Table 6.
Efficacy of antiemetics and central neuromodulators in gastroparesis
| Medication/trial design | N, Etiology | Dose | Duration | Efficacy | Reference |
|---|---|---|---|---|---|
| Aprepitant PC, PG, DB, RCT | 126 pts with at least moderate chronic nausea and vomiting | p.o. 125mg/day | 4-weeks | Aprepitant did not reduce symptoms of nausea (primary outcome measure) but significantly reduced secondary outcomes: in symptom severity for nausea, vomiting and overall symptoms. Adverse events (mild or moderate severity) commoner in aprepitant (35%) vs placebo (17%). | Pasricha 2018, ref. 103 |
| Tradipitant PC, PG, DB, RCT | 152 adults with IG (91) or DG (61) | p.o. 85 mg bid | 4 weeks | Significant decrease in nausea score (reduction of 1.2) at week 4; significant increase in nausea-free days at week 4 with even greater effects in patients with nausea and vomiting at baseline (n = 101). A >1-point improvement in GCSI score in 46.6% on tradipitant compared with 23.5% on placebo. |
Carlin 2021, ref. 104 |
| Nortriptyline PG, PC, DB RCT | 130 IG | dose escalation at 3-week intervals (10, 25, 50, 75 mg) to 75 mg at 12 weeks | 15 weeks | No difference in primary outcome measure (decrease from the patient’s baseline GCSI score of at least 50% on 2 consecutive 3-week GCSI assessments during 15 weeks of treatment); more treatment cessation in nortriptyline group (29%) than placebo group (9%); numbers of adverse events not different. | Parkman 2013, ref. 105 |
| Haloperidol PC, RCT | 33 Emergency Dept. patients with acute exacerbation of diagnosed gastroparesis | 5mg vs. placebo both + conventional therapy (selected by treating physician) | Single dose | One hour after therapy, the mean pain and nausea scores in the haloperidol group were 3.13 and 1.83 compared to 7.17 and 3.39 in the placebo group (symptoms on 10-point scale). No adverse events were reported. |
Roldan 2017, ref. 106 |
| STW5 or STW5-11 vs. cisapride DB, double dummy, RCT | 186 dysmotility type of FD | NA | NA | The lower limit of the confidence interval for both herbal preparations was above the pre-defined lower limit of the equivalence border and hypothesis of non-inferiority was proven for STW 5 & STW 5-II. | Rosch 2002, ref. 107 |
| STW 5 PC, PG, DB, RCT | 103 patients with FD and gastroparesis | 20 drops tid | 4 weeks | Improvement of the GIS (P=0.08) and the proportion of patients with a treatment response (P=0.03) were more pronounced in the STW 5 group compared to placebo. No effect on GEBT. | Braden 2009, ref. 108 |
| Survey questionnaire of treatment of nausea in in clinical practice | 102 patients: gastroparesis 43.1%, FD 27.5%, PSG 8.8%, other 2.0%, undetermined multiple 10.8%. | Patient-reported best treatments were marijuana, ondansetron, and promethazine. Least effective treatments were erythromycin, diphenhydramine, buspirone, gabapentin, pregabalin, acupuncture, and Iberogast. Promethazine was more effective in patients with a higher GCSI. | Zikos 2018, ref. 109 |
DB=double-blind; DG=diabetic gastroparesis; DM=diabetic; FD=functional dyspepsia; GCSI=Gastroparesis Cardinal Symptom Index; GE=gastric emptying; GEBT=gastric emptying breath test; GIS=gastrointestinal symptom; IG=idiopathic gastroparesis; NA=not available; PC=placebo-controlled; p.o.=oral; PG=parallel-group; PSG=post-surgical gastroparesis; RCT=randomized, controlled trial; XO=crossover