Consumption of Sutherlandia frutescens by HIV-Seropositive South African Adults: An Adaptive Double-Blind Randomized Placebo Controlled Trial

PLoS One. 2015 Jul 17;10(7):e0128522. doi: 10.1371/journal.pone.0128522. eCollection 2015.


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: NCT00549523.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Administration, Oral
  • Adult
  • Antitubercular Agents / therapeutic use
  • CD4 Lymphocyte Count
  • Drug Administration Schedule
  • Fabaceae / chemistry*
  • Female
  • HIV Infections / blood
  • HIV Infections / diet therapy
  • HIV Infections / immunology
  • HIV Infections / virology*
  • HIV-1 / immunology
  • Herb-Drug Interactions
  • Humans
  • Isoniazid / adverse effects*
  • Male
  • Opportunistic Infections / immunology
  • Opportunistic Infections / prevention & control*
  • Patient Safety
  • Plant Leaves / chemistry*
  • T-Lymphocytes / immunology
  • T-Lymphocytes / virology
  • Tuberculosis, Pulmonary / immunology
  • Tuberculosis, Pulmonary / prevention & control*
  • Viral Load / immunology


  • Antitubercular Agents
  • Isoniazid

Associated data