scholarly journals Effectiveness and adequacy of blinding in the moderation of pain outcomes: Systematic review and meta-analyses of dry needling trials

PeerJ ◽  
2018 ◽  
Vol 6 ◽  
pp. e5318 ◽  
Author(s):  
Felicity A. Braithwaite ◽  
Julie L. Walters ◽  
Lok Sze Katrina Li ◽  
G. Lorimer Moseley ◽  
Marie T. Williams ◽  
...  

Background Blinding is critical to clinical trials because it allows for separation of specific intervention effects from bias, by equalising all factors between groups except for the proposed mechanism of action. Absent or inadequate blinding in clinical trials has consistently been shown in large meta-analyses to result in overestimation of intervention effects. Blinding in dry needling trials, particularly blinding of participants and therapists, is a practical challenge; therefore, specific effects of dry needling have yet to be determined. Despite this, dry needling is widely used by health practitioners internationally for the treatment of pain. This review presents the first empirical account of the influence of blinding on intervention effect estimates in dry needling trials. The aim of this systematic review was to determine whether participant beliefs about group allocation relative to actual allocation (blinding effectiveness), and/or adequacy of blinding procedures, moderated pain outcomes in dry needling trials. Methods Twelve databases (MEDLINE, EMBASE, AMED, Scopus, CINAHL, PEDro, The Cochrane Library, Trove, ProQuest, trial registries) were searched from inception to February 2016. Trials that compared active dry needling with a sham that simulated dry needling were included. Two independent reviewers performed screening, data extraction, and critical appraisal. Available blinding effectiveness data were converted to a blinding index, a quantitative measurement of blinding, and meta-regression was used to investigate the influence of the blinding index on pain. Adequacy of blinding procedures was based on critical appraisal, and subgroup meta-analyses were used to investigate the influence of blinding adequacy on pain. Meta-analytical techniques used inverse-variance random-effects models. Results The search identified 4,894 individual publications with 24 eligible for inclusion in the quantitative syntheses. In 19 trials risk of methodological bias was high or unclear. Five trials were adequately blinded, and blinding was assessed and sufficiently reported to compute the blinding index in 10 trials. There was no evidence of a moderating effect of blinding index on pain. For short-term and long-term pain assessments pooled effects for inadequately blinded trials were statistically significant in favour of active dry needling, whereas there was no evidence of a difference between active and sham groups for adequately blinded trials. Discussion The small number and size of included trials meant there was insufficient evidence to conclusively determine if a moderating effect of blinding effectiveness or adequacy existed. However, with the caveats of small sample size, generally unclear risk of bias, statistical heterogeneity, potential publication bias, and the limitations of subgroup analyses, the available evidence suggests that inadequate blinding procedures could lead to exaggerated intervention effects in dry needling trials.

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034541
Author(s):  
Charlotte Wahlich ◽  
Umar A R Chaudhry ◽  
Rebecca Fortescue ◽  
Derek G Cook ◽  
Shashivadan Hirani ◽  
...  

ObjectiveTo identify randomised controlled trials (RCTs) of physical activity (PA) interventions with objective PA outcomes in adults and to evaluate whether intervention effects were sustained beyond 12 months.DesignSystematic review and meta-analysis.Data sourcesSeven databases (Medline, Embase, PsycINFO, Web of Science, Cochrane library, CINAHL (Cumulative Index of Nursing and Allied Health Literature) and ASSIA (Applied Social Sciences Index and Abstracts)) were searched from January 2000 until December 2019.Eligibility criteriaRCTs reporting objective PA outcomes beyond 12 months with community-based participants aged ≥18 years were included; those where controls received active interventions, including advice to increase PA levels, were excluded.Data extraction and synthesisTwo independent reviewers completed extraction of aggregate data and assessed risk of bias. Meta-analyses used random-effects models at different follow-up points. Primary outcomes were daily steps and weekly minutes of moderate-to-vigorous PA (MVPA).ResultsOf 33 282 records identified, nine studies (at generally low risk of bias) were included, five in meta-analyses with 12 months to 4 year follow-up. We observed 12 month increases for intervention vs control participants in steps/day (mean difference (MD)=554 (95% CIs: 384 to 724) p<0.0001, I2=0%; 2446 participants; four studies) and weekly MVPA minutes (MD=35 (95% CI: 27 to 43) p<0.0001, I2=0%; 2647 participants; four studies). Effects were sustained up to 4 years for steps/day (MD=494 (95% CI: 251 to 738) p<0.0001, I2=0%; 1944 participants; four studies) and weekly MVPA minutes (MD=25 (95% CI: 13 to 37) p<0.0001, I2=0%; 1458 participants; three studies).ConclusionsThere are few PA interventions with objective follow-up beyond 12 months, more studies are needed. However, this review provided evidence of PA intervention effects beyond 12 months and sustained up to 4 years for both steps/day and MVPA. These findings have important implications for potential long-term health benefits.PROSPERO registration numberCRD42017075753.


Vaccines ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 348
Author(s):  
Carla Pires

Background: Vaccine hesitancy is related to a delay in acceptance or refusal of vaccination. Aim: to perform a systematic review of clinical trials on vaccine hesitancy (2015–2020). Methods: a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria (PRISMA). Five databases were screened—PubMed, Cochrane Library, DOAJ, SciELO and b-on—which comprise multiple resources. Keywords: “Vaccine hesitancy” and (“randomized controlled trial” or “clinical trial”). Inclusion criteria: trials about “vaccine hesitancy” enrolling patients and/or health professionals (2015–2020). Exclusion criteria: studies about other topics, repeated and qualitative studies, reviews and papers written in languages other than English, Portuguese, French or Spanish. Results: a total of 35 trials out of 90 were selected (19 PubMed, 14 Cochrane Library, 0 DOAJ, 0 SciELO and 2 b-on). Selected trials were classified into five topics: children/pediatric (n = 5); online or electronic information (n = 5); vaccination against a specific disease (n = 15) (e.g., influenza or COVID-2019); miscellaneous (n = 4); and educational strategies (n = 6). Conclusion: the provision of online or electronic information (e.g., through virtual reality, social websites of experts, or apps), communication-based interventions and training of health professionals, residents or subjects seemed to improve vaccine hesitancy.


Author(s):  
Bruna Francielle Toneti ◽  
Rafael Fernando Mendes Barbosa ◽  
Leandro Yukio Mano ◽  
Luana Okino Sawada ◽  
Igor Goulart de Oliveira ◽  
...  

Objective: to analyze, in the literature, evidence about the benefits of the integrative and complementary practice of Qigong with regard to the health of adults and the elderly. Method: a systematic review by searching for studies in the PubMed, CINAHL, LILACS, EMBASE and Cochrane Library databases. Randomized and non-randomized clinical trials were included; in Portuguese, English and Spanish; from 2008 to 2018. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses strategy was adopted, as well as the recommendation of the Cochrane Collaboration for assessing the risk of bias in the clinical trials analyzed. Results: 28 studies were selected that indicated the benefit of the practice to the target audience, which can be used for numerous health conditions, such as: cancer; fibromyalgia; Parkinson’s disease; Chronic Obstructive Pulmonary Disease; Burnout; stress; social isolation; chronic low back pain; cervical pain; buzz; osteoarthritis; fatigue; depression; and cardiovascular diseases. However, there was a great risk of bias in terms of the blinding of the research studies. Conclusion: the practice of Qigong produces positive results on health, mainly in the medium and long term. This study contributes to the advancement in the use of integrative and complementary practices in nursing, since it brings together the scientific production in the area from the best research results available.


Author(s):  
Hamed Abdollahi ◽  
Mina Abdolahi ◽  
Mohsen Sedighiyan ◽  
Arash Jafarieh

Background: Recent clinical trial studies have reported that L-carnitine supplementation can reduce the mortality rate in patients with sepsis, but there are no definitive results in this context. The current systematic review and metaanalysis aimed to evaluate the effect of L-carnitine supplementation on 28-day and one-year mortality in septic patients. Methods: A systemically search conducted on Pubmed, Scopus and Cochrane Library databases up to June 2019 without any language restriction. The publications were reviewed based on Cochrane handbook and preferred reporting items for systematic reviews and meta-analyses (PRISMA). To compare the effects of L-carnitine with placebo, Risk Ratio (RR) with 95% confidence intervals (CI) were pooled according to random effects model. Results: Across five enrolled clinical trials, we found that L-carnitine supplementation reduce one-year mortality in septic patients with SOFA> 12 (RR: 0.68; 95% CI: 0.49 to 0.96; P= 0.03) but had no significant effect on reducing 28-day mortality ((RR: 0.93; 95% CI: 0.68 to 1.28; P= 0.65) compared to placebo. Finally, we observed that based on current trials, Lcarnitine supplementation may not have clinically a significant effect on mortality rate. Conclusions: L-carnitine patients with higher SOFA score can reduce the mortality rate. However, the number of trials, study duration and using dosage of L-carnitine are limited in this context and further large prospective trials are required to clarify the effect of L-carnitine on mortality rate in septic patients.


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