Rosa N Schnyer, University of Arizona, Tucson and Fayez K Ghishan, Co-Investigator: Andrew Weil

The Pediatric Center for Complementary and Alternative Medicine at the University of Arizona focuses on pediatric health issues. A major portion of the program is designed to train pediatric fellows in the area of complementary and alternative medicine. The Center is augmented by an administrative core with a biostatistical component and four cores including bioenergetics, biopsychosocial, biopharmacologic, and biomechanical cores. The program incorporates allopathic physicians and complementary and alternative medicine practitioners from various disciplines to form a cohesive program to advance knowledge in regard to alternative approaches in pediatric patients. There are three projects:

1. "A Randomized, Controlled Trial of the Use of Cranial Sacral Osteopathic Manipulation and Botanical Treatment on Recurrent Otitis Media in Children",
2. "Prospective Studies of the Use of Osteopathic Manipulation and/or Acupuncture on Muscle Tension in Children with Spastic Cerebral Palsy",
3. "Treatment of Functional Abdominal Pain in Children: Evaluation of Relaxation/Guided Imagery and Chamomile Tea as Therapeutic Modalities."

This presentation will focus primarily on Project 2, which involves the use of acupuncture in the treatment of spastic Cerebral Palsy.

Cerebral Palsy CAM protocol: Dr. Buris Duncan, Principal Investigator

After a year of developing the infrastructure and establishing the details of implementation, the protocol and study design have been fine-tuned and finally established. The primary objectives of the study are to explore osteopathic manipulation and/or acupuncture in:

1. Decreasing the degree of muscle tone in children with spastic CP,
2. Improving functional abilities and "quality of life". There are three arms to the study (25 children each). Children are randomly assigned into:

1. Control group as a wait list,
2. Osteopathic group,
3. Acupuncture group.

During a six month intervention the children either receive a total of 14 treatment sessions (1/2 hour each - 7 hours) of osteopathy craniosacral manipulation & myofascial release, or a total of 30 acupuncture treatment sessions (1/2 hour each - 15 hours) which include scalp, body and auricular points. The control arm of the study involves non-therapeutic play (total of 11 hours). As a pilot study, a few children have been selected to receive a combination of osteopathic and acupuncture therapies; these children receive a weekly sequence of osteopathic manipulation followed by acupuncture for a total of 13 osteopathic and 26 acupuncture treatment sessions in six months. Children and their families self-select themselves for this pilot study, given the enormous time commitment.

A total of 43 children have been enrolled in the study. 27 children are currently actively receiving treatment, and 3 are in the process of receiving baseline evaluations. 11 children have dropped out and 2 have been deemed ineligible. Reasons for dropping out include: child is having surgery, difficulty with the time commitment, or the child was moved into a different foster home.

The acupuncture protocol has been manualized; the manual was written by Joe Balensi the main acupuncture provider in the study with Rosa N. Schnyer, Burris Duncan and Sharon Mc Donough-Means; the first draft is available for comments at:
www.chinesemedicinesampler.com/CPHTML/critiquerequest.htm

NIH Progress Reports: Pilot Studies of Chronic Low Back Pain and Fibromyalgia

Sherman KJ, Northwest Institute of Acupuncture and Oriental Medicine and Department of Epidemiology, University of Washington, Seattle, WA

The Northwest Institute of Acupuncture and Oriental Medicine is collaborating with researchers at two Seattle biomedical institutions to conduct pilot studies of acupuncture as a treatment for chronic low back pain and for fibromyalgia. In the back pain study, a five arm pilot clinical trial, with two treatment arms (individualized acupuncture and a standardized prescription) and three control arms (needle control, non-needle control, standard care control) is currently being conducted. Literature reviews, reviews of clinical treatment data, and a survey of acupuncturists informed the development of proposed treatments in three of the arms of the study. A non-needle control that simulated the sensation of needling among acupuncture naïve patients was developed. In the fibromyalgia study, a four arm clinical trial with a directed acupuncture treatment and three control groups (acupuncture for another condition, acupuncture using non-channel, non-point needling, and non-needle simulated acupuncture) is nearly underway.

Funding acupuncture research: The NCCAM perspective
Christine H. Goertz, National Center for Complementary and Alternative Medicine, NIH, Bethesda, MD

In 1998 Congress expanded the status, mandate, and authority of the Office of Alternative Medicine at the National Institutes of Health (NIH) by enacting legislation to create the National Center for Complementary and Alternative Medicine (NCCAM).

The NCCAM is charged to "conduct basic and applied research (intramural and extramural), research training, and disseminate health information and other programs with respect to identifying, investigating, and validating CAM treatments, diagnostic and prevention modalities, disciplines and systems." Congress has expressed growing support for the NCCAM’s mission by providing progressive budget increases for the Center. Succinctly, NCCAM is dedicated to exploring complementary and alternative healing practices in the context of rigorous science; training researchers; and disseminating authoritative information.

Some of the first grants awarded by the NCCAM were in the area of acupuncture research. We currently support studies investigating acupuncture treatment for depression, fibromyalgia, hypertension, diarrhea in HIV patients, carpal tunnel syndrome, back pain, depression in pregnancy and knee arthritis. We have also funded work focused on the underlying mechanisms of action, or biology, of acupuncture.

One indication of the NCCAM’s continuing interest in acupuncture research is a concept clearance presented to the NCCAM National Advisory Committee in September 2000 on the biology of acupuncture. The goal of this initiative is to promote innovative research that will advance our understanding of the underlying mechanisms of this unique form of therapy, and permit improved clinical trials that may yield improved clinical applications.

Acquiring the crucial information needed to develop improved intervention and therapeutic strategies employing acupuncture requires a broad range of basic studies including, but not limited to:

1. Elucidating the basic biology and biochemistry of acupuncture;
2. Characterizing the actions of acupuncture at both cellular and system levels;
3. Defining actions of acupuncture on the endocrine, immune, and nervous systems, including any interactions between these three systems;
4. Identifying the biological and psychological sources of individual differences in response to acupuncture therapy, including genetic variation;
5. Defining and characterizing of the biological basis for individual acupuncture points;
6. Investigating the scientific basis for key traditional acupuncture concepts such as Qi and the meridian system;
7. Developing objective methods to overcome the technical challenges faced when studying the efficacy of acupuncture.

Applications combining multidisciplinary approaches and applications that include collaborations between practitioners of acupuncture and scientists with expertise in the disciplines of anatomy, biochemistry, cellular biology, endocrinology, imaging technologies, immunology, neurology, pharmacology, physiology, etc. are strongly encouraged. The use of current paradigms and technical approaches in these fields to the study of acupuncture is encouraged.

Although inroads in the biology of acupuncture have been made, there are still critical gaps in the literature. This initiative will support innovative research intended to increase the knowledge base and expand clinical applications of acupuncture. The mechanisms of support will include the investigator-initiated research project grant (R01), and the exploratory/developmental research grant (R21) and proposed funding is 1.5 million dollars in total costs in FY 2001.