Safety and efficacy of CKBM-A01, a Chinese herbal medicine, among asymptomatic HIV patients.

Complementary remedies represent a potential alternative treatment for chronic diseases, including HIV/AIDS cases not meeting criteria for using highly active antiretroviral therapy (HAART). This study evaluated the safety and efficacy of CKBM-A01, a Chinese herbal medicine, and patient quality of life (QoL). Asymptomatic HIV patients with CD4 counts of 250-350 cells/microl were recruited into this open-labeled trial. Liquid CKBM-A01 was prescribed for a 36-week period. Study participants recorded all symptoms themselves on diary cards. Study parameters, including CD4 cell counts, HIV viral loads, and blood chemistry, were periodically monitored and questionnaires were used to assess QoL and to help with risk reduction. Eighteen volunteers, mean age (+/- SD) 32.07 (+/- 6.88) years, had a median (interquartile range, IQR) baseline CD4 count of 292 (268.50-338.25) cells/microl. No serious drug-related adVerse events due to CKBM-A01 were detected during the study. Intermittent diarrhea was reported in 55.6%, weakness or skin rash/itching in 50%, and increased bowel movement in 33.7%. No significant changes in log viral load or CD4 cell counts were observed at the end of the study. Most of the volunteers (72.2%) expressed satisfaction with CKBM-A01 and had a positive perception. Common colds and nasal symptoms were significantly lower during treatment (p = 0.019). CKBM-A01 appeared to be safe but gave no significant improvement in QoL in asymptomatic HIV patients, and gave no significant improvement in the treatment of HIV based on CD4 cell counts and viral loads.