Table 1. Basic characteristics of included studies.
| Author, Year | Country | Duration | Study design | Inclusion criteria | Etiology | No of post-ps |
Age | Patients randomized (male/female) |
|---|---|---|---|---|---|---|---|---|
| Halgreen, 1986 | Denmark | NR | Single, randomized, double-blind, placebo-controlled, cross-over | Adults, CP, reduced EPF, with a meal-stimulated duodenal lipase concentration of less than 50 kU/L and a SFE > 7 g/day. | A4; I3 O3; H1 |
NR | 29-59 (51) | 11(6/5) |
| Paris, 1993 | France | June 1986 to June 1987 | Single, randomized, double-blind, placebo-controlled, parallel | Radiologically or perioperatively confirmed CAP, Previous steatorrhea ≥ 10 g/24 h). |
A 60 | R, not clearly | 47 | 41(35/6) |
| O’Keefe, 2001 | South Africa | NR | Single, randomized, placebo-controlled, parallel | ≥ 18 y, evidence of CP (CT, US, ERCP et al) and EPI(SFE > 10 g/day in run-in phase) | A 27; I 2 | 9 | 49.1 ± 1.8 years vs. 57.8 ± 2.1 | 29(28/1) |
| Safdi, 2006 | USA | NR | Multicenter, randomized, double-blind, placebo-controlled parallel | ≥ 18 y, documented CP, EPI(CFA < 80% and/or SFE > 10 g/day in run-in phase) | NR | NR | Placebo 51 PERT 51.9 |
27(9/18) |
| Whitcomb, 2010 | USA& Europe | April 2007 to August 2008 | Multicenter, randomized, double-blind, placebo-controlled parallel | ≥ 18y, EPI (stool elastase < 100 μ g / g, or SFE > 15 g/day in run-in phase), CP(radiographically or histologically proven) total or partial pancreatectomy > 180 days | NR | 14 | PERT 52 Placebo 50.6 |
54(39/15) |
| Thorat, 2012 | India | June 2008 to May 2010 | Multicenter, randomized, double-blind, placebo-controlled parallel | ≥ 18y, EPI(CFA < 80% during the run-in phase), CP(radiographically or histologically proven) | NR | 18 | PERT 42.6 Placebo 43.2 | 62(47/15) |
| Seiler, 2013 | Europe | NR | Multicenter, Randomized, double-blind, placebo-controlled parallel | ≥ 18y, severe EPI(baseline CFA < 80%)due to partial or total PR ≥ 6 months prior to study start, stable condition after surgery(Karnofsky index ≥ 70) | Pancreatic surgery | 58 | PERT 57.6 Placebo 59.3 | 58 |
CP: chronic pancreatitis. CAP: chronic alcoholic pancreatitis PS: pancreatic surgery. A: alcoholic. I: idiopathic. O: obstructive. H: hyperlipidemic. EPI: exocrine pancreatic insufficiency. EPF: exocrine pancreatic function. R: reported. NR: not reported. CFA: coefficient of fat absorption. SFE: stool fat excretion. PERT: pancreatic enzyme replacement therapy.