The use of randomized control trials in complementary therapies: exploring the issues

Abstract

The current popularity of complementary therapies presents an interesting challenge to nurses and midwives. If they are to deliver such therapies themselves, or support patients in choosing appropriate therapies they will need to consider the professional and legal issues, in particular those regarding safety. Evidence for the effectiveness for complementary therapies is also a requirement in order that their integration into nursing practice can be justified. Purchasers are currently hampered by the lack of credible evidence for effectiveness and until that evidence is provided, access to such therapies through the National Health Service (NHS) will remain limited. The form that evidence should take has led to a lively debate about possible methodological approaches. There appears to be a clash between the medical profession and those working in the field of complementary therapy research, with the medical establishment advocating randomized control trials (RCTs). This contrasts with the view held by some advocates of complementary therapies that the RCT approach is reductionist and not applicable to such approaches. The pivot of the debate on the methodological approaches for evaluating complementary therapies is the contrast of two apparently different and diverse world-views, and the assertion that methods developed in one world-view are not transferable to the other. There is also some confusion within the field of complementary therapy over the applicability of RCTs to therapies such as acupuncture, and the mistaken assumption that trials which include a control group, are also required to be double-blind. This paper is based on the need for good quality evidence of effectiveness in complementary therapy. It will set out the concerns associated with the use of RCTs within complementary therapy, together with the benefits and limitations of this approach. The paper will go on to review research options and propose some suggestions for future methodological approaches.

A Non-Randomised Pilot Study to Compare Complementary and Conventional Treatments of Acute Sinusitis

“…This should be regarded as an advantage rather than disadvantage of the current trial as it imitates real-life situations. In the notation of Richardson [21] this type of research is called pragmatic and contrasted to explanatory trials which try sub-divide each strategy into its constituent parts. Our study was not randomised.…”

Are there risks associated with using mindfulness in the treatment of psychopathology?

“…However, the scope of any form of empirical inquiry -whether quantitative or qualitative -is governed by the hypothesis for which the study is designed to test. For example, randomized controlled trial designs are frequently employed in MBI efficacy studies yet some authors consider randomized controlled trials to be reductionist due to evaluating only a limited number of predefined outcomes (and thus disregarding participants' wider experiences) [5] Given that robust empirical studies explicitly investigating whether MBI participation can incur adverse effects have yet to be undertaken, the eventuality of MBIs leading to nonsalutary health outcomes remains a possibility. This possibility is made even more real by the fact that: adverse effects have been observed for other (i.e., nonmindfulness) forms of meditation [6,7]; there are detailed accounts in the classical Buddhist meditation literature of how meditation and/or mindfulness practice can detrimentally impact upon psychosocial (and spiritual) functioning [3]; and in the opinion of the present authors, studies yielding flat or negative effects can often experience difficulty in being accepted for publication.…”

Key Issues in Clinical and Epidemiological Research in Complementary and Alternative Medicine – a Systematic Literature Review

“…Over the years, the general nature of research questions in CAM has shifted from efficacy to effectiveness [2,36,81]. Pragmatic trials involve randomisation [20,33,83,84] and treatment has to be defined adequately and clearly [53,83,85]. In contrast to the wide use of explanatory RCTs addressing efficacy, pragmatic trials have greater external validity [19,20,38,44,52,83,85,86].…”