“I assumed that one was a placebo”: Exploring the consent process in a sham controlled acupressure trial

Hughes, John; Russell, William Howard; Breckons, Matthew; Richardson, Janet; Lloyd‐Williams, Mari; Molassiotis, Alex

doi:10.1016/j.ctim.2014.07.005

Cited by 4 publications

(4 citation statements)

References 24 publications

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“…could be affected by the participants’ expectations to treatment, which subsequently exaggerates therapeutic effects, future studies could consider including some objective measures. Some scholars point out that instead of using the word of “sham” or “placebo”, informing participants that the aim of study is to compare two different treatment procedures would be more credible to reach a successful blinding of study subjects [ 2 , 94 ]. This kind of incomplete informed consent may be in debate for ethical reasons [ 2 ].…”

Section: Implications For Future Research and Practicementioning

confidence: 99%

“…This kind of incomplete informed consent may be in debate for ethical reasons [ 2 ]. However, according to the results of a nested qualitative study within a RCT using acupressure (both true and sham) for controlling chemotherapy-induced nausea, it was acceptable for the study participants to receive this kind of consent process [ 94 ]. Meanwhile, from the findings of this review as well as other studies on sham acupoint stimulation [ 92 , 95 ], sham interventions can also contribute to symptom improvement, and thus, it seems plausible to view the sham acupressure as a non-specific treatment approach in nature.…”

Section: Implications For Future Research and Practicementioning

confidence: 99%

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Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

et al. 2015

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ObjectivesTo explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method.MethodsRandomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes.ResultsSixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and “non-acupoint” stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes.ConclusionsA great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes cannot be derived because of significant clinical heterogeneity among the analyzed trials. Non-acupoints are generally recommended but the definite locations should be identified with caution. For studies using single sham acupoints on hands or legs, it is suggested to apply identical acupressure devices on the same acupoint as in the active intervention without any stimulation. While for studies on pain, stimulation of sham acupoints should be avoided.

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Section: Implications For Future Research and Practicementioning

confidence: 99%

Section: Implications For Future Research and Practicementioning

confidence: 99%

Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

et al. 2015

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“…The sample size was determined based on other nested qualitative studies in RCTs, where the sample size ranged between 30 and 40 interviews [ 37 , 38 ]. To capture experience over time, interviewees were interviewed at two time points.…”

Section: Methodsmentioning

confidence: 99%

How Do Patients with Chronic Neck Pain Experience the Effects of Qigong and Exercise Therapy? A Qualitative Interview Study

Holmberg

Farahani

Witt

2016

Evidence-Based Complementary and Alternative Medicine

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Background. The high prevalence of chronic neck pain in high income countries impacts quality of life and the social and work-related activities of those afflicted. We aimed to understand how mind-body therapies and exercise therapy may influence the experience of pain among patients with chronic neck pain. Methods. This qualitative interview study investigated how patients with chronic neck pain experienced the effects of exercise or qigong therapy at two time points: during an intervention at three months and after the intervention at six months. Interviews were analysed thematically across interviews and within person-cases. Based on other qualitative studies, a sample size of 20 participants was deemed appropriate. Results. The sample (n = 20) consisted of 16 women and four men (age range: 29 to 59). Patients' experiences differed according to the therapies' philosophies. Exercise therapy group interviewees described a focus on correct posture and muscle tension release. Qigong group interviewees discussed calming and relaxing effects. Maintaining regular exercise was easier to achieve with exercise therapy. Conclusions. The findings of this study may help health care providers when counselling chronic pain patients on self-help interventions by informing them of different bodily and emotional experiences of mind-body interventions compared to exercise therapy.

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“…The informed consent process has not been well studied in relation to acupuncture studies. Hughes and colleagues examined the consent process in a RCT of sham acupressure which did not explicitly indicate that participants may receive a sham intervention [ 6 ]. Participants in this study indicated that they believed they were fully informed when giving consent that it was acceptable to use a sham intervention, and that the majority indicated they assumed one of the treatment arms would be a placebo.…”

Section: Introductionmentioning

confidence: 99%

A survey of study participants’ understanding of informed consent to participate in a randomised controlled trial of acupuncture

Smith¹,

Fogarty²

2015

BMC Complement Altern Med

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BackgroundIt is important that potential study participants are appropriately informed and understand what is involved with their research participation. A few studies have examined study participants’ understanding of the informed consent process and the adequacy of the information they received when agreeing to participate in a randomised controlled trial. Deficiencies in the consent process have been found. This topic remains an under researched area of acupuncture research. The aim of this study was to examine participants’ understanding of their informed consent and the adequacy of the information presented when agreeing to participate in a randomised controlled trial of acupuncture.MethodsAll women who participated in a randomised controlled trial over an 11 month period were invited to participate in a survey. An anonymous self-completion questionnaire was designed and covered participants’ understanding of informed consent in the clinical trial, their views of the information provided, the opportunity to ask questions, the use of sham acupuncture, their recall of study visits and processes for withdrawal, and their reason for participating in the trial.ResultsA response rate of 59 % was obtained. Over 90 % of subjects indicated there was plenty of opportunity to discuss the study prior to giving consent, and 89 % indicated that questions asked were answered to their satisfaction. The majority of women indicated the amount of information describing acupuncture was about right, however 24 % would have liked more. Information describing sham acupuncture was not considered adequate by 48 % of women, and 35 % would have liked more information, 30 % could not recall why, or were uncertain why a sham group was used. Participants indicated less understanding of the information relating to payment if they became ill due to study participation, risks and discomforts from the study interventions, which of the procedures were experimental and for how long they would be involved in the study.ConclusionTrial participants’ understanding of informed consent was overall satisfactory but highlighted some areas of deficiency. Future studies could consider use of supplementary material such as Q and A fact sheets.

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“I assumed that one was a placebo”: Exploring the consent process in a sham controlled acupressure trial

Cited by 4 publications

References 24 publications

Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

How Do Patients with Chronic Neck Pain Experience the Effects of Qigong and Exercise Therapy? A Qualitative Interview Study

A survey of study participants’ understanding of informed consent to participate in a randomised controlled trial of acupuncture

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