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Background Traditional Chinese medicine (TCM) offers various treatment modalities guided by TCM diagnoses. In the United States, acupuncture is a commonly employed TCM method for treating a variety of chronic illnesses. Three systematic reviews have been reported recently, reaching differing conclusions about the efficacy of acupuncture for the treatment of fibromyalgia (FM). Among the FM acupuncture studies considered in these reviews, none used TCM diagnosis as an inclusion/exclusion criterion or adjusted treatment based on TCM diagnosis. Overlooking TCM diagnosis may be a reason for such disparate results. Primary study objective To obtain TCM diagnoses in a sample of women meeting 1990 American College of Rheumatology criteria for FM who were recruited for a yoga study and to investigate whether there is significant variability. Methods/design Two TCM practitioners conducted baseline TCM diagnostic examinations on 56 women with FM. A consensus diagnosis was reached based on standardised history, palpation and examination. Canonical discriminate analysis identified two baseline items which predicted TCM diagnosis. Setting School of Nursing, Oregon Health & Science University. Participants Women, ages 23-75, with FM recruited to a yoga intervention study Results Three primary TCM diagnoses were found in the population: Qi and Blood Deficiency (46.4%, CI 33.0% to 60.36%), Qi and Blood Stagnation (26.8%, CI 15.8% to 40.3%), and Liver Qi Stagnation (19.6%, CI 10.2% to 32.4%). Conclusion It is likely that previous studies of FM were treating a heterogeneous study population where variable results might be expected. Future acupuncture studies should either control for TCM diagnosis or consider its usefulness as an inclusion/ exclusion criterion. [ABSTRACT FROM AUTHOR]