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Color plates are on p. 8 separately.journal articl

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

<div><p>Background</p><p><i>Sutherlandia frutescens</i> (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 <i>S</i>. <i>frutescens</i> by HIV seropositive adults with CD4 T-lymphocyte count of >350 cells/μL.</p><p>Methods</p><p>In Stage 1 56 participants were randomized to <i>S</i>. <i>frutescens</i> 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 <i>S</i>. <i>frutescens</i> or placebo. In the final analysis data from Stage 1 and Stage 2 were combined such that 107 participants were analysed (54 in the <i>S</i>. <i>frutescens</i> 1,200 mg arm and 53 in the placebo arm).</p><p>Results</p><p><i>S</i>. <i>frutescens</i> 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 <i>S</i>. <i>frutescens</i> 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).</p><p>Conclusion</p><p>A possible interaction between <i>S</i>. <i>frutescens</i> 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 <i>S</i>. <i>frutescens</i> in this cohort were identified.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="http://clinicaltrials.gov/show/NCT00549523" target="_blank">NCT00549523</a></p></div

Changes in biochemical and hematological parameters over time in the combined Stage 1 and Stage 2 analysis <i>S</i>. <i>frutescens</i> 1,200 mg (N = 54) and placebo (N = 53).

<p>Abbreviations: HDL (high density lipoprotein); LDL (low density lipoprotein)</p><p>*P-value for interaction effect of groups over time.</p><p>Changes in biochemical and hematological parameters over time in the combined Stage 1 and Stage 2 analysis <i>S</i>. <i>frutescens</i> 1,200 mg (N = 54) and placebo (N = 53).</p

Baseline demographic and clinical characteristics.

<p>Baseline demographic and clinical characteristics.</p

Infection outcomes in the combined Stage 1 and Stage 2 analysis <i>S</i>. <i>frutescens</i> 1,200 mg (N = 54) and placebo (N = 53).

<p>Abbreviation: BOI (burden of infection)</p><p>Infection outcomes in the combined Stage 1 and Stage 2 analysis <i>S</i>. <i>frutescens</i> 1,200 mg (N = 54) and placebo (N = 53).</p

CONSORT diagram.

<p>CONSORT diagram.</p

Changes in CD4 T-lymphocyte count and HIV viral load over time in the combined Stage 1 and Stage 2 analysis <i>S</i>. <i>frutescens</i> 1,200 mg (N = 54) and placebo (N = 53).

<p>*P-value for interaction effect of groups over time.</p><p>Changes in CD4 T-lymphocyte count and HIV viral load over time in the combined Stage 1 and Stage 2 analysis <i>S</i>. <i>frutescens</i> 1,200 mg (N = 54) and placebo (N = 53).</p