HIV-AIDS Laboratory, Molecular Biology & Genetics Unit, Jawaharlal Nehru Centre for Advanced Scientific Research, Bangalore, India.
Indian J Med Res. 2013 Jun;137(6):1128-44.
BACKGROUND & OBJECTIVES: The complementary and alternative medicines (CAM) have not been systematically evaluated for the management of HIV/AIDS patients. In a prospective, single-site, open-label, non-randomized, controlled, pilot trial, we evaluated a polyherbal formulation (PHF) for its safety and efficacy in treating subjects with HIV-AIDS.
A total of 32 and 31 subjects were enrolled under the PHF and highly active antiretroviral treatment (HAART) arms, respectively, and followed up for a period of 24 months. Plasma viral RNA, CD4 cell count and blood chemistry were monitored at 3-month intervals. Following mid-term safety evaluation, 12 subjects from the PHF arm were shifted to HAART and were followed separately as PHF-to-HAART arm, for the rest of the period.
The HAART arm was characterized by significant improvements in CD4 cell count (154.4 cells/μl/year, P<0.001) and reduction in plasma viral load within 3 to 6 months (-0.431+ 0.004 log 10 IU/month, P<0.001). In contrast, the PHF arm showed a profile of CD4 cell loss at remarkably slower kinetics (14.3 cells/μl/year, P=0.021) and insignificant reduction in the viral load. The PHF and HAART arms did not differ significantly in the occurrence of AIDS-related illnesses over the study period of 24 months. In the PHF-to-HAART arm, the rates of CD4 count and reduction in viral load were significant and comparable to that of the HAART group. In the PHF arm, at 1 month, a significant increase in CD4 cell count and a concomitant decrease in viral load were seen.
INTERPRETATION & CONCLUSIONS: The PHF appears to have provided protection by delaying the kinetics of CD4 cell reduction. Given the several study limitations, drawing assertive inferences from the data is challenging. Future studies with a stringent study design are warranted to confirm these findings.
对于 HIV/AIDS 患者的治疗，补充替代医学（CAM）尚未进行系统评估。在一项前瞻性、单站点、开放性、非随机、对照、试点试验中，我们评估了一种复方草药制剂（PHF）治疗 HIV/AIDS 患者的安全性和疗效。
PHF 和高效抗逆转录病毒治疗（HAART）组分别纳入 32 例和 31 例患者，并随访 24 个月。每 3 个月监测血浆病毒 RNA、CD4 细胞计数和血液化学。中期安全性评估后，PHF 组的 12 例患者转为 HAART，并在其余时间内单独作为 PHF 至 HAART 组进行随访。
HAART 组的 CD4 细胞计数显著改善（154.4 个细胞/μl/年，P<0.001），血浆病毒载量在 3 至 6 个月内降低（-0.431+0.004 log 10 IU/月，P<0.001）。相比之下，PHF 组的 CD4 细胞丢失呈明显较慢的动力学（14.3 个细胞/μl/年，P=0.021），病毒载量无明显降低。在 24 个月的研究期间，PHF 和 HAART 组在发生 AIDS 相关疾病方面没有显著差异。在 PHF 至 HAART 组中，CD4 计数和病毒载量的降低率显著且与 HAART 组相当。在 PHF 组中，在第 1 个月时，CD4 细胞计数显著增加，同时病毒载量降低。
PHF 似乎通过延迟 CD4 细胞减少的动力学提供了保护。鉴于研究的几个局限性，从数据中得出有把握的推论具有挑战性。需要进行具有严格研究设计的未来研究来证实这些发现。
