The Effect of Ramelteon on Heartburn Symptoms of Patients With Gastroesophageal Reflux Disease and Chronic Insomnia: A Pilot Study.

BACKGROUND: There is a bidirectional relationship between gastroesophageal reflux disease (GERD) and sleep. It has been demonstrated that antireflux treatment can improve sleep quality in GERD patients with nighttime reflux. MATERIALS AND METHODS: Patients with heartburn and/or regurgitation ≥3 times/week and insomnia for ≥3 months were included. Patients were assessed at baseline with the demographic, GERD symptom assessment scale, Epworth sleepiness scale, Berlin sleep apnea, Pittsburgh sleep quality index, and the Insomnia severity index questionnaires. Subjects underwent an upper endoscopy followed by pH testing. Subsequently, subjects were randomized, in a double-blind, placebo-controlled trial, to receive either ramelteon 8 mg or placebo before bedtime for 4 weeks. During the last week of treatment, subjects completed a daily GERD symptom and sleep diary and underwent actigraphy. RESULTS: Sixteen patients completed the study, 8 in each arm (mean age and M/F were 48.5 vs. 57.8 y, and 8/0 vs. 6/2, respectively). Patients who received ramelteon demonstrated a statistically significant decrease in symptom score as compared with those who received placebo for daytime heartburn (-42% vs. -29%), nighttime heartburn (-42% vs. 78%), 24-hour heartburn (-42% vs. -3%), and 24-hour acid regurgitation (-26% vs. 19%) (all P<0.05). Insomnia severity index score was significantly reduced in patients receiving ramelteon as compared with placebo (-46% vs. -5%, P<0.05). Ramelteon group also demonstrated a significant improvement in sleep efficiency and sleep latency, as compared with placebo, P<0.05). No significant adverse events were observed with ramelteon. CONCLUSIONS: Ramelteon significantly improved symptoms in patients with GERD. In addition, ramelteon significantly improved patients' sleep experience. Further studies are needed in the future (NCT01128582).

Naps are associated more commonly with gastroesophageal reflux, compared with nocturnal sleep.

BACKGROUND & AIMS: Acid reflux during nighttime sleep has been associated with more severe gastroesophageal reflux disease (GERD). Napping is common, especially after lunch time, in many cultures. We aimed to compare reflux characteristics between nighttime sleep and naps in patients with GERD. METHODS: We performed a study of 15 patients (mean age, 58.5 ± 18.4 y; 10 men) with heartburn and/or regurgitation at least 3 times/week for the past 3 months, who experienced a nap in addition to regular nighttime sleep. All were evaluated using the demographics and GERD Symptoms Checklist questionnaires. Patients underwent pH testing concomitantly with actigraphy when they were not receiving antireflux treatment; only patients with abnormal results from pH tests were included in the study. Raw data from actigraphy analyses were superimposed over those collected from pH monitoring, matched by time. Integrative software was used to determine recumbent-awake, recumbent-asleep, and naps alongside pH monitoring data. RESULTS: The mean duration of nocturnal sleep time and nap time were 446.0 ± 100.7 minutes and 61.9 ± 51.8 minutes, respectively. The mean number of reflux events per hour was significantly greater during nap than nocturnal sleep time (40.1 ± 69.9/h vs 3.5 ± 4.2/h; P < .05). The mean duration of reflux events was longer during nap than nocturnal sleep time (1.9 ± 2.8 min vs 1.5 ± 2.7 min). The percentage of time spent at a pH less than 4 was significantly greater during naptime than nocturnal sleep time (36.2% ± 38.8% vs 8.9% ± 11.6%; P < .05). Arousals from naps were rare, compared with nocturnal sleep (mean, 0.7 ± 1.1 vs 4.2 ± 2.9; P < .05). Patients also experienced more acid reflux associated with symptoms during nap than nocturnal sleep (mean, 8.08% vs 0.45%; P < .05). CONCLUSIONS: We associated naps with significantly greater numbers of, and duration of, esophageal acid exposure and symptoms, compared with nocturnal sleep. Naps therefore might have important effects on disease severity.

The relationship between type 2 diabetes mellitus and failure to proton pump inhibitor treatment in gastroesophageal reflux disease.

BACKGROUND: There is limited information regarding the contribution of diabetes mellitus (DM) to proton pump inhibitor (PPI) failure in gastroesophageal reflux disease (GERD) patients. AIM: To determine whether type 2 DM is a risk factor for PPI failure and the potential predictive factors for PPI failure among type 2 DM patients with GERD. DESIGN: A case-control study was performed using hospital medical records of GERD patients treated with a PPI. The prevalence of type 2 DM and other risk factors (established >1 y before study enrollment) was determined in the PPI failure (treatment with more than once daily PPI) as compared with PPI responders. RESULTS: A total of 732 GERD patients receiving PPI therapy, including 285 who failed PPI treatment, were included. The overall prevalence of PPI failure was significantly higher in diabetic versus nondiabetic patients. The relationship between PPI failure and type 2 DM depended on body mass index. Only in obese patients the odds ratio of PPI failure was significantly higher in type 2 DM as compared with non-DM patients. In the subgroup of GERD patients with type 2 DM (n=349), PPI failure was significantly associated with female sex, the presence of general comorbidities, and adequate DM control. Duration of DM, type of antidiabetic medication prescribed, and DM-associated complications were not associated with PPI failure. CONCLUSIONS: PPI failure was significantly associated with type 2 DM in obese patients. Among GERD patients with type 2 DM, failure of PPI treatment was significantly associated with female sex and the presence of general comorbidities.