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/mm3 on average, while that in the control group lowered by 27.33 ± 85.28 /mm3. 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 CD45RA+ 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.Conclusion: 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.
Key wordsHIV/AIDS principle for supplementing Qi nourishing Yin clearing heat and detoxication Zhongyan-4 T-Iymphocyte subsets HIV viral load
Unable to display preview. Download preview PDF.
- 1.John G Bartlett, Joel E Callant. Diagnosis and treatment of HIV infection. Beijing: Science Publication Press, 2002: 2.Google Scholar
- 2.Su CL. Primary research of clinical treatment of AIDS. J Tradit Chin Med 1990;31(2): 26–29.Google Scholar
- 3.Jiang XY. The pathogenesis of AIDS. J Chin Med 2001; 16(6): 41–42.Google Scholar
- 4.Huang BS. The treatment of AIDS with TCM. Harbin: Heilongjiang Science and Technology Publishing House, 1990: 25.Google Scholar
- 5.Xue BS. The knowledge of HIV/AIDS with TCM theory. J Tradit Chin Med 1991;32(1): 20.Google Scholar
- 6.Yang FZ, Yan JH. Exploring Yuan Qi theory in HIV/AIDS. J Basic Theory Tradit Chin Med 2003; 9(8): 4–5.Google Scholar
- 7.Yang FZ. Wang J. Developing research of HIV/AIDS in the TCM pathogenesis. J Inform Tradit Chin Med 2004; 11 (4): 365–367.Google Scholar
- 8.Zhao WS. Present clinical immunology. Beijing: People’s Miltary Publication Press, 1994: 683–686.Google Scholar
- 9.Lu WB, editor. Preventing and treating HIV/AIDS. Beijing: People’s Medical Publishing Hourse, 1994: 170–181.Google Scholar
- 10.Jian TJ, Zhao M.Wang J, et al. Clinical research of liver damage of HIV complicated with HCV infection. J New Chin Materia Med 2004; 3(4): 22–24.Google Scholar
- 11.Yang FZ, Wang J, Zhao M, et al. The relativity research of traditional Chinese medicine syndromes and T lymphocyte and virus loading. China J Tradit Chin Med Pharmacy 2004: 19(12): 733–737.Google Scholar