Evaluating complementary medicine: methodological challenges of randomised controlled trials

doi:10.1136/bmj.325.7368.832

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Su Mason, honorary principal research fellowa (medsam@leeds.ac.uk),
Philip Tovey, principal research fellowb,
Andrew F Long, professorc

^aNorthern and Yorkshire Clinical Trials and Research Unit, Academic Unit of Epidemiology and Health Services Research, University of Leeds, Leeds LS2 9NG,
^bSchool of Healthcare Studies, University of Leeds
^cHealth Care Practice Research and Development Unit, University of Salford, Salford M5 4WT

Correspondence to: S Mason

Accepted 10 April 2002

Complementary medicine is increasingly popular for treating many different problems. Doctors and patients need evidence about complementary treatments, but randomised controlled trials need to be carefully designed to take holism into account and avoid invalid results

You think that by understanding one, you can understand two, for one and one is two. But to understand two, you must first understand “and.” Sufi saying1

Complementary medicine should be evaluated as rigorously as conventional medicine to protect the public from charlatans and unsafe practices,2^–5 but many practitioners of complementary medicine are reticent about evaluation of their practice. Sceptics maintain that this is because of fear that investigations will find treatments ineffective and threaten livelihoods. In defence, many practitioners argue that research methods dissect their practice in a reductionist manner and fail to take into account complementary medicine's holistic nature leading to invalid evaluation.

Summary points

Complementary medicine has a different philosophy from conventional medicine, presenting challenges to research methodology
Rigorous evaluation of complementary medicine could provide much needed evidence of its effectiveness
Good design of randomised controlled trials will avoid invalid results and misrepresentation of the holistic essence of complementary medicine
Practitioners need to be recognised as a component in or contributor to complementary treatment
Both specific and non-specific outcome measures with long follow up are needed to adequately encompass the essence of complementary medicine

Nature of complementary medicine

Complementary medicine comprises many different disciplines, a wide spectrum of practices and philosophies which differ from conventional medicine. Conventional medicine traditionally aims to diagnose illness and treat, cure, or alleviate symptoms. Many complementary disciplines aim not only to relieve symptoms and restore wellness but also to help individuals in a process of self healing within a holistic view of health. In this view, individuals are more than just mind, body, and spirit in a social—family …