Azim Mirzazade, Akbar Fotouhi, Farshid Alla’oddini, Kamran Yazdani, Arash Arya, Fariba Asghari, Shahriar Shayan Far,
Volume 1, Issue 2 (18 2002)
Abstract
Introduction: Anethum is an herbal medicine composed of the three plants species Anethum, Fumaria and Cichorium, and has been widely marketed and prescribed as lipid-lowering agent in Iran in recent years. No controlled clinical trial of this medicine has so far been carried out, however. We studied the efficacy and short-term side effects of Anethum in patients with isolated hypertriglyceridaemia.
Methods: 151 people (54 men and 97 women) with serum triglyceride ≥250mg/dl and serum cholesterol <240mg/dl were enrolled in this study. Participants were randomly assigned to one of four treatment groups: Anethum, nicotinic acid, clofibrate, and placebo. They were seen at the Doctor Shariati University Hospital lipid clinic once every two weeks. Serum lipid profile was measured at 2 and 4 months after start of therapy. Relevant patient details, including sex, body mass index, mean total cholesterol and high-density lipoprotein, cigarette smoking, previous myocardial infarction, physical activity, and oral contraceptive use were recorded before enrolment.
Results: Four months after treatment was started, serum triglyceride had decreased 12.5% in the Anethum group and 6.8% in the placebo group (p=0.999). During the same period, serum triglyceride had decreased 48.8% in the nicotinic acid group and 54.4% in the clofibrate group (p=0.006 with respect to both placebo and Anethum). Furthermore, the nicotinic acid group showed a 7.8% decrease in serum total cholesterol (p=0.009 with respect to the other three groups). HDL-C decreased 9.8% in the Anethum group, 17.5% in the nicotinic acid group, 8.1% in the clofibrate group, and 9.1% in the placebo group (p=0.149 between first three groups and placebo). 81.8% of the nicotinic acid, 57.1% of the clofibrate, 8.0% of the Anethum and 30% of the placebo group experienced side effects during the same period. The most common complaints in the Anethum were actually non-specific ones.
Conclusion: We conclude that Anethum does not exert any therapeutic effect on isolated hypertriglyceridaemia.
Fariba Asghari, Akbar Fotouhi,
Volume 4, Issue 0 (Vol4, Ethics in Clinical Researchese 2005)
Abstract
Background: Clinical trial is the standard method to assess efficacy of a medical intervention. Because of its experimental nature, meaning that subjects are exposed to an intervention with uncertain outcome and according to historical evidences of criminal researches, clinical trial is of something of a lightning rod for ethical concerns. Ethical issues surrounding clinical trials are very pervasive and in many respects, they are as important as the Methodological issues. Patients place a great deal of trust in clinical investigators and often participate in trial when the chance of personal benefit is low. The clinical investigators must continue to earn this trust by demon storable commitment to ethical standards.
Methods: In this article after reviewing the appropriateness and necessity of clinical trial and its required methodological characteristics, ethical issues consisting importance of protocol, informed consent, study on vulnerable subjects, compensation, conflict of interest and responsibility of ethical committees in evaluation of clinical trial will be discussed.
Conclusion: To assess efficacy of a medical intervention, clinical trial is ethicly not only inevitable but also necessary. However it doesn't reduce necessity of attention to the participants rights.
