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Study under review: Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study
Introduction
Cancer is the leading cause of death worldwide. Behind lung cancer, colorectal cancer[1] is the most common cause of cancer death and the fourth most common cancer after lung, breast, and prostate cancer. There were around 1.8 million cases of colorectal cancer worldwide in 2018, resulting in close to 900,000 deaths. Most colorectal cancer cases develop from benign tumors (adenoma) that undergo genetic changes[2] over time (at least 10 years) to ultimately become cancerous (carcinoma). This process, often called the adenoma-carcinoma sequence, is depicted in Figure 1.
Figure 1: The adenoma-carcinoma sequence

Reference: Nguyen et al. Oncol Lett 2018 Jul.[3]
Early detection[4] through colonoscopy screenings is associated with reduced risk of recurrent colorectal cancer and death, and removal of colorectal adenomas appear to reduce the risk of colorectal cancer mortality[5] and incidence[6]. However, recurrence is common[7] and most potential nutritional[8] or pharmacological chemopreventive agents are not recommended[9] due to inconclusive results, short study duration, and side effects.
Multiple compounds have been studied for chemoprevention, including aspirin, non-steroidal anti-inflammatory drugs, COX2 inhibitors, vitamin D, calcium, folic acid, and metformin. Berberine is a molecule extracted primarily from the barberry plant, which was used in Asian and European traditional medicine, though it is found in other plants, too[10]. Berberine has demonstrated a strong anti-cancer potential[11] in in vitro and animal models[12]. It has been shown to modulate the tumor microenvironment and inhibit tumorigenesis, perhaps in part due to changing the composition of the microbiota.
In humans, clinical trials[13] have demonstrated the therapeutic potential of berberine, which is often hailed as a natural alternative[14] to metformin in the treatment of metabolic disease, diabetes, hyperlipidemia, hypertension, and other diseases, with good tolerance and minimal side effects, but very few human studies have examined the anti-cancer influence of berberine. The authors of this multicenter, randomized, double-blind, controlled trial investigated the clinical potential of berberine for the prevention of colorectal adenoma recurrence.
Colorectal cancer is one of the most common and deadly cancers that generally develops over time from benign tumors (adenoma) in the colon. While early detection reduces the risk of colorectal cancer mortality and incidence, recurrence is common. Thus, researchers have been investigating potential chemoprotective agents. Berberine has demonstrated strong anti-cancer potential in in vitro and animal models, but no human trials have been conducted. The authors of the study under review aimed to evaluate the preventive potential of berberine for colorectal adenoma recurrence.
What was studied?
What were the findings?
The bigger picture
Frequently asked questions
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