Randomized double-blinded and controlled clinical trial on treatment of HIV/AIDS by Zhongyan-4.
OBJECTIVE
To assess the efficacy and safety of Zhongyan-4 (ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin, clearing heat and detoxication) in treating HIV/AIDS patients in the early or middle stage.


METHODS
Adopted was randomized double-blinded and placebo-parallel-controlled method, with 72 HIV/AIDS patients randomly divided into the ZY-4 group (36 patients) treated with ZY-4 and the control group (36 patients) treated with placebo. The treatment course was six months. The index of CD(4)(+), CD(8)(+) counts, body weight, clinical symptom scoring were estimated at 4 time points (0, 1, 3 and 6 month in the course), and also the viral load before and after treatment. The whole course of observation was completed in 63 patients, 30 in the ZY-4 group and 33 in the control group.


RESULTS
CD(4)(+) count in the ZY-4 group got elevated by 7.70 +/- 150.96/mm(3) on average, while that in the control group lowered by 27.33 +/- 85.28/mm(3). Fifteen out of the 30 patients in the ZY-4 group had their CD(4)(+) count increased, which was evidently much higher than that in the control group (8/33, P < 0.05), suggesting that the efficacy of ZY-4 is superior to that of placebo in elevating CD(4)(+) count. Moreover, ZY-4 showed actions in elevating CD(45)RA(+) and CD(8)(+) count, reducing HIV virus load, improving clinical symptom/sign and increasing body weight of patients. No obvious adverse reaction was found in the clinical trial.


CONCLUSIONS
ZY-4 has an immunity-protective and/or rebuilding function in HIV/AIDS patients in the early and middle stage, and also shows effects in lowering viral load, increasing body weight and improving symptoms and signs to a certain degree.
Wang
Jian
J
Department of AIDS, Institute of Basic Theory, China Academy of Chinese Medical Sciences, Beijing 100700. Tiger@email.com.cn
Yang
Feng-zhen
FZ
Zhao
Min
M
Zhang
Yun-hui
YH
Zhang
Yong-xiang
YX
Liu
Ying
Y
Liu
Wei-min
WM
Wang
Fu-sheng
FS
Xu
Shu-ling
SL
Yu
Zhi-min
ZM
Xie
Yan-ming
YM
Zhou
Xian-zhi
XZ
Jiang
Tian-jun
TJ
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight; D018791:CD4 Lymphocyte Count; D016516:CD4-CD8 Ratio; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D017493:Leukocyte Common Antigens / Q000032:analysis; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D019562:Viral Load
D019380:Anti-HIV Agents; D004365:Drugs, Chinese Herbal; C513938:zhongyan-4; D017493:Leukocyte Common Antigens