Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trialBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.38238.601447.3A (Published 18 November 2004) Cite this as: BMJ 2004;329:1216
- Jorge Vas (), chief medical officer1,
- Camila Méndez, epidemiologist2,
- Emilio Perea-Milla, chief medical officer3,
- Evelia Vega, chief medical officer7,
- María Dolores Panadero, pharmacologist2,
- José María León, professor4,
- Miguel Ángel Borge, chief medical officer6,
- Olga Gaspar, nurse1,
- Francisco Sánchez-Rodríguez, technician5,
- Inmaculada Aguilar, nurse1,
- Rosario Jurado, nurse1
- 1 Pain Treatment Unit, Centro de Salud “Dos Hermanas A” (Distrito Sanitario Sevilla-Sur), 41700 Dos Hermanas, Spain
- 2 Distrito Sanitario Sevilla-Sur, Alcalá de Guadaira 41500, Spain
- 4 Department of Social Psychology, Universidad de Sevilla, 41018 Sevilla, Spain,
- 3 Research Support Unit, Hospital Costa del Sol, 29600 Marbella, Spain, 4 Department of Social Psychology, Universidad de Sevilla, 41018 Sevilla, Spain
- 5 Servicio Andaluz de Salud, Servicio de Ordenación Sanitaria, 41001 Sevilla, Spain
- 6 Municipal Medical Services, 41927 Mairena del Aljarafe, Spain
- 7 Pain Treatment Unit, Centro de Salud “Castilleja de la Cuesta,” 41950 Castilleja de la Cuesta, Spain
- Correspondence to: J Vas
- Accepted 7 September 2004
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.
We thank M J Cano,J G de Hoyos,E Bassas, and C Andrés for their work in the conduct of the study, and J G de Hoyos for his useful comments on the initial protocol.
Contributors JV, CM, EP-M, and JML designed the study. EV, MAB, MDP, OG, FS-R, IA, and RJ contributed to conduct of the study and writing of the paper. Statistical analysis was done by EP-M, CM, and JML. EV revised the final version of the manuscript.
Funding This study was partly financed by Servicio Andaluz de Salud (Grant No 192/99). The acupuncture materials and the drugs used in the study were provided by the Sevilla-Sur health district authorities.
Competing interests None declared.
Ethical approval Valme Hospital Ethics Committee, Seville.