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Mirtazapine benefits patients with functional dyspepsia, weight loss
In patients with functional dyspepsia and weight loss, the antidepressant and H1-, alpha-2-, 5-hydroxytryptamine-2c- and 5-hydroxytryptamine-3-receptor antagonist mirtazapine was found to significantly improve early satiation, quality of life, gastrointestinal-specific anxiety, nutrient tolerance and weight loss, according to results from a randomized, double-blind, placebo-controlled mechanistic pilot trial.
“Mirtazapine was acceptably well-tolerated in the present study, but [two] out of 17 patients discontinued the drug for drowsiness, a well-known adverse event with mirtazapine use,” the researchers wrote. “Hence, the present pilot study shows that mirtazapine has the potential to become the treatment of choice for [functional dyspepsia] patients with weight loss, and evaluation in larger multicenter studies is warranted.”
The researchers enrolled 34 patients in the study (29 women; mean age, 35.9 years). The patients did not present with depression or anxiety and had greater than 10% loss of original body weight. Following a run-in period, 17 patients were randomly assigned to receive placebo and 17 were randomly assigned to mirtazapine at 15 mg per day for 8 weeks.
Data on dyspepsia symptom severity, quality of life and gastrointestinal-specific anxiety were collected at baseline and at 4- and 8-week follow-up, and patients were given a nutrient challenge test and weighed at baseline and follow-up.
There were no serious adverse events. Two patients per group dropped out of the study; two in the mirtazapine group for symptoms of drowsiness and two in the placebo group due to lack of therapeutic effect.
Paul Moayyedi
Mirtazapine was found to significantly reduce mean dyspepsia symptom severity scores compared to baseline (P = .003 at 4 weeks vs. P = .017 at 8 weeks). Improvements at weeks 4 and 8 for early satiation, quality of life, gastrointestinal-specific anxiety, weight, and nutrient tolerance were significantly greater in the mirtazapine group compared with the placebo group.
“These data are important and interesting but do not support the routine use of mirtazapine in [functional dyspepsia]. The main reason for this is that sample size is simply not large enough to be confident of a treatment effect,” Paul Moayyedi, MB, ChB, and Rebecca Anglin, MD, from McMaster University Hamilton, Ontario, Canada, wrote in a related editorial. “It is possible that mirtazapine may be particularly effective in this subgroup of patients. New approaches to treating [functional dyspepsia] are always welcome, but more data are needed before mirtazapine is ready for prime time.” – by Suzanne Reist
Disclosures: The researchers report no relevant financial disclosures.