Does Prior Acupuncture Exposure Affect Perception of Blinded Real Or Sham Acupuncture?

Dilli, Caitlin; Childs, Rebecca; Berk, Julie; Christian, Mary K.; Nguyen, Nancy; Brown, Riki; Kluger, Benzi M.

doi:10.1136/acupmed-2013-010449

Cited by 10 publications

(8 citation statements)

References 15 publications

(24 reference statements)

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“…This brings concern to Asian researchers that the study participants will easily distinguish real from placebo acupuncture. The rationale behind such fear is not simple, as studies examining the influence of the participant’s previous experience on detecting placebo acupuncture presented conflicting results [ 37 , 38 ]. The notion that blinding may be hampered if trial participants are fully informed on details of placebo acupuncture, is partly explained in our BI analysis.…”

Section: Discussionmentioning

confidence: 99%

Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

Cheon

Park

Chae

et al. 2018

BMC Med Res Methodol

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BackgroundWhile full disclosure of information on placebo control in participant information leaflets (PILs) in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes.MethodsAuthors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI) as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model.ResultsIn 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38). In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03), probably due to enhanced expectations.ConclusionsHow participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we have few empirical findings on this issue, future studies are needed to determine whether the present findings are relevant to other medical disciplines and at the same time a routine practice of fully disclosing placebo information in PILs calls for reevaluation.Electronic supplementary materialThe online version of this article (10.1186/s12874-018-0474-1) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

Cheon

Park

Chae

et al. 2018

BMC Med Res Methodol

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“…However, a systematic review implies that sham acupuncture may have equal therapeutic effect to real acupuncture [ 43 ]. Furthermore, patients with experience of acupuncture treatment can distinguish between real and sham acupuncture [ 44 ], which may introduce bias to acupuncture study. Therefore, sham acupuncture was not used as control in our study.…”

Section: Discussionmentioning

confidence: 99%

Electroacupuncture for Bladder Function Recovery in Patients Undergoing Spinal Anesthesia

Gao

Zhou

Dong

et al. 2014

Evidence-Based Complementary and Alternative Medicine

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Purpose. To determine the efficacy of electroacupuncture on recovering postanesthetic bladder function. Materials and Methods. Sixty-one patients undergoing spinal anaesthesia were recruited and allocated into electroacupuncture or control group randomly. Patients in electroacupuncture group received electroacupuncture therapy whereas ones in control group were not given any intervention. Primary endpoint was incidence of bladder overdistension and postoperative urinary retention. Secondary endpoints included time to spontaneous micturition, voided volume, and adverse events. Results. All patients (31 in electroacupuncture group and 30 in control group) completed the evaluation. During postoperative follow-up, patients in electroacupuncture group presented a significant lower proportion of bladder overdistension than counterparts in control group (16.1% versus 53.3%, P < 0.01). However, no significant difference was found in incidence of postoperative urinary retention between the two groups (0% versus 6.7%, P > 0.05). Furthermore, a shorter time to spontaneous micturition was found in electroacupuncture group compared to control group (228 min versus 313 min, P < 0.001), whereas urine volume and adverse events had no significant difference between the two groups. Conclusions. Electroacupuncture reduced the proportion of bladder overdistension and shortened the time to spontaneous micturition in patients undergoing spinal anesthesia. Electroacupuncture may be a therapeutic strategy for postanesthetic bladder dysfunction.

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“…Initially, participants with any prior acupuncture exposure were excluded because of concerns that prior acupuncture experience could interfere with blinding. 29 However, because of recruitment issues and low concerns regarding patients with few exposures, the study criteria were subsequently modified to allow participants with no acupuncture for the past 6 months. No bias was detected in these participants and all participants were monitored for treatment assignment perceptions.…”

Section: Participantsmentioning

confidence: 99%

“…Some studies suggest that acupuncture-experienced participants might distinguish sham from verum acupuncture more easily, and these studies suggest that such individuals should be excluded from acupuncture trials. 29,34 However, this practice could limit recruitment in areas of the country where acupuncture use is prevalent and could exclude participants who would be most interested in acupuncture. In either case, this issue should be addressed and the criteria should be justified.…”

Section: Inclusion and Exclusion Criteriamentioning

confidence: 99%

See 1 more Smart Citation

Acupuncture for Symptomatic Treatment of Fatigue in Parkinson's Disease: Trial Design and Implementation

Corbin

Childs

Dilli

et al. 2016

Medical Acupuncture

Self Cite

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Background: Acupuncture use is increasing worldwide for many conditions, including movement disorders. Clinical research in acupuncture has also increased to test anecdotal reports of clinical benefits empirically and investigate potential mechanisms. Method: This article describes considerations for designing a double-blinded, randomized, placebo-controlled clinical trial of acupuncture for fatigue in Parkinson's disease (PD) and describes the current authors' experience in the implementation and early conduct of this trial. Relevant literature is also reviewed to provide guidance for other researchers seeking to perform clinical research relevant to PD and related disorders. Results: Trial design should be driven by a well-defined research question and sufficient detail to meet Standards for Reporting Interventions in Clinical Trials of Acupuncture criteria when a trial is complete. Important items for review include: randomization and blinding; recruitment and participant selection; sham methodology choice; staff training; and practical implementation of study procedures. Sample forms used for the current authors' trial are shared. Conclusions: High-quality clinical trials of acupuncture can provide valuable information for clinicians, patients, and policymakers. Acupuncture trials differ in critical ways from pharmaceutical trials and might require additional considerations regarding design and implementation. Adequate preparation for the unique challenges of acupuncture studies can improve trial implementation, design, efficiency, and impact.

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Does Prior Acupuncture Exposure Affect Perception of Blinded Real Or Sham Acupuncture?

Cited by 10 publications

References 15 publications

Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

Electroacupuncture for Bladder Function Recovery in Patients Undergoing Spinal Anesthesia

Acupuncture for Symptomatic Treatment of Fatigue in Parkinson's Disease: Trial Design and Implementation

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