Avaliação da eficácia terapêutica da tintura de jalapa no tratamento da constipação intestinal funcional

Abstract

The Operculina alata, known as Jalapa, is a plant whose root is used by the population because of its laxative effect. A double-blind clinical trial, placebo controlled, randomized, parallel evaluated the therapeutic efficacy of tincture of Jalapa in the treatment of functional constipation in the Unit of Clinical Pharmacology, Ceará, Brazil. There were two treatment groups, the Jalapa group and the Placebo group, both consisting of 38 volunteers with functional constipation. The study had 3 phases, seven days in each phase, in which the volunteer data recorded in a diary of bowel movements. During the pre-treatment there was the selection of volunteers. In the treatment occurred the randomization and administration of tincture of Jalapa or placebo. The post-treatment were observed after the voluntary suspension of tincture of Jalapa or placebo. The effectiveness was evaluated through the primary variables: average frequency of evacuations (AFE), average consistency of faeces (ACF) and global improvement of constipation (GIC). Secondary variables were the proportion of evacuations with pain (PED), proportion of effort evacuations (PEE), number of consecutive days without evacuation (DWE) and degree of improvement in constipation. All volunteer participants were female. In the placebo group there was lost segment of 5 volunteers and in the Jalapa group, only two were removed. Most volunteers came from the city of Fortaleza. The lower level of education found the primary school was represented by 10.5% of the sample. There was use of laxative agents by 69.8% of volunteers. In the pre-treatment, Jalapa and Placebo groups showed statistically similar in age, BMI and ACF, but differed in the AFE, where the Placebo group (0321 ± 0108) showed that the largest group Jalapa (0262 ± 0132). In the treatment and post-treatment, the AFE and ACF were significantly higher in Jalapa group than in the Placebo group, with 55.26% of volunteers of the Jalapa group showing increased values of AFE and ACF, which was represented by the GIC with 3.5 times more likely to improve the constipation with the tincture of Jalapa that with placebo. The values of the PED, the PEE and the DWE in Jalapa group were lower and statistically significant than those in the placebo group during treatment and post-treatment. The proportion of volunteers reported that the Jalapa group reasonable and complete relief of symptoms of constipation during treatment and after treatment was significantly higher than in the placebo group. There were changes in systolic blood pressure, diastolic and heart rate, but were without clinical relevance. There were no changes in body mass and serious adverse events, but highlighted to dizziness, headache and abdominal pain. This study found that the tincture of Jalapa is effective in the acute treatment of functional constipation in volunteers studied.