Berberine safe, effective in reducing risk for recurrent colorectal adenoma
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Berberine, a supplement originally extracted from the Chinese herb Coptis chinensis, helped to reduce risk for recurrent colorectal adenoma, according to study results.
Ying-Xuan Chen, MD, from the division of gastroenterology and hepatology at Shanghai Jiao-Tong University School of Medicine in China, and colleagues wrote that while berberine has been used to treat diarrhea and enteritis, recent research has shown it may have anti-tumor activity.
“Our previous study demonstrated that berberine could prevent tumorigenesis of colorectal cancer in mice by changing the structure of the microbiota,” they wrote. “In recent years, berberine has also been shown to be effective in clinical trials for the treatment of type 2 diabetes and dyslipidemia, displaying good tolerance and minimal side effects.”
Researchers aimed to further investigate the clinical potential and safety of berberine in a double-blind, randomized trial. They included 891 patients with histologically confirmed adenomas who underwent complete polypectomy within 6 months of recruitment.
Investigators randomly assigned patients to receive either 0.3 g of berberine twice daily or placebo. Patients then underwent follow-up colonoscopy at 1 year, and if no adenomas were detected, they scheduled another colonoscopy at 2 years.
The study continued until the last patient reached a 2-year follow-up. The primary efficacy endpoint was the recurrence of adenomas at any follow-up colonoscopy.
During follow-up, 155 patients in the berberine group (36%) and 216 patients in the placebo group (47%) received a diagnosis of recurrent adenomas (RR = 0.77; 95% CI, 0.66–0.91). Investigators did not identify any cases of colorectal cancer during follow-up.
The most common adverse event was constipation, reported in 1% of patients in the berberine group and less than 0.5% in the placebo group.
Chen and colleagues wrote that berberine reduced the risk for recurrent adenoma and polypoid lesions after polypectomy.
“The low cost and safety profile of berberine suggest its potential in the chemoprevention of colorectal cancer,” they wrote. “The mechanism of berberine’s actions needs to be further elucidated.” – by Alex Young
Disclosure: The authors report no relevant financial disclosures.
Perspective
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Strengths of this research include that it was a large study with two groups – placebo and medication - that had close to 500 people. It was a randomized controlled trial conducted across several centers in China. In addition, the completion rate was high. It evaluates a novel mechanism for preventing adenoma recurrence through the alteration of the microbiome
Other medications that have been studied for the prevention of colorectal cancer or adenomas have had mixed results or lead to side effects, such as NSAIDs.
I don’t think that berberine is ready for prime time. What makes me hesitant is that I don’t know the quality of the colonoscopy in the study. The one-year adenoma recurrence rates were high for both groups. In a Western population, which has a higher rate of colon cancer and adenomas than an Asian population, you should not see recurrence for several years. Having adenomas at 1-2 years is indicative of missed lesions on initial colonoscopy. This is a novel drug whose mechanism of action was to alter the stool microbiome. We do not know if the drug did alter the microbiome in the Berberine group compared to the placebo group. Is the drug actually doing what was proposed? Is this a true representation of the general population (e.g. the adenoma rate is high in the young population)? An effective drug should prevent colorectal cancer. Though Berberine resulted in a reduction in recurrent adenomas, it is unclear what its effects on CRC incidence are. It is unclear what the long-term effects are from a 1 to 2-year study, and we will not know until the 5 or 10 year follow-up results become available.
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