Whether the medical profession approves or not, the uptake of complementary medicine by the public is high and increasing.1 As individuals we can either ignore or accept this, but as a profession we are unlikely to adopt complementary medicine as standard healthcare unless rigorous, scientific standards are applied to the evaluation of therapies.2 While some complementary medical disciplines have begun to apply these successfully,3-5 the overall state of the evidence is still inconclusive. Spiritual healing is one discipline where further evaluation is required.6, 7

Spiritual healing is a non-invasive complementary therapy that has been widely available in the United Kingdom since 1977.8 In theory it transfers "healing energy", derived from an intangible source, from the healer to the patient, with no physical contact or requirement for formal religious faith. It has several potential applications, including the treatment of chronic conditions, pain and addiction.

A recent systematic review of randomised controlled trials (RCTs) of "distant healing" (including spiritual healing) was unable to conclude whether this was an effective intervention, and called for more trials with rigorous methods.7 These should specifically include control groups receiving placebo ("sham") treatment.7

The Chief Scientist Office at the Scottish Executive Health Department has recently awarded research funding for a randomised controlled trial of spiritual healing in asthma.9 This will compare the effectiveness of four sessions of spiritual healing with placebo treatment (given by an actor) and with a control group receiving normal care. Participants will be recruited from respondents to press advertisements.

The double-blind RCT is considered to be the "gold standard" method of evaluating therapies for reasons which are now well-established.10, 11 Advantages include the minimisation of bias and confounding, and distinguishing treatment effects from placebo effects.

There are, though, a number of problems with the conduct and interpretation of RCTs.10, 12, 13 It is important to know whether we are assessing efficacy (does the treatment work?) or effectiveness (will the treatment work in practice?). This distinction guides analysis and interpretation.

There may be difficulties extrapolating the findings from the study population (which will usually exclude the extremes of age, individuals with co-morbidity, and other groups) to the general population (which includes all of these). It may only be possible to apply the findings from an RCT to the individual in the surgery, ward or clinic if the individual could have been recruited to the study population. RCTs usually focus on one "primary" outcome measure. However the effectiveness of most treatments extends beyond this, to include immeasurable concepts such as quality of life, as well as a host of "secondary" outcome measures, for which the study is unlikely to be powered.

An RCT of spiritual healing faces particular challenges. The strength of the placebo effect is at the heart of these. While most research views a placebo effect as a "menace", to be minimised by study design or analysis, a recent UK House of Lords report saw the placebo effect in spiritual healing as a positive one, difficult or impossible to distinguish from any "true" effect, and therefore an integral part of the overall treatment effect.14 The House of Lords considered that there was therefore "lesser need of proof of treatment-specific effects but [researchers] should control their claims according to the evidence available to them."

This argument is supported by Walach,15 who criticised the negative interpretation of an RCT of spiritual healing in chronic pain which employed a "sham" treated control group.16 He argues that placebo produces "nonspecific" (though important) components of the treatment effect, and is therefore valid and valuable. Furthermore, given the theory that governs spiritual healing, even the most rigorously designed "sham" treatment could still be considered to transfer healing energy unconsciously.

Spiritual healing has a particular potential to affect life beyond the primary outcome measure. An important component of evaluation is therefore the inclusion of a wide raft of outcome measures, addressing as great a breadth of health and quality of life dimensions as practical. This will provide a full picture of the treatment effect (if any is present), including a look at the "nonspecific" effects (but will also increase the likelihood of "statistically significant" effects occurring by chance).

The strength of the placebo effect is related to the level of expectation.17 Spiritual healing is therefore likely to be more effective among those who intuitively expect an effect, and less effective among sceptics. Thus, an RCT that recruited from the general population would be likely to under-estimate the effectiveness of spiritual healing (and placebo).

In real life, sceptics are unlikely to accept referral for spiritual healing. The recruitment strategy for the CSO-funded project can therefore be justified, though the researchers should be aware of correspondingly over-estimating any treatment effect.  The CSO-funded trial includes three study arms, and this is appropriate. However, this will still not fully distinguish treatment effect from placebo effect (if the latter is considered to include the former) .

How can we respond? There are three options:

(1) presume in advance that the science cannot be sound;

(2) accept that placebo and healing are indistinguishable, and judge the results accordingly;

(3) call for more research into the nature of the placebo effect.

The first option is the approach of the ostrich, and the third is probably ideal.15 The second option leaves us with the dilemma of how to explain the results of trials to our patients, who may be receiving expensive placebo, while benefiting nonetheless. In many ways this is no different from traditional medicine.

In the wider field of complementary medicine, these issues present methodological challenges, but it is ideally through trials such as these that effectiveness may be determined,7, 18 and clinical science may advance.

Tel+44 (0)1224-553972

Fax +44 (0)1224-840683

email: blairsmith@abdn.ac.uk

 

Acknowledgements: The author is funded by a NHS R&D National Primary Care Career Scientist Award, which is funded through the Chief Scientist Office of the Scottish Executive Department of Health.

 

R e f e r e n c e s

 1 Rees L, Weil A. Integrated medicine. Br Med J 2001;322:119-120.

 2 Ernst E. Complementary medicine: too good to be true? Journal of the Royal Society of Medicine 1999;92: 1-2.

 3 Cochrane Library. The Complementary Medicine Field Module. Oxford: Update Software, 1998.

 4 Vincent C. Complementary medicine: state of the evidence. Journal of the Royal Society of Medicine 1999; 92: 170-177.

 5 Cooke B, Ernst E. Aromatherapy: a systematic review. British Journal of General Practice 2000; 50: 493-496.

 6 Fox R. Healing powers. Journal of the Royal Society of Medicine 1998; 91: 177.

 7  Astin JA, Harkness E, Ernst E. The efficacy of "distant healing": a systematic review of randomized controlled trials. Annals of Internal Medicine 2000; 132: 903-910.

 8 National Federation of Spiritual Healers. Code of Conduct. Sunbury-on-Thames: NFSH, 1995.

 9 Scottish Executive Health Department. Research notes. Health Bulletin 2002; 60: 94.

10 Altman D. Better reporting of randomised controlled trials: the CONSORT statement. Br Med J 1997; 314: 1126-1127.

11 Bossuyt PM. Better standards for better reporting of RCTs. Br Med J 2001; 322: 1317-1318.

12 Mant D. Can randomised trials inform clinical decisions about individual patients? The Lancet 1999; 353: 743-746.

13 Rosser WW. Application of evidence from randomised controlled trials to general practice. The Lancet 1999; 353: 661-664.

14 House of Lords Select Committee on Science and Technology. 6th Report, Complementary and Alternative Medicine. House of Lords, 2000.

15 Walach H. The efficacy paradox in randomized controlled trials of CAM and elsewhere: beware of the placebo trap. Journal of Alternative and Complementary Medicine 2001; 7: 213-218.

16 Abbott NC, Harkness EF, Stevinson C, Marshall FP, Conn DA, Ernst E. Spiritual healing as a therapy for chronic pain: a randomized controlled trial. Pain 2001; 91: 79-89.

17 Kirsch I. Specifying nonspecifics: psychological mechanisms of placebo effects, in Harrington A (ed) "The Placebo Effect: Interdisciplinary Explorations." Cambridge, MA: Harvard University Press, 1997: 166-186

18  Margolin A, Avents AS, Kleber HD. Investigating alternative medicine therapies in randomized controlled trials. JAMA 1998; 280: 1626-1628.

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