| Abstrakt: |
Background: In Systemic Sclerosis (SSc), peripheral vasculopathy typically manifests as Raynaud Phenomenon (RP) or Digital Ulceration (DU). These have a significant impact in patients' daily life and can ultimately progress to critical ischemia. Despite some pharmacological options already available, a satisfactory outcome for RP and DU in SSc remains elusive. Through the last 2 decades, botulinum toxin (BT) has been reported as beneficial in this scenario. Objectives: To systematically identify and review avai - lable literature evaluating the efficacy of BT on RP/DU in patients with SSc. Methods: A systematic literature search was performed in MEDLINE with the MeSH terms "systemic sclerosis" and "botulinum toxin". All retrieved articles were screened by title and abstract and the eligible ones were kept for full-text review. Reference lists were additionally searched. Original studies evaluating the efficacy of BT in treating RP/DU in patients with SSc aged =18 years old, were considered for inclusion. Study quality assessment was performed with the National Institute of Health (NIH) qualitative assessment tools. Results: The systematic search identified 26 unique search results, of which 19 were excluded after title and abstract screening. After full-text review of the remaining 7, 5 original research papers were included: 2 randomized controlled trials (RCT), 2 case series and 1 case control study (table), in a total of 133 patients. One RCT showed discouraging results (worse blood flow in treated arm) (1), but used a significant lower dose of BT (50U/hand). Despite this, and despite the heterogeneity of outcomes measurements, all reported at least 1 significant improvement of RP outcomes (1-5). Four studies also reported promising results concerning DU healing, with resolution of baseline DU at the end of follow-up in 66.7-100% of the sample (2,3,4) and a RCT showing superiority to placebo in doses of 1000 and 2000U/hand (5). An improvement was also reported in 2 studies, regarding hand function outcomes (3,4). The only adverse effect described was transient hand weakness, affecting only 0-16.7% of study patients. Besides the variety of outcomes, injection protocols differed in every study, including types of BT administered, with one using serotype B. Conclusion: Despite the small number of studies, results point to BT as an effective and safe treatment option for peripheral vasculopathy manifestations of SSc, as it ameliorates RP crisis and contributes to DU healing. However, more randomized controlled trials (RCT) are needed, with unvarying outcomes and injection protocols. [ABSTRACT FROM AUTHOR] |
