Evidence map›Paper›PMID 26186450›Full record

Trial reportPloS one2015

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

Douglas Wilson, Kathy Goggin, Karen Williams, Mary M Gerkovich, Nceba Gqaleni, James Syce, Patricia Bartman, Quinton Johnson, William R Folk

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00549523 (A Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of Lessertia Frutescens), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00549523 phase1 / phase2completednot on this map

A Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of Lessertia Frutescens (L.)Goldblatt and J.C. Manning (Syn. Sutherlandia Frutescens (L.)R. Br.)in HIV-infected South African Adults

TypeinterventionalSponsorUniversity of Missouri-ColumbiaRan2008 to 2012Enrolled133ConditionsHIV InfectionsArmsPlacebo, Low Dose, Mid Dose, High Dose
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. The effect ofFrontiers in physiology · 2023
    Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 2 countries.

Douglas WilsonDepartment of Internal Medicine, Edendale Hospital, Pietermaritzburg, University of KwaZulu-Natal, Durban, South Africa.
Kathy GogginHealth 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.
Karen WilliamsBiomedical and Health Informatics, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, United States of America.
Mary M GerkovichBiomedical and Health Informatics, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, United States of America.
Nceba GqaleniAIK Innovations (Pty) Ltd, Durban University of Technology, Durban, South Africa.
James SyceSchool of Pharmacy, University of the Western Cape, Cape Town, South Africa.
Patricia BartmanDepartment of Internal Medicine Research Unit, Edendale Hospital, Pietermaritzburg, KwaZulu-Natal, South Africa.
Quinton JohnsonGeorge Campus, Nelson Mandela Metropolitan University, George, South Africa.
William R FolkDepartment of Biochemistry, University of Missouri, Columbia, Missouri, United States of America.
University of Missouri–Kansas City · USChildren's Mercy Hospital · USDurban University of Technology · ZAEdendale Hospital · ZANelson Mandela University · ZAUniversity of KwaZulu-Natal · ZAUniversity of Missouri · USUniversity of the Western Cape · ZA

Funding

TICIPS: HIV/AIDS, Secondary Infections and Immune ModulationU19AT003264 · NCCIH · UNIVERSITY OF MISSOURI-COLUMBIA · PI FOLK, WILLIAM ROBERT · 2005 to 2010
$4.5M
NCCIH NIH HHS U19 AT003264
6 · The paper itself

Abstract

backgroundSutherlandia 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.

methodsIn 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).

resultsS. 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).

conclusionA 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 registrationClinicalTrials.gov NCT00549523.

Indexed as

Administration, OralAdultAntitubercular AgentsCD4 Lymphocyte CountDrug Administration ScheduleFabaceaeFemaleHerb-Drug InteractionsHIV-1HIV InfectionsHumansIsoniazidMaleOpportunistic InfectionsPatient SafetyPlant LeavesAntitubercular AgentsIsoniazid

Identifiers

PMID26186450
PMCPMC4506018
OpenAlexW2115206594

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.