Clinical trial: a multistrain probiotic preparation significantly reduces symptoms of irritable bowel syndrome in a double-blind placebo-controlled study

Background  The efficacy of probiotics in alleviating the symptoms of irritable bowel syndrome (IBS) appears to be both strain- and dose-related.
Aim  To investigate the effect of LAB4, a multistrain probiotic preparation on symptoms of IBS. This probiotic preparation has not previously been assessed in IBS.
Methods  Fifty-two participants with IBS, as defined by the Rome II criteria, participated in this double blind, randomized, placebo-controlled study. Participants were randomized to receive either a probiotic preparation comprising two strains of Lactobacillus acidophilus CUL60 (NCIMB 30157) and CUL21 (NCIMB 30156), Bifidobacterium lactis CUL34 (NCIMB 30172) and Bifidobacterium bifidum CUL20 (NCIMB 30153) at a total of 2.5 × 10¹⁰ cfu/capsule or a placebo for 8 weeks. Participants reported their IBS symptoms using a questionnaire fortnightly during the intervention and at 2 weeks post-intervention.
Results  A significantly greater improvement in the Symptom Severity Score of IBS and in scores for quality of life, days with pain and satisfaction with bowel habit was observed over the 8-week intervention period in the volunteers receiving the probiotic preparation than in the placebo group.
Conclusion  LAB4 multistrain probiotic supplement may benefit subjects with IBS.     

Risperidone in the treatment of tourette syndrome: a double-blind, placebo-controlled trial.

A double-blind, placebo-controlled trial was performed to determine the efficacy and tolerability of 8 weeks of treatment with risperidone in the management of 48 adolescent and adult patients with Tourette syndrome. Twenty-four patients were randomly assigned to treatment with risperidone in doses of 0.5 to 6.0 mg/day, and 24 were assigned to placebo. The dosage of medication was increased in fixed increments during the first week of double-blind treatment and thereafter in a flexible dose regimen according to clinical response. Risperidone, at a median dose of 2.5 mg/day (range, 1 to 6 mg/day), was found to be significantly ( p < 0.05) superior to placebo on the Global Severity Rating of the Tourette Syndrome Severity Scale. The proportion of patients who improved by at least one point on this seven-point scale was 60.8% in the risperidone group and 26.1% in the placebo group. Treatment with risperidone was accompanied by an improvement in global functioning in patients with average to above-average impairment at baseline as measured by the Global Assessment of Functioning scale. With respect to extrapyramidal symptom scores measured on the Extrapyramidal Symptom Rating Scale, hypokinesia and tremor increased in the risperidone group, but the effect on tremor was largely confined to subjects with higher baseline tremor scores. There were no significant differences in dystonic reactions, dyskinetic movements, subjective parkinsonism, or akathisia. Risperidone did not increase obsessive-compulsive symptoms. Fatigue and somnolence were the most common adverse events associated with risperidone.     

Clinical trial: a randomized-controlled crossover study of intrapyloric injection of botulinum toxin in gastroparesis

BACKGROUND: Uncontrolled studies suggest benefit of intrapyloric injection of botulinum toxin (botox) for the treatment of gastroparesis, but controlled data are lacking. AIM: To perform a controlled study of botox injection in gastroparesis. METHODS: Twenty-three gastroparesis patients (five men, age 45 +/- 3, 19 idiopathic) underwent two upper endoscopies with 4-week interval, with injection of saline or botox 4 x 25 U in a randomized double-blind-controlled crossover fashion. Before the start of the study and 4 weeks after each treatment, they underwent a solid and liquid gastric emptying breath test with measurement of meal-related symptom scores, and filled out the Gastroparesis Cardinal Symptom Index. Results (mean S.E.M.) were compared using Student's t-test. RESULTS: Twelve patients received botox and 11 saline as the first injection. Significant improvement in emptying and Gastroparesis Cardinal Symptom Index was seen after initial injection of saline or botox. No further improvement occurred after the second injection (respectively, botox and saline). Pooled data for both treatment groups showed no significant difference in improvements of solid t(1/2) (3.4 +/- 7.4 vs. 16.3 +/- 8.3, N.S.) and liquid t(1/2) (8.2 +/- 13.7 vs. 22.5 +/- 7.7, N.S.), meal-related symptom scores or Gastroparesis Cardinal Symptoms Index (GCSI; 6.1 +/- 1.5 vs. 3.8 +/- 1.5, N.S.). CONCLUSION: In a cohort of predominantly idiopathic gastroparesis patients, botox is not superior to placebo in improving either symptoms or the rate of gastric emptying.     

Differential effects of escitalopram on attention: a placebo-controlled, double-blind cross-over study

Rationale

The role of serotonin (5-HT) in attention is not fully understood yet.

Objective

We aimed to investigate whether attention is modulated after treatment with escitalopram, a selective serotonin reuptake inhibitor (SSRI).

Methods

We administered 10 mg of escitalopram to 20 healthy subjects in a placebo-controlled, double-blind cross-over design for 1 day or to another 20 participants for a period of 7 days. Attention was assessed at time of plasma peak escitalopram concentration using the computerised Attention Network Test (ANT), which is a combined flanker and cued reaction time task.

Results

The results showed differential effects of serotonergic manipulation on attention depending on sequence of intake. For the acute treatment, we found significant differences between escitalopram and placebo for all warning conditions dependent of sequence of intake: participants receiving escitalopram as first treatment showed significant slower reaction times in all warning conditions as compared with placebo while participants receiving escitalopram as second treatment showed significant faster reaction times as compared with placebo. For the sub-chronic treatment, we found significant differences between escitalopram and placebo depending on sequence of intake, but only for the flanker condition: participants receiving escitalopram first had significant slower reaction times in incongruent trials with escitalopram as compared with placebo while participants starting with placebo had significant shorter reaction times in incongruent trials with escitalopram.

Conclusions

Thus, the results showed a differential effect of escitalopram in cognition, especially in attention, and are discussed with regard to an interaction between serotonin and familiarity with the attention test.     

Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome – results of two randomized, placebo-controlled studies

Background Effective treatments for irritable bowel syndrome with constipation (IBS‐C) are lacking. Aim To assess the efficacy and safety of lubiprostone in IBS‐C. Methods A combined analysis was performed among 1171 patients with a Rome II diagnosis of IBS‐C in two phase‐3 randomized trials of lubiprostone 8 mcg vs. placebo twice daily for 12 weeks. Using a balanced seven‐point Likert scale ranging from significantly relieved (+3), to significantly worse (?3), patients responded on their electronic diary to the question: ‘How would you rate your relief of IBS symptoms over the past week compared to how you felt before you entered the study?’. The primary efficacy endpoint was the percentage of overall responders. Results Using an intent‐to‐treat analysis with last observation carried forward, a significantly higher percentage of lubiprostone‐treated patients were considered overall responders compared with those treated with placebo (17.9% vs. 10.1%, P = 0.001). Patients treated with lubiprostone reported a similar incidence of adverse events to those treated with placebo. Conclusions The percentage of overall responders based on patient‐rated assessments of IBS‐C symptoms was significantly improved in patients treated with lubiprostone 8 mcg twice daily compared to those treated with placebo. Lubiprostone was well tolerated with a favourable safety profile.     

Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation – a 12-week, randomized, double-blind, placebo-controlled study

Background  Chronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL).
Aim  A randomized, double-blind, placebo-controlled, phase III trial to evaluate the efficacy and safety of a selective, high-affinity 5-HT₄ receptor agonist, prucalopride, in patients with chronic constipation [≤2 spontaneous complete bowel movements (SCBMs)/week].
Methods  Placebo, 2 or 4 mg prucalopride was administered orally once daily, for 12 weeks. The primary efficacy endpoint was the proportion of patients with ≥3 SCBMs/week, averaged over 12 weeks. Other assessments included BM frequency, constipation-related QoL and symptoms and tolerability.
Results  Among 641 patients, significantly more patients taking prucalopride 2 or 4 mg (24%) than placebo (12%), achieved the primary efficacy endpoint (≥3 SCBMs/week) or an increase of ≥1 SCBMs/week; 43% and 47% vs. 28% respectively. Prucalopride-treated patients also achieved significantly greater satisfaction with treatment and bowel function, and improved perception of constipation severity and constipation-related QoL, compared with placebo. Most frequent treatment-related adverse events were headache, abdominal pain, nausea and diarrhoea (mainly during day 1). There were no differences in comparison to placebo in the incidence of serious adverse effects or cardiovascular events.
Conclusion  Over 12 weeks, prucalopride was effective and well tolerated in chronic constipation.     

Etodolac therapy for osteoarthritis: a double-blind, placebo-controlled trial

The efficacy of etodolac (600 mg/day) and placebo were compared in a 4-week double-blind, parallel-group study involving 104 patients with osteoarthritis of the knee and 106 with osteoarthritis of the hip. Most patients had improvement of their symptoms during the study, but significantly more improvement was seen in the patients taking etodolac. Patients with osteoarthritis of the knee taking etodolac had significantly (p less than 0.05) more improvement than placebo-treated patients in joint swelling, weight-bearing pain, and patient's overall assessment. Patients with osteoarthritis of the hip taking etodolac had significantly (p less than 0.05) greater improvement than placebo-treated patients in hip abduction, weight-bearing pain, joint tenderness, investigator's overall assessment, and patient's overall assessment. The frequency of adverse events was not statistically different in the two treatment groups. However, significantly (p = 0.05) more etodolac-treated patients (n = 9) than placebo-treated patients (n = 2) reported indigestion. The incidence of adverse events was similar in patients aged 65 years and older to that in patients younger than 65 years. Results of laboratory evaluations indicated that etodolac therapy was associated with no more hepatic or renal enzyme abnormalities than was placebo.     

A double-blind,placebo-controlled trial of sertraline in depressed adolescent alcoholics: a pilot study

In order to preliminarily evaluate the efficacy, safety and tolerability of the serotonin reuptake inhibitor, sertraline, in the treatment of adolescents with a primary depressive disorder and a comorbid alcohol use disorder, a 12-week double-blind, placebo-controlled trial of sertraline plus cognitive behavior group therapy was conducted. Subjects were 10 outpatient treatment-seeking adolescents. Baseline assessment included the K-SADS, HAM-D, SCID, and the Time-Line Follow-Back. The HAM-D and the Time-Line Follow-Back were performed weekly thereafter. Both groups showed a significant reduction in depression scores with an average reduction between baseline and endpoint HAM-D score of -9.8 (F(1,8)=26.14, p相似文献   

Loperamide oxide in acute diarrhoea: a double-blind, placebo-controlled trial

Background: Loperamide is an established treatment of acute diarrhoea with only rare adverse reactions. The pro-drug loperamide oxide is converted to loperamide by anaerobic bacteria in the lower alimentary tract. With the use of loperamide oxide, it was expected to obtain similar antidiarrhoeal efficacy as with loperamide, but with a lower dose and a lower plasma concentration. The incidence of adverse reactions might be reduced with the use of loperamide oxide. Methods: Loperamide oxide (0.5 and 1 mg capsules) was compared with placebo in a double-blind treatment of acute diarrhoea of 242 patients. Relief of diarrhoea was significantly more rapid for either dose of loperamide oxide than for placebo. Both the investigators’and the patients’global assessment of the treatment significantly favoured the loperamide oxide 1 mg capsule, but not 0.5 mg, over placebo. Adverse experiences were less frequent in the drug-treated than in the placebo-treated group. Conclusion: These results suggest that loperamide oxide 1 mg produces effective relief of diarrhoeal symptoms.     

Randomized,double-blind,placebo-controlled trial of prednisolone in post-infectious irritable bowel syndrome

BACKGROUND: Post-infectious irritable bowel syndrome is associated with increased serotonin-containing enterochromaffin cells and lymphocytes in rectal biopsies. Animal studies have suggested that steroids reduce the lymphocyte response and suppress some of the post-infectious changes in neuromuscular function. AIM: To evaluate whether steroids reduce the number of enterochromaffin cells and improve the symptoms of post-infectious irritable bowel syndrome. METHODS: Twenty-nine patients with post-infectious irritable bowel syndrome underwent a randomized, double-blind, placebo-controlled trial of 3 weeks of oral prednisolone, 30 mg/day. Mucosal enterochromaffin cells, T lymphocytes and mast cells were assessed in rectal biopsies before and after treatment, and bowel symptoms were recorded in a daily diary. RESULTS: Initial enterochromaffin cell counts were increased and correlated with initial lamina propria T-lymphocyte counts (r = 0.460, P = 0.014). Enterochromaffin cell counts did not change significantly after either prednisolone (- 0.8% +/- 9.2%) or placebo (7.9% +/- 7.9%) (P = 0.5). Although lamina propria T-lymphocyte counts decreased significantly after prednisolone (22.0% +/- 5.6%, P = 0.003), but not after placebo (11.5% +/- 8.6%, P = 0.1), this was not associated with any significant treatment-related improvement in abdominal pain, diarrhoea, frequency or urgency. CONCLUSIONS: Prednisolone does not appear to reduce the number of enterochromaffin cells or cause an improvement in symptoms in post-infectious irritable bowel syndrome. Other approaches to this persistent condition are indicated.     

Nicotine gum in smoking cessation: a placebo-controlled, double-blind trial

Sixty subjects were run in a study comparing the use of nicotine gum with placebo gum during cessation from smoking. Subjects were given clinic support and chewed the gum ad libitum. A survival analysis showed the two groups differed significantly in successful abstinence over time (p less than .03). Differences between groups appeared early (within weeks) and, at six months, a 28% superiority of nicotine over placebo gum was demonstrated with mean success rates of 48% and 20%, respectively. Between six months and one year, relapse in the nicotine group accounted for the 30% vs. 20% success rates for nicotine and placebo observed at one year. In a pilot study ("dispensary") testing the efficacy of the two gums when intervention was minimal, subjects in both groups resumed smoking within the first two weeks. The enhanced short-term success rates with nicotine gum in the clinic study are attributed to an effective interaction between use of the active preparation and clinic support. Long-term cessation may require extended maintenance procedures and/or an identification of optimal gum use.     

Nutcracker oesophagus: a double-blind, placebo-controlled, cross-over study of the effects of lansoprazole

BACKGROUND: Nutcracker oesophagus is characterized by high-amplitude oesophageal contractions. Recent data have shown a high prevalence of gastro-oesophageal acid reflux in patients with nutcracker oesophagus and, in open-label trials, patients seemed to benefit from acid suppression. Therefore, it has been suggested that non-cardiac chest pain in patients with nutcracker oesophagus may be related to reflux rather than to the motor abnormality itself. AIMS: To investigate the effect of intensive acid-suppressive treatment on chest pain in patients with nutcracker oesophagus. METHODS: Nineteen patients with nutcracker oesophagus received lansoprazole or placebo in a double-blind, randomized, cross-over study. RESULTS: Significant reductions in pain intensity (P < 0.006) and pain duration (P < 0.05) were registered during the study. The magnitude of symptom relief achieved with lansoprazole did not differ significantly from that achieved with placebo. The motility pattern did not change during the study. CONCLUSIONS: This study does not prove that acid-suppressive therapy is effective for pain relief in nutcracker oesophagus. As the amelioration of pain was not accompanied by any change in the nutcracker oesophagus pattern, it is unlikely that the high-amplitude oesophageal contractions are the cause of pain. Thus, the possible role of acid in the pathophysiology of pain in nutcracker oesophagus needs further study.     

Otilonium bromide in irritable bowel syndrome: a double-blind, placebo-controlled, 15-week study

Aim:

To evaluate the efficacy of otilonium bromide, a spasmolytic agent, in the treatment of irritable bowel syndrome using modern and validated diagnostic criteria.

Methods:

Three hundred and seventy-eight patients with irritable bowel syndrome were enrolled in the study. At entry, endoscopy/barium enema, clinical examination and laboratory tests were used to rule out organic diseases. After a 2-week placebo run-in, 325 patients were randomly assigned to receive either otilonium bromide 40 mg t.d.s. or placebo for 15 weeks. Abdominal pain, abdominal distension and disturbed defecation were scored at the beginning of the study and every 5 weeks. A global determination of well-being by visual analogue scale and the tenderness of the sigmoid colon were also scored.

Results:

The reduction in the number of abdominal pain episodes was significantly higher (P < 0.01) in otilonium bromide patients (55.3%) than in those taking placebo (39.9%) as was the severity of abdominal distension (42.0% vs. 30.2%; P < 0.05). Bowel disturbance improved in both groups, but without any statistically significant difference. The visual analogue scale of well-being revealed a significant improvement (P < 0.05) in patients taking otilonium bromide. The investigators’ global positive assessment was in favour of otilonium bromide (65.2%) compared with placebo (49.6%) (P < 0.01).

Conclusions:

Otilonium bromide may represent an effective treatment for irritable bowel syndrome because it reduces its predominant symptom (abdominal pain/discomfort) more than placebo does.

     

Neurological, cardiovascular and metabolic effects of mefloquine in healthy volunteers: a double-blind, placebo-controlled trial

1 To assess neurological, cardiovascular, metabolic and other side-effects of mefloquine given in conventional prophylactic dose to healthy volunteers, a double-blind, randomized, placebo-controlled trial was conducted. In addition, the identity of the active drug was concealed until the end of the trial.
2 A total of 106 healthy adults were recruited, of whom 95 (mean age 24 years; 45% males) completed the full study protocol.
3 Subjects had a baseline assessment, received placebo as first dose, were randomized to mefloquine 250  mg or placebo weekly for 4 weeks starting a week later, and were reassessed after the 2nd and 4th active/placebo doses. Subjects kept a daily symptom diary from 2 weeks before until 2 weeks after the dosing period.
4 Plasma mefloquine assay suggested compliance in all 46 subjects allocated active treatment (week 5 mean±s.d.; 2.35±0.94  μmol l⁻¹). Mefloquine did not alter calcium homoeostasis but produced a mean 0.5  mmol l⁻¹ fall in serum glucose over the study period ( P <0.001) and relative hyperinsulinaemia. Symbol digit modalities, and digit forwards and backwards test scores, were similar in active and placebo groups across the three assessments, as were lying/standing blood pressure and high-tone hearing loss. Electrocardiographic QT_c interval prolongation and diarrhoea were mild but transient side-effects of mefloquine ( P <0.01). Neurological symptoms were comparable in the two groups throughout the study. There was no evidence of drug toxicity in 11 subjects who withdrew.
5 Mefloquine prophylaxis does not appear to produce low-grade but debilitating neurological symptoms or to alter the results of sensitive tests of cerebral function. However, there may be situations in which mefloquine might contribute to hypoglycaemia and cardiac dysrhythmias.     

Added donepezil for stable schizophrenia: a double-blind,placebo-controlled trial

Rationale Schizophrenia is a disorder with cognitive deficits that could stem from cholinergic dysfunction. Objectives Our aim was to examine if donepezil administered to stable, medicated outpatients with schizophrenia improves cognition and psychopathology. Methods We conducted a double-blind placebo-controlled trial of donepezil up to 10 mg/day added for 8 weeks to ongoing antipsychotic treatment in 36 typical community-treated schizophrenia patients not selected for cognitive impairment. Results Donepezil did not improve measures of cognition or psychopathology. It was well tolerated. Conclusion Consistent with other studies, addition of donepezil to stable patients with schizophrenia did not improve cognition or measures of psychopathology. This result does not support the hypothesis that residual symptoms and cognitive problems result from a cholinergic deficit that can be remedied by an acetylcholinesterase inhibitor. A donepezil add-on strategy might make sense in selected schizophrenia cases where a pathological process is known to affect cholinergic neurons (e.g., history of head injury or comorbid dementia).     

Anxiogenic effects of Sumatriptan in panic disorder: a double-blind, placebo-controlled study.

BACKGROUND: Several lines of evidence point to serotonergic abnormalities in patients with panic disorder (PD). Our goal was to further examine central serotonergic function in panic patients using autonomic and subjective responses to the postsynaptic serotonin 5-HT1D receptor agonist Sumatriptan. METHOD: Using a double-blind, randomized, placebo-controlled design, we assessed autonomic and subjective responses to oral Sumatriptan (100 mg) and placebo in 15 patients with PD, free of medication. Subjective responses were measured using the Hamilton Anxiety Rating Scale (HAM-A), National Institute of Mental Health Anxiety Scale (NIMHA), a modified version of the Panic Symptom Inventory (PI), Hamilton Depression Rating Scale (HAM-D), and Montgomery-Asberg Depression Rating Scale (MADRS). RESULTS: PD patients exhibited significantly enhanced autonomic and subjective responses following challenge with Sumatriptan. We observed an increased pulse rate and augmentation of various parameters measured on different anxiety scales. A constant inclination of aggravation of the measured parameters was detected during the hour post challenge. CONCLUSION: Oral administration of Sumatriptan, a 5-HT1D agonist, has been associated with an anxiogenic effect in PD patients.     

Tetrodotoxin alleviates acute heroin withdrawal syndrome: a multicentre, randomized, double-blind, placebo-controlled study

1. Tetrodotoxin (TTX) is a powerful sodium channel blocker extracted from the puffer fish. The efficacy and safety of TTX as monotherapy for the treatment of acute heroin withdrawal syndrome were evaluated in the present study. This 7-day, multicentre, randomized, double-blind, placebo-controlled study was carried out between December 2008 and October 2009. In total, 216 patients who met the Diagnostic and Statistical Manual of Mental Disorders IV diagnosis of heroin addiction were recruited. After providing written informed consent, subjects were randomly assigned to double-blind treatment in one of the following groups: 5 μg TTX group (group 1), 10 μg TTX group (group 2) or the placebo group (group 3). 2. Evidence suggests that both 5 and 10 μg TTX significantly reduced withdrawal symptoms by day 3 compared with placebo, and there was no significant difference in the incidence of adverse events in the three groups. 3. In conclusion, this clinical trial shows that TTX (5 and 10 μg given t.i.d.) is effective in alleviating opiate withdrawal symptoms with few side-effects.     

A randomized, double-blind, placebo-controlled trial of fluvoxamine in patients with schizophrenia: a preliminary study

ABSTRACT: Cognitive impairments in schizophrenia are associated with suboptimal psychosocial performance. Several lines of evidence have suggested that endoplasmic reticulum protein sigma-1 receptors were involved in cognitive impairments in patients with schizophrenia and that the sigma-1 receptor agonist fluvoxamine was effective in treating cognitive impairments in animal models of schizophrenia and in some patients with schizophrenia. A randomized, double-blind, placebo-controlled, parallel trial of fluvoxamine adjunctive therapy in patients with schizophrenia was performed. A total of 48 patients with chronic schizophrenia were enrolled. Subjects were randomly assigned to an 8-week administration of add-on fluvoxamine (n = 24, titrated up to 150 mg/d) or placebo (n =24) in a total 12-week double-blind trial. The primary outcome measure was the Cambridge Neuropsychological Test Automated Battery (CANTAB), assessing visual memory, working memory, attention, and executive function. The secondary outcome measures were the Positive and Negative Syndrome Scale, the Scale for the Assessment of Negative Symptoms, the Quality of Life Scale, and the Montgomery-?sberg Depression Rating Scale. Fluvoxamine was well tolerated. No significant time × group interaction effects were observed in the scores of the CANTAB, Positive and Negative Syndrome Scale, Scale for the Assessment of Negative Symptoms, Quality of Life Scale, or the Montgomery-?sberg Depression Rating Scale. However, in secondary analyses, the change from baseline to end point on the Spatial Working Memory strategy score (executive function) of CANTAB improved in the fluvoxamine group. This study suggests no major benefit of fluvoxamine adjunctive therapy to improve cognitive impairments in patients with schizophrenia. Nevertheless, a further study using a large sample size will be needed to confirm the secondary analyses findings.     

Clinical trial: oral ondansetron for reducing vomiting secondary to acute gastroenteritis in children – a double-blind randomized study

Background  Vomiting as a consequence of gastroenteritis frequently occurs in children. It is still debatable whether vomiting should be treated with antiemetic drugs.
Aim  To investigate potential beneficial effects of ondansetron in treating vomiting during acute gastroenteritis.
Methods  A randomized, double blind, placebo-controlled trial was performed in our emergency departments. Children, aged 5 months to 8 years, were randomized to receive either ondansetron 0.2 mg/kg or placebo at 8h intervals. The primary outcome measure was the frequency of emesis during an 8-h-period after enrolment.
Results  A hundred and nine patients were enrolled; 54 received placebo and 55 received ondansetron. As compared with the children who received placebo, children who received ondansetron were less likely to vomit both during the first 8-h follow-up in the emergency department [relative risk (RR): 0.33, 95% CI: 0.19–0.56, NNT: 2, 95% CI: 1.6–3.5], and during the next 24-h follow-up (RR: 0.15, 95% CI: 0.07–0.33, NNT: 2, 95% CI: 1.3–2.1).
Conclusion  Ondansetron may be an effective and efficient treatment that reduces the incidence of vomiting from gastroenteritis during both the first 8 h and the next 24 h, and is probably a useful adjunct to oral rehydration.     

Oxcarbazepine in patients with impulsive aggression: a double-blind, placebo-controlled trial

OBJECTIVE: Impulsive aggression is a common clinically significant symptom, but there are few controlled studies evaluating drug treatment. This study evaluated oxcarbazepine in patients with impulsive aggression and whether diagnosis or other baseline characteristics predict response. METHOD: Eligible outpatients had clinically significant impulsive aggression, without other psychiatric symptoms clearly requiring treatment. Patients were randomized to oxcarbazepine or placebo, double-blind, for 10 weeks, at a variable dose increasing to 1200 mg/d if tolerated and to 2400 mg/d if aggression persisted. Primary outcome measures were (1) change in a Global Overt Aggression rating derived from the Overt Aggression Scale-Modified and (2) patient-rated global improvement. RESULTS: Of 48 patients, 24 per group, 9 dropped out due to adverse events, but 45 completed at least 4 weeks on double-blind medication. Analyses showed consistent evidence of benefit from oxcarbazepine, compared with placebo, on both primary efficacy measures and most secondary measures. There were no significant interactions between diagnosis or other baseline characteristics and differential response to oxcarbazepine or placebo. CONCLUSION: Oxcarbazepine appears to benefit adults with clinically significant impulsive aggression.