Drug interventions versus placebo for the treatment of Raynaud’s phenomenon: generic protocol

Rirash, Fadumo; Tingey, Paul; Harding, Sarah E; Maxwell, Lara; Ghogomu, Elizabeth Tanjong; Maltez, Nancy; Tugwell, Peter; Wells, George A.; Pope, Janet

doi:10.1002/14651858.cd011813.pub2

Cited by 2 publications

(3 citation statements)

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“…The main strengths of our study were the stratified randomization, the multicenter, double‐blind, placebo‐controlled design, the inclusion and primary end point visits taking place during winter months, and outcomes in accordance with the generic protocol on drug interventions for RP treatment published by the Cochrane Library (27). Patient compliance with paper diary recording was also excellent, similar to what was reported with an electronic diary (35).…”

Section: Discussionmentioning

confidence: 99%

“…This AE was classified as mild‐to‐moderate for muscle fatigability and severe for inability to perform usual movements. Primary and secondary outcomes were chosen according to Cochrane Library recommendations for studies on RP (27).…”

Section: Methodsmentioning

confidence: 99%

“…The sponsor was Assistance Publique–Hôpitaux de Paris. The study design and end points were in accordance with the Cochrane Library generic protocol on drug interventions to treat RP (27). A list of BRASS trial investigators is provided in Supplementary Appendix A available on the Arthritis & Rheumatology website at https://onlinelibrary.wiley.com/doi/10.1002/art.42342.…”

Section: Methodsmentioning

confidence: 99%

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Efficacy and Safety of Botulinum Toxin in Adults with Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Study

Senet

Maillard

Diot

et al. 2022

Arthritis & Rheumatology

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Objective To determine whether a single session of botulinum toxin type A (BTA) injections into both hands more effectively decreases the frequency of systemic sclerosis–associated Raynaud's phenomenon (SSc‐RP) episodes than placebo. Methods This multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group phase III trial in patients with SSc‐RP assessed the effect of 50‐unit BTA or placebo injections into the palms of both hands around each neurovascular bundle during 1 session in winter. The primary end point was the between‐group difference in the median change in the number of RP episodes from baseline (day 0) to 4 weeks postinjection. Values between the groups were compared with the Wilcoxon rank‐sum test. Results The intent‐to‐treat analysis included 46 BTA‐treated patients and 44 placebo recipients. At 4 weeks after assigned treatment injections, the median number of daily RP episodes decreased comparably in the BTA and placebo groups (median change –1 episode/day [interquartile range (IQR) –1.5, 0 episodes/day] and –1 episode/day [IQR –2.5, 0 episodes/day], respectively) (P = 0.77 versus placebo). Moreover, change in Raynaud's Condition Score, quality of life assessed by Health Assessment Questionnaire disability index, and hand function assessed by shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and Cochin Hand Function Scale from baseline to follow‐up weeks 4, 12, and 24 did not differ significantly between groups. The BTA group experienced transient hand muscle weakness significantly more frequently (P = 0.003). Conclusion Neither the primary nor secondary end points were reached, and our results do not support any beneficial effect of palmar BTA injections to treat SSc‐RP.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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