Reply to "The discussion on the validity of sham controls and patient blinding in a sham-controlled acupuncture trial" [Integr Med Res 2022; 11: 100795].
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SUBMITTER: Kim M
PROVIDER: S-EPMC8857644 | biostudies-literature | 2022 Jun
REPOSITORIES: biostudies-literature
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Reply to "The discussion on the validity of sham controls and patient blinding in a sham-controlled acupuncture trial" [Integr Med Res 2022; 11: 100795].
Kim Mikyung M Kwon O-Jin OJ Lee Jun-Hwan JH Kim Joo-Hee JH
Integrative medicine research 20220201 2
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Project description:IntroductionAlthough various sham acupuncture techniques have been employed to ensure blinding in randomised controlled trials (RCTs) of acupuncture, the effectiveness of blinding in these trials and its influence on trial effect size estimates remain unclear. The objectives of this study are the following: (1) to investigate the proportion and study characteristics of sham-controlled trials reporting on blinding assessment, (2) to assess the blinding effectiveness of different types of sham acupuncture, (3) to investigate the relationship between blinding effectiveness and effect sizes in acupuncture RCTs.Methods and analysisWe will search PubMed and EMBASE from inception to 1 January 2025 to identify RCTs that compared acupuncture with sham acupuncture in humans with any disease or symptom, with no restrictions on language. Paired investigators will independently determine eligibility and use pilot-tested standardised forms for data extraction. We will calculate the proportion of sham-controlled trials that assessed and reported blinding success and conduct descriptive analyses of general study characteristics, acupuncture treatment details, sham acupuncture details and blinding assessments for included trials. We will assess the effectiveness of blinding success using the James blinding index (BI) and Bang BI, and pool data from included trials using random-effects models. We will use Hedges' g, a standardised mean difference, with its 95% CI, to calculate treatment effects. We will use Pearson's r correlation coefficient to assess the relationship between blinding effectiveness and trial effect sizes when variable distributions meet the assumptions of normality and linearity; otherwise, we will consider employing non-parametric tests. When sufficient data are available, we will also use random-effects meta-regression to explore the relationship.Ethics and disseminationEthical approval is not required. The findings of this study will be disseminated through peer-reviewed publications, conference presentations and condensed summaries for clinicians, health policymakers and guideline developers regarding the design, conduct, analysis and interpretation of blinded assessment of sham acupuncture RCTs.Study registrationOpen Science Framework (https://doi.org/10.17605/OSF.IO/B3U7K).
| S-EPMC11784118 | biostudies-literature
Project description:Objective: Demand for complementary medicine, in particular, acupuncture, has increased over the past few years but widespread acceptance has been limited, in part, by the lack of high-quality studies, including lack of blinding. Acupuncture studies traditionally have difficulty with blinding as sham acupuncture can have up to a 40%-50% analgesic effect. This study randomized patients between Acupuncture and No Acupuncture (standard of care) without using sham needles. The primary outcome was adequate blinding of electro-auricular acupuncture in the intraoperative setting with secondary outcomes of pain/nausea control. Materials and Methods: Forty patients undergoing anterior cruciate ligament reconstruction were enrolled. Subjects were randomly assigned to receive acupuncture (Enhanced Electro-Auricular Trauma Protocol) or No Acupuncture during their surgeries. All patients received spinal anesthesia and intravenous midazolam, ketamine, and propofol for sedation. 1000 mg of intravenous (IV) acetaminophen and up to 30 mg of IV ketorolac were given at closure. No opioids or peripheral nerve blocks were administered intraoperatively. Results: Bang's Blinding indices were 0.2 (95% confidence interval [CI]: -0.02, 0.42) in the Acupuncture group, and 0.11 (95% CI: -0.10, 0.31) in the No Acupuncture group on postoperative day 1. Both groups had adequate blinding. There were no differences in pain scores, nausea/vomiting incidence, opioid consumption 0-24 hours, or patient satisfaction. Five patients in the No Acupuncture group received rescue blocks, while no patients in the Acupuncture group needed a rescue block (Fisher's exact test: p = 0.047). Conclusions: This study proved the primary hypothesis that adequate blinding of intraoperative acupuncture can be performed when patients are under sedation and neuraxial anesthesia. This research is registered at ClinicalTrials.gov as Clinical Trial Registration #: NCT03711734.
| S-EPMC8403191 | biostudies-literature
Project description:ObjectiveInfantile colic is a painful condition in the first months of infancy. Acupuncture is used in Scandinavia as a treatment for infantile colic. A randomized controlled trial was carried out with the aim of testing the hypothesis that acupuncture treatment has a clinically relevant effect for this condition.DesignA prospective, blinding-validated, randomized controlled multicentre trial in general practice. Research assistants and parents were blinded.Setting13 GPs' offices in Southern Norway.InterventionThree days of bilateral needling of the acupuncture point ST36, with no treatment as control.Subjects113 patients were recruited; 23 patients were excluded, and 90 randomized; 79 diaries and 84 interviews were analysed.Main outcome measuresDifference in changes in crying time during the trial period between the intervention and control group.ResultsThe blinding validation questions showed a random distribution with p = 0.41 and 0.60, indicating true blinding. We found no statistically significant difference in crying time reduction between acupuncture and control group at any of the measured intervals, nor in the main analysis of differences in changes over time (p = 0.26). There was a tendency in favour of the acupuncture group, with a non-significant total baseline-corrected mean of 13 minutes (95% CI -24 to + 51) difference in crying time between the groups. This was not considered clinically relevant, according to protocol.ConclusionThis trial of acupuncture treatment for infantile colic showed no statistically significant or clinically relevant effect. With the current evidence, the authors suggest that acupuncture for infantile colic should be restricted to clinical trials.
| S-EPMC3860294 | biostudies-literature
Project description:BACKGROUND:Knee osteoarthritis (KOA) is one of the most common musculoskeletal disorders. Although the available evidence for its efficacy is inconclusive, acupuncture is used as an alternative therapy for KOA. The aim of this trial is to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. METHODS/DESIGN:This is a study protocol for a randomised, three-arm, multicentre, clinical trial. A total of 480 patients with KOA will be randomly assigned to the electro-acupuncture group, the manual acupuncture group or the sham acupuncture group in a 1:1:1 ratio. All patients will receive 24 sessions over 8 weeks. Participants will complete the trial by visiting the research centre at week 26 for a follow-up assessment. The primary outcome is the success rate: the proportion of patients achieving a minimal clinically important improvement, which is defined as ≥2 points on the numerical rating scale and ≥6 points on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at week 8 compared with baseline. Secondary outcomes include the numerical rating scale, WOMAC score, global patient assessment and quality of life at weeks 4, 8, 16 and 26 after randomisation. DISCUSSION:This trial may provide high-quality evidence for the efficacy of acupuncture in the treatment of KOA. The results of this study will be published in peer-reviewed journals. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03274713 . Registered on 20 November 2017.
| S-EPMC6347816 | biostudies-literature
Project description:ImportanceMotor aphasia is common among patients with stroke. Acupuncture is recommended as an alternative therapy for poststroke aphasia, but its efficacy remains uncertain.ObjectiveTo investigate the effects of acupuncture on language function, neurological function, and quality of life in patients with poststroke motor aphasia.Design, setting, and participantsThis multicenter, sham-controlled, randomized clinical trial was conducted in 3 tertiary hospitals in China from October 21, 2019, to November 13, 2021. Adult patients with poststroke motor aphasia were enrolled. Data analysis was performed from February to April 2023.InterventionsEligible participants were randomly allocated (1:1) to manual acupuncture (MA) or sham acupuncture (SA) groups. Both groups underwent language training and conventional treatments.Main outcomes and measuresThe primary outcomes were the aphasia quotient (AQ) of the Western Aphasia Battery (WAB) and scores on the Chinese Functional Communication Profile (CFCP) at 6 weeks. Secondary outcomes included WAB subitems, Boston Diagnostic Aphasia Examination, National Institutes of Health Stroke Scale, Stroke-Specific Quality of Life Scale, Stroke and Aphasia Quality of Life Scale-39, and Health Scale of Traditional Chinese Medicine scores at 6 weeks and 6 months after onset. All statistical analyses were performed according to the intention-to-treat principle.ResultsAmong 252 randomized patients (198 men [78.6%]; mean [SD] age, 60.7 [7.5] years), 231 were included in the modified intention-to-treat analysis (115 in the MA group and 116 in the SA group). Compared with the SA group, the MA group had significant increases in AQ (difference, 7.99 points; 95% CI, 3.42-12.55 points; P = .001) and CFCP (difference, 23.51 points; 95% CI, 11.10-35.93 points; P < .001) scores at week 6 and showed significant improvements in AQ (difference, 10.34; 95% CI, 5.75-14.93; P < .001) and CFCP (difference, 27.43; 95% CI, 14.75-40.10; P < .001) scores at the end of follow-up.Conclusions and relevanceIn this randomized clinical trial, patients with poststroke motor aphasia who received 6 weeks of MA compared with those who received SA demonstrated statistically significant improvements in language function, quality of life, and neurological impairment from week 6 of treatment to the end of follow-up at 6 months after onset.Trial registrationChinese Clinical Trial Registry: ChiCTR1900026740.
| S-EPMC10804271 | biostudies-literature
Project description:BackgroundWhether acupuncture treatment employing multiple penetrating, skin-touch placebo, or no-touch placebo needles designed for double blinding actually do blind practitioners and patients has not been investigated. We aimed to investigate this question.Subjects120 patients with functional neck/shoulder stiffness but in otherwise healthy condition were randomly assigned to a treatment using four penetrating, four skin-touch placebo, or four no-touch placebo needles. Each of six acupuncturists applied four needles to four acupoints in the neck/shoulder of 20 patients. Acupuncturists and patients were asked to guess the treatment mode and their confidence in their guesses on 100 mm visual analog scales.ResultsThe kappa coefficients between practitioner guesses and treatment type and between patient guesses and treatment type were 0.15 and 0.44, respectively. The median score of practitioner confidence was 46.8, and no significant difference in confidence between correct and incorrect guesses was revealed for any treatment. The median score of patient confidence for correct guesses was 77.6. The kappa coefficient between practitioner and patient guesses was 0.06.ConclusionsThe practitioners were blinded to the nature of treatment using the same multiple needles, but patient blinding was insufficient. Further improvement is necessary to achieve satisfactory patient blinding with these acupuncture needles.
| S-EPMC5532973 | biostudies-literature
Project description:BackgroundSham acupuncture is a widely accepted control in acupuncture clinical trials. Given the nature of acupuncture, it is warranted to assess the blinding of sham-controlled trials. Despite the sham acupuncture design having been widely used, the overall blinding of sham acupuncture and the characteristics of blinding assessment in acupuncture trials are unclear. This research aims to assess the blinding status of acupuncture clinical trials and explore the blinding assessment characteristics in acupuncture trials.MethodsThis meta-analysis included all the acupuncture clinical trials published in English that performed blinding assessments and reported the results. We searched PubMed, Embase, and Web of Science for randomized controlled trials (RCTs) from inception to April 2024. The primary outcome is Bang's Blinding Index (Bang's BI) and 95% credibility interval (CrI) was pooled using a Bayesian hierarchical model. The study adheres to the PRISMA guidelines.ResultsSixty-four eligible studies published from 1999 to 2024 were included. The mean of Bang's BI was - 0.24 (95% CrI - 0.34 to - 0.14, tau2 = 0.13) for the sham acupuncture group and 0.41 (95% CrI 0.32 to 0.49, tau2 = 0.10) for the verum acupuncture group. The characteristics of blinding showed that 62.50% of the trials had a Bang's BI greater than 0 in the verum group and less than 0 in the sham group; in 28.15% of the trials, the Bang's BI was greater than 0 in the verum group and greater than 0 in the sham group. Subgroup analysis revealed that area, number of research centers, treatment sessions, acupoints number, and evaluation timepoint can influence blinding results.ConclusionOverall blinding status in current acupuncture clinical trials shows a majority correctly guessing for the verum group and opposite guessing for the sham group. However, in some acupuncture trials, the blinding of sham acupuncture might be compromised. Factors such as the Asian population, penetrating sham needling, and querying participants about their group assignment during the study increase the risk of unblinding and warrant careful consideration in sham acupuncture control design. Furthermore, researchers should closely monitor the blinding status of sham acupuncture and transparently report details of blinding assessments.Systematic review registrationPROSPERO CRD42023403595.
| S-EPMC11624600 | biostudies-literature
Project description:BackgroundClinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia.MethodsRandomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding.ResultsAt present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments.DiscussionOur approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.
| S-EPMC7529889 | biostudies-literature
Project description:Studies using transcranial direct current stimulation (tDCS) typically incorporate a fade-in, short-stimulation, fade-out sham (placebo) protocol, which is assumed to be indistinct from a 10-30 min active protocol on the scalp. However, many studies report that participants can dissociate active stimulation from sham, even during low-intensity 1 mA currents. We recently identified differences in the perception of an active (10 min of 1 mA) and a sham (20 s of 1 mA) protocol that lasted for 5 min after the cessation of sham. In the present study we assessed whether delivery of a higher-intensity 2 mA current would exacerbate these differences. Two protocols were delivered to 32 adults in a double-blinded, within-subjects design (active: 10 min of 2 mA, and sham: 20 s of 2 mA), with the anode over the left primary motor cortex and the cathode on the right forehead. Participants were asked "Is the stimulation on?" and "How sure are you?" at 30 s intervals during and after stimulation. The differences between active and sham were more consistent and sustained during 2 mA than during 1 mA. We then quantified how well participants were able to track the presence and absence of stimulation (i.e. their sensitivity) during the experiment using cross-correlations. Current strength was a good classifier of sensitivity during active tDCS, but exhibited only moderate specificity during sham. The accuracy of the end-of-study guess was no better than chance at predicting sensitivity. Our results indicate that the traditional end-of-study guess poorly reflects the sensitivity of participants to stimulation, and may not be a valid method of assessing sham blinding.
| S-EPMC8048983 | biostudies-literature
Project description:BACKGROUND:Acupuncture is widely used for knee osteoarthritis (KOA), despite contradictory evidence. This study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. METHODS/DESIGN:This is a multi-center three-arm randomized controlled trial. It will enroll 480 participants with KOA in China. Participants will be randomly assigned 1:1:1 to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8 weeks. The primary outcome is the response rate, which is the proportion of patients who achieve the minimal clinically important improvement in pain and function at 8 weeks. The primary outcome will be analyzed using the Z-test with the intention-to-treat set. Secondary outcomes include pain, function, global patient assessment, and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data. DISCUSSION:The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and to enhance the transparency of the trial. The aim of the trial is to provide high-quality evidence on the efficacy of acupuncture for KOA. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03366363 . Registered on 20 November 2017.
| S-EPMC6610899 | biostudies-literature