Andry Fiterman Costa

Randomized clinical trial of a phytotherapic compound containing Pimpinella anisum, Foeniculum vulgare, Sambucus nigra, and Cassia augustifolia for chronic constipation.

BackgroundA phytotherapic compound containing Pimpinella anisum L., Foeniculum vulgare Miller, Sambucus nigra L., and Cassia augustifolia is largely used in Brazil for the treatment of constipation. However, the laxative efficacy of the compound has never been tested in a randomized clinical trial. The aim of this study was to evaluate the efficacy and safety of the product.MethodsThis randomized, crossover, placebo-controlled, single-blinded trial included 20 patients presenting with chronic constipation according to the criteria of the American Association of Gastroenterology. The order of treatments was counterbalanced across subjects: half of the subjects received the phytotherapic compound for a 5-day period, whereas the other half received placebo for the same period. Both treatment periods were separated by a 9-day washout period followed by the reverse treatment for another 5-day period. The primary endpoint was colonic transit time (CTT), measured radiologically. Secondary endpoints included number of evacuations per day, perception of bowel function, adverse effects, and quality of life.ResultsMean CTT assessed by X ray was 15.7 hours (95%CI 11.1-20.2) in the active treatment period and 42.3 hours (95%CI 33.5-51.1) during the placebo treatment (p < 0.001). Number of evacuations per day increased during the use of active tea; significant differences were observed as of the second day of treatment (p < 0.001). Patient perception of bowel function was improved (p < 0.01), but quality of life did not show significant differences among the study periods. Except for a small reduction in serum potassium levels during the active treatment, no significant differences were observed in terms of adverse effects throughout the study period.ConclusionsThe findings of this randomized controlled trial allow to conclude that the phytotherapic compound assessed has laxative efficacy and is a safe alternative option for the treatment of constipation.Trial registrationClinicalTrial.gov NCT00872430

Validação de versão para o português de questionário sobre qualidade de vida para mulher com endometriose (Endometriosis Health Profile Questionnaire - EHP-30)

PURPOSE: the objective of the present study was the development of the Brazilian Portuguese version of Endometriosis Health Profile Questionnaire (EHP-30), the cross-cultural adaptation to Brazil and the evaluation of EHP-30 Portuguese psychometric measures in a Brazilian sample. METHODS: the original instrument in English was translated into Portuguese following international guidelines, going through all stages of translation, back-translation and comparison of the versions for cross-cultural adaptation, face and content validity. A sample of 54 patients with endometriosis was used for internal consistency analyses using the Cronbach alpha. Test-retest reliability was evaluated through the intraclass correlation coefficient (ICC). In order to evaluate the convergent construct validity, the correlation between EHP-30 Portuguese and WHOQOL-Bref and Beck Depression Inventory (BDI) was tested. RESULTS: internal consistency presented alpha values of 0.8 to 0.9 suggesting homogeneity between questions. The test-retest reliability presented ICC of 0.8 to 0.9 showing instrument stability. In the construct validation, strong correlations were demonstrated of the EHP-30 Portuguese self-image scale with physical (-0.6) and psychological domains (-0.6) of WHOQOL-Bref, and EHP-30 Portuguese social support scale with BDI (0.5), confirming good correlation with other quality of life evaluation instruments. CONCLUSIONS: the EHP-30 Portuguese was found to be an easy, quickly applied instrument, and well-accepted by the patients. It presented good psychometric properties with appropriate reliability measures (internal consistency and test-retest reliability) and construct validity. These results show that EHP-30 Portuguese is an adequate instrument for quality of life evaluation in Brazilian women with endometriosis, both in clinical and research setting.

Intravenous apyrase administration reduces arterial thrombosis in a rabbit model of endothelial denudation in vivo.

The role of adenine nucleotides on vascular and platelet functions has long been established. Apyrase (CD39) takes part of a family of ecto-enzymes that hydrolyze adenosine diphosphate and adenosine triphosphate. The participation of apyrase in the thromboregulatory system is under study. An in vivo experimental model of acute arterial thrombosis was used to test the hypothesis that administering a soluble form of potato apyrase could prevent thrombus formation. Twenty-five white New Zealand male rabbits suffered balloon aortic endothelium denudation and, after 15 days, they were submitted to a thrombosis-triggering protocol with a procoagulant (Russels viper venom) and epinephrine. After the thrombosis-triggering protocol, 12 animals received two soluble apyrase administrations intravenously (with 90 min intervals), while 13 control animals received no apyrase. Three hours after the triggering protocol, the animals were killed and the rate and area of arterial thrombosis were analyzed. The rate of thrombosis in the apyrase group was significantly lower than that of the control group (16.7 versus 69%, respectively; P = 0.015), as was the area of thrombosis (1.7 ± 4.3 versus 21.7 ± 37.4 mm2, respectively; P = 0.008). Our results confirm that apyrase participates in homeostasis through a potent anti-thrombotic effect.

Atherosclerosis and acute arterial thrombosis in rabbits : a model using balloon desendothelization without dietary intervention

Acute thrombosis can be induced in rabbits by a triggering protocol using Russells viper venom and histamine given after 8 months of a 1% cholesterol diet and balloon desendothelization. In the present study, we tested the hypothesis that aortic desendothelization performed 4 months before the triggering protocol without a high cholesterol diet is a highly effective and less expensive way of producing arterial atherosclerosis and thrombosis. Nineteen male New Zealand white rabbits on a normal diet were studied. The control group (N = 9) received no intervention during the 4-month observation period, while the other group (N = 10) was submitted to aortic balloon desendothelization using a 4F Fogarty catheter. At the end of this period, all animals were killed 48 h after receiving the first dose of the triggering treatment. Eight of 10 rabbits (80%) in the balloon-trauma group presented platelet-rich arterial thrombosis while none of the animals in the control group had thrombus formation (P < 0.01). Thus, this model, using balloon desendothelization without dietary manipulation, induces arterial atherosclerosis and thrombosis and may provide possibilities to test new therapeutic approaches.