Adjunctive Incremental Pregabalin Therapy Leads to Better Pain Relief in Patients With Chronic Pancreatitis: A Double-blind Randomized Controlled Trial.

Abstract

Objectives: Gabapentinoids like pregabalin have been inadequately explored in patients with painful chronic pancreatitis (CP) on a long-term basis. The objective was to study the pain relief on pregabalin as an adjunct therapy for 12 weeks in painful CP.

Materials and methods: In this double blind, randomized placebo-controlled trial, patients with painful CP with no ongoing inflammation(no pseudocyst/inflammatory head mass) or significant obstruction were randomized to receive either incremental doses of pregabalin or placebo for 12 weeks. The primary outcome was change in Izbicki pain score. Change in the quality of life (QoL) (SF-36 questionnaire), interference of pain with daily life [modified brief pain inventory- short form (mBPI-SF)] and patients' global impression of change (PGIC) were assessed as secondary outcomes. Tolerability and adverse effects were noted as safety outcomes. As an exploratory outcome, the role of quantitative sensory testing (QST) to predict patients' response to pregabalin was assessed.

Results: Fifty-five patients with painful CP (age 29.9±10.6 y; 79% males; median illness duration 36 mo) were randomized to receive pregabalin (n=30) or placebo (n=25). Change in Izbicki pain score was significantly better in pregabalin group [pregabalin: -23.75 (IQR: -9.69 to -43.75) versus placebo: -8.75 (3.44 to -17.50); P=0.005]. Overall QoL and PGIC were also better and interference of pain with daily activities reduced in the pregabalin group [median change BPI severity pregabalin: -1.83 (-0.83 to -3.75) versus placebo: -0.67 (0.33 to -1.42); P=0.008; BPI interference pregabalin: -2.64 (-0.33 to -5.21) versus placebo: -0.43 (1.18 to -2.29); P=0.009]. Frequent adverse events included sleepiness (51.7%) and giddiness (58%) but drug discontinuation occurred in only 10.4% of patients. No QST parameters could predict pain response to pregabalin.

Conclusions: Pregabalin is a useful adjunct to pain management in patients with CP.