Abstract
Objectives: Raynaud’s phenomenon (RP) is a significant cause of morbidity. Vasodilator medications can cause unwanted adverse effects, with behavioural and lifestyle changes forming the mainstay of symptom self-management, however this is difficult to implement successfully. The objectives of this study were to evaluate the efficacy of behaviour-change interventions for adults with RP and identify learning points for future RP treatment development..
Design: Systematic literature review and narrative synthesis of findings.
Data sources: EMBASE, PubMED, Cochrane and Psychinfo were searched for eligible studies on 22nd August 2017
Eligibility criteria: randomised controlled trials (RCTs) of behaviour-change interventions with at least one control comparator arm.
Data extraction and synthesis: Study selection, data extraction and risk-of-bias were assessed independently by two reviewers, and reached consensus with the third when necessary. Primary outcomes of interest included severity/impact, frequency and duration of RP episodes, pain, disability, adverse events and study withdrawal.
Results: Of 638 articles retrieved, eight studies fulfilled criteria for inclusion. Biofeedback was the active behaviour-change treatment arm for seven studies, with one study reporting a behavioural intervention. Studies were published 1978–2002; six were USA based studies, one German and one Swedish. Using Cochrane Risk of Bias assessment, studies were assessed to be overall at high risk-of-bias was concluded, with the exception of one large RCT. The total sample included 495 participants (study median=29), with a median age of 39.5y and preponderance towards females (73%). Five studies reported significant effects in primary outcomes of interest, however due to missing data and high risk-of-bias across studies, relative efficacy of interventions could not be assessed.
Conclusions: There is no evidence to support or refute claims of the efficacy or safety of behaviour-change interventions for the management of RP. There remains a strong case for developing and testing behaviour-change interventions that focus on self-management of RP, however theoretical development and advancement in trial quality is imperative to underpin future work.
Design: Systematic literature review and narrative synthesis of findings.
Data sources: EMBASE, PubMED, Cochrane and Psychinfo were searched for eligible studies on 22nd August 2017
Eligibility criteria: randomised controlled trials (RCTs) of behaviour-change interventions with at least one control comparator arm.
Data extraction and synthesis: Study selection, data extraction and risk-of-bias were assessed independently by two reviewers, and reached consensus with the third when necessary. Primary outcomes of interest included severity/impact, frequency and duration of RP episodes, pain, disability, adverse events and study withdrawal.
Results: Of 638 articles retrieved, eight studies fulfilled criteria for inclusion. Biofeedback was the active behaviour-change treatment arm for seven studies, with one study reporting a behavioural intervention. Studies were published 1978–2002; six were USA based studies, one German and one Swedish. Using Cochrane Risk of Bias assessment, studies were assessed to be overall at high risk-of-bias was concluded, with the exception of one large RCT. The total sample included 495 participants (study median=29), with a median age of 39.5y and preponderance towards females (73%). Five studies reported significant effects in primary outcomes of interest, however due to missing data and high risk-of-bias across studies, relative efficacy of interventions could not be assessed.
Conclusions: There is no evidence to support or refute claims of the efficacy or safety of behaviour-change interventions for the management of RP. There remains a strong case for developing and testing behaviour-change interventions that focus on self-management of RP, however theoretical development and advancement in trial quality is imperative to underpin future work.
| Original language | English |
|---|---|
| Publication status | Published - Oct 2018 |
