A Randomized Clinical Trial of Berberine Hydrochloride in Patients with Diarrhea‐Predominant Irritable Bowel Syndrome

Abstract

We aimed to evaluate clinical symptoms in diarrhea predominant irritable bowel syndrome (IBS-D) receiving berberine hydrochloride in a randomized double-blind placebo-controlled clinical trial. Overall, 196 patients with IBS-D were recruited for this study; consequently, 132 patients randomized to receive daily 400 mg of berberine hydrochloride, delivered twice daily or placebo for 8 weeks followed by a 4-week washout period. After a 2-week run-in period, diarrhea, abdominal pain, urgent need for defecation frequency and any adverse events were recorded daily. Prior to administration of the medication and after completing the treatment, assessment of IBS symptom scores, depression and anxiety scale scores and the IBS scale for quality of life (QOL) was carried out. The effects of berberine hydrochloride on IBS-D, defined by a reduction of diarrhea frequency (P = 0.032), abdominal pain frequency (P < 0.01) and urgent need for defecation frequency (P < 0.01), were significantly more pronounced in the berberine group than the placebo group in the 8 weeks of treatment. A trend of improvement (P < 0.05) was observed with berberine hydrochloride for IBS symptom score, depression score and anxiety score and the IBSQOL, compared with placebo. At last, berberine hydrochloride was well tolerated. So we concluded that berberine hydrochloride is well tolerated and reduces IBS-D symptoms, which effectively improved patients QOL.

Berberine and barberry (Berberis vulgaris): A clinical review

“…In a randomized double‐blind placebo‐controlled clinical trial in 196 patients with diarrhea predominant irritable bowel syndrome (IBS‐D), daily administration of 400 mg of berberine twice daily for 8 weeks reduced IBS‐D symptoms, including reduction of abdominal pain frequency ( p < 0.01), diarrhea frequency ( p = 0.032), and urgent need for defecation frequency ( p < 0.01; Chen et al, ).…”

“…Berberine has been widely used for treating of diarrhea and gastroenteritis in China for a long time (Zhang et al, 2012). Various pharmacological effects, including the inhibition of smooth muscle contraction , inhibition of intestinal fluid accumulation and ion secretion (Alzamora et al, 2011), antiinflammatory (Amasheh et al, 2010), and anti-microbial (Gu et al, 2011) frequency (p = 0.032), and urgent need for defecation frequency (p < 0.01; Chen et al, 2015).…”

Nanoemulsion-based delivery system for enhanced oral bioavailability and Caco-2 cell monolayers permeability of berberine hydrochloride

“…BBH has a variety of pharmacological activities such as antitumor (James et al, 2011;Tan et al, 2011;Cheng et al, 2015), antimicrobial (Zhang et al, 2010;Sun et al, 2014;Wen et al, 2016), antiinflammation (Lee et al, 2007;Wen et al, 2016), and reduce irritable bowel syndrome (Chen et al, 2015;Habtemariam, 2016). However, oral administration of BBH exhibited low bioavailability and poor stability (Tan et al, 2011;Liu et al, 2014) mainly due to its hydrophobic properties resulted from the chemical structure, which contains two methoxy groups and a quaternary ammonium cation.…”

Berberine delays onset of collagen induced arthritis through T cell suppression

“…One potential prophylactic candidate, berberine (BBR), merits further exploration as it has already proved to be of importance for a variety of diseases through successful clinical trials, such as polycystic ovary syndrome [30,31], type II diabetes [32,33], diarrhea-predominant irritable bowel syndrome [34], psoriasis [35], and osteoarthritis [36]. Additionally, current clinical trials are assessing BBR's ability to help ulcerative colitis (UC) patients maintain remission (NCT No.02962245), to prevent colorectal cancer development in UC patients who are in remission (NCT No.…”