Atheromod-B F.C Tablet

Prevention of Atherosclerosis

Reduction in cholesterol, LDL and triglyceride; increase in HDL

Reduction of blood sugar

Antioxidant and hepatoprotective

Adjuvant treatment for alleviation of Irritable Bowel Syndrome (IBS) symptoms

Adjuvant treatment for functional dydpepsia

Commission E has approved the use of artichoke (Cynara scolymus) for hepatic and gallbladder disorders and cases of loss of appetite and this plant has been used to treat dyspepsia.(1,2) In several in vitro and in vivo studies, the choleretic, diuretic, laxative, hypolipidemic and hypoglycemic, anti-oxidative and hepatoprotective properties of artichoke and its effect in alleviation of IBS symptoms have been thoroughly studied.

In treatment of dyspepsia, increase in flow of bile by the liver is necessary. Chlorogenic acid and cynarin increase the flow of bile.(7) Cynaropicrin and sesquiterpene lactones have hypoglycemic and hypolipidemic properties. Cynarin reduces serum cholesterol by increasing biliary excretion of sterols and through its choleretic and cholagogous properties, but high doses and extended time of treatment is necessary. A review of clinical data from 1936 to 1994 has shown that Artichoke Leaf Essential Oil (ALE) has reduced the levels of cholesterol and/or triglyceride about 5 to 45%, but in this study, the variations of laboratory conditions in various studies was not regarded. ALE prevents atherosclerosis through 2 mechanisms: inhibition of cholesterol synthesis and inhibition of LDL oxidation.

In what follows, researches related to the uses of this medication have been summed up:

  1. Dyspepsia: in a randomized, double-blind clinical trail, 247 patients with functional dyspepsia received ALE (2×320 mg, 3 times a day) or placebo for 6 weeks. The results of data analysis from 244 patients (129 patients in the treatment group and 155 patients in the placebo group) showed that, in comparison with the placebo group, the general improvement and quality of life in the ALE group was significantly higher (p<0.01).

In a clinical study without control, in 553 patients with non-specified gastrointestinal discomfort (dyspepsia), 320-640 mg standard ALE three times per day, resulted in decrease in nausea, stomachache, constipation and flatulence in 70% of the patients.

  1. IBS: In a 2-month survey, 208 patients with IBS who simultaneously suffered from dyspepsia took ALE. After the treatment, significant reduction in prevalence of IBS equal to 26.4% (p<0.001), report of significant defecation pattern altering between diarrhea/constipation to the normal state (p<0.001), considerable reduction in the total score in Nepean Dyspepsia Index (NDI) equal to 41%( p<0.001) and considerable improvement in Quality of Life (QOL) score equal to 20% was observed.

In a monitoring of the drug after entering the market, a sub-group of patients with IBS symptoms along with dyspeptic syndrome took ALE for 6 weeks. The analysis of data was indicative of significant decrease in severity of symptoms and desirable general evaluation by physicians and patients. Furthermore, 96% of the patients evaluated the effect of ALE better or at least as good as their previous treatments and ALE manifested good tolerance.

  1. Hyperlipidemia and Hyperglycemia: 30 female and male patients with type II diabetes aging 35-45 were studied in 2 groups of treatment and control for 90 days. The treatment group (15 patients) took as snacks 2 in the morning and 2 in the evening wheat biscuits containing 6 g artichoke powder. The results of the study was indicative of significant reduction in fasting blood sugar and blood sugar after the meal, total cholesterol, triglyceride and LDL, and significant increase in HDL in the treatment group (p<0.01).

In another study, 75 patients with mild to moderate hypercholesterolemia, who were otherwise healthy, took 1280 mg standard extract of artichoke daily for 12 weeks. At the end of the study, total plasma cholesterol decreased on average 4.2%, but in the placebo group a 1.9% increase was observed and this difference between the two groups was statistically significant. In this study, no statistically significant difference was observed between the two groups with regard to LDL, HDL or TG. The researcher came to the conclusion that the extract of artichoke leaves causes moderate but desirable decrease in total cholesterol levels.

  1. Antioxidant and Hepatoprotective: Cynarin and caffeic acid show considerable hepatoprotective activity against CCL4, in vivo. This protective activity has been demonstrated for artichoke extract as well and is related to its antioxidant activities.

3 times per day, 1-2 tablets each time with a meal.

Dosage form

F.C Tablet

 

Packaging

350 mg tablets in 10-tablet blisters or plastic containers of 100 in cardboard box

Patient information leaflet inside

Ingredients

Artichoke leaf extract

Active Ingredients

caffeic acid derivatives including clorogenic acid and cynarin

Contraindications and Cautions

Use of Atheromod-B F.C Tablet in cases of biliary obstruction and existence of hypersensitivity to plants of the family Compositae is contraindicated.(8) In case of gallstone, only use under supervision of a physician.(1)

 

Adverse Effects

Artichoke’s safety and tolerance, which has been demonstrated in clinical studies, is good to very good. No cases of allergic reactions have been reported after ingestion of the plant; However, contact with the fresh plant can cause contact dermatitis.(1)

 

Drug Interaction

No reported drug interaction.

 

Administration during Pregnancy and Lactation

No evidence indicates to the toxicity of artichoke during pregnancy or lactation; however, it is not to be taken in excessive amounts.(8)

 

Further Notes

  • Increase in blood lipids, especially cholesterol, is a globally-known risk factor for atherosclerosis, which is a prevalent condition in advanced ages and an important cause for mortality. Use of Atheromod-B F.F Tablets has significant effect on lowering the risk of atherosclerosis, without the adverse effects of chemical lipid-lowering drugs.
  • In case allergic reactions occur, discontinue use and consult your physician.
  • Do not use expired products.
  • Keep Atheromod-B F.F Tablets, like all other medication, away from sight and reach of children.
  • Keep the medicine in its container, away from light and in 15-30°C.
  • Keep this leaflet; you may need to read it again.

Based on presence of at least 2.21 mg clorogenic acid in each mean tablet.