Randomised controlled trials of homeopathy in humans: characterising the research journal literature for systematic review

Homeopathy ◽  
2013 ◽  
Vol 102 (01) ◽  
pp. 3-24 ◽  
Author(s):  
Daniela Hacke ◽  
Jürgen Clausen ◽  
Ton Nicolai ◽  
David S. Riley ◽  
Peter Fisher ◽  
...  

Introduction: A new programme of systematic reviews of randomised controlled trials (RCTs) in homeopathy will distinguish important attributes of RCT records, including: placebo controlled versus other-than-placebo (OTP) controlled; individualised versus non-individualised homeopathy; peer-reviewed (PR) versus non peer-reviewed (NPR) sources. Aims: (a) To outline the methods used to search and categorise the RCT literature; (b) to report details of the records retrieved; (c) to compare our retrieved records with those reported in two previous systematic reviews (Linde et al., 1997; Shang et al., 2005). Methods: Ten major electronic databases were searched for records published up to the end of 2011. A record was accepted for subsequent systematic review if it was a substantive report of a clinical trial of homeopathic treatment or prophylaxis in humans, randomised and controlled, and published in a PR or NPR journal. Results: 489 records were potentially eligible: 226 were rejected as non-journal, minor or repeat publications, or lacking randomisation and/or controls and/or a ‘homeopathic’ intervention; 263 (164 PR, 99 NPR) were acceptable for systematic review. The 263 accepted records comprised 217 (137 PR, 80 NPR) placebo-controlled RCTs, of which 121 were included by, 66 were published after, and 30 were potentially eligible for, but not listed by, Linde or Shang. The 137 PR records of placebo-controlled RCTs comprise 41 on individualised homeopathy and 96 on non-individualised homeopathy. Conclusion: Our findings clarify the RCT literature in homeopathy. The 263 accepted journal papers will be the basis for our forthcoming programme of systematic reviews.

Homeopathy ◽  
2015 ◽  
Vol 104 (03) ◽  
pp. 164-169 ◽  
Author(s):  
Robert T Mathie ◽  
Michel Van Wassenhoven ◽  
Jennifer Jacobs ◽  
Menachem Oberbaum ◽  
Helmut Roniger ◽  
...  

Background: Though potentially an important limitation in the literature of randomised controlled trials (RCTs) of homeopathy, the model validity of homeopathic treatment (MVHT) has not previously been systematically investigated. Objective: As an integral part of a programme of systematic reviews, to assess MVHT of eligible RCTs of individualised homeopathic treatment. Methods: From 46 previously identified papers in the category, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were thus the subject of the study. For each of six domains of assessment per trial, MVHT was judged independently by three randomly allocated assessors from our group, who reached a final verdict by consensus discussion as necessary. Results: Nineteen trials were judged overall as ‘acceptable’ MVHT, nine as ‘uncertain’ MVHT, and four as ‘inadequate’ MVHT. Conclusions: These results do not support concern that deficient MVHT has frequently undermined the published findings of RCTs of individualised homeopathy. However, the 13 trials with ‘uncertain’ or ‘inadequate’ MVHT will be a focus of attention in supplementary meta-analysis. New RCTs of individualised homeopathy must aim to maximise MVHT and to enable its assessment through clear reporting.


2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Giulia Di Stefano ◽  
Andrea Di Lionardo ◽  
Giuseppe Di Pietro ◽  
Giorgio Cruccu ◽  
Andrea Truini

Despite an increasing number of available therapies, the treatment of neuropathic pain remains a major issue. Systematic reviews and meta-analyses indicate that only a minority of patients with neuropathic pain have an adequate response to pharmacological treatment and that most drugs have dose-limiting side effects. We conducted a systematic review and meta-analysis of randomised controlled trials published in the last five years. We searched for relevant papers within PubMed, EMBASE, the Cochrane Database of Systematic Reviews, and the Clinical Trials database (ClinicalTrials.gov). Two authors independently selected studies for inclusion, data extraction, and bias assessment. We identified 39 randomised controlled trials and included 16 in the meta-analysis. Trial outcomes were generally modest even for first-line drugs such as tricyclic antidepressants, serotonin-noradrenaline reuptake inhibitors, and gabapentinoids. Many drugs acting on new pain targets are currently under development. Clinical data are currently available for sodium channel isoform-specific antagonists, anti-nerve growth factor molecules, and fatty acid amide hydrolase inhibitors.


BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e052506
Author(s):  
Christine Newman ◽  
Oratile Kgosidialwa ◽  
Louise Dervan ◽  
Delia Bogdanet ◽  
Aoife Maria Egan ◽  
...  

IntroductionDiabetes mellitus is the most common metabolic complication of pregnancy and its prevalence worldwide is rising. The number of randomised controlled trials (RCTs) being conducted in people with diabetes is also increasing. Many studies preferentially publish findings on clinical endpoints and do not report patient-reported outcomes (PROs). In studies that do include PROs, PRO reporting is often of poor quality.MethodsWe will conduct this systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Using a combination of medical subject headings and keywords (combined using Boolean operators), we will search web-based databases (PubMed, Cochrane and EMBASE) for RCTs published in English between 2013 and 2021. Two reviewers will review titles and abstracts. We will review the full texts of any relevant abstracts and extract the following data: date of publication or recruitment period, journal of publication, country of study, multicentre or single centre, population and number of participants, type of intervention, frequency of PRO assessment and type of PRO (or PRO measurement) used. We will also record if the PRO was a primary, secondary or exploratory outcome. We will exclude reviews, observational studies, unpublished data for example, conference abstracts and trial protocols. Any published RCT that includes data on a PRO as a primary or secondary outcome will then be compared against the Consolidated Standards of Reporting Trials—Patient-Reported Outcome extension checklist, a structured and approved framework for the publication of results of PROs.Ethics and disseminationEthical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 24 March 2021 (CA 2592). We aim to publish our findings in a peer-reviewed journal and present our findings at national and international conferences.Systematic review registrationThis systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number CRD42021234917.


PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0247139
Author(s):  
Christopher Y. K. Williams ◽  
Adam T. Townson ◽  
Milan Kapur ◽  
Alice F. Ferreira ◽  
Rebecca Nunn ◽  
...  

Background A significant proportion of the worldwide population is at risk of social isolation and loneliness as a result of the COVID-19 pandemic. We aimed to identify effective interventions to reduce social isolation and loneliness that are compatible with COVID-19 shielding and social distancing measures. Methods and findings In this rapid systematic review, we searched six electronic databases (Medline, Embase, Web of Science, PsycINFO, Cochrane Database of Systematic Reviews and SCOPUS) from inception to April 2020 for systematic reviews appraising interventions for loneliness and/or social isolation. Primary studies from those reviews were eligible if they included: 1) participants in a non-hospital setting; 2) interventions to reduce social isolation and/or loneliness that would be feasible during COVID-19 shielding measures; 3) a relevant control group; and 4) quantitative measures of social isolation, social support or loneliness. At least two authors independently screened studies, extracted data, and assessed risk of bias using the Downs and Black checklist. Study registration: PROSPERO CRD42020178654. We identified 45 RCTs and 13 non-randomised controlled trials; none were conducted during the COVID-19 pandemic. The nature, type, and potential effectiveness of interventions varied greatly. Effective interventions for loneliness include psychological therapies such as mindfulness, lessons on friendship, robotic pets, and social facilitation software. Few interventions improved social isolation. Overall, 37 of 58 studies were of “Fair” quality, as measured by the Downs & Black checklist. The main study limitations identified were the inclusion of studies of variable quality; the applicability of our findings to the entire population; and the current poor understanding of the types of loneliness and isolation experienced by different groups affected by the COVID-19 pandemic. Conclusions Many effective interventions involved cognitive or educational components, or facilitated communication between peers. These interventions may require minor modifications to align with COVID-19 shielding/social distancing measures. Future high-quality randomised controlled trials conducted under shielding/social distancing constraints are urgently needed.


Homeopathy ◽  
2018 ◽  
Vol 107 (S 01) ◽  
pp. 55-78
Author(s):  
Robert Mathie ◽  
Petter Viksveen ◽  
Susanne Ulbrich-Zürni ◽  
Lynn Legg ◽  
E. Roberts ◽  
...  

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kishan Patel ◽  
Martyn T. Cobourne ◽  
Nikolaos Pandis ◽  
Jadbinder Seehra

Abstract Background A systematic review of the evidence should be undertaken to support the justification for undertaking a clinical trial. The aim of this study was to examine whether reports of orthodontic Randomised Clinical Trials (RCTs) cite prior systematic reviews (SR) to explain the rationale or justification of the trial. Study characteristics that predicated the citation of SR in the RCT report were also explored. Material and methods Orthodontic RCTs published between 1st January 2010 to 31st December 2020 in seven orthodontic journals were identified. All titles and abstracts were screened independently by two authors. Descriptive statistics and associations were assessed for the study characteristics. Logistic regression was used to identify predicators of SR inclusion in the trial report. Results 301 RCTs fulfilling the eligibility criteria were assessed. 220 SRs were available of which 74.5% (N = 164) were cited, and 24.5% (N = 56) were not included but were available in the literature within 12 months of trial commencement. When a SR was not included in the introduction or no SR was available within 12 months of trial commencement, interventional studies were commonly cited. The continent of the corresponding author predicated the possibility of inclusion of a SR in the introduction (OR 0.36; 95% CI 0.18–0.71; p = 0.003). Conclusions A quarter of orthodontic RCTs (24.5%) included in this study did not cite a SR in the introduction section to justify the rationale of the trial when a relevant SR was available. To reduce research waste and optimal usage of resources, researchers should identify or conduct a systematic review of the evidence to support the rationale and justification of the trial.


2020 ◽  
Vol 3 ◽  
pp. 72 ◽  
Author(s):  
Tala Raad ◽  
Elena George ◽  
Anne Griffin ◽  
Louise Larkin ◽  
Alexander Fraser ◽  
...  

Background: Rheumatoid arthritis (RA) is an autoimmune disease characterised by swollen and painful joints. It is hypothesised that changes in lifestyle factors such as consuming a healthier diet may  reduce the severity of RA symptoms. People living with RA commonly make alterations to their dietary intake with the hope of improving their symptoms. This systematic review aims to discuss the effects of dietary interventions with and without omega-3 supplementation for the management of rheumatoid arthritis. Methods: A systematic review of randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) will be conducted. MEDLINE, EMBASE, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Methodology Register) and CINAHL will be searched from inception without using date restrictions. Primary outcomes will include measures of disease activity, inflammation and quality of life among adults living with RA. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and the methodological appraisal of the studies will be assessed independently by two different reviewers (TR and AG) using the Cochrane Risk-of-Bias Tool for RCTs, and Risk-of-Bias In Non-Randomised Studies Tool for NRCTs. Ethics and dissemination: Ethical approval is not required for this systematic review. Only publically available data from previously published studies will be used. The findings of this systematic review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. PROSPERO registration: CRD42020147415 (11/02/2020).


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Malene Øen ◽  
Knut N. Leknes ◽  
Bodil Lund ◽  
Dagmar F. Bunæs

Abstract Background Microbial biofilm accumulation is the main cause of peri-implantitis. The majority of surgical peri-implantitis treatment protocols suggests adjunctive use of systemic antibiotics to target specific putative bacteria. The aim of this systematic review was to critically evaluate the adjunctive use of systemically administered antibiotics in surgical treatment of peri-implantitis by reviewing previously published systematic reviews and primary studies. Methods A systematic literature search was conducted in four electronic databases (MEDLINE, The Cochrane Library, EMBASE, and Web of Science) for randomised controlled trials, cohort studies, case–control studies, and systematic reviews reporting surgical treatment of peri-implantitis with and without adjunctive systemically administered antibiotic therapy. The included systematic reviews and primary studies were qualitatively assessed using AMSTAR and GRADE, respectively. No restrictions were set for date of publication, journal, or language. Results The literature search identified 681 papers. Only seven systematic reviews and two primary studies met the inclusion criteria. Four out of seven included systematic reviews concluded that no evidence exists for use of systemic antibiotics to improve the clinical outcomes in surgical treatment of peri-implantitis. One review did not estimate the level of evidence, one did not clearly state any beneficial effect, whereas one reported a limited adjunctive effect. Further, the two included primary studies did not show a long-term significant benefit of adjunctive use of systemically administrated antibiotics. However, one study reported a short-term adjunctive effect in patients with modified surface implants. Due to heterogeneity in study design, low number of included primary studies, and grade of bias, no meta-analysis was performed. Conclusion The use of systemically administered antibiotics as an adjunct to surgical interventions of peri-implantitis cannot be justified as a part of a standard treatment protocol. A pervasive problem is the lack of uniform diagnosis criteria for peri-implantitis, deficient information about patient characteristics, absence of high quality long-term randomised controlled trials, and authors’ declaration on conflict of interest.


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