Study Design in Acupuncture Research
Janet Steiss DVM, PhD
Scott-Ritchey Research Centre
College of Veterinary Medicine
Auburn University AL 36849, USA
International Veterinary Acupuncture Society (IVAS) 25th Annual Congress,
Lexington, KY, USA, September 1999
Scott-Ritchey Research Centre
College of Veterinary Medicine
Auburn University AL 36849, USA
International Veterinary Acupuncture Society (IVAS) 25th Annual Congress,
Lexington, KY, USA, September 1999
Introduction: Thirty years ago, it was impossible to explain the scientific basis of acupuncture (AP) analgesia to Westerners. Research into the endorphins, enkephalins and descending inhibition of pain has changed that. Now, more laboratory trials and clinical investigations are needed. Western science may not yet be able to reliably measure certain AP effects, such as the bioenergetic/biomagnetic effects. However, many of the effects attributed to AP are measurable.
Much discussion has centred on whether AP either can be or should be tested in controlled trials. At one extreme, we stand in awe of an approach to healing which is based on several thousand years of empirical observation. At the other extreme, we accept only what has been proven by modern statistical methods and outcomes research. We have all heard of masters from the east whose patients have miraculous recoveries. However, we can also be masters in our own house. To paraphrase a leader in the profession of Physical Therapy, when advocating research (1): "Extending our body of knowledge and validating our practice through research earn public trust. Maintaining this trust and our professional viability requires each of us to accept our individual responsibility to support research". From another point of view (2), "There now is a greater emphasis than ever on research, documentation, and outcomes studies to justify our methods. Shouldn't alternative therapies be held to the same standard? When we lose the science, we lose community respect. When we lose that, we lose voice, financial advantages, professional standing and, eventually vocational longevity.....We should be doing clinical trials and outcomes research on the alternatives to determine their efficacy and clinical applications".
The purpose of this presentation is to indicate sources of pertinent information that are available for those involved in designing or evaluating clinical trials of AP. Some specific considerations in designing such experiments have been discussed in the author's previous presentation (Steiss J (1999) Evaluating a Double Blind Study of Acupuncture Therapy for Chronic Lameness in Horses. Proceedings of 25th IVAS Congress, Lexington, KY).
What clinical trials have been published? Like surgery, an AP treatment is a procedure rather than a drug. It is difficult to evaluate AP by the gold standard of randomised blinded trials, and almost impossible to conduct double-blind trials. Much of the clinical data available for AP consists of case-series, such as those often reported for new surgical procedures (3).
However, it may be surprising to see how many controlled AP trials already exist. A bibliography was prepared in support of the NIH Consensus Development Conference on AP held in Bethesda, MD in November, 1997 (3). This document was compiled specifically to help answer the question of whether, based on the clinical data, AP therapy is likely to be helpful in a given clinical problem. It is a primary bibliographic resource. Several computerised databases were searched. Also, the entire NLM collection of journals on the subject of AP was hand-searched. Most of the Medical AP Research Foundation topic sections were divided into sections labelled "selected controlled trials" and "other data" . This bibliography includes citations indexed from January 1970 through September 1997. Another resource that may be useful in the future is ACULARS, the AP Literature Analysis and Retrieval System, produced by the Beijing Institute of Information and Library of the Academy of Traditional Chinese Medicine. Because of its cost and because much of the information is not in English, that database was not used in the NIH bibliography.
That bibliography includes selected controlled trials of AP under the following headings that could be pertinent to veterinary medicine:
What other sources of information have relevant data? There are many published articles, books and web sites that can be useful to an investigator when designing a controlled trial, or to a reader wanting to evaluate the literature (for example, see references 4-6). In addition, the Professional Veterinary Acupuncture List (PVA-L) archive has pertinent discussions on this topic.
References:
Much discussion has centred on whether AP either can be or should be tested in controlled trials. At one extreme, we stand in awe of an approach to healing which is based on several thousand years of empirical observation. At the other extreme, we accept only what has been proven by modern statistical methods and outcomes research. We have all heard of masters from the east whose patients have miraculous recoveries. However, we can also be masters in our own house. To paraphrase a leader in the profession of Physical Therapy, when advocating research (1): "Extending our body of knowledge and validating our practice through research earn public trust. Maintaining this trust and our professional viability requires each of us to accept our individual responsibility to support research". From another point of view (2), "There now is a greater emphasis than ever on research, documentation, and outcomes studies to justify our methods. Shouldn't alternative therapies be held to the same standard? When we lose the science, we lose community respect. When we lose that, we lose voice, financial advantages, professional standing and, eventually vocational longevity.....We should be doing clinical trials and outcomes research on the alternatives to determine their efficacy and clinical applications".
The purpose of this presentation is to indicate sources of pertinent information that are available for those involved in designing or evaluating clinical trials of AP. Some specific considerations in designing such experiments have been discussed in the author's previous presentation (Steiss J (1999) Evaluating a Double Blind Study of Acupuncture Therapy for Chronic Lameness in Horses. Proceedings of 25th IVAS Congress, Lexington, KY).
What clinical trials have been published? Like surgery, an AP treatment is a procedure rather than a drug. It is difficult to evaluate AP by the gold standard of randomised blinded trials, and almost impossible to conduct double-blind trials. Much of the clinical data available for AP consists of case-series, such as those often reported for new surgical procedures (3).
However, it may be surprising to see how many controlled AP trials already exist. A bibliography was prepared in support of the NIH Consensus Development Conference on AP held in Bethesda, MD in November, 1997 (3). This document was compiled specifically to help answer the question of whether, based on the clinical data, AP therapy is likely to be helpful in a given clinical problem. It is a primary bibliographic resource. Several computerised databases were searched. Also, the entire NLM collection of journals on the subject of AP was hand-searched. Most of the Medical AP Research Foundation topic sections were divided into sections labelled "selected controlled trials" and "other data" . This bibliography includes citations indexed from January 1970 through September 1997. Another resource that may be useful in the future is ACULARS, the AP Literature Analysis and Retrieval System, produced by the Beijing Institute of Information and Library of the Academy of Traditional Chinese Medicine. Because of its cost and because much of the information is not in English, that database was not used in the NIH bibliography.
That bibliography includes selected controlled trials of AP under the following headings that could be pertinent to veterinary medicine:
- Allergy and Immunology
- Auricular AP
- Biochemistry and Physiology
- Cardiovascular System
- Dermatology
- Face, Sinuses , Mouth, and Throat
- Gastroenterology
- General Pain
- Genitourinary, Pelvic, and Reproductive Systems
- Low Back
- Lower Extremities
- Nausea, Vomiting, and Postoperative Problems
- Neck and Shoulders
- Nervous System and Special Senses
- Research Methods
- Upper Extremities and Breast
- Veterinary Medicine
What other sources of information have relevant data? There are many published articles, books and web sites that can be useful to an investigator when designing a controlled trial, or to a reader wanting to evaluate the literature (for example, see references 4-6). In addition, the Professional Veterinary Acupuncture List (PVA-L) archive has pertinent discussions on this topic.
References:
- Gossman M, as quoted in PT Magazine Feb 1999: 32.
- Woltersdorf MA. On the edge. PT Magazine, March 1999:124.
- Klein, Lori J.; Trachtenberg, Alan I., compilers. Acupuncture [bibliography online]. Bethesda (MD): National Library of Medicine; 1997 Oct (Current bibliographies in medicine; no. 97-6). 2302 citations, Jan 1970 through Oct 1997. URL http://www.nlm.nih.gov/pubs/cbm/acupuncture.html
- Vincent C, Furnham A. Complementary Medicine: A Research Perspective. Chichester: John Wiley & Sons, 1997, chapter 7 (Richardson P: The placebo effect in orthodox and complementary medicine); chapter 8 (Research methods and research problems in complementary medicine); chapter 9 (The quality of medical information and the evaluation of acupuncture, osteopathy and chiropractic); and, chapter 12 (A research agenda).
- Shen J. Adjunct antiemetic electroacupuncture in myeloablative chemotherapy: Methodological issue in acupuncture clinical trial. AMPAC meeting minutes, Sept 1998. URL http://altmed.od.nih.gov/nccam/news-events/ampac/1998/sep/9.html
- Ballegaard S. Acupuncture and the cardiovascular system: A scientific challenge. Acupuncture in Medicine May 1998. URL http://www.medical-acupuncture.co.uk/journal/may1998/one.shtml
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