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1.
Background: Although the use of the antimicrobial, trimeth oprim-sulfamethoxazole, in combination with the antisecretory and antimotility agent, loperamide, has been shown to be efficacious in the treatment of traveler's diarrhea, the use of fluoroquinolone antimicrobials in combination with loperamide has less support in the literature. The present study was designed to compare the efficacy of ofloxacin versus ofloxacin plus loperamide in the treatment of acute traveler's diarrhea.
Method: This prospective, randomized, evaluator-blinded treatment trial was conducted in Guadalajara, Mexico, during the summers of 1992–1994. Adults newly arrived in Mexico from the United States who developed acute diarrhea of less than 2 weeks' duration were randomized to receive orally either: A) ofloxacin, 400 mg once; B) ofloxacin, 200 mg twice a day for six doses; or C) ofloxacin, 400 mg once, plus loperamide, 4 mg once followed by 2 mg after each loose stool, not to exceed 16 mg per day, for 3 days. The duration of illness was the number of hours elapsed from the beginning of therapy to the passage of the last unformed stool.
Results: Ofloxacin and loperamide were well tolerated. Combination therapy with single dose ofloxacin plus loperamide was significantly more efficacious in reducing the duration of diarrhea than single dose ofloxacin or ofloxacin given for 3 days (p < .00001). Furthermore, combination therapy was more efficacious when enterotoxigenic Escherichia coli (ETEC) was the pathogen (p < .01) or when no pathogen was isolated (p < .001). Sixty-three percent of subjects passed no further unformed stools after the initial doses of combination therapy, and 91% were well by the end of the first 24 hours.
Conclusions: The combined use of a single dose of ofloxacin with loperamide is safe and more efficacious in the treatment of traveler's diarrhea than use of ofloxacin alone.  相似文献   

2.
Background  The use of placebo in randomized clinical trials (PC-RCTs) is often required to evaluate drug efficacy in maintenance of Crohn's disease (CD).
Aim  To determine pooled estimates of placebo rates of maintaining clinical remission and endoscopic recurrence following surgery for CD and identify factors that influenced placebo outcomes.
Methods  We performed a systematic review and meta-analysis of PC-RCTs evaluating post-operative maintenance therapies for CD identified from MEDLINE from 1966 to 2005.
Results  Twelve studies met our inclusion criteria. The pooled placebo rate of maintaining clinical remission was 56% (95% CI 47–64%; range 34–89%) during a median follow-up of 52 weeks (range 12–156 weeks), but significant heterogeneity existed among the studies ( P  < 0.001). Prior steroid therapy was the only factor found to be associated with maintaining remission ( P  = 0.04). The pooled placebo endoscopic recurrence rate was 58% (95% CI 51–65%; range 36–80%) during a median follow-up of 52 weeks (range 12–156 weeks), with significant heterogeneity noted ( P  = 0.0003). Prior surgery, concomitant small bowel and colonic disease, fistulizing phenotype, or prior immunomodulator therapy influenced endoscopic recurrence ( P  < 0.05).
Conclusion  Placebo rates in PC-RCTs evaluating post-operative clinical and endoscopic recurrence demonstrate significant variability, which is influenced by specific study characteristics.  相似文献   

3.
Background : European air travelers returning from Algeria, Egypt, Mexico, Morocco, and Tunisia were interviewed about their experience of travelers' diseases upon arrival in Brussels. Diarrhea was mentioned by 37% of the adults and 27% of the children. These subjects were questioned about the types of measures taken, type and duration of drug treatment (if any), and about duration of diarrhea and side effects experienced.
Methods : Final analysis was performed based on 2160 interviews. The largest proportion of diarrhea was reported in the age group 15–24 years (46%).
Results : The majority of the 2160 subjects had opted for drug treatment (81%): 927 subjects for loperamide alone, 235 for loperamide in combination with nifuroxazide, and 178 for nifuroxazide alone. Other drugs had been used less frequently. The median time to recovery was 2.4 days with loperamide compared to 3.2 days with nifuroxazide and to 3.4 days for the no-treatment group.
Conclusions : A stratification of the results by severity of the diarrhea suggests a rank of antidiarrheal potency as follows: loperamide > nifuroxazide > no-drug treatment. The side effect with the highest incidence was constipation (2.4% with loperamide).  相似文献   

4.
Background.  In recent years, the number of travelers aged >40 years who acquire hepatitis A while traveling has increased. Therefore, there is a need to review hepatitis A vaccination protocols in travelers. The aims of the study were to assess immunity levels to hepatitis A virus (HAV) in international travelers >40 years and to determine the least costly immunization strategy.
Methods.  A serological examination of HAV antibodies in 427 international travelers aged >40 years traveling endemic zones was carried out. The prevalence of antibodies in each age group was assessed. The costs of two preventive strategies, direct vaccination of all subjects (independent of the immune status) or screening and subsequent vaccination of susceptible subjects were compared. The critical value of prevalence (CVP) (the value at which the costs for the two strategies are equal) was calculated.
Results.  Total prevalence of HAV antibodies was 78.9% [95% confidence interval (CI): 74.8–82.5] and was 80.0% (95% CI: 73.8–85.2) in men and 77.9% (95% CI: 71.9–83.2) in women. There was a positive association with age. In the 40 to 49, 50 to 59, 60 to 69, and 70 to 95 years age groups, the prevalence rates were 62.6 (95% CI: 53.8–71.5), 76.8 (95% CI: 70.0–82.7), 91.7 (95% CI: 85.2–95.6), and 97.5% (95% CI: 87.4–99.6), respectively. The CVP was 58.4% using two doses of vaccine.
Conclusions.  The CVP was lower than the prevalence rate found in our international travelers. Therefore, we recommend systematic screening for HAV antibodies before selective vaccination of international travelers aged >40 years traveling to hepatitis A endemic zones.  相似文献   

5.
Background  Uncertainty exists regarding the use of zinc in the treatment of acute gastroenteritis in children living in Europe, where zinc deficiency is rare.
Aim  To review evidence for the effectiveness of zinc in treating acute gastroenteritis in children, with special emphasis on data from developed countries.
Methods  MEDLINE, EMBASE, and the Cochrane Library were searched through November 2007 for randomized controlled trials (RCTs) relevant to acute gastroenteritis in children younger than 5 years of age and zinc; additional references were obtained from the reviewed articles.
Results  Eighteen RCTs (11 180 participants, mainly from developing countries) met the inclusion criteria. Use of zinc was associated with a significant reduction in diarrhoea duration (13 RCTs, 5643 infants, weighted mean difference −0.69 day, 95% CI −0.97 to −0.40) and the risk of diarrhoea lasting longer than 7 days [eight RCTs, n  = 5769, relative risk (RR) 0.71, 95% CI 0.53–0.96]. No significant reduction in stool volume was observed for those receiving zinc compared with placebo (three RCTs, n  = 606, standardized mean difference, −0.38, 95% CI −1.04 to 0.27). Combined data from five RCTs ( n  = 3156) showed that zinc significantly increased the chance of vomiting compared to the control agent (RR 1.2, 95% CI 1.05–1.4).
Conclusions  These data confirm that zinc supplementation can be useful for treating acute gastroenteritis in children, particularly those from developing countries. However, the role of zinc supplements in treating children with acute gastroenteritis in developed countries needs further evaluation.  相似文献   

6.
Background : The objective of the study was to compare the safety and efficacy of three treatment protocols for the prevention of travelers' diarrhea: once-daily ciprofloxacin versus trimethoprim/sulfamethoxazole (TMP/SMZ) once daily versus placebo for the prevention of travelers' diarrhea.
Method : The study population was comprised of participants in 2-week medical-missions projects based in Latin America and the Caribbean. The diverse age group and varied study sites closely resembles the population of travelers who seek pretravel advice from physicians. A prospective, randomized, double-blind, placebo-controlled comparison was designed. Subjects who developed diarrhea, defined as three stools in 8 hours plus one or more signs of an enteric infection, were considered prophylaxis failures. Stool specimens were collected and examined for the presence of enteric pathogens. DNA probes were used to determine the presence of diarrheagenic E. coli. Bacterial colony blots were used. Adverse events were recorded by participants in a diary.
Results : Three hundred and forty-four subjects were entered in the study, of which two hundred and seventy-eight subjects met the criteria for the efficacy and safety review. Subjects were randomly assigned to receive ciprofloxacin (500 mg), TMP/SMZ (160/ 800 mg), or placebo. Five of the 99 (5%) subjects taking ciprofloxacin, 14 of the 87 (16%) taking TMP/SMZ, and 30 of the 92 (33%) taking placebo experienced diarrhea. Bacterial pathogens were identified more commonly in the TMP/SMZ and placebo groups than in the ciprofloxacin-treated group. The incidence of adverse reactions was 9.0%, 14.8%, and 7.5% for ciprofloxacin, TMP SMZ, and placebo subjects, respectively (p = .287).
Conclusion : Ciprofloxacin 500 mg once daily provides safe and effective prophylaxis for travelers' diarrhea and is superior to TMP/SMZ (160/800 mg). ( J Travel Med 1:136–142, 1994)  相似文献   

7.
Background: The etiology of diarrhea among expatriates in Thailand was investigated.
Methods: One hundred and five stool specimens were collected from Americans and Europeans who had developed diarrhea while residing in Thailand. These stools were analyzed for bacterial enteric pathogens.
Results: Enterotoxigenic Escherichia coli was isolated from 18 (17%) persons and Campylobacter from 10 (10%). Shigella and Salmonella were each isolated from 8 (8%) persons. Vibrio sp., enteroinvasive Escherichia coli, and enteropathogenic Escherichia coli were found in rare cases.
Conclusions: Bacterial pathogens, particularly Campylobacter, were isolated significantly less often in patients who had lived in Thailand for more than 1 year, compared with those who had lived there less than 1 year (relative risk: 0.62, 95% confidence interval: 0.40–0.97, p=.03).  相似文献   

8.
PURPOSE: A meta-analysis of randomized, controlled trials that evaluated the effect of the macrolide antibiotic, azithromycin, on clinical outcomes in patients with coronary artery disease (CAD) was conducted. METHODS: A systematic literature search of MEDLINE, EMBASE, Web of Science, and the Cochrane Database of Systematic Reviews was conducted using specific search terms. Randomized, controlled trials comparing azithromycin or placebo in secondary CAD patients with adequately reported data on mortality and clinical cardiac endpoints were included. A random-effects model was used. RESULTS: Six studies (n=13,778) met the inclusion criteria. The trials varied in their design. On meta-analysis, azithromycin resulted in a nonsignificant reduction in mortality versus placebo (odds ratio [OR], 0.91; 95% confidence interval [CI], 0.77-1.09; p=0.31). Four trials reported the rate of nonfatal myocardial infarction (MI). Azithromycin did not have an effect on the rate of nonfatal MI versus placebo (OR, 0.95; 95% CI, 0.80-1.13; p=0.57). Five trials reported rates of hospitalization in which no significant difference was seen with azithromycin versus placebo (OR, 0.97; 95% CI, 0.80-1.17; p=0.76). Six trials were used to evaluate the composite cardiovascular endpoint. Again, no significant benefit was seen with azithromycin versus placebo (OR, 0.93; 95% CI, 0.84-1.03; p=0.218). CONCLUSION: Meta-analysis showed that azithromycin does not appear to reduce the frequency of recurrent cardiac events in patients with CAD. Results from ongoing trials may clarify the role of azithromycin in the secondary prevention of coronary events.  相似文献   

9.
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.  相似文献   

10.
Systematic review: nutritional support in acute pancreatitis   总被引:1,自引:0,他引:1  
Background  There has been controversy concerning the merits of enteral and parenteral nutrition compared with no supplementary nutrition in the management of patients with acute pancreatitis.
Aim  To perform a systematic review of the data from randomized controlled trials (RCTs) in acute pancreatitis that compares enteral nutrition with no supplementary nutrition, parenteral nutrition with no supplementary nutrition and enteral nutrition with parenteral nutrition.
Methods  A search was undertaken in the MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials.
Results  Fifteen RCTs were included. Enteral nutrition, when compared with no supplementary nutrition, was associated with no significant change in infectious complications: ratio of relative risks (RR) 0.56, 95% confidence interval (CI) 0.07–4.32, P  = 0.58, but a significant reduction in mortality: ratio of RR 0.22, 95% CI 0.07–0.70, P  = 0.01. Parenteral nutrition, when compared with no supplementary nutrition, was associated with no significant change in infectious complications: RR 1.36, 95% CI 0.18–10.40; P  = 0.77, but a significant reduction in mortality: RR 0.36, 95% CI 0.13–0.97, P  = 0.04. Enteral nutrition, when compared with parenteral nutrition, was associated with a significant reduction in infectious complications: RR 0.41, 95% CI 0.30–0.57, P  < 0.001, but no significant change in mortality: RR 0.60, 95% CI 0.32–1.14, P  = 0.12.
Conclusions  The use of either enteral or parenteral nutrition, in comparison with no supplementary nutrition, is associated with a lower risk of death in acute pancreatitis. Enteral nutrition is associated with a lower risk of infectious complications compared with parenteral nutrition.  相似文献   

11.
BACKGROUND: Antibacterial drugs appear to be effective in shortening the illness of a majority of cases of travelers' diarrhea. METHODS: This was a subanalysis from two randomized, double-blind, placebo-controlled trials in adult travelers with acute diarrhea treated with rifaximin 200 mg three times a day or placebo for 3 days. Efficacy was assessed by the interval beginning with the first dose of medication and ending with the last unformed stool passed after becoming well [time to last unformed stool (TLUS)]; number of unformed stools passed; percent with clinical improvement; and incidence of wellness achieved. RESULTS: Stool pathogens were not identified in pretreatment samples in 122 of 322 (38%) patients and 106 of 230 (46%) randomized to rifaximin and placebo, respectively. Among pathogen-negative patients, rifaximin was more effective than placebo for median TLUS (33 vs 68 h, p < 0.005), mean number of unformed stools passed (6.5 vs 8.6, p < 0.0001), and clinical wellness (77% vs 61%, p = 0.01). The adverse-event profiles between rifaximin and placebo were similar. CONCLUSIONS: More than one third of patients with travelers' diarrhea had pathogen-negative illness. Rifaximin was effective in treating the illness without associated side effects. These results are consistent with the hypothesis that undetected bacterial pathogens are the most likely cause of travelers' diarrhea without definable cause.  相似文献   

12.
Background: Both the presence of fecal leukocytes and occult blood in stool specimens of travelers with diarrhea have been used as indicators of colonie inflammation due to bacterial infection. This study was conducted to determine if storage temperature of stool specimens can affect the detection of leukocytes and occult blood.
Methods: Sixteen specimens positive for occult blood and 23 specimens positive for leukocytes were divided into two aliquots. Each aliquot was held at 4°C or 25°C and reexamined daily for fecal leukocytes or occult blood.
Results: Four percent of the positive leukocytes specimens and 56% of the occult blood positive specimens were still positive on the fifth day when they were held at 4°C. When the samples were held at 25°C, leukocytes could not be detected after 3 days, but 19% were positive for occult blood on the fifth day.
Conclusion: The results indicate that storage temperature of stool specimens was associated with a difference in detection rate.  相似文献   

13.
BACKGROUND: Alvimopan is a selective, competitive mu-opioid receptor antagonist with limited oral bioavailability which may be used to reduce length of post-operative ileus. AIM: The study compared alvimopan with placebo following bowel resection or total abdominal hysterectomy. METHODS: A meta-analysis of randomized-controlled trials published between 2001 and 2006 of alvimopan vs. placebo was performed. The primary efficacy end-points were composite measures of passage of flatus, stool, and tolerance of solid food (GI-3) and passage of stool and tolerance of solid food (GI-2). The incidence of treatment emergent adverse events was assessed. RESULTS: Five trials matched the selection criteria, reporting on 2195 patients. A total of 1521 (69.3%) had alvimopan and 674 (30.7%) placebo. GI-3 significantly improved (hazard ratio 1.30; 95% confidence intervals 1.16, 1.45, P < 0.001), as did GI-2 (hazard ratio 1.61; 95% confidence intervals 1.26, 2.05, P < 0.001) on alvimopan 12 mg. Time to discharge (hazard ratio 1.26; 95% confidence intervals 1.13, 1.40, P < 0.001), time to bowel motion (hazard ratio 1.74; 95% confidence intervals 1.29, 2.35, P < 0.001), and time to solid food (hazard ratio 1.14; 95% confidence intervals 1.01, 1.30, P < 0.04) also improved significantly. No difference was noted in the incidence of treatment emergent adverse events. CONCLUSIONS: Alvimopan showed significant advantages over placebo in restoring gastro-intestinal function, and reduced time to discharge following major abdominal surgery, with acceptable side effects.  相似文献   

14.
AIMS: Allopurinol improves endothelial function in chronic heart failure by reducing oxidative stress. We wished to explore if such an effect would attenuate autonomic dysfunction in CHF in line with many other effective therapies in CHF. METHODS: We performed a prospective, randomized, double-blind cross-over study in 16 patients with NYHA Class II-IV chronic heart failure (mean age 67 +/- 10 years, 13 male, comparing allopurinol (2 months) at a daily dose of 300 mg (if creatinine < 150 micromol l-1) or 100 mg (if creatinine > 150 micromol l-1) with matched placebo. Mean heart rate and dysrhythmia counts were recorded from 24 h Holter tapes at monthly intervals for 6 months. We assessed autonomic function using standard time domain heart rate variability parameters (HRV): SDNN, SDANN, SDNN index, rMSSD and TI. RESULTS: Allopurinol had no significant effect on heart rate variability compared with placebo; the results are expressed as a difference in means +/- s.d. with 95% confidence interval (CI) between allopurinol and placebo: SDNN mean = 6.5 +/- 4.8 ms, P = 0.18 and 95% CI (-3.7, 17); TI mean = -2.1 +/- 1.4, P = 0.16 and 95% CI (-5.2, 0.8); SDANN mean = -2.8 +/- 7 ms, P = 0.68 and 95% CI (-18, 12); SDNNi mean = 2 +/- 6.6, P = 0.7 and 95% CI (-12, 16); RMSSD mean = -0.9 +/- 2, P = 0.68 and 95% CI (-5.6, 3.7). For mean heart rate the corresponding results were 0.9 +/- 1.4, P = 0.5 and 95% CI (-2, 3.8). Log 24 h ventricular ectopic counts (VEC) were 0.032 +/- 0.37, P = 0.7 and 95% CI (-0.1, 0.2). Patient compliance with study medication was good since allopurinol showed its expected effect of reducing plasma uric acid (P < 0.001). CONCLUSIONS: Allopurinol at doses, which are known to reduce oxidative stress appear to have no significant effect on resting autonomic tone, as indicated by time domain heart rate variability or on dysrhythmia count in stable heart failure patients.  相似文献   

15.
Bias in reporting clinical trials   总被引:1,自引:0,他引:1       下载免费PDF全文
Aims To conduct a randomized placebo controlled double-blind crossover trial in order to evaluate a loratadine-pseudoephedrine combination (L+PS) in children with seasonal allergic rhinitis.
Methods Forty children (15 males; 25 females), aged 3–15 years, were included in this study. They were randomized to receive L+PS (0.2  mg  kg−1 body weight–2.4  mg  kg−1 body weight respectively) or placebo (PLA) for 14 days. After 7 days of washout, patients were shifted to the other treatment for a further 14 days. Nasal symptoms (sneezing/itching, congestion, nasal dripping) and signs (turbinal swelling, retronasal drainage), rated on a scale ranging from: 1. absent to 5. very intense, and their sum or mean total symptom score (MTSS) were used as efficacy measurement.
Results Significant relief was observed; post-treatment MTSS difference and its percent change were respectively; L+PS=−4.29; 95% CI: −3.64 and −4.94 (27.8%), and PLA=−1.63; 95% CI: −0.95 and −2.31 (10.7%) ( P <0.001 baseline vs endpoint and between treatments). Furthermore, L+PS and PLA significantly modified symptoms, but only L+PS significantly modified signs. No clinical changes were observed during the trial; only one patient showed slight transient insomnia when receiving L+PS.
Conclusions It is concluded that L+PS is useful and well tolerated in children with seasonal allergic rhinitis. However, elements such as placebo effect must be taken into account for planning future trials.  相似文献   

16.
Background  Convincing evidence that probiotic administration can lower the risk of antibiotic-associated diarrhoea is limited to certain micro-organisms.
Aim  To determine the efficacy of administration of Lactobacillus rhamnosus (strains E/N , Oxy and Pen ) for the prevention of antibiotic-associated diarrhoea in children.
Methods  Children (aged 3 months to 14 years) with common infections were enrolled in a double-blind, randomized, placebo-controlled trial in which they received standard antibiotic treatment plus 2 × 1010 colony forming units of a probiotic ( n  = 120) or a placebo ( n  = 120), administered orally twice daily throughout antibiotic treatment. Analyses were by intention to treat.
Results  Any diarrhoea (≥3 loose or watery stools/day for ≥48 h occurring during or up to 2 weeks after the antibiotic therapy) occurred in nine (7.5%) patients in the probiotic group and in 20 (17%) patients in the placebo group (relative risk, RR 0.45, 95% confidence interval, CI 0.2–0.9). Three (2.5%) children in the probiotic group developed AAD (diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea) compared to nine (7.5%) in the placebo group (RR 0.33, 95% CI 0.1–1.06). No adverse events were observed.
Conclusion  Administration of L. rhamnosus (strains E/N , Oxy and Pen ) to children receiving antibiotics reduced the risk of any diarrhoea, as defined in this study.  相似文献   

17.
Background.  Current data on risk of travelers' diarrhea (TD) among visitors to Thailand largely comes from US military personnel, Peace Corps volunteers, or expatriates. We performed a 14-month systematic study of the incidence rate and characteristics of TD and a smaller study of etiology of the disease among visitors to Phuket and Chiang Mai.
Methods.  One randomly selected day each week from August 2005 until October 2006, data were collected from foreign tourists departing from airports serving Phuket and Chiang Mai. A separate subgroup of subjects with TD acquired in Phuket were invited to submit a stool sample for enteropathogens.
Results.  Based on 22,401 completed questionnaires, the attack rate for TD was highest among residents from Australia or New Zealand (16%), while those from the United States and Europe had attack rates of 7% to 8%. Independent risk factors for the development of TD were eating outside the hotel and eating meat. In contrast, a history of drinking tap water and consuming ice cream were protective. In 56 subjects studied for etiology, Aeromonas spp were found in 8 subjects (14%), enterotoxigenic Escherichia coli (ETEC) or Vibrio spp each was found in 7 (13%) with O1 V. cholera (cholera) seen in one, mixed pathogens were found in 3 (5%), with no pathogen being detected in 33 (59%).
Conclusions.  Phuket and Chiang Mai should not be considered high-risk destinations for development of TD among US and European travelers to Thailand. In the study, Aeromonas , ETEC, and Vibrio spp were the most frequent enteropathogens identified.  相似文献   

18.
Background  The evidence on whether antioxidant supplements prevent gastrointestinal cancers is contradictory.
Aim  To assess the beneficial and harmful effects of antioxidant supplements in preventing gastrointestinal cancers.
Methods  Using the Cochrane Collaboration methodology, we reviewed the randomized trials comparing antioxidant supplements with placebo or no intervention on the occurrence of gastrointestinal cancers. We searched electronic databases and reference lists until October, 2007. Our outcome measures were gastrointestinal cancers, overall mortality and adverse events. Outcomes were reported as relative risks (RR) with 95% confidence intervals (CI) based on random-effects and fixed-effect models meta-analyses.
Results  We identified 20 randomized trials (211 818 participants) assessing beta-carotene, vitamin A, vitamin C, vitamin E, and selenium. The trial quality was generally high. The antioxidant supplements were without a significant effect on the occurrence of gastrointestinal cancers (RR 0.94, 95% CI 0.83–1.06, I 2  = 54.0%). The heterogeneity seemed to be explained by bias risk (low-bias risk trials RR 1.04, 95% CI 0.96–1.13 compared to high-bias risk trials RR 0.59, 95% CI 0.43–0.80, test of interaction P  < 0.0005) and type of antioxidant supplement (beta-carotene potentially increasing and selenium potentially decreasing cancer risk). Antioxidant supplements had no significant effect on mortality in a random-effects model meta-analysis (RR 1.02, 95% CI 0.97–1.07, I 2  = 53.5%) but significantly increased mortality in a fixed-effect model meta-analysis (RR 1.04, 95% CI 1.02–1.07).
Conclusions  We could not find evidence that the studied antioxidant supplements prevented gastrointestinal cancers. On the contrary, they seem to increase overall mortality.  相似文献   

19.
Background  Glucocorticosteroids versus placebo or no intervention for patients with alcoholic hepatitis have been evaluated for more than 35 years. However, the results of randomized trials and meta-analyses differ substantially.
Aim  To review all randomized clinical trials of glucocorticosteroids vs. placebo or no intervention for patients with alcoholic hepatitis.
Methods  We searched for randomized trials published before July 2007. The trials were assessed for risk of bias.
Results  We included 15 trials with a total of 721 randomized patients. The overall mortality rate was 39.5%. Twelve of the fifteen trials were at risk of bias. Glucocorticosteroids did not statistically reduce mortality compared with placebo or no intervention (relative risk 0.83, 95% CI 0.63–1.11). Glucocorticosteroids significantly reduced mortality in the subgroup of trials with patients with Maddrey's score of at least 32 or hepatic encephalopathy and with low-bias risk. In all analyses, heterogeneity was significant and substantial. Trial sequential analyses using heterogeneity-adjusted information size demonstrated no significant effect of glucocorticosteroids on mortality. Weighted logistic regression analyses taking prognostic factors at randomization into consideration found no significant effect of glucocorticosteroids on mortality.
Conclusions  The current evidence base of mainly heterogeneous with high bias risk trials does not support the use of glucocorticosteroids in alcoholic hepatitis. Large, low-bias risk placebo-controlled randomized trials are needed.  相似文献   

20.
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