Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2005; 10: 17–8
RCTs are considered to be the gold standard for testing the effectiveness of interventions, although there is opposition to using RCTs in CAM. We designed an RCT to test the additional benefit from acupuncture over advice and exercises delivered by physiotherapists for knee pain in older adults. Secondary objectives include investigation of treatment preferences and expectations.
The trial has been designed to meet key design complexities within the CAM literature: generalisability, patient preferences and expectations, treatment credibility and individualisation, and randomisation. (Ernst E. RCTs for CAM. Focus Alternat Complement Ther 2005; 10: 9–12. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005; 330: 1202–5.) Consenting patients are randomly allocated to either a course of advice and exercise (A&E), A&E plus acupuncture or A&E plus sham acupuncture. Follow-up is at 2 weeks by telephone and at 6 weeks, 6 months and 12 months by postal questionnaire. The primary outcome measure is the Western Ontario and McMaster Universities Osteoarthritis Index. The trial involves 41 physiotherapy centres, 104 physiotherapists and has recruited 235 of the 350 patients needed to date.
Interim analysis is not being performed. We will present the objectives and the methods of the trial, including baseline comparability characteristics and follow-up rates. The presentation will focus on the adaptations we have used as part of the trial design and methods, and the content of the interventions.
RCTs are valuable tools in the investigation of acupuncture and design complexities can be overcome. The authors welcome participants to discuss the trial design, methods and adaptations.
The authors acknowledge grant support from the Arthritis Research Campaign.
