A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer

• Patients aged 18-80 years
• Patients who had histologically documented colon or rectal cancer with a low risk of recurrent disease
• Patients with Dukes' stage A or B1 colon or rectal cancer (tumor-node-metastasis [TNM] stage T1 to T2, N0, M0) who had undergone curative resection of the primary tumor were immediately eligible for enrollment
• Patients with Dukes' stage B2 or C (T3 to T4, N0 to N1, M0) colon or rectal cancer who had undergone curative resection of the primary tumor were eligible if they had been free of disease for more than five years after curative surgery
• Eligible participants had to have undergone, after adequate preparation, colonoscopy to the cecum (or small-bowel anastomosis), with removal of all polyps, within four months before study entry
• Patients were eligible if they were in good general health, with an expected survival of at least five years; willing to provide and able to understand informed consent and to cooperate with the study procedures; not currently enrolled in a clinical trial of colon-cancer treatment or other chemoprevention trial; and not pregnant or nursing.

Exclusion Criteria:

• Patients who are hypersensitive or intolerant to the drugs
• Patients had familial polyposis
• Patients had invasive cancer other than nonmelanoma skin cancer within 5 years before the intake appointment
• 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 had a history of inflammatory bowel disease
• Patients with hemolytic anemia and glucose -6- phosphate dehydrogenase deficiency
• Patients had received immunosuppressive therapy within the previous 6 months
• 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
• Patients with any condition that could be worsened by supplemental Berberine hydrochloride