scholarly journals Systematic review of randomized controlled trials of therapeutic hypothermia as a neuroprotectant in post cardiac arrest patients

CJEM ◽  
2006 ◽  
Vol 8 (05) ◽  
pp. 329-337 ◽  
Author(s):  
Ka Wai Cheung ◽  
Robert S. Green ◽  
Kirk D. Magee

ABSTRACTObjective:Several randomized controlled trials have suggested that mild induced hypothermia may improve neurologic outcome in comatose cardiac arrest survivors. This systematic review of randomized controlled trials was designed to determine if mild induced hypothermia improves neurologic outcome, decreases mortality, or is associated with an increased incidence of adverse events.Data sources:The following databases were reviewed: Cochrane Controlled Trials Register (Issue 4, 2005), MEDLINE (January 1966 to November 2005), EMBASE (1980 to November 2005), CINAHL (1982 to November 2005) and Web of Science (1989 to November 2005). For each included study, references were reviewed and the primary author contacted to identify any additional studies.Study selection:Studies that met inclusion criteria were randomized controlled trials of adult patients (>18 years of age) with primary cardiac arrest who remained comatose after return of spontaneous circulation. Patients had to be randomized to mild induced hypothermia (32°C-34°C) or normothermia within 24 hours of presentation. Only studies reporting pre-determined outcomes including discharge neurologic outcome, mortality or significant treatment-related adverse events were included. There were no language or publication restrictions.Data synthesis:Four studies involving 436 patients, with 232 cooled to a core temperature of 32°C-34°C met inclusion criteria. Pooled data demonstrated that mild hypothermia decreased inhospital mortality (relative ratio [RR] 0.75; 95% confidence interval [CI], 0.62-0.92) and reduced the incidence of poor neurologic outcome (RR 0.74; 95% CI, 0.62-0.84). Numbers needed to treat were 7 patients to save 1 life, and 5 patients to improve neurologic outcome. There was no evidence of treatment-limiting side effects.Conclusions:Therapeutically induced mild hypothermia decreases in-hospital mortality and improves neurologic outcome in comatose cardiac arrest survivors. The possibility of treatment-limiting side effects cannot be excluded.

Resuscitation ◽  
2014 ◽  
Vol 85 (6) ◽  
pp. 732-740 ◽  
Author(s):  
Steve Lin ◽  
Clifton W. Callaway ◽  
Prakesh S. Shah ◽  
Justin D. Wagner ◽  
Joseph Beyene ◽  
...  

Author(s):  
Sumanta Saha ◽  
Sujata Saha

Background and Purpose: The dapagliflozin’s safety profile in insulin-treated adult type-1 diabetes mellites (T1DM) patients remains poorly explored. Therefore, this systematic review and meta-analysis compared the risk of all-cause side effects, study discontinuation of participants due to side effects, urinary tract infection (UTI), diabetic ketoacidosis, and hypoglycemia between dapagliflozin 10 mg and dapagliflozin 5 mg, dapagliflozin 10 mg and placebo, and dapagliflozin 5 mg and placebo.Materials and Methods: Parallel-arm randomized controlled trials juxtaposing the above outcomes between the afore-mentioned interventions were eligible for inclusion in this study and were searched in PubMed, Embase, and Scopus. Utilizing the Cochrane tool, the risk of bias was assessed in the recruited trials. Finally, by random-effect meta-analysis, each outcome was compared among the above interventions, and the risk ratio was estimated.Results: Four trials of varying length (1-52 weeks) sourcing data from almost 1760 participants from about 32 nations were reviewed. Overall, the trials had a low or unclear risk of bias, and only one was at a high risk of bias.  Compared to the placebo, the risk of side effects was higher in those treated with dapagliflozin 5 mg (RR=1.10; 95% CI=1.02-1.18; p=0.014; I2=0%). UTI risk was less with the 10mg dapagliflozin than its lower dose (RR=0.50; 95% CI=0.32-0.79; p-value=0.003; I2=0%). All the remaining comparisons were statistically not significantly different between the juxtaposed intervention pairs.Conclusion: In contrast to placebo, dapagliflozin 5mg increased the risk of overall adversities in insulin-treated type-1 diabetes, and dapagliflozin 10 mg had a reduced risk of UTI than its 5mg preparation.


2021 ◽  
Vol 8 ◽  
Author(s):  
Yu-Ting Wang ◽  
Chong Xiao ◽  
Hong Liu ◽  
Xi Fu ◽  
Yi-Feng Ren ◽  
...  

Objective: To evaluate the efficacy and safety of preoperative oral gabapentin in preventing postoperative Catheter-Related Bladder Discomfort (CRBD) in surgical patients.Methods: Randomized controlled trials in which gabapentin was used for the prevention of CRBD in surgical patients with transurethral catheterization were evaluated. The primary outcome was the incidence of moderate-to-severe CRBD at 0, 1, 2, and 6 h after surgery, and secondary outcomes included the incidence of any grade CRBD, postoperative pain, and adverse events. Pooled risk ratios (RRs) and mean difference (MD), 95% confidence intervals (CIs), and P values were estimated using fixed and random effects statistical models. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to rate the levels of certainty for key results.Results: A total of 6 randomized controlled trials involving 679 participants were included in the meta-analysis. Gabapentin significantly reduced the risk of moderate-to-severe CRBD at 0, 1, 2, and 6 h (0 h: RR = 0.19, 95% CI: 0.11 to 0.31, p < 0.00001; 1 h: RR = 0.40, 95% CI: 0.25 to 0.66, p < 0.001; 2 h: RR = 0.38, 95% CI: 0.26 to 0.56, p < 0.00001; 6 h: RR = 0.20, 95% CI: 0.11 to 0.38, p < 0.00001). The overall incidence of CRBD at 1 h showed no statistical difference between the two groups (RR = 0.55, 95% CI: 0.30 to 1.00, p = 0.05). The risk of CRBD was significantly reduced in the gabapentin group at 0, 2, and 6 h after surgery (0 h: RR = 0.59, 95% CI: 0.46 to 0.74, p < 0.0001; 2 h: RR = 0.62, 95% CI: 0.51 to 0.75, p < 0.00001; 6 h: RR = 0.66, 95% CI: 0.52 to 0.83, p < 0.001). In addition, gabapentin was associated with low postoperative pain intensity without significant side effects.Conclusion: Preoperative oral gabapentin as an adjunct to surgery is effective in decreasing the risk and severity of CRBD over a short time after surgery, and it can decrease postoperative pain without significant side effects. Overall, the level of certainty was moderate to low.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/#recordDetails, identifier: CRD42021228171.


2020 ◽  
Vol 3 (1) ◽  
pp. 72-82
Author(s):  
Fanaras Konstantinos ◽  
Reinhard Heun

AbstractObjectivesRhodiola rosea is an adaptogen herb from the Crassulaceae family, which has been vastly used in the Russian and Chinese medicine. The herb is used against depression, anxiety, mental and physical fatigue and to promote overall health. In this systematic review, we examined the effects of R. rosea on depression, anxiety and mood, as these are the most relevant to mental health.MethodsLiterature searches were made in PubMed using the term ‘Rhodiola rosea’. Inclusion criteria were: Randomized controlled trials using interventions of R. rosea on any type of participants, while focusing on the effects of the intervention on depression, anxiety or mood. Mixed interventions of R. rosea with other herbs were excluded. Studies not published in English or Greek were excluded.ResultsA total of 39 randomized controlled trials were identified and their abstract was screened. After screening, a total of 17 papers were excluded because they were focusing on irrelevant outcomes. The full text of the remaining 22 papers was read and an additional 17 papers were excluded. These papers were excluded because they were eventually not focusing on our main outcome or they were using R. rosea interventions with other herbs. In the end, a total of 5 papers (n = 327 participants) were found eligible for our systematic review. In these studies, R. rosea seems to improve the symptoms of mild to moderate depression, symptoms of mild anxiety and to enhance mood. The last date of our search was October 13, 2019.ConclusionRhodiola rosea supplementation may alleviate symptoms of mild to moderate depression and mild anxiety, while it may also enhance mood. The findings of our review are not definite due to the lack of available experimental data. Randomized controlled trials with a low risk of bias are needed to further study the herb.


Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2913 ◽  
Author(s):  
Maria Pina Dore ◽  
Stefano Bibbò ◽  
Gianni Fresi ◽  
Gabrio Bassotti ◽  
Giovanni Mario Pes

Probiotics demonstrated to be effective in the treatment of inflammatory bowel disease (IBD). However, the safety profile of probiotics is insufficiently explored. In the present systematic review and meta-analysis, we examined the occurrence of side effects related to probiotic/synbiotic use in randomized controlled trials (RCTs) of IBD patients as compared with placebo. Eligible RCTs in adult patients with IBD were identified by accessing the Medline database via PubMed, EMBASE, CENTRAL and the Cochrane central register of controlled trials up to December 2018. Occurrence of side effects was retrieved and recorded. Data were pooled and the relative risks (RRs) with their 95% confidence intervals (CIs) were calculated. The low-moderate study heterogeneity, assessed by the I2 statistic, allowed to use of a fixed-effects modelling for meta-analysis. Nine RCTs among 2337, including 826 patients (442 treated with probiotics/symbiotic and 384 with placebo) were analyzed. Eight were double-blind RCTs, and six enrolled ulcerative colitis (UC) patients. Although the risk for the overall side effects (RR 1.35, 95%CI 0.93–1.94; I2 = 25%) and for gastrointestinal symptoms (RR 1.78, 95%CI 0.99–3.20; I2 = 20%) was higher in IBD patients taking probiotics than in those exposed to placebo, statistical significance was achieved only for abdominal pain (RR 2.59, 95%CI 1.28–5.22; I2 = 40%). In conclusion, despite the small number of RCTs and the variety of probiotic used and schedule across studies, these findings highlight the level of research effort still required to identify the most appropriate use of probiotics in IBD.


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