Introduction

Functional dyspepsia (FD) is a common gastrointestinal disorder with limited treatment options. Itopride, a compound that combines dopamine D2 receptor antagonism with inhibition of acetylcholinesterase, may offer benefits over other prokinetics.

Aims & Methods

This meta-analysis evaluates the therapeutic efficacy of Itopride compared to placebo and other prokinetic agents in managing FD symptoms.
A total of 19 randomized controlled trials were included in the analysis, comprising six placebo-controlled studies (n=1981, 976 on placebo and 1005 on Itopride) and 13 trials comparing Itopride to another prokinetic (n=1077, 515 on Itopride and 562 on control prokinetics including mosapride citrate, levosulpiride, metoclopramide, domperidone, and cisapride). Meta-analyses were conducted using a random-effects (DerSimonian and Laird) model. Outcome measures included overall responder rate and symptom assessment, comparing Itopride to 1) all prokinetics and 2) placebo. In addition, Itopride was compared to placebo and domperidone for symptom scores of epigastric pain and early satiation. Results are presented as Cohen’s d (95% CI) or odds ratios(OR) (95% CI).

Results

Analysis of responder rates from seven placebo-controlled and nine active comparator studies showed a statistically significant benefit of Itopride over placebo (OR=1.25, 1.07 to 1.45, p=0.01), with no significant difference when compared to other prokinetics (OR=1.11, 0.93 to 1.34).
When assessing overall symptom scores, three placebo-controlled and four prokinetic-controlled trials were analyzed. Itopride showed a moderate effect size compared to other prokinetics (Cohen’s d=0.51, 0.13 to 0.88, p=0.01) and a large but not statistically significant effect compared to placebo (Cohen’s d=1.14, -0.43 to 2.71).
Early satiation was assessed in six domperidone-controlled trials, yielding a significant odds ratio of 1.37 (1.02 to 2.67, p=0.04). A large but not statistically significant difference was found compared to placebo (two trials, Cohen’s d=1.10, -0.47 to 2.67). For epigastric pain, a moderate but not statistically significant difference was found with placebo (two trials, Cohen’s d=0.68, -0.01 to 1.38) or domperidone (four trials, OR=0.85, 0.63 to 1.16).

Conclusion

This meta-analysis suggests that Itopride provides significant symptom relief in patients with FD compared to placebo, particularly in overall responder rates. While Itopride’s benefits over other prokinetics were modest in general symptom relief, it demonstrated a statistically significant advantage over domperidone for early satiation.