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AMERICAN GINSENG FOR THE TREATMENT OF HIV FATIGUE: A RANDOMIZED CLINICAL TRIAL
Adriana Andrade1, Jeff Sloan2, Chun-Su Yuan3, Brent Bauer2, Paul Novotny2, Judith Rabkin4, Jeffrey Hsu1, Adrian Dobs1, Todd Brown1
1The Johns Hopkins Univ, Baltimore, MD, USA,2Mayo Clinic, Rochester, MN, USA,3Univ of Chicago Med, Chicago, IL, USA,4Columbia Univ, New York, NY, USA
HIV-related fatigue is prevalent and linked to neurocognitive deficits, nonadherence, poor quality of life (QOL) and physical functioning, but targeted treatment for HIV fatigue is not available. Research suggests American ginseng (AG) may ameliorate cancer fatigue. We examined the safety and efficacy of AG for HIV-related fatigue.
We conducted a 6-week, double-blind, parallel-arm, placebo-controlled trial comparing encapsulated, standardized AG powdered root (≥5% total ginsenoside content confirmed yearly by HPLC) 1000 and 3000mg PO QD to placebo. HIV-infected adults, on stable ART, undetectable viral load (VL), with a Fatigue Severity Score (FSS) >=4.5, and without other illness associated with fatigue, received AG or placebo for 4 wks, and were observed until wk 6. Primary endpoint was change in FSS from baseline to wk 4. Secondary outcomes assessed other measures of fatigue (sleep quality, depression, and QOL (MOS HIV)). Changes were compared between groups using nonparametric Wilcoxon tests supplemented with repeated measures mixed models to adjust for age, gender, race, baseline insomnia and depression.
Of the 120 planned subjects, 96 were enrolled (African-American race (91%) and male (54%) with a median age of 52.5 years and median CD4 count of 624 ul/mL); 32 were randomized to AG 1000mg, 31 to AG 3000mg, and 33 to placebo. FSS changes were not significantly different between either of the AG arms and placebo. Mean (SD) FSS decreases were: -24.7 (18.6) on AG 1000mg, -16.9 (15.0) on AG 3000mg, and -18.7 (17.4) on placebo (p=0.15 AG 1000mg vs placebo, p=0.73 AG 3000mg vs placebo). Self-reported assessment of having much or very much improvement in fatigue was not different between arms: 45% on AG 1000mg, 34% on AG 3000mg, and 39% on placebo. In a post-hoc analysis, combining the 2 AG arms confirmed that fatigue was no different than placebo in the primary endpoint, but AG showed modest improvements in fatigue on 3/4 subscales of Brief Fatigue Inventory (p = 0.01-0.03) and trends toward improvement in 4 of 10 subscales of the MOS HIV QOL questionnaire (p = 0.01-0.07) compared to placebo. Adverse events were not different between the study arms. Overall mean adherence was ≥96% for all study arms.
AG did not reduce fatigue compared to placebo with short-term administration to HIV-infected subjects with fatigue. The clinical significance of small improvements in the AG arms in some of the secondary endpoints relative to the large placebo effect is unclear.