A recent NIH Consensus Development Conference on Acupuncture noted that many studies have evaluated acupuncture, but """"""""provide equivocal results because of design, sample size, and other factors."""""""" The report concluded that studies overcoming these methodologic challenges would be necessary if valid conclusions were to be reached concerning the efficacy of acupuncture. The goals of the proposed study are to develop and evaluate methods for improving the scientific quality of randomized trials evaluating the efficacy of acupuncture, and to use this information to design and pilot test a randomized clinical trial of the efficacy of acupuncture for persistent low back pain. We will first develop the methods necessary for a valid and meaningful evaluation of acupuncture. We will document the range of diagnoses and treatments for low back pain and the extent to which treatment choice depends on diagnosis. This will involve review of key acupuncture texts, analyses of acupuncture practice data and a survey of a random sample of licensed acupuncturists. We will also conduct a study of the extent of variation in acupuncturists' assessments, diagnoses, and treatments for the same patient. We will use this information to identify an appropriate standardized acupuncture treatment protocol for low back pain that is consistent with common practice and considered credible to practitioners. We will identify and evaluate appropriate comparison treatments, including a credible non-needle treatment and a needle- control treatment, that are indistinguishable from real acupuncture by acupuncture-naive subjects. We will also identify methods for """""""" blinding"""""""" therapists in controlled trials, or at least minimizing potential bias from being unblinded. The findings from these methodological investigations will then be used to design and implement a pilot randomized trial that addresses the following questions: 1) Is acupuncture effective for persistent low back pain?, 2) Is acupuncture more effective when needles are inserted in acupuncture points believed to be effective than when they are inserted in sites believed to be ineffective?, 3) Is acupuncture more effective than standard medical care? 4) Is individualized acupuncture more effective than standardized acupuncture? We will randomize a total of 100 subjects to standardized acupuncture, individualized acupuncture, non-specific needle acupuncture, non-needle (placebo) acupuncture or usual medical care. We will measure each treatment's impact on symptoms, function, satisfaction and utilization/costs of care after 4 weeks, 10 weeks, and 6 months. The pilot study will test the feasibility of conducting a full-scale trial and permit estimation of sample size, requirements.
| Cherkin, Daniel C; Sherman, Karen J; Deyo, Richard A et al. (2003) A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med 138:898-906 |
