Meta-analysis: ondansetron for vomiting in acute gastroenteritis in children

BACKGROUND: Vomiting is a common sympton in children with gastroenteritis, but its treatment remains controversial. AIM: To investigate potential beneficial effects of ondansetron, compared with placebo or no intervention, in treating vomiting during acute gastroenteritis in children. METHODS: The following electronic databases were searched through August 2006: MEDLINE, EMBASE, CINAHL and The Cochrane Library; additional references were obtained from reviewed articles. Only randomized-controlled trials (RCTs) were included. RESULTS: Four RCTs involving 490 patients with vomiting during acute gastroenteritis were included. Combined data from three RCTs (n = 466) showed that ondansetron compared with the control significantly increased the chance for vomiting cessation soon after drug administration [relative risk (RR): 1.3, 95% confidence interval (CI): 1.2-1.5, number needed to treat (NNT): 5, 95% CI: 4-8], but this effect was not observed at 24 h (three RCTs, n = 144, RR 1.2, 95% CI: 0.9-1.7). Ondansetron significantly reduced the risk of intravenous rehydration (two RCTs, n = 359, RR 0.4, 95% CI: 0.3-0.7, NNT 7, 95% CI: 5-14). Outcome measures not significantly different after ondansetron treatment were the need for hospitalization and return emergency department visits. CONCLUSIONS: Despite some clinical benefits, there is insufficient evidence to recommend the routine use of ondansetron for vomiting during acute gastroenteritis in children.     

Nitazoxanide in the treatment of viral gastroenteritis: a randomized double-blind placebo-controlled clinical trial

Summary

Background

Enteric viruses including noroviruses and rotavirus are leading causes of diarrhoeal disease and gastroenteritis worldwide, and there is no effective treatment.

Aim

To evaluate nitazoxanide, a thiazolide anti‐infective agent, in treating viral gastroenteritis in adults and adolescents.

Methods

50 out‐patients at least 12 years of age (mean 33.5 years) presenting with diarrhoea and stool‐positive by enzyme‐linked immunosorbent assay for norovirus, rotavirus or adenovirus were enrolled in a double‐blind, placebo‐controlled clinical trial. Patients were randomly assigned either nitazoxanide 500 mg or placebo twice daily for 3 days. The primary end point was time from first dose to resolution of symptoms. Analysis was modified intent‐to‐treat for 45 patients, excluding five patients with other identified enteropathogens at baseline.

Results

The median time from first dose to resolution of symptoms was 1.5 days (IQR: 0.5–2.5) for nitazoxanide‐treated patients and 2.5 days (IQR: 1.5–4.5) for the placebo group. Significant reductions in time to resolution of symptoms were observed for all patients analysed (P < 0.0001) and for subsets of patients with rotavirus (P = 0.0052) and norovirus (P = 0.0295). The number of patients with adenovirus (n = 5) was too small to draw any conclusion. No significant adverse events were reported.

Conclusions

Nitazoxanide may play an important role in managing viral gastroenteritis in adults.

     

Venlafaxine for acute heroin detoxification: a double-blind, randomized, control trial

OBJECTIVES: Dissatisfaction with current available heroin detoxification regimens has led to the search for alternatives. Evidences have shown that several neurotransmission systems, including serotonin, are involved in opioid withdrawal. This study investigated the efficacy and tolerability of venlafaxine, a serotonin-norepinephrine reuptake inhibitor, in managing heroin withdrawal symptoms. METHODS: This was a randomized, double-blind, and placebo-controlled 7-day trial. Thirty-four heroin-dependent inpatients seeking detoxification were enrolled and assigned to either the venlafaxine (n = 15) or the placebo group (n = 19). The subjects received either venlafaxine 300 mg/d or placebo as their treatment regimen. Outcome measures were Objective Opioid Withdrawal Scale, total sleeping time, visual analog scale for subjective withdrawal severity, Clinical Global Impression scores on discharge, patient's impression of treatment, and amount of ancillary medications used. Data of outcome measures were analyzed by generalized estimating equation model. RESULTS: We analyzed the data from 20 subjects (8 in venlafaxine group and 12 in placebo group) who remained in the study after the fifth day of the trial. Objective Opioid Withdrawal Scale, visual analog scale, and total sleeping time demonstrated a significant efficacy of venlafaxine compared with the placebo group (P < 0.0001, P = 0.0195, and P < 0.0001, respectively). There was no difference in Clinical Global Impression and patient's impression of treatment between the 2 groups, although the placebo group needed more ancillary medications. CONCLUSIONS: Despite the small sample size, this study showed that venlafaxine is effective in alleviating withdrawal symptoms of heroin with good tolerability and safety.     

Clinical trial: effects of botulinum toxin on levator ani syndrome – a double-blind, placebo-controlled study

Background  Levator ani syndrome is characterized by anorectal discomfort/pain, treatment of which is unsatisfactory. We hypothesized that Botulinum toxin relieves spasm and improves symptoms.
Aim  To perform a randomized, placebo-controlled, crossover study to examine the efficacy and safety of botulinum toxin in patients with levator ani syndrome.
Methods  Twelve patients with levator ani syndrome (≥1 year) received anal intra sphincteric injections of 100 units of botulinum toxin A and placebo at 90-day intervals using EMG guidance. Daily frequency, severity, duration and intensity of pain (VAS) were recorded. Anorectal manometry, balloon expulsion and pudendal nerve latency tests were performed to examine the physiological changes and adverse effects.
Results  Seven patients (male/female = 4/3) completed the study and three had incomplete data, but all 10 underwent in an ITT analysis; two others dropped out. After administration of botulinum toxin, the mean frequency, intensity and duration of pain were unchanged ( P  = 0.31) compared with baseline. The 90-day mean VAS pain score was 6.79 ± 0.27 vs. baseline score of 7.08 ± 0.29 ( P  = 0.25). Anal sphincter pressures, rectal sensory thresholds, pudendal nerve latency and balloon expulsion times were unchanged after drug or placebo administration.
Conclusions  Injection of botulinum toxin into anal sphincter is safe, but it does not improve anorectal pain in levator ani syndrome.     

Effect of oral omeprazole in reducing re-bleeding in bleeding peptic ulcers: a prospective,double-blind,randomized, clinical trial

BACKGROUND: Endoscopic therapies and continuous intravenous omeprazole can decrease the morbidity and duration of hospital stay of patients with high-risk peptic ulcer. AIM: To evaluate the role of oral omeprazole in high-risk bleeders. METHODS: After injection therapy of 160 patients with high-risk peptic ulcer, 80 received oral omeprazole and 80 received placebo, and all were followed up. RESULTS: One hundred and forty-nine patients (71 omeprazole and 78 placebo) completed the study. Eleven patients were excluded from the study. Thirty-seven (25%) patients had gastric ulcer and 112 (75%) had duodenal ulcer. Fifty-seven (38%) ulcers showed visible vessels, 80 (54%) showed oozing of blood and 12 (8%) showed a spurting artery. Only one patient died (placebo group). The mean hospital stays were 62.8 +/- 28.6 h and 75 +/- 39 h in the omeprazole and placebo groups, respectively (P = 0.032). The mean amounts of blood transfused were 1.13 +/- 1.36 and 1.68 +/- 1.68 bags in the omeprazole and placebo groups, respectively (P = 0.029). The re-bleeding rate was lower in the omeprazole group than in the placebo group (12 vs. 26, respectively; P = 0.022). CONCLUSION: Oral omeprazole is effective in decreasing the hospital stay, re-bleeding rate and the need for blood transfusion in high-risk ulcer bleeders treated with endoscopic injection therapy.     

Intramuscular (IM) ziprasidone 20 mg is effective in reducing acute agitation associated with psychosis: a double-blind, randomized trial

RATIONALE: Intramuscular (IM) conventional antipsychotics and/or benzodiazepines are effective in the short-term treatment of acutely agitated psychotic patients but may be associated with adverse effects. A short-acting IM formulation of the novel antipsychotic, ziprasidone, which may offer advantages over conventional agents, has been developed. OBJECTIVE: To compare ziprasidone IM 2 mg (n=38) and 20 mg (n=41) in the acute control and short-term management of agitated psychotic patients. METHODS: A prospective, randomized, double-blind, 24-h study assessed efficacy using the Behavioral Activity Rating Scale (BARS) and the PANSS. The BARS is a validated rating scale for the assessment of treatment response in acute agitation associated with psychosis. Following the initial dose, three more doses could be given 4 h apart if needed during the 24-h period. RESULTS: The mean BARS score had decreased 15 min after the first 20 mg IM dose and was statistically significantly lower than the 2 mg group at 30 min post-dose. The improvement with the 20 mg dose increased until 2 h, and was maintained until at least 4 h post-dose (P<0.001). Two hours after the first injection, almost all of the patients receiving ziprasidone 20 mg were BARS responders compared with just one-third of those receiving 2 mg ziprasidone (P<0.001). The calming effect of ziprasidone was also evident by the significant reduction in PANSS agitation items (P<0.05) and CGI-severity at 4 h (P=0.008). Both ziprasidone doses were very well tolerated. Ziprasidone IM 20 mg was not associated with EPS, dystonia, akathisia, respiratory depression or with excessive sedation. CONCLUSIONS: Ziprasidone IM 20 mg substantially and significantly reduced the symptoms of acute agitation in patients with psychotic disorders. Ziprasidone 20 mg IM was very well tolerated and produced no dystonia or akathisia.     

托氟沙星治疗急性细菌性感染的随机双盲对照试验

目的 :评价新药托氟沙星治疗急性细菌性感染的临床安全性、有效性。方法 :以司帕沙星胶囊为对照药物 ,进行随机双盲对照治疗急性细菌性感染的试验。试验组 2 9例 [男性 13例 ,女性 16例 ,年龄 (4 0±s15 )a]用托氟沙星 15 0mg ,po ,tid ;对照组31例 [男性 14例 ,女性 17例 ,年龄 (4 1± 16 )a]用司帕沙星 30 0mg ,po ,qd ;疗程均为 7～10d ,重者延长至 14d。结果 :试验组的临床痊愈率和有效率分别为 79%和 93% ,对照组分别为 84 %和 10 0 % ;2组的细菌清除率分别为 91%和 96 % ;不良反应发生率分别为 13%和 8% ;差异均无显著意义 (P >0 .0 5 )。结论 :托氟沙星治疗急性细菌性感染是有效和安全的 ,与司帕沙星相当     

Dextroamphetamine for cocaine-dependence treatment: a double-blind randomized clinical trial

A properly implemented agonist treatment regimen should improve retention and reduce illicit drug use. Cocaine-dependent subjects (N = 128) were enrolled in a 12-week randomized, double-blind, placebo-controlled trial. In the multistage dosing design, subjects initially received placebo (PBO) or 15 to 30 mg of dextroamphetamine sulfate, sustained-release capsules. At week 5, the dose doubled to 30 mg or 60 mg for active groups. Subjects attended the clinic twice a week, provided urine samples, obtained medication, and had one behavioral therapy session a week. Retention was best for the 15- to 30-mg group, whereas the proportion of benzoylecgonine-positive urine screens was, from lowest to highest, 30 to 60 mg, 15 to 30 mg, and PBO at study end. Dosing must be refined. The results provide support for additional examination of the agonist model in psychostimulant-dependence treatment.     

Olanzapine compared to lithium in mania: a double-blind randomized controlled trial

Neuroleptics are of established efficacy in mania. Controlled data on the use of olanzapine in mania is however, absent. In this study, 30 patients meeting DSM-IV criteria for mania were randomly allocated to receive either olanzapine or lithium in a 4 week double-blind randomized controlled design. There were no significant outcome differences between the two groups on any of the primary outcome measures, the Brief Psychiatric Rating Scale (lithium 28.2; olanzapine 28.0; P = 0.44); Clinical Global Impression (CGI) improvement scale (lithium 2.75, olanzapine 2.36; P = 0.163) or the Mania Scale (lithium 13.2, olanzapine 10.2; P = 0.315). Olanzapine was however, significantly superior to lithium on the CGI-severity scale at week 4 (lithium 2.83, olanzapine 2.29; P = 0.025). Olanzapine did not differ from lithium in terms of treatment emergent extrapyramidal side-effects as measured by the Simpson-Angus Scale. Olanzapine appears to be at least as effective as lithium in the treatment of mania.     

Acute gastroenteritis in children: role of anti-emetic medication for gastroenteritis-related vomiting

Acute gastroenteritis is associated with significant morbidity in developed countries and each year is the cause of death of several million children in developing countries. Acute gastroenteritis is usually self-limiting. Oral rehydration therapy (ORT) is effective and successful in the majority of patients. Vomiting is common at the outset of viral gastroenteritis and can limit the effectiveness of ORT. Treatment with newer anti-emetic medications has been reported to facilitate ORT and to minimize the risk of dehydration and the need for intravenous hydration and hospitalization.The role of anti-emetic medications in the treatment of gastroenteritis-related vomiting is not clear. Some physicians agree with the use of anti-emetic medications because vomiting is unpleasant and distressing for the child and parents alike, and because vomiting can increase the likelihood of dehydration, electrolyte imbalance, and the need for intravenous hydration or hospitalization. Several surveys have shown that anti-emetic medications are commonly prescribed in the treatment of pediatric gastroenteritis and that adverse events are uncommon. Efficacy studies of the newer anti-emetic medications are now available and reveal that some are effective and help facilitate ORT. Other physicians disagree with the use of anti-emetic medications because acute gastroenteritis is a self-limiting condition, vomiting might help rid the body of toxic substances, there was previously a relative lack of published evidence of clinical benefit, and there are potential adverse events associated with the use of an anti-emetic medication. Anti-emetic medications that are currently available include ondansetron, granisetron, tropisetron, dolasetron, ramosetron, promethazine, dimenhydrinate, metoclopramide, domperidone, droperidol, prochlorperazine, and trimethobenzamide. Randomized, placebo-controlled trials suggest that ondansetron is efficacious and superior to other anti-emetic medications in the treatment of gastroenteritis-related vomiting. A recent double-blind clinical trial showed that a single oral dose of ondansetron reduces gastroenteritis-related vomiting and facilitates ORT without significant adverse events. Ondansetron shows promise as a first-line anti-emetic, and judicious use of this agent might increase the success of ORT, minimize the need for intravenous therapy and hospitalization, and reduce healthcare costs. Ondansetron should be considered in situations where vomiting hinders ORT, but a larger randomized, placebo-controlled trial is necessary before the medication can be routinely recommended for the treatment of gastroenteritis-related vomiting in children.     

Topical heparin for the treatment of acute superficial phlebitis secondary to indwelling intravenous catheter A double-blind, randomized, placebo-controlled trial

Objective: To assess the clinical efficacy of a topical gel containing 1000 IU · g⁻¹ of heparin, applied three times daily for a maximal period of 7 days to patients with acute superficial phlebitis secondary to indwelling intravenous catheter. Methods: A Double-blind, randomized, placebo-controlled study was conducted in one of the internal medicine wards of a tertiary General Hospital in Barcelona, Spain. Inpatients of both genders over 18 years of age that developed superficial phlebitis and gave informed consent were included in the study. The sample size estimation was 132 patients. Sixty-six patients were allocated to each group. There were five protocol deviations and 24 withdrawals in the intervention group, and one protocol deviation and 25 withdrawals in the control group. Consequently, 37 patients in the intervention group and 40 in the control group completed the trial. The main outcome measure was the disappearance of the symptoms and signs of superficial phlebitis. Clinical course, investigator's global impression and adverse events were also recorded. Results: According to the intention-to-treat analysis, after treatment for 7 days superficial phlebitis healed in 27 of the 61 patients (44.3%) who received topical heparin, and in 17 of the 65 patients (26.1%) receiving placebo, giving a relative risk [95% confidence interval (CI)] of 1.69 (1.03–2.78). This indicates that six patients (95% CI, 3–72) have to be treated in order to induce one additional healing. The clinical course and the overall clinical impression were similar in both groups. One patient treated with topical heparin developed mild urticaria. Conclusion: Topical heparin is safe and effective for the treatment of superficial phlebitis secondary to indwelling intravenous catheter. Received: 10 August 1998 / Accepted in revised form: 19 October 1998     

Efficacy and tolerability of DHEP-heparin plaster in reducing pain in mild-to-moderate muscle contusions: a double-blind,randomized trial

Abstract

Objectives:

To investigate if the 180-mg diclofenac epolamine and heparin sodium 5600?IU medicated plaster (DHEP-heparin) is more effective for pain reduction in mild-to-moderate contusions than the reference diclofenac epolamine 180?mg plaster (DHEP).     

Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea in children: a randomized double-blind placebo-controlled trial

BACKGROUND: Co-treatment with Saccharomyces boulardii appears to lower the risk of antibiotic-associated diarrhoea in adults receiving broad-spectrum antibiotics. AIM: To determine whether S. boulardii prevents antibiotic-associated diarrhoea in children. METHODS: A total of 269 children (aged 6 months to 14 years) with otitis media and/or respiratory tract infections were enrolled in a double-blind, randomized placebo-controlled trial in which they received standard antibiotic treatment plus 250 mg of S. boulardii (experimental group, n = 132) or a placebo (control group, n = 137) orally twice daily for the duration of antibiotic treatment. Analyses were based on allocated treatment and included data from 246 children. RESULTS: Patients receiving S. boulardii had a lower prevalence of diarrhoea (> or =3 loose or watery stools/day for > or =48 h occurring during or up to 2 weeks after the antibiotic therapy) than those receiving placebo [nine of 119 (8%) vs. 29 of 127 (23%), relative risk: 0.3, 95% confidence interval: 0.2-0.7]. S. boulardii also reduced the risk of antibiotic-associated diarrhoea (diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea) compared with placebo [four of 119 (3.4%) vs. 22 of 127 (17.3%), relative risk: 0.2; 95% confidence interval: 0.07-0.5]. No adverse events were observed. CONCLUSION: This is the first randomized-controlled trial evidence that S. boulardii effectively reduces the risk of antibiotic-associated diarrhoea in children.     

Clinical trial: prophylactic intravenous alanyl-glutamine reduces the severity of gastrointestinal toxicity induced by chemotherapy – a randomized crossover study

Background  Glutamine has been shown in numerous studies to reduce intestinal permeability which can be increased by chemotherapy. However, there have been few reports that conduct on its clinical effect on gastrointestinal toxicity.
Aim  To examine whether prophylactic intravenous alanyl-glutamine dipeptide can ameliorate clinical manifestations of gastrointestinal toxicity induced by chemotherapy.
Methods  Forty-four patients with gastric or colorectal cancer developing WHO side-effect grading system of grade 2 or higher were randomized to either control group ( n  = 22) or Gln group ( n  = 22) during next cycle of chemotherapy. Patients were crossed over to the alternate treatment during chemotherapy cycle 2. In the control group, the patients received the same chemotherapy regimens as screening cycle and in the Gln group, the patients received chemotherapy and alanyl-glutamine. Prophylactic intravenous 20 g of alanyl-glutamine dipeptide was given for 5 days.
Results  Compared with the control group, the plasma glutamine level in the Gln group was significantly higher and the plasma endotoxin level was significantly lower. The scores of nausea/vomiting and diarrhoea decreased significantly.
Conclusion  Prophylactic intravenous alanyl-glutamine is effective in preventing intestinal permeability disruption induced by chemotherapy and clinical manifestations of gastrointestinal toxicity.     

Efficacy and tolerability of DHEP-heparin plaster in reducing pain in mild-to-moderate muscle contusions: a double-blind, randomized trial

Abstract Objectives: To investigate if the 180-mg diclofenac epolamine and heparin sodium 5600?IU medicated plaster (DHEP-heparin) is more effective for pain reduction in mild-to-moderate contusions than the reference diclofenac epolamine 180?mg plaster (DHEP). Research design and methods: This multicenter, multinational, prospective, double-blind versus reference comparator and versus placebo, controlled trial had balanced random assignment in three parallel treatment groups. The DHEP-heparin medicated plaster was compared to the DHEP medicated plaster and a placebo medicated plaster. A total of 331 outpatients, aged ≥18 and ≤65 years, with unilateral mild-to-moderate muscle contusion, pain on standardized movement of ≥50?mm, and superficial hematoma of ≤10?×?14?cm(2) completed the study. Plasters were applied each morning, for ≥20 hours daily for 14 consecutive days. Outcomes were assessed in three visits, over 14 days, plus patients' daily self-assessment. Clinical trial registration: 05DCz/FHp11 - Eudra CT n: 2005-003829-31 Main outcome measures: Primary efficacy endpoint was mean change from baseline in pain on movement after 3 days of treatment, compared between groups. Secondary efficacy endpoints included mean daily change from baseline in pain on movement during treatment, pain level as assessed at control visits after 7 and 14 days, time (days) to hematoma disappearance based on patients' daily evaluations, rescue medication use, and overall treatment efficacy as judged by both patients and investigators. Results: Pain progressively declined in all groups, more rapidly in DHEP-heparin recipients, compared to DHEP, and in both active treatment groups compared to placebo. Adverse events were recorded in 24 of the 355 (6.7%) exposed patients, and generally resolved without need to interrupt treatment. Conclusion: The DHEP-heparin plaster is superior to the reference DHEP plaster in reducing pain associated with mild-to-moderate muscle contusion. Both active treatments were significantly more effective than placebo, and each showed a comparably favorable, placebo-like safety profile.