Interventions targeting the reduction or discontinuation of long-term use of benzodiazepine receptor agonists: protocol for an overview of systematic reviews

Kristien Coteur; Cristín Ryan; Susan M Smith; Greg Sheaf; Marjorie DeWert; David Gardner; Cathal Cadogan

doi:10.12688/hrbopenres.13976.1

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Study Protocol

Interventions targeting the reduction or discontinuation of long-term use of benzodiazepine receptor agonists: protocol for an overview of systematic reviews

[version 1; peer review: 2 approved with reservations]

Kristien Coteur¹, Cristín Ryan², Susan M Smith³, [...] Greg Sheaf⁴, Marjorie DeWert⁵, David Gardner⁶, Cathal Cadogan ²

Kristien Coteur¹, Cristín Ryan², [...] Susan M Smith³, Greg Sheaf⁴, Marjorie DeWert⁵, David Gardner⁶, Cathal Cadogan ²

PUBLISHED 14 Nov 2024

Author details Author details

¹ Department of Public Health and Primary Care, KU Leuven, Leuven, Flanders, Belgium
² School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Leinster, Ireland
³ School of Medicine, Discipline of Public Health and Primary Care Trinity College Dublin, Dublin, Leinster, Ireland
⁴ The Library of Trinity College, Trinity College Dublin, Dublin, Leinster, Ireland
⁵ none, none, USA
⁶ Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada

Kristien Coteur
Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation

Cristín Ryan
Roles: Investigation, Methodology, Writing – Review & Editing

Susan M Smith
Roles: Investigation, Methodology, Writing – Review & Editing

Greg Sheaf
Roles: Data Curation, Investigation, Methodology, Resources, Software, Writing – Review & Editing

Marjorie DeWert
Roles: Investigation, Methodology, Writing – Review & Editing

David Gardner
Roles: Investigation, Methodology, Writing – Review & Editing

Cathal Cadogan
Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background

Benzodiazepine receptor agonists (BZRAs) are commonly prescribed to treat anxiety and insomnia. Although guidelines recommend limiting prescriptions to short-term use (<4 weeks), BZRAs are often continued long-term. Due to the associated risks (e.g. memory impairment, falls/fractures), it is recommended that long-term BZRA use should be discontinued. Several systematic reviews have studied the effectiveness of pharmacological and non-pharmacological interventions targeting long-term BZRA use; however, an overview of the evidence across intervention types and healthcare settings is lacking.

Aim

To identify and narratively synthesise systematic reviews that assess the effectiveness of interventions targeting the reduction or discontinuation of long-term BZRA use.

Methods

An overview of systematic reviews will be conducted. Five electronic databases (MEDLINE, Embase, Web of Science, PsycINFO, CINAHL) will be searched for systematic reviews of randomised controlled trials of interventions targeting the reduction or discontinuation of long-term BZRA use in adults in any setting. All types and combinations of interventions are eligible for inclusion (e.g. psychosocial interventions, pharmacological interventions). Interventions will be evaluated against usual care. Article screening and data extraction will be conducted by two reviewers independently. Overlap in primary publications will be assessed by calculating the corrected covered area and graphically represented. Methodological quality of included reviews will be assessed using the AMSTAR-2 tool. Results will be synthesised narratively. The certainty of evidence will be assessed using the GRADE approach.

Conclusions

This overview of reviews will narratively synthesise the evidence from systematic reviews of the effectiveness of interventions targeting long-term BZRA use. The review will provide an extensive overview of the existing evidence, which will inform future research and policy decisions about interventions for reducing and discontinuing long-term BZRA use.

Keywords

benzodiazepines, hypnotics and sedatives, deprescribing, drug tapering, psychosocial intervention, pharmacological intervention, systematic review, umbrella review, overview of reviews

Corresponding author: Cathal Cadogan

Competing interests: No competing interests were disclosed.

Grant information: Health Research Board [ILP-HSR-2022-006].

Copyright: © 2024 Coteur K et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Coteur K, Ryan C, Smith SM et al. Interventions targeting the reduction or discontinuation of long-term use of benzodiazepine receptor agonists: protocol for an overview of systematic reviews [version 1; peer review: 2 approved with reservations]. HRB Open Res 2024, 7:71 (https://doi.org/10.12688/hrbopenres.13976.1) First published: 14 Nov 2024, 7:71 (https://doi.org/10.12688/hrbopenres.13976.1) Latest published: 14 Nov 2024, 7:71 (https://doi.org/10.12688/hrbopenres.13976.1)

Introduction

Benzodiazepine receptor agonists (BZRAs) – including benzodiazepines and Z-drugs (i.e. zolpidem, (es)zopiclone, zaleplon) – are commonly used for their anxiolytic and hypnotic effects. The annual rate of use among adults in ambulatory care is approximately 12%^1,2. Rates are higher for older adults, women^1–3, and in institutional care settings. Use rates between 32%⁴ and 44%⁵ have been reported for inpatients of geriatric units in hospitals, and 39%⁶ to 53%⁷ for residents of nursing homes.

Prescribing guidelines typically recommend that BZRAs should be used at the lowest possible dose and for the shortest possible duration, with a maximum of one to two weeks for insomnia, or four weeks for anxiety^8–11. However, prescribers acknowledge that their use of BZRAs typically extends beyond guideline recommendations. In a recent European survey, physicians estimated their typical duration of BZRA use for insomnia to be 15 weeks, with large differences among participating countries ranging from 8 weeks by UK participants to 23 weeks by Spanish participants¹². Rates of long-term BZRA use are approximately 3% among the general population¹³, and between 23%⁶ to 50–54%^7,14 in nursing homes. Long-term BZRA use is a significant healthcare issue as it is associated with considerable health risks, such as cognitive and psychomotor impairment, as well as increased risk of falls^13,15–17.

Discontinuation of BZRA use can be challenging due to the development of physical dependence which may result in withdrawal symptoms of varying severity^18–20. These symptoms include but are not limited to low energy, anxiety, insomnia, concentration difficulties, irritability, abdominal and muscle cramps, tremors, and delirium^18–20. Patients have reported continuing BZRA use to avoid withdrawal symptoms²¹.

The effectiveness of pharmacological and non-pharmacological interventions targeting the reduction and discontinuation of long-term BZRA use has been subject of multiple reviews^22–34. The gold standard approach for discontinuing long-term BZRA use is a slow, gradual dose reduction (GDR) proportionate to the existing dose³⁵ with regular follow-up to allow for the dose reduction plan to be adjusted as required^17,36. GDR reduces the risk for withdrawal symptoms and limits symptom duration and severity^19,37,38. However, to date, there has been no overview of the existing systematic reviews which makes it difficult to fully understand the current state of the existing evidence base. The aim of this review is to provide a comprehensive overview of the evidence from existing systematic reviews regarding the effectiveness of interventions targeting the reduction or discontinuation of long-term BZRA use. The objectives are to:

1. Identify and narratively synthesise the evidence from systematic reviews of randomised controlled trials (RCTs) regarding the effectiveness of interventions targeting the reduction or discontinuation of long-term BZRA use;
2. Appraise the quality of the identified systematic reviews.
3. Assess the certainty of the available evidence.

Methods

Design

An overview of systematic reviews will be conducted. This protocol has been developed following PRISMA-P³⁹ and the guidance on overviews of reviews in the Cochrane Handbook for Systematic Reviews of Interventions⁴⁰. The final review will be reported using the Preferred Reporting Items for Overviews of Reviews (PRIOR) checklist⁴¹.

Eligibility criteria

The Population-Intervention-Comparison-Outcomes(s) (PICO) concept was used to structure the clinical research question and align the eligibility criteria with the review’s aim.

Population. Interventions in the systematic review must aim to reduce or discontinue long-term BZRA use by targeting adult (≥18 years old) patients or clinicians, in any healthcare setting. For this overview, “long-term” use is a minimum of 12 weeks or as defined by the author.

Intervention and comparator(s). Eligible systematic reviews may include all types of interventions targeting the reduction or discontinuation of long-term BZRA use, inclusive of psychosocial and pharmacological interventions. The comparator should at least consist of usual care (i.e. no intervention). Comparisons to other interventions targeting BZRA reduction or discontinuation without a comparison to usual care will be excluded. We will exclude interventions for the treatment of diagnosed substance use disorders that include BZRA dependence because they require a different therapeutic paradigm and are often delivered in specific settings managing substance use disorders. We will also exclude interventions that target BZRAs as part of a wider initiative aimed at reducing potentially inappropriate medications in patients with polypharmacy but that don’t include a specific targeted intervention.

Outcomes. Eligible systematic reviews must assess the effectiveness of the intervention(s) in terms of reducing or discontinuing long-term BZRA use, as defined by the study authors.

Study type. Eligible systematic reviews will focus on RCTs that compare interventions targeting the reduction or discontinuation of long-term BZRA use against usual care (i.e. no intervention). Systematic reviews are defined as reviews with a pre-defined systematic strategy for searching multiple databases, selecting studies, synthesising findings, and using a quality appraisal tool, guided by a clear aim⁴². In the event that several versions of the same systematic review exist, the most recent version will be selected. The following types of articles will be excluded: rapid reviews, scoping reviews, umbrella reviews or overviews of reviews, protocols for systematic reviews and/or meta-analysis, reviews comprising viewpoints or opinions as primary source of evidence, and conference abstracts. The reference list of all included reviews will be screened for additional references.

Only systematic reviews published since 2003 will be included. A limit of 20 years per date of the first search is maintained, to ensure maximum relevancy of the included literature as more recent systematic reviews will include both older and newer RCTs. There will be no language restrictions.

Search strategy

The following electronic databases will be searched: MEDLINE, Embase, Web of Science, PsycINFO and CINAHL. A detailed search strategy will be developed around the following three concepts following the guidance of an information retrieval expert: (1) medication reduction/discontinuation, (2) BZRAs, and (3) systematic review of randomised controlled studies.

Selection process. Following the database searches, retrieved records will be uploaded to Covidence^®, an online systematic review management software tool, to assist the screening process. All titles/abstract will be independently screened by two reviewers. If a systematic review appears to meet inclusion criteria, or its eligibility cannot be assessed based on the title and abstract alone, the full text will be retrieved and screened by two reviewers independently. Any disagreements will be resolved by discussion, and if needed consultation with a third reviewer, until consensus is reached.

Data collection. Data from systematic reviews will be extracted into a predefined data charting template. The following information will be collected: a) key review characteristics (including citation details, review objectives, number of databases searched, date range, date of last search update, number of included studies and participants, quality appraisal tool used and quality ratings of primary publications), b) patient characteristics (demographics, BZRA indication, BZRA use history, co-morbidities, concomitant psychotropic medication use, exclusion criteria), c) basic characteristics of the intervention(s) and comparator(s) being reviewed (e.g. brief or complex, psychosocial or pharmacological, uni- or multidisciplinary, theoretical basis, intensity, frequency, duration, other key elements), d) the outcomes regarding reduction or discontinuation of BZRA, e) patient reported outcome measures (e.g. effect on anxiety or insomnia) and f) their certainty assessments, if available. Finally, g) descriptive characteristics of the primary publications in the systematic review (citation details, study design, geographical location) will be extracted.

The data extraction template will be piloted by the reviewers to maximise consistency and amended if needed. Data extraction will also be conducted by two reviewers, working independently. Any disagreements will be resolved by discussion. If any of the required details are not available from the published systematic reviews, the reviewers will document this gap in the overview. Overlap in the primary publications will be calculated using the corrected covered area measure introduced by Pieper et al. in 2014⁴³, and visually represented in a graph using the GROOVE tool⁴⁴.

Data analysis. Findings will be synthesised narratively, and also reported in tabular format. The summary of evidence table will be presented as per Cochrane guidance, including a description of the population, intervention(s), comparison(s), and outcomes, e.g. BZRA reduction, or BZRA discontinuation, and the quality of evidence.

The primary outcome that will be assessed in this overview is the effectiveness of interventions regarding the reduction or discontinuation of long-term BZRA use. Secondary outcomes that are of interest to the research group include patient-reported outcome measures such as the interventions’ effect on anxiety and insomnia, quality of life, adverse drug withdrawal events, daytime dysfunction, use of healthcare services, as well as other parameters for cost-effectiveness of the intervention.

Assessment of methodological quality and certainty of evidence. The Assessment of Multiple Systematic Reviews (AMSTAR) 2 tool⁴⁵ will be used to assess the methodological quality of included reviews. All included reviews will be evaluated by two reviewers, working independently. Any disagreements will be resolved through discussion.

There will be two levels of certainty assessment in this overview of reviews. Firstly, assessments concerning the certainty of evidence within individual systematic reviews as conducted by its authors. The results will be extracted and presented in the overview table summarising the characteristics of the included systematic reviews, when available. Secondly, the certainty of evidence of the overview’s findings. This will be independently assessed by two reviewers using the GRADE tool⁴⁶. The reviewers will consider the critical appraisal results, imprecision, inconsistency, indirectness, and possible publication bias, e.g. bias due to negative results not being published or inadequate reporting of missing results. Any discrepancies in the assessment will be resolved by discussion.

Discussion

This overview of reviews will narratively synthesise the evidence from systematic reviews about the effectiveness of interventions targeting the reduction or discontinuation of long-term BZRA use, irrespective of intervention type, target population or healthcare setting. The review will provide an extensive overview of the existing evidence, showing the amount of high quality research for particular interventions. Simultaneously, the overview will reveal gaps in the current body of evidence, which will inform future research and could help to drive improvement in healthcare. For example, it can map which patient variables have been considered in BZRA discontinuation studies.

Its findings may inform future healthcare policy decisions as well as intervention development and implementation research. Given the growing interest in deprescribing as a research domain, and the ongoing development of novel interventions targeting the reduction/discontinuation of long-term BZRA use, there is a need for a comprehensive and high-quality evidence synthesis.

Ethics and consent

Ethics and consent is not required.

Other information

Dissemination of findings

The overview of reviews will be submitted for publication in a peer-reviewed international journal.

Study status

As of the publication of this protocol, database searches and screening are completed.

Data availability

No underlying data are associated with this protocol.

Extended data

OSF: Interventions targeting the reduction or discontinuation of long-term use of benzodiazepine receptor agonists: an overview of systematic reviews.

DOI:https://osf.io/697ad⁴⁷

This project contains the following extended data:

Coteur et al. 2024_PRISMA-P-checklist.
Coteur et al. 2024_search strategy MEDLINE

Protocol registration: https://osf.io/697ad/registrations.

Reporting guidelines

OSF: PRISMA-P checklist for Interventions targeting the reduction or discontinuation of long-term use of benzodiazepine receptor agonists: Protocol for an overview of systematic reviews. https://doi/10.17605/OSF.IO/697AD⁴⁷.

Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

Author contributions

Kristien Coteur: Conceptualization, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation

Cristín Ryan: Investigation, Methodology, Writing – Review & Editing

Susan M Smith: Investigation, Methodology, Writing – Review & Editing

Greg Sheaf: Data Curation, Investigation, Methodology, Resources, Software, Writing – Review & Editing

Marjorie DeWert : Investigation, Methodology, Writing – Review & Editing

David Gardner: Investigation, Methodology, Writing – Review & Editing

Cathal Cadogan: Conceptualization, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation

Faculty Opinions recommended

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