Table 2.
Clinical trials using hymecromone (4-MU) in humans.
Reference | Patient type | Study type | n | Dose | Duration | Adverse events/notes |
---|---|---|---|---|---|---|
(153) | Patients requiring cholecystectomy, age >14 | Double-blind, randomized, placebo-controlled | 25 | 2400 mg/day × 7.5 days then 1200 mg × 7 days | 2 weeks | Decreased drain output and need for post-op analgesics, two pts with mild headaches in treatment group, three with decreased appetite and diarrhea in placebo group |
(149) | Post-cholecystectomy dyspepsia, age >60, mean 58.5 years | Double-blind, randomized, placebo-controlled | 15 | 600 mg BID | 3 weeks | N/A |
(152) | Biliary dyskinesia | Randomized controlled trial vs. tiropramide 300 mg | 20 | 1200 mg daily | 3 months | N/A |
(149) | Patients requiring cholecystectomy, age 29–84 | Placebo-controlled, randomized | 13 | 1600 mg/day | 3 weeks | N/A |
(155) | Healthy, age 21–35 | Pharmacokinetics | 8 | 400 mg IV, 800 mg IV, 600 mg PO solution, 1200 mg PO solution, 1200 mg tablets | Once | N/A |
(150) | Healthy, age 22–30 | Prospective, double-blind, randomized cross-over study | 20 | 400 mg IV | Once, after meal | N/A |
(148) | Healthy | Placebo-controlled, multicenter, randomized | 61 | 600 mg with lunch, 600 mg with dinner | 2 weeks | N/A |
(154) | Healthy, age 20–37 | 4-methylumbelliferone PO and IV | 20 | 800 mg × 1 (PO and IV) | Once, with meal | N/A |