A randomized open-label trial of on-demand rabeprazole vs ranitidine for patients with non-erosive reflux disease.

AIM: To compare the efficacy of the proton-pump inhibitor, rabeprazole, with that of the H2-receptor antagonist, ranitidine, as on-demand therapy for relieving symptoms associated with non-erosive reflux disease (NERD). METHODS: This is a single center, prospective, randomized, open-label trial of on-demand therapy with rabeprazole (group A) vs ranitidine (group B) for 4 wk. Eighty-three patients who presented to the American University of Beirut Medical Center with persistent gastroesophageal reflux disease (GERD) symptoms and a normal upper gastrointestinal endoscopy were eligible for the study. Patients in group A (n = 44) were allowed a maximum rabeprazole dose of 20 mg twice daily, while those in group B (n = 39) were allowed a maximum ranitidine dose of 300 mg twice daily. Efficacy was assessed by patient evaluation of global symptom relief, scores of the SF-36 quality of life (QoL) questionnaires, total number of pills used, and number of medication-free days. RESULTS: Among the 83 patients who were enrolled in the study, 76 patients (40 in the rabeprazole group and 36 in the ranitidine group) completed the 4-wk trial. Baseline characteristics were comparable between both groups. After 4 wk, there was no significant difference in the subjective global symptom relief between the rabeprazole and the ranitidine groups (71.4% vs 65.4%, respectively; P = 0.9). There were no statistically significant differences between mean cumulative scores of the SF-36 QoL questionnaire for the two study groups (rabeprazole 22.40 ± 27.53 vs ranitidine 17.28 ± 37.06; P = 0.582). There was no significant difference in the mean number of pills used (rabeprazole 35.70 ± 29.75 vs ranitidine 32.86 ± 26.98; P = 0.66). There was also no statistically significant difference in the mean number of medication-free days between both groups. CONCLUSION: Rabeprazole has a comparable efficacy compared to ranitidine when given on-demand for the treatment of NERD. Both medications were associated with improved quality of life.

Persistent snoring under conscious sedation during colonoscopy is a predictor of obstructive sleep apnea.

BACKGROUND: Obstructive sleep apnea (OSA) is characterized by cessation of breathing during sleep. Conscious sedation (CS) induces sleep and may uncover sleep-related breathing disorders. OBJECTIVE: To determine whether snoring during CS is a sensitive predictor of OSA. DESIGN: Matched cohort study. SETTING: University-based ambulatory endoscopy center. PATIENTS: Consecutive patients undergoing colonoscopy completed a detailed sleep questionnaire and physical examination geared toward detecting OSA (body mass index [BMI], neck circumference, and the presence of craniofacial abnormalities). The endoscopist was blinded to the information. INTERVENTIONS: Portable nocturnal polysomnography. MAIN OUTCOME MEASUREMENTS: Patients who snored during CS in the left lateral decubitus position for 10 seconds or longer were referred for polysomnography. Sex- and BMI-matched patients who did not snore served as control subjects. RESULTS: A total of 131 patients were enrolled, and 24 (18.3%) of them snored. These patients (22 men, 2 women) had a predominance of Mallampati grade III/IV, higher Stanford and Epworth scale scores, and greater BMI and neck circumference and were more likely to report daytime sleepiness, decreased vigilance, and personality and mood changes (all P values <.05). All investigated patients who snored during CS had evidence of OSA versus 4 of 18 control subjects (mean apnea-hypopnea index: 40 events vs 5 events; P < .0001) (100% positive predictive value; 77.8% negative predictive value). Moderate or severe OSA was detected in 14 of 20 patients versus 1 of 18 control subjects (P < .001; 70% positive predictive value; 94.4% negative predictive value, 93% sensitivity, 74% specificity). Data obtained from sleep questionnaires and physical examination failed to accurately predict OSA. LIMITATIONS: Single-center nature and relatively small number of patients developing the outcome variable. CONCLUSIONS: Snoring during CS is a strong predictor of OSA. Given the medical and financial burden of undiagnosed OSA, these patients should be carefully identified and referred for sleep medication evaluation.

A randomized controlled trial of imipramine in patients with irritable bowel syndrome.

AIM: To study the efficacy of low-dose imipramine in relieving symptoms associated with the irritable bowel syndrome (IBS). METHODS: A randomized, double-blind trial of 25 mg imipramine vs matched placebo for 12 wk was performed. Doubling the dose was allowed once at week 2 in case of an unsatisfactory early response. Primary efficacy variables were subjective global symptom relief and quality of life (QoL) using SF-36 at week 12. RESULTS: One hundred and seven patients were enrolled by advertisement or referral by general practitioners and 56 (31 imipramine: 25 placebo) completed the 16-wk study. Baseline characteristics were comparable. A high overall dropout rate was noted in the imipramine and placebo arms (47.5% vs 47.9%, P > 0.05), a mean of 25.0 and 37.4 d from enrollment, respectively (P < 0.05). At the end of 12 wk, there was a significant difference in global symptom relief with imipramine over placebo (per-protocol: 80.6% vs 48.0%, P = 0.01) and a trend on intent-to-treat (ITT) analysis (42.4% vs 25.0%, P = 0.06). This improvement was evident early and persisted to week 16 (P = 0.024 and 0.053 by per-protocol and ITT analyses, respectively). Mean cumulative and component-specific SF-36 scores improved in the imipramine group only (per-protocol, P < 0.01). Drug-related adverse events leading to patient dropout were more common in the imipramine group (25.4% vs 12.5%, P > 0.05). CONCLUSION: Imipramine may be effective in the treatment of IBS patients and is associated with improved QoL. Careful patient selection, initiation of a low dose with gradual escalation and monitoring for side effects may result in an improved therapeutic response.

Gross lower gastrointestinal bleeding in patients on anticoagulant and/or antiplatelet therapy: endoscopic findings, management, and clinical outcomes.

OBJECTIVES: Gross gastrointestinal (GI) bleeding is a serious complication of anticoagulant/antiplatelet drug therapy. This study compares the frequencies of colorectal pathologies, endoscopic and resuscitative management measures, and clinical outcomes of patients hospitalized with lower GI bleeding (LGIB) while using anticoagulants/antiplatelets with those of patients not using them. METHODS: A retrospective review of the records of 166 admissions for patients with gross LGIB over 12 years was conducted. The colonoscopic findings, management measures, and clinical outcomes were compared between 2 groups. Group A composed of 100 patients using any antiplatelet/anticoagulant, and group B 66 patients not using any such drugs. Independent t tests and chi were used to test for association between taking antiplatelet/anticoagulant and other variables. RESULTS: Patients in group A were older and had more comorbidities than patients in group B. Severe LGIB occurred in 55.1% and 35.4% in groups A and B, respectively (P=0.01). Severity was not related to old age or the presence of comorbidities. A higher percentage of patients in group A had a hospital stay > or =6 days (44% vs. 27.3%; P<0.03), required blood transfusions (68% vs. 51.5%; P=0.03), and had in-hospital complications (37% vs. 22.7%; P=0.052). The most common source of bleeding was diverticulosis in both groups. Colorectal abnormalities were present in most patients; and in those using warfarin, colon cancer was common. CONCLUSIONS: Use of antiplatelets/anticoagulant drugs is an independent predictor of severe LGIB and is associated with adverse outcomes. Colonoscopy is required in patients who bleed while using such drugs.

Lidocaine lollipop as single-agent anesthesia in upper GI endoscopy.

BACKGROUND: Conscious sedation is usually achieved during EGD by a combination of intravenous benzodiazepines and opiates; however, these have potential serious adverse effects. The addition of topical oropharyngeal anesthetics such as lidocaine may be useful. Recent data suggest that the administration of topical lidocaine by means of a lollipop is effective for endotracheal intubation and bronchoscopy. OBJECTIVE: Our purpose was to evaluate the safety and efficacy of a lidocaine lollipop as single-agent anesthesia for EGD and to determine whether its use reduces the need for intravenous sedatives and analgesics. DESIGN: Single-blinded, randomized, prospective study. SETTING: University hospital. PATIENTS: 50 patients undergoing diagnostic EGD. INTERVENTIONS: Patients were randomized to either lidocaine lollipop or lidocaine spray. Intravenous meperidine and midazolam were administered during the procedure as needed. MAIN OUTCOME MEASUREMENTS: The success and safety of local anesthesia by lidocaine lollipop in addition to the need for intravenous sedation. RESULTS: Patients were equally randomized between the lollipop and the spray groups. The lollipop group had less gag reflex, accommodated scope introduction more, and tolerated the procedure better. Thirty-two percent of patients receiving the lollipop required sedation compared with 96% of patients in the spray group (P < .001). The majority in the lollipop group were satisfied with their mode of anesthesia compared with the spray group. CONCLUSIONS: Lidocaine lollipop is a promising form of local oropharyngeal anesthesia for EGD. Its use resulted in sparing the use of intravenous sedation. It is well tolerated and safe and may be particularly important in the elderly, patients with comorbidities, and office-based endoscopy.