Sham interventions in randomized clinical trials of acupuncture

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A recent review of sham applications in Germany.

 

Complement Ther Med. 2003 Dec;11(4):235-42.

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Sham interventions in randomized clinical trials of acupuncture--a

review.

 

Dincer F, Linde K.

 

Department of Clinical Medicine II, Centre for Complementary Medicine

Research, Technische Universitat Munchen, Munich, Germany.

 

BACKGROUND AND OBJECTIVES: For non-drug interventions such as

acupuncture, it is difficult to establish placebo or sham controls

that are both inert and indistinguishable. We reviewed sham-controlled

clinical trials of acupuncture to investigate (a) which types of sham

interventions have been used in the past; (b) in what respects true

and sham interventions differed; and © whether trials using

different types of sham yielded different results. METHODS: 47

randomized controlled trials comparing true and sham acupuncture

interventions for pain and a variety of other conditions were

identified from systematic reviews and through a search in PubMed.

Details of patients, interventions, sham interventions and outcomes

were extracted in a standardized manner. RESULTS: In two trials the

sham intervention consisted of superficial needling of the true

acupuncture points, four trials used true acupuncture points which

were not indicated for the condition being treated, in 27 trials

needles were inserted outside true acupuncture points, five trials

used placebo needles and nine trials used pseudo-interventions such as

switched off-laser acupuncture devices. True and sham interventions

often differed in a variety of other variables, such as manipulation

of needles, depth of insertion, achievement of an irradiating needling

sensation (de-chi), etc. There was no clear association between the

type of sham intervention used and the results of the trials.

CONCLUSION: Randomized trials investigating the specific effects of

acupuncture have used a great variety of sham interventions as

controls. Summarizing all the different sham interventions as

" placebo " controls seems misleading and scientifically unacceptable.

 

PMID: 15022656 [PubMed - in process]

 

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Michael