Impact of sham acupuncture information disclosure in participant information leaflets on participant blinding and trial outcomes: a randomised controlled trial

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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

BACKGROUND While 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 ...

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Author’s response to reviews Title: 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 Authors:

ANSWER> We agree on the reviewer‟s point that some tricks may be necessary as far as such practice is ethically legitimate. While our study taking an example of placebo-controlled trials of acupuncture suggests that information on placebo in PILs may affect blinding and outcomes thus routinely accepted placebo information disclosure in PILs should be revisited, we chose to cautiously call for m...

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Acupuncture for persistent allergic rhinitis: a randomised, sham-controlled trial.

OBJECTIVE To investigate the effectiveness and safety of acupuncture in persistent allergic rhinitis (PAR) DESIGN: Randomised, single-blind, sham-controlled trial conducted from May 2004 to February 2005. PARTICIPANTS AND INTERVENTION 80 patients with PAR (age, 16-70 years) were randomly assigned to receive real or sham acupuncture. After a 1-week baseline period, participants were treated tw...

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Injury risk in runners using standard or motion control shoes: a randomised controlled trial with participant and assessor blinding

BACKGROUND/AIM This randomised controlled trial investigated if the usage of running shoes with a motion control system modifies injury risk in regular leisure-time runners compared to standard shoes, and if this influence depends on foot morphology. METHODS Recreational runners (n=372) were given either the motion control or the standard version of a regular running shoe model and were follo...

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Impact of different privacy conditions and incentives on survey response rate, participant representativeness, and disclosure of sensitive information: a randomized controlled trial

BACKGROUND Anonymous survey methods appear to promote greater disclosure of sensitive or stigmatizing information compared to non-anonymous methods. Higher disclosure rates have traditionally been interpreted as being more accurate than lower rates. We examined the impact of 3 increasingly private mailed survey conditions-ranging from potentially identifiable to completely anonymous-on survey r...

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ژورنال

عنوان ژورنال: Integrative Medicine Research

سال: 2020

ISSN: 2213-4220

DOI: 10.1016/j.imr.2020.100504