Safety and efficacy of fenproporex for obesity treatment: a systematic review

ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to treat obesity. RESULTS Only four controlled studies met the inclusion criteria. One randomized, placebo-controlled trial on Fenproporex was found on electronic databases. Three placebo-controlled studies (in non-indexed journals) were identified by hand-searching. Patients with cardiovascular and other comorbidities were excluded in all studies. Trials lasted from 40 to 364 days and doses ranged from 20 to 33.6 mg/d. All controlled studies found that weight loss among Fenproporex-treated patients was greater than that produced by the placebo, but drug effect was modest. Fenproporex produced additional weight reductions of 4.7 kg (one year), 3.8 kg (six months) and 1.55 kg (two months) in average, in relation to diet and exercise only (three trials). Insomnia, irritability, and anxiety were the most frequently reported side effects in the four studies. CONCLUSIONS There is a paucity of randomized, placebo-controlled trials on Fenproporex and those identified here present major methodological flaws. These studies suggest that Fenproporex is modestly effective in promoting weight loss. Nonetheless, they failed to provide evidence that it reduces obesity-associated morbidity and mortality. Data from these studies are insufficient to determine the risk-benefit profile of Fenproporex. Abuse potential and amphetamine-like adverse effects are causes for concern

Caracterização vocal de pacientes com hipertireoidismo e hipotireoidismo Vocal characterization of patients with hyperthyroidism and hypothyroidism

OBJETIVO: Caracterizar a qualidade vocal, por meio de análise computadorizada e perceptivo-auditiva, de pacientes com hipertireoidismo (grupo A) e hipotireoidismo (grupo B). MÉTODOS: Vinte mulheres não fumantes, com idades entre 18 e 55 anos, atendidas no Ambulatório de Endocrinologia da instituição, foram avaliadas após o diagnóstico clínico e laboratorial de hipertireoidismo ou hipotireoidismo. Os parâmetros investigados foram: tempo da doença, presença de queixa vocal, tempos máximos de fonação /a/, /s/ e /z/, freqüência fundamental (F0), ruído glótico (GNE). Os aspectos avaliados na análise perceptivo-auditiva, foram: coordenação pneumo-fonoarticulatória (coordenada ou incoordenada), pitch, loudness, ataque vocal, ressonância, velocidade de fala e qualidade vocal, que poderia ter até duas das seguintes classificações: neutra, rouca, soprosa, áspera ou tensa, e grau: leve, moderado ou severo. Os dados foram tabulados e analisados estatisticamente através do programa EPI-INFO 6.04b, método qualitativo Fisher, com nível de significância menor do que 0.05. RESULTADOS: A análise perceptivo-auditiva mostrou que sete pacientes hipotireoideos e nove pacientes hipertireoideos apresentaram alteração na qualidade vocal. Oito pacientes em ambos os grupos apresentaram incoordenação pneumo-fonoarticulatória. Oito pacientes do grupo A e seis pacientes do grupo B referiam queixas vocais como rouquidão e voz grossa, respectivamente. Na análise acústica, nove pacientes apresentaram o ruído glótico alterado. CONCLUSÃO: Os resultados evidenciaram grande incidência de alteração vocal nos grupos estudados (grupos dos pacientes com hipertireoidismo e com hipotireoidismo), o que demonstra a relação entre disfonia e disfunções tireoideanas.<br>PURPOSE: To characterize the vocal quality of subjects with hyperthyroidism (group A), and hypothyroidism (group B) through a computer-aided and auditory-perceptive analysis. METHODS: Twenty non-smoking women with ages between 18 and 55 years from the Endocrinology Ambulatory of the institution were evaluated after clinical and lab diagnosis for hyperthyroidism or hypothyroidism. The parameters investigated were: period bearing the disease, vocal complaint, maximum phonation time /a/, /s/, and /z/, fundamental frequency (F0), glottal noise (GNE). The aspects evaluated in the auditory-perceptive analysis were: pneumo-phono-articulatory coordination (coordinated or uncoordinated), pitch, loudness, vocal attack, resonance, speech speed and vocal quality, that could be classified as one or two of the following: neutral, hoarse, whispered, coarse, or tense, and degree: light, moderate or severe. Data were statistically analyzed through the EPI-INFO 6.04b software, Fisher qualitative method, considering a significance level of 0.05. RESULTS: The auditory-perceptive analysis showed that seven patients with hypothyroidism and nine with hyperthyroidism presented changes in vocal quality. Eight subjects from both groups presented pneumo-phono-articulatory incoordination. Eight subjects from group A and six from group B referred vocal complaints, such as hoarseness and thick voice, respectively. In the acoustic analysis, nine subjects presented change in glottal noise. CONCLUSION: The results showed great incidence of vocal changes on the studied groups (both hyper and hypothyroidism groups), which evidences the relation between dysphonia and thyroidal dysfunctions