Focus on Alternative and Complementary Therapies
www.pharmpress.com/fact
Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 1997; 2: 192
In various molecular, cellular and in vivo test systems artichoke (Cynara scolymus L) leaf extract (ALE) showed antioxidative, hepatoprotective, choleretic and anticholestatic effects as well as inhibiting actions on de novo cholesterol bio-synthesis in rat and human hepatocytes. The antidyspeptic action which is based on the proven choleretic action has been confirmed in several clinical studies. However, the study duration usually did not exceed several weeks. Therefore, a six-month observation study has been conducted. The results of an interim data analysis after completion of 138 patients will be presented.
138 patients (mean age = 68.8 years, m/f: 51%/49%) suffering from dyspepsia were monitored over 6 months (post-marketing surveillance study). The patients were treated with a standardised high dose special extract (Extr. Cynarae e fol. Aquos. Sicc (3.8–5.5:1) (Hepar SL® forte):1 (median). The data analysis was performed by descriptive and explorative statistical methods.
The following symptom reductions compared to initial values (=100%) were registered: vomiting - 72.7%, nausea - 68.4%, abdominal pain - 73.3%, meteorism - 67%, flatulence - 79.7%, fat intolerance - 52.5%. The total blood cholesterol decreased by 11.2%, the triglycerides by 11.4%. After 6 months, the investigators evaluated the global efficacy as being excellent in 25.2% of the patients, good in 57.8%, moderate in 14.1%, minimal in 2.2%, with no effect in 0.7%. The overall effect of the medication reached a maximum after 4 months and remained stable for the rest of the observation period. In 44.9% the global tolerance was excellent, in 50.7% it was good, in 2.9% moderate, in 1.5% bad (patients’ evaluation). No adverse reactions have been reported by now.
The preliminary results are in accordance with data obtained in studies with a shorter duration of treatment (≤ 6 weeks) and indicate that ALE can be considered effective and safe in long term application.
