A team from Pescara, Italy, assessed the effects of 1-month treatment with baclofen, a gamma-aminobutyric acid (GABAB) agonist, in patients with gastroesophageal reflux disease (GERD).
They presented their findings at Digestive Diseases Week 2002, held this week in San Francisco, California, USA.
Previous studies have shown that short-term administration of baclofen, for 24 hours, reduces reflux episodes in GERD patients and in controls.
The researchers assessed its effect on 24-hour pH-metry and symptoms before and after the treatment.
A total of 14 GERD patients were included in the study.
At entry all patients underwent a 24-hour esophageal pH-metry.
In addition, they completed a questionnaire on various symptoms, including bitter taste, belching, fasting epigastric pain, post-prandial epigastric pain, nocturnal epigastric pain, heartburn, regurgitation, and dysphagia.
The intensity and frequency of each symptom were scored from 0 to 4.
|Mean number of reflux episodes:|
Before baclofen: 257
After treatment: 54
Patients were randomly assigned to receive baclofen (10 mg orally, four times daily [n = 10]) or placebo (n = 4).
The authors then re-evaluated 24-hour pH-metry and total symptoms score at the end of treatment.
In each recording, the pH was analyzed for total number of acid reflux and percentage of time with pH < 4 in the esophagus.
Two patients in the baclofen group dropped out during treatment due to nocturna dyspnea and slight hypotension.
The mean number of reflux episodes was significantly lower after treatment with baclofen (257 before baclofen, 54 after baclofen).
Furthermore, the percentage of time with pH < 4, was also significantly lower after treatment with baclofen (6% before baclofen, 3% after baclofen).
There was no difference in reflux episodes and in percentage of time with pH < 4 after treatment in the 4 patients treated with placebo.
The researchers found that the intensity and frequency of symptoms were both significantly improved after treatment with baclofen (mean total symptoms score: intensity 1.7 before baclofen, 0.4 after; frequency 2.2 before baclofen, 0.4 after).
However, there was no difference in intensity and frequency of the symptom score after treatment with placebo.
Dr Antonio Francesco Ciccaglione said on behalf of his colleagues, "Baclofen, given for 1 month, reduces esophageal acid reflux and significantly improves symptoms in patients with GERD.
"These results suggest that baclofen may be a useful therapy in GERD", he concluded.