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Heikki Joensuu - One of the best experts on this subject based on the ideXlab platform.
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comparison of granulocyte macrophage colony stimulating factor and Sucralfate mouthwashes in the prevention of radiation induced mucositis a double blind prospective randomized phase iii study
International Journal of Radiation Oncology Biology Physics, 2002Co-Authors: Kauko Saarilahti, Mikael Kajanti, Timo Joensuu, Mauri Kouri, Heikki JoensuuAbstract:Abstract Purpose: To compare granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwashes with Sucralfate mouthwashes in the prevention of radiation-induced mucositis. Methods and Materials: Forty patients with radically operated head-and-neck cancer were randomly allocated to use either GM-CSF ( n = 21) or Sucralfate ( n = 19) mouthwashes during postoperative radiotherapy (RT). All patients received conventionally fractionated RT to a total dose of 50–60 Gy in 2-Gy daily fractions during 5–6 weeks to the primary site and regional lymphatics. A minimum of 50% of the oral cavity and oropharyngeal mucosa was included in the clinical target volume. GM-CSF mouthwashes consisted of 37.5 μg GM-CSF and Sucralfate mouthwashes of 1.0 g of Sucralfate distilled in water. Both washes were used 4 times daily, beginning after the first week of RT and continued to the end of the RT course. Symptoms related to radiation mucositis and body weight, serum prealbumin level, and blood cell counts were monitored weekly. Results: Oral mucositis tended to be less severe in the GM-CSF group ( p = 0.072). Complete ( n = 1) or partial ( n = 4) healing of mucositis occurred during the RT course in 5 patients (24%) in the GM-CSF group and in none of the patients in the Sucralfate group ( p = 0.049). Patients who received GM-CSF had less mucosal pain ( p = 0.058) and were less often prescribed opioids for pain ( p = 0.042). Three patients in the Sucralfate group needed hospitalization for mucositis during RT compared with none in the GM-CSF group. Four patients (21%) in the Sucralfate group and none in the GM-CSF group required an interruption in the RT course ( p = 0.042). No significant differences in weight, prealbumin level, or blood cell count were found between the groups, and both mouthwashes were well tolerated. Conclusion: GM-CSF mouthwashes may be moderately more effective than Sucralfate mouthwashes in preventing radiation-induced mucositis and mucositis-related pain, and their use may lead to less frequent RT course interruptions from mucositis. The present findings need to be confirmed before adopting GM-CSF mouthwashes in routine clinical use.
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Granulocyte macrophage-colony stimulating factor (GM-CSF) and Sucralfate in prevention of radiation-induced mucositis: a prospective randomized study
International Journal of Radiation Oncology Biology Physics, 2000Co-Authors: Tuula A. Makkonen, Juhani Tuominen, Antti Jekunen, Pekka Vilja, Heikki Minn, Heikki JoensuuAbstract:Abstract Purpose: To compare subcutaneously given molgramostim (GM-CSF) and Sucralfate mouth washings to Sucralfate mouth washings in prevention of radiation-induced mucositis. Methods and Materials: Forty head and neck cancer patients were randomly assigned to use either GM-CSF and Sucralfate ( n = 20) or Sucralfate alone ( n = 20) during radiotherapy. Sucralfate was used as 1.0 g mouth washing 6 times daily after the first 10 Gy of radiotherapy, and 150–300 μg GM-CSF was given subcutaneously. The grade of radiation mucositis and blood cell counts were monitored weekly. Salivary lactoferrin was measured as a surrogate marker for oral mucositis. Results: We found no significant difference between the molgramostim and the control groups in the oral mucositis grade, oral pain, use of analgesic drugs, weight loss, or survival. The median maximum neutrophil counts (median, 9.2 × 10 9 /L vs. 5.9 × 10 9 /L, p = 0.0005), eosinophil counts (median, 1.3 × 10 9 /L vs. 0.2 × 10 9 /L, p = 0.0004), and salivary lactoferrin concentrations were higher in patients who received GM-CSF. The most common toxicities in the GM-CSF plus Sucralfate group were skin reactions at the GM-CSF injection site (65%), fever (30%), bone pain (25%), and nausea (15%), whereas the toxicity of Sucralfate given alone was minimal. Conclusion: We found no evidence indicating that subcutaneously given GM-CSF reduces the severity of radiation-induced mucositis.
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Sucralfate mouth washing in the prevention of radiation induced mucositis a placebo controlled double blind randomized study
International Journal of Radiation Oncology Biology Physics, 1994Co-Authors: Tuula A. Makkonen, Pekka Vilja, Pia Bostrom, Heikki JoensuuAbstract:Abstract Purpose: To evaluate the value of Sucralfate mouth washings in prevention of radiation-induced mucositis. Methods and Materials: Forty patients with head and neck cancer were randomized to use either Sucralfate mouth washing 1 g six times daily during irradiation ( n = 20 ) or to placebo washing ( n = 20). Mouth washing was started at the beginning of radiation therapy and continued to the end of the therapy (7–10 weeks). Assessment of the degree of radiation mucositis and collection of stimulated saliva samples were done weekly during the therapy. Salivary lactoferrin and albumin, suggested markers for the degree of mucositis, were analyzed from stimulated whole saliva samples. Results: All patients developed radiation-induced mucositis of varying degree after irradiation of about 30 Gy. No difference in the visually assessed degree of mucositis or oral pain reported by the patients was found between the study and the control groups. However, the patients treated with Sucralfate used less anesthetic mouth washing and their salivary lactoferrin and albumin levels were lower. Conclusion: Although the trial produced no direct clinical evidence indicating that Sucralfate mouth rinses prevent radiation-induced mucositis, the decrease in the salivary lactoferrin and albumin levels suggests that Sucralfate has a slight protective effect on the oral mucosa.
Waleed Alhazzani - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and safety of stress ulcer prophylaxis in critically ill patients: a network meta-analysis of randomized trials
Intensive Care Medicine, 2018Co-Authors: Waleed Alhazzani, Mustafa Alquraini, Fayez Alshamsi, Morten Hylander Moller, Anders Perner, Mette Krag, Emilie Belley-cote, Diane Heels-ansdell, Romina Brignardello-petersen, Saleh AlmenawerAbstract:Purpose Stress ulcer prophylaxis (SUP) is commonly prescribed in the intensive care unit. However, data from systematic reviews and conventional meta-analyses are limited by imprecision and restricted to direct comparisons. We conducted a network meta-analysis of randomized clinical trials (RCTs) to examine the safety and efficacy of drugs available for SUP in critically ill patients. Methods We searched MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials through April 2017 for randomized controlled trials that examined the efficacy and safety of proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), and Sucralfate for SUP in critically ill patients. No date or language restrictions were applied. Data on study characteristics, methods, outcomes, and risk of bias were abstracted by two reviewers. Results Of 96 potentially eligible studies, we included 57 trials enrolling 7293 patients. The results showed that PPIs are probably more effective for preventing clinically important gastrointestinal bleeding (CIB) than H2RAs [odds ratio (OR) 0.38; 95% confidence interval (95% CI) 0.20, 0.73], Sucralfate (OR 0.30; 95% CI 0.13, 0.69), and placebo (OR 0.24; 95% CI 0.10, 0.60) (all moderate quality evidence). There were no convincing differences among H2RA, Sucralfate, and placebo. PPIs probably increase the risk of developing pneumonia compared with H2RAs (OR 1.27; 95% CI 0.96, 1.68), Sucralfate (OR 1.65; 95% CI 1.20, 2.27), and placebo (OR 1.52; 95% CI 0.95, 2.42) (all moderate quality). Mortality is probably similar across interventions (moderate quality). Estimates of baseline risks of bleeding varied significantly across studies, and only one study reported on Clostridium difficile infection. Definitions of pneumonia varied considerably. Most studies on Sucralfate predate pneumonia prevention strategies. Conclusions Our results provide moderate quality evidence that PPIs are the most effective agents in preventing CIB, but they may increase the risk of pneumonia. The balance of benefits and harms leaves the routine use of SUP open to question.
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efficacy and safety of stress ulcer prophylaxis in critically ill patients a network meta analysis of randomized trials
Intensive Care Medicine, 2018Co-Authors: Mustafa Alquraini, Fayez Alshamsi, Morten Hylander Moller, Emilie P Belleycote, Waleed Alhazzani, Diane Heelsansdell, Romina Brignardellopetersen, Anders Perner, Mette KragAbstract:Stress ulcer prophylaxis (SUP) is commonly prescribed in the intensive care unit. However, data from systematic reviews and conventional meta-analyses are limited by imprecision and restricted to direct comparisons. We conducted a network meta-analysis of randomized clinical trials (RCTs) to examine the safety and efficacy of drugs available for SUP in critically ill patients. We searched MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials through April 2017 for randomized controlled trials that examined the efficacy and safety of proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), and Sucralfate for SUP in critically ill patients. No date or language restrictions were applied. Data on study characteristics, methods, outcomes, and risk of bias were abstracted by two reviewers. Of 96 potentially eligible studies, we included 57 trials enrolling 7293 patients. The results showed that PPIs are probably more effective for preventing clinically important gastrointestinal bleeding (CIB) than H2RAs [odds ratio (OR) 0.38; 95% confidence interval (95% CI) 0.20, 0.73], Sucralfate (OR 0.30; 95% CI 0.13, 0.69), and placebo (OR 0.24; 95% CI 0.10, 0.60) (all moderate quality evidence). There were no convincing differences among H2RA, Sucralfate, and placebo. PPIs probably increase the risk of developing pneumonia compared with H2RAs (OR 1.27; 95% CI 0.96, 1.68), Sucralfate (OR 1.65; 95% CI 1.20, 2.27), and placebo (OR 1.52; 95% CI 0.95, 2.42) (all moderate quality). Mortality is probably similar across interventions (moderate quality). Estimates of baseline risks of bleeding varied significantly across studies, and only one study reported on Clostridium difficile infection. Definitions of pneumonia varied considerably. Most studies on Sucralfate predate pneumonia prevention strategies. Our results provide moderate quality evidence that PPIs are the most effective agents in preventing CIB, but they may increase the risk of pneumonia. The balance of benefits and harms leaves the routine use of SUP open to question.
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Sucralfate versus histamine 2 receptor antagonists for stress ulcer prophylaxis in adult critically ill patients a meta analysis and trial sequential analysis of randomized trials
Journal of Critical Care, 2017Co-Authors: Mustafa Alquraini, Fayez Alshamsi, Morten Hylander Moller, Emilie P Belleycote, Saleh A Almenawer, Roman Jaeschke, Robert Maclaren, Waleed AlhazzaniAbstract:Abstract Purpose To determine the impact of using Sucralfate versus H2RAs for SUP on patient important outcomes. Materials and methods We searched CENTRAL, MEDLINE, EMBASE, ACPJC, clinical trials registries, and conference proceedings through June 2016 for randomized controlled trials (RCTs) comparing Sucralfate to H2RAs for SUP in adult critically ill patients. Results 21 RCTs enrolling 3121 patients met inclusion criteria. There was no significant difference between Sucralfate compared to H2RAs in the risk of clinically important GI bleeding (risk ratio [RR] 1.19; 95% CI [confidence interval] 0.79, 1.80; P = 0.42; I 2 = 0%; low quality evidence). However, there was a statistically significant lower risk of ICU acquired pneumonia with Sucralfate compared to H2RAs (RR 0.84; 95% CI 0.72, 0.98; P = 0.03; I 2 = 0%; moderate quality evidence). Sucralfate did not significantly affect the risk of death (RR 0.95; 95% CI 0.82, 1.10; P = 0.51; I 2 = 0%; high quality evidence), or duration of ICU stay in days (mean difference − 0.39; 95% CI [− 1.12, 0.34]; P = 0.29; I 2 = 0%; moderate quality evidence). Trial sequential analysis adjusted estimates were consistent with conventional estimates. Conclusion Moderate quality evidence suggests that Sucralfate reduced ICU acquired pneumonia compared to H2RAs in adult critically ill patients, with no significant impact on GI bleeding or death.
Geoff P Delaney - One of the best experts on this subject based on the ideXlab platform.
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effect of oral Sucralfate on late rectal injury associated with radiotherapy for prostate cancer a double blind randomized trial
International Journal of Radiation Oncology Biology Physics, 2004Co-Authors: Andrew Kneebone, Hedy Mameghan, Terry Bolin, M Berry, Sandra Turner, John H Kearsley, Peter Graham, Richard Fisher, Geoff P DelaneyAbstract:Abstract Purpose To assess whether oral Sucralfate is effective in preventing late rectal injury in prostate cancer patients treated with radiotherapy. Methods and materials A double-blind, placebo-controlled, randomized trial was conducted across four institutions in Australia. Patients receiving definitive radiotherapy for prostate cancer were randomized to receive either 3 g of oral Sucralfate suspension or placebo twice daily. Data on patients' symptoms were collected for 2 years, and flexible sigmoidoscopy was scheduled at 12 months after treatment. Results A total of 338 patients were randomized, of whom 298 had adequate follow-up data available for an analysis of late symptoms. Of the 298 patients, 143 were randomized to receive Sucralfate and 155 placebo. The cumulative incidence of Radiation Therapy Oncology Group Grade 2 or worse late rectal toxicity at 2 years was 28% for placebo and 22% for the Sucralfate arm ( p = 0.23; 95% confidence interval for the difference −3% to 16%). Seventeen percent of patients in the Sucralfate group had significant bleeding (Grade 2 or worse) compared with 23% in the placebo group ( p = 0.18, 95% confidence interval −15% to 3%). No statistically significant difference was found between the two groups with respect to bowel frequency ( p = 0.99), mucus discharge ( p = 0.64), or fecal incontinence ( p = 0.90). Sigmoidoscopy findings showed a nonstatistically significant reduction in Grade 2 or worse rectal changes from 32% with placebo to 27% in the Sucralfate group ( p = 0.25). Conclusion This trial demonstrated no statistically significant reduction in the incidence of late rectal toxicity in patients randomized to receive Sucralfate. However, this result was considered inconclusive, because the trial was unable to exclude clinically important differences in the late toxicity rates.
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the effect of oral Sucralfate on the acute proctitis associated with prostate radiotherapy a double blind randomized trial
International Journal of Radiation Oncology Biology Physics, 2001Co-Authors: Andrew Kneebone, Hedy Mameghan, Terry Bolin, M Berry, Sandra Turner, John H Kearsley, Peter Graham, Richard Fisher, Geoff P DelaneyAbstract:Abstract Purpose: Acute rectal complications occur in the majority of patients receiving external-beam radiotherapy for carcinoma of the prostate. Sucralfate has been proposed to reduce radiation-induced mucosal injury by forming a protective barrier on ulcer bases, binding local growth factors, and stimulating angiogenesis. However, there is conflicting clinical evidence as to whether Sucralfate, taken prophylactically during radiotherapy, can ameliorate the symptoms of acute radiation proctitis. Methods and Materials: A double-blind randomized trial was conducted at four Radiation Oncology Departments in Sydney, Australia, between February 1995 and June 1997. A total of 338 patients with clinically localized prostate cancer receiving small volume radiotherapy, of whom 335 were evaluable, were randomized to receive either 3 g of oral Sucralfate suspension or placebo twice a day during radiotherapy. Patients kept a daily record of their bowel symptoms and were graded according to the RTOG/EORTC acute toxicity criteria. Results: One hundred sixty-four patients received Sucralfate and 171 received placebo. Both groups were well balanced with regard to patient, tumor, treatment factors, and baseline symptoms, except that the placebo group had a significantly more liquid baseline stool consistency score ( p = 0.004). Patients kept a daily diary of symptoms during radiotherapy. After adjusting for baseline values, there was no significant difference between the two groups with regard to stool frequency ( p = 0.41), consistency ( p = 0.20), flatus ( p = 0.25), mucus ( p = 0.54), and pain ( p = 0.73). However, there was more bleeding in the Sucralfate group, with 64% of patients noticing rectal bleeding, compared with 47% in the placebo group ( p = 0.001). There was no significant difference between the two groups with respect to RTOG/EORTC acute toxicity ( p = 0.88; Sucralfate 13%, 44%, 43% and placebo 15%, 44%, 40% for grade 0, 1, and 2, respectively). Conclusion: This study suggests that oral Sucralfate taken prophylactically during radiotherapy does not ameliorate the symptoms of acute radiation proctitis and may increase acute bleeding. The cause of the increased bleeding in the Sucralfate group is unclear. As the pathogenesis of acute and late reactions are different, late follow-up, which includes sigmoidoscopic evaluation, is currently being performed on this cohort of patients.
Fayez Alshamsi - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and safety of stress ulcer prophylaxis in critically ill patients: a network meta-analysis of randomized trials
Intensive Care Medicine, 2018Co-Authors: Waleed Alhazzani, Mustafa Alquraini, Fayez Alshamsi, Morten Hylander Moller, Anders Perner, Mette Krag, Emilie Belley-cote, Diane Heels-ansdell, Romina Brignardello-petersen, Saleh AlmenawerAbstract:Purpose Stress ulcer prophylaxis (SUP) is commonly prescribed in the intensive care unit. However, data from systematic reviews and conventional meta-analyses are limited by imprecision and restricted to direct comparisons. We conducted a network meta-analysis of randomized clinical trials (RCTs) to examine the safety and efficacy of drugs available for SUP in critically ill patients. Methods We searched MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials through April 2017 for randomized controlled trials that examined the efficacy and safety of proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), and Sucralfate for SUP in critically ill patients. No date or language restrictions were applied. Data on study characteristics, methods, outcomes, and risk of bias were abstracted by two reviewers. Results Of 96 potentially eligible studies, we included 57 trials enrolling 7293 patients. The results showed that PPIs are probably more effective for preventing clinically important gastrointestinal bleeding (CIB) than H2RAs [odds ratio (OR) 0.38; 95% confidence interval (95% CI) 0.20, 0.73], Sucralfate (OR 0.30; 95% CI 0.13, 0.69), and placebo (OR 0.24; 95% CI 0.10, 0.60) (all moderate quality evidence). There were no convincing differences among H2RA, Sucralfate, and placebo. PPIs probably increase the risk of developing pneumonia compared with H2RAs (OR 1.27; 95% CI 0.96, 1.68), Sucralfate (OR 1.65; 95% CI 1.20, 2.27), and placebo (OR 1.52; 95% CI 0.95, 2.42) (all moderate quality). Mortality is probably similar across interventions (moderate quality). Estimates of baseline risks of bleeding varied significantly across studies, and only one study reported on Clostridium difficile infection. Definitions of pneumonia varied considerably. Most studies on Sucralfate predate pneumonia prevention strategies. Conclusions Our results provide moderate quality evidence that PPIs are the most effective agents in preventing CIB, but they may increase the risk of pneumonia. The balance of benefits and harms leaves the routine use of SUP open to question.
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efficacy and safety of stress ulcer prophylaxis in critically ill patients a network meta analysis of randomized trials
Intensive Care Medicine, 2018Co-Authors: Mustafa Alquraini, Fayez Alshamsi, Morten Hylander Moller, Emilie P Belleycote, Waleed Alhazzani, Diane Heelsansdell, Romina Brignardellopetersen, Anders Perner, Mette KragAbstract:Stress ulcer prophylaxis (SUP) is commonly prescribed in the intensive care unit. However, data from systematic reviews and conventional meta-analyses are limited by imprecision and restricted to direct comparisons. We conducted a network meta-analysis of randomized clinical trials (RCTs) to examine the safety and efficacy of drugs available for SUP in critically ill patients. We searched MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials through April 2017 for randomized controlled trials that examined the efficacy and safety of proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), and Sucralfate for SUP in critically ill patients. No date or language restrictions were applied. Data on study characteristics, methods, outcomes, and risk of bias were abstracted by two reviewers. Of 96 potentially eligible studies, we included 57 trials enrolling 7293 patients. The results showed that PPIs are probably more effective for preventing clinically important gastrointestinal bleeding (CIB) than H2RAs [odds ratio (OR) 0.38; 95% confidence interval (95% CI) 0.20, 0.73], Sucralfate (OR 0.30; 95% CI 0.13, 0.69), and placebo (OR 0.24; 95% CI 0.10, 0.60) (all moderate quality evidence). There were no convincing differences among H2RA, Sucralfate, and placebo. PPIs probably increase the risk of developing pneumonia compared with H2RAs (OR 1.27; 95% CI 0.96, 1.68), Sucralfate (OR 1.65; 95% CI 1.20, 2.27), and placebo (OR 1.52; 95% CI 0.95, 2.42) (all moderate quality). Mortality is probably similar across interventions (moderate quality). Estimates of baseline risks of bleeding varied significantly across studies, and only one study reported on Clostridium difficile infection. Definitions of pneumonia varied considerably. Most studies on Sucralfate predate pneumonia prevention strategies. Our results provide moderate quality evidence that PPIs are the most effective agents in preventing CIB, but they may increase the risk of pneumonia. The balance of benefits and harms leaves the routine use of SUP open to question.
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Sucralfate versus histamine 2 receptor antagonists for stress ulcer prophylaxis in adult critically ill patients a meta analysis and trial sequential analysis of randomized trials
Journal of Critical Care, 2017Co-Authors: Mustafa Alquraini, Fayez Alshamsi, Morten Hylander Moller, Emilie P Belleycote, Saleh A Almenawer, Roman Jaeschke, Robert Maclaren, Waleed AlhazzaniAbstract:Abstract Purpose To determine the impact of using Sucralfate versus H2RAs for SUP on patient important outcomes. Materials and methods We searched CENTRAL, MEDLINE, EMBASE, ACPJC, clinical trials registries, and conference proceedings through June 2016 for randomized controlled trials (RCTs) comparing Sucralfate to H2RAs for SUP in adult critically ill patients. Results 21 RCTs enrolling 3121 patients met inclusion criteria. There was no significant difference between Sucralfate compared to H2RAs in the risk of clinically important GI bleeding (risk ratio [RR] 1.19; 95% CI [confidence interval] 0.79, 1.80; P = 0.42; I 2 = 0%; low quality evidence). However, there was a statistically significant lower risk of ICU acquired pneumonia with Sucralfate compared to H2RAs (RR 0.84; 95% CI 0.72, 0.98; P = 0.03; I 2 = 0%; moderate quality evidence). Sucralfate did not significantly affect the risk of death (RR 0.95; 95% CI 0.82, 1.10; P = 0.51; I 2 = 0%; high quality evidence), or duration of ICU stay in days (mean difference − 0.39; 95% CI [− 1.12, 0.34]; P = 0.29; I 2 = 0%; moderate quality evidence). Trial sequential analysis adjusted estimates were consistent with conventional estimates. Conclusion Moderate quality evidence suggests that Sucralfate reduced ICU acquired pneumonia compared to H2RAs in adult critically ill patients, with no significant impact on GI bleeding or death.
Mustafa Alquraini - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and safety of stress ulcer prophylaxis in critically ill patients: a network meta-analysis of randomized trials
Intensive Care Medicine, 2018Co-Authors: Waleed Alhazzani, Mustafa Alquraini, Fayez Alshamsi, Morten Hylander Moller, Anders Perner, Mette Krag, Emilie Belley-cote, Diane Heels-ansdell, Romina Brignardello-petersen, Saleh AlmenawerAbstract:Purpose Stress ulcer prophylaxis (SUP) is commonly prescribed in the intensive care unit. However, data from systematic reviews and conventional meta-analyses are limited by imprecision and restricted to direct comparisons. We conducted a network meta-analysis of randomized clinical trials (RCTs) to examine the safety and efficacy of drugs available for SUP in critically ill patients. Methods We searched MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials through April 2017 for randomized controlled trials that examined the efficacy and safety of proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), and Sucralfate for SUP in critically ill patients. No date or language restrictions were applied. Data on study characteristics, methods, outcomes, and risk of bias were abstracted by two reviewers. Results Of 96 potentially eligible studies, we included 57 trials enrolling 7293 patients. The results showed that PPIs are probably more effective for preventing clinically important gastrointestinal bleeding (CIB) than H2RAs [odds ratio (OR) 0.38; 95% confidence interval (95% CI) 0.20, 0.73], Sucralfate (OR 0.30; 95% CI 0.13, 0.69), and placebo (OR 0.24; 95% CI 0.10, 0.60) (all moderate quality evidence). There were no convincing differences among H2RA, Sucralfate, and placebo. PPIs probably increase the risk of developing pneumonia compared with H2RAs (OR 1.27; 95% CI 0.96, 1.68), Sucralfate (OR 1.65; 95% CI 1.20, 2.27), and placebo (OR 1.52; 95% CI 0.95, 2.42) (all moderate quality). Mortality is probably similar across interventions (moderate quality). Estimates of baseline risks of bleeding varied significantly across studies, and only one study reported on Clostridium difficile infection. Definitions of pneumonia varied considerably. Most studies on Sucralfate predate pneumonia prevention strategies. Conclusions Our results provide moderate quality evidence that PPIs are the most effective agents in preventing CIB, but they may increase the risk of pneumonia. The balance of benefits and harms leaves the routine use of SUP open to question.
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efficacy and safety of stress ulcer prophylaxis in critically ill patients a network meta analysis of randomized trials
Intensive Care Medicine, 2018Co-Authors: Mustafa Alquraini, Fayez Alshamsi, Morten Hylander Moller, Emilie P Belleycote, Waleed Alhazzani, Diane Heelsansdell, Romina Brignardellopetersen, Anders Perner, Mette KragAbstract:Stress ulcer prophylaxis (SUP) is commonly prescribed in the intensive care unit. However, data from systematic reviews and conventional meta-analyses are limited by imprecision and restricted to direct comparisons. We conducted a network meta-analysis of randomized clinical trials (RCTs) to examine the safety and efficacy of drugs available for SUP in critically ill patients. We searched MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials through April 2017 for randomized controlled trials that examined the efficacy and safety of proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), and Sucralfate for SUP in critically ill patients. No date or language restrictions were applied. Data on study characteristics, methods, outcomes, and risk of bias were abstracted by two reviewers. Of 96 potentially eligible studies, we included 57 trials enrolling 7293 patients. The results showed that PPIs are probably more effective for preventing clinically important gastrointestinal bleeding (CIB) than H2RAs [odds ratio (OR) 0.38; 95% confidence interval (95% CI) 0.20, 0.73], Sucralfate (OR 0.30; 95% CI 0.13, 0.69), and placebo (OR 0.24; 95% CI 0.10, 0.60) (all moderate quality evidence). There were no convincing differences among H2RA, Sucralfate, and placebo. PPIs probably increase the risk of developing pneumonia compared with H2RAs (OR 1.27; 95% CI 0.96, 1.68), Sucralfate (OR 1.65; 95% CI 1.20, 2.27), and placebo (OR 1.52; 95% CI 0.95, 2.42) (all moderate quality). Mortality is probably similar across interventions (moderate quality). Estimates of baseline risks of bleeding varied significantly across studies, and only one study reported on Clostridium difficile infection. Definitions of pneumonia varied considerably. Most studies on Sucralfate predate pneumonia prevention strategies. Our results provide moderate quality evidence that PPIs are the most effective agents in preventing CIB, but they may increase the risk of pneumonia. The balance of benefits and harms leaves the routine use of SUP open to question.
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Sucralfate versus histamine 2 receptor antagonists for stress ulcer prophylaxis in adult critically ill patients a meta analysis and trial sequential analysis of randomized trials
Journal of Critical Care, 2017Co-Authors: Mustafa Alquraini, Fayez Alshamsi, Morten Hylander Moller, Emilie P Belleycote, Saleh A Almenawer, Roman Jaeschke, Robert Maclaren, Waleed AlhazzaniAbstract:Abstract Purpose To determine the impact of using Sucralfate versus H2RAs for SUP on patient important outcomes. Materials and methods We searched CENTRAL, MEDLINE, EMBASE, ACPJC, clinical trials registries, and conference proceedings through June 2016 for randomized controlled trials (RCTs) comparing Sucralfate to H2RAs for SUP in adult critically ill patients. Results 21 RCTs enrolling 3121 patients met inclusion criteria. There was no significant difference between Sucralfate compared to H2RAs in the risk of clinically important GI bleeding (risk ratio [RR] 1.19; 95% CI [confidence interval] 0.79, 1.80; P = 0.42; I 2 = 0%; low quality evidence). However, there was a statistically significant lower risk of ICU acquired pneumonia with Sucralfate compared to H2RAs (RR 0.84; 95% CI 0.72, 0.98; P = 0.03; I 2 = 0%; moderate quality evidence). Sucralfate did not significantly affect the risk of death (RR 0.95; 95% CI 0.82, 1.10; P = 0.51; I 2 = 0%; high quality evidence), or duration of ICU stay in days (mean difference − 0.39; 95% CI [− 1.12, 0.34]; P = 0.29; I 2 = 0%; moderate quality evidence). Trial sequential analysis adjusted estimates were consistent with conventional estimates. Conclusion Moderate quality evidence suggests that Sucralfate reduced ICU acquired pneumonia compared to H2RAs in adult critically ill patients, with no significant impact on GI bleeding or death.
