Weber R, Loy M, Christen L, Schaller S, Christen S, Joyce CR, Cohen MR; International Conference on AIDS.
Int Conf AIDS. 1998; 12: 850 (abstract no. 42381).
Division of Infectious Diseases, University Hospital, Zurich, Switzerland.
OBJECTIVE: To study the effect of a treatment with Chinese herbs on quality of life and course of HIV infection. DESIGN: Six month randomized, placebo-controlled, double-blind trial. PARTICIPANTS: 68 HIV infected adults with CD4 cell counts below or equal 500/mm3, on stable antiretroviral therapy or no antiretroviral treatment, under medical care of a physician, without intravenous drug use. INTERVENTION: 4 x 7 pills/day containing either a placebo or a standardized preparation of 35 Chinese herbs. MEASUREMENTS: Symptoms, progression of HIV infection, HIV-1-RNA load, CD4 lymphocyte counts, quality of life (MOS-questionnaire, SEIQoL examination), coping (SOC), depression (ADS), anxiety (STAI). RESULTS: The investigators are still blinded. Results of group A and B were compared. Baseline data of the two groups were equal. A total of 54 men and 14 women were enrolled. Median age was 36 years (range: 26-54). Median CD4 cell counts were 198 (3-700) and 245 (0-900) per mm3, HIV-1-RNA was 35,612 (171-501,838) and 52'027 (146-2,017,770) copies/ml in group A and B, respectively. Six and 9 patients had a history of AIDS. 25 and 27 patients, respectively, had no antiretroviral therapy at study entry. 24 and 29 participants remained on study drugs until study end, and no toxicities were found. Adherence to therapy was high. Until study end, HIV-RNA levels remained stable, and CD4 cell counts declined. The number and severity of reported symptoms and quality of life remained stable over time, and there were no significant differences between groups A and B, as well as between participants and dropouts. During the study period, 2 patients died. Psychometric testing revealed an overall increase in depression in both groups. Group A had significantly better coping scores at all measurements. Dropouts could mainly be attributed to patients who started antiretroviral treatment. CONCLUSIONS: A placebo-controlled trial of complementary medicine was feasible. The number of participants was lower than expected. Expectations as to favourable effects of this Chinese herb treatment were not fulfilled. The participants remained fairly stable regarding all variables tested including clinical, virologic, immunologic, psychometric and quality of life data. The study has to be interpreted in consideration of historical perspectives because it was planned, approved and initiated before antiretroviral triple-drug combination was available.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Adult
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- Clinical Trials as Topic
- Disease Progression
- Double-Blind Method
- Drug Therapy, Combination
- Female
- HIV Infections
- HIV Seropositivity
- Humans
- Male
- Placebos
- drug therapy
- therapy
Other ID:
UI: 102231179
From Meeting Abstracts