Trial reportArthritis & rheumatology (Hoboken, N.J.)2017
The Therapeutic Efficacy of Botulinum Toxin in Treating Scleroderma-Associated Raynaud's Phenomenon: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
44 citing papers in PubMed, 5 syntheses or guidelines pooled it, 118 citations in OpenAlex.
- A systematic review of therapeutic procedures for the treatment of morphea and systemic sclerosis.Lasers in medical science · 2026Pooled it
- A systematic review of botulinum toxin as a treatment for Raynaud's disease secondary to scleroderma.Clinical rheumatology · 2025Pooled it
- 2023 Brazilian Society of Rheumatology guidelines for the treatment of systemic sclerosis.Advances in rheumatology (London, England) · 2024Guideline
- Locoregional Treatments for Digital Ulcers in Systemic Sclerosis: A Systematic Review.Acta dermato-venereologica · 2021Pooled it
- Pooled it
- Efficacy of adipose stromal cells-enriched high-density fat graft combined with BTX-A for Raynaud's phenomenon: a prospective cohort study.Arthritis research & therapy · 2025Trial
- [S2k guidelines on diagnostics and treatment of systemic sclerosis : Full version].Zeitschrift fur Rheumatologie · 2025Review
- Aesthetic Treatment Considerations in Patients with Cutaneous Autoimmune Disease.The Journal of clinical and aesthetic dermatology · 2025Review
- Wound, pressure ulcer, and burn guidelines (2023)-4: Guidelines for the management of connective tissue disease/vasculitis-associated skin ulcers, third edition.The Journal of dermatology · 2025Article
- Exploring New and Potential Indications for Botulinum Toxin Treatment: An Updated Literature Review.Cureus · 2024Review
- Review
- Toxin for Treating Raynaud Conditions in Hands (The TORCH Study): A Systematic Review and Meta-analysis.Plastic and reconstructive surgery. Global open · 2024Article
- Article
- Analysis of Hand Function, Upper Limb Disability, and Its Relationship with Peripheral Vascular Alterations in Raynaud's Phenomenon.Diagnostics (Basel, Switzerland) · 2023Article
- Efficacy analysis of minimally invasive surgery for Raynaud's syndrome.BMC surgery · 2023Article
- State-of-the-art evidence in the treatment of systemic sclerosis.Nature reviews. Rheumatology · 2023Review
- Considerations for Hand Surgery in Patients With Scleroderma.Hand (New York, N.Y.) · 2023Review
- Evaluation of Clinical Recovery After Surgical Treatment for Hand Ischemia From Vasospastic and Occlusive Disease Using PROMIS.Hand (New York, N.Y.) · 2023Article
- Review
- [Functional vascular acrosyndromes].Innere Medizin (Heidelberg, Germany) · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
Abstract
objectiveTo assess the therapeutic efficacy of local injections of botulinum toxin type A (Btx-A) in improving blood flow to the hands of patients with Raynaud's phenomenon (RP) secondary to scleroderma.
methodsIn this randomized, double-blind, placebo-controlled clinical trial, patients with scleroderma-associated RP received Btx-A (50 units in 2.5 ml sterile saline) in one randomly selected hand and sterile saline (2.5 ml) in the opposite hand. Follow-up at 1 and 4 months postinjection included laser Doppler imaging of hands, patient-reported outcomes, and physical examination. We compared outcomes using paired t-tests and population-average generalized models with generalized estimating equations.
resultsOf 40 patients enrolled, 25 had limited scleroderma and 15 had diffuse scleroderma. From baseline to 1-month follow-up, there was a greater reduction in average blood flow in Btx-A-treated hands compared to placebo-treated hands. The model estimated that this difference was statistically significant (average difference -30.08 flux units [95% confidence interval -56.19, -3.98], P for interaction = 0.024). This difference was mainly influenced by patients with longstanding RP and diffuse scleroderma. Change in blood flow at 4-month follow-up was not significantly different between groups. Clinical measures (QuickDASH, McCabe Cold Sensitivity Score, pain on a visual analog scale, and Raynaud's Condition Score) improved slightly for Btx-A-treated hands.
conclusionOur laboratory-based laser Doppler imaging flow data do not support using Btx-A to treat RP in all scleroderma patients. The secondary clinical outcomes suggest some positive effect, but its clinical meaningfulness is questionable. The role of Btx-A in treating RP should be further studied with more homogeneous patient populations and in unique clinical situations such as acute digital ischemia.
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