Effect of a simethicone-containing tablet on colonic gas elimination in breath

The effect of a tablet containing the antiflatulent, simethicone, on intestinal hydrogen (H2) elimination in breath was studied. In three trials, normal subjects (age 12-52 years) received, on subsequent days, lactulose or lactulose with two tablets of either simethicone or placebo in randomized order. Breath samples were collected over 210 min and analyzed by gas chromatography for H2. The time course of H2 expiration above baseline levels was calculated and compared for the three tests. No significant differences in transit time were found. Cumulative H2 expiration was significantly lower after simethicone compared to placebo. H2 production from stool incubated with simethicone or placebo indicated that the drug had no effect in reducing the fermentative production of H2 in vitro. Interestingly, the vehicle present in the tablets could be fermented by intestinal bacteria. Simethicone reduced the amount of H2 eliminated in breath, but this effect was offset partially by H2 production from the fermentation of unabsorbable substances used in the formulation of the tablets.     

The Differing Effects of Acute and Chronic Alcohol on Gastric and Intestinal Permeability

Objective: Acute and chronic alcohol intake cause GI symptoms because of either alcohol-induced structural or functional abnormalities. In theory, the disruption of the integrity of the gut mucosa should be reflected by changes in the absorption of molecular probes, such as lactulose, mannitol, and sucrose. Accordingly, we investigated the effects of acute and chronic ethanol on the permeability of the gastric and small intestinal mucosa. Methods: We measured the absorption of sucrose, mannitol, and lactulose in 20 controls and 18 alcoholics within 3 days after their last drink. We evaluated the reversibility of the abnormalities in alcoholics by repeat testing after 7 to 14 days of sobriety. The acute effects of ethanol in normal controls and abstinent alcoholics were also studied after the administration of ethanol by both the oral and IV routes. Results: The absorptions of lactulose and sucrose in chronic alcoholics were normal. However, the alcoholics demonstrated a significant decrease in mannitol absorption and a corresponding increase in the lactulose/mannitol ratio. Both parameters returned to normal after a period of sobriety. Acute ethanol did not significantly affect mannitol or lactulose absorption, whereas oral ethanol significantly increased sucrose absorption. Conclusions: Chronic ethanol re-versibly affects the integrity of small intestinal villi without significantly affecting gastrointestinal permeability. In contrast, a single oral dose of ethanol increases gas-troduodenal permeability but has no effect on the lactulose or mannitol permeability of the small intestine. These regional changes in gut permeabilities may contribute to alcohol-induced GI symptoms.     

Effect of antispasmodic agents, alone or in combination, in the treatment of Irritable Bowel Syndrome: Systematic review and meta-analysis

IntroductionIrritable bowel syndrome (IBS) is characterized by recurrent abdominal pain, bloating, and changes in bowel habit.AimsTo determine the clinical effectiveness of the antispasmodic agents available in Mexico for the treatment of IBS.MethodsWe carried out a systematic review and meta-analysis of randomized controlled clinical trials on antispasmodic agents for IBS treatment. Clinical trials identified from January 1960 to May 2011 were searched for in MEDLINE, the Cochrane Library, and in the ClinicalTrials.gov registry. Treatment response was evaluated by global improvement of symptoms or abdominal pain, abdominal distention/bloating, and frequency of adverse events. The effect of antispasmodics vs placebo was expressed in OR and 95% CI.ResultsTwenty-seven studies were identified, 23 of which fulfilled inclusion criteria. The studied agents were pinaverium bromide, mebeverine, otilonium, trimebutine, alverine, hyoscine, alverine/simethicone, pinaverium/simethicone, fenoverine, and dicyclomine. A total of 2585 patients were included in the meta-analysis. Global improvement was 1.55 (CI 95%: 1.33 to 1.83). Otilonium and the alverine/simethicone combination produced significant values in global improvement while the pinaverium/simethicone combination showed improvement in bloating. As for pain, 2394 patients were included with an OR of 1.52 (IC 95%: 1.28 a 1.80), favoring antispasmodics.ConclusionsAntispasmodics were more effective than placebo in IBS, without any significant adverse events. The addition of simethicone improved the properties of the antispasmodic agents, as seen with the alverine/simethicone and pinaverium/simethicone combinations.     

Effect of Amitryptiline on Symptoms, Sleep, and Visceral Perception in Patients With Functional Dyspepsia

Objective : Tricyclic antidepressants in low doses are widely used in the therapy of patients with functional gastrointestinal disorders, yet the mechanism(s) of action of these drugs in these disorders is not known. In the current study, we sought to determine in a group of patients with functional dyspepsia and associated poor sleep how amitryptiline affects digestive symptoms, perceptual responses to gastric distension, and subjective and objective measures of sleep. Methods : Patients were randomized to 4 wk of amitryptiline 50 mg taken at bedtime versus placebo. There was a 3-wk washout phase, followed by a cross-over to the alternate treatment. Perceptual sensitivity to gastric distention and sleep EEG were recorded at the end of each treatment period. Diaries of symptoms were maintained throughout. Results : Seven of seven patients reported significantly less severe gastrointestinal symptoms after 4 wk on amitryptiline compared to placebo. Five of seven patients had evidence for altered perception of gastric balloon distension during placebo. However, the subjective symptom improvement on amitryptiline was not associated with a normalization of the perceptual responses to gastric distension. Baseline sleep dysfunction in the form of reduced sleep efficiency, increased arousal, or abnormal amounts of REM sleep was found in all seven patients. Amitryptiline significantly reduced absolute and relative amounts of REM sleep, but had no effect on sleep parameters related to nonregenerative sleep. Conclusion : The beneficial effect of low dose amitryptiline seen in functional dyspepsia is not related to changes in perception of gastric distension, or to measures of arousal from sleep. An increased tolerance to aversive visceral sensations may play a role in the therapeutic effect.     

The effect of oral N-acetylcysteine in chronic bronchitis: a quantitative systematic review.

The role of N-acetylcysteine (NAC) in the treatment of chronic bronchitis is unclear. Since a number of studies have been published on this topic, a systematic review of published studies seems justified. A systematic search (Medline, Embase, Cochrane Library, bibliographies, no language restriction) for published randomized trials comparing oral NAC with placebo in patients with chronic bronchitis was performed. Dichotomous data on prevention of exacerbation, improvement of symptoms and adverse effects were extracted from original reports. The relative benefit and number-needed-to-treat were calculated for both individual trials and combined data. Thirty-nine trials were retrieved; eleven (2,011 analysed patients), published 1976-1994, were regarded as relevant and valid according to preset criteria. In nine studies, 351 of 723 (48.5%) patients receiving NAC had no exacerbation compared with 229 of 733 (31.2%) patients receiving placebo (relative benefit 1.56 (95% confidence interval (CI) 1.37-1.77), number-needed-to-treat 5.8 (95% CI 4.5-8.1). There was no evidence of any effect of study period (12-24 weeks) or cumulative dose of NAC on efficacy. In five trials, 286 of 466 (61.4%) patients receiving NAC reported improvement of their symptoms compared with 160 of 462 (34.6%) patients receiving placebo (relative benefit 1.78 (95% CI 1.54-2.05), number-needed-to-treat 3.7 (95% CI 3.0-4.9)). With NAC, 68 of 666 (10.2%) patients reported gastrointestinal adverse effects compared with 73 of 671 (10.9%) taking placebo. With NAC, 79 of 1,207 (6.5%) patients withdrew from the study due to adverse effects, compared with 87 of 1,234 (7.1%) receiving placebo. In conclusion, with treatment periods of approximately 12-24 weeks, oral N-acetylcysteine reduces the risk of exacerbations and improves symptoms in patients with chronic bronchitis compared with placebo, without increasing the risk of adverse effects. Whether this benefit is sufficient to justify the routine and long-term use of N-acetylcysteine in all patients with chronic bronchitis should be addressed in further studies and cost-effectiveness analyses.     

乳果糖治疗妊娠期妇女便秘的随机、双盲、安慰剂对照多中心临床研究

目的 观察乳果糖治疗妊娠期妇女便秘的疗效及安全性。方法 本研究为多中心、随机、双盲、安慰剂对照临床研究，共观察63例便秘孕期妇女。试验为期3周，包括1周导入期，2周双盲治疗期。每日治疗剂量为早餐时服用乳果糖或安慰剂30ml，3d后可酌情调整为15或45ml。每例受试者在日记卡上记录每天便次并依照Bristol粪便量表记录相应便型。整个研究中还观察受试者治疗后出现的不良事件（TEAE）并随访至其分娩。结果治疗最后1周时，乳果糖组的平均粪便性状明显改善，与导入期相比，增加值明显高于安慰剂组（1．32比0．68，P=0．019），同期乳果糖组的有效率也高于安慰剂组（61．3％比46．9％）。治疗结束时，乳果糖组有更多的受试者有明显改善或改善（64．6％比50．5％）。同样在乳果糖组中，有更多的受试者对治疗表示非常满意或较为满意（61．3％比45．2％）。整个研究过程中，无一例严重TEAE发生。乳果糖组TEAE较安慰剂组常见[15（48．4％）比7（21．9％）]，但均为轻度胃肠道反应。两组最常见的TEAE在乳果糖组为恶心、呕吐症状[6（19．4％）]，安慰剂组为腹泻[2（6．3％）]。安慰剂组中有1例因TEAE（呕吐）退出研究。两组受试者的生命体征、体检和妊娠结局（新生儿体重、身高、APGAR评分）均无异常。结论 研究表明乳果糖为治疗妊娠期便秘的有效、安全药物。     

Misoprostol treatment exacerbates abdominal discomfort in patients with non-ulcer dyspepsia and erosive prepyloric changes. A double-blind, placebo-controlled, multicentre study

One hundred and thirty-seven consecutive outpatients with non-ulcer dyspepsia (NUD) and erosive prepyloric changes (EPC) were randomly allocated to double-blind treatment with 400-micrograms misoprostol tablets twice daily or placebo for 4 weeks. Misoprostol had a significant worsening effect on epigastric pain, nausea, meteorism, lower abdominal pain, and diarrhoea, as compared with placebo. The fact that symptoms in patients with NUD and EPC were exacerbated by an antisecretory dose of misoprostol indicates that the symptoms are largely unrelated to gastric acid.     

Misoprostol Treatment Exacerbates Abdominal Discomfort in Patients with Non-Ulcer Dyspepsia and Erosive Prepyloric Changes: A Double-Blind,Placebo-Controlled,Multicentre Study

One hundred and thirty-seven consecutive outpatients with non-ulcer dyspepsia (NUD) and erosive prepyloric changes (EPC) were randomly allocated to double-blind treatment with 400-μg misoprostol tablets twice daily or placebo for 4 weeks. Misoprostol had a significant worsening effect on epigastric pain, nausea, meteorism, lower abdominal pain, and diarrhoea, as compared with placebo. The fact that symptoms in patients with NUD and EPC were exacerbated by an antisecretory dose of misoprostol indicates that the symptoms are largely unrelated to gastric acid.     

Misoprostol in the treatment of NSAID-induced gastroduodenal lesions.

The cytoprotective effect of misoprostol co-administered with non-steroidal anti-inflammatory drugs (NSAIDs) was assessed in a double blind, placebo controlled study. Thirty-seven patients with rheumatoid arthritis receiving NSAIDs, having upper gastrointestinal symptoms and endoscopically confirmed gastric and/or duodenal lesions, were randomised to receive either misoprostol 200 micrograms or placebo tablets twice daily for 4 weeks. Of 31 evaluable cases, 13 of 16 (81%) patients receiving misoprostol showed endoscopic improvement as compared to 10 of 15 (67%) receiving placebo (P:NS). A significant decrease in mean (+/- SEM) mucosal lesion score was observed with misoprostol (from 3.38 +/- 0.32 to 1.32 +/- 0.44; P less than 0.001) but no change was seen with placebo (from 2.80 +/- 0.42 to 1.60 +/- 0.53; P:NS). Symptomatic relief was similar in both groups, being 44% and 40% respectively. Two patients complained of diarrhea in each group and one developed menorrhagia with misoprostol. It is concluded that though misoprostol decreased the number of NSAID-induced mucosal lesions, it was unable to relieve gastrointestinal symptoms.     

Gastrointestinal safety of AZD3582, a cyclooxygenase inhibiting nitric oxide donator: proof of concept study in humans

BACKGROUND: Cyclooxygenase inhibiting nitric oxide donators (CINODs) are a new class of anti-inflammatory and analgesic drugs that may minimise gastrointestinal toxicity compared with standard non-steroidal anti-inflammatory drugs (NSAIDs) by virtue of nitric oxide donation. METHODS: A proof of concept study of the gastrointestinal safety of AZD3582, the first CINOD available for human testing, was conducted. Thirty one subjects were randomised to receive placebo, naproxen 500 mg twice daily, or its nitroxybutyl derivative AZD3582 in an equimolar dose (750 mg twice daily) for 12 days in a double blind three period crossover volunteer study. At the start and end of each dosing period, gastroduodenal injury was assessed by endoscopy and small bowel permeability by differential urinary excretion of lactulose and L-rhamnose. Pharmacokinetic profiles were assessed at steady state. RESULTS: On naproxen, the mean total number of gastroduodenal erosions was 11.5 (and one subject developed an acute ulcer) versus 4.1 on AZD3582 (p<0.0001). More than half of the subjects had no erosions on AZD3582. Differences were seen for both the stomach and duodenum. Naproxen increased intestinal permeability (lactulose:L-rhamnose ratio 0.030 before v 0.040 after treatment) whereas AZD3582 (0.029 before, 0.029 after; p=0.006 v naproxen) and placebo (0.030 before, 0.028 after; p<0.001 v naproxen) did not. The steady state bioavailability of naproxen metabolised from AZD3582 was 95% (95% confidence interval 87-101%) of that after naproxen administration. CONCLUSIONS: This human study supports animal data showing reduced gastrointestinal toxicity with the CINOD AZD3582. The potential combination of effective pain relief and gastrointestinal protection offered by AZD3582 warrants further evaluation in human clinical studies.     

Cimetidine tablets or suspension for the prevention of gastrointestinal mucosal lesions caused by non-steroidal, anti-inflammatory drugs

We compared the protection offered by cimetidine 400 mg b.i.d. as tablets or suspension vs. placebo, in Naproxen-induced gastrointestinal damage in 17 healthy males. Upper endoscopy was performed before and after each drug period, with separate evaluation of duodenal mucosa distal to the duodenal bulb. 51Cr-EDTA absorption tests were done to assess distal mucosal integrity, and symptoms were registered. All regimens caused a significant increase in mucosal damage (p less than 0.01). Cimetidine tablets gave a significantly lower damage score than placebo for gastritis/duodenitis and hemorrhagic lesions in the stomach/duodenal bulb, and for the sum of scores in both scoring regions (p = 0.02). Cimetidine suspension was not significantly different from placebo for any of the endoscopic parameters. The 51Cr-EDTA absorption was significantly increased after all drug periods. However, there was no difference between the three drug combinations. Symptoms reported were mild and equal in the three groups. Cimetidine tablets offered protection against Naproxen-induced mucosal damage, primarily in the stomach and duodenal bulb, but lacked any effect on permeability changes. Cimetidine suspension was not significantly different from placebo in any respect.     

Beclomethasone dipropionate aerosol treatment of hay fever. A dose-response investigation.

In a controlled, double-blind study 20 children and adults, suffering from summer hay fever, were treated intranasally with a daily dose of 200 mug, 300 mug or 400 mug beclomethasone dipropionate (Beconase, Becotide Nasal) or with placebo for 2 weeks during the hay fever season. No beneficial effect of the placebo treatment was observed. In patients treated with 200 mug and 300 mug beclomethasone dipropionate a day there was a moderate decrease in nasal symptom scores and in use of antihistamine tablets. As the results indicated 400 mug a day to have the most pronounced effect on nasal symptoms, this dosage is recommended for children as well as adults suffering from summer hay fever.     

Efficacy of Probiotics and Nutrients in Functional Gastrointestinal Disorders: A Preliminary Clinical Trial

The purpose of this study was to evaluate the efficacy and safety of commonly used probiotics and nutrients available for functional gastrointestinal disorders (FGID). Five different combinations of probiotics and nutrients, or placebo, were taken daily over 12 weeks. In this randomized controlled clinical trial, men and women 21 to 72 years of age with FGID symptoms of indigestion, bloating, and abdominal discomfort were assigned to one of six groups, 12 patients per group. Gastrointestinal Quality of Life Index (GIQLI) and visual analogue scale (VAS) for GI symptoms, SF-36, lactulose and mannitol test (LMT), and urine indican levels were evaluated. GIQLI, VAS scores, and LMT did not change significantly (P > 0.05). There were clinically notable improvements in two of the combination formulations. While the nonsignificant improvements in GI symptoms could suggest that combination probiotics and nutrients may be beneficial in conditions such as FGID, no conclusive evidence was found in this pilot trial. Further investigations to explore the findings are discussed.     

Intestinal permeability in patients with coeliac disease and relatives of patients with coeliac disease.

The functional integrity of the small bowel is impaired in coeliac disease. Intestinal permeability, as measured by the sugar absorption test probably reflects this phenomenon. In the sugar absorption test a solution of lactulose and mannitol was given to the fasting patient and the lactulose/mannitol ratio measured in urine collected over a period of five hours. The sugar absorption test was performed in nine patients with coeliac disease with an abnormal jejunum on histological examination, 10 relatives of patients with coeliac disease with aspecific symptoms but no villous atrophy, six patients with aspecific gastrointestinal symptoms but no villous atrophy, and 22 healthy controls to determine whether functional integrity is different in these groups. The lactulose/mannitol ratio (mean (SEM) is significantly higher in both coeliac disease (0.243 (0.034), p < 0.0001)) and relatives of patients with coeliac disease (0.158 (0.040), p < 0.005)) v both healthy controls (0.043 (0.006)) and patients with aspecific gastrointestinal symptoms (0.040 (0.011)). The lactulose/mannitol ratio in relatives of coeliac disease patients was significantly lower than in the coeliac disease patient group (p = 0.04). The lactulose/mannitol ratio was the same in healthy controls and patients with aspecific gastrointestinal symptoms. It is concluded that the sugar absorption test is a sensitive test that distinguishes between patients with coeliac disease and healthy controls. The explanation for the increased permeability in relatives of patients with coeliac disease is uncertain. Increased intestinal permeability may be related to constitutional factors in people susceptible to coeliac disease and may detect latent coeliac disease. The sugar absorption test may therefore be helpful in family studies of coeliac disease.     

DICLOFENAC (VOLTAROL) IN RHEUMATOID ARTHRITIS: A REPORT OF A DOUBLE-BLIND TRIAL

A double-blind trial compared diclofenac with placebo in 44out-patients. One patient in the diclofenac group dropped outbecause of dyspepsia following psychological shock. In the placebogroup one patient dropped out because of dyspepsia and one becauseof poor therapeutic effect. Twenty of those who completed thetrial received diclofenac. The dosage was one tablet (25 mg diclofenac) t.d.s. during thefirst week. In the second (final) week, most patients had fouror six tablets. Diclofenac had a significantly greater effect on pain, grip,morning stiffness, joint tenderness and swelling, and in comparisonto previous treatments, even though the placebo group requiredsignificantly more rescue analgesic. A few patients in each group had slight dyspepsia. One in theactive and six in the placebo group complained of minor centralnervous system symptoms. There were no serious side-effects. Haematological, biochemical and urinary analyses showed no clinicallyimportant changes. It is concluded that, under the conditions described, diclofenac(Voltarol) is effective in relieving the symptoms of inflammatorypolyarthritis. It is as well tolerated as placebo medication,and had no detrimental haematological or biochemical effects.     

常规剂量胃肠动力药物对口-结肠转运时间的影响

背景：胃肠传输障碍是发生胃肠道症状的最重要原因之一,目前尚缺乏常用胃肠动力药物改善胃肠传输功能疗效的对比研究。目的：研究常规剂量胃肠动力药物对健康志愿者口-结肠转运时间（OCTT）的影响。方法：采用随机、双盲、拉丁方设计的自身对照研究方案,以乳果糖氢呼气试验检测7名健康志愿者的OCTT。口服乳果糖前30 min分别给予多潘立酮10 mg、莫沙必利5 mg、枸橼酸莫沙必利分散片5 mg（服用乳果糖前15 min给予）、伊托必利50 mg、匹维溴铵50 mg和曲美布汀100 mg,并比较不同药物的OCTT。结果：7名健康志愿者的基线平均OCTT为（112.0±3.2）min,多潘立酮、莫沙必利、枸橼酸莫沙必利分散片、伊托必利、匹维溴铵和曲美布汀的OCTT分别为（96.0±2.4）min、（72.2±2.6）min、（71.4±2.0）min、（105.0±2.6）min、（87.0±3.2）min、（135.0±4.1）min,与基线相比差异均有统计学意义（P〈0.05）。枸橼酸莫沙必利分散片的OCTT显著低于其他胃肠动力药物（P〈0.05）。结论：常规剂量枸橼酸莫沙必利分散片对OCTT的促进作用优于其他胃肠动力药物。     

Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation

AIM： To evaluate the effectiveness of simethicone in enhancing visibility and efficacy during colonoscopy.
METHODS： A prospective, double-blind, randomized, placebo-controlled study was conducted. One hundred and twenty-four patients were allocated to receive 2 doses of sodium phosphate plus 240 mg of tablet simethicone or placebo as bowel preparation. Visibility was blindly assessed for the amount of air bubbles and adequacy of colon preparation. Total colonoscopic time, side effects of the medication, endoscopist and patient satisfaction were also compared.
RESULTS： Sodium phosphate plus simethicone, compared to sodium phosphate plus placebo, improved visibility by diminishing air bubbles （100.00% vs 42.37%, P 〈 0.0002） but simethicone failed to demonstrate improvement in adequacy of colon preparation （90.16% vs 81.36%, P = 0.17）. Endoscopist and patient satisfaction were increased significantly in the simethicone group. However, there was no difference in the total duration of colonoscopy and side effects of the medication.
CONCLUSION： The addition of simethicone is of benefit for colonoscopic bowel preparation by diminishing air bubbles, which results in enhanced visibility. Endoscopist and patient satisfaction is also increased.     

Comparison of Scintigraphy and Lactulose Breath Hydrogen Test for Assessment of Orocecal Transit (Lactulose Accelerates Small Bowel Transit)

The lactulose breath test (LBT) andgastroenterocolonic scintigraphy (GECS) can both be usedto measure orocecal transit time (OCTT). The aims ofthis study were (1) to measure OCTT by LBT and GECS and (2) to determine whether lactulose altersorocecal transit. Methods: Eight normal subjectsunderwent simultaneous breath hydrogen testing, GECS,and duodenal manometry while receiving either 10 glactulose or placebo with a radiolabeled solid/liquidtest meal during two studies. There was a goodcorrelation between OCTT by LBT and GECS when performedsimultaneously (r = 0.95; P < 0.001). OCTT by GECSwith lactulose was significantly faster (P = 0.004) than byGECS without lactulose, despite no change in gastricemptying of liquids and slowing of gastric emptying ofsolids (P = 0.02). The postprandial duodenal motility index was greater with lactulose than withplacebo (P = 0.031). This study demonstrates that LBTand GECS (without lactulose) are not equivalent measuresof OCTT. The standard LBT accelerates OCTT and slows gastric emptying. Therefore, lactulose has adirect accelerating effect on small intestinaltransit.     

Controlled trial of medical therapy for active upper gastrointestinal bleeding and prevention of rebleeding

This multicentered, placebo-controlled trial evaluated the efficacy of medical therapy to stop bleeding in 285 patients with active upper gastrointestinal bleeding (bleeding phase) and 194 patients who had ceased gastrointestinal bleeding and in whom therapy was instituted to prevent rebleeding during the same hospitalization (prevention phase). Patients in the bleeding phase were given cimetidine (300 mg every six hours) or intravenous placebo. There was no significant overall difference between intravenous cimetidine (71 percent) and placebo (77 percent) in stopping acute upper gastrointestinal bleeding. There was also no significant difference noted between intravenous cimetidine and placebo when specific bleeding lesions were evaluated. Once gastrointestinal bleeding had stopped, recurrence of bleeding while receiving prevention therapy (cimetidine tablets 300 mg one three times a day and at bedtime, or Mylanta II liquid 30 ml every hour, or cimetidine plus hourly antacids, or placebo) was evaluated in 194 of the patients in the bleeding phase. Twenty-four percent (12 of 51 patients) rebled while receiving cimetidine, 13 percent (five of 39 patients) rebled while receiving hourly antacids, 11 percent (six of 54 patients) rebled while receiving cimetidine plus hourly antacids, and 26 percent (13 of 50 patients) rebled while receiving placebo. None of these prevention regimens reached statistical significance (p = 0.13). Evaluation of specific bleeding lesions within this group also failed to show any significant value of prevention therapy. In conclusion: (1) intravenous cimetidine offers no advantage over placebo in stopping active upper gastrointestinal bleeding; (2) the occurrence of rebleeding during the same hospitalization does not appear to be significantly affected by any of the medical regimens used for prevention. These findings would suggest that the cessation of active bleeding and the prevention of recurrent upper gastrointestinal bleeding during a single hospitalization appear to be unaffected by therapy directed at acid neutralization or reduction.     

Specific immunotherapy with high dose SO standardized grass allergen tablets was safe and well tolerated.

BACKGROUND: Sublingual immunotherapy with grass allergen tablets may be the future treatment for grass pollen allergy because it reduces symptoms and medication use, improves quality of life and is easy to use. Rhinoconjunctivitis and asthma co-exist and we aimed to find a safe dose range of a self-administered grass allergen tablet (ALK Abello A/S) in patients suffering from rhinoconjunctivitis and asthma. METHODS: Four doses were investigated in a randomised, double-blind, placebo-controlled, dose escalation trial. Outside the pollen season 4 groups of 12 patients commenced treatment in a staggered manner, at intervals of 1 week. For 28 days doses of 75000 (approximately 15microg Phleum pratense protein 5), 150,000, 300,000, 500,000 standardised quality tablet (SQ-T) units or placebo were given once daily as sublingual tablets. RESULTS: Fourty three patients were randomised to receive either active treatment or placebo (3:1). Each dose group consisted of 12 patients except the 500000 SQ-T group (5 active, 2 placebo). No asthma exacerbations were seen and no serious or severe adverse events were reported. The majority of adverse events were local reactions. The number of adverse events was dose related. No patients withdrew from the study. CONCLUSIONS: Treatment with grass allergen tablets in doses up to 500000 SQ-T in patients with asthma and rhinoconjunctivitis was safe and well tolerated.