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Complementary and alternative medical treatments: can they really be evaluated by randomised controlled trials?
  1. Leon Wan
  1. Correspondence to Dr Leon Wan, Pennine Acute Hospitals NHS Trust, Manchester, UK; leonwan{at}doctors.org.uk

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Complementary and alternative medicine (CAM) has grown in popularity with the changing burden of disease towards chronic illness. Arguably, this has not coincided with any significant increase in ‘evidence-based medicine’ supporting its use. CAM differs from conventional medicine in that therapy is often tailored to the individual patient. This personalised, holistic approach is fundamentally at odds with the constraints of the randomised controlled trial (RCT).

RCTs try to separate the objective effects of pharmacological medications or medical procedures from the ritual of treatment. However, the context in which a CAM treatment is provided is arguably an intrinsic part of how effective that treatment is.1

Standardisation of therapeutic practice is commonplace in RCTs and is arguably vital for their quality, as it reduces variables that could introduce bias. Although standardised pre-prepared treatments do exist in CAM, best practice is widely considered to be characterised by adaptable and individualised treatment.2 These integral subjectivities, otherwise considered ‘biases’ in RCTs, are believed to be an important part of effective practice. Limiting these factors distorts the validity of results,2 and attempting to measure an isolated ‘active ingredient’ may detract from the overall efficacy.

Blinding poses a problem for CAM treatments such as acupuncture—how can one blind a technical procedure? Regarding trials using sham acupuncture (eg, using retracting needles) one acupuncturist remarked during a recent interview study: “If I were to do a double blind study on acupuncture, I'd have to be ignorant about whether I was giving correct or incorrect treatment… it can never be blind from the practitioner's side”.3

According to practitioners and patients, both the physical and psychological effects of acupuncture are critical in treatment. Irrespective of treatment rationale, acupuncturists generally agree that elicitation of the de qi sensation is important for therapeutic effects, as it correlates with Aδ nerve fibre stimulation. In Chinese medicine, de qi, which can be perceived by both patient and practitioner, is believed to generate synchronicity between the two parties. Only when both patient and practitioner are aware of the attainment of de qi is the therapy considered to be complete. Clearly this is incompatible with double-blinding.

Informed consent is necessary, from an ethical perspective, in order to notify patients that they may be receiving a ‘placebo’. However, this potentially changes the patient's psychological state and relationship with the practitioner. Indeed the analysis by Kaptchuk et al4 of a 2008 acupuncture trial revealed that many patients were worried about whether they were receiving a placebo or not, and whether their doubts or conclusions might affect their clinical outcomes. Although this also applies to conventional medicine, patient engagement is arguably more critical for efficacy in CAM.

While experimental RCTs aim to establish causality by isolating one specific ‘active ingredient’, pragmatic trials look at the overall effect of one treatment compared with another. This rationale is more practical and can be more easily applied to medical decision-making, leading to greater clinical validity. Patients are still randomised, but blinding does not occur where it may not be appropriate. The integrity of the delivery of treatment is maintained, without the restrictions that RCTs may apply. The downside to this approach is that specific and non-specific effects cannot be separated.

Greater utilisation of pragmatic trials, which take into account overall effectiveness and can also be used to assess cost-effectiveness, could help medical decision-making. For example, a large 2006 non-commercially funded UK-wide pragmatic trial of acupuncture for chronic back pain and a linked cost-effectiveness study by Ratcliffe et al5 resulted in the National Institute for Health and Care Excellence (NICE) including acupuncture in its 2009 guidelines for the early management of low back pain in adults (https://www.nice.org.uk/guidance/cg88).

Ratcliffe et al5 summarised that “the base case estimate is £4241 per QALY (quality adjusted life year) gained. Sensitivity analysis showed acupuncture to have more than a 90% probability of being cost effective. Acupuncture costs less and is more effective than usual care.” It has also been shown that acupuncture can reduce the need for medication and GP/hospital visits while maintaining patient quality of life.2

In summary, despite the growing body of evidence to support wider use of CAM treatment, RCT data are still inconclusive in many areas. However, many aspects of RCTs are incompatible with the ‘proper’ practise of CAM. Pragmatic trial data could be utilised more by commissioning bodies when evaluating CAM modalities, such as acupuncture, in order to better compare clinical effectiveness and cost-effectiveness.

References

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Footnotes

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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