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PLOS ONE  2007 

A Randomized, Double-Blind, Placebo-Controlled Trial of Lessertia frutescens in Healthy Adults

DOI: 10.1371/journal.pctr.0020016

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Abstract:

Objectives Indigenous medicines are widely used throughout Africa, despite a lack of scientific evidence for their safety or efficacy. The aims of this study were: (a) to conduct a pilot study of the safety of a common indigenous South African phytotherapy, Lessertia frutescens (Sutherlandia), in healthy adults; and (b) to contribute to establishing procedures for ethical and scientifically rigorous clinical trials of African indigenous medicines. Design A randomized, double-blind, placebo-controlled trial of Sutherlandia leaf powder in healthy adults. Setting Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, South Africa. Participants 25 adults who provided informed consent and had no known significant diseases or allergic conditions nor clinically abnormal laboratory blood profiles during screening. Intervention 12 participants randomized to a treatment arm consumed 400 mg capsules of Sutherlandia leaf powder twice daily (800 mg/d). 13 individuals randomized to the control arm consumed a placebo capsule. Each participant received 180 capsules for the trial duration of 3 mo. Outcome Measures The primary endpoint was frequency of adverse events; secondary endpoints were changes in physical, vital, blood, and biomarker indices. Results There were no significant differences in general adverse events or physical, vital, blood, and biomarker indices between the treatment and placebo groups (p > 0.05). However, participants consuming Sutherlandia reported improved appetite compared to those in the placebo group (p = 0.01). Although the treatment group exhibited a lower respiration rate (p < 0.04) and higher platelet count (p = 0.03), MCH (p = 0.01), MCHC (p = 0.02), total protein (p = 0.03), and albumin (p = 0.03), than the placebo group, these differences remained within the normal physiological range, and were not clinically relevant. The Sutherlandia biomarker canavanine was undetectable in participant plasma. Conclusion Consumption of 800 mg/d Sutherlandia leaf powder capsules for 3 mo was tolerated by healthy adults. Trial Registration ClinicalTrials.gov NCT00376415

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