Nephrology & Hypertension Division, Department of Internal Medicine, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo National General Hospital, Jl. Diponegoro 71, Jakarta 10430, Indonesia.
Phytomedicine. 2011 Feb 15;18(4):251-8. doi: 10.1016/j.phymed.2010.08.016. Epub 2010 Oct 30.
A double-blind, randomized, parallel and active-controlled clinical study was conducted to evaluate the anti-hypertensive effect as well as the tolerability of Olive leaf extract in comparison with Captopril in patients with stage-1 hypertension. Additionally, this study also investigated the hypolipidemic effects of Olive leaf extract in such patients. It consisted of a run-in period of 4 weeks continued subsequently by an 8-week treatment period. Olive (Olea europaea L.) leaf extract (EFLA(®)943) was given orally at the dose of 500 mg twice daily in a flat-dose manner throughout the 8 weeks. Captopril was given at the dosage regimen of 12.5 mg twice daily at start. After 2 weeks, if necessary, the dose of Captopril would be titrated to 25 mg twice daily, based on subject's response to treatment. The primary efficacy endpoint was reduction in systolic blood pressure (SBP) from baseline to week-8 of treatment. The secondary efficacy endpoints were SBP as well as diastolic blood pressure (DBP) changes at every time-point evaluation and lipid profile improvement. Evaluation of BP was performed every week for 8 weeks of treatment; while of lipid profile at a 4-week interval. Mean SBP at baseline was 149.3±5.58 mmHg in Olive group and 148.4±5.56 mmHg in Captopril group; and mean DBPs were 93.9±4.51 and 93.8±4.88 mmHg, respectively. After 8 weeks of treatment, both groups experienced a significant reduction of SBP as well as DBP from baseline; while such reductions were not significantly different between groups. Means of SBP reduction from baseline to the end of study were -11.5±8.5 and -13.7±7.6 mmHg in Olive and Captopril groups, respectively; and those of DBP were -4.8±5.5 and -6.4±5.2 mmHg, respectively. A significant reduction of triglyceride level was observed in Olive group, but not in Captopril group. In conclusion, Olive (Olea europaea) leaf extract, at the dosage regimen of 500 mg twice daily, was similarly effective in lowering systolic and diastolic blood pressures in subjects with stage-1 hypertension as Captopril, given at its effective dose of 12.5-25 mg twice daily.
一项双盲、随机、平行、阳性药物对照的临床研究旨在评估橄榄叶提取物在 1 期高血压患者中的降压效果和耐受性，并与卡托普利进行比较。此外，该研究还观察了橄榄叶提取物在这些患者中的调脂作用。该研究包括 4 周的导入期，随后进行 8 周的治疗期。橄榄（Olea europaea L.）叶提取物（EFLA®943）以 500mg，每日 2 次的固定剂量口服给药，持续 8 周。卡托普利以 12.5mg，每日 2 次的起始剂量给药。2 周后，如果需要，根据患者的治疗反应，将卡托普利的剂量滴定至 25mg，每日 2 次。主要疗效终点为治疗 8 周时收缩压（SBP）从基线的下降。次要疗效终点为每个时间点评估的 SBP 和舒张压（DBP）变化以及血脂谱改善。治疗 8 周期间每周评估血压，4 周间隔评估血脂谱。橄榄组的基线平均 SBP 为 149.3±5.58mmHg，卡托普利组为 148.4±5.56mmHg；平均 DBP 分别为 93.9±4.51mmHg 和 93.8±4.88mmHg。治疗 8 周后，两组 SBP 和 DBP 均较基线显著下降；但两组间无显著差异。橄榄组和卡托普利组从基线到研究结束时 SBP 下降的平均值分别为-11.5±8.5mmHg 和-13.7±7.6mmHg；DBP 下降的平均值分别为-4.8±5.5mmHg 和-6.4±5.2mmHg。橄榄组的甘油三酯水平显著降低，但卡托普利组没有。总之，橄榄（Olea europaea）叶提取物，每日 2 次，每次 500mg 的剂量方案，与每日 2 次、有效剂量为 12.5-25mg 的卡托普利在 1 期高血压患者中降低收缩压和舒张压的效果相似。
