Nocturnal gastro-oesophageal reflux
Evidence basis: randomised trials
One small randomised crossover trial found significantly more supine acid reflux after a late meal, but an earlier controlled trial found no difference and a formal review found no efficacy evidence.
Population: Adults with symptomatic gastro-oesophageal reflux disease. The positive crossover trial enrolled 32 and analysed 30 patients (63% male, mean age 46 years, mean BMI 28 kg/m2, esophagitis in 37% and hiatal hernia in 47%). The null trial studied 20 symptomatic reflux patients, with a second experiment in 17 patients of whom 12 were analysed. The evidence-based review covered the published literature from 1975 to 2004.
Research details
Summary
The randomised evidence points both ways and rests on small samples. In a prospective randomised unblinded crossover trial, 32 patients with typical reflux symptoms were randomised to eat a standard meal either 6 h or 2 h before going to bed for two consecutive nights, with acid exposure measured over 48 h by a Bravo wireless pH system; 30 patients completed, and following the late evening meal there was significantly more supine reflux (P = 0.002) than after the early meal, with significantly more supine reflux after the late meal in patients with hiatal hernia and in overweight individuals. An earlier controlled trial in 20 symptomatic reflux patients compared a non-provocative meal before 19:00 with a late evening meal at 21:00 and found no significant differences in the number or duration of reflux events, acid exposure (total %), or polysomnographic measures of per cent of sleep stages between the two nights. In the same paper, ranitidine significantly decreased acid contact time and the mean duration of reflux events after a late provocative meal, with improved subjective discomfort and sleep disturbance, but again no significant polysomnographic differences. An evidence-based review that screened 2,039 studies, identified 100 relevant ones and found only 16 clinical trials of lifestyle measures concluded that head-of-bed elevation and weight loss are the effective lifestyle interventions for reflux disease and that there is no evidence supporting an improvement in reflux measures after dietary interventions. No retrieved trial reports a clinical endpoint such as esophagitis healing, medication use or symptom scores over time.
Why this certainty
Rated Limited because the direction is genuinely inconsistent between two small randomised or controlled crossover trials and a formal evidence-based review, so no pooled direction can be asserted. It is not rated Very limited because at least one randomised crossover trial with objective pH monitoring did find a significant difference in the expected direction. It cannot reach Moderate because all studies are small, unblinded, and use surrogate acid-exposure endpoints rather than clinical outcomes, and no synthesis of randomised reflux-timing trials was retrieved.
Limitations
The supporting trial was unblinded and small, and the outcome was oesophageal acid exposure - a physiological surrogate rather than a clinical endpoint such as symptoms or mucosal healing. The contradicting trial was also small, used a non-provocative rather than standardised provocative meal in its first experiment, and analysed only 12 of 17 patients in its second. Effect sizes were not reported for the main comparison in either trial, only P values, and the retrieved abstracts truncate the subgroup numbers. The evidence-based review concluded that no published evidence of efficacy existed for dietary measures in reflux disease, meaning the intervention most people are actually advised to try has never been properly tested against a control with clinical outcomes.
Effect estimate
Supine oesophageal acid exposure after a meal 2 h versus 6 h before bed in reflux patients: significantly more supine reflux after the late meal (P = 0.002, n = 30 completing a randomised crossover trial) (Piesman 2007). No significant difference in reflux events, acid exposure or sleep-stage percentages after a 21:00 versus pre-19:00 meal (n = 20) (Orr 1998).
- Nocturnal reflux episodes following the administration of a standardized meal. Does timing matter?
- Sleep-related gastro-oesophageal reflux: provocation with a late evening meal and treatment with acid suppression.
- Are lifestyle measures effective in patients with gastroesophageal reflux disease? An evidence-based approach.

