title: Efficacy of Raynaud's phenomenon and digital ulcer pharmacological treatment in systemic sclerosis patients: a systematic literature review.
abstract: To evaluate the efficacy of current treatments for the Raynaud phenomenon (RP) in patients with systemic sclerosis (SSc), a systematic literature search was performed using Medline, EMBASE, and Cochrane Central Register of Controlled Trials (from 1961 to October 2011). We included meta-analyses, systematic reviews, clinical trials, and high-quality cohort studies published in English or Spanish. Patient populations had to include adults diagnosed with limited cutaneous or diffuse SSc who had associated RP and/or digital ulcers under pharmacological treatment. Efficacy of treatments was evaluated based on: number of RP episodes, RP severity, episode-free time, ulcer improvement/healing, and appearance of new ulcers. We used the Jadad scale of methodological quality to evaluate the quality of randomized clinical trials, and the 2009 Oxford Centre for Evidence-Based Medicine classification for other studies. Of a total of 1617 studies identified, only 27 fulfilled inclusion criteria. Drugs received the following grade recommendations: Grade A for nifedipine, nicardipine, quinapril, IV iloprost, bosentan, tadalafil, and MQx-503; Grade B for beraprost, cicaprost, DMSO, cyclofenil, and atorvastatin; and Grade C for misoprostol, prazosin, OPC-2826, enalapril, sildenafil, antioxidant, and stanazolol. Calcium channel blockers, prostanoids, tadalafil, and bosentan received the highest recommendation level for their effectiveness. However, most systematic reviews reviewed just a handful of studies with small sample sizes and short follow-ups. Our review shows that the existing evidence on the efficacy of RP treatment in SSc patients is inconclusive which calls for further research, especially in the form of prospective studies of high quality with long-term follow-ups.
authors.affiliation: Servicio de Reumatología, Hospitales Universitarios Grupo Madrid (Madrid, Montepríncipe, Sanchinarro y Torrelodones), c/Oña nº10, 28050, Madrid, Spain, reumatologia.hms@hmhospitales.com.
authors.forename: Paloma
authors.initials: P
authors.lastname: García de la Peña Lefebvre
authors.forename: María Betina
authors.initials: MB
authors.lastname: Nishishinya
authors.forename: Claudia Alejandra
authors.initials: CA
authors.lastname: Pereda
authors.forename: Estíbaliz
authors.initials: E
authors.lastname: Loza
authors.forename: Walter Alberto
authors.initials: WA
authors.lastname: Sifuentes Giraldo
authors.forename: José Andrés
authors.initials: JA
authors.lastname: Román Ivorra
authors.forename: Patricia
authors.initials: P
authors.lastname: Carreira
authors.forename: Iñigo
authors.initials: I
authors.lastname: Rúa-Figueroa
authors.forename: Jose María
authors.initials: JM
authors.lastname: Pego-Reigosa
authors.forename: Santiago
authors.initials: S
authors.lastname: Muñoz-Fernández
mesh_terms: D006801:Humans; D011928:Raynaud Disease / Q000150:complications / Q000188:drug therapy*; D012595:Scleroderma, Systemic / Q000150:complications*; D012883:Skin Ulcer / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*
chemical_list: D014665:Vasodilator Agents
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