Assuntos
Anti-Inflamatórios não Esteroides/efeitos adversos , Polimorfismo de Nucleotídeo Único , Tromboxano-A Sintase/genética , Urticária/genética , Doença Aguda , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Araquidonato 5-Lipoxigenase/genética , Hipersensibilidade a Drogas/etiologia , Hipersensibilidade a Drogas/genética , Feminino , Genótipo , Humanos , Masculino , Pessoa de Meia-Idade , Fenótipo , Urticária/induzido quimicamente , Adulto JovemRESUMO
BACKGROUND: Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature. OBJECTIVE: To explore the safety and efficacy of omalizumab in controlling UCOL. METHODS: We conducted a multicenter randomized mixed double-blind and open-label (first 4 months blinded followed by 8 months open-label) placebo-controlled clinical trial in 22 patients suffering from UCOL who were unresponsive to a double dose of antihistamines. We performed an exercise challenge test during each visit as our main outcome variable. RESULTS: The overall rate of exercise challenge test negative at week 48 was 31.3%, with an average increase in exercise challenge test negative rate of 2.9% points (95% CI, 1.5-4.2) per visit. Statistically significant differences in the negative exercise challenge test rate between the placebo and active intervention groups were not observed during the blinded period (first 4 months of the study). However, from the fourth dose, a progressive improvement was observed. When comparing before and after treatment, statistically significant improvements in all secondary outcome measures were noted after 4 doses (UCOL score: P = .0015; visual analog scale score: P = .0108; days with symptoms: P = .0125) and after 8 doses (UCOL score: P = .0005; chronic urticaria quality of life questionnaire: P = .0105; visual analog scale score: P = .0008; and days with symptoms: P = .0144). In the follow-up visit after the cessation of treatment, the symptoms reappeared, with positive exercise challenge test result and significant increases in all variables. Only 4 of 22 patients remained asymptomatic after 3 months of no treatment. No adverse effects were reported. CONCLUSIONS: This randomized mixed double-blind and open-label placebo-controlled trial showed evidence of the safety and potential efficacy of omalizumab in patients with UCOL.
Assuntos
Antialérgicos/uso terapêutico , Temperatura Corporal , Urticária Crônica/tratamento farmacológico , Omalizumab/uso terapêutico , Qualidade de Vida , Adulto , Cetirizina/administração & dosagem , Urticária Crônica/etiologia , Método Duplo-Cego , Teste de Esforço , Feminino , Antagonistas não Sedativos dos Receptores H1 da Histamina/administração & dosagem , Temperatura Alta/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Falha de Tratamento , Resultado do Tratamento , Adulto JovemRESUMO
AIM: To study the quality of controlled clinical trials on glaucoma. METHODS: Two hundred and twenty-six clinical trials published between 1980 and 1999 were selected from seven international ophthalmological journals. Their quality was assessed by four researchers with epidemiological skills using a structured questionnaire. RESULTS: Sample size was pre-estimated in 34 (15.0%) papers, which were of greater size (P = 0.05). Randomization was performed in 98.2% of the trials, although the procedure of randomization was scarcely reported. Masking was reported in 56.6% of the papers, and was more frequent in medical treatments (P < 0.001). The basal characteristics of the groups were compared in 139 papers (61.5%). Patient losses during the follow-up period were fully described in only 27 trials. Intention-to-treat analysis was used in 17 (7.7%) papers. Most trials reported P values, but a measure of effect (mean, proportion, or relative risk) appeared in only 16 trials (7.7%). Trials performed in the US more frequently compared baseline characteristics of the groups (P = 0.03), described the patient flow (P = 0.04), and used adequate statistical procedures (P = 0.03). Those trials that included a statistician or an epidemiologist among the authors were more commonly blinded (P = 0.06) and they always avoided the analyses of subgroups (P = 0.006). Several methodological issues have improved throughout the studied period. CONCLUSIONS: Several methodological characteristics should be improved when reporting a clinical trial on glaucoma. Using a checklist like that suggested by the CONSORT can help to achieve this.
Assuntos
Ensaios Clínicos Controlados como Assunto/normas , Glaucoma , Pressão Intraocular , Editoração/normas , Controle de Qualidade , Ensaios Clínicos Controlados como Assunto/estatística & dados numéricos , Humanos , Hipertensão Ocular , Editoração/estatística & dados numéricos , Projetos de Pesquisa/normasRESUMO
The quality of 287 clinical trials on asthma treatment published between 1984 and 1997 is described in this article, using a scale adding to a maximum of 14 points. The mean quality score was 8.60 (standard deviation 1.55). Quality improved throughout time from 8.17 +/- 1.40 before 1989 until 9.55 +/- 1.66 after 1992. Several methodological issues were associated with higher quality, namely parallel design, longer length of the follow-up, complete description of the exclusion criteria, description of the initial and ending recruitment dates, higher sample size, explicit sample size calculation, blinding, full description of randomization, intention-to-treat analysis, full description of the intervention, and evaluation of bias. The higher statistical significance, however, was not associated with higher clinical trial quality.