Evaluating complementary medicine: methodological challenges of randomised controlled trials

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Abstract
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 or work—environment: as well as promoting wellness, some complementary medicine contains a philosophy that everything is interconnected, and consequently intrinsically bound in a therapeutic relationship between the individual and practitioner.1 Linked to the idea of self healing is a spiritual component: some complementary practitioners believe that illness has a corrective purpose, showing the underlying disharmony in people's lives and enabling identification of areas for change.6 Illness is, in addition, recognised as complex, embracing factors such as genetic predisposition, environment, and diet. Conventional medical relief of symptoms or even “cure” may be considered a temporary respite if the individual does not tackle the underlying cause—for example, by releasing suppressed anger, forgiving, or reducing stress by changing job or being more accepting of circumstances. Complementary treatment aims to be tailored to the individual's stage in life, exploring different underlying causes and solutions. The challenge for research methodology is to fuse the philosophical concerns of stakeholders with the highest standards of methodological rigour. Taking complementary practitioners' criticisms of randomised controlled trials seriously enables methods to be modified so that the concerns of all stakeholders are taken into account. This ensures that as far as possible what is being assessed under experimental conditions is consistent with everyday complementary practice. In this paper, we consider the core methodological difficulties in assessing complementary medicine and offer practical solutions.7–9 Some evidence from unmodified trials can be rejected as invalid and is therefore ignored; anecdotes from practice are rejected as meaningless. Unless evidence is generated in a way that satisfies all parties, it is unlikely to have an impact on the objective of having evidence based decision making and practice.