Blinding Strategies in Dry Needling Trials: Systematic Review and Meta-Analysis

2019 ◽  
Vol 99 (11) ◽  
pp. 1461-1480 ◽  
Author(s):  
Felicity A Braithwaite ◽  
Julie L Walters ◽  
Lok Sze Katrina Li ◽  
G Lorimer Moseley ◽  
Marie T Williams ◽  
...  

Abstract Background Blinding of participants and therapists in trials of physical interventions is a significant and ongoing challenge. There is no widely accepted sham protocol for dry needling. Purpose The purpose of this review was to summarize the effectiveness and limitations of blinding strategies and types of shams that have been used in dry needling trials. Data Sources Twelve databases were searched from inception to February 2016. Study Selection Trials that compared active dry needling with a sham that simulated dry needling were included. Data Extraction The main domains of data extraction were participant/therapist details, intervention details, blinding strategies, blinding assessment outcomes, and key conclusions of authors. Reported blinding strategies and sham types were synthesized descriptively, with available blinding effectiveness data synthesized using a chance-corrected measurement of blinding (blinding index). Data Synthesis The search identified 4894 individual publications with 27 trials eligible for inclusion. In 22 trials, risk of methodological bias was high or unclear. Across trials, blinding strategies and sham types were heterogeneous. Notably, no trials attempted therapist blinding. Sham protocols have focused on participant blinding using strategies related to group standardization and simulation of tactile sensations. There has been little attention given to the other senses or cognitive strategies to enhance intervention credibility. Nonpenetrating sham types may provide effective participant blinding. Limitations Trials were clinically and methodologically diverse, which limited the comparability of blinding effectiveness across trials. Reported blinding evaluations had a high risk of chance findings with power clearly achieved in only 1 trial. Conclusions Evidence-based consensus on a sham protocol for dry needling is required. Recommendations provided in this review may be used to develop sham protocols so that future protocols are more consistent and potentially more effective.

2021 ◽  
pp. 106002802110497
Author(s):  
Akshaya Srikanth Bhagavathula ◽  
Kota Vidyasaga ◽  
Eyob Alemayehu Gebreyohannes ◽  
Wubshet Tesfaye

Objective: This study aimed to comprehensively evaluate the risk of gastrointestinal bleeding (GIB) with statin monotherapy or with concomitant warfarin use. Data Sources: PubMed, Web of Science, and EMBASE (via Scopus) were searched for observational studies that reported the risk of GIB in adults on statin therapy or with concomitant warfarin use until August 28, 2021. Study Selection and Data Extraction: Observational studies evaluating the risk of GIB in adults (age >18 years) on statin medication or concomitant use with warfarin were included. Data Synthesis: In all, 14 studies with a total of 5 235 123 participants, reporting 48 677 GIB events (43 734 from statin users and 4943 from users of statin combined with warfarin), were included in the analyses. The pooled analysis revealed no difference in the risk of GIB with statin monotherapy (relative risk [RR]: 0.65; 95% CI: 0.42-1.02) or concomitant statin + warfarin use (RR: 0.97; 95% CI: 0.91-1.02). Prior use of statin was not associated with GIB risk (RR: 0.88; 95% CI: 0.63-1.22), whereas a shorter duration of statin use (<5 years) was associated with a lower risk of GIB (RR: 0.42; 95% CI: 0.18-0.97). Relevance to Patient Care and Clinical Practice: This analysis provides strong evidence on the association between statin use (with/without warfarin) and risk of GIB. Conclusion: Statin alone or combined with warfarin was not significantly associated with either an increased or decreased risk of GIB. The GIB risk was significantly lower when statins were used for a short duration (<5 years). The putative relationship between statins and GIB in warfarin users warrant further investigation.


2019 ◽  
Vol 105 (4) ◽  
pp. 1009-1019 ◽  
Author(s):  
Xiaodong Sun ◽  
Ningning Hou ◽  
Hongsheng Wang ◽  
Lin Ma ◽  
Jinhong Sun ◽  
...  

Abstract Context Thyroid autoimmunity (TAI), the most common cause of (sub)clinical hypothyroidism, is associated with adverse pregnancy outcomes. The benefits of levothyroxine (LT4) intervention in women with TAI remain controversial. Objective The purpose of this analysis is to determine the effect of LT4 on pregnancy outcomes in euthyroid women with TAI. Data sources Databases were searched up to May 2019. Study selection Randomized controlled trails (RCTs) and retrospective studies that reported effects of LT4 administration on pregnancy outcomes in euthyroid women with TAI were screened. Data extraction Quality assessment and data extraction were conducted independently by 2 researchers. Conflicts were settled by a third researcher. Data synthesis Six trials comprising 2249 women were included. Overall, no beneficial effect on pregnancy outcomes was observed with LT4 supplementation. For women with individualized initial LT4 dosages, the risk of miscarriage decreased (relative risk [RR] 0.62, 95% CI: 0.41-0.93, I2 = 28%); there was no difference among women with fixed LT4 dosages (RR 0.96, 95% CI: 0.74-1.24, I2 = 0%). Women who initiated LT4 treatment in early pregnancy had a significantly lower preterm birth rate (RR 0.54, 95% CI: 0.31-0.92, I2 = 0%) than those who received no treatment or placebo. No improvement was observed among women who initiated treatment before conception (RR 1.14, 95% CI: 0.71-1.84, I2 = 0%). Conclusion No definitive evidence showed improvement of pregnancy outcomes with LT4 supplementation in euthyroid women with TAI. However, therapeutic strategies, especially dosages and initial times of intervention, may be of great importance. Additional large RCTs are needed in the future.


2021 ◽  
pp. tobaccocontrol-2021-056717
Author(s):  
Joseph G L Lee ◽  
Amanda Y Kong ◽  
Kerry B Sewell ◽  
Shelley D Golden ◽  
Todd B Combs ◽  
...  

ObjectiveWe sought to conduct a systematic review and meta-analysis of evidence to inform policies that reduce density and proximity of tobacco retailers.Data sourcesTen databases were searched on 16 October 2020: MEDLINE via PubMed, PsycINFO, Global Health, LILACS, Embase, ABI/Inform, CINAHL, Business Source Complete, Web of Science and Scopus, plus grey literature searches using Google and the RAND Publication Database.Study selectionIncluded studies used inferential statistics about adult participants to examine associations between tobacco retailer density/proximity and tobacco use behaviours and health outcomes. Of 7373 studies reviewed by independent coders, 37 (0.5%) met inclusion criteria.Data extractionEffect sizes were converted to a relative risk reduction (RRR) metric, indicating the presumed reduction in tobacco use outcomes based on reducing tobacco retailer density and decreasing proximity.Data synthesisWe conducted a random effects meta-analysis and examined heterogeneity across 27 studies through subgroup analyses and meta-regression. Tobacco retailer density (RRR=2.55, 95% CI 1.91 to 3.19, k=155) and proximity (RRR=2.38, 95% CI 1.39 to 3.37, k=100) were associated with tobacco use behaviours. Pooled results including both density and proximity found an estimated 2.48% reduction in risk of tobacco use from reductions in tobacco retailer density and proximity (RRR=2.48, 95% CI 1.95 to 3.02, k=255). Results for health outcomes came from just two studies and were not significant. Considerable heterogeneity existed.ConclusionsAcross studies, lower levels of tobacco retailer density and decreased proximity are associated with lower tobacco use. Reducing tobacco supply by limiting retailer density and proximity may lead to reductions in tobacco use. Policy evaluations are needed.


2020 ◽  
Vol 30 (1) ◽  
pp. 8-15 ◽  
Author(s):  
Jasmine N Khouja ◽  
Steph F Suddell ◽  
Sarah E Peters ◽  
Amy E Taylor ◽  
Marcus R Munafò

ObjectiveThe aim of this review was to investigate whether e-cigarette use compared with non-use in young non-smokers is associated with subsequent cigarette smoking.Data sourcesPubMed, Embase, Web of Science, Wiley Cochrane Library databases, and the 2018 Society for Research on Nicotine and Tobacco and Society for Behavioural Medicine conference abstracts.Study selectionAll studies of young people (up to age 30 years) with a measure of e-cigarette use prior to smoking and an outcome measure of smoking where an OR could be calculated were included (excluding reviews and animal studies).Data extractionIndependent extraction was completed by multiple authors using a preprepared extraction form.Data synthesisOf 9199 results, 17 studies were included in the meta-analysis. There was strong evidence for an association between e-cigarette use among non-smokers and later smoking (OR: 4.59, 95% CI: 3.60 to 5.85) when the results were meta-analysed in a random-effects model. However, there was high heterogeneity (I2=88%).ConclusionsAlthough the association between e-cigarette use among non-smokers and subsequent smoking appears strong, the available evidence is limited by the reliance on self-report measures of smoking history without biochemical verification. None of the studies included negative controls which would provide stronger evidence for whether the association may be causal. Much of the evidence also failed to consider the nicotine content of e-liquids used by non-smokers meaning it is difficult to make conclusions about whether nicotine is the mechanism driving this association.


2012 ◽  
Vol 72 (12) ◽  
pp. 1947-1955 ◽  
Author(s):  
Sandra Garcês ◽  
Jocelyne Demengeot ◽  
Elizabeth Benito-Garcia

BackgroundImmunogenicity of aTNFs is one of the mechanisms behind treatment failure.ObjectiveTo assess the effect of anti-drug antibodies (ADA) on drug response to infliximab, adalimumab and etanercept, and the effect of immunosuppression on ADA detection, in patients with Rheumatoid Arthritis, Spondyloarthritis, Psoriasis and Inflammatory Bowel Diseases.Data sourcesPubMed, EMBASE, Cochrane databases, article reference lists (through August 19 2012).Study selectionOut of 2082 studies, 17 were used in the meta-analysis (1RCT; 16 observational studies).Data extractionTwo reviewers extracted data. Risk ratios (RR), 95% CI, using random-effect models, sensitivity analysis, meta-regressions and Egger's test were calculated.Data synthesisOf 865 patients, ADA against infliximab or adalimumab reduced drug response rate by 68% (RR=0.68, 95% CI=0.12 to 0.36), an effect attenuated by concomitant methotrexate (MTX): <74% MTX+: RR=0.23, 95% CI=0.15 to 0.36; ≥74% MTX+: RR=0.32, 95% CI=0.22 to 0.48. Anti-etanercept antibodies were not detected. Of 936 patients, concomitant MTX or azathioprine/mercaptopurine reduced ADA frequency by 47% (RR=0.53, 95% CI=0.42 to 0.67), particularly when ADA were assessed by RIA (RR=0.36, 95% CI=0.23 to 0.55) compared with ELISA (RR=0.63, 95% CI=0.53 to 0.74).ConclusionsADA reduces drug response, an effect that can be attenuated by concomitant immunosuppression, which reduces ADA frequency. Drug immunogenicity should be considered for the management of patients receiving biological therapies.


2019 ◽  
Author(s):  
Jasmine N Khouja ◽  
Steph F Suddell ◽  
Sarah Peters ◽  
Amy E Taylor ◽  
Marcus R Munafò

AbstractObjectiveThe aim of this review was to investigate whether e-cigarette use compared to non-use in young non-smokers is associated with subsequent cigarette smoking.Data sourcesPubMed, Embase, Web of Science, Wiley Cochrane Library databases, and the 2018 Society for Research on Nicotine and Tobacco and Society for Behavioural Medicine conference abstracts.Study selectionAll studies of young people (up to age 30 years) with a measure of e-cigarette use prior to smoking and an outcome measure of smoking where an odds ratio could be calculated were included (excluding reviews and animal studies).Data ExtractionIndependent extraction was completed by multiple authors using a pre-prepared extraction form.Data synthesisOf 9,199 results, 17 studies were included in the meta-analysis. There was strong evidence for an association between e-cigarette use among non-smokers and later smoking (OR 4.59, 95% CI 3.60 to 5.85) when the results were meta-analysed in a random effects model. However, there was high heterogeneity (I2 = 88%).ConclusionsWhilst the association between e-cigarette use among non-smokers and subsequent smoking appears strong, the available evidence is limited by the reliance on self-report measures of smoking history without biochemical verification. None of the studies included negative controls which would provide stronger evidence for whether the association may be causal. Much of the evidence also failed to consider the nicotine content of e-liquids used by non-smokers meaning it is difficult to make conclusions about whether nicotine is the mechanism driving this association.


Author(s):  
Kalyan Kumar Gangopadhyay ◽  
Jagat J Mukherjee ◽  
Binayak Sinha ◽  
Samit Ghosal

AbstractObjectiveThere are no controlled studies on the role of systemic corticosteroids (CS) in patients with coronavirus disease 2019 (COVID-19). In the absence of high-quality evidence, understandably the recommendations from various organizations are cautious. Several randomized controlled trials are underway but shall take time to conclude. We therefore undertook a meta-analysis to ascertain the role of CS in the management of critically ill patients with COVID-19.Data SourcesElectronic databases, including Pubmed, Cochrane library and Embase, were searched, using the keywords of interest and the PICO search technique, from inception to 12th April 2020.Study SelectionStudies highlighting the use of CS in coronavirus infection with severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS) and COVID-19 were selected based on pre-determined inclusion criteria.Data extractionData was extracted into an excel sheet and transferred to comprehensive meta-analysis software version 3, Biostat Inc., Englewood, NJ, USA, for analysis.Data synthesisFive studies with SARS-CoV-2 infection were included in the meta-analysis. The rate ratio (RR) for mortality in patients with SARS-CoV-2 infection was 1.26 (95% CI: 0.96-1.65, I2: 74.46), indicating lack of benefit of CS therapy on mortality in critically ill patients with COVID-19. The RR for mortality on analysis of the three studies that particularly reported on patients with significant pulmonary compromise secondary to SARS-CoV-2 infection was neutral (RR: 0.91, 95% CI: 0.63-1.33, I2: 63.38).ConclusionsThe use of CS in critically ill patients with COVID-19 did not improve or worsen mortality. Pending further information from controlled studies, CS can be used in critically ill patients with COVID-19 with ‘critical illness related corticosteroid insufficiency’ and moderate to severe ARDS without the risk of increased mortality.


2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Abdou Fatawou Modiyinji ◽  
Jean Joel Bigna ◽  
Sebastien Kenmoe ◽  
Fredy Brice N. Simo ◽  
Marie A. Amougou ◽  
...  

Abstract Background Hepatitis E virus (HEV) is a major cause of acute hepatitis in humans worldwide and have high burden in the resource-limited countries. Better knowledge of the epidemiology of hepatitis in animals in Africa can help to understand the epidemiology among humans. The objective of this study was to summarize the prevalence of HEV infection and distribution of HEV genotypes among animals in Africa. Methods In this systematic review and meta-analysis, we comprehensively searched PubMed, EMBASE, African Journals Online, and Africa Index Medicus from January 1st, 2000 to March 22th, 2020 without any language restriction. We considered cross-sectional studies of HEV infection in animals in Africa. Study selection, data extraction, and methodological quality of included studies were done independently by two investigators. Prevalence data were pooled using the random-effects meta-analysis. This review was registered in PROSPERO, CRD42018087684. Results Twenty-five studies (13 species and 6983 animals) were included. The prevalence (antibodies or ribonucleic acid [RNA]) of HEV infection in animals varied widely depending on biological markers of HEV infection measured: 23.4% (95% confidence interval; 12.0–37.2) for anti-HEV immunoglobulins G, 13.1% (3.1–28.3) for anti-HEV immunoglobulins M, and 1.8% (0.2–4.3) for RNA; with substantial heterogeneity. In subgroup analysis, the immunoglobulins G seroprevalence was higher among pigs 37.8% (13.9–65.4). The following HEV genotypes were reported in animals: Rat-HEV genotype 1 (rats and horses), HEV-3 (pigs), HEV-7 (dromedaries), and Bat hepeviruses (bats). Conclusions We found a high prevalence of HEV infection in animals in Africa and HEV genotypes close to that of humans. Some animals in Africa could be the reservoir of HEV, highlighting the need of molecular epidemiological studies for investigating zoonotic transmission.


2020 ◽  
Vol 9 (4) ◽  
pp. e000843
Author(s):  
Kelly Bos ◽  
Maarten J van der Laan ◽  
Dave A Dongelmans

PurposeThe purpose of this systematic review was to identify an appropriate method—a user-friendly and validated method—that prioritises recommendations following analyses of adverse events (AEs) based on objective features.Data sourcesThe electronic databases PubMed/MEDLINE, Embase (Ovid), Cochrane Library, PsycINFO (Ovid) and ERIC (Ovid) were searched.Study selectionStudies were considered eligible when reporting on methods to prioritise recommendations.Data extractionTwo teams of reviewers performed the data extraction which was defined prior to this phase.Results of data synthesisEleven methods were identified that are designed to prioritise recommendations. After completing the data extraction, none of the methods met all the predefined criteria. Nine methods were considered user-friendly. One study validated the developed method. Five methods prioritised recommendations based on objective features, not affected by personal opinion or knowledge and expected to be reproducible by different users.ConclusionThere are several methods available to prioritise recommendations following analyses of AEs. All these methods can be used to discuss and select recommendations for implementation. None of the methods is a user-friendly and validated method that prioritises recommendations based on objective features. Although there are possibilities to further improve their features, the ‘Typology of safety functions’ by de Dianous and Fiévez, and the ‘Hierarchy of hazard controls’ by McCaughan have the most potential to select high-quality recommendations as they have only a few clearly defined categories in a well-arranged ordinal sequence.


2017 ◽  
Vol 51 (9) ◽  
pp. 797-803 ◽  
Author(s):  
Donald C. Moore ◽  
Annie E. Pellegrino

Objective: To review the incidence, risk factors, and management of pegfilgrastim-induced bone pain (PIBP). Data Sources: PubMed was searched from 1980 to March 31, 2017, using the terms pegfilgrastim and bone pain. Study Selection and Data Extraction: English-language, human studies and reviews assessing the incidence, risk factors, and management of PIBP were incorporated. Data Synthesis: A total of 3 randomized, prospective studies and 2 retrospective studies evaluated pharmacological management of PIBP. Naproxen compared with placebo demonstrated a reduction in the degree, incidence, and duration of bone pain secondary to pegfilgrastim. Loratadine was not effective in reducing the incidence of bone pain prophylactically, but a retrospective study evaluating dual antihistamine blockade with loratadine and famotidine demonstrated a decreased incidence in bone pain when administered before pegfilgrastim. Conclusion: Naproxen is effective at managing PIBP. Although commonly used, antihistamines have a paucity of data supporting their use. Dose reductions of pegfilgrastim and opioids may also be potential management options; however, data supporting these treatment modalities are scarce.


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