Effect of low dose amitriptyline on gastrointestinal function in healthy volunteers: a randomized, double blind, and placebo-controlled cross-over study / 中华消化杂志

ABSTRACT

Objective To explore the effects of low dose amitriptyline (AMT) on gastrointestinal function and its adverse effects in healthy volunteers.Methods In this randomized,double-blind,placebo-controlled cross-over study,28 healthy volunteers were divided into AMT with placebo group (n=14) and placebo with AMT group (n=14).The former took AMT for seven days at first stage,followed with a 14 days wash out stage and then took placebo for seven days at second stage.Patients of the latter group took medication in reverse order.The dose of medication was 12.5 mg three times per day.The subjects underwent drinking-ultrasonography test and lactulose hydrogen breath test before taking medication and between the seventh and eighth day of first and second stage.The data were analyzed by two stages cross-over analysis,Wilcoxon signed-rank test and chi-square test.Results The results of drinking-ultrasonography test showed that there were no significant differences in proximal gastric cross-sectional area between AMT and placebo after drinking 200,400,600 and 800 mL water (all P＞ 0.05).After drinking 800 mL water,there were no significant differences in gastric liquid emptying rate between AMT and placebo at the fifth and the tenth minutes (both P＞0.05).After drinking 600 mL and 800 mL water,the visual analogue scale (VAS) of AMT was significantly lower than that of placebo (2.98±0.85 vs 3.57±0.94,Z=4.412,P＜0.01; 4.57±0.98 vs 5.57±0.82,Z=4.170,P＜0.01).The results of lactulose hydrogen breath test revealed that orocecal transit time of AMT was obviously longer than that of placebo ((109.29±29.68) min vs (96.61±23.90) min,F=9.918,P＜0.01)).The common adverse effects were mild sleepiness,bitter taste and dry mouth.Conclusions Low dose AMT can prolong orocecal transit time and improve gastric sensitivity,but can not significantly affect proximal gastric accommodation and gastric liquid emptying.The adverse effects are mild and the safety is good.