Ying L, Xia L, Qiaoli Y, Wen Z, Qingfei X, Fuchun Z, Jianping M, Mingxiang Z, Wenhui L, Jianhua H and Jian W*
Background and Importance: Antiretroviral therapy-associated side effects may lead to an increased risk of dyslipidemia on HIV patients. Exploring an alternative approach to treat antiretroviral therapy (ART)-associated dyslipidemia, especially for those who cannot tolerate statins is important. This study investigated whether the Jiangzhi granule is effective and safe on dyslipidemia in patients with HIV infection receiving highly active antiretroviral therapy.
Methods: Design, setting, and participants- A randomized, double blind, multicenter and placebo-controlled clinical trial of the Jiangzhi granule vs placebo in a factorial design for 24 weeks was conducted in 286 patients infected with HIV with dyslipidemia who were receiving ART at five Class III Grade I hospitals in China between November 2013 to September 2015.
Interventions: Daily oral Jiangzhi granule compared with placebo.
Main outcomes and measures: The primary outcomes included total cholesterol (TC), triglyceride (TG), high density cholesterol (HDL), and low-density cholesterol (LDL) at 24 weeks. The secondary outcomes included apolipoprotein, immune index, viral load, clinical symptoms and WHO Quality of Life Scale at 24 weeks. The primary outcomes were based on the rules: (a) Blood lipid test reached to one of the following items is excellent: TC decreased value ≥ 20%; TG decreased value ≥ 40%; HDL-C increased value ≥ 0.26 mmol/L; TC-HDL-C/HDL-C decreased value ≥ 20%; blood lipid test returned to normal; (b) blood lipid test reached to one of the following items is effective: TC decreased value ≥ 10% but <20%; TG decreased value ≥ 20% but <40%; HDL-C increased value ≥ 0.104 mmol/L but <0.26 mmol/L; TC-HDL-C/HDL-C decreased value ≥ 10% but <20%; (c) blood lipid test did not reach to one of the above items (considered not efficacious). The effective rate is the value sum of excellent and effective divide by the value of all analyzed patients.
Results: There were 286 participants enrolled and randomized into the study. Of these, 250 participants were ART-naive throughout this study. In intent-to-treat analysis, the Jiangzhi granule was found to reduce the TG value and rise the HDL-C value of patients. Stratified analyses of the TC value show that the Jiangzhi granule can reduce the TC value of patients older than 45 years (p=0.02). Stratified analyses of the HDL-C value show that the Jiangzhi granule can increase the HDL-C value of patients (p=0.03). In the study period, the blood and urine routine examination of the patients and the liver and renal function of the patients were normal. We found no serious adverse reactions.
Conclusions and Relevance: In ART-HIV-infected adults with dyslipidemia, 24-weeks treatment with the Jiangzhi granule was found to be safe and significantly reduced the TG value and raised the HDL-C value. The Jiangzhi granule may be effective medicine in ART-HIV-infected adults with dyslipidemia.
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