of the ACC Conference X, Journal of Chiropractic Education Spr 2003; 17(1): 48.

Pfefer, MT, Rasmussen S, Uhl NS, Cooper S, Treatment of a lumbar disc herniation utilizing sacro occipital chiropractic technique Proceedings of the ACC Conference X, Journal of Chiropractic Education Spr 2003; 17(1): 72.

Cooperstein R, Lisi A, Correlation of Ankle Joint Complex Range of Motion, Leg Checks, PSIS Measurements, and Radiological Findings Proceedings of the ACC Conference X, Journal of Chiropractic Education Spr 2003; 17(1): 51.

Blum CL, " Chiropractic Treatment of Mild Head Trauma: A Case History "Proceedings of the 2002 International Conference on Spinal Manipulation , Toronto Ontario, Canada, Oct 2002;:136-8.

Goeselin G, McKnight R, Sacroiliac Joint Stiffness in Sacro-Occipital Technique Category II Subjects: Poster Presentations - Diagnostic Sciences European Journal of Chiropractic 2002; 49: 210-1.

Gleberzon BJ, Chiropractic "Name Techniques": A Review of the Literature Poster Presentation - Special Interest   European Journal of Chiropractic 2002; 49: 242-3.

Klingensmith RD, Blum CL The relationship between pelvic block placement and radiographic pelvic analysis. 10th Annual Vertebral Subluxation Research Conference Hayward, CA, Dec 7-8, 2002

Pick MG, Beyond the Neuron Integrative Bodywork: Towards Unifying Principles International Conference, London: University of Westminster and Journal of Bodywork and Movement Therapies 16/18 Nov 2001.

Kenin S, Humphreys BK, Hubbard B, Cramer GD, Attachments from the Spinal Dura to the Ligamentum Nuchae: Incidence, MRI Appearance, and Strength of Attachment Proceedings of the 2000 International Conference of Spinal Manipulation 2000 Sep: 202-4.

Blum CL, " Incongruent sacro-occipital technique examination findings: Two unusual case histories ." Proceedings of the ACC Conference IX, Journal of Chiropractic Education Spr 2002; 16(1): 67.

Lisi AJ, Cooperstein R, Morschhauser E, " A pilot study of provacation testing with pelvic wedges: Can prone blocking demonstrate a directional preference ?" Proceedings of the ACC Conference IX, Journal of Chiropractic Education Spr 2002; 16(1): 30-1.

Hong S, Duray SM, Morter HB, Zhang Q, Examination of Variations in Dense Connective Tissue Attachments for the Rectus Capitis Posterior Minor to the Dura Mater . Proceedings of the ACC Conference IX, Journal of Chiropractic Education Spr 2002; 16(1): 19-20.

Getzoff H, Ten Reasons Why I Like Sacro Occipital Technique 9th Annual Clinical Meeting of the American Academy of Pain Management , Las Vegas, NV, Sep 1998.

Pick MG, Spinal-cranial morphology and physiology: A review of the relationships between osseous, meningeal and neuronal structures and their role in the cranio-sacral respiratory rhythms Association of Swiss Chiropractors Conference: BŸrgenstock Hotels and Resorts : September 18, 1998.

Pick MG, Anatomy & physiology of cranial motion: A look into the various intercranial rhythmic motions and their effects upon the brain, meninges and cranial bones Association of Swiss Chiropractors Conference: BŸrgenstock Hotels and Resorts : September 18, 1998.

Pick MG, Cranial palpation: Hand utilization techniques & cranial rhythmic identification Association of Swiss Chiropractors Conference: BŸrgenstock Hotels and Resorts : September 18, 1998.

Pick MG, Morphology of the cranial vault sutures: A comprehensive description of the vault sutures interarticular unions and developing a working knowledge toward their manipulative strategies Association of Swiss Chiropractors Conference: BŸrgenstock Hotels and Resorts : September 18, 1998.

Remeta EM, Indicators for Disc Herniation Supported by Magnetic Resonance Imaging (MRI): Poster Presentation 9th Annual Clinical Meeting of the American Academy of Pain Management , Las Vegas, NV, Sep 1998.

Hack GD, The Anatomical Basis for the Effectiveness of Chiropractic Spinal Manipulation in Treating Headache Proceedings of the 1998 International Conference on Spinal Manipulation : Vancouver, British Columbia, Canada July 16-19, 1998: 114-15.

Sanders GE, Unger JF Cranial Distortion and Category II Pelvic Blocking – A Pilot Study: Poster Presentation (Diagnostic Sciences) Proceedings of the Scientific Symposium - 1997 World Chiropractic Congress : Tokyo, Japan Jun 6-8, 1997: 252 .

Unger JF Temporomandibular Joint Dysfunction (TMJD): Work Shop [In English and Japanese] Proceedings of the Scientific Symposium - 1997 World Chiropractic Congress : Tokyo, Japan Jun 6-8, 1997: 274.

Klingensmith RD, Chiropractic Evaluation and Care for Lumbosacral Pain American Academy of Pain Management Washington DC, Sep 1996.

Getzoff H, Sacro Occipital Technique (SOT): A Method of Chiropractic Proceedings of Pathways to Success – Credentialing and Technique Validity: Assessing the Comparative Validity of Chiropractic Techniques, 28 Jun 1996: 1-4.

Unger JF, The Legacy of a Chiropractor, Inventor and Researcher: Dr. Major Bertrand DeJarnette Conference Proceedings of the Chiropractic Centennial Foundation : Davenport, Iowa, Sep 14-16, 1995: 35-6.

Unger J, The Effects of a Pelvic Blocking Procedure Upon Muscle Strength: A Pilot Study Conference Proceedings of the Chiropractic Centennial 1995 Jul: 376-7.

Getzoff H, Sacro Occipital Technique Assessment ACA Council on Technic- Proceedings of the Third National Symposium on the Comparison of Chiropractic Procedures: "The Cervical Subluxation Complex"- Seattle Washington Feb 1995: 69-73.

Phillips CJ, Chiropractic and Pediatrics Cranial Compression and Distraction: a Possible Implication in Otitis Media Proceedings of the 1994 International conference on Spinal Manipulation : Palm Springs, California Jun 10-11, 1994: 136-39.

Unger J, Sweat S, Flanagan S, Chudkowski S , An Effect of Sacro Occipital Technique on Blood Pressure Proceeding of the International Conference on Spinal Manipulation . 1993 Oct : 87.

Arcadi V, Birth Induced TMJ Dysfunction: The Most Common Cause of Breastfeeding Difficulties Proceedings Of The National Conference On Chiropractic. 1993 Oct: 18-22.

Vail B, Evaluation and Cranial Treatment of the Pediatric Patient With Sagittal Suture Synostosis: A Case Report Proceedings Of The National Conference On Chiropractic 1993 Oct: 58-63.

Hewitt, E.; Chiropractic Treatment Of A 7-Month-Old With Chronic Constipation: A Case Report Proceedings Of The National Conference On Chiropractic. 1992 Nov : 16-23.

Blum CL, Cranial Therapeutic Treatment of Downs Syndrome : Poster Presentation, Proceedings of the 7th Annual Conference on Research and Education , Palm Springs, California, June 19-21, 1992: 279-81.

Hospers LA EEG and CEEG studies before and after upper cervical or SOT category 11 adjustment in children after head trauma, in epilepsy, and in “hyperactivity.” ,Proc of the Nat’l Conference on Chiropractic and Pediatrics (ICA) 1992;84-139.

Phillips C, Case Study: The Effect of Utilizing Spinal Manipulation and Craniosacral Therapy as the Treatment Approach for Attention Deficit-Hyperactivity Disorder Proceedings Of The National Conference On Chiropractic 1991 Nov: 57-74 .

Unger J, Short Lever Manual Force Mechanically Assisted Procedures in Sacro Occipital Technic (SOT) Transactions of the Consortium for Chiropractic Research 1991 Jun: 305-9.

Pick MG, Outline of SOT Presentation Transactions of the Consortium for Chiropractic Research 1991 Jun: 166-7.

Kinsinger FS, A Comparative Study of Activator Methods and Sacro Occipital Technique in Low Back Pain: Short Term Effects on Biomechanical Measures Proceedings of the 1991 International Conference of Spinal Manipulation 1991 Apr: 87-9.

Shambaugh P, Pearlman RC, Hauck K, Changes in Brain Stem Evoked Response as a Result of Chiropractic Treatment ,Proceeding of the 1991 International Conference on Spinal Manipulation , Apr 1991: 227-9.

Jansen RD, Nansel DD, Szlazak M, Four Quadrant Forceplate Analysis of Postural Sway: Frequency Domain Characteristics Transactions of the Pacific Consortium for Chiropractic Research: {Proceedings of the Third Annual Conference on Research and Education Jun 18-19, 1988; A3: 1 – 11.

Davis J, Hamilton A, Rouzer P, A Radiographic Definition of Sacroiliac Joints: Their Normal Anatomy and Sprain States Transactions of the Consortium for Chiropractic Research 1987 Jun.

Mootz R, Jameson S, Menke M, Inter and Intra-Rater Reliability of Occipital Fiber Palpation Proceedings of the Fifth Annual Conservative Health Science Research Conference Oct 1986: 37-9.

Blum CL, Biodynamics of the Cranium: A Survey Proceedings: Conference on Current Topics in Chiropractic: Reviews of the Literature 1984 May 19-20; F3: 1-15.

From: Charles Blum, DC - SOTO-USA
Sent: August 9, 2003
To: Aetna Chiropractic Reviews – Dr. Robert Frank
Subject: Sacro Occipital Technique Reply to Aetna’s Policy Statement
SOT A Chiropractic Technique and its Considered As A Standard Of Care For Chiropractic Treatment

SOT A CHIROPRACTIC TECHNIQUE AND ITS CONSIDERED AS A STANDARD OF CARE FOR CHIROPRACTIC TREATMENT

SOT is a method of chiropractic that was developed over 80 years ago and is used by a high percentage of chiropractors nationally. All 50 states within the United States accept SOT for re-licensing credit or chiropractors nationally. All 50 states, within the United States, allow SOT as part of the scope of practice of chiropractors in their state. Most chiropractic colleges nationwide have had SOT as part of either their undergraduate or postgraduate programs.

The following three specific issues also point to SOT being considered as one standard form of chiropractic treatment within the field of chiropractic.

1. A Job Analysis of Chiropractic published by the National Board of Chiropractic Examiners and its relationship to SOT.

2. The Mercy Guidelines evaluation of SOT’s major form of treatment the pelvic blocks.

3. Various articles published in peer review literature that discuss chiropractic “named” techniques which all include SOT as one of the major chiropractic techniques.

Job Analysis of Chiropractic

The National Board of Chiropractic Examiners (NBCE) published a Job Analysis of Chiropractic. The Job Analysis was first published in 1993; in 1994, and the NBCE released a companion volume that included a state-by-state statistical report on chiropractic practice. The “Job Analysis 2000,” is considered the largest and most comprehensive as compared to all prior volumes. [1]

The project director, author and editor of all three volumes was Mark Christensen, PhD, the director of testing for the NBCE. To gather the necessary information for Job Analysis 2000, 9,244 U.S. doctors of chiropractic were selected from the 59,820 licensed Daces in 1998. This selection process was designed to provide reliable data at the state and national level. [1]

With regard to the section of the study entitled “the most utilized chiropractic adjustive techniques/ procedures adjustive” SOT fared as follows:

“% of DC's Utilizing SOT in 1991: 41.3%
% of DC's Utilizing SOT in 1998: 49.0%” [1]

The Mercy Guidelines

The "Guidelines for Chiropractic Quality Assurance and Practice Parameters," [2] also know as the Mercy Guidelines, was for most of the 1990s considered the accepted guidelines for chiropractic healthcare. While the majority of the SOT related literature published in the peer review literature was published following the review of the authors, their review still came to specific determinations regarding SOT's major treatment modality, the pelvic blocks. Using Kaminsky's [3] method of analysis for chiropractic methods and techniques the Mercy review committee determined the following regarding SOT "Pelvic Blocks":

Pelvic Blocks: These paired wedges are used primarily for positioning the lumbosacral and sacroiliac joints to produce a sustained stretch. This procedure is in fairly common use, and there is reasonable rationale and expert opinion on its utility in certain situations. [2]

Rating: Promising for the care of patients with neuromusculoskeletal problems. [2]

Evidence: Class III - Evidence provided by expert legal opinion, descriptive studies or case reports. [2]

Consensus Level: 1 - Established: Accepted as appropriate by the practicing chiropractic community for the given indication in the specified patient population. [2]

There has been a great deal of literature published following the publication of the Mercy Guidelines as well as other SOT published literature that was not available at the time of review. Therefore while the consensus level could not possibly be any higher, the evidence level certainly would be.

Chiropractic Named Techniques

Chiropractic researchers have attempted to evaluate and discuss various “named” chiropractic techniques. In all efforts to evaluate named techniques, SOT is always one method that is listed, and commonly considered a major form of care in chiropractic. [4-6] While the majority of these studies have not had full access to the SOT published literature, SOTO-USA has attempted to remedy that situation recently. While the current text to be published shortly by Gleberzon and Cooperstein on “Named” Chiropractic Techniques treats SOT quite favorably, even this text was written without access to all published studies on SOT related treatment.

One study performed by a review of the Applied Chiropractic Department, at Canadian Memorial Chiropractic College, completed in 1998, involving faculty, clinicians and students, “revealed that 87% of students are in favor of more exposure to named techniques.” [5] It was determined that 53%of the students had interest in learning Sacro Occipital Technique [5], which is similar to the NBCE study. [1]

References

1.    Christensen M, NBCE's Job Analysis 2000, NBCE: 901 54th Avenue, Greeley, CO 80634 (970) 356-9100 nbce@nbce.org [http://www.chiroweb.com/archives/18/14/23.html]

2.    Haldeman S, Chapman-Smith D, Peterson DM, Guidelines for Chiropractic Quality Assurance and Practice Parameters:Proceedings of the Mercy Center Consensus Conference, Aspen Publisher,Inc.: Gaithersburg, Maryland; 1993: 106-8.

3.    Kaminski M, Validation of Chiropractic Methods, Journal of Manipulative and Physiological Therapeutics, 1987; 110(2):61-4.

4.     Gleberzon BJ, Chiropractic Name Techniques in Canada: A Continued Look at Demographic Trends and Their Impact on Issues of Jurisprudence J Can Chiropr Assoc 2002; 46(4): 241-56.

5.     Gleberzon BJ, Incorporating Named Techniquesinto a Chiropractic College Curriculum: A Compilation of Investigative Reports   The Journal of Chiropractic Education 2000;14(1):33-4.

6.     Bergmann TF, Various Forms of Chiropractic Technique, Chiropractic Technique May 1993; 5(2):53-5.

From: Charles Blum, DC - SOTO-USA
Sent: August 9, 2003
To: Aetna Chiropractic Reviews – Dr. Robert Frank
Subject: Sacro Occipital Technique Reply to Aetna’s Policy Statement
Randomized Controlled Studies and Their Use as a Sole Qualification of Chiropractic By Aetna

RANDOMIZED CONTROLLED STUDIES AND THEIR USE AS A SOLE QUALIFICATION OF A CHIROPRACTIC BY AETNA

The issue of using Randomized Controlled Studies (RCTs) as sole criteria to base the acceptance of SOT as an accepted chiropractic treatment isan untenable position. This is based on the following:

1. An “evidence base” must be built on a variety of investigational methods and there can be inherent problems with RCTs.

2. If Aetna is going to use the criteria that all methods of care should be held to the standard that they need to be evaluated through “well-designed prospective randomized controlled clinical trials in the peer-reviewedpublished medical literature demonstrating their effectiveness,” then:
a. Why is there coverage of most surgical procedures and pharmaceutical medications, which do not follow that criterion?

b. Why is there is not coverage for chiropractic non-musculoskeletal treatment based on RCTs that suggest otherwise?

c. Why is there coverage for antibiotics for the treatment of otitis media in lieu of manipulation?

3. Presently in publication, there is a well designed prospective randomized controlled clinical trial, which successfully shows SOT as a positive method of chiropractic care.

RCTs and Evidence Based Study

In communication with Anthony L. Rosner, Ph.D., Director of Research and Education,
Foundation for Chiropractic Education and Research he notes that there is an abundance of references which have been published within the past few years, which demonstrate how, the "evidence base" must be built upona VARIETY of investigational methods (including observational studies, cohort studies, case series and the like). Many of these studies go farther and point out how meta-analyses and RCTs have been misinterpreted and become counterproductive. [1] Rosner has a paper to be published in September2003 issue of he Journal of Manipulative and Physiologic Therapeutics thatdemonstrates how RCTs and meta-analyses have been misused and abused fromthe point of view of 7 case studies dealing with both the medical and chiropracticliterature. [2]

No less than the leading epidemiologist David Sackett has gone on record saying how RCTs taken by themselves produce a distorted and misleadingpicture of clinical response. [3] Cooperstein and Perle suggest asolution is to “Recognize that case reports and non-controlled studies maybe of redeeming value due to their clinical relevance and RCTs may havemethodological flaws.” [4]

RCTs and Medical Coverage by Aetna

A considerable number of covered medical services are not supported by RCTs: According to David Eddy, the list begins with many forms of surgery and extends to glaucoma treatments. [3] According to Aetna's policy, if congruent across the board, many traditional medical services would have to also not be covered. [http://www.shef.ac.uk/%7Escharr/ir/percent.html]

RCTs: SMT for Non-Musculoskeletal Condition

If RCTs are the “gold standard” for Aetna then why is chiropracticcare not covered for non-musculoskeletal conditions? How can Aetna notrecognize the work of Meeker and Haldeman [5,6] in which SMT is supportedby no less than 75 RCTs, 46 of which are positive, 29 equivocal, and 0negative? Included in this list are headache, neck pain, and elbowpain for musculoskeletal conditions AND dysmenorrhea, infantile colic,premenstrual syndrome, and hypertension for non-musculoskeletal conditions.

RCTs: Antibiotics in Lieu of Manipulation for Treatment of Otitis Media

If Aetna is going to use the RCT as a guideline to cover or not cover treatment how do you explain that according to a recent study published in the British Journal of Medicine by Little, Gould, Moore, Warner, Dunleavey, and Williamson they concluded, “In children with otitis media but without fever and vomiting antibiotic treatment has little benefit and a poor outcome is unlikely.” [7] Yet in your policy statement (number 0107) you make it clear that "the use of manipulation in lieu of antibiotics for treatment ofsuppurative otitis media" is NOT a covered service.

RCTs: Sacro Occipital Technique

Even though RCTs can have their limitations SOT is looking toward the future with the goal of producing more studies many of them RCTs. The chiropractic research community upon evaluating our research base has recommended that it is common to have a base of 100s of case histories on a topic before a RCT is attempted for evaluation. Presently there isa study that was ongoing

A preliminary study was presented at the International Conference on Spinal Manipulation in Toronto, Canada, which included as part of theaccepted techniques used in this study, sacro occipital technique. Selected subjects were randomly assigned to 4 groups and chiropractic treatmentwas carried out across 23 centers around Sydney, Australia. Theirstudy concluded that direct chiropractic treatment (6 weeks) reduces salivarycortisol levels over the 14-week period of the trial. The resultsof their study strongly suggested that somatovisceral mechanisms are involvedwith chiropractic treatment. [8]

References

1.     Rosner A, Personal Communication, Anthony L. Rosner, Ph.D., Director of Research and Education, Foundation for Chiropractic Education and Research, Suite 315, 1330 Beacon Street, Brookline, MA 02446-3202 [telephone: 617-734-3397, rosnerfcer@aol.com, www.fcer.org]

2.     Rosner A. Fables of foibles: Inherent problems with RCTs. Journal of Manipulative and Physiological Therapeutics 2003; 26(7): [In press].

3.     Smith R, "Where is the wisdom...? The poverty of medical evidence." British Medical Journal 1991; 303(6806): 798-799.

4.    Cooperstein R, Perle Stephen, “ Condition-specific Indications for Chiropractic Adjustive Procedures for the Low Back: Literature and Clinical Effectiveness Ratings of an Expert Panel ”Top Clin Chiropr 2002;9(3): 19-29.

5.    Meeker WC, Mootz RD, Haldeman S. Back to basics....The state of chiropractic research. Topics in Clinical Chiropractic 2002;9(1): 1-13.

6.    Meeker WC, Haldeman S. Chiropractic: A profession at the crossroads of main-stream and alternative medicine. Annals of Internal Medicine 2002; 136: 216-227.

7.     Little P, Gould C, Moore M, Warner G, Dunleavey J, Williamson A, Predictors of poor outcome and benefits from antibiotics in children with acute otitis media: pragmatic randomized trial British Medical Journal 2002;325:22 ( 6 July ).

8.     Ali S, Hayek R, Holland R, McKelvey SE, Boyce K, " Effect of Chiropractic Treatments on the Endocrine and Immune System in Asthmatic Patients, "   Proceedings of the 2002 International Conference on Spinal Manipulation , Toronto Ontario, Canada, Oct 2002:57-8 (See Enclosed)

From: Charles Blum, DC - SOTO-USA
Sent: August 9, 2003
To: Aetna Chiropractic Reviews – Dr. Robert Frank
Subject: Sacro Occipital Technique Reply to Aetna’s Policy Statement
Summary

SUMMARY

As scientific research attempts to grapple with healthcare one major step forward has been understanding the importance of building an evidence base to develop a consensus regarding treatments such as chiropracticand sacro occipital technique in particular. The current literaturesuggest that RCTs are not the only way, and sometimes “RCTs taken by themselvescan produce a distorted and misleading picture of clinical response.” [1]Apparently observational studies, cohort studies, case series and othersare needed to reach a level of greater understanding and building a solidevidentiary base. [2]

RCTs are too stringent a form of investigation and if used by Aetna in a consistent manner to evaluate all its covered forms of healthcare would leave few if any ever covered. Therefore other factors must be taken into account for a proper evaluation of a chiropractic technique such as sacro occipital technique. These factors can be SOT’s published literature in peer review journals and its acceptance within the chiropractic community. This acceptance spans all state boards of all 50 states, encompasses SOT as a viable taught method of chiropractic for over 80 years, is illustrated by the NBCE report that almost 50% of the chiropractors practice SOT [3], and that the Mercy Guideline’s consensus describes SOT pelvic blocks as“Established: Accepted as appropriate by the practicing chiropractic communityfor the given indication in the specified patient population.” [4]

I look forward to your reply and thank you for your time to evaluate the enclosed books and documents.

Sincerely,

Charles L. Blum, DC
President – Sacro Occipital Technique Organization - USA

Enclosures:

• The Compendium of Sacro Occipital Technique Literature 1984-2000
• The SOT Collection: Supplement to the Year 2000
• SOT Related Reference Articles Post 2000
• Randomized Controlled Study Relating to SOT from ICSM Conference

cc.

Robert D. Klingensmith, DC
Executive Director - Sacro Occipital Technique Organization – USA
P.O. Box 24936, Winston-Salem, North Carolina 27114-4936

References

1.     Smith R, "Where is the wisdom...? The poverty of medical evidence." British Medical Journal 1991; 303(6806): 798-799.

2.    Rosner A. Fables of foibles: Inherent problems with RCTs. Journal of Manipulative and Physiological Therapeutics 2003; 26(7): [In press].

3.    Christensen M, NBCE's Job Analysis 2000, NBCE: 901 54th Avenue, Greeley, CO 80634 (970) 356-9100 nbce@nbce.org [http://www.chiroweb.com/archives/18/14/23.html]

4.    Haldeman S, Chapman-Smith D, Peterson DM, Guidelines for Chiropractic Quality Assurance and Practice Parameters:Proceedings of the Mercy Center Consensus Conference, Aspen Publisher,Inc.: Gaithersburg, Maryland; 1993: 106-8.

From: Charles Blum, DC - SOTO-USA
Sent: August 9, 2003
To: Aetna Chiropractic Reviews – Dr. Robert Frank
Subject: Sacro Occipital Technique Reply to Aetna’s Policy Statement
Sacro Occipital Technique Related Peer Reviewed Articles PublishedFollowing The Year 2000

SACRO OCCIPITAL TECHNIQUE RELATED PEER REVIEWED ARTICLES PUBLISHEDFOLLOWING THE YEAR 2000

Hestœk L, Leboeuf-Yde C, Are chiropractic tests for the lumbo-pelvic spine reliable and valid? A systematic critical literature review , Journal of Manipulative and Physiological Therapeutics May 2000;23:258–75.

Coopertein R, Padded Wedges for Lumbopelvic MechanicalAnalysis   Journal of the American Chiropractic Association,Oct 2000: 24-6.

Holtrop DP, Resolution of Suckling Intolerance in a 6-month-old Chiropractic Patient Journal of Manipulative and Physiological Therapeutics, Nov/Dec 2000;23(9):615-18.

Crisera PN, The cytological implications of primary respiration Medical Hypotheses Jan 2001; 56 (1): 40-51

Blum, CL, Role of Chiropractic and Sacro Occipital Techniquein Asthma Journal of Chiropractic Medicine , Mar 2002; 1(1): 16-22.

Farmer, JA, Blum, CL, " Dural Port Therapy ", Journal of Chiropractic Medicine , Spr 2002; 1(2): 1-8.

Blum, CL, " Chiropractic and Pilates Therapy for the Treatment of Adult Scoliosis ", Journal of Manipulative and Physiological Therapeutics, May 2002.; 25(4)

Cooperstein R, Perle Stephen, “ Condition-specific Indications forChiropractic Adjustive Procedures for the Low Back: Literature and ClinicalEffectiveness Ratings of an Expert Panel ”Top Clin Chiropr 2002;9(3):19-29.

Klingensmith RD, Blum CL, The Relationship Between Pelvic Block Placement and Radiographic Pelvic Analysis Journal of Chiropractic Medicine Summer 2003; 2(3): 102-6 .

Cuthbert S, Blum, CL, Symptomatic Arnold-Chiari Malformationand Cranial Nerve Dysfunction: A Case Study of Applied KinesiologyCranial Evaluation and Treatment , Journal of Manipulative and Physiological Therapeutics, [In Press]

Blum CL, “Lovett Brothers” The relationship between the cervical and lumbar vertebra . Journal of Vertebral Subluxation Research, [In Press]

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From: Aetna Response Robert Frank , DC
Sent:    August 22, 2003
To:    Charles Blum, DC
Subject: Sacro Occipital Technique: Aetna

Good morning Dr. Blum,

I hope this finds you well. I have received the information you have sent and will ask you to please highlight the prospective randomized controlled clinical studies and resubmit them to the Ct. address you have on file. Thank you,

Robert Frank, DC

From: Charles Blum, DC - SOTO-USA
Sent: August 22, 2003
To: Aetna Chiropractic Reviews - Robert Frank, DC
Subject: RCTS and SOT – Ali, Hayek, Holland, McKelvey , & Boyce

August 22, 2003

Dear Dr. Frank

You were sent the two books which had the peer reviewed literaturerelated to SOT as well as recent copies of peer reviewed published literaturein the sleeves of the booklet sent to you. In the section on RCTsthe study you are requesting is also included.

However I am attaching the pdf {see below] file of the article foryour review.

The books and articles all support my position. Have you read what I have sent you? Maybe you did not get the literature. I am confused by your questions.

When Aetna labels something as "experimental/investigational" and rejects its coverage of a procedure by stating that it needs "prospective randomized controlled clinical studies" Aetna is holding SOT to a standard it isnot holding other chiropractic and medical techniques and procedures. With the literature I have sent you I fail to understand how there is any premise to the question of SOT being "experimental/investigational."

Charles L. Blum, DC, CSCP

Ali S, Hayek R, Holland   R, McKelvey SE, Boyce K, " Effect of Chiropractic Treatments on the Endocrine   and Immune System in Asthmatic Patients , “ Proceedings of the 2002 International Conference on Spinal Manipulation , Toronto Ontario, Canada, Oct 2002: 57-8.

[Reprinted with permission from the Foundation for Chiropractic Education and Research (FCER) www.fcer.org]

Background and Objective:   Bronchial asthma is a condition characterized by widespread bronchial obstruction due to muscular spasm producing expiratory wheezing with prolongation of expiration. In this multifactorial condition, a thick, white mucus is produced by the respiratory epithelium of the bronchi leading to obstruction of the airways and considerable difficulty in breathing.   While individuals may be exposed to the same or very similar environments, the question of why some become asthmatics while others do not is a taxing one. We hypothesize that chronic physical and/or psychological stress is in part the answer. Stress is associated with an increase incirculating cortisol, which among other things causes a reductionin immunity and increases smooth muscle contractibility. Reductionin immunoglobulin A (IgA) associated with the respiratory epithelial liningmakes an individual more susceptible to spasm of he respiratory smoothmuscle due to pathogenic invasion.   This is compounded by themuscles increases sensitivity to contraction due to inhibition ofcatecholamine uptake. The broad aims of this FCER funded study isto determine whether stress is a factor in the pathophysiology of asthmaand to determine if chiropractic management of asthmatics can alleviate stress induced asthma. More specifically for this meeting, our study aims to determine whether chiropractic treatment has beneficial effectson the endocrine system through measurement of salivary cortisoland on the immune system via salivary IgA determination.

Methods : Both asthmatic and non-asthmatic patients are sourced through advertisements and press releases in state and local newspapers, bulletins of asthma interest groups, schools, community health groups and radio and television, in the greater Sydney area. Interested subjects phone a hotline and details regarding their brief medical history and treatment regimes are requested. Subjects are sent correspondence on two separate occasions detailing the trial aims and objectives and the requirementsof each patient and consent forms. Subjects are further requestedto attend an information seminar before they are required to take full spinalx-rays. Subjects are selected for the trial based on their medicalhistory, age, procedural understanding, wellness questionnaire and on theoutcomes of their x-rays. Selected subjects are randomly assigned to4 groups consisting of a) chiropractic treatment at centers (3 times perweek), b) no treatment at centers, c) not treatment at home and d) non asthmaticsno treatment at home. Patients undergo a 14-week program consistingof a 2-week pre treatment, 6-week treatment and 6-week post treatment regime. Chiropractic treatment is carried out across 23 centers around Sydney. All clinicians are University educated and registered and all attend at leastone of our research orientation seminars to ensure research standards, protocolsand procedures are strictly adhered to. The accepted techniques include high velocity low amplitude spinal adjustments, diversified, passive wedge (SOT), and activator methods.

All patients are administered an asthma questionnaire, the SF-36 wellness questionnaire, and the depression, anxiety stress scales (DASS) at thecommencement, midway through and completion of the 14 weeks. All patients provide saliva at 8am and 8pm three times a week onTuesdays, Thursdays and Sundays.   Saliva samples are assayedfor cortisol, IgA, osmolarity, albumin and creatinine is used tocheck the quality of the saliva samples provided to ensure that changesin the former are specific to stress and immunity. A total of 400patients will be involved in the trial providing over 35,000 samples andover 176,000 assays will be performed. This is the largest, most comprehensivetrial of this type attempted.

Results:   We report here the cortisol and IgA patterns that are emerging from the data collected and analyzed thus far. We are this stage reluctant to commence a full comprehensive statistical analysis of all the data at hand as it is not “best practice” to do so.

The results we have to date suggest a decrease in salivary cortisol over the 14-week period for patients receiving chiropractic care comparedto those who are not. However we do note an initial increasein cortisol at the commencement of treatment follow4ed by a decrease overthe 6 weeks post treatment period. Mean morning salivary cortisol forthe A group at the commencement of the trial is 6.2 ug/dL which increases to 7.7. ug/dL in the first 2-3 weeks of treatment. Mean salivary cortisol however decreases to its lowest levels over the 14-week trial period to4.6 ug/dL in the last two weeks of the trial. In contrast, mean salivary cortisol values remained unchanged over the 14-week trial period for group B and group C. While group B does not show an overall decrease incortisol, we do observe a slight increase 2-3 weeks into clinic visit for some patients.

In concert with this we also note an increase in salivary IgA levels for both groups A and B but not in group C. This is in line with our hypothesis outlined above. Perhaps the most striking feature of our IgA data to date is that IgA levels in asthmaticsare very erratic throughout the period of the trial suggesting repeated infections or other stressors of the respiratory system. This erratic nature of IgA by in large disappears after chiropractic treatment (group A), whereas it is maintained in groups B and C.

Conclusion:   the FCER funded study aims to determine the effects of chiropractic treatment of the endocrine and immune system of asthmatic patients. We have determined from the data thus far that direct chiropractic treatment (6 weeks) reduces salivary cortisol levels over the 14-week period of this trial. We do however note an initial increase associated with the first 2-3 weeks of treatment. This could either be due to anxiety associated with visiting a clinic or due to the physical nature of the chiropractic treatment. That some patients showed a slight increase 2-3 weeks into clinic visit suggest the former. However full analysis of the data at the conclusion of the trial with respect to individual patient changes versus treatment regime received will be required to finalize this question.   There is no indication at this stage that the reduction in cortisol after chiropractic treatment is due to the well characterized placebo effect as both group B and Group C cortisol values remained unchanged from the start to the end of the trial.

In support of our hypothesis outlined above we show an increase in salivary IgA levels for group A patients. We expect this to be partly responsible for the decrease in the severity and number of asthmatic attaches experienced by these patients. The most striking feature was the decrease in the erratic nature of IgA levels for group A patients. We attribute this to an increase in basal IgA levels associated with decreased cortisol and hence a better ability of patients to ward off potential pathogenic invasion (or the like) which ultimately shows the increasing /decreasing erratic IgA patterns we observe.

Whether chiropractic treatment effects both the endocrine and immune systems independently or one system through the other requires further analysis of our biochemical data and questionnaire data for individual patients.   Full analysis of our data, which we plan at the conclusion of this trial, will also have the benefit of answering a large number of questions related to the efficacy of chiropractic treatment regimes. It is the comprehensive nature of this trial that will make this possible. Our results strongly suggest somatovisceral mechanisms are involved in chiropractic treatment.

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From: Aetna Response Robert Frank , DC
Sent: August 22, 2003
To: Charles Blum, DC
Subject: Sacro Occipital Technique: Aetna

Good afternoon Dr. Blum,

The issue at hand is not the methodology of studies, however, the original issue was Aetna classification of SOT as experimental/investigational as per your email to Dr. Siegel of 7/17. I would appreciate it if you send the prospective randomized controlled clinical studies or please identify those which support your position. Thank you for your cooperation,

Robert Frank, DC

From: Charles Blum, DC - SOTO-USA
Sent: August 22, 2003
To: Aetna Chiropractic Reviews - Robert Frank, DC
Subject: RCTS and SOT

Dear Dr. Frank,

I hope you are well and having a good day.

I am confused with your request. What I sent you describes the issues associated with Randomized Controlled Trials (RCTs) as well as has attached to that section is the one study that was presented by the Foundation for Chiropractic Education and Research (FCER) at the recent International Conference on Spinal Manipulation (ICSM) this year in Toronto. The paper is in process of being prepared for a peer reviewed journal but at this time that is the only RCT related to Sacro Occipital Technique (SOT).

Since most if not all other chiropractic techniques, that Aetna accept, also do not have RCTs as well as most medical procedures, the whole issue of RCTs to justify acceptance or rejection of SOT is without foundation. As you can see from the website [http://www.shef.ac.uk/%7Escharr/ir/percent.html] any justification for using RCTs as a sole criteria is not "evidence based."

Maybe your communication represents misperception on my account and if that is so I am truly sorry, but can you be a bit clearer about your request.

Sincerely,

Charles

Charles L. Blum, DC, CSCP
drcblum@aol.com
www.soto-usa.org

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From: Aetna Response Robert Frank, DC
Sent:    August 22, 2003
To:    Charles Blum, DC
Subject: Sacro Occipital Technique: Aetna Request for RCTs?

Good morning Dr. Blum,

I hope this finds you well. I have received the information you have sent and will ask you to please highlight the prospective randomized controlled clinical studies and resubmit them to the Ct. address you have on file. Thank you,

Robert Frank, DC

From: Charles Blum, DC - SOTO-USA
Sent: September 9, 2003
To: Aetna Chiropractic Reviews - Robert Frank, DC
Subject: RCTS and SOT – Concato, Shah, &, Horwitz

September 9, 2003

Dear Dr. Frank,

I hope you are well and had a good Labor Day. I was contacting you to check on any update regarding the information that I had sent you via the mail.

Please review the following abstract, which I found and thought you might find interesting. I think it is time that Aetna stops hiding behind its thinly veiled use of RCTs to pick and choose which procedure it approves be it medical or chiropractic.

Concato J, Shah N, Horwitz RI.   Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000 Jun 22;342(25):1887-92.
Department of Internal Medicine, Yale University School of Medicine, New Haven, Conn 06510, USA. john.concato@yale.edu

BACKGROUND: In the hierarchy of research designs, the results of randomized, controlled trials are considered to be evidence of the highest grade, whereas observational studies are viewed as having less validity because they reportedly overestimate treatment effects. We used published meta-analyses to identify randomized clinical trials and observational studies that examined the same clinical topics. We then compared the results of the original reports according to the type of research design. METHODS: A search of the Medline data base for articles published in five major medical journals from 1991 to 1995 identified meta-analyses of randomized, controlled trials and meta-analyses of either cohort or case-control studies that assessed the same intervention. For each of five topics, summary estimates and 95 percent confidence intervals were calculated on the basis of data from the individual randomized, controlled trials and the individual observational studies. RESULTS: For the five clinical topics and 99 reports evaluated, the average results of the observational studies were remarkably similar to those of the randomized, controlled trials. For example, analysis of 13 randomized, controlled trials of the effectiveness of bacille Calmette-Guerin vaccine in preventing active tuberculosis yielded a relative risk of 0.49 (95 percent confidence interval, 0.34 to 0.70) among vaccinated patients, as compared with an odds ratio of 0.50 (95 percent confidence interval, 0.39 to 0.65) from 10 case-control studies. In addition, the range of the point estimates for the effect of vaccination was wider for the randomized, controlled trials (0.20 to 1.56) than for the observational studies (0.17 to 0.84). CONCLUSIONS: The results of well-designed observational studies (with either a cohort or a case-control design) do not systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.

Charles

Charles L. Blum, DC, CSCP
drcblum@aol.com
www.soto-usa.org

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From: Charles Blum, DC - SOTO-USA
Sent: September 30, 2003
To: Aetna Chiropractic Reviews - Robert Frank, DC
Subject: RCTS and SOT – Rosner

September 30, 2003

Dear Dr. Frank,

I just wanted to check in and find out if there was any update regarding Aetna's position on Sacro Occipital Technique. Also I wanted to share the latest article by Dr. Rosner relating why relying on RCTs as a sole criteria has significant limitations and is at least questionable. [Please see attached.]

Sincerely,

Charles

Charles L. Blum, DC, CSCP
drcblum@aol.com
www.soto-usa.org

Rosner A, Commentary: Fables or foibles: Inherent problems with RCTs Journal of Manipulative and Physiological Therapeutics Sep 2003; 26(7)
[http://www2.us.elsevierhealth.com/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=fullfree&id=as0161475403000940]

For 50 years, the accepted standard by which the usefulness of a therapeutic treatment is judged has been the randomized controlled trial (RCT), building from Hippocrates' premise 2000 years ago that experience combined with reason was the therapy of choice for patients; that is, any treatment plan should both seem reasonable in theory and then be tested experimentally. Assuming that threats to both internal and external validity could be ruled out, the RCT became what is commonly regarded as the highest quality of clinical outcome study that could be mounted to allow inferences about cause and effect relationships to be drawn. The thinking was that the more rigorous and fastidious the design, the more credibility could be attached to the conclusions drawn from the outcomes of the study and the more likely the intervention was thought to have brought about those outcomes. 1One of the strongest proponents of the RCT through the 1950s and 1960s was the British epidemiologist Archie Cochrane, who held that this type of experimental approach was essential for upgrading the quality of medical evidence. 2In common hierarchical schemes of clinical experimental design, the RCT has been ranked the highest in rigor, as shown in Table 1 .3Even greater rigor has been presumed to occur with the statistical combination and weighting of the results of multiple RCTs in a meta-analysis to generate a more conclusive estimate of effect size. 4,5

Hierarchy of experimental designs 3

1. Control group outcomes study (including RCTs).

2. Single-subject experiment, replicated single-subject experiments.

3. Single-group outcome study.

4. Systematic case study.

5. Anecdotal case report.

Designs are presented in descending order of rigor.

RCT, Randomized control trial.

From the point of view of clinical practice, however, especially in areas in which physical treatments are applied, the principles of fastidious treatments and blinding begin to wear thin and in a few recent examples regarding spinal manipulation, appear to have fallen apart completely. This difficulty is by no means confined to physical treatments, as the literature pertaining to the use of medications has also suggested that the inexperienced use and/or uncritical acceptance of the results of RCTs can lead to confusion. In this presentation, a few representative samples will be introduced as 7 case studies, which ironically would be ranked among the lowest in experimental rigor by the aforementioned hierarchy of clinical evidence. 3

1. Reduction of meta-analyses to subjective value scales

In their efforts to compare 2 different preparations of heparin for their respective abilities to prevent postoperative thrombosis, Juni et al 6 have demonstrated that diametrically opposing results can be obtained in different meta-analyses, depending on which of 25 scales is used to distinguish between high-quality and low-quality RCTs. The root of the problem is evident from the variability of weights given to 3 prominent features of RCTs (randomization, blinding, and withdrawals), as shown in Table 2 by the 25 studies, which have compared the 2 therapeutic agents.

In 1 study, a third of the total weighting of the quality of the trial is afforded to both randomization and blinding, whereas in another study cited in the article, none of the quality scoring is derived from these 2 features. Widely skewed intermediate values for the 3 aspects of RCTs under discussion are apparent from the 23 other scales presented. The astute reader will immediately suspect that sharply conflicting conclusions might be drawn from these different studies, and these are amply borne out by the statistical plots shown in Figure 1 . Here, each of the meta-analyses listed resolve the 17 studies they have reviewed into high-quality and low-quality strata, based on each of their scoring systems.

It can be seen that 10 of the studies selected show a statistically superior effect of 1 heparin preparation, low-molecular weight heparin (LMWH), over the other but only for the low-quality studies. Seven other studies reveal precisely the opposite effect, in which the high-quality but not the low-quality studies display a statistically significant superiority of LMWH.

Depending on which scale is used, therefore, it is possible to either demonstrate or refute the clinical superiority of one clinical treatment over another. In this manner, therefore, all the rigor and labor-intensive elements of the RCT and its interpretation by the meta-analysis are simply reduced to the subjective and undoubtedly capricious human element of value judgment through the arbitrary assignment of numbers in the weighting of experimental quality. 6

2. Occult “salami” publications

At times, authors of studies have been known to present their data in more than 1 forum in the scientific literature, resulting in what has become referred to as mass-produced or “salami” publications. Because the exclusivity of such data is unknown, it will be oversampled by the unsuspecting author of a meta-analysis or systematic literature review and thus will be given more weight than it merits. One such instance has been reported in the evaluation of nonsteroidal anti-inflammatory drugs (NSAIDs) in treating rheumatoid arthritis, in which 44 publications of 31 clinical trials were found to result in an oversampling of at least 18%. Twenty of these studies were published in 2 different sources, 10 studies were published in 3 different sources, and 1 study was published in 5 different sources. The fact that these data were published elsewhere was not noted in 32 of the 44 articles. Even more unsettling is the finding that in about half of the articles, the first author and total number of authors were different, and there appeared to be important discrepancies between versions of the same trial. 7

Further evidence is shown in studies of risperidone, an antipsychotic agent. In this instance, 20 articles plus unpublished reports actually represented only 9 trials 8. Finally, a report from Tramer et al 9 has described how 84 trials involving 11,980 patients using ondansetron for postoperative emesis resulted from only 70 trials employing 8645 patients. It was believed that the duplicate data led to a 23% overestimation of the efficacy of ondansetron.

Here, it is clear that the “one man, one vote” principle of systematic data review has been violated, such that clinical observations derived from the RCTs of certain authors have been given excessive credibility. Care must be taken to ensure that the data incorporated into an analysis of the effect of a particular treatment in an RCT are scored only once, a highly formidable if not impossible task.

3. Manipulation of experimental results

One of the more startling analyses of RCTs has been presented by Johansen and Gotzsche, 10 who reviewed a meta-analysis comparing fluconazole and amphotericin B, 2 antifungal agents. To begin, in 3 large trials comprising 43% of the patients identified for meta-analysis, the results from amphotericin B were combined with the results for nystatin, known to be an ineffective drug for fungal infections. Worse, 79% of the patients in these trials were randomized to receive amphotericin orally, which is perplexing and disturbing, since amphotericin B is known to be poorly absorbed and is normally administered intravenously.

When questioned more closely about the sources of their data, 12 of the 15 authors were found to be less than fully compliant, with 1 suggesting that the trial was “old” and that the primary data resided with the drug manufacturer, another claiming that sufficient time was lacking to respond, and a third professing the lack of access to the database because of a change of affiliation. The final surprise, which appeared to belie the validity of this entire undertaking, was the fact that Pfizer, the manufacturer of the superior drug, provided employment to 12 of the 15 authors in studies involving 92% of the total number of patients evaluated. It would appear that the intention all along was to manipulate the trials to favor the successful pharmaceutical product.

4. Flawed RCT no. 1: Misrepresentation of therapies and overgeneralization of results

A widely publicized study by Cherkin et al 11 , which appeared in The New England Journal of Medicine , represents an inaccurate depiction of the 3 treatments which are presumably compared (chiropractic care, physical therapy, and medical intervention). These are reduced, respectively, to a single side-posture manipulation, the McKenzie method, and an education booklet. While these applications are certainly indicated in a fastidious design, there is no justification for the authors, who found little difference in outcomes between the 3 interventions with greater costs associated with the side-posture or McKenzie treatments, to then state as a conclusion: “Given the limited benefits and high costs, it seems unwise to refer all patients with low back pain for chiropractic or McKenzie therapy.”

First, one must be aware that there are several chiropractic techniques applicable to the management of low back pain; among them are low-force (the Logan Basic or Sacro-Occipital) techniques, flexion-distraction, use of a drop table, and traction. In this trial, only 1 high-velocity technique (side-posture) was applied, and it might not be equally effective for all patients. Furthermore, important ancillary procedures which are intrinsic to the chiropractic visit appear to have been denied to patients. In particular, extension exercises were forbidden, and patients were most likely not given any literature, even though these 2 options are considered to be parts of a customary chiropractic regimen for office visits. It appears that these 2 elements were permitted only in the other 2 arms of the trial. In short, the chiropractic treatment administered in this particular investigation appears to have been only a pale shadow of the actual therapy administered to patients in the real world. This would only add further irony to the inappropriate conclusion quoted from the authors above.

Additional problems with this trial surface with the examination of baseline characteristics regarding severity among the 3 groups tested, creating a bias in the outcomes. First, the percentage of patients who had prior chiropractic care for low back pain appears to be substantially lower for the chiropractic cohort (24%) than for the McKenzie and medical booklet groups (35% and 40%). This problem is only magnified by the authors' citation of another prominent investigation, noting that “the British study found the benefits of chiropractic to be most evident among patients who had previously been treated by chiropractors.” Second, the chiropractic cohort indicates the highest percentage of patients who, because of low back pain and prior to their therapy, encountered more than 1 day of best rest (35% vs 24% and 22% for the McKenzie and medical booklet cohorts, respectively), more than 1 day of work lost (39% vs 41% and 30% for the McKenzie and medical booklet cohorts, respectively], and more than a single day of restricted activity (72% vs 65% and 52% for the McKenzie and medical booklet cohorts, respectively).

Curiously, the outcomes in the figure between weeks 0 and 1 were not shown in the original article but indeed represent the bulk of improvement in the 3 patient cohorts (the change from the baseline scores to those observed at 1 week of follow-up is depicted by the dotted line). In this chart, there does appear to be a tendency for the “chiropractic” group to show greater improvement at most of the weeks of follow-up evaluated, although statistically this is not borne out. Even with these abbreviated interventions, larger group sizes in this trial might have overcome what could have been a type II error and delivered statistically robust differences in both outcomes and baseline characteristics shown above. These are but a few of the deficiencies of this particular study, which have been outlined extensively elsewhere. 12 -14 In summary, this study is a poor representation of therapies which have been successfully applied to live patients in physicians' offices worldwide. The deficiencies in its design undercut its validity to the point of compromising the reliability of the study as a whole. Indeed, the Royal College of General Practitioners, in a recent systematic review of the literature designed to update guidelines issued by the government of the United Kingdom for the management of low back pain (which themselves conflict with the Cherkin et al 11 study by citing spinal manipulation as a treatment of choice for low back pain 15 ), has concluded that this RCT under discussion neither adds to nor detracts from the evidence base regarding appropriate interventions for low back pain. 16

5. Flawed RCT no. 2: Improper sham procedure

An equally widely publicized study appearing in The New England Journal of Medicine purported to add further negative evidence to the efficacy of spinal manipulation, stating that “the addition of chiropractic spinal manipulation to usual medical care for four months had no effect on the control of childhood asthma.” This statement was based on the failure of active and sham-manipulated patient groups aged 7 to 16 years in a clinical trial to be differentiated in terms of their outcomes in both quality of life and airway function. What is indisputable is that there were major improvements from baseline to follow-up observed in each of the groups. 17

The problem arises when one considers what was actually done in the sham procedures. Prolonged applications to no less than 3 distinct anatomical areas (gluteal, scapular, and cranial) to the patient are described. Admittedly, these are not high-velocity contact procedures, but this evades the issue. Two pieces of evidence strongly suggest that simple contact with patients through sham procedures will produce a significant effect. The first indicates that with respect to the reflexive inhibition of the alpha-motoneuron pool in human subjects, sham and active manipulative procedures display little difference. This is to suggest that cutaneous receptors, muscle spindles, and joint mechanoreceptors individually or in concert are significantly affected by so-called sham procedures. 18 The second demonstrates that 2 groups of children, aged 4 to 8 and 9 to 16, display profound changes in pulmonary functions, attitude and behavior scores, and cortisol levels following massage, as compared to a noncontact control group. 19 Thus, it would appear that physical contact with the patient is sufficient to trigger a cascade of physiological changes, which seem to have been erroneously dismissed in the asthma study. What appears to have been underemphasized by both the authors and most readers of the asthma study is that chiropractic encompasses a broad range of both high-velocity and low-force techniques together with ancillary procedures, many of which have obviously been embedded in the sham procedures described. In its attempt to craft a fastidious design, this trial gives the impression of missing the forest for the trees by attempting to portray the essence of chiropractic care as the lack of differentiation between the sham and manipulated experimental groups.

6. Flawed RCT no. 3: Inconsistencies between pilot and full-scale trial and sham procedures

Another recently published RCT would have appeared to replicate the problems with the asthma trial by invoking a contact sham procedure and then failing to find a significant difference in outcomes between sham and actively manipulated patient groups—this time in women complaining of primary dysmenorrhea. 20

What is curious in this instance, however, is that the same authors did find significant differences between the 2 experimental groups in their own pilot study published previously. 21 This is plainly apparent in Table 3 , in which both pain and prostaglandin (KDPGF2a) levels are seen to decrease significantly in the active spinal manipulative therapy as opposed to the sham low-force manipulation group in the pilot study, whereas no such pattern can be detected in the full-scale investigation.

However, a closer examination of the data explains at least what appears to have happened regarding the scales. Pain baseline levels in the full-scale study can be observed to be virtually 1.5 to 2 units less than the corresponding values in the pilot study. Since the baseline values in the full-scale study are close to the expected final outcome levels, their accurate measurement is a moot point. The reason is that the qualifying criteria for patients in the full-scale trial as opposed to the pilot were changed: instead of having to immediately report to the clinic with menstrual pain, patients were now allowed up to 48 hours to register for the trial, resulting in having many patients recording no pain at all during baseline measurements. Decreased prostaglandin levels at baseline also seem to be apparent for the patients in the full-scale trial, again raising the probability that finding a downward trend during the course of any treatment during the investigation would be less likely to occur.

As for the asthma trial discussed above, it would have been far preferable to have a control group of patients having experienced no physical contact if chiropractic procedures were to be more accurately evaluated. The fact that a much larger group of chiropractors applied the sham procedure in the full-scale trial as opposed to a single practitioner in the pilot raises questions regarding the uniformity of training and reproducibility of contact procedures, the lack of which would have created a significant scattering of patient outcome measurements. Final discrepancies between the pilot and full-scale trial which are mystifying include the application of an effleurage in the full-scale trial prior to administering either the sham or high-velocity procedure, the pretreatment obscuring the therapeutic effects being followed, and the lack of a 24-hour period of abstention from exercise in the full-scale investigation, which had been included in the pilot study. All these differences may have been related to difficulties of recruiting a sufficient number of patients for the full-scale as opposed to the pilot trial, underscoring how the constraints of an experimental procedure may carry the investigation even farther afield from what is presumed to occur in the physician's office.

To their great credit, the authors state their conclusions far more precisely and conservatively than those seen in the previously discussed trials: “The [results of this trial] are strong evidence that either the low force mimic maneuver was an insufficient placebo treatment or, in fact, that manual therapy does not relieve the pain in women with primary dysmenorrhea.” The concern is that both sections, rather than simply the latter portion of this statement, can be carried into any future citations in research publications, as well as into the public consciousness.

7. Flawed RCT no. 4: Effects may be obscured by small samples sizes in a type II error

In comparing patient groups given either high-velocity cervical spinal manipulation or low-level laser treatments as a control, Nilsson 22 observed a tendency of the manipulated group to fare better in terms of pain experienced, headache hours per day, and use of analgesics to alleviate discomfort (Fig 3 ). The first trial involving 39 patients showed a trend toward improvement in all categories but failed to reach the usual level of statistical significance.

Upon increasing the total patient number to 54 with resumed recruitment, however, the investigators arrived at statistically significant differences in all 3 parameters ( P= .04 to .03). 23 Had the aforementioned asthma 17 or low back pain trials 11 been repeated with larger patient numbers, trends which appeared in much of the data might have become statistically significant differences, overcoming a type II error. Clearly, the potential exists to misinterpret the results of an RCT if they are not reviewed from a multiplicity of viewpoints rather than accepting statistical numbers at face value.

From the preceding, we can appreciate that the following principles need to be maintained as a checklist with which to avoid being mislead bya published RCT:

Outcomes of meta-analyses depend on the scoring systems used for inputs.

A potential exists for corruption in the comparison of pharmaceutical agents.

Oversampling of data may occur from duplicate (“salami”) publications.

Fastidious interventions in RCTs must not be confused with actual clinical treatments.

RCTs which include physical methods of intervention must be checked for inappropriate sham procedures.

Trends in RCTs may be obscured by type II errors produced by smallsample sizes.

The results of RCTs must be confined to the parameters expressed within the investigation and not indiscriminately generalized to clinical practice.

Further concerns about the integrity of RCTs have been stoked by a recent review of 136 research projects addressing a malignant blood disease. The authors of this particular study found a disparity of positive results, depending on the funding source of research, reporting that 74% of the trials reviewed favored a new treatment when they were funded by a for-profit source and that figure being reduced to 47% when funding was provided by nonprofit sources. Moreover, inferior controls were found in 60% of occasions when a particular trial was supported by a for-profit entity but only 21% of the time when a nonprofit source provided funding. The authors were forced to conclude that the uncertainty principle (known as clinical equipoise) appears to have been violated, generating a bias in research. 24

Adding to the leveling of the hierarchical playing field of experimental design discussed above in Table 1 is the intriguing observation from Benson and Hartz, 25 which suggests that observational studies since 1984 have risen sufficiently in quality to match the findings of the more lofty RCTs. In a search of both the Abridged Index Medicus and the Cochrane databases to identify 2 or more treatments for the same condition, the authors located 136 reports addressing 19 diverse treatments. They found that in most cases, estimates of the treatment effects from observational studies and RCTs were similar; in only 2 out of the 19 analyses did the magnitude of observational studies lie outside the 95% confidence interval for the combined magnitude of RCTs. Thus, there was little evidence that estimates of combined treatment effects from observational studies reported after 1984 were either consistently larger or qualitatively different from those obtained in the more fastidiously constructed RCTs.

In the rush to worship RCTs and extoll their fastidious construction, it is easy to forget what gave rise to performing the RCT in the first place, the astute clinical observation. Indeed, the epidemiologist David Sackett 26 has attempted to reconcile this dilemma by indicating that both observations taken in the doctor's office and rigorous experimental design are needed to build the evidence required for clinical treatment: “External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision.”

The problems of uncritically accepting evidence from randomized controlled trials and meta-analyses in clinical decision-making have been extensively reviewed elsewhere. 27 -31 To build the proper documentation for evidence-based medicine, therefore, one needs to be able to evaluate RCTs realistically in the proper context. Some of the irregularities discussed in this report might tempt the clinical researcher to cast a jaundiced eye on RCTs perse; rather, he or she should simply be prepared to synthesize the proper design and interpretation of RCTs with sound observations gleaned from the individual patient.

Conclusion

The 7 case studies reviewed in this report combined with an emerging concept in the medical literature both suggest that reviews of clinical research should accommodate our increased recognition of the values of cohort studies and case series. The alternative would have been to assume categorically that observational studies rather than RCTs provide inferior guidance to clinical decision-making. From this discussion, it is apparent that a well-crafted cohort study or case series may be of greater informative value than a flawed or corrupted RCT. To assume that the entire range of clinical treatment for any modality has been successfully captured by the precision of analytical methods in the scientific literature, indicates Horwitz, 32 would be tantamount to claiming that a medical librarian who has access to systematic reviews, meta-analyses, Medline, and practice guidelines provides the same quality of health care as an experienced physician.

References

1.   Bull JP. The historical development of clinical therapeutics. J Chronic Dis 1959;10:218-248.

2.   Mechanic D. Bringing science to medicine: the origins of evidence-based practice. Health Aff 1998;17:250-251.

3.   Blanchard EB. Biofeedback and the modification of cardiovascular dysfunctions. In: Gatchel RJ, Price KP, editors. Clinical applicationof biofeedback: appraisal and status. New York: Pergamon Press; 1979.

4.   Beecher HK. The powerful placebo. JAMA 1955;159:1602-1606.

5.   Glass GB. Primary, secondary, and meta-analysis of research. J Educ Res 1976;7:177-188.

6.   Juni P, Witsch A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA 1999;282:1054-1060.

7.   Gotzsche PC. Multiple publication of reports of drug trials. Eur J Clin Pharmacol 1989;36:429-432.

8.   Huston P, Moher D. Redudancy, disaggregation, and the integrity of medical research. Lancet 1996;347:1024-1026.

9.   Tramer MR, Reynolds DJM, Moore RA, McQuay HJ. Impact of covert duplicate publication on meta-analysis: a case study. BMJ 1997;315:635-640.

10.   Johansen HK, Gotzsche PC. Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis. JAMA 1999;282:1752-1759.

11.   Cherkin DC, Deyo RA, Battie M, Street J, Barlow W.A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low backpain. N Engl J Med 1998;339:1021-1029.

12.   Rosner AL. Evidence-based clinical guidelines for the management of acute low back pain: response to the guidelines prepared for the Australian Medical Health and Research Council. J Manipulative Physiol Ther 2001;24:214-220.

13.   Freeman MD, Rossignol AM. A critical evaluation of the methodology of a low-back pain clinical trial. J ManipulativePhysiol Ther 2000;23:363-364.

14.   Chapman-Smith D. Back pain, science, politics and money. The Chiropractic Report 1998;12:1-4, 6-8.

15.   Rosen M. Back pain. Report of a Clinical StandardsAdvisory Group committee on back pain. London: Her Majesty's StationeryOffice; 1994. p. 46, 58, 60.

16.   Royal College of General Practitioners. Unpublished update of CSAG guidelines [reference 15]. 1999.

17.   Balon J, Aker PD, Crowther ER, Danielson C, Cox PG, O'Shaugnessy D, et al. A comparison of active and simulated chiropractic manipulation as adjunctive treatment for childhood asthma. N Engl JMed 1998;339:1013-1020.

18.   Dishman JD, Bulbulian R. Spinal reflex attenuationassociated with spinal manipulation. Spine 2000;25:2519-2525.

19.   Field T, Henteleff T, Hernandez M, Martinez E, Mavunda K, Kuhn C, et al. Children with asthma have improved pulmonary functions after massage therapy. J Pediatr 1998;32:854-858.

20.   Kokjohn K, Schmid DM, Triano JJ, Brennan PC. The effect of spinal manipulation on pain and prostaglandin levels in women with primary dysmenorrhea. J Manipulative Physiol Ther 1992;15:279-285.

21.   Hondras MA, Long CR, Brennan PC. Spinal manipulative therapy vs. a low force mimic maneuver for women with primary dysmenorrhea: a randomized, observer-blinded, clinical trial. Pain 1999;81:105-114.

22.   Nilsson N. A randomized controlled trial of the effect of spinal manipulation in the treatment of cervicgogenic headache. J Manipulative Physiol Ther 1995;18:435-440.

23.   Nilsson N, Christensen HW, Hartvigsen J. The effect of spinal manipulation in the treatment of cervicogenic headaches. J Manipulative Physiol Ther 1997;20:326-330.

24.   Djulbegovic B, Lacevic M, Cantor A, Fields K, Bennett CL, Adams JR, et al. The uncertainty principle and industry-sponsored research. Lancet 2000;356:635-638.

25.   Benson K, Hartz AJ. A comparison of observational studies and randomized controlled trials. N Engl J Med 2000;342:1878-1886.

26.   Sackett DL. Editorial: evidence-based medicine. Spine 1998;23:1085-1086.

27.   Feinstein AR, Horwitz RI. Problems in the “evidence” of “evidence-based medicine”. Am J Med 1997;103:529-535.

28.   Feinstein AR. Meta-analysis: statistical alchemy for the 21st century. J Clin Epidemiol 1995;48:71-79.

29.   Kaptchuk T. The double-blind, randomized, placebo-controlled trial: gold standard or golden calf?. J Clin Epidemiol 2001;54:541-549.

30.   Jonas W. The evidence house: how to build an inclusive base for complementary medicine. West J Med 2001;175:79-80.

31.   Radford MJ, Foody JM. How do observational studiesexpand the evidence base for therapy?. JAMA 2001;286:1228-1230.

32.   Horwitz RI. The dark side of evidence-based medicine. Cleve Clin J Med 1996;63:320-323.

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From: Aetna Response Robert Frank , DC
Sent: October 22, 2003
To: Charles Blum, DC
Subject: Request for SOT Studies

Good morning Dr. Blum,

Anita relayed your message. I have spoken to members of our Clinical
Policy Committee, who have indicated that you should highlight those
specific studies which support your position. The review process is
quite lengthy, so I will be unable to give you specific updates.
However, the sooner I receive the specific list of studies from you, the
sooner they can be reviewed. Thank you for your anticipated
cooperation,

From: Charles Blum, DC - SOTO-USA
Sent: October 22, 2003
To: Aetna Chiropractic Reviews - Robert Frank, DC
Subject: RCTS and SOT – Request for Clarification

October 22, 2003

Dear Dr. Frank,

Thank you so much for your reply.

I need some clarity as to what specific questions or what is being investigated regarding sacro occipital technique (SOT). The issue as I understand this is that Aetna is not suppose to hold a chiropractic technique let alone chiropractic, to a different standard then it might hold medical related procedures.

The main issue is that there is an abundance of SOT published studies in peer review journal, SOT has been a method of chiropractic for over 75 years, 50% of the chiropractic profession in the USA use some aspect oft his method of care and chiropractic literature on chiropractic techniques consider SOT one of the major chiropractic techniques.

What is Aenta's criteria for off label uses of medications and the abundance of medical procedures, I submitted that are also on the website, discussed by Sackett the epidemiologist, which show that approximately 50-75% of many procedures are not based on RCTs or evidence based medicine.

What needle in a haystack is the review committee looking for? How is their position justified? I fail to understand how there is any issue that needs further clarification. However I will do what I can if I can have very clear and specific criteria as to what is needed per the published literature. But please do not give me back the rhetoric regarding quality RCTs published in approved medical journals, especially since this would limit most procedures used in health care today.

Thanks for your help, support, and follow-up.

Sincerely,

Charles

Charles Blum, DC
drcblum@aol.com
www.soto-usa.org

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From: Aetna Response Robert Frank , DC
Sent: January 09, 2004
To: Charles Blum, DC
Subject: Back to the RCTs

January 09, 2004
Good morning Dr. Blum,

I hope this finds you and yours well. In response to your voice mail of 1/8/04, I again request that you cite the specific prospective randomized, controlled, clinical studies that support S.O.T. as an effective CMT for the treatment of NMS conditions.

It was relayed to me, via the review committee, that these studies be published in peer-reviewed, scientific journals and I ask the same of you. I trust this answers your questions and appreciate your anticipated cooperation.

Robert Frank, DC

From: Charles Blum, DC - SOTO-USA
Sent: January 09, 2004
To: Aetna Chiropractic Reviews - Robert Frank, DC
Subject: RCTS and SOT – Double Standard

Dear Dr. Frank,

Thanks so much for your reply. As I have responded to this on multiple occasions I am unclear why the question is continually asked. I have sent you various published articles that were in blinded peer review journals however there was only one paper that was written involving a randomized control study and SOT which I have also sent to you.

The point that you have never addressed is that Aetna is holding SOT to a different standard than any other chiropractic technique and most medical procedures as well. How can you possible ask for "specific prospective randomized, controlled, clinical studies that support S.O.T. as an effective CMT for the treatment of NMS conditions" and "that these studies be published in peer-reviewed, scientific journals" and use this as an ultimate criteria for Aetna's position? This is a position that is just for SOT considering Aetna's position on other chiropractic techniques, medical procedures, and prescription medication.

Have you not received the multiple emails with abstracts I have sent to you on this issue? Why has there never been any reply to what I had sent on that specific topic?

Thanks again for your reply,

Charles

Charles L. Blum, DC
Santa Monica, California
drcblum@aol.com
www.soto-usa.org

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From: Aetna Response Robert Frank , DC
Sent:    January 13, 2003
To:    Charles Blum, DC From: Aetna – Dr. Robert Frank
Subject: Aetna’s Response or Non-Response

January 13, 2003

Good afternoon Dr. Blum,

I have taken your concerns and documents to the Clinical Policy Committee. The following is the committee's response:

Thank you for your correspondence regarding Aetna's policy on the sacro-occipital technique. Aetna considers the sacro-occipital technique to be experimental and investigational.

Although there is adequate evidence of the effectiveness of chiropractic in the treatment of back pain and other musculoskeletal conditions (see, e.g., Bigos, et al., 1994; Mohseni-Bandpei, et al., 1998; Bronfort, etal., 2001), there is inadequate evidence to support the safety and effectiveness of the sacro-occipital technique. Aetna's policy is based on a lack of adequate evidence of its effectiveness in improving clinical outcomes from prospective clinical studies in the peer-reviewed published medical literature. Aetna's position is based, not on the quantity of references to the sacro-occipital technique, but on the poor quality of evidence supporting the safety and effectiveness of this technique from prospective clinical outcome studies in the peer-reviewed published clinical literature.

Thank you again for your correspondence on Aetna's policy on the sacro-occipital technique.

References:

Bigos S, Bowyer O, Braen G, et al. Acute Low Back Problems in Adults. Clinical Practice Guideline No. 14. AHCPR Publication No. 95-0642. Rockville, MD: Agency for Health Care Policy and Research; December 1994.

Mohseni-Bandpei MA, Stephenson R, Richardson B. Spinal manipulation in the treatment of low back pain: A review of the literature with particular emphasis on randomized controlled clinical trials. Physical Therapy Reviews. 1998;3(4):185-194.

Bronfort G, Assendelft WJ, Evans R, et al. Efficacy of spinal manipulation for chronic headache: a systematic review. J Manipulative & Physiological Therapeutics. 2001;24(7):457-466.

Homola S. Sacro-occipital technique. In: Chirobase. A Skeptical Guide to Chiropractic History, Theories, and Current Practices. Available at: http://www.chirobase.org/05RB/BCC/11d.html. Accessed January 13, 2004.

From: Charles Blum, DC - SOTO-USA
Sent: January 13, 2004
To: Aetna Chiropractic Reviews - Robert Frank, DC
Subject: Question to Aetna’s Clinical Policy Committee

January 13, 2004

Dear Dr. Frank,

Thank you so much for getting back to me and taking my "concerns and documents to the Clinical Policy Committee." I was disappointed to see the repeated litany, "Aetna considers the sacro-occipital technique to be experimental and investigational." Sadly the response is a non sequitur and is non responsive to my requests for a rationale.

While I am happy that Aetna appreciates the effectiveness of chiropractic in the treatment of back pain and other musculoskeletal conditions (see, e.g., Bigos, et al., 1994; Mohseni-Bandpei, et al., 1998; Bronfort, etal., 2001).   I would like you to submit where there is any substance to the statement that, "the safety ... of the sacro-occipital technique" is in question. The chirobase article you reference was written in 1963, quite outdated and significantly inaccurate at this time. I have been in contact with the chirobase site discussing my rewriting the article and updating its information. I am also sure that anyone referencing that site is aware that there can often be a degree of bias with anything written on that site, particularly using an article written over 40 years ago to describe a chiropractic technique that had significantly evolved since 1963.

While SOT has been used for over 70 years by doctors successfully, the publishing in the journals is only beginning the past 2 decades. Regretfully for chiropractic SOT is in the forefront of chiropractic techniques in this regard. Of the various chiropractic methods of evaluating the lumbo-pelvic spine, other than palpation for pain, only SOT had a method that showed some validity. "Only tests for palpation for pain had consistently acceptable results. Motion palpation of the lumbar spine might be valid but showed poor reliability, whereas motion palpation of the sacroiliac joints seemed to be slightly reliable but was not shown to be valid. Measures of leg-length inequality seemed to correlate with radiographic measurements but consensus on method and interpretation is lacking. For the sacrooccipital technique, some evidence favors the validity of the arm-fossa test but the rest of the test regimen remains poorly documented. Documentation of applied kinesiology was not available. Palpation for muscle tension, palpation for misalignment, and visual inspection were either undocumented, unreliable, or not valid." [1]

The committee's statement, "Aetna's policy is based on a lack of adequate evidence of its effectiveness in improving clinical outcomes from prospective clinical studies in the peer-reviewed published medical literature. Aetna's position is based, not on the quantity of references to the sacro-occipital technique, but on the poor quality of evidence supporting the safety and effectiveness of this technique from prospective clinical outcome studies in the peer-reviewed published clinical literature," has some flaws in their rationale. These flaws are as followed:

1.    Compared to any chiropractic technique, sacro-occipital technique (SOT) has a significant number of published articles. Admittedly SOT still has work to do improving the quality of any and all studies performed, but still compared to other chiropractic techniques, the quality and quantity of the research puts SOT is in the upper echelon.

2.    As I have stated in multiple communications, SOT has been used for over 70 years by tens of thousands of chiropractors, its primary method of treatment the pelvic blocks was highly approved by the (now outdated) Mercy Guidelines [2], National Board of Chiropractic Examiners Study found that close to 50% of all chiropractors use SOT [3], and all studies ever written describing chiropractic techniques consider SOT as one of its "major" techniques [4-6].

3.    There is no doubt that the committee needs to address their acceptance of many medical procedures that have poor quality of evidence [7], that the SOT observational studies can have some merit [8], and that there is some question as to the ultimate use of RCTs [9] especially in lieu of the consistent clinical findings of SOT for over 70 years.

4.    Lastly, the "grandfathering" or "off-label" use of medications is commonly accepted in the medical field (general practice [10-11], pediatrics [12-13], psychiatry [14], dermatology [15], obstetrics [16], and oncology [17]) and Aetna often does not dispute the use of medications in this manner. This is based on the anecdotal evidence of medical healthcare practitioners weighed against the cost of needed research versus the benefit of the pharmaceutical agent used. SOT has been a technique used for over 70 years, is widely accepted by chiropractic healthcare practitioners over that time, its safety has not been questioned in the literature and the literature is building consistent greater evidence for its effectiveness. Compared to other chiropractic techniques and medical procedures not labeled by Aetna, "experimental and investigational" sacro-occipital technique has a significantly greater evidence base.

The committee's statement is inconsistent and holds sacro-occipital technique to a different standard than what it holds other chiropractic techniques as well as many medical modes of care. I would greatly appreciate if the committee would kindly respond to this email and evaluate the enclosed with an open mind.

Sincerely,

Charles

Charles L. Blum, DC
Santa Monica, California
drcblum@aol.com
www.soto-usa.org

References

1.    Hestœk L, Leboeuf-Yde C, Are chiropractic tests for the lumbo-pelvic spine reliable and valid? A systematic critical literature review Journal of Manipulative and Physiological Therapeutics 2000 (May);23:258–75.

2.    Haldeman S, Chapman-Smith D, Peterson DM, Guidelines for Chiropractic Quality Assurance and Practice Parameters:Proceedings of the Mercy Center Consensus Conference, Aspen Publisher,Inc.: Gaithersburg, Maryland; 1993: 106-8.

3.    Christensen M, NBCE's Job Analysis 2000, NBCE: 901 54th Avenue, Greeley, CO 80634 (970) 356-9100 nbce@nbce.org [http://www.chiroweb.com/archives/18/14/23.html]

4.    Gleberzon BJ, Chiropractic Name Techniques inCanada: A Continued Look at Demographic Trends and Their Impact on Issuesof Jurisprudence J Can Chiropr Assoc 2002; 46(4): 241-56.

5.    Gleberzon BJ, Incorporating Named Techniques into a Chiropractic College Curriculum: A Compilation of Investigative Reports   The Journal of Chiropractic Education 2000;14(1): 33-4.

6.    Bergmann TF, Various Forms of Chiropractic Technique, Chiropractic Technique May 1993; 5(2):53-5.

7.    Booth A, Djulbegovic B, Guthrie B, Perleth M, Sackett D, et al, What proportion of healthcare isevidence based? Resource Guide. [http://www.shef.ac.uk/%7Escharr/ir/percent.html]

8.    Concato J, Shah N, Horwitz RI.   Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000 Jun 22;342(25):1887-92. Department of Internal Medicine, Yale University School of Medicine, New Haven, Conn 06510, USA. john.concato@yale.edu

9.    Rosner A, Fables or FoiblesL Inherent Problems with RCTs Journal of Manipulative and Physiological Therapeutics ;26(7): 460-7.

10.    O'Reilly J, Dalal A. Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approveddrugs. Ann Health Law. 2003 Summer;12(2):295-324.

11.    McIntyre J, Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off label prescribing of drugs in general practice.Arch Dis Child. 2000 Dec;83(6):498-501

12.    Cuzzolin L, Zaccaron A, Fanos V. Unlicensed and off-label uses of drugs in paediatrics: a review of the literature. Fundam Clin Pharmacol. 2003 Feb;17(1):125-31. Review.

13.    Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol. 2002 Dec;54(6):665-70.

14.    Weiss E, Hummer M, Koller D, Pharmd, Ulmer H, Fleischhacker WW. Off-label use of antipsychotic drugs. J Clin Psychopharmacol. 2000 Dec;20(6):695-8.

15.    Li VW, Jaffe MP, Li WW, Haynes HA. Off-labeldermatologic therapies. Usage, risks, and mechanisms. Arch Dermatol.1998 Nov;134(11):1449-54.

16.    Rayburn WF. A physician's prerogative to prescribe drugs for off-label uses during pregnancy. Obstet Gynecol. 1993 Jun;81(6):1052-5.

17.    Kocs D, Fendrick AM. Effect of off-label useof oncology drugs on pharmaceutical costs: the rituximab experience. AmJ Manag Care. 2003 May;9(5):393-400.

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From: Charles Blum, DC - SOTO-USA
Sent: January 27, 2004
To: Aetna Chiropractic Reviews - Robert Frank, DC
Subject: Still Awaiting Aetna’s Clinical Policy Committee Response

January 27, 2004

Dear Dr. Frank,

I have not received a reply from you from the enclosed sent January 13, 2004. I will give you a call to see if you are receiving my emails. Thanks so much for your help, I realize you are going out of your way to assist me in this process.

Sincerely,

Charles

From: Aetna Response Robert Frank , DC
Sent:    January 28, 2004
To:    Charles Blum, DC From: Aetna – Dr. Robert Frank
Subject: Aetna’s Non-Response

January 28, 2004

Good Morning Dr. Blum,

I hope this finds you well. I have taken your email to the Review Committee and upon review of these materials, there is no change in Aetna's position on S.O.T. warranted at this time.

Robert Frank, D.C.

From: Charles Blum, DC - SOTO-USA
Sent: January 28, 2004
To: Aetna Chiropractic Reviews - Robert Frank, DC
Subject: Regarding Aetna’s Clinical Policy Committee’s Response

January 28, 2004

Dear Dr. Frank,

Thank you for your reply. I suppose the ultimate position of the review committee is to not respond to my email or its questions of having a double standard. Most likely by not responding to my questions it can then maintain its position without any necessary rationale. I will continue to pursue this but will be working through other channels at this time. Thank you for your help and follow through.

Sincerely,

Charles

Charles L. Blum, DC
Santa Monica, California
drcblum@aol.com
www.soto-usa.org

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