ABSTRACT
BACKGROUND: There is limited evidence supporting the use of alternative treatments for patients with nonstable vitiligo. OBJECTIVE: This study aimed to review the effects of oral mini-pulse (OMP) therapy in the management of nonsegmental vitiligo. METHODS: The following databases were searched between inception and May 2020 for relevant studies: Scopus, Web of Science, MEDLINE, and Embase. All randomized controlled trials that compared OMP therapy with any other active treatment or placebo for nonstable vitiligo were included. The Cochrane's risk of bias tool was used to evaluate the risk of bias (ROB) in selected studies, and the overall quality of evidence of each outcome was assessed using the Grading Recommendations, Assessment, Development, and Evaluations (GRADE) system. RESULTS: Four studies met our selection criteria. All of them were conducted in India and included 246 patients. OMP therapy included betamethasone or dexamethasone. The duration of treatment was 6 months in all studies. Up to 32% of patients achieved a repigmentation rate of >75% when OMP therapy was administered as monotherapy. No difference was observed between OMP therapy and other treatments in arresting the disease, and weight gain was the most frequent adverse effect. The overall ROB in all included studies was relatively high because of the randomization process, outcome measurement and informed selection of outcomes. CONCLUSION: Based on the findings of these studies, OMP therapy did not demonstrate additional value compared with other treatments. Hence, there is an urgent need to conduct high-quality clinical trials to evaluate this therapy.
Subject(s)
Vitiligo , Betamethasone , Humans , India , Vitiligo/drug therapyABSTRACT
OBJECTIVE: To evaluate sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists in patients with type 2 diabetes at varying cardiovascular and renal risk. DESIGN: Network meta-analysis. DATA SOURCES: Medline, Embase, and Cochrane CENTRAL up to 11 August 2020. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials comparing SGLT-2 inhibitors or GLP-1 receptor agonists with placebo, standard care, or other glucose lowering treatment in adults with type 2 diabetes with follow up of 24 weeks or longer. Studies were screened independently by two reviewers for eligibility, extracted data, and assessed risk of bias. MAIN OUTCOME MEASURES: Frequentist random effects network meta-analysis was carried out and GRADE (grading of recommendations assessment, development, and evaluation) used to assess evidence certainty. Results included estimated absolute effects of treatment per 1000 patients treated for five years for patients at very low risk (no cardiovascular risk factors), low risk (three or more cardiovascular risk factors), moderate risk (cardiovascular disease), high risk (chronic kidney disease), and very high risk (cardiovascular disease and kidney disease). A guideline panel provided oversight of the systematic review. RESULTS: 764 trials including 421 346 patients proved eligible. All results refer to the addition of SGLT-2 inhibitors and GLP-1 receptor agonists to existing diabetes treatment. Both classes of drugs lowered all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, and kidney failure (high certainty evidence). Notable differences were found between the two agents: SGLT-2 inhibitors reduced admission to hospital for heart failure more than GLP-1 receptor agonists, and GLP-1 receptor agonists reduced non-fatal stroke more than SGLT-2 inhibitors (which appeared to have no effect). SGLT-2 inhibitors caused genital infection (high certainty), whereas GLP-1 receptor agonists might cause severe gastrointestinal events (low certainty). Low certainty evidence suggested that SGLT-2 inhibitors and GLP-1 receptor agonists might lower body weight. Little or no evidence was found for the effect of SGLT-2 inhibitors or GLP-1 receptor agonists on limb amputation, blindness, eye disease, neuropathic pain, or health related quality of life. The absolute benefits of these drugs vary substantially across patients from low to very high risk of cardiovascular and renal outcomes (eg, SGLT-2 inhibitors resulted in 3 to 40 fewer deaths in 1000 patients over five years; see interactive decision support tool (https://magicevidence.org/match-it/200820dist/#!/) for all outcomes. CONCLUSIONS: In patients with type 2 diabetes, SGLT-2 inhibitors and GLP-1 receptor agonists reduced cardiovascular and renal outcomes, with some differences in benefits and harms. Absolute benefits are determined by individual risk profiles of patients, with clear implications for clinical practice, as reflected in the BMJ Rapid Recommendations directly informed by this systematic review. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019153180.
