Pain is the major complaint of the estimated one million U.S. consumers who use acupuncture each year. Although acupuncture is widely available in chronic pain clinics, the effectiveness of acupuncture for chronic pain remains in question. Our aim was to assess the effectiveness of acupuncture as a treatment for chronic pain within the context of the methodological quality of the studies. MEDLINE (1966-99), two complementary medicine databases, 69 conference proceedings, and the bibliographies of other articles and reviews were searched. Trials were included if they were randomized, had populations with pain longer than three months, used needles rather than surface electrodes, and were in English. Data were extracted by two independent reviewers using a validated instrument. Inter-rater disagreements were resolved by discussion. Fifty one studies met inclusion criteria. Clinical heterogeneity precluded statistical pooling. Results were positive in 21 studies, negative in 3 and neutral in 27. Three fourths of the studies received a low-quality score and low-quality trials were significantly associated with positive results (P=0.05). High-quality studies clustered in designs using sham acupuncture as the control group, where the risk of false negative (type II) errors is high due to large sample size requirements. Six or more acupuncture treatments were significantly associated with positive outcomes (P=0.03) even after adjusting for study quality. We conclude there is limited evidence that acupuncture is more effective than no treatment for chronic pain; and inconclusive evidence that acupuncture is more effective than placebo, sham acupuncture or standard care. However, we have found an important relationship between the methodology of the studies and their results that should guide future research.