Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

Inclusion Criteria: * Patients aged 18-65 years * Patients with familial adenomatous polyposis, who had not had their entire colorectum removed, and who had five or more polyps 2 mm or more in diameter that could be assessed endoscopically * All potential subjects received genetic counseling before undergoing genetic testing for APC gene mutations. * Eligible subjects had a disease-causing mutation of the APC gene but had no endoscopically detectable colorectal adenomatous polyps and no history of colonic surgery Exclusion Criteria: * Patients who are hypersensitive or intolerant to the drugs * Patients who had a history of colectomy or colectomy anticipated within 8 months after randomization * Patients with abnormal results of serum laboratory tests (a white-cell count of less than 4000 per cubic millimeter, a platelet count of less than 100,000 per cubic millimeter, a blood urea nitrogen level of more than 25 mg per deciliter (8.9 mmol per liter), a serum creatinine level of more than 1.5 mg per deciliter (132.6 µmol per liter)) * Patients with diabetes mellitus, severe renal disease or cardiovascular disease (defined by a New York Heart Association functional classof III or IV) * Patients with hypercalcemia or urolithiasis * Patients with hemolytic anemia and glucose -6- phosphate dehydrogenase deficiency * Patients had clinically obvious narcotic or alcohol dependence during the previous 6 months * Patients had used NSAIDs including aspirin at any dose on 3 or more days per month during each of the 3 months before enrollment or for a period of 36 days in the previous year; or had a history of stroke, transient ischemic attacks, angina, myocardial infarction, or atherosclerotic peripheral vascular disease * Pregnant women, women during breast-feeding period, or women with expect pregnancy * Patients with a history of subtotal gastrectomy or partial bowel resection * Patients who are not able to cooperate * Individual who are involved in designing, planning or performing this clinical trial * Patients with medical conditions who are not appropriate to participate the study * Patients with any condition that could be worsened by supplemental Berberine hydrochloride