Toxicology and safety of the tincture of Operculina alata in patients with functional constipation

Abstract

The tincture of Operculina alata, popularly known as "tincture of jalapa", is used in Northeast Brazil to treat constipation and encephalic vascular accident, but it has not yet been adequately tested for safety and efficacy. The aim of this study was to evaluate the toxicology and safety of the tincture of O. alata in patients with functional constipation. This was a double-blind, randomized, placebo-controlled clinical trial. The study consisted of three phases: pre-treatment, treatment and post-treatment, each phase with duration of seven days. Arterial pressure, heart rate, body weight, adverse events, hematological, metabolic, liver and kidney functions were monitored. Forty patients were randomized to receive tincture of O. alata and 43 patients to receive placebo. There were statistical differences in the clinical aspects between groups, but these changes were not considered clinically significant. Adverse events were considered not serious and of mild intensity, especially dizziness, headache, abdominal pain and nausea. This clinical trial confirmed the safety of the tincture of O. alata in the pharmaceutical form and dosage tested, allowing the product to be safely used in a larger population for the assessment of its clinical efficacy.