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Can Quality Research
On Acupuncture Be Performed?
Juan Antonio Guerra de Hoyos, MD
Elena Bassas Baena de León, MD
Maria del Carmen Andres Martín, MD
Francisco Antonio Verdugo Morilla, MD
Maria Jose Gonzales Moreno, RN
ABSTRACT
Since the introduction of acupuncture in Western countries, debates at the conceptual and empirical levels have occurred regarding how to justify acupuncture practice. Much of the previous research in Eastern and Western countries has lacked quality, producing heterogeneous and conflicting results. Poor application of general research procedures, and specific difficulties related to adapting research designs to acupuncture, have contributed to this problem. To improve the quality of research on acupuncture, it is necessary to upgrade general research procedures and develop a clear, well-adapted methodology that is specific to the field. This analysis examines acupuncture research and presents solutions for improving it. Research can be planned and conducted by a multidisciplinary team (including acupuncture practitioners, researchers, and methodologists) to enhance acupuncture's efficacy and safety, as well as to establish a solid body of evidence that justifies acupuncture practice.
KEY WORDS
Complementary and Alternative Medicine, Acupuncture, Research Quality, Research Design, Trials Quality
INTRODUCTION
The practice of acupuncture and Oriental medicine has increased in Western countries, leading to conflicts between Western medicine and Oriental medicine ideologies. Differences exist at the conceptual level (i.e., in world views and medical paradigms, with Oriental medicine being considered as "alternative," "complementary," or "integrative," or simply being rejected), and at the empirical/pragmatic level (i.e., treatment interventions and their efficacy, cost-effectiveness, and safety).1
Much of the research in Eastern and Western countries has lacked quality2 and produced conflicting results, emerging when the studies were systematically reviewed.3-5 Valid and clear conclusions are difficult to reach due to problems with general research procedures or difficulties specific to acupuncture. Most researchers advocate adoption of the randomized controlled trial (RCT) design, conventional medicine's "gold standard," to acupuncture.6,7 Various solutions have been proposed for overcoming these difficulties, but these methods have not produced consistently successful results.4,8-13 Drawing on the authors' personal perspectives, this analysis describes some of the problems in acupuncture research and presents a potential solution.
PROBLEMS IN ACUPUNCTURE RESEARCH 14-16
Types of Research
Most research falls into two general categories: (1) observational case series, which do not create ethical problems, are easy to perform (but easily flawed), and do not establish acupuncture efficacy; and (2) controlled trials, which are required to control bias and create major adaptation problems related to the nature of acupuncture. Vital in any research is to select adequate designs to investigate questions regarding differences between techniques and their benefits, harm, efficacy, effectiveness, and cost-effectiveness.
General Research Procedures and Issues
All researchers must address several issues to conduct studies effectively. Some critical flaws include sample sizes that are too small to detect differences in the outcomes, incorrect randomization, inadequacies in outcome measures (e.g., lack of validation, no patient centering, surrogate measures being used, or focusing on symptoms and not on functioning or activity performance), and inadequate follow-up. Other important flaws include not describing the protocol (e.g., type of randomization, diagnosis method, treatment method, and precautions against bias) in published results, making it difficult to apply quality checklists or perform systemic reviews and meta-analyses.
Acupuncture-Specific Research Issues
Research is expensive and requires intensive training. Time and funds are needed to create the kind of multidisciplinary team needed to study a discipline that is not yet fully accepted in the Western medical mainstream. Western governments and industries have only cautiously begun to promote research in this field. Many conventional researchers and practitioners still believe that acupuncture is a useless endeavor, and deem colleagues who enter this field as being unwise.
In addition, highly specific, practical, unresolved problems include:
- Finding a credible placebo that does not interact with patients' neurophysiology, and does not produce unspecific and specific effects
- Keeping practitioners blinded
- Using standardized vs individualized points
- Applying the Chinese diagnostic approach and outcome measures (in terms of Yin/Yang equilibrium) vs Western diagnosis
- Controlling the skill of the practitioner and the manipulation used.Several designs have been tried, each with their advantages and shortcomings:
- Acupuncture vs no treatment (waiting list)
- Acupuncture vs placebo, with skin non-penetrating placebo (e.g., nail pressure, blunt or retractile needle, dummy device, inactive transcutaneous electrical nerve stimulation [TENS], etc.), or with skin-penetrating placebo (e.g., deep or superficial puncture next to active points or on inactive points)
- Acupuncture vs Western treatment (medication, physiotherapy, TENS, etc.)
- Acupuncture plus Western treatment vs acupuncture alone.
SOLUTIONS AND SUGGESTIONS
A New Type of Protocol
Real acupuncture plus medication vs placebo acupuncture plus medication is a new design being used for two RCT protocols already in progress (Ruiz JV, principal investigator: Comparative randomized trial of acupuncture as complementary treatment for knee osteoarthritis; de Hoyos JA, principal investigator: Simple blind modified randomized clinical trial of acupuncture treatment for shoulder soft tissue lesions).
Researchers are treating the patients in both study groups as similarly as possible by attempting to eliminate differences in patients' expectations, and by keeping the study blinded. Because medication is also given, both groups receive treatment, thus obviating the ethical problems engendered when a study group receives placebo. For these two trials, the researchers who apply the placebo treatment use a retractile needle (to avoid skin penetration and unspecific needle effects), and connect the needle to an electroacupuncture device with functioning leads but without generating any current, to preserve patient blinding and credibility.
Basic Recommendations
There are also some basic recommendations for conducting acupuncture studies. It is worthwhile to become familiar with standard rigorous research methods as well as acupuncture-related diagnostic and treatment patterns. Reading literature about both research and acupuncture is basic. Biases toward conventional or other paradigms should be discarded; results are the objective. What was done? How was it done? What happened? Did the protocol meet the gold standard? If not, what flaws need to be addressed?
Part of setting up the research includes creating a balanced multidisciplinary team with experts on acupuncture and research methodology to develop a quality research protocol. This team should be fully capable of documenting all that goes on in the trial – addressing specific and general problems, choosing correct statistical methods and outcome measures, and designing precautions to avoid different types of biases.
It is essential to adopt a rigorous design. Patients must be blinded; there should be a blinded independent evaluator. Data and statistics should be managed by an independent person, if possible.
During a trial, researchers should look for external and independent revision of the protocol and trial realization. While being rigorous, it is desirable to respect the Eastern pattern of diagnosis and expert techniques. Finally, trial results must be prepared as accurately and thoroughly as possible to ensure complete honesty in reporting, regardless of whether the findings agree with previous hypotheses.
REFERENCES
- Berman BM, Swyers JP, Hartnoll SM, Singh BB, Bausell B. The public debate over alternative medicine: the importance of finding a middle ground. Altern Ther Health Med. 2000;6:98-101.
- Tang JL, Zhan SY, Ernst EC. Review of randomised controlled trials of Traditional Chinese Medicine. BMJ. 1999;319:160-161.
- Ernst E, White AR. A review of problems in clinical acupuncture research. Am J Chin Med. 1997;25:3-11.
- Vickers A, Cassileth B, Ernst E, et al. How should we research unconventional therapies? a panel report from the Conference on Complementary and Alternative Medicine Research Methodology, National Institutes of Health. Int J Technol Assess Health Care. 1997;13:111-121.
- Moroz A. Issues in acupuncture research: the failure of quantitative methodologies and the possibilities for viable, alternative solutions. Am J Acupuncture. 1999;27:95-103.
- Gauss W, Hogel J. Studies on the efficacy of unconventional therapies: problems and designs. Arzneimittelforschung. 1995;45:88-92.
- Ernst E, Armstrong NC, White AR, Pittler MH. Research is needed to determine how to integrate complementary medicine into the NHS. BMJ. 1998;317:1654.
- Ernst E, Resch KL. The "optional cross-over design" for randomized controlled trials. Fundam Clin Pharmacol. 1995;9:508-511.
- Lewith GT, Machin D. On the evaluation of the clinical effects of acupuncture. Pain. 1983;16:111-127.
- Lewith GT, Machin D. A method of assessing the clinical effects of acupuncture. Acupunct Electrother Res. 1981;6:265-276.
- Ryan D. Toward improving the reliability of clinical acupuncture trials: arguments against the validity of "sham acupuncture" as controls. Am J Acupuncture. 1999;27:105-109.
- White AR, Ernst E. A trial method for assessing the adequacy of acupuncture treatments. Altern Ther Health Med. 1998;4:66-71.
- Birch S, Hammerschlag R, Berman BM. Acupuncture in the treatment of pain. J Altern Complement Med. 1996;2:101-124.
- Borkovec TD Nau S. Credibility of analogue therapy rationales. J Behav Ther Exp Psychiatry. 1972;3:257-260.
- Lewith GT, Vincent C. On the evaluation of the clinical effects of acupuncture: a problem reassessed and a framework for future research. J Altern Complement Med. 1996;2:79-90.
- Hammerschlag R. Methodological and ethical issues in clinical trials of acupuncture. J Altern Complement Med. 1998;4:159-171.
AUTHORS' INFORMATION
Dr Juan Antonio Guerra de Hoyos (J A Guerra) specializes in Internal Medicine. He is a Doctor of Acupuncture and a General Practitioner in Primary Care at the Servicio Andaluz de Salud (S.A.S.), Distrito Este-Sur de Sevilla, Centro de Salud de Torreblanca, Sevilla, Spain.
Juan Antonio Guerra de Hoyos, MD*
c/ La Maria n 26
DP 41008
Sevilla, Spain
Phone: 954213758 • E-mail: med010042@saludalia.com; juanantonioguerradehoyos@hotmail.com
Dr Elena Bassas Baena de León (E Bassas) specializes in Internal Medicine and Clinical Analysis, is a Doctor of Acupuncture, and is an Area Specialist at the S.A.S, Hospital Comarcal de Riotinto, Huelva, Spain.
Elena Bassas Baena de Leon, MD
E-mail: turku62@hotmail.com
Dr Maria del Carmen Andres Martín (M C Andres) is a Surgeon and Doctor of Acupuncture in private practice in Sevilla, Spain.
Maria del Carmen Andres Martín, MD
E-mail: madresma@nexo.es
Dr Francisco Antonio Verdugo Morilla (F A Verdugo) is a General Physician and Doctor of Acupuncture in private practice in Sevilla, Spain.
Francisco Antonio Verdugo Morilla, MD
E-mail: faverdugo@hotmail.com; fverdugo@teleline.es
Maria Jose Gonzales Moreno is a Registered Nurse and Professor of Nursing at the School Medical University in Sevilla, Spain.
*Send all correspondence and reprint requests to Dr de Hoyos at the above address.
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