This long-term extension of an 8-week randomized, naturalistic study in patients with panic disorder with or without agoraphobia compared the efficacy and safety of clonazepam (n = 47) and paroxetine (n = 37) over a 3-year total treatment duration. Target doses for all patients were 2 mg/d clonazepam and 40 mg/d paroxetine (both taken at bedtime). This study reports data from the long-term period (34 months), following the initial 8-week treatment phase. Thus, total treatment duration was 36 months. Patients with a good primary outcome during acute treatment continued monotherapy with clonazepam or paroxetine, but patients with partial primary treatment success were switched to the combination therapy. At initiation of the long-term study, the mean doses of clonazepam and paroxetine were 1.9 (SD, 0.30) and 38.4 (SD, 3.74) mg/d, respectively. These doses were maintained until month 36 (clonazepam 1.9 [SD, 0.29] mg/d and paroxetine 38.2 [SD, 3.87] mg/d). Long-term treatment with clonazepam led to a small but significantly better Clinical Global Impression (CGI)-Improvement rating than treatment with paroxetine (mean difference: CGI-Severity scale -3.48 vs -3.24, respectively, P = 0.02; CGI-Improvement scale 1.06 vs 1.11, respectively, P = 0.04). Both treatments similarly reduced the number of panic attacks and severity of anxiety. Patients treated with clonazepam had significantly fewer adverse events than those treated with paroxetine (28.9% vs 70.6%, P < 0.001). The efficacy of clonazepam and paroxetine for the treatment of panic disorder was maintained over the long-term course. There was a significant advantage with clonazepam over paroxetine with respect to the frequency and nature of adverse events.
ResumoIntrodução: Apesar do papel fundamental da função sexual na qualidade de vida da população, há uma escassez na literatura brasileira de instrumentos específi cos para sua avaliação e que possam ser utilizados tanto para homens quanto para mulheres. A adaptação da Scale for Quality of Sexual Function (QSF), uma escala unissex, é um passo importante na obtenção de instrumentos que permitam a comparação de resultados entre diferentes populações. Objetivo: Descrever o processo de tradução e adaptação semântica da QSF para o português brasileiro. Métodos: A adaptação do instrumento envolveu cinco fases: 1) duas traduções independentes, 2) uma versão de consenso realizada por tradutores e especialistas, 3) avaliação da versão gerada por mais um especialista que não participou das etapas anteriores, 4) retrotradução com avaliação do autor da escala original e, por fi m, 5) aplicação da versão obtida em um grupo experimental. Resultados: São descritas todas as etapas de adaptação do instrumento. A participação de especialistas tanto da área de saúde mental quanto de sexualidade humana, desde a primeira fase do processo, contribuiu para discussões amplas, que permitiram a melhor adequação dos itens, tanto conceitual quanto culturalmente. Participaram da aplicação experimental sujeitos de diferentes níveis de escolaridade de ambos os sexos, não sendo detectadas difi culdades na compreensão dos itens. Conclusão: Por meio dos procedimentos adotados, foi possível elaborar uma versão da QSF em português brasileiro. Descritores: Escalas, psicometria, disfunção sexual fi siológica, disfunções sexuais psicogênicas, sexualidade. AbstractIntroduction: Despite the important role played by sexual function in quality of life, there is a scarcity of instruments in the Brazilian literature specifi cally designed to assess this aspect, and especially of instruments that can be used with both men and women. The adaptation of the Scale for Quality of Sexual Function (QSF), a unisex scale, is an important step in the production of instruments that allow to compare results obtained in different populations. Objective: To describe the translation and semantic adaptation of the QSF into Brazilian Portuguese. Methods: Instrument adaptation involved fi ve phases: 1) two independent translations, 2) a consensual version produced by translators and experts, 3) evaluation of this version by a different expert, not involved in the previous phases, 4) back translation with evaluation by the author of the original scale, and, fi nally, 5) application of the fi nal Brazilian Portuguese version in a experimental group. Results: All stages of the adaptation process are described. The participation of experts from the fi elds of both mental health and human sexuality since the fi rst stage of the process contributed to broader discussions, which allowed to achieve the best possible adequacy for each item, both conceptually and culturally. The experimental application of the fi nal, adapted version of the scale involved both men and women with diffe...
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