Efficacy and safety of pancreatic enzyme replacement therapy on exocrine pancreatic insufficiency: a meta-analysis.

ABSTRACT

BACKGROUND: Pancreatic enzyme replacement therapy (PERT) is widely applied to patients with exocrine pancreatic insufficiency (EPI), but its effect and safety has not been quantified. Therefore we performed a meta-analysis to determine the efficacy and tolerance of PERT on patients with EPI. MATERIALS AND METHODS: PubMed, Medline, Cochrane library database, Evidence-based medicine/clinical trials published before December 2016 were searched by two independent reviewers to identify prospective randomized controlled trials (RCTs). RESULTS: Seven RCTs, randomizing a total of 282 patients, were filtrated and assessed qualitatively (Jadad score). PERT increased CFA (WMD 26.56, 20.35 to 32.76, I2= 79.6%, P < 0.001) compared with baseline, and CFA (WMD 17.97, 12.61 to 23.34, I2 = 76.7%, P < 0.001) vs. placebo. Meanwhile, CNA, SFE, SNE and SW were significantly improved in PERT compared with baseline and placebo, with no statistical differences in adverse events. Subgroup analysis indicated that standard forms of PERT displayed more effectiveness with significantly decreased heterogeneity, and large sample size also reduced the heterogeneity to some degree. CONCLUSIONS: PERT is demonstrated to be effective and tolerable in patients with EPI, especially using standard administration of PERT. Larger and higher quality studies on EPI are demanded to long-term effect of standard PERT treatment.