AIMS: To determine the effectiveness of acupuncture as a therapy complementary to the pharmacological treatment of osteoarthritis of the knee. METHODS: Randomised, single blind, placebo controlled trial. Patients with osteoarthritis of the knee were randomly assigned to either 12 sessions of true acupuncture or 12 sessions of placebo acupuncture (Streitberger needle), these sessions taking place once a week. A baseline measurement was carried out, followed by further observations at 4, 8, 12 and 16 weeks. The clinical variables were the WOMAC (Western Ontario and McMaster Universities Osteoarthritis) index, knee pain measured by a visual analogue scale (pain VAS), the weekly consumption of diclofenac and the Profile of the Quality of Life of the Chronically Ill (PQLC). The two groups were compared for each of the clinical variables per protocol and by intention to treat. A multiple linear regression model for the dependent variables was constructed. RESULTS: Ninety seven outpatients were selected, with 88 remaining for the per protocol analysis; the analysis of homogeneity concluded that the lost subjects were not significantly different from those that completed the study. The multivariate per protocol model for the relative pain VAS variable showed a difference in improvement of 43.7% (95% CI 29.4% to 58.0%) for acupuncture, compared with the control group. In an intention to treat analysis, the relative improvement was 32.4% (20.3% to 44.4%). In a per protocol analysis, the total WOMAC showed a relative decrease of 52.0% (34.3% to 69.6%) in favour of the acupuncture group, or 37.6% (22.4% to 52.8%) in an intention to treat analysis. CONCLUSIONS: The group treated with acupuncture showed significantly better effects, both clinically and statistically, in the reduction of pain intensity as measured by pain VAS, on the WOMAC index and in decreased consumption of diclofenac.

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