Sucralfate versus Placebo in Reflux Esophagitis: A Double-Blind Multicenter Study

The healing capacity and symptom relief were studied in 138 patients with symptomatic endoscopically verified reflux esophagitis treated with Sucralfate (n = 69) or placebo (n = 69), 1 g four times daily (granules suspended in half a glass of water), for at most up to 12 weeks. The reflux esophagitis (modified Savary-Miller scale) was distributed with 71 patients having grade 1, 39 patients having grade 2 or 3, and 28 patients having grade 4. All patients were told to follow the antireflux regimen. Antacid tablets were supplied, to be used only for the relief of severe pain, and were counted. The esophageal lesions were completely healed in 42% (sucralfate) and 35% (placebo) after 6 weeks of treatment (NS). Corresponding cumulative healing rates at 12 weeks of treatment were 54% and 41% (NS), respectively. The symptom improvement, however, was significantly better in the sucralfate group after 3 weeks of treatment. The results indicate a symptomatic benefit of sucralfate in reflux esophagitis.     

Cisapride for Gastroesophageal Reflux Disease: A Placebo-Controlled, Double-Blind Study

Objectives : To evaluate the safety and efficacy of cisapride in patients with gastroesophageal reflux disease. Methods : Patients (N = 177) were randomized to double-blind treatment with cisapride (10 or 20 mg q.i.d .) or placebo for 12 wk. Efficacy was determined by pre- and poststudy endoscopies, symptom assessments by patient and physician, and Maalox consumption. Safety evaluations included vital signs, electrocardiograms, clinical laboratory tests, and reports of adverse events. Results : Cisapride 10 ing significantly reduced daytime and nighttime heartburn at 4 wk compared with placebo. Cisapride 20 mg reduced both daytime and nighttime heartburn at 4, 8, and 12 wk, compared with placebo, and was also significantly superior to the 10-mg dose at 12 wk. The percent of patients with endoscopic healing was significantly higher with cisapride 20 mg than with placebo [healing: 51 vs 36% ( p ≤ 0.044)1. Maalox usage declined significantly with cisapride 20 mg compared with placebo. No clinically significant changes in safety variables occurred with cisapride. The most frequently reported adverse events in the cisapride group were diarrhea, headache, and sinusitis. Conclusions : Cisapride 10 and 20 mg q.i.d . were safe and well tolerated in a population of patients with mild-to-moderate gastro-esophageal reflux disease. Both symptoms and endoscopic grade improved after 12 wk of treatment with cisapride 20 mg q.i.d .     

Domperidone plus Magnesium Hydroxide and Aluminum Hydroxide: A Valid Therapy in Children with Gastroesophageal Reflux: A Double-Blind Randomized Study versus Placebo

Carroccio A, laeono G. Montalto G, Cavataio F, Soresi M, Notarbartolo A. Domperidone plus magnesium hydroxide and aluminum hydroxide: a valid therapy in children with gastroesophageal reflux. A double-blind randomized study versus placebo. Scand J Gastroenterol 1994;29:300-304.

To evaluate the efficacy of different drug combinations in treating severe gastroesophageal reflux (GER), we studied 80 children with GER. The patients were randomly divided into four groups: group A was treated with domperidone plus magnesium hydroxide and aluminum hydroxide, group B with domperidone plus alginate, group C with domperidone alone, and group D received placebo. At the time of diagnosis and 8 weeks after treatment the patients were clinically evaluated and underwent 24-h continuous esophageal pH monitoring. After treatment a complete regression of symptoms was observed in 16 of 20 patients in group A, in 8 of 20 in group B (A versus B, p < 0.018), in 9 of 20 in group C (A versus C. p< 0.034), and in 7 of 20 in group D (A versus D, p< 0.001). Moreover, there was a statistically significant improvement in several pH-metric variables studied in all treatment groups; in addition, a comparison of the pH-metric data of the four groups after treatment indicated that reflux variables were significantly lower in group A than in the other groups. We concluded that the domperidone plus magnesium hydroxide and aluminum hydroxide combination was more effective than the other drugs we used in treating GER and in modifying the objective pH-metric variables in pediatric patients.     

Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux: A Double-Blind,Randomized, Sham-Controlled Trial

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尼扎替丁治疗老年胃食管反流病

目的观察尼扎替丁治疗老年胃食管反流病的疗效。方法将116例老年胃食管反流病随机分为3组A组40例,B组38例,C组38例,分别应用奥美拉唑20 mg、尼扎替丁150 mg、雷尼替丁150 mg,bid×4周;然后分别改为20 mg、150 mg、150 mg qd至6个月。于治疗4周、3月、6月后观察各组总有效率。结果显示B组4周、3月、6月总有效率分别为81．58％、89．47％、94．47％,与A组相比(分别为85．00％、90．00％、95．00％)无显著性差异(P＞0．05);而与C组相比(分别为65．79％、76．72％、78．95％)有显著性差异(P＜0．05)。症状积分与总有效率结果一致。结论尼扎替丁治疗老年胃食管反流病与奥美拉唑疗效相仿,优于雷尼替丁,且价廉、副作用少。     

Methotrexate in Chronic Active Crohn's Disease: A Double-Blind, Randomized, Israeli Multicenter Trial

Background: At present only one large controlled study has indicated that parenteral methotrexate may he effective in chronic active Crohn's disease (CD). Aim : To evaluate the effectiveness of oral methotrexate in chronic steroid-dependent CD. Patients : Patients with active CD, who have received steroids and/or immunosuppressives for at least 4 months during the preceding 12 months and with a current Harvey-Bradshaw index of ≥ 7 were studied. Methods : Methotrexate (12.5 mg weekly) or 6-mercaptopurine (50 mg daily), or placebo were given during the 9 months of the trial in addition to steroids and 5-aminosancyIic acid as clinically indicated. Results : Eighty-four patients were included (methotrexate, 26 patients; 6-mercaptopurine, 32 patients; placebo, 26 patients). The proportion of patients entering first remission as well as the proportions of patients relapsing after first remission were not significantly different between the groups. The mean Harvey-Bradshaw index and the mean monthly steroid dose were also similar. However, when each patient was evaluated as his or her own control, the reduction in steroid dose, the general well being, and the reduction in abdominal pain were significantly better in the methotrexate treated patients. Conclusions : Methotrexate at a weekly oral dose of 12.5 mg was found to he moderately better than 6-mercaptopu-rine and placebo in patients with chronic active CD.     

莫沙必利治疗胃食管反流病的随机、双盲、安慰剂交叉对照研究

目前对促胃肠动力药莫沙必利改善中国汉族胃食管反流病（GERD）患者胃食管反流症状和食管运动障碍的作用尚缺乏系统观察。目的：观察莫沙必利对中国汉族人群中GERD患者的治疗作用。方法：采用随机、双盲、安慰剂交叉对照研究设计，选取有典型胃食管反流症状的GERD患者23例行胃食管反流症状评估、食管测压以及24h食管DH和胆红素联合监测，对比研究莫沙必利和安慰剂各1周交叉治疗对胃食管反流症状的改善情况，以及对食管运动功能和胃食管反流事件的影响。结果：与安慰剂治疗相比，莫沙必利治疗可降低胃食管反流总症状积分，加快食管体部蠕动波传导速度，增加湿咽成功率，减少食管下端pH〈4总反流次数和长时间（≥5min）反流次数，降低pH〈4总时间百分比和DeMeester计分，降低食管下端胆汁反流总时间百分比，差异均有统计学意义（P〈0．05）。结论：莫沙必利治疗1周可有效改善本组中国汉族GERD患者的胃食管反流症状，部分改善食管运动障碍以及酸反流和胆汁反流．是治疗GERD安全、有效的药物。     

Gastroesophageal Reflux Disease and Tooth Erosion: A Cross-Sectional Observational Study

Background/Aims

Gastroesophageal reflux disease (GERD) is common in children. Recurrent exposure to gastric acid in GERD may contribute to tooth erosion.

Methods

In this prospective study, 54 GERD patients qualified according to endoscopy, pH-metry, and the GERD questionnaire and 58 healthy controls qualified by the GERD questionnaire were assessed. Two groups underwent dental evaluations for the presence, severity, and patterns of erosion and for the stage of dentition using a Tooth Wear Index. The health care providers who performed the dental exams did not know which children had been diagnosed with GERD.

Results

A total of 112 children, 3 to 12 years old were enrolled in the study, and 53 of 54 (98.1%) GERD patients and 11 of 58 (19.0%) controls had dental erosions (p<0.0001). In GERD patients, the posterior occlusal surfaces of milk teeth were more affected (p<0.0001). There was no correlation between GERD and the affected surfaces in permanent teeth, nor in the patterns or erosion grades (localized or general). In both groups, milk teeth had more erosions than permanent teeth, but the difference was not statistically significant.

Conclusions

According to this study, there is a positive correlation between GERD and dental erosion. Posterior occlusal surface erosions in milk teeth could indicate GERD.     

Metoclopramide in Gastroesophageal Reflux Disease: Rationale for its Use and Results of a Double-Blind Trial

We investigated the acute effect of metoclopramide on lower esophageal sphincter pressure, esophageal contraction amplitude, and gastric emptying and compared metoclopramide, 10 mg four times a day, to placebo in improving the symptoms and objective parameters of reflux esophagitis in 19 patients in a randomized, double-blind 4-wk outpatient trial. Orally administered metoclopramide, 10 mg, significantly accelerated gastric emptying of a semisolid meal in patients in whom it was delayed; lower esophageal sphincter pressure was significantly increased for up to 90 min, but there were no changes in esophageal contraction amplitude. During the treatment trial, metoclopramide resulted in an overall improvement in heartburn and regurgitation of 60%, significantly better than 32% improvement after placebo (p less than 0.05). Compared to baseline symptoms scores, metoclopramide significantly improved both daytime and nighttime heartburn and regurgitation. Compared to placebo-treated patients, the metoclopramide group had significantly fewer episodes of daytime heartburn and regurgitation (p less than 0.05), while nighttime symptoms significantly improved with both treatments. Mean antacid consumption was significantly reduced by metoclopramide, 61%, compared to placebo-treated patients, 21% (p less than 0.05), who were ingesting a mean of 1.9 oz of antacid daily. Endoscopic and histological improvement were similar in both groups, although histological healing occurred in three patients after metoclopramide compared with none in the placebo group. Our data suggest that: 1) gastric emptying and lower esophageal sphincter pressure were significantly improved by acute administration of oral metoclopramide; 2) metoclopramide therapy for 4 wk is significantly more effective than placebo (medium dose antacid therapy) in relieving the symptoms of gastroesophageal reflux without significantly altering objective parameters of esophagitis; 3) metoclopramide effectively addresses the diffuse upper gastrointestinal motor disturbances present in reflux esophagitis patients.     

A 26-Week,Randomized, Double-Blind,Placebo-Controlled,Multicenter Study to Evaluate the Effect of Omalizumab on Asthma Control in Patients with Persistent Allergic Asthma

Objective. The 2007 National Heart, Lung, and Blood Institute (NHLBI) asthma guidelines shifted the focus of care from asthma severity to ongoing assessment of asthma control using the components of impairment and risk. We evaluated the effect of omalizumab on asthma control in patients with persistent allergic asthma inadequately controlled with NHLBI Step 4 or above asthma therapy. Methods. In this double-blind, placebo-controlled study, patients ≥12 years (n = 271) received omalizumab (n = 136) or placebo (n = 135) every 2 or 4 weeks for 24 weeks. The primary efficacy variable, change from baseline in Asthma Control Test (ACT) total score, and Investigator’s Global Evaluation of Treatment Effectiveness (IGETE, secondary efficacy variable) were evaluated at week 24. Results. ACT score improved more with omalizumab compared with placebo (least squares means [LSMs]: 5.01, 4.36); however, the difference was not significant (p = .1779). Similarly, IGETE was not significantly different (p = .1177), but more patients treated with omalizumab (26/127, 20%) compared with placebo (19/131, 15%) had IGETE rated as “Excellent.” Significant benefits were observed for omalizumab compared with placebo for change in ACT score (LSMs: 6.66, 5.27; p = .0334) and IGETE (p = .0321) at week 24 in a subgroup of patients with very poorly controlled asthma (ACT ≤ 15) at baseline. There were no significant differences for the subgroup of patients with forced expiratory volume in 1 second ≤ 80% predicted at baseline. Adverse events (AEs) were similar between groups with no drug-related serious AEs or deaths. Conclusions. For allergic asthma patients with NHLBI Step 4 or above asthma therapy, omalizumab consistently improved asthma control; however, compared with placebo, differences were not significant. Placebo-treated patients had substantial improvement in their ACT score, which may have limited the ability to detect differences between treatment groups. Subgroup analyses showed significant improvements with omalizumab versus placebo in patients with very poorly controlled asthma.     

21世纪的常见病:胃食管反流病

胃食管反流病(gastroesophageal reflux disease,GERD)是指胃食管反流所致的烧心、反酸症状或食管下段组织病理学改变。糜烂性食管炎(erosive esophagitis,EE)是GERD的一个亚组,内镜下可见食管黏膜破损(参考1994年洛杉矶反流性食管炎的内镜分类)。如胃食管反流引起烧心、反酸症状,但内镜下无食管黏膜破损,而24hpH监测显示食管有异常酸暴露,这一GERD亚组称为内镜阴性反流病(endoscopic negative re-     

苯磺贝他斯汀与氯雷他定治疗过敏性鼻炎:多中心随机双盲临床试验

目的对苯磺贝他斯汀治疗过敏性鼻炎的有效性和安全性进行评价,并与氯雷他定做比较。方法采用多中心、随机、双盲、平行对照的临床试验,试验组过敏性鼻炎患者120例,每日用苯磺贝他斯汀片10mg,早晚各一次。对照组过敏性鼻炎患者120例,每日用氯雷他定片10mg,每日1次。两组均连续用药14d。疗效评价以治疗的总有效率作为主要指标,症状积分下降指数和鼻腔检查积分下降指数作为次要指标。结果治疗后,苯磺贝他斯汀受试者总有效率为91.4%,氯雷他定组为91.2%,P=0.984;药物不良反应总发生率分别为16.1%,25.4%。经统计学检验,两组差异均无显著统计学意义。其中苯磺贝他斯汀组嗜睡发生率为4.2%;氯雷他定组为14.4%,P=0.012。结论苯磺贝他斯汀治疗过敏性鼻炎与氯雷他定一样安全有效,且苯磺贝他斯汀组的嗜睡发生率低于氯雷他定组。     

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of Nocturnal Roxatidine in tHe Treatment of Active Duodenal Ulcer Disease

This multicenter randomized, double-blind, 4-wk study compared the new H2-receptor antagonistic roxatidine (R) to placebo (P) for treatment of endoscopically diagnosed active duodenal ulcer disease. Subjects were evaluated after 2 and 4 wk of treatment. Those whose ulcer was unhealed at 2 wk received 2 more weeks of treatment before final evaluation. Ulcer healing (endoscopically determined) with roxatidine was more effective than placebo at both wk 0-2 (R = 33.9%, P = 21.9%, p = 0.018) and wk 2-4 (R = 68.2%, P = 29.7%, p less than 0.001), with an overall 4-wk effectiveness of 78.9% compared to 44.8% (p less than 0.001). At the end of treatment, average maximum ulcer diameter diminished 83% in R and 50% in P (p less than 0.001). Roxatidine was also more effective than placebo in decreasing abdominal pain (p less than 0.001), decreasing the number of antacid tablets taken for pain relief (p less than 0.001), improving dyspeptic symptoms (p less than 0.001), and permitting return to a normal routine for subjects with previous illness-imposed restrictions on work and/or other daily activities. The profile of laboratory values and adverse experiences demonstrated roxatidine to be safe and well-tolerated. The efficacy of roxatidine as evaluated by the healing rate of duodenal ulcer and reduction in abdominal pain emphasize its value as an addition to the family of H2-receptor antagonists.     

Empirical Therapy versus Diagnostic Tests in Gastroesophageal Reflux Disease (A Medical Decision Analysis)

Our objective was to describe the conditionsthat determine the costs of empirical therapy ingastroesophageal reflux disease (GERD). Our design wasa threshold analysis using a decision tree. The costs of medications were estimated from the averagewholesale prices. The costs of diagnostic procedureswere expressed as the sum of physician and facilitycosts. A decision tree was modeled to calculate the threshold probability of GERD, for whichempirical therapy became the preferred managementstrategy. Bayes' formula was used to transform thesensitivity and specificity of various symptoms and thejoint occurrence of multiple symptoms into diseaseprobabilities. The decision in favor of empiricaltherapy is influenced by four factors: the probabilityof GERD, the duration or costs of GERD therapy, the costs of erroneous empirical therapy inpatients with diagnosis other than GERD, and the costsof diagnostic procedures. In general, the expectedbenefit of saving the costs of a diagnostic procedureoutweighs the costs of occasional erroneous empiricaltherapy. However, if surgical therapy is considered orantisecretory therapy is administered for a time periodof 10 or more years, diagnostic confirmation of GERD should be sought. In the long run, thefailure to differentiate between peptic ulcer and GERDresults in the highest cost associated with erroneousempirical therapy. In patients with multiplecharacteristic symptoms of GERD, the diagnosis can beascertained with sufficient confidence to warrantempirical therapy.