Consumption of Sutherlandia frutescens by HIV-Seropositive South African Adults: An Adaptive Double-Blind Randomized Placebo Controlled Trial
What this study found
Sutherlandia frutescens did not improve HIV disease markers and did not show a clear safety advantage over placebo. CD4 count and viral load declined over time in both groups, with no significant between-group interaction effects for CD4 (P = 0.632) or viral load (P = 0.829). The burden of infection was higher in the Sutherlandia arm, with mean BOI 9.0 versus 5.0 days for placebo (P = 0.045), and two serious adverse events occurred in the Sutherlandia arm. The main conclusion was that up to 2,400 mg daily did not meaningfully alter CD4 count or viral load, but a possible interaction with…
- Study & population
- This was a two-stage, adaptive, double-blind, randomized, placebo-controlled trial in HIV-seropositive adults from KwaZulu-Natal, South Africa.
- Intervention
- Sutherlandia frutescens dried leaf powder was given as oral capsules at 1,200 mg twice daily for 24 weeks, for a total daily dose of 2,400 mg.
- Key limitation
- The active-arm sample was modest and the treatment period was only 24 weeks, limiting power to detect smaller effects and longer-term safety signals.
View source
Open PDFOriginal abstract
Background Sutherlandia frutescens (L.) R. Br. is widely used as an over the counter complementary medicine and in traditional medications by HIV seropositive adults living in South Africa; however the plant’s safety has not been objectively studied. An adaptive two-stage randomized double-blind placebo controlled study was used to evaluate the safety of consuming dried S. frutescens by HIV seropositive adults with CD4 T-lymphocyte count of >350 cells/μL. Methods In Stage 1 56 participants were randomized to S. frutescens 400, 800 or 1,200 mg twice daily or matching placebo for 24 weeks. In Stage 2 77 additional participants were randomized to either 1,200 mg S. frutescens or placebo. In the final analysis data from Stage 1 and Stage 2 were combined such that 107 participants were analysed (54 in the S. frutescens 1,200 mg arm and 53 in the placebo arm). Results S. frutescens did not change HIV viral load, and CD4 T-lymphocyte count was similar in the two arms at 24 weeks; however, mean and total burden of infection (BOI; defined as days of infection-related events in each participant) was greater in the S. frutescens arm: mean (SD) 5.0 (5.5) vs. 9.0 (12.7) days (p = 0.045), attributed to two tuberculosis cases in subjects taking isoniazid preventive therapy (IPT). Conclusion A possible interaction between S. frutescens and IPT needs further evaluation, and may presage antagonistic interactions with other herbs having similar biochemical (antioxidant) properties. No other safety issues relating to consumption of S. frutescens in this cohort were identified. Trial Registration ClinicalTrials.gov NCT00549523