A controlled trial of placebo versus real acupuncture

Goddard, Greg; Shen, Yishan; Steele, Brian E.; Springer, Nathan M.

doi:10.1016/j.jpain.2004.12.009

Cited by 45 publications

(36 citation statements)

References 26 publications

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“…They reported that their procedure was indistinguishable from the same procedure using real needles in acupuncture naïve subjects. Our data also agrees with the results presented by Goddard et al 13 who also concluded that their subjects were not able to reliably differentiate between real and placebo acupuncture. Finally, a study by Takakura and Yajima 10 used a penetrating (real) and non-penetrating needle (sham) acupuncture on 114 healthy volunteers who were informed that they would receive either a non-penetrating or a penetrating needle.…”

Section: Discussionsupporting

confidence: 92%

“…The sham needle study method used by Goddard et al 13 was quite similar to our method with the main difference being that in their study the acupuncturist had to manually perceive when the shortened (sham needle) needle touched the skin and they would have to be careful not to push hard enough to allow the needle to penetrate the skin. In our study, we used a fi xed length clear guide tube with the bottom portion of the tube covered by the foam.…”

Section: Discussionmentioning

confidence: 99%

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Validation of a Simplified Sham Acupuncture Technique for Its Use in Clinical Research: A Randomised, Single Blind, Crossover Study

et al. 2010

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ObjectivesThe validity of a new sham acupuncture technique was tested on acupuncture naïve healthy subjects. Methods The procedure was tested in accupoints LI4 and ST6 in a randomised, single blind and crossover study. The participants were blind to which technique they received. 32 healthy volunteers (15 men, 17 women, aged between 20 and 62 years, mean age 34 years) were recruited at the Universidad de la República, Uruguay. Interventions Participants were randomly assigned to one of two groups: (1) real acupuncture or (2) sham acupuncture. After 30 min, the patients were 'needled' again in a crossover design. Main outcome measures A yes/no questionnaire was used to assess the credibility and characteristics of the procedure. Results For the credibility question (do you think you received real acupuncture?) no statistically signifi cant group differences were evident before or after the crossover. Subjects who answered yes to this question ranged from 14/16 (87.5%) before crossover to 10/16 (62.5%) after crossover for the sham and 12/16 (75%) before crossover to 15/16 (93.8%) after crossover for the real acupuncture. The question that showed a signifi cant difference (only after crossover) was the question, "did you feel the needle penetrating the skin?"; after crossover 12/16 (75%) subjects in the real acupuncture group said yes and 2/16 (12%) subjects in the sham group said yes to this question (p<0.01). Conclusions These data suggests that this method is credible and constitutes a simple and inexpensive technique for use as a control in clinical research in acupuncture naïve subjects. INTRODUCTIONEvidence based medicine requires well-controlled research studies with adequate placebo techniques that mimic all aspects of the active intervention but are inert. Acupuncture therapy is used world wide for the treatment of several diseases but the lack of research studies with acceptable controls has been a major methodological problem. The lack of adequate sham procedure in the past has led researchers to compare real acupuncture with a wide variety of other interventions. For example, it is still common to see published peer-reviewed research in which the sham procedure consists on needling non-acupuncture points or minimal subcutaneous stimulation in acupuncture points.3 4 It was argued that procedures which imply needle insertion are not acceptable as controls because they can elicit neurobiological responses at various levels in the central nervous system, including the primary and secondary somatosensory cortex, anterior cingulated cortex and the insula region. 6The National Institutes of Health already recognised this methodological problem a decade ago during the Consensus Conference on Acupuncture 1 and concluded that "Although there have been many studies of its potential usefulness, many of these studies provide equivocal results because of design, sample size, and other factors". Furthermore, it was specifi cally stated that the lack of appropriate controls such as placebos and sham acupunctur...

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Validation of a Simplified Sham Acupuncture Technique for Its Use in Clinical Research: A Randomised, Single Blind, Crossover Study

et al. 2010

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“…One question is whether this is caused by the treatment as such or by less specific placebo-or procedurerelated effects; this should be evaluated with a proper placebo model. Placebo needles have been developed but probably cause neuronal stimulation [33,34]. We are not aware of any study that has used the placebo acupuncture needle on hot flushes in women with breast cancer; when the present study was designed, no such needle was available.…”

Section: Discussionmentioning

confidence: 99%

“…Acupuncture has not yet been sufficiently compared with placebo. Although placebo needles exist [33][34][35], they are probably not completely non-effective, and induce neuronal stimulation [36,37]. Moreover, a placebo needle was not available when this study was designed.…”

Section: Introductionmentioning

confidence: 99%

Long-term follow-up of acupuncture and hormone therapy on hot flushes in women with breast cancer: a prospective, randomized, controlled multicenter trial

Frisk¹,

Carlhäll²,

Källström³

et al. 2008

Climacteric

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Objective To evaluate the effects of electro-acupuncture (EA) and hormone therapy (HT) on vasomotor symptoms in women with a history of breast cancer.Methods Forty-five women were randomized to EA (n = 27) for 12 weeks or HT (n = 18) for 24 months. The number of and distress caused by hot flushes were registered daily before, during and up to 24 months after start of treatment.Results In 19 women who completed 12 weeks of EA, the median number of hot flushes/24 h decreased from 9.6 (interquartile range (IQR) 6.6-9.9) at baseline to 4.3 (IQR 1.0-7.1) at 12 weeks of treatment (p < 0.001). At 12 months after start of treatment, 14 women with only the initial 12 weeks of EA had a median number of flushes/24 h of 4.9 (IQR 1.8-7.3), and at 24 months seven women with no other treatment than EA had 2.1 (IQR 1.6-2.8) flushes/24 h. Another five women had a decreased number of flushes after having additional EA. The 18 women with HT had a baseline median number of flushes/24 h of 6.6 (IQR 4.0-8.9), and 0.0 (IQR 0.0-1.6; p = 0.001) at 12 weeks.Conclusion Electro-acupuncture is a possible treatment of vasomotor symptoms for women with breast cancer and should be further studied for this group of women.

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“…In addition, these controls were often investigated in inexperienced subjects (29,39), so the blinding of this method should be considered when the subjects have had extensive experience in acupuncture.…”

Section: Problems With Study Designmentioning

confidence: 99%

Is acupuncture no more than a placebo? Extensive discussion required about possible bias

Deng

Zhao

et al. 2015

Experimental and Therapeutic Medicine

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Abstract. Numerous randomized controlled trials (RCTs) of acupuncture have been conducted in recent years. The results of several studies implied that acupuncture was only a powerful placebo; however, certain studies demonstrated that verum acupuncture had a greater effect than placebo and the mechanisms between a verum acupuncture group and a placebo/sham group were different. Researchers attempted to investigate the inherent factors that may potentially influence the results of trials. Certain problems observed in acupuncture RCTs also occurred in RCTs in other fields, including insufficient sample size, high dropout rates, inadequate follow-up and randomization. The study of acupuncture is so complex that specific methodological challenges are raised, which are frequently overlooked, including sham interventions, blinding, powerful placebo effects (even stronger than an inert pill) and variations in acupuncture administration. The aforementioned problems may contribute to bias, and researchers systematically attempt to solve these problems. The present review aimed to suggest techniques to design high-quality studies, minimize the placebo effect and optimize acupuncture administration in acupuncture studies. If these problems are addressed, then the results of acupuncture studies may be different.

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A controlled trial of placebo versus real acupuncture

Cited by 45 publications

References 26 publications

Validation of a Simplified Sham Acupuncture Technique for Its Use in Clinical Research: A Randomised, Single Blind, Crossover Study

Validation of a Simplified Sham Acupuncture Technique for Its Use in Clinical Research: A Randomised, Single Blind, Crossover Study

Long-term follow-up of acupuncture and hormone therapy on hot flushes in women with breast cancer: a prospective, randomized, controlled multicenter trial

Is acupuncture no more than a placebo? Extensive discussion required about possible bias

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