Table 4.
Summary of clinical trials with domperidone
| Type of Study | N, etiology | Dose | Duration | Symptom improvement vs. baseline (OPEN) or vs. placebo (RCT) | Δ Gastric emptying | Adverse effects | Reference |
|---|---|---|---|---|---|---|---|
| Open, po | 3 DM | 10mg qid | 1 wk | Yes, not quantified | Improved, not quantified | NA | Watts 1985, ref. 74 |
| Open, po | 12 IG, 3 DM, 2 PS | 20mg qid | 48 mo | 68.3% (P < 0.05) | 34.5% (P <.05) | ↑ prolactin (100%), symptoms (17.6%) | Soykan 1997, ref. 75 |
| Retrospective, p° | 57 DM | Max. dose 80mg/day | 377 days | 70% patients improved | NA | 16% | Kozarek 1990, ref. 76 |
| Open, | 6 DM | 20mg qid | 6 mo | 79.2% (P < 0.01) | 26.9% (NS) | NA | Koch 1989, ref. 77 |
| Open | 12 DM | 20mg tid | Single oral dose 40mg | chronic oral administration 20mg tid (35–51 days) reduced symptoms | ↑ solid and liquid emptying | NA | Horowitz 1985, ref. 78 |
| RCT, PG, PC, withdrawal study | 208 DM | 20mg qid | 4 wk | 53.8% lower overall score with domperidone (P = 0.025) | NA | 2–3% ↑ prolactin, similar to placebo | Silvers 1998 ref. 79 |
| RCT, PC, XO + open label 1yr | 13 DM | NA | 8 wk | ↓ in symptom frequency and intensity (P < 0.03); symptomatic improvement averaging >1y | NA | NA | Braun 1989, ref. 80 |
| RCT, PC, XO | 6 DM | 10mg i.v. | Single | NA | ↑ homogenized solid emptying | NA | Heer 1983, ref. 81 |
| RCT, PC, XO cisapride (C) or DOM (D) | 8 IG; 3 DM | 0.8mg/kg (C) tid or 0.9mg/kg (D) tid | 4 wk | No overall benefit over placebo; 2 of 3 DM improved | NA | Gas pains, skin rash | Franzese 2002, ref. 82 |
| RCT, PC, XO | 11 upper GI distress: 3 DM + severe gastric retention | 10mg qid | 4 wk each Rx | 2/3 diabetics improved with DOM Rx; among total 11 patients, no superiority of DOM over placebo | NA | Abdominal gas pains, skin rash, itching, sweating, dizziness, constipation | Nagler 1981, ref. 83 |
| RCT, PG, DOM vs. metoclopramide | 93 DM | DOM 20mg qid; metoclopramide 10 mg qid | 4 wk | 41.19% improved vs. baseline (NA); NS vs. metoclopramide | NA | Somnolence 49% metoclopramide, 29% DOM | Patterson 1999, ref. 84 |
| RCT, PG, PC in second phase among initial responders over 4weeks | 208 DM responders to initial single-blind treatment with same dose | 20mg domperidone qid | 4 wk | Symptom severity increased in both groups, worse with placebo. For HRQOL (SF-36), improvement in physical component score, borderline in physical functioning, but no difference in 7/8 other HRQOL subscales | NA | Not reported in study | Farup 1998, ref. 85 |
| Cohorts in NIH gastroparesis consortium (63% IG) | 181 in DOM group, 567 in non-DOM group | Not standardized | Up to 96 weeks | DOM patients: moderate but significantly more improvement in gastroparesis outcomes: GCSI, nausea, fullness, upper abdominal pain, GERD scores, and PAGI-QOL | NA | No significant cardiovascular or other DOM-related complications | Sarosiek 2021, ref. 86 |
(Reproduced from ref. 1, Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L. Clinical Guideline: Management of Gastroparesis. Am J Gastroenterol 2013;108:18–37) DM=diabetic; DOM=domperidone; GCSI=Gastroparesis Cardinal Symptom Index; GERD=gastroesophageal reflux disease; GI=gastrointestinal; HR-QOL=health-related quality of life; IG=idiopathic gastroparesis; NA=not available; NS=not significant; PC=placebo-controlled; po=oral; PAGI-QOL=Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life; PG=parallel-group; PS=post-surgical gastroparesis; RCT=randomized, controlled trial; Rx=treatment; XO=crossover