Acotiamide for Dyspepsia: Improvement and Symptom Relief

Feeling better after meals and having no symptoms left are different outcomes. Acotiamide’s phase III trial counted both.

What the trial counted

In Japan, 897 adults aged 20–64 were randomized; 892 took treatment and entered the analysis. They received acotiamide 100 mg or placebo three times daily before meals for four weeks. Their predominant symptoms were meal-related; people with recent heartburn or IBS were excluded.¹

At the last treatment assessment, 52.2% with acotiamide versus 34.8% with placebo reported being improved or extremely improved. All three symptoms disappeared in 15.3% versus 9.0%: post-meal fullness, upper abdominal bloating and becoming full too soon. These results do not establish a lasting cure. Zeria and Astellas funded the study; two authors were Zeria employees.¹

The differences were 17.4 percentage points (95% CI 11.0–23.7) for improvement and 6.3 (2.1–10.5) for symptom elimination.²

A useful appointment question is: “Are we judging whether I can finish a meal more comfortably, whether symptoms are less frequent, or whether they disappear?” Write the target down before treatment starts. A broad improvement rating cannot tell you which symptom changed.

Who the treatment is for

Japan’s current Acofide label covers those three symptoms in functional dyspepsia. It says efficacy for upper abdominal pain or burning has not been established and requires excluding structural disease, including stomach cancer. Japanese prescribing status does not establish access in another country.²

The Asian consensus published in 2026 says drugs such as acotiamide may help functional dyspepsia, particularly postprandial distress syndrome, with moderate-quality evidence. It also describes considerable overlap between symptom subtypes. A symptom label alone does not identify one proven underlying mechanism.³

Bring a description of where the discomfort occurs and whether the problem begins with the first few bites, after finishing, or hours later. Ask what diagnosis has been established and which locally available treatment fits that assessment.

Set a review date

The Japanese label advises considering discontinuation if symptoms have not improved after one month. With sustained improvement, it also advises considering stopping rather than continuing indefinitely. Listed adverse effects include diarrhea, constipation and liver-test changes; anticholinergic medicines can weaken its action. Review the full medicine list with the prescriber.²

For a follow-up, record your agreed symptom, meal timing, missed doses and unwanted effects. Ask what amount of improvement would justify continuing and what would trigger reassessment. Keep medication changes with the prescribing clinician.

Bloated by Dinner includes “Your First Thirty Days,” with a Belly Clock log for meals, symptoms and medicines, plus a visit plan for discussing the recorded pattern.