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Randomised clinical trial: the effect of baclofen in patients with gastro-oesophageal reflux--a randomised prospective study.
Aliment Pharmacol Ther. 2012 May; 35(9):1036-44.AP

Abstract

BACKGROUND

Baclofen, a GABA(B) agonist, has been shown to reduce transient lower oesophageal sphincter relaxations (TLESRs), a major cause of gastro-oesophageal reflux disease (GERD).

AIM

To examine the effect and tolerability of baclofen in GERD patients over a 2-week period.

METHODS

Forty-three GERD patients with abnormal 24-h pH tests were prospectively randomised to receive baclofen or placebo in a double-blind fashion for 2 weeks. Oesophageal manometry, 24-h pH monitoring, and a standard questionnaire was administered, before and after treatment.

RESULTS

Thirty-four patients completed the study. In the baclofen group there were significant decreases in 24-h pH score (P = 0.020), percent of upright reflux episodes (P = 0.016), percent total time pH <4 (P = 0.003), number of reflux episodes (P = 0.018), number of reflux episodes longer than 5 min (P = 0.016), number of postprandial reflux episodes (P = 0.045), and percentage of time pH <4 (P = 0.003). No significant changes in reflux parameters were noted in the placebo group. Patients receiving baclofen had significantly less belching (P = 0.038), regurgitation (P = 0.036) and overall symptom score (P = 0.004) whereas placebo patients had less heartburn (P = 0.001), chest pain (P = 0.002), regurgitation (P = 0.017) and overall symptom score (P = 0.000). However, there were no significant differences in changes of reflux parameters or symptoms when comparing the two groups. Drowsiness did not limit baclofen use.

CONCLUSIONS

Baclofen was associated with a significant decrease in percent upright reflux by 24-h pH monitoring and a significant improvement in belching, regurgitation and overall symptom score. Baclofen may be more effective in patients with predominantly upright reflux and belching.

Authors+Show Affiliations

Walter Reed National Military Medical Center, Department of Gastroenterology, Bethesda, MD, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22428773

Citation

Cossentino, M J., et al. "Randomised Clinical Trial: the Effect of Baclofen in Patients With Gastro-oesophageal Reflux--a Randomised Prospective Study." Alimentary Pharmacology & Therapeutics, vol. 35, no. 9, 2012, pp. 1036-44.
Cossentino MJ, Mann K, Armbruster SP, et al. Randomised clinical trial: the effect of baclofen in patients with gastro-oesophageal reflux--a randomised prospective study. Aliment Pharmacol Ther. 2012;35(9):1036-44.
Cossentino, M. J., Mann, K., Armbruster, S. P., Lake, J. M., Maydonovitch, C., & Wong, R. K. (2012). Randomised clinical trial: the effect of baclofen in patients with gastro-oesophageal reflux--a randomised prospective study. Alimentary Pharmacology & Therapeutics, 35(9), 1036-44. https://doi.org/10.1111/j.1365-2036.2012.05068.x
Cossentino MJ, et al. Randomised Clinical Trial: the Effect of Baclofen in Patients With Gastro-oesophageal Reflux--a Randomised Prospective Study. Aliment Pharmacol Ther. 2012;35(9):1036-44. PubMed PMID: 22428773.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised clinical trial: the effect of baclofen in patients with gastro-oesophageal reflux--a randomised prospective study. AU - Cossentino,M J, AU - Mann,K, AU - Armbruster,S P, AU - Lake,J M, AU - Maydonovitch,C, AU - Wong,R K H, Y1 - 2012/03/20/ PY - 2011/11/21/received PY - 2011/12/12/revised PY - 2012/02/27/revised PY - 2012/02/28/accepted PY - 2012/3/21/entrez PY - 2012/3/21/pubmed PY - 2014/10/21/medline SP - 1036 EP - 44 JF - Alimentary pharmacology & therapeutics JO - Aliment Pharmacol Ther VL - 35 IS - 9 N2 - BACKGROUND: Baclofen, a GABA(B) agonist, has been shown to reduce transient lower oesophageal sphincter relaxations (TLESRs), a major cause of gastro-oesophageal reflux disease (GERD). AIM: To examine the effect and tolerability of baclofen in GERD patients over a 2-week period. METHODS: Forty-three GERD patients with abnormal 24-h pH tests were prospectively randomised to receive baclofen or placebo in a double-blind fashion for 2 weeks. Oesophageal manometry, 24-h pH monitoring, and a standard questionnaire was administered, before and after treatment. RESULTS: Thirty-four patients completed the study. In the baclofen group there were significant decreases in 24-h pH score (P = 0.020), percent of upright reflux episodes (P = 0.016), percent total time pH <4 (P = 0.003), number of reflux episodes (P = 0.018), number of reflux episodes longer than 5 min (P = 0.016), number of postprandial reflux episodes (P = 0.045), and percentage of time pH <4 (P = 0.003). No significant changes in reflux parameters were noted in the placebo group. Patients receiving baclofen had significantly less belching (P = 0.038), regurgitation (P = 0.036) and overall symptom score (P = 0.004) whereas placebo patients had less heartburn (P = 0.001), chest pain (P = 0.002), regurgitation (P = 0.017) and overall symptom score (P = 0.000). However, there were no significant differences in changes of reflux parameters or symptoms when comparing the two groups. Drowsiness did not limit baclofen use. CONCLUSIONS: Baclofen was associated with a significant decrease in percent upright reflux by 24-h pH monitoring and a significant improvement in belching, regurgitation and overall symptom score. Baclofen may be more effective in patients with predominantly upright reflux and belching. SN - 1365-2036 UR - https://www.unboundmedicine.com/medline/citation/22428773/Randomised_clinical_trial:_the_effect_of_baclofen_in_patients_with_gastro_oesophageal_reflux__a_randomised_prospective_study_ L2 - https://doi.org/10.1111/j.1365-2036.2012.05068.x DB - PRIME DP - Unbound Medicine ER -