Defining the Features of Registry Based Randomised Controlled Trials (rRCT): A Systematic Review

Abstract Background: Registry Based Randomised Controlled Trials have been described as pragmatic studies utilising patient data embedded in large scale registries, to facilitate key clinical trial procedures such as case report completion, randomisation and follow up data. While the practice of utilising registries to support the conduct of randomised trials is increasing, the reporting of how a registry is used within a trial can vary, causing difficulty in identifying registry based randomised trials and interpreting their exact definition. Methods: The databases PubMed, Embase, Cinahl Plus, Scopus and the Cochrane Central Register of Controlled Trials will be searched using a combination of subject headings, MeSH and free text terms. Search terms will be adapted accordingly for each database, with English language articles included and no other filters applied. Also, grey literature and reference lists will be searched, contacting trial authors for clarification when necessary. Two independent reviewers will complete study screening, selection and quality assessment. A preliminary synthesis will be conducted tabulating the relevant evidence into separate data extraction tables. A narrative synthesis approach will be adopted based on the Guidance on the Conduct of Narrative Synthesis in Systematic Reviews.Results: The present study will synthesise existing registry based randomised trial literature and define their key features.Conclusions: It is essential that trialists and researchers can review published trials and endeavour to duplicate trial designs. There is a lack of consensus in terms of the reporting of registry based randomised trials, making replication of this emerging trial design difficult. This review will clearly summarise and define the key features of these randomised trials, to allow researchers understand and reproduce the novel registry based randomised controlled trial methodology. Systematic Review Registration: PROPSERO CRD42020192419

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Chloroquine and hydroxychloroquine for the treatment of COVID-19: A living systematic review protocol

10.1101/2020.04.03.20052530 ◽

2020 ◽

Cited By ~ 1

Author(s):

Rocío Bravo-Jeria ◽

María Ximena Rojas Reyes ◽

Juan Víctor Ariel Franco ◽

María Paz Acuña ◽

Luz Ángela Torres López ◽

...

Keyword(s):

Systematic Review ◽

Direct Evidence ◽

Grey Literature ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomised Trials ◽

Eligibility Criteria ◽

Central Register ◽

Randomised Controlled ◽

Meta Analyses

ABSTRACTObjectiveTo determine the relative impact of the use of chloroquine and hydroxychloroquine on outcomes important to patients with COVID 19.DesignThis is the protocol of a living systematic review.Data sourcesWe will conduct searches in PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), trial registries, grey literature and in a centralised repository in L·OVE (Living OVerview of Evidence). L·OVE is a platform that maps PICO questions to evidence from Epistemonikos database. In response to the COVID-19 emergency, L·OVE was adapted to expand the range of evidence it covers and customised to group all COVID-19 evidence in one place. The search will cover the period until the day before submission to a journal.Eligibility criteria for selecting studies and methodsWe will follow a common protocol for multiple parallel systematic reviews, already published and submitted to PROSPERO (awaiting ID allocation).We will include randomised controlled trials evaluating the effect of chloroquine and hydroxychloroquine — as monotherapy or in combination with other drugs — versus placebo or no treatment in patients with COVID-19. Randomised trials evaluating chloroquine and hydroxychloroquine in infections caused by other coronaviruses, such as MERS-CoV and SARS-CoV, and non-randomised studies in COVID-19 will be searched in case no direct evidence from randomised trials is found, or if the direct evidence provides low- or very low-certainty for critical outcomes.Two reviewers will independently screen each study for eligibility, extract data, and assess the risk of bias. We will perform random-effects meta-analyses and use GRADE to assess the certainty of the evidence for each outcome.A living, web-based version of this review will be openly available during the COVID-19 pandemic. We will resubmit it if the conclusions change or there are substantial updates.Ethics and disseminationNo ethics approval is considered necessary. The results of this review will be widely disseminated via peer-reviewed publications, social networks and traditional media.

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Comparative efficacy and safety of interventions for treating head lice: a protocol for systematic review and network meta-analysis

BMJ Paediatrics Open ◽

10.1136/bmjpo-2021-001129 ◽

2021 ◽

Vol 5 (1) ◽

pp. e001129

Author(s):

Bill Stevenson ◽

Wubshet Tesfaye ◽

Julia Christenson ◽

Cynthia Mathew ◽

Solomon Abrha ◽

...

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Grey Literature ◽

Risk Of Bias ◽

Controlled Trials ◽

Head Lice ◽

Efficacy And Safety ◽

Randomised Controlled ◽

Meta Analyses

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.

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Lowering blood pressure after acute intracerebral haemorrhage: protocol for a systematic review and meta-analysis using individual patient data from randomised controlled trials participating in the Blood Pressure in Acute Stroke Collaboration (BASC)

BMJ Open ◽

10.1136/bmjopen-2019-030121 ◽

2019 ◽

Vol 9 (7) ◽

pp. e030121 ◽

Cited By ~ 3

Author(s):

Tom J Moullaali ◽

Xia Wang ◽

Lisa J Woodhouse ◽

Zhe Kang Law ◽

Candice Delcourt ◽

...

Keyword(s):

Systematic Review ◽

Blood Pressure ◽

Acute Stroke ◽

Intracerebral Haemorrhage ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Patient Data ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomised Controlled

IntroductionConflicting results from multiple randomised trials indicate that the methods and effects of blood pressure (BP) reduction after acute intracerebral haemorrhage (ICH) are complex. The Blood pressure in Acute Stroke Collaboration is an international collaboration, which aims to determine the optimal management of BP after acute stroke including ICH.Methods and analysisA systematic review will be undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (IPD) guideline. A search of Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception will be conducted to identify randomised controlled trials of BP management in adults with acute spontaneous (non-traumatic) ICH enrolled within the first 7 days of symptom onset. Authors of studies that meet the inclusion criteria will be invited to share their IPD. The primary outcome will be functional outcome according to the modified Rankin Scale. Safety outcomes will be early neurological deterioration, symptomatic hypotension and serious adverse events. Secondary outcomes will include death and neuroradiological and haemodynamic variables. Meta-analyses of pooled IPD using the intention-to-treat dataset of included trials, including subgroup analyses to assess modification of the effects of BP lowering by time to treatment, treatment strategy and patient’s demographic, clinical and prestroke neuroradiological characteristics.Ethics and disseminationNo new patient data will be collected nor is there any deviation from the original purposes of each study where ethical approvals were granted; therefore, further ethical approval is not required. Results will be reported in international peer-reviewed journals.PROSPERO registration numberCRD42019141136.

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Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2018-026842 ◽

2019 ◽

Vol 9 (3) ◽

pp. e026842 ◽

Cited By ~ 1

Author(s):

Irene Gómez-Gómez ◽

Emma Motrico ◽

Patricia Moreno-Peral ◽

Alina Rigabert ◽

Sonia Conejo-Cerón ◽

...

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Depression Symptoms ◽

Controlled Trials ◽

Cochrane Central Register ◽

Lifestyle Interventions ◽

Symptoms Of Depression ◽

Multiple Risk ◽

Randomised Controlled

IntroductionMany studies have explored the impact of lifestyle interventions on depression. However, little is known about the effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression. Our objective is to assess the effectiveness of complex multiple-risk lifestyle interventions in reducing depressive symptoms in the adult population by the acquisition of at least two healthy habits—healthy diet, physical activity and/or smoking cessation. For such purpose, a systematic review and meta-analysis of randomised controlled trials will be conducted.Method and analysisMEDLINE (through Ovid and PubMed), Scopus, Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, OpenGrey Register (System for Information on Grey Literature in Europe) and the International Clinical Trials Registry Platform will be searched for relevant articles. Additionally, a supplementary manual search will be performed using lists of references, references to expert authors and other systematic reviews and/or meta-analyses. Study selection, data extraction (target habits, country, target populations, conditions and statistical data to name a few) and assessment of the risk of bias will be performed separately by two independent researchers. The primary outcome measure will be the reduction of depression symptoms, as measured by validated instruments. We will calculate pooled standardised mean differences and 95% CIs using random-effect models. Heterogeneity, sensitivity and publication bias will be assessed, and sub-group analysis will be performed. Heterogeneity will be explored by random-effects meta-regression analysis.Ethics and disseminationEthical approval is not required for this study. The results of this systematic review and meta-analysis will be presented in relevant conferences and published in a peer-review journal. The findings of this study could have important clinical and scientific implications for the improvement of symptoms of depression.PROSPERO registration numberCRD42018100253; Pre-results.

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A systematic review of pharmacists’ interventions to support medicines optimisation in patients with visual impairment

International Journal of Clinical Pharmacy ◽

10.1007/s11096-019-00907-2 ◽

2019 ◽

Vol 41 (6) ◽

pp. 1400-1407 ◽

Cited By ~ 1

Author(s):

Basma Y. Kentab ◽

Heather E. Barry ◽

Sinaa A. Al-Aqeel ◽

Carmel M. Hughes

Keyword(s):

Systematic Review ◽

Visual Impairment ◽

Randomised Controlled Trials ◽

Grey Literature ◽

Cochrane Library ◽

Future Research ◽

Controlled Trials ◽

Medicines Optimisation ◽

Randomised Controlled ◽

The Impact

Abstract Background People with visual impairment often report poorer health and encounter many challenges when using medicines. Pharmacists can play a significant role in optimising medicines use for these patients. However, little is known about pharmacists’ current practices when providing services to this population nor the impact of such services, if any, on medicines optimisation-related outcomes. Aim of the review This systematic review aims to identify the types, and assess the effectiveness of, interventions provided by pharmacists on medicines optimisation-related outcomes. Method Systematic searches of the following electronic databases were carried out from date of inception to March 2018: Cochrane Library; MEDLINE; EMBASE; International Pharmaceutical Abstracts; Scopus; and Cumulative Index to Nursing and Allied Health Literature. Several trial registries and grey literature resources were also searched. Any randomised controlled trials, non-randomised controlled trials, controlled before-and-after studies, or interrupted time series analyses reporting on interventions provided by pharmacists to adult visually impaired patients and/or their caregivers in order to improve medicines optimisation-related outcomes of medicine safety, adherence, patient satisfaction, shared decision making, or quality of life were included. Results A total of 1877 titles/abstracts were screened, and 27 full text articles were assessed for eligibility. On examination of full texts, no studies met the inclusion criteria for this review. Conclusion This review highlights the need for future research that would be vital for promoting the safe and effective use of medicines and the delivery of pharmaceutical care services to people with visual impairment.

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Benefits of probiotics in preterm neonates in low-income and medium-income countries: a systematic review of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2017-017638 ◽

2017 ◽

Vol 7 (12) ◽

pp. e017638 ◽

Cited By ~ 31

Author(s):

Girish Deshpande ◽

Gayatri Jape ◽

Shripada Rao ◽

Sanjay Patole

Keyword(s):

Systematic Review ◽

Mortality Rate ◽

Low Income ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Preterm Neonates ◽

Controlled Trials ◽

Cochrane Central Register ◽

Mortality And Morbidity ◽

Randomised Controlled

ObjectiveAlthough there is an overall reduction in underfive mortality rate, the progress in reducing neonatal mortality rate has been very slow. Over the last 20 years, preterm births have steadily increased in low-income and medium-income countries (LMICs) particularly in sub-Saharan Africa and South Asia. Preterm birth is associated with increased mortality and morbidity, particularly in LMICs. Based on systematic reviews of randomised controlled trials (RCTs), many neonatal units in high-income countries have adopted probiotics as standard of care for preterm neonates. We aimed to systematically review the safety and efficacy of probiotics in reducing mortality and morbidity in preterm neonates in LMICs.DesignSystematic review and meta-analysis of RCTs.Data sourcesMedline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and E-abstracts from Pediatric Academic Society meetings and other paediatric and neonatal conference proceedings were searched in January 2017.Eligibility criteriaRCTs comparing probiotics versus placebo/no probiotic in preterm neonates (gestation<37 weeks) conducted in LMICs.ResultsTotal 23 (n=4783) RCTs from 4 continents and 10 LMICs were eligible for inclusion in the meta-analysis using fixed effect model. The risk of necrotising enterocolitis (NEC greater than or equal to stage II) (risk ratio (RR) 0.46 (95% CI 0.34 to 0.61), P<0.00001, numbers needed to treat (NNT) 25 (95% CI 20 to 50)), late-onset sepsis (LOS) (RR 0.80 (95% CI 0.71 to 0.91), P=0.0009, NNT 25 (95% CI 17 to 100)) and all-cause mortality (RR 0.73 (95% CI 0.59 to 0.90), P=0.003, NNT 50 (95% CI 25 to 100)) were significantly lower in probiotic supplemented neonates. The results were significant on random effects model analysis and after excluding studies with high risk of bias. No significant adverse effects were reported.ConclusionProbiotics have significant potential to reduce mortality and morbidity (eg, NEC, LOS) in preterm neonates in LMICs.

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Effectiveness of personal letters to healthcare professionals in changing professional behaviours: a systematic review protocol

Systematic Reviews ◽

10.1186/s13643-021-01650-4 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Aikaterini Grimani ◽

Louis Goffe ◽

Mei Yee Tang ◽

Fiona Beyer ◽

Falko F. Sniehotta ◽

...

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Healthcare Professionals ◽

Grey Literature ◽

Behavioural Change ◽

Risk Of Bias ◽

Cochrane Library ◽

Controlled Trials ◽

Behaviour Change Techniques ◽

Randomised Controlled

Abstract Background Letters are regularly sent by healthcare organisations to healthcare professionals to encourage them to take action, change practice or implement guidance. However, whether letters are an effective tool in delivering a change in healthcare professional behaviour is currently uncertain. In addition, there are currently no evidence-based guidelines to support health providers and authorities with advice on how to formulate the communication, what information and behaviour change techniques to include in order to optimise the potential effect on the behaviour of the receivers. To address this research gap, we seek to inform such guidance through this systematic review, which aims to provide comprehensive evidence of the effectiveness of personal letters to healthcare professionals in changing their professional behaviours. Methods/design A comprehensive literature search of published and unpublished studies (the grey literature) in electronic databases will be conducted to identify randomised controlled trials (RCTs) that meet our inclusion criteria. We will include RCTs evaluating the effectiveness of personal letters to healthcare professionals in changing professional behaviours. The primary outcome will be behavioural change. The search will be conducted in five electronic databases (from their inception onwards): MEDLINE, Embase, PsycINFO, the Cochrane Library and CINAHL. We will also conduct supplementary searches in Google Scholar, hand search relevant journals, and conduct backward and forward citation searching for included studies and relevant reviews. A systematic approach to searching, screening, reviewing and data extraction will be applied in accordance with the process recommended by the Cochrane Collaboration. Two researchers will examine titles, abstracts, full-texts for eligibility independently. Risk of bias will be assessed using the Cochrane Risk of Bias 2 (RoB 2) tool for randomised controlled trials. Disagreements will be resolved by a consensus procedure. Discussion Health policy makers across government are expected to benefit from being able to increase compliance in clinical settings by applying theories of behaviour to design of policy communications. The synthesised findings will be disseminated through peer-reviewed publication. Systematic review registration PROSPERO CRD42020167674

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Prayer as a pain intervention: protocol of a systematic review of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-047580 ◽

2021 ◽

Vol 11 (7) ◽

pp. e047580

Author(s):

Alexandra Ferreira-Valente ◽

Margarida Jarego ◽

Inês Queiroz-Garcia ◽

Filipa Pimenta ◽

Rui Miguel Costa ◽

...

Keyword(s):

Systematic Review ◽

Pain Management ◽

Randomised Controlled Trials ◽

The Body ◽

Religious Practices ◽

Controlled Trials ◽

Cochrane Central Register ◽

Pain Experience ◽

Intervention Protocol ◽

Randomised Controlled

BackgroundPain is a universal experience and the most common reason for seeking healthcare. Inadequate pain management negatively impacts numerous aspects of patient health. Multidisciplinary treatment programmes, including psychosocial interventions, are more useful for pain management than purely biomedical treatment alone. Recently, researchers showed increasing interest in understanding the role of spirituality/religiosity and spiritual/religious practices on pain experience, with engagement in religious practices, such as prayer, showing to positively impact pain experience in religious individuals. This systematic review will seek to summarise and integrate the existing findings from randomised controlled trials assessing the effects of prayer and prayer-based interventions on pain experience.MethodsThe systematic review procedures and its report will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement. Electronic searches in nine databases (Web of Science Core Collection, MEDLINE, SCIELO Citation Index, PubMed, Cochrane Central Register of Controlled Clinical Trial, PsycINFO, Scopus, LILACS and Open-SIGLE) will be performed to identify randomised controlled trials of prayer-based interventions. Two independent researchers will assess studies for inclusion and extract data from each paper. Risk of bias assessment will be assessed independently by two reviewers based on the Consolidated Standards of Reporting Trials statement. Qualitative synthesis of the body of research will be conducted using a narrative summary synthesis method. Meta-analysis will be limited to studies reporting on the same primary outcome. Formal searches are planned to start in June 2021. The final report is anticipated to be completed by September 2021.DiscussionFindings will be useful to (1) understand the condition of our knowledge in this field and (2) provide evidence for prayer effectiveness in reducing pain intensity and pain-related stress and increasing pain tolerance in adults experiencing acute or chronic pain.PROSPERO registration numberCRD42020221733.

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Impact of levothyroxine in women with positive thyroid antibodies on pregnancy outcomes: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-043751 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043751

Author(s):

Lorraine Lau ◽

Jamie L Benham ◽

Patricia Lemieux ◽

Jennifer Yamamoto ◽

Lois E Donovan

Keyword(s):

Systematic Review ◽

Preterm Delivery ◽

Pregnancy Outcomes ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Significant Difference ◽

Randomised Controlled

ObjectiveTo evaluate the effect of levothyroxine therapy on pregnancy outcomes compared with placebo or no treatment in women without overt hypothyroidism with presence of thyroid peroxidase antibodies (TPOAb) and/or thyroglobulin antibodies (TgAb).DesignSystematic review and meta-analysis of randomised controlled trialsStudy eligibility criteriaPrespecified criteria for inclusion were: randomised trials of levothyroxine versus control (placebo or no treatment) among women with positive TPOAb or TgAb who were pregnant or considering conception.Data sourcesOvid MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched from 1980 to 5 November 2020.Outcome measuresPrespecified data elements were extracted and where appropriate, meta-analyses were conducted. Main outcomes include pregnancy achieved, miscarriage, preterm delivery and live birth.Risk of bias assessmentCochrane Risk of Bias Tool for Quality Assessment of Randomised Controlled Trials.ResultsFrom 3023 citations, 79 citations were identified for full-text review. Of these, six trials (total of 2263 women) were included for qualitative and quantitative analyses. Risk of bias was deemed low for only one trial. There was no significant difference in the relative risk (RR) of pregnancy achieved (RR 1.03; 95% CI 0.93 to 1.13), miscarriage (RR 0.93; 95% CI 0.76 to 1.14), preterm delivery (RR 0.66; 95% CI 0.39 to 1.10) or live births (RR 1.01; 95% CI 0.89 to 1.16) in thyroid autoimmune women treated with levothyroxine compared with controls. Sensitivity analyses of preterm birth identified study quality and timing of levothyroxine initiation as sources of heterogeneity.ConclusionsAmong pregnant women or women planning conception, with thyroid autoimmunity, there is a lack of evidence of benefit for levothyroxine use (moderate to high Grading of Recommendations, Assessment, Development and Evaluations). Recommendations to use levothyroxine in this setting need to be reconsidered.PROSPERO registration numberCRD42019130459.

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Exercise for premenstrual syndrome: a systematic review and meta-analysis of randomised controlled trials

BJGP Open ◽

10.3399/bjgpopen20x101032 ◽

2020 ◽

Vol 4 (3) ◽

pp. bjgpopen20X101032 ◽

Cited By ~ 1

Author(s):

Emma Pearce ◽

Kate Jolly ◽

Laura L Jones ◽

Gemma Matthewman ◽

Mandana Zanganeh ◽

...

Keyword(s):

Systematic Review ◽

Premenstrual Syndrome ◽

Randomised Controlled Trials ◽

Primary Outcome ◽

Meta Analysis ◽

Current Evidence ◽

Controlled Trials ◽

Cochrane Central Register ◽

Exercise Interventions ◽

Randomised Controlled

BackgroundExercise is recommended as a treatment for premenstrual syndrome (PMS) in clinical guidelines, but this is currently based on poor-quality trial evidence.AimTo systematically review the evidence for the effectiveness of exercise as a treatment for PMS.Design & settingThis systematic review searched eight major databases, including MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL), and two trial registries from inception until April 2019.MethodRandomised controlled trials (RCTs) comparing exercise interventions of a minimum of 8-weeks duration with non-exercise comparator groups in women with PMS were included. Mean change scores for any continuous PMS outcome measure were extracted from eligible trials and standardised mean differences (SMDs) were calculated where possible. Random-effects meta-analysis of the effect of exercise on global PMS symptoms was the primary outcome. Secondary analyses examined the effects of exercise on predetermined clusters of psychological, physical, and behavioural symptoms.ResultsA total of 436 non-duplicate returns were screened, with 15 RCTs eligible for inclusion (n = 717). Seven trials contributed data to the primary outcome meta-analysis (n = 265); participants randomised to an exercise intervention reported reduced global PMS symptom scores (SMD = -1.08; 95% confidence interval [CI] = -1.88 to -0.29) versus comparator, but with substantial heterogeneity (I2 = 87%). Secondary results for psychological (SMD = -1.67; 95% CI = -2.38 to -0.96), physical (SMD = -1.62; 95% CI = -2.41 to -0.83) and behavioural (SMD = -1.94; 95% CI = -2.45 to -1.44) symptom groupings displayed similar findings. Most trials (87%) were considered at high risk of bias.ConclusionBased on current evidence, exercise may be an effective treatment for PMS, but some uncertainty remains.

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