The purpose of this clinical trial is a short course study about effectiveness and side effects of Anethum in combined hyperlipidemic patients. Two hundred and ninety eight older than fifteen years old patients with combined hyperlipidemia (serum total cholesterol >240mg/dl and triglyceride >250mg/dl) were included in this controlled, double blind, randomized clinical trial. Two hundred and three patients (68.1%) completed the two months period of trial. After two weeks of therapeutic lifestyle changes (diet and sports), patients were randomized into five following groups 1. Nicotinic Acid 3g daily 2. Nicotinic Acid 3g daily plus Cholestyramine 12g daily 3. Clofibrate 2g daily 4. Anethum 6 tablets daily and 5. Placebo 3 capsules daily. After two months, there was no significant differences between the changes observed in lipid profile in Anethum and placebo groups. Considering the effect on total cholesterol level, the difference between Anethum group (-5%), the first (-22.1%) and the second group (-17.2%) (P<0.000) the effect on triglyceride level, the difference between Anethum group (-16.3%), the first (-54.8%) and the third group (-38%) (P<0.000) and the effect on HDL-cholesterol level, the difference between Anethum group (+1%) and the first group (+30.8%) (P=0.001) was significant. The least complaints were in Anethum group (16%) and the most in the second group (74%). No changes in other biochemical tests were significantly different between Anethum and placebo groups. According to these results there is no superiority for Anethum in comparison of placebo to improve the lipid profile in combined hyperlipidemic patients for a two-month course. Although the side effects of Anethum are less than other well defined drugs.

Anethum is a herbal drug production and prescription of which, as a lipid lowering drug, has been approved in Iran. Its widespread use and lack of studies done on it emphasizes on the necessity of a controlled clinical trial. Two hundred and one hypercholesterolemic patients (total cholesterol >240 mg/d) diagnosed on basis of two consecutive lab tests, separated by at least two weeks, comprised the study population. Patients were randomized into the following therapy groups after 2 weeks of diet therapy: 1) Cholestyramine 12 g per day, 2) Nicotinic acid 3 g per day, 3) Cholestyramine 12g per day plus Nicotinic acid 3 g per day, 4) Anethum 6 tablets per day, 5) Placebo. One hundred and fourteen patients completed the 2 months follow up. A third lab test at the end of the course revealed a 2.0% reduction of cholesterol level in the anethum group. Triglyceride had %3.1 rise in anethum group (not significant). Low density lipoprotein cholesterol (LDL-C) was increased by 6.1% in the anethum group (not significant). The most common side effects of anethum were non specific complaints (i.e. malaise and fatigue). One patient discontinued therapy because of abdominal pain. Anethum caused a 2.2 mg/dl rise in blood urea nitrogen (P=0.016) and 0.12 mg/dl rise in creatinine (P=0.019). Based on the results, we conclude that anethum is not significantly different from placebo in its therapeutic effects, moreover there are clinical evidence on its untoward effects by increasing LDL-C. Although this study hasn’t proved untoward effects of anethum statistically but showes lack of any beneficial effects.