INTRODUCTION: This is the first prospective, double-blinded, randomized, placebo-controlled trial to evaluate the safety and efficacy of a stimulant laxative compared with an osmotic agent for the treatment of chronic idiopathic constipation. METHODS: Patients were randomly administered stimulant laxative (senna, 1.0 g), osmotic agent (magnesium oxide [MgO], 1.5 g), or placebo for 28 consecutive days. The primary endpoint was overall symptom improvement. Secondary endpoints were spontaneous bowel movement (SBM), complete SBM, and patient assessment of constipation quality of life (QOL). RESULTS: Ninety patients (mean age, 42 years; 93% women; mean duration of symptoms, 9.9 years) were enrolled; all completed the study. The response rate for overall improvement was 11.7% in the placebo group, 69.2% in the senna group, and 68.3% in the MgO group (P < 0.0001). Change in SBM was significantly greater in the senna and MgO groups than that in the placebo group (P < 0.001). Similarly, change in complete SBM was significantly greater in the senna and MgO groups than that in the placebo group (P < 0.01). On the patient assessment of constipation QOL, significant improvements were seen in the senna and MgO groups compared with those in the placebo group (senna, P < 0.05; MgO, P < 0.001). The frequency of severe treatment-related adverse events was 0%. DISCUSSION: Senna and MgO significantly improved the frequency of bowel movements and QOL score and seem to be effective in the treatment of constipation.

Background/Aims Magnesium oxide (MgO) has been frequently used as a treatment for chronic constipation (CC) since the 1980s in Japan. The aim of this study is to evaluate its therapeutic effects of MgO in Japanese CC patients. Methods We conducted a randomized, double-blind placebo-controlled study. Thirty-four female patients with mild to moderate constipation were randomly assigned to either placebo (n = 17) or MgO group (n = 17) 0.5 g × 3/day for 28 days. Primary endpoint was overall improvement over the 4-week study period. Secondary endpoints were changes from baseline in spontaneous bowel movement (SBM), response rates of complete spontaneous bowel movement (CSBM), stool form, colonic transit time (CTT), abdominal symptom, and quality of life. Results One patient failed to complete the medication regimen and was omitted from analysis: data from 16 placebo and 17 MgO patients were analyzed. The primary endpoint was met by 25.0% of placebo vs 70.6% of MgO group (P = 0.015). MgO significantly improved SBM changes compared to placebo (P = 0.002). However, MgO did not significantly improved response rates of CSBM compared to placebo (P = 0.76). In addition, MgO significantly improved Bristol stool form scale changes (P < 0.001) and significantly improved CTT compared to the placebo group (P < 0.001). MgO significantly improved the Japanese version of the patient assessment of constipation quality of life (P = 0.003). Conclusion Our placebo-controlled study demonstrated that MgO was effective treatment for improving defecation status and shortened CTT in Japanese CC patients with mild to moderate symptoms.

Background/AimsHigh-resolution esophageal manometry (HREM) is considered to be the gold standard for the diagnosis of achalasia. However, the Japan Esophageal Society recommends that esophagography is also accurate in either diagnosing or excluding the disorder. Accordingly, we compared the efficacy of esophagography and HREM in diagnosing achalasia patients with upper gastrointestinal symptoms.MethodsHREM was performed in 126 patients with dysphagia. The final diagnosis of achalasia was done using HREM. Demographic data, symptoms, quality of life (QOL) were also obtained. We assessed the patients who were not able to be diagnosed by esophagography and compared the diagnostic values for esophagography with HREM-based achalasia diagnosis as the gold standard.ResultsA total of 48 cases of patients with achalasia, including 21 men and 27 women (mean age, 48.4 ± 19.6 years), were included in the study. Two patients were excluded. Of the remaining 46 patients, 36 (78.3%) patients were diagnosed as having achalasia by esophagography. The diagnostic sensitivity, specificity, and accuracy of esophagography were 78.3%, 88.0%, and 83.0%, respectively. Patients with type III achalasia had significantly lower physical QOL score than those with type I or II achalasia. Although the mental QOL score in patients with type III achalasia tended to decrease compared with that in patients with type I and II achalasia, the difference was not statistically significant.ConclusionsDiagnosing esophageal achalasia by using esophagography alone has limited yield. Therefore, HREM should be used in patients with dysphagia and in whom achalasia cannot be diagnosed using EGD or esophagography.

Objective The percentage of patients with nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin- (LDA-) induced ulcers who complain of gastrointestinal symptoms has generally been considered to be low. The aim of this study was to examine and compare the symptoms and quality of life (QOL) at peptic ulcer onset. Methods This study involved 200 patients who were confirmed by endoscopy to be in the acute stage of gastroduodenal ulcer (A1-H1). Patients completed a self-administered questionnaire (Global Overall Symptom score and SF-8) at ulcer onset, and data were compared between NSAIDs/LDA ulcers and non-NSAIDs/LDA ulcers. Results The upper gastrointestinal symptoms score was significantly lower for patients using LDA only (20.5 ± 9.4 in the nonusing group, 19.6 ± 8.6 in the NSAIDs-only group, 16.7 ± 11.6 in the LDA-only group, and 18.5 ± 7.2 in the NSAIDs/LDA group, P < 0.05). The QOL score (physical summary) was significantly lower in the NSAID group (42.1 ± 9.9) than in the nonusing group (47.6 ± 7.6) (P < 0.05). Patients' characteristics showed no significant differences among the groups, with the exception of age. Conclusion The severity of upper abdominal symptoms at peptic ulcer onset was similar between NSAID users and nonusers.

Patients with quiescent inflammatory bowel disease (IBD) frequently suffer diarrhea-predominant irritable bowel syndrome (IBS-D)-like symptoms, such as abdominal pain or stool irregularities. Here, we assessed the effect of ramosetron, a serotonin type 3 (5-HT3) receptor antagonist, on IBS-D-like symptoms in patients with quiescent IBD. Seventy patients with quiescent IBD, who met the Rome III diagnostic criteria for IBS-D, were randomly assigned to receive either ramosetron (5 μg; n = 35) or a placebo (n = 35) orally once daily for 4 weeks. The primary endpoint was the responder rate for global assessment of relief from overall IBS-D-like symptoms. The responder rates for relief of abdominal pain/discomfort and improvement of bowel habits were also evaluated. The responder rate for relief from overall IBS-D-like symptoms at the final evaluation point was significantly higher in the ramosetron group (35.5%) than in the placebo group (11.4%) (p = 0.037). The responder rate for improvement of bowel habits was significantly higher in the ramosetron group (38.7%) than in the placebo group (14.3%) (p = 0.028). The reduction of stool frequency was significantly greater in the ramosetron group than in the placebo group (p = 0.044). Ramosetron is effective for relief of overall IBS-D-like symptoms in patients with quiescent IBD.