Artichokes were greatly valued by the ancient Greeks (fourth century B.C.) for treating digestive disorders. Clinical studies have been conducted on aqueous extracts of the leaves. The extracts characteristically contain caffeoylquinic acid derivatives, including caffeic acid, chlorogenic acid, and cynarin (1,5-dicaffeoylquinic acid) (Kraft, 1997).

Cynara-SL™ contains 320 mg per capsule of a dried aqueous extract called LI 120, with an herb-to-extract ratio of 3.8 to 5.5:1. It is manufactured in Germany by Lichtwer Pharma AG and distributed in the United States by Lichtwer Pharma U.S., Inc. This extract is marketed in Europe as Hepar-SL forte®.

Valverde Artischocke, which is manufactured by Novartis Consumer Health GmbH in Germany, is not provided in the United States. The tablets contain 450 mg of a dried aqueous extract called CY-450 with a ratio of 25 to 35:1. Artichoke preparations may relieve digestive complaints through increases in the formation and flow of bile.

The increased flow of bile is called choleresis. Bile is excreted from the liver, stored in the gallbladder, and released into the intestine. Bile acids form a complex with dietary fats in the intestine and thereby assist in their digestion and absorption (Kraft, 1997).

In addition, stimulation of bile production results in reduced serum cholesterol, as cholesterol is pulled from the blood to be converted into bile acids. The increased flow of bile may also be beneficial for patients with irritable bowel syndrome (IBS) (Walker, Middleton, and Petrowicz, 2001).

• Cynara-SL (LI 120) - Choleresis (Bile Secretion)

A mode of action study using the Lichtwer product Cynara-SL (Hepar-SL) demonstrated that artichoke extract increased the flow of bile. Administration of six capsules (1.92 g) intraduodenally caused a peak increase (100 to 150 percent compared to baseline) in bile one hour later (Kirchhoff et al., 1994).

According to Dr. David Heber, this study inferred, but did not clearly demonstrate, therapeutic benefit for dyspepsia; the one-day study was too short, was not conducted on subjects with dyspepsia, and the product was not delivered orally.

• Valverde Artischocke - Hyperlipoproteinemia (Elevated Cholesterol Levels)

A study with the Novartis product Valverde Artischocke on 131 patients with elevated cholesterol (total serum cholesterol greater than 280 mg/dl) reported a 20.2 percent decrease in cholesterol, compared to 7.2 percent in the placebo group.

The product was given in a dose of 900 mg, twice daily, before meals, for six weeks (Englisch et al., 2000). This well-conducted trial indicates efficacy of Valverde Artischocke in the treatment of elevated cholesterol.

A review of metabolic, pharmacological, and clinical studies described two postmarketing surveillance studies (Kraft, 1997). The first study, reported by Held (1991), included 417 patients with hepatic and biliary tract disease who were treated for four weeks with artichoke leaf extract (product not named).

Prior to the study, the average duration of symptoms of abdominal pain, bloating, meteorism, constipation, lack of appetite, and nausea was four months. Elimination of these symptoms occurred in 65 to 77 percent of patients after one week, and in 52 to 82 percent of patients after four weeks.

The second postmarketing surveillance study was published by Fintelmann (1996) and Fintelmann and Menssen (1996). It included 553 subjects with dyspepsia who were administered the Lichtwer product Hepar-SL. The authors reported a clinically impressive and statistically significant improvement for 87 percent of patients within six weeks of treatment.

In a subset of 302 patients for whom cholesterol values were routinely determined, serum cholesterol and serum triglyceride concentrations dropped significantly (p <>

Walker, Middleton, and Petrowicz (2001) reported an analysis of another patient subset with key symptoms of irritable bowel syndrome (279 in number). These patients experienced significant reductions in symptoms (71 percent) after six weeks of treatment with six capsules per day, with improvement noted within ten days.

Although the initial survey by Fintelmann and Menssen (1996) did not include all the diagnostic criteria for IBS, patients were included if they had at least three of five key symptoms.

No adverse reactions or side effects were reported in the clinical studies described. The Fintelmann (1996) postmarketing study reported that 1.3 percent of 553 subjects experienced mild reactions, such as flatulence, feeling of weakness, and hunger.