Randomised clinical trial: pregabalin attenuates the development of acid-induced
oesophageal hypersensitivity in healthy volunteers - a placebo-controlled study.
Author(s): Chua YC, Ng KS, Sharma A, Jafari J, Surguy S, Yazaki E, Knowles CH, Aziz Q.
Affiliation(s): Wingate Institute, Centre for Digestive Diseases, Barts and the London School of
Medicine and Dentistry, Queen Mary University of London, UK.
Publication date & source: 2012, Aliment Pharmacol Ther. , 35(3):319-26
BACKGROUND: Acid infusion in humans induces primary and secondary oesophageal
hypersensitivity. The effects of pregabalin, a centrally-acting modulator of
voltage-sensitive calcium channels, on development of acid-induced oesophageal
hypersensitivity remain unknown.
AIM: To study the effects of pregabalin on development of secondary oesophageal
hypersensitivity in healthy humans.
METHODS: Placebo-controlled, double-blind, randomised, cross-over study of 15
healthy volunteers (six women, age 21-56 years). After oesophageal manometry,
baseline pain thresholds (PTs) to proximal oesophageal electrical stimulation
were determined using bipolar ring electrodes. A 30-min infusion of HCl was
performed in the distal oesophagus followed by PT measurements at 30 and 90 min.
This protocol was repeated after administration of pregabalin (dosing schedule:
75 mg twice daily for 3 days then 150 mg twice daily for 1 day and then 150 mg on
the morning of study) or placebo.
RESULTS: T0 PTs were similar in patients after receiving placebo or pregabalin
[mean (s.d.) 32.9 mA (20.5) vs. 34.1 (15.7), P = 0.42]. Pregabalin reduced
development of acid-induced hypersensitivity in the proximal oesophagus at 30 min
[mean change in PT (C.I.) placebo -6.2 mA (-11.3 to +1.3) vs. pregabalin +0.20 mA
(-2.7 to +3.3)] and 90 min [placebo -3.7 mA (-10.0 to +2.0) vs. pregabalin +0.7
mA (-4.7 to 7.3)] overall P = 0.001. Pregabalin reduced median visual analogue
scale score for acid-induced pain (1/10 vs. placebo 3/10, P = 0.027).
CONCLUSIONS: Pregabalin attenuates development of secondary hypersensitivity in
the proximal oesophagus after distal oesophageal acidification; it may thus have
a role in treatment of patients with proven oesophageal pain hypersensitivity.