RESUMO
BACKGROUND: This is an updated version of a Cochrane Review first published in 2014. Phimosis is a condition in which the prepuce (foreskin) cannot be fully retracted past the head of the penis (glans). Phimosis is often treated surgically by circumcision or prepuce plasty; however, reports of non-invasive treatment using topical corticosteroids applied for four to eight weeks have suggested favorable outcomes. OBJECTIVES: To assess the effects of topical corticosteroids applied to the stenotic portion of the prepuce for the treatment of phimosis in boys compared with placebo or no treatment. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS, and ClinicalTrial.gov. We checked reference lists of included studies and relevant reviews for additional studies. There were no restrictions on the language of publication. The date of the last search was 4 October 2023. SELECTION CRITERIA: We included all randomized controlled trials (RCTs) that compared the use of any topical corticosteroid with placebo or no treatment for boys with any type or degree of phimosis. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data related to the review's primary and secondary outcomes, and assessed the studies' risk of bias. We used the random-effects model for statistical analyses and expressed dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs). We contacted the authors of the primary articles to request details of the study design and specific outcome data. We used GRADE to assess the certainty of evidence on a per-outcome basis. MAIN RESULTS: In this update, we identified two new studies with 111 participants, bringing the total number of included studies to 14 (1459 randomized participants). We found that types of corticosteroids investigated, participant age, degree of phimosis, type of phimosis, and treatment duration varied considerably among studies. Compared with placebo or no treatment, topical corticosteroids may increase the complete resolution of phimosis after four to eight weeks of treatment (RR 2.73, 95% CI 1.79 to 4.16; I² = 72%; 10 trials, 834 participants; low-certainty evidence). Based on 252 complete resolutions per 1000 boys in the control group, this corresponds to 436 more complete resolutions per 1000 boys (95% CI 199 more to 796 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious inconsistency. Topical corticosteroids may also increase the partial resolution of phimosis at four to eight weeks of treatment compared with placebo or no treatment (RR 1.68, 95% CI 1.17 to 2.40; I² = 44%; 7 trials, 745 participants; low-certainty evidence). Based on 297 partial resolutions per 1000 boys in the control group, this corresponds to 202 more partial resolutions per 1000 boys (95% CI 50 more to 416 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious inconsistency. We are uncertain of the effect of topical corticosteroids compared to placebo on change in retractability score (standardized mean difference [SMD] -1.48, 95% CI -2.93 to -0.03; I²91%; 2 trials, 177 participants; very low-certainty evidence). We downgraded the certainty of the evidence by one level for serious study limitations, one level for serious heterogeneity, and one level for serious imprecision. Compared with placebo, topical corticosteroids may increase the long-term complete resolution of phimosis six or more months after treatment (RR 4.09, 95% CI 2.80 to 5.97; I² = 0%; 2 trials, 280 participants; low-certainty evidence). Based on 171 long-term complete resolutions per 1000 boys in the control group, this corresponds to 528 more complete resolutions per 1000 boys (95% CI 308 more to 850 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious imprecision. There may be little or no difference in the risk of adverse effects between topical corticosteroids and placebo or no treatment (RR 0.28, 95% CI 0.03 to 2.62; I² = 22%; 11 trials, 1091 participants; low-certainty evidence). Only two of 11 studies that recorded adverse effects reported any adverse effects; one event occurred in the corticosteroid group and six in the control group. We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious imprecision. AUTHORS' CONCLUSIONS: Topical corticosteroids, compared to placebo or no treatment, may increase complete and partial resolution of phimosis when assessed after four to eight weeks of treatment, and may increase long-term complete resolution of phimosis assessed six or more months after treatment. Topical corticosteroids may have few or no adverse effects, and we are uncertain about their effect on retractability scores. The body of evidence is limited by poor reporting of methods in the studies, important clinical heterogeneity, and serious imprecision in the results. Future, higher-quality trials with long-term follow-up would likely improve our understanding of the effects of topical corticoids on phimosis in boys.
Assuntos
Circuncisão Masculina , Fármacos Dermatológicos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Fimose , Masculino , Humanos , Fimose/tratamento farmacológico , Fimose/cirurgia , Corticosteroides/uso terapêuticoRESUMO
OBJETIVO: Presentar una metodología para la evaluación de la relación costo-efectividad en centros de atención primaria de salud (APS) a partir del modelo de atención familiar promovido en Chile y evaluar los resultados de los dos primeros años de funcionamiento del primer centro piloto que funciona bajo este nuevo modelo de atención primaria. MÉTODOS. Se realizó un estudio de costo-efectividad, con una perspectiva social y un horizonte temporal de un año. Para comparar el centro intervenido (universitario) con el centro de control (municipal) se construyó el índice compuesto de calidad de los centros de salud familiar (ICCESFAM), que combina indicadores técnicos y la percepción de los usuarios de los centros en seis dimensiones: accesibilidad, continuidad de la atención médica, enfoque clínico preventivo y promocional, resolutividad, participación, y enfoque biopsicosocial y familiar. Para calcular los costos se tomó en cuenta el gasto en los centros, el ahorro producido al resto del sistema sanitario y el gasto de bolsillo de los pacientes. Se estimó la razón costo-efectividad incremental (RCEI) y se realizó un análisis de sensibilidad. RESULTADOS: El centro de salud universitario resultó 13,4 por ciento más caro (US$ 8,93 anuales adicionales por inscrito) y más efectivo (ICCESFAM 13,3 por ciento mayor) que el municipal. Estos resultados hacen que la RCEI sea de US$ 0,67 por cada punto porcentual adicional que aumenta el ICCESFAM. CONCLUSIONES: Según el modelo elaborado de evaluación de centros de APS, los centros que siguen el modelo de salud familiar chileno son más efectivos, tanto por sus indicadores técnicos como por la valoración de sus usuarios, que los centros de APS tradicionales.
OBJECTIVE: Present a methodology for evaluating cost-effectiveness in primary health care centers (PHCs) in Chile based on the family health care model promoted in Chile and evaluate the results of the first two years of operation of the first pilot center to work under this new primary-care model. METHODS: A cost-effectiveness study with a social perspective and a one-year time frame was conducted. In order to compare the university health center in question with the control (a municipal health center), a Family Health Center Composite Quality Index (FHCCQI) was devised. It combines technical indicators and user perceptions of the health centers in six areas: access, continuity of medical care, a preventive and promotional clinical approach, problem-solving capability, participation, and a biopsychosocial and family approach. In order to calculate the costs, the centers' expenses, the savings realized in the rest of the health system, and patients' out-of-pocket expenditures were considered. The incremental cost-effectiveness ratio (ICR) was estimated and a sensitivity analysis was performed. RESULTS: The university health center was 13.4 percent more expensive (an additional US$ 8.93 per annum per enrollee) and was more effective (FHCCQI 13.3 percent greater) than the municipal one. Accordingly, the ICR is US$ 0.67 for each additional percentage point of FHCCQI increase. CONCLUSIONS: According to the PHC evaluation model that was implemented, the centers that follow the Chilean family health care model are more effective than traditional PHC centers, as measured by both technical indicators and user ratings.