Table 3. Clinical trials on treatment of pancreatic exocrine insufficiency.
| Study | Run-in phase | No of PERT | No of placebo | Fat intake/day(g) | Intervention | Time of stool fat collection | Mean change of CFA (pert vs. placebo) | Adverse events | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Type | Dosage(oral) | Time (days) |
||||||||
| Halgreen, 1986 | 14 days | 11 | 11 | 100 | Pancreaze® EC, MS (L: 4000 NFU A: 20,000 NFU, P: 25,000 NFU) | Meal:2 capsules, tid. snack:1 bid. | 14 | 2-day equilibration followed by 3-day collection | NR | NR |
| Paris, 1993 |
7–9 days | 32 | 28 | ≥ 100 | Panzytrat® 25 000 EC, MT (L: 25000, A: 22500, P: 1250) Ph. Eur | meal:2capsules tid. | 7 | 4-day equilibration followed by 3-day collection | 23.7 vs. 19.7 | PERT:12.5% Placebo:10.7% |
| O’Keefe, 2001 |
7-day placebo followed by 7-day PERT |
15 | 14 | 100 | Pancreatic enzyme supplement, EC, MMS (L: 10,000 USP U A: 33,200 USP U, P: 37,500 USP U) | Meal: 4 capsules tid. snack:2 bid. | 14 | 4-day equilibration followed by 3-day collection in placebo period, 11-day equilibration followed by 3-day collection in PERT period | 26.8 vs. 0, P = 0.002 | NR |
| Safdi, 2006 |
14- day placebo | 13 | 14 | ≥ 100 | Creon 10 EC, delayed-release MMS (L: 10000 USP U, P: 37500 USP U, A: 33200 USP U) | Meal:4 capsules tid. snack:2 capsules bid. | 14 | 11-day equilibration followed by 3-day collection | 36.7 vs. 12.1, P = 0.0185 | PERT:35.7%, Placebo:23.1% |
| Whitcomb, 2010 | 5-day placebo | 25 | 29 | ≥ 100 | Creon (pancrelipase)12,000 MMS USP U | Meal:6 capsules tid. snack:3 capsules bid. | 7 | 2-day equilibration followed by 3-day collection in run-in phase | 32.1 vs. 8.8, P < 0.0001 | PERT:20.0%, Placebo:20.7% |
| Thorat, 2012 |
7-day followed by 7-day PERT |
34 | 28 | ≥ 100 | Creon 40000 MMS Ph. Eur |
Meal: 2 capsules tid. snack: 1 bid. | 7 | 4-day equilibration followed by 3-day collection | 18.5 vs. 4.1, P = 0.001 | PERT:35.3%, Placebo: 25.0% |
| Seiler, 2013 |
7-day followed by 7-day PERT |
32 | 26 | Reported, not given |
Creon 25000 MMS Ph. Eur |
Meal: 3 capsules tid. Snack:2 bid. |
7 | 4-day equilibration followed by 3-day collection |
21.4 vs. -4.2, P < 0.001 | PERT:37.5% Placebo:26.9% |
PERT: pancreatic enzyme replacement therapy. EC: enteric-coated MS: microspheres. MT: microtablet. L: lipase. A: amylase. P: protease. MMS: minimicrospheres. FA: fat absorption. SFE: Stool fat excretion. CFA: coefficient of fat absorption. NR: not reported. NFU: national formulary units. IU: international unit. USP U: United States Pharmacopeia units. Ph. Eur: European pharmacopoeia.
(1 USP = 1 Ph. Eur. = 1 NFU)