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Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial [with consumer summary]
Vas J, Mendez C, Perea-Milla E, Vega E, Panadero MD, Leon JM, Borge MA, Gaspar O, Sanchez-Rodriguez F, Aguilar I, Jurado R
BMJ 2004 Nov 20;329(7476):1216-1220
clinical trial
9/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVES: To analyse the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical function during treatment; modifications in the consumption of diclofenac during treatment; and changes in the patient's quality of life. DESIGN: Randomised, controlled, single blind trial, with blinded evaluation and statistical analysis of results. SETTING: Pain management unit in a public primary care centre in southern Spain, over a period of two years. PARTICIPANTS: 97 outpatients presenting with osteoarthritis of the knee. INTERVENTIONS: Patients were randomly separated into two groups, one receiving acupuncture plus diclofenac (n = 48) and the other placebo acupuncture plus diclofenac (n = 49). MAIN OUTCOME MEASURES: The clinical variables examined included intensity of pain as measured by a visual analogue scale; pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index; dosage of diclofenac taken during treatment; and the profile of quality of life in the chronically ill (PQLC) instrument, evaluated before and after the treatment programme. RESULTS: 88 patients completed the trial. In the intention to treat analysis, the WOMAC index presented a greater reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8) The reduction was greater in the subscale of functional activity. The same result was observed in the pain visual analogue scale, with a reduction of 26.6 (18.5 to 34.8). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability (p = 0.021) and psychological functioning (p = 0.046). Three patients reported bruising after the acupuncture sessions. CONCLUSIONS: Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee.
Reproduced with permission from the BMJ Publishing Group.

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