Meta-analysis of healing and prevention of digital ulcers in systemic sclerosis

source extracted confidence: high 2026-04-09
#clinical-trials-as-topic #fingers #humans #scleroderma-systemic #skin-ulcer

Meta-analysis of healing and prevention of digital ulcers in systemic sclerosis

Tingey et al., 2013 | Arthritis Care Res (Hoboken) | Meta Analysis

Citation

Tingey Theresa, Shu Jenny, ... Pope Janet. Meta-analysis of healing and prevention of digital ulcers in systemic sclerosis. Arthritis Care Res (Hoboken). 2013-Sep;65(9):1460-71. doi:10.1002/acr.22018

Abstract

OBJECTIVE: To assess the efficacy of therapies in healing and preventing digital ulcers (DUs) in systemic sclerosis (SSc; scleroderma). METHODS: Medline and EMBASE databases, and American College of Rheumatology and European League Against Rheumatism abstracts, were searched. Randomized controlled trials (RCTs) with outcomes investigating healing or prevention of DUs in SSc and comparing a pharmacologic therapy with placebo or an active agent were included. The pooled risk ratios (RRs) using the fixed-effects model were calculated and heterogeneity was tested using the I(2) statistic. RESULTS: Sixty studies were found; 19 were not randomized, and 10 did not give DU quantitative data or no comparison of a different drug, leaving 31 RCTs with a total of 1,989 patients. Quality was 3 of 5 or less for 11 trials. DUs were not the primary outcome in many RCTs. Phosphodiesterase type 5 (PDE-5) inhibitors were significant for DU healing (RR 3.28 [95% confidence interval (95% CI) 1.32, 8.13], P = 0.01). Two large bosentan trials were significant for mean number of new DUs (standardized mean difference [SMD] -0.34 [95% CI -0.57, -0.11], P = 0.004). Oral prostacyclins were not statistically different from placebo, but intravenous (IV) iloprost prevented new DUs (SMD 0.77 [95% CI -1.46, -0.08], P = 0.03). Single trials for atorvastatin and vitamin E were positive in the prevention and healing of DU, respectively. There were many negative trials: antiplatelet therapy, oral N-acetylcysteine, heparin, dimethyl sulfoxide, ketanserin, prazosin, prostaglandin E1, cyclofenil, quinapril, and topical nitroglycerin formulation. CONCLUSION: Small sample sizes, few comparative trials, and heterogeneity limits the conclusions. The results suggest a role for PDE-5 inhibitors in the healing of DUs; bosentan and IV iloprost may prevent new DUs.

Key Findings

Sixty studies were found; 19 were not randomized, and 10 did not give DU quantitative data or no comparison of a different drug, leaving 31 RCTs with a total of 1,989 patients. Quality was 3 of 5 or less for 11 trials. DUs were not the primary outcome in many RCTs. Phosphodiesterase type 5 (PDE-5) inhibitors were significant for DU healing (RR 3.28 [95% confidence interval (95% CI) 1.32, 8.13], P = 0.01). Two large bosentan trials were significant for mean number of new DUs (standardized mean di

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 1989
Age Range See abstract
Condition See abstract

MeSH Terms

  • Clinical Trials as Topic
  • Fingers
  • Humans
  • Scleroderma, Systemic
  • Skin Ulcer
  • Wound Healing

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't
  • Vertical: vitamin-e

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09