scholarly journals Comparative effectiveness and safety of pharmaceuticals assessed in observational studies compared with randomized controlled trials

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Yoon Duk Hong ◽  
Jeroen P. Jansen ◽  
John Guerino ◽  
Marc L. Berger ◽  
William Crown ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Observational Studies ◽  
Treatment Effects ◽  
Relative Effect ◽  
Effect Estimate ◽  
Controlled Trials ◽  
Regulatory Decision ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Biased Estimates

Abstract Background There have been ongoing efforts to understand when and how data from observational studies can be applied to clinical and regulatory decision making. The objective of this review was to assess the comparability of relative treatment effects of pharmaceuticals from observational studies and randomized controlled trials (RCTs). Methods We searched PubMed and Embase for systematic literature reviews published between January 1, 1990, and January 31, 2020, that reported relative treatment effects of pharmaceuticals from both observational studies and RCTs. We extracted pooled relative effect estimates from observational studies and RCTs for each outcome, intervention-comparator, or indication assessed in the reviews. We calculated the ratio of the relative effect estimate from observational studies over that from RCTs, along with the corresponding 95% confidence interval (CI) for each pair of pooled RCT and observational study estimates, and we evaluated the consistency in relative treatment effects. Results Thirty systematic reviews across 7 therapeutic areas were identified from the literature. We analyzed 74 pairs of pooled relative effect estimates from RCTs and observational studies from 29 reviews. There was no statistically significant difference (based on the 95% CI) in relative effect estimates between RCTs and observational studies in 79.7% of pairs. There was an extreme difference (ratio < 0.7 or > 1.43) in 43.2% of pairs, and, in 17.6% of pairs, there was a significant difference and the estimates pointed in opposite directions. Conclusions Overall, our review shows that while there is no significant difference in the relative risk ratios between the majority of RCTs and observational studies compared, there is significant variation in about 20% of comparisons. The source of this variation should be the subject of further inquiry to elucidate how much of the variation is due to differences in patient populations versus biased estimates arising from issues with study design or analytical/statistical methods.

scholarly journals Eye Acupuncture Treatment for Stroke: A Systematic Review and Meta-Analysis

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Zeng-Hua Bai ◽  
Zhi-Xing Zhang ◽  
Chun-Ri Li ◽  
Mei Wang ◽  
Meong-Ju Kim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Western Medicine ◽  
Current Evidence ◽  
Effect Estimate ◽  
Controlled Trials ◽  
Search Activity ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Eye Acupuncture

There were applications of eye acupuncture for stroke patients. Unfortunately, similar to many other Traditional Chinese Medicine (TCM) treatments, it lacks comprehensive evaluation and system review for its effect and safety.Objective. This study is a systematic review to appraise the safety and effectiveness of eye acupuncture for stroke.Methods. “Eye acupuncture therapy” in eleven databases was searched by randomized controlled trials and quasi-randomized controlled trials. The search activity was ended in April 2014. The data were extracted and assessed by three independent authors. Rev Man 5.0 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval.Results. Sixteen trials (1120 patients) were involved with generally poor methodological quality. The study indicated that when eye acupuncture was combined with western medicine compared to western medicine, there was a significant difference in the areas of mental state, swallow function, and NDS. When eye acupuncture was combined with western medicine and rehabilitation compared to western medicine and rehabilitation, there was significant difference in the changes of SSS, FMA, and constipation symptoms evaluation. No adverse events or side effects have been reported.Conclusions. The current evidence is insufficient and the rigorously designed trials are warranted.

scholarly journals Larazotide Acetate for Treatment of Celiac Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Author(s):  
Ahmed Abu-Zaid ◽  
Noor Tariq Alhaddab ◽  
Razan Abdulkarim Alnujaidi ◽  
Hadeel Abdulaziz Alharbi ◽  
Fulwah Alangri ◽  
...  
Keyword(s):  
Systematic Review ◽  
Celiac Disease ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Free Subgroup ◽  
Effect Estimate ◽  
Controlled Trials ◽  
Gluten Free ◽  
Randomized Controlled ◽  
Significant Difference

Purpose: The standard of care for treatment of celiac disease (CD) is a stringent lifetime gluten-free diet (GFD), which is very challenging. Larazotide acetate (AT-1001) is an anti-zonulin which functions as a gut permeability regulator for treatment of CD. We endeavored to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) which studied the efficacy and safety of larazotide acetate in patients with CD. Methods: We examined four databases from inception to 20-August-2020 using related keywords. We identified all relevant RCTs and judged their risk of bias. We pooled continuous outcomes as mean difference and dichotomous outcomes as risk ratio with 95% confidence interval under fixed-effects meta-analysis model. Results: Four RCTs met our eligibility criteria, comprising 626 patients (larazotide acetate, n=465, placebo, n=161). Three and two studies reported outcomes of patients undergoing gluten challenge and GFD, respectively. For change in lactulose-to-mannitol ratio, the overall effect estimate did not reveal a significant difference between larazotide acetate and placebo groups. For change in total gastrointestinal symptom rating scale (GSRS), subgroup analysis showed that larazotide acetate significantly yielded better symptomatic improvement in the gluten challenge but not gluten free subgroup. Similar finding was found for change in celiac-disease GSRS (CD-GSRS) favoring the gluten challenge over gluten free subgroup. When compared to placebo, larazotide acetate favorably reduced the adverse event (AE) of gluten-related diarrhea in patients who underwent gluten challenge. Other AEs were comparable between both treatment groups. Conclusions: Larazotide acetate is well-endured and superior to placebo in alleviating gastrointestinal symptoms.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals Time to onset of cannabidiol treatment effects in Dravet syndrome: Analysis from two randomized controlled trials

Epilepsia ◽  
2021 ◽  
Author(s):  
Jennifer Madan Cohen ◽  
Daniel Checketts ◽  
Eduardo Dunayevich ◽  
Boudewijn Gunning ◽  
Ann Hyslop ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Treatment Effects ◽  
Dravet Syndrome ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Time To Onset ◽  
Syndrome Analysis

scholarly journals Effect of janus kinase inhibitors and methotrexate combination on malignancy in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Vinod Solipuram ◽  
Akhila Mohan ◽  
Roshniben Patel ◽  
Ruoning Ni
Keyword(s):  
Rheumatoid Arthritis ◽  
Combination Therapy ◽  
Randomized Controlled Trials ◽  
Random Effect ◽  
Janus Kinase ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Significant Difference ◽  
Risk Of Malignancy

Abstract Background Rheumatoid arthritis (RA) is a systemic autoimmune disease. The combination therapy of methotrexate (MTX) and Janus kinase inhibitor (JAKi) is commonly used. Patients with RA are at increased risk of malignancy, however, it remains unclear whether the combination therapy is associated with a higher risk. Objective To assess the malignancy risk among patients with RA receiving combination therapy of JAKi and MTX compared to MTX alone. Methods PubMed, Cochrane and Embase were thoroughly searched for randomized controlled trials (RCTs) in patients with RA receiving JAKi and MTX, from inception to July 2020. Primary endpoints were malignancy events, Non melanomatous skin cancer (NMSC) and malignancy excluding NMSC and secondary endpoints were serious adverse events (SAE), deaths. Risk ratio (RR) and 95% CI were calculated using the Mantel–Haenszel random-effect method. Results 659 publications were screened and 13 RCTs with a total of 6911 patients were included in the analysis. There was no statistically significant difference in malignancy [RR = 1.42; 95% CI (0.59, 3.41)], neither NMSC [RR = 1.44 (0.36, 5.76)] nor malignancies excluding NMSC [RR = 1.12 (0.40, 3.13)]. No statistically significant difference between the two groups for SAE [RR = 1.15 (0.90, 1.47)] and deaths [RR = 1.99 (0.75, 5.27)] was found. Conclusion The adjunction of JAKi to MTX is not associated with an increased risk of malignancy when compared to MTX alone. There is no increased risk of SAE and deaths when compared to MTX alone in patients with RA.

Efficacy of Benson’s Relaxation Technique on Anxiety and Depression among Patients Undergoing Hemodialysis: A Systematic Review

2021 ◽  
pp. 105477382110247
Author(s):  
Haya Ibrahim Ali Abu Maloh ◽  
Kim Lam Soh ◽  
Mohannad Eid AbuRuz ◽  
Seng Choi Chong ◽  
Siti Irma Fadhilah Ismail ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Scientific Evidence ◽  
Relaxation Technique ◽  
Anxiety And Depression ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Depression Level ◽  
Ebsco Host

This study aimed to evaluate the efficacy of Benson’s relaxation technique on anxiety and depression among patients undergoing hemodialysis. A systematic review of randomized controlled trials was conducted. Searching databases included EBSCO Host, PubMed, ProQuest, Science Direct, Sage Journals, Ovid, and Google Scholar from January 2000 to September 2020. Five randomized controlled trials were identified. Findings revealed a statistically significant decrease in anxiety score. Concerning depression; one RCT showed a statistically significant decrease and two RCTs revealed a non-significant difference in depression level. The overall quality of the RCTs was not high. Despite that the RCTs showed benefits of BRT in managing anxiety. However, this is not the same for depression. The lack of high-quality scientific evidence supporting its retinue use indicates that additional well designed randomized controlled trials in multiple countries are warranted to support the efficacy of Benson’s relaxation technique on anxiety and depression among patients undergoing hemodialysis.

scholarly journals Cemented versus uncemented fixation in total hip replacement: a systematic review and meta-analysis of randomized controlled trials

2013 ◽  
Vol 5 (1) ◽  
pp. 8 ◽  
Author(s):  
Ali Abdulkarim ◽  
Prasad Ellanti ◽  
Nicola Motterlini ◽  
Tom Fahey ◽  
John M. O’Byrne
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Implant Fixation ◽  
Short Term ◽  
Optimal Method ◽  
Radiographic Findings ◽  
Total Hip ◽  
Randomized Controlled ◽  
Significant Difference

The optimal method of fixation for primary total hip replacements (THR), particularly fixation with or without the use of cement is still controversial. In a systematic review and metaanalysis of all randomized controlled trials comparing cemented versus uncemented THRS available in the published literature, we found that there is no significant difference between cemented and uncemented THRs in terms of implant survival as measured by the revision rate. Better short-term clinical outcome, particularly an improved pain score can be obtained with cemented fixation. However, the results are unclear for the long-term clinical and functional outcome between the two groups. No difference was evident in the mortality and the post operative complication rate. On the other hand, the radiographic findings were variable and do not seem to correlate with clinical findings as differences in the surgical technique and prosthesis design might be associated with the incidence of osteolysis. We concluded in our review that cemented THR is similar if not superior to uncemented THR, and provides better short term clinical outcomes. Further research, improved methodology and longer follow up are necessary to better define specific subgroups of patients in whom the relative benefits of cemented and uncemented implant fixation can be clearly demonstrated.

Early Versus Routine Stoma Closure in Patients With Colorectal Resection: A Meta-Analysis of 7 Randomized Controlled Trials

2020 ◽  
Vol 27 (3) ◽  
pp. 291-298
Author(s):  
Yinyin Guo ◽  
Yanxin Luo ◽  
Hui Zhao ◽  
Liangliang Bai ◽  
Juan Li ◽  
...  
Keyword(s):  
Colorectal Surgery ◽  
Randomized Controlled Trials ◽  
Bowel Obstruction ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Wound Complications ◽  
Controlled Trials ◽  
Stoma Closure ◽  
Randomized Controlled ◽  
Significant Difference

Background. A substantial proportion of patients undergoing colorectal surgery receive a temporary stoma, and the timing for stoma closure remains unclear. The aim of this study was to evaluate the safety and feasibility of early stoma closure (ESC) compared with routine stoma closure (RSC) after colorectal surgery. Methods. We comprehensively searched PubMed, Embase, and the Cochrane Library for randomized controlled trials that compared ESC and RSC after colorectal surgery. Results. A total of 7 randomized controlled trials with 814 enrolled patients were identified for this meta-analysis. There were no significant differences between the ESC and RSC groups regarding the complications of stoma closure (26.8% and 16.6%, respectively; odds ratio [OR]: 1.30; 95% confidence interval [CI]: 0.89-1.90; P = .17). A subgroup analysis was conducted by Clavien-Dindo grade of complication, and no significant difference was observed in any subgroup ( P > .05). However, the ESC group had a significantly higher risk of wound complications than the RSC group (17.6% and 7.8%, respectively; OR: 2.61; 95% CI: 1.43-4.76; P = .002), and the RSC group had more cases of small bowel obstruction than the ESC group (3.1% and 8.4%, respectively; OR: 0.37; 95% CI: 0.15-0.87; P = .02). Conclusions. ESC is a safe and effective therapeutic approach in patients who have undergone colorectal surgery; it is associated with a reduced risk of bowel obstruction but a higher risk of wound complications.

scholarly journals The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 9 (10) ◽  
pp. 3151
Author(s):  
Chang-Hoon Koo ◽  
Jin-Woo Park ◽  
Jung-Hee Ryu ◽  
Sung-Hee Han
Keyword(s):  
Virtual Reality ◽  
Randomized Controlled Trials ◽  
Pediatric Patients ◽  
Meta Analysis ◽  
Random Effect Model ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference

Virtual reality (VR), a technology that provides a stimulated sensory experience, has recently been implemented in various fields of medicine. Several studies have investigated the efficacy of VR on preoperative anxiety. The purpose of this meta-analysis was to validate whether VR could relieve preoperative anxiety in patients undergoing surgery. Electronic databases were searched to identify all randomized controlled trials (RCTs) investigating the effect of VR on preoperative anxiety. The primary outcome was defined as the preoperative anxiety scores. We estimated the effect size using the standard mean difference (SMD) with a 95% confidence interval (CI) using a random effect model. Ultimately, 10 RCTs, with a total of 813 patients, were included in the final analysis. Preoperative anxiety was significantly lower in the VR group than in the control group (SMD −0.64, 95% CI −1.08 to −0.20, p = 0.004). In a subgroup analysis, the preoperative anxiety scores were lower in the VR group than in the control group in pediatric patients (SMD −0.71, 95% CI −1.14 to −0.27, p = 0.002), whereas a significant difference was not observed between the two groups in adult patients (p = 0.226). The results of this meta-analysis indicated that VR could decrease preoperative anxiety, especially in pediatric patients.

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