Introduction to Randomised Sham
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In view of the wide usage of acupuncture, any conclusion that one might try to draw in the future should be based on data on patient and clinically relevant outcomes, assessed in large, high-quality randomised sham-controlled trials with homogeneous groups of participants and transparent funding.
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Large-sized, high-quality randomised sham-controlled trials with homogeneous groups of participants and transparent funding are lacking.
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Methods As part of a randomised sham-controlled feasibility trial of 20 sessions of high-frequency rTMS to the left dorsolateral prefrontal cortex, 26 of 34 trial participants completed arterial spin labelling (ASL) functional magnetic resonance imaging (fMRI) to quantify regional and global resting state CBF before (pre-randomisation baseline) and after real or sham treatment (1-month post-randomisation).
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Design We performed a multicentre, single-blind, randomised sham-controlled trial of patients with persistent dysphagia (>3 months) after laparoscopic fundoplication.
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Given the lack of randomisation and controls in this study, prospective randomised sham-controlled stimulation trials are now warranted to establish the efficacy of interventional neurorehabilitation following craniotomy.
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The most important message from all reviews, best practice documents, and editorials is that there is a great need for welldesigned, randomised sham controlled studies exploring the histological understanding, the use of energy-based therapies in urogynaecology, and long-term consequences of therapy [3].
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In view of the wide usage of acupuncture, any conclusion that one might try to draw in the future should be based on data on patient and clinically relevant outcomes, assessed in large, high-quality randomised sham-controlled trials with homogeneous groups of participants and transparent funding.
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MethodsElectronic search of Medline and PsycInfo identified 19 studies with stimulation frequency of 18–20 Hz using F8-coil (k = 8 randomised sham-controlled trials, RCTs, k = 3 open-label; n = 168 patients) or H1-coil (k = 1 RCT, k = 7 open-label; n = 200).
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However, the first randomised sham-controlled trial, Symplicity HTN-3, failed to demonstrate a significant difference in BP reduction between the RAD and the sham control arm, which subsequently led to a major reduction in the clinical application of this procedure.
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Large-sized, high-quality randomised sham-controlled trials with homogeneous groups of participants and transparent funding are lacking.
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Further randomised sham-controlled trials are needed to further assess this treatment.
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gov database offers a great overview of the concluded studies as well many ongoing ones, including multi-centric randomised sham-controlled trials, which might alleviate some of the authors’ pessimism regarding the present and future quality of evidence on the topic.
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