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

Luciana Kelly Ximenes dos Santos Gilmara Holanda da Cunha Francisco Vagnaldo Fechine Andréa Vieira Pontes Jonaina Costa de Oliveira Fernando Antonio Frota Bezerra Manoel Odorico de Moraes Maria Elisabete Amaral de Moraes About the authors

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.

Operculina alata; Operculina alata; Operculina alata; Operculina alata; Operculina alata; Tincture of Jalapa see Operculina alata

Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Av. Prof. Lineu Prestes, n. 580, 05508-000 S. Paulo/SP Brasil, Tel.: (55 11) 3091-3824 - São Paulo - SP - Brazil