Treatments for lymphocytic colitis

Chande N, Al Yatama N, Bhanji T, Nguyen TM, McDonald J, MacDonald JK

What is lymphocytic colitis?

Lymphocytic colitis is a type of microscopic colitis, a condition characterized by chronic non-bloody watery diarrhea. People with lymphocytic colitis have a normal appearing bowel when assessed by an endoscope (a camera used to look at the bowel) or an X-ray; but have microscopic (histological) inflammation of the bowel when assessed by a biopsy (a tissue sample taken during endoscopy). The cause of this disorder is unknown. This review is an update of a previously published Cochrane review.

What treatments have been tried for lymphocytic colitis?

Budesonide, mesalazine with or without cholestyramine, beclometasone dipropionate and bismuth subsalicylate (i.e. Pepto-Bismol®) have been tried as treatment for lymphocytic colitis. Budesonide is an immunosuppressive steroid drug that is quickly metabolized by the liver resulting in reduced steroid-related side-effects. It is taken by mouth. Beclometasone dipropionate is also a steroid drug. Steroid drugs are used to treat inflammation. Mesalazine (also known as 5-ASA) is an anti-inflammatory drug which is often taken by mouth. Cholestyramine is a drug that helps the body remove bile acids. Pepto-Bismol®, is an antacid medication used to treat temporary discomforts of the stomach and gastrointestinal tract.

What did the researchers investigate?

The researchers investigated whether these drugs improve the symptoms of lymphocytic colitis (e.g. diarrhea) or microscopic inflammation and whether any side effects result from treatment. The researchers searched the medical literature extensively up to 11 August 2016.

What did the researchers find?

Five studies including 149 participants were identified. These studies assessed budesonide versus placebo (e.g. a sugar pill), mesalazine versus mesalazine plus cholestyramine and beclometasone dipropionate versus mesalazine and Pepto-Bismol® versus placebo. The study which compared mesalazine to mesalazine plus cholestyramine and the study which compared beclometasone dipropionate to mesalazine were judged to be of low quality. The study which compared Pepto-Bismol® bismuth subsalicylate to a placebo was judged as low quality due to a very small sample size (5 participants) and limited data. The other three studies were judged to be high quality.

A pooled analysis of two studies (57 participants) showed that budesonide (9 mg/day for 6 to 8 weeks) was superior to placebo for improvement of diarrhea and improvement of microscopic inflammation of the bowel. Improvement in diarrhea was noted in 88% of budesonide participants compared to 38% of placebo participants. Improvement in microscopic inflammation was reported in 78% of budesonide participants compared to 33% of placebo participants. Forty-one participants were enrolled in the study that compared mesalazine (2.4. g/day) to mesalazine plus cholestyramine (4 g/day). Improvement in diarrhea was noted in 85% of participants in the mesalazine group compared to 86% of participants in the mesalazine plus cholestyramine group. Five patients were enrolled in the trial studying Pepto-Bismol® (nine 262 mg tablets daily for 8 weeks versus placebo). There were no differences in improvement of diarrhea or in improvement of microscopic inflammation of the bowel. Forty-six participants were enrolled in the trial studying beclometasone dipropionate (5 mg/day or 10 mg/day) versus mesalazine (2.4 g/day). Although participants receiving beclometasone dipropionate (84%) and mesalazine (86%) had improved diarrhea at 8 weeks, this improvement was not maintained at 12 months (26% and 20%, respectively). Side effects reported in the budesonide studies include nausea, vomiting, neck pain, abdominal pain, excessive sweating and headache. Side effects reported in the mesalazine plus cholestyramine study included nausea and skin rash. Side effects in the beclometasone dipropionate trial included nausea, sleepiness and change of mood. No side effects were reported in the Pepto-Bismol® study.

Low quality evidence suggests that budesonide may be an effective therapy for the treatment of lymphocytic colitis. Low quality evidence also suggests that mesalazine with or without cholestyramine and beclometasone dipropionate may be effective for treatment of lymphocytic colitis. No conclusions can be made regarding bismuth subsalicylate due to the very small number of participants in the study. In the future, researchers should consider further large placebo-controlled trials of budesonide to confirm the suggested benefit and safety of this therapy. Bismuth subsalicylate, which has less potential for toxicity than budesonide, also warrants further study. The effectiveness and safety of mesalazine with or without cholestyramine, and beclometasone dipropionate need to be investigated in a large placebo-controlled studies.

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