scholarly journals Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials

2016 ◽  
Vol 16 (2) ◽  
pp. 135-146 ◽  
Author(s):  
Tae-Young Choi ◽  
Jong In Kim ◽  
Hyun-Ja Lim ◽  
Myeong Soo Lee

Background. Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia. Methods. A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers. Results. Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so. Conclusion. There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Melina von Wernsdorff ◽  
Martin Loef ◽  
Brunna Tuschen-Caffier ◽  
Stefan Schmidt

AbstractOpen-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.


2021 ◽  
Vol 15 ◽  
pp. 175346662110280
Author(s):  
Roberto Ariel Abeldaño Zuñiga ◽  
Ruth Ana María González-Villoria ◽  
María Vanesa Elizondo ◽  
Anel Yaneli Nicolás Osorio ◽  
David Gómez Martínez ◽  
...  

Aims: Given the variability of previously reported results, this systematic review aims to determine the clinical effectiveness of convalescent plasma employed in the treatment of hospitalized patients diagnosed with COVID-19. Methods: We conducted a systematic review of controlled clinical trials assessing treatment with convalescent plasma for hospitalized patients diagnosed with SARS-CoV-2 infection. The outcomes were mortality, clinical improvement, and ventilation requirement. Results: A total of 51 studies were retrieved from the databases. Five articles were finally included in the data extraction and qualitative and quantitative synthesis of results. The overall risk of bias in the reviewed articles was established at low-risk only in two trials. The meta-analysis suggests that there is no benefit of convalescent plasma compared with standard care or placebo in reducing the overall mortality and the ventilation requirement. However, there could be a benefit for the clinical improvement in patients treated with plasma. Conclusion: Current results led to assume that the convalescent plasma transfusion cannot reduce the mortality or ventilation requirement in hospitalized patients diagnosed with SARS-CoV-2 infection. More controlled clinical trials conducted with methodologies that ensure a low risk of bias are still needed. The reviews of this paper are available via the supplemental material section.


2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sophie Juul ◽  
Emil Eik Nielsen ◽  
Joshua Feinberg ◽  
Faiza Siddiqui ◽  
...  

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19. Methods/design We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; “active placebo;” no intervention; standard care; an “active” intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately. Discussion COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease. Systematic review registration PROSPERO CRD42020196492


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ana Carolina de Figueiredo Costa ◽  
Thays Allane Cordeiro Maia ◽  
Paulo Goberlânio de Barros Silva ◽  
Lucas Guimarães Abreu ◽  
Delane Viana Gondim ◽  
...  

Abstract Objectives The aim of this systematic review and meta-analysis was to assess the effects of low-level laser therapy (LLLT) on the orthodontic mini-implants (OMI) stability. Materials and methods An unrestricted electronic database search in PubMed, Science Direct, Embase, Scopus, Web of Science, Cochrane Library, LILACS, Google Scholar, and ClinicalTrials.gov and a hand search were performed up to December 2020. Randomized clinical trials (RCTs) or non-randomized clinical trials (Non-RCTs) that assessed the effects of LLLT on the OMI stability were included. Data regarding the general information, LLLT characteristics, and outcomes were extracted. The authors performed risk of bias assessment with Cochrane Collaboration’s or ROBINS-I tool. Meta-analysis was also conducted. Results Five RCTs and one Non-RCT were included and 108 patients were evaluated. The LLLT characteristics presented different wavelength, power, energy density, irradiation time, and protocol duration. Five RCTs had a low risk of selection bias. Two RCTs had a low risk of performance and detection bias. All RCTs had a low risk of attrition bias, reporting bias and other bias. The Non-RCT presented a low risk of bias for all criteria, except for the bias in selection of participants. The meta-analysis revealed that LLLT significantly increased the OMI stability (p < 0.001, Cohen’s d = 0.67) and the highest clinical benefit was showed after 1 (p < 0.001, Cohen’s d = 0.75), 2 (p < 0.001, Cohen’s d = 1.21), and 3 (p < 0.001, Cohen’s d = 1.51) months of OMI placement. Conclusions LLLT shows positive effects on the OMI stability.


2020 ◽  
Vol 5 ◽  
pp. 60 ◽  
Author(s):  
Brittany J. Maguire ◽  
Philippe J. Guérin

Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website (COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.


2021 ◽  
pp. 194173812199871
Author(s):  
Raphael Einsfeld Simões Ferreira ◽  
Rafael Leite Pacheco ◽  
Carolina de Oliveira Cruz Latorraca ◽  
Rachel Riera ◽  
Ricardo Guilherme Eid ◽  
...  

Context: Caffeine is 1 of the most popular supplements consumed by athletes, and the evidence for improving soccer performance remains limited. Objective: To investigate and update the effects (benefits and harms) of caffeine to improve performance on soccer players. Data Sources: Electronic search in Medline (via PubMed), CENTRAL, Embase, SPORTDiscus, and LILACS, from inception to March 28, 2020. Study Selection: Randomized clinical trials (RCTs) assessing the effects of caffeine on the performance of soccer players. Study Design: Systematic review with meta-analysis. Level of Evidence: Level 1. Data Extraction: Data extraction was conducted independently by 2 authors using a piloted form. We assessed methodological quality (Cochrane risk-of-bias [RoB] table) and the certainty of the evidence (GRADE [Grading of Recommendations Assessment, Development and Evaluation] approach). Results: Sixteen RCTs were included. Overall methodological quality was classified as unclear to low risk of bias. When assessing aerobic endurance, meta-analyses did not demonstrate the differences between caffeine and placebo (mean difference [MD], 44.9 m; 95% confidence interval [CI], −77.7 to 167.6). Similarly, no difference was observed during time to fatigue test (MD, 169.8 seconds; 95% CI, −71.8 to 411.6). Considering anaerobic power, meta-analyses also did not find differences for vertical jump (MD, 1.01 cm; 95% CI, −0.68 to 2.69) and repeated sprint tests (MD, −0.02 seconds; 95% CI, −0.09 to 0.04), as well as reaction time agility test (MD, 0.02 seconds; 95% CI, −0.01 to 0.04) and rating of perceived exertion (MD, 0.16 points; 95% CI, −0.55 to 0.87). Regarding safety, a few minor adverse events were reported. Based on the GRADE approach, the certainty of this evidence was classified as very low to low. Conclusions: We found no significant improvement in soccer-related performance with caffeine compared with placebo or no intervention. However, caffeine appears to be safe.


2021 ◽  
Author(s):  
Yee Hung Gan ◽  
Nway Aye Saint ◽  
Yen Suan Sin

Abstract Background: Acupuncture clinical trial is important to evaluate the efficacy of acupuncture. However, it is challenging to achieve effective blinding due to the nature of acupuncture. A standardised placebo control method of acupuncture has yet to be established. The study focuses on the non-penetrating sham acupuncture because it eliminates the placebo effect and generates lesser physiological responses. The study aims to evaluate and compare the participant blinding effectiveness of non-penetrating sham acupuncture devices, and analyse the factors which may influence the participant blinding.Methods: The study followed the PRISMA guidelines. An electronic search was conducted on PubMed, Ovid and CNKI up until 1st of October 2020 to include English and Chinese randomised controlled trials which evaluated the awareness on the type of acupuncture (real or sham) in any population who received acupuncture. Data screening, data extraction and quality assessment were done independently by two researchers and discrepancies were sorted out via discussion with a co-researcher. Data analysis was performed using RevMan 5.4.1.Results: 34 full-text articles had been included in the systematic review and meta-analysis. The quality of the studies ranged from moderate to good. Generally, non-penetrating sham acupuncture devices were effective in blinding participants in clinical trials. The foam device demonstrated a better blinding effect, followed by Streitberger, Park and Takakura devices. Sham needles with no skin contact could not blind the participants successfully. Naive, experienced, healthy and diseased participants all could be blinded using non-penetrating sham acupuncture devices but naive and healthy participants could be blinded comparatively easily. Acupoints from different regions could achieve blinding, however, the acupoints on the back could blind the participants more easily compared to the other areas.Conclusion: Non-penetrating sham acupuncture devices are valid placebo control for acupuncture clinical trials. The foam device has a better blinding effect, followed by Streitberger, Park and Takakura devices. Recruiting naive healthy participants and choosing acupoints from the back can achieve better blinding effects in the participants.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041931
Author(s):  
Ning Sun ◽  
Wenwei Zuo ◽  
Yuanfang Zhou ◽  
Ying Cheng ◽  
Shirui Cheng ◽  
...  

IntroductionBiliary colic (BC) is a severe pain associated with nausea and vomiting, which is the most common symptom among the gallstone population. This protocol proposes a methodology for conducting a systematic review and meta-analysis that aims to assess the benefits and safety of acupuncture in patients with BC.Methods and analysisClinical trials will be identified through nine databases from inception to December 2020, using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Allied and Complementary Medicine Database (AMED), CINAHL, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), VIP Database and Wanfang Database. Search words will be used for the BC and acupuncture. The analysis would include randomised, controlled, clinical trials of adults with BC that were published in either Chinese or English. The primary outcome is to measure pain relief. Two or three reviewers should be in charge of study selection, data extraction and evaluating the risk of bias. RevMan software (V.5.4) will be used to perform the assessment of the risk of bias and data synthesis.Ethics and disseminationEthics approval will not be required for this review, as it will only involve the collection of literature previously published. The results of this meta-analysis will be disseminated in a peer-reviewed journal or relevant conference, through publication.Trial registration numberCRD42020167510.


2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Iatagan R. Josino ◽  
Antônio C. Madruga-Neto ◽  
Igor B. Ribeiro ◽  
Hugo G. Guedes ◽  
Vitor O. Brunaldi ◽  
...  

Background. The use of bougies and balloons to dilate benign esophageal strictures (BES) is a consolidated procedure. However, the amount of evidence available in scientific literature supporting which is the best technique is very low, despite the great prevalence and importance of such pathology. This systematic review with meta-analysis aims at comparing both techniques, providing good quality of evidence. Methods. We searched for randomized clinical trials (RCTs) published from insertion to November 2017, using MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, LILACS, and grey literature. After the data extraction, a meta-analysis was performed. The main outcomes were symptomatic relief and recurrence rate. The secondary outcomes were bleeding, perforation, and postprocedure pain. Results. We included 5 randomized clinical trials (RCTs), totalizing 461 patients. Among them, 151 were treated with bougie dilation and 225 underwent balloon dilation. Regarding symptomatic relief, recurrence, bleeding, and perforation rates, there were no differences between the methods. Concerning postprocedure pain, patients submitted to balloon dilation had less intense pain (RD 0.27, 95% IC −0.42 to −0.07, P=0.007). Conclusion. We conclude that there is no difference between bougie and balloon dilation of BESs regarding symptomatic relief, recurrence rate at 12 months, bleeding, and perforation. Patients undergoing balloon dilation present less severe postprocedure pain.


Author(s):  
Tomasz Stefura ◽  
Artur Kacprzyk ◽  
Jakub Droś ◽  
Marta Krzysztofik ◽  
Oksana Skomarovska ◽  
...  

Abstract Tissue fillers injections remain to be one of the most commonly performed cosmetic procedures. The aim of this meta-analysis was to systematize and present available data on the aesthetic outcomes and safety of treating the nasolabial fold area with tissue fillers. We conducted a systematic review of randomized clinical trials that report outcomes concerning treatment of nasolabial fold area with tissue fillers. We searched the MEDLINE/PubMed, ScienceDirect, EMBASE, BIOSIS, SciELO, Scopus, Cochrane Controlled Register of Trials, CNKI and Web of Science databases. Primary outcomes included aesthetic improvement measured using the Wrinkle Severity Rating Scale score and Global Aesthetic Improvement Scale. Secondary outcomes were incidence rates of complications occurring after the procedure. At baseline, the pooled mean WSRS score was 3.23 (95% CI: 3.20–3.26). One month after the procedure, the pooled WSRS score had reached 1.79 (95% CI: 1.74–1.83). After six months it was 2.02 (95% CI: 1.99–2.05) and after 12 months it was 2.46 (95% CI: 2.4–2.52). One month after the procedure, the pooled GAIS score had reached 2.21 (95% CI: 2.14–2.28). After six months, it was 2.32 (95% CI: 2.26–2.37), and after 12 months, it was 1.27 (95% CI: 1.12–1.42). Overall, the pooled incidence of all complications was 0.58 (95% CI: 0.46–0.7). Most common included lumpiness (43%), tenderness (41%), swelling (34%) and bruising (29%). Tissue fillers used for nasolabial fold area treatment allow achieving a satisfying and sustainable improvement. Most common complications include tenderness, lumpiness, swelling, and bruising. Level of Evidence II "This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors  www.springer.com/00266."


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