title: Consumption of Sutherlandia frutescens by HIV-Seropositive South African Adults: An Adaptive Double-Blind Randomized Placebo Controlled Trial.
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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00549523.
authors.affiliation: Department of Internal Medicine, Edendale Hospital, Pietermaritzburg, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Douglas
authors.initials: D
authors.lastname: Wilson
authors.affiliation: Health Services and Outcomes Research, Children's Mercy Hospital and Clinics, University of Missouri-Kansas City Schools of Medicine and Pharmacy, Kansas City, Missouri, United States of America.
authors.forename: Kathy
authors.initials: K
authors.lastname: Goggin
authors.affiliation: Biomedical and Health Informatics, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, United States of America.
authors.forename: Karen
authors.initials: K
authors.lastname: Williams
authors.affiliation: Biomedical and Health Informatics, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, United States of America.
authors.forename: Mary M
authors.initials: MM
authors.lastname: Gerkovich
authors.affiliation: AIK Innovations (Pty) Ltd, Durban University of Technology, Durban, South Africa.
authors.forename: Nceba
authors.initials: N
authors.lastname: Gqaleni
authors.affiliation: School of Pharmacy, University of the Western Cape, Cape Town, South Africa.
authors.forename: James
authors.initials: J
authors.lastname: Syce
authors.affiliation: Department of Internal Medicine Research Unit, Edendale Hospital, Pietermaritzburg, KwaZulu-Natal, South Africa.
authors.forename: Patricia
authors.initials: P
authors.lastname: Bartman
authors.affiliation: George Campus, Nelson Mandela Metropolitan University, George, South Africa.
authors.forename: Quinton
authors.initials: Q
authors.lastname: Johnson
authors.affiliation: Department of Biochemistry, University of Missouri, Columbia, Missouri, United States of America.
authors.forename: William R
authors.initials: WR
authors.lastname: Folk
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D007887:Fabaceae / Q000737:chemistry*; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000178:diet therapy / Q000276:immunology / Q000821:virology*; D015497:HIV-1 / Q000276:immunology; D041743:Herb-Drug Interactions; D006801:Humans; D007538:Isoniazid / Q000009:adverse effects*; D008297:Male; D009894:Opportunistic Infections / Q000276:immunology / Q000517:prevention & control*; D061214:Patient Safety; D018515:Plant Leaves / Q000737:chemistry*; D013601:T-Lymphocytes / Q000276:immunology / Q000821:virology; D014397:Tuberculosis, Pulmonary / Q000276:immunology / Q000517:prevention & control*; D019562:Viral Load / Q000276:immunology
chemical_list: D000995:Antitubercular Agents; D007538:Isoniazid