scholarly journals Don’t abandon RCTs in IVF. We don’t even understand them

2019 ◽  
Vol 34 (11) ◽  
pp. 2093-2098 ◽  
Author(s):  
J Wilkinson ◽  
D R Brison ◽  
J M N Duffy ◽  
C M Farquhar ◽  
S Lensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Status Quo ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Infertility Treatments ◽  
The Status ◽  
Quality Evidence

Abstract The conclusion of the Human Fertilisation and Embryology Authority that ‘add-on’ therapies in IVF are not supported by high-quality evidence has prompted new questions regarding the role of the randomized controlled trial (RCT) in evaluating infertility treatments. Critics argue that trials are cumbersome tools that provide irrelevant answers. Instead, they argue that greater emphasis should be placed on large observational databases, which can be analysed using powerful algorithms to determine which treatments work and for whom. Although the validity of these arguments rests upon the sciences of statistics and epidemiology, the discussion to date has largely been conducted without reference to these fields. We aim to remedy this omission, by evaluating the arguments against RCTs in IVF from a primarily methodological perspective. We suggest that, while criticism of the status quo is warranted, a retreat from RCTs is more likely to make things worse for patients and clinicians.

scholarly journals The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled, multicenter trial.

2020 ◽  
Author(s):  
Tao Bai ◽  
Haoyu Zeng ◽  
Yanqin Long ◽  
Xiaoqing Li ◽  
Xiaohong Sun ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Controlled Trial ◽  
Control Group ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Multicenter Randomized Controlled Trial ◽  
Irritable Bowel ◽  
Experimental Group ◽  
Quality Evidence

Abstract Background: Irritable bowel syndrome (IBS) is one of the most acommon functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients’ quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy, however, in a lack of high-quality evidence of efficacy, no specific strain- and dose-probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the bifidobacterium quadruple viable tablet in the treatment of IBS-D.Methods/design: A multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients fulfill the eligible criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency, the secondary outcome include evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events and concomitant medication will be taken into account for intervention safety assessment during the trial.Discussion: This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotics intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis.Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1800017721 ( http://www.chictr.org.cn/showproj.aspx?proj=29440 ). Registered on 10 August 2018.

scholarly journals The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled, multicenter trial.

2019 ◽  
Author(s):  
Haoyu Zeng ◽  
Tao Bai ◽  
Yanqin Long ◽  
Xiaoqing Li ◽  
Xiaohong Sun ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Controlled Trial ◽  
Control Group ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Multicenter Randomized Controlled Trial ◽  
Irritable Bowel ◽  
Experimental Group ◽  
Quality Evidence

Abstract Background Irritable bowel syndrome (IBS) is one of the most acommon functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients’ quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy, however, in a lack of high-quality evidence of efficacy, no specific strain- and dose-probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the bifidobacterium quadruple viable tablet in the treatment of IBS-D. Methods/design A multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients fulfill the eligible criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency, the secondary outcome include evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events and concomitant medication will be taken into account for intervention safety assessment during the trial. Discussion This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotics intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis.

scholarly journals The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled, multicenter trial.

2019 ◽  
Author(s):  
Haoyu Zeng ◽  
Tao Bai ◽  
Yanqin Long ◽  
Xiaoqing Li ◽  
Xiaohong Sun ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Controlled Trial ◽  
Control Group ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Multicenter Randomized Controlled Trial ◽  
Irritable Bowel ◽  
Experimental Group ◽  
Quality Evidence

Abstract Background: Irritable bowel syndrome (IBS) is one of the most acommon functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients’ quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy, however, in a lack of high-quality evidence of efficacy, no specific strain- and dose-probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the bifidobacterium quadruple viable tablet in the treatment of IBS-D. Methods/design: A multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients fulfill the eligible criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency, the secondary outcome include evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events and concomitant medication will be taken into account for intervention safety assessment during the trial. Discussion: This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotics intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis.

Role of preoperative pregabalin in reducing inhalational anesthetic requirements in abdominal hysterectomy: randomized controlled trial

2020 ◽  
Vol 86 (1) ◽  
Author(s):  
Nesrine A. El-Refai ◽  
Jehan H. Shehata ◽  
Ahmed Lotfy ◽  
Ahmed M. Elbadawy ◽  
Reham A. Abdel Rahman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Abdominal Hysterectomy ◽  
Randomized Controlled ◽  
Inhalational Anesthetic

Role of Chewing Gum in Reducing Postoperative Ileus after Reversal of Ileostomy: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Samiullah Bhatti ◽  
Yusra Jahangir Malik ◽  
Shabbar Hussain Changazi ◽  
Usman Ali Rahman ◽  
Awais Amjad Malik ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Ileus ◽  
Controlled Trial ◽  
Chewing Gum ◽  
Randomized Controlled
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