Shaker Mohamed Kamal, Hassany Mohamed, Eysa Basem, Adel AbdulMoneim, Zidan Ahmed, Mohamed Shahnaz
Department of Tropical Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
National Hepatology and Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.
BMC Complement Med Ther. 2025 Jan 9;25(1):8. doi: 10.1186/s12906-024-04692-y.
Nonalcoholic steatohepatitis (NASH) is a severe form of nonalcoholic fatty liver disease (NAFLD) characterized by damage and inflammation of hepatocytes. Some medicinal plants have shown antioxidant and anti-inflammatory effects on liver cells. We aimed to investigate the hepatoprotective effect of Heptex® capsules containing 200 mg of Dukung Anak (a powdered extract from aerial parts of Phyllanthus niruri) and 100 mg of Milk Thistle (a powdered extract from fruits of Silybum marianum) in patients with an apparent risk factor for NASH.
This was a phase II, randomized, double-blind, placebo-controlled, three-arm, interventional clinical trial. Patients were randomized in a 1:1:1 ratio to receive placebo, low dose (one capsule) of Heptex®, or high dose (two capsules) of Heptex®. After 36 weeks, liver enzymes, Fib-4 score, lipid profile, CAP score, and kPa score were evaluated. Patients were monitored for safety throughout the treatment duration.
A total of 146 patients were enrolled in the study. A significant decrease was observed in ALT levels in the low-dose group (57 IU/L to 40 IU/L, p = 0.026) and the high-dose group (61 IU/L to 47.5 IU/L, p < 0.0001) and in AST levels in the high-dose group (43.5 IU/L to 32 IU/L, p = 0.001), with no significant difference between the relative percent change in ALT (p = 0.465) or AST (p = 0.632) between the three groups. No significant difference was revealed between the three groups regarding the median change in Fib-4 score at the end of treatment (p = 0.985). No significant change in the lipid profile was observed in any of the three groups except for the total cholesterol level, which significantly decreased from 210 IU/L to 187 IU/L, p = 0.031 in the low-dose group.
Heptex® capsules were safe and well tolerated over a treatment period of 36 weeks. However, the hepatoprotective effect in patients at risk of NASH still needs further assessment using more accurate investigation tools, a larger sample size, and/ or higher doses of the combination.
Retrospectively registered (registration date: 25/04/2022; trial registration number: NCT05343780).
非酒精性脂肪性肝炎（NASH）是一种严重的非酒精性脂肪性肝病（NAFLD），其特征是肝细胞受损和炎症。一些药用植物已显示出对肝细胞的抗氧化和抗炎作用。我们旨在研究含有200毫克杜昆阿纳克（一种来自叶下珠地上部分的粉末提取物）和100毫克水飞蓟宾（一种来自水飞蓟果实的粉末提取物）的Heptex®胶囊对有明显NASH风险因素患者的肝脏保护作用。
这是一项II期、随机、双盲、安慰剂对照、三臂干预性临床试验。患者按1:1:1的比例随机分组，分别接受安慰剂、低剂量（一粒胶囊）的Heptex®或高剂量（两粒胶囊）的Heptex®。36周后，评估肝酶、Fib-4评分、血脂谱、CAP评分和kPa评分。在整个治疗期间对患者进行安全性监测。
共有146名患者纳入研究。低剂量组（从57 IU/L降至40 IU/L，p = 0.026）和高剂量组（从61 IU/L降至47.5 IU/L，p < 0.0001）的ALT水平显著降低，高剂量组的AST水平（从43.5 IU/L降至32 IU/L，p = 0.001）也显著降低，三组之间ALT（p = 0.465）或AST（p = 0.632）的相对百分比变化无显著差异。治疗结束时，三组之间Fib-4评分的中位数变化无显著差异（p = 0.985）。除低剂量组总胆固醇水平从210 IU/L显著降至187 IU/L（p = 0.031）外，三组中任何一组的血脂谱均无显著变化。
在36周的治疗期内，Heptex®胶囊安全且耐受性良好。然而，对于有NASH风险的患者，其肝脏保护作用仍需使用更准确的研究工具、更大的样本量和/或更高剂量的组合进行进一步评估。
回顾性注册（注册日期：2022年4月25日；试验注册号：NCT05343780）。
