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.

scholarly journals Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: a study protocol for a multicenter randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jing-wen Sun ◽  
Ming-liang Sun ◽  
Da Li ◽  
Jun Zhao ◽  
Su-hua Shi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Group A ◽  
Irritable Bowel ◽  
Group B ◽  
Experimental Group

Abstract Background Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease is found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients compared with those of conventional treatments. We also aim to identify the optimal acupoint combination recommended for IBS and to clarify the clinical advantage of the “multiacupoint co-effect and synergistic effect.” Methods and analysis A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly stratified into acupuncture group A, acupuncture group B, or the control group in a 1:1:1 ratio with a central web-based randomization system. The prespecified acupoints used in the control group will include bilateral Tianshu (ST25), Shangjuxu (ST37), Neiguan (PC6), and Zusanli (ST36). The prespecified acupoints used in experimental group A will include bilateral Tianshu (ST25), Shangjuxu (ST37), and Neiguan (PC6). The prespecified acupoints used in experimental group B will include bilateral Tianshu (ST25), Shangjuxu (ST37), and Zusanli (ST36). Each patient will receive 12 acupuncture treatments over 4 weeks and will be followed up for 4 weeks. The primary outcome is the IBS-Symptom Severity Scale (IBS-SSS) score. The secondary outcomes include the Bristol Stool Form Scale (BSFS), Work and Social Adjustment Score (WSAS), IBS-Quality of Life (IBS-QOL), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS) scores. Both the primary outcome and the secondary outcome measures will be collected at baseline, at 2 and 4 weeks during the intervention, and at 6 weeks and 8 weeks after the intervention. Ethics and dissemination The entire project has been approved by the ethics committee of the Beijing University of Chinese Medicine (2020BZYLL0903). Discussion This is a multicenter randomized controlled trial for IBS in China. The findings may shed light on the efficacy of acupuncture as an alternative to conventional IBS treatment. The results of the trial will be disseminated in peer-reviewed publications. Trial registration Chinese Clinical Trials Register ChiCTR2000041215. First registered on 12 December 2020. http://www.chictr.org.cn/.

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 Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

scholarly journals The impact of vildagliptin on the daily glucose profile and coronary plaque stability in impaired glucose tolerance patients with coronary artery disease: VOGUE—A multicenter randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hiroyuki Yamamoto ◽  
Akihide Konishi ◽  
Toshiro Shinke ◽  
Hiromasa Otake ◽  
Masaru Kuroda ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Fibrous Cap ◽  
Multicenter Randomized Controlled Trial ◽  
The Mean ◽  
Artery Disease ◽  
Fibrous Cap Thickness ◽  
The Impact

Abstract Background The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). Methods This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. Results A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was − 18.8 mg/dl (95% confidence interval, − 30.8 to − 6.8) (p = 0.0064) for the MAGE (vildagliptin, − 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), − 22.8° (− 40.6° to − 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, − 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, − 15.1 ± 25.2 μm). Conclusions Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058

scholarly journals The effects of transcutaneous electrical nerve stimulation during the first stage of labor: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anne Njogu ◽  
Si Qin ◽  
Yujie Chen ◽  
Lizhen Hu ◽  
Yang Luo
Keyword(s):  
Transcutaneous Electrical Nerve Stimulation ◽  
Controlled Trial ◽  
Labor Pain ◽  
Control Group ◽  
Electrical Nerve Stimulation ◽  
Randomized Controlled ◽  
Active Labor ◽  
Vas Scores ◽  
Experimental Group ◽  
First Stage Of Labor

Abstract Background Labor pain during childbirth can have devastating effects on the progress of labor, mother, and fetus. Consequently, the management of labor pain is crucial for the well-being of the mother and fetus. Transcutaneous electrical nerve stimulation (TENS) is a non -pharmacological analgesic technique. It uses a low-voltage electrical current to activate descending inhibitory systems in the central nervous system to relieve pain. This study aimed to determine the effects of TENS therapy in the first stage of labor. Methods In this single-blind randomized controlled trial, we screened low-risk pregnant women who anticipated spontaneous vaginal delivery. Women were assigned (1:1) to either the experimental group (received TENS therapy in the first stage of labor) or the control group (received routine obstetric care). The women, midwives, and researchers working in the gynecology and obstetric department were aware of the treatment group, but statisticians analysis the data were blinded. The primary outcome was labor pain intensity, assessed by visual analog scale (VAS) immediately after the randomization, at 30, 60, and 120 min after TENS therapy, and 2–24 h post-delivery. We used SPSS 21.0 software in data analysis. An independent sample t-test compared the mean VAS scores and labor duration between groups. A Chi-square test was employed to compare categorical variables between the groups. A significant level of ≤0.05 was statistically significant. Results A total of 326 pregnant women were eligible: experimental group (n = 161) and control group (n = 165). The experimental group had statistically significantly lower mean VAS scores at a different time (30, 60, and 120 min post-intervention and 2–24 h post-delivery) than the control group (p < 0.001). The experimental group demonstrated a statistically significant shorter duration of the active labor phase than the control group (p < 0.001). Conclusion This study indicates that TENS can be used as a non-pharmacological therapy to reduce pain and shorten the active labor phase. Trial registration ISRCTN registry, ISRCTN23857995. Registered on 11/12/2020, ‘retrospectively registered.

scholarly journals TRADE-OFFS BETWEEN EPISTEMIC AND MORAL VALUES IN EVIDENCE-BASED POLICY

2018 ◽  
Vol 35 (1) ◽  
pp. 49-78 ◽  
Author(s):  
Donal Khosrowi
Keyword(s):  
Controlled Trials ◽  
Evidence Based ◽  
Epistemic Values ◽  
High Quality ◽  
Political Values ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Evidence Based Policy ◽  
Trade Offs ◽  
Quality Evidence

Abstract:Proponents of evidence-based policy (EBP) call for public policy to be informed by high-quality evidence from randomized controlled trials. This methodological preference aims to promote several epistemic values, e.g. rigour, unbiasedness, precision, and the ability to obtain causal conclusions. I argue that there is a trade-off between these epistemic values and several non-epistemic, moral and political values. This is because the evidence afforded by standard EBP methods is differentially useful for pursuing different moral and political values. I expand on how this challenges ideals of value-freedom and -neutrality in EBP, and offer suggestions for how EBP methodology might be revised.

scholarly journals Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-pelvic Stability and Adductor Strength in Women Soccer Players. A Randomized Controlled Study.

2020 ◽  
Author(s):  
Héctor Guerrero-Tapia ◽  
Rodrigo Martín-Baeza ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Repeated Measures ◽  
Controlled Trial ◽  
Gluteus Medius ◽  
Soccer Players ◽  
Controlled Study ◽  
Control Group ◽  
Extrinsic Factors ◽  
Randomized Controlled ◽  
Limb Injuries ◽  
Experimental Group

Abstract Background: Abdominal and lumbo-pelvic stability alterations may origin lower limb injuries, such as for example adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: This randomized controlled trial conducted over an 8-week period included 25 female footballers randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbo-pelvic stability and adductor strength.Results. Lumbo-pelvic stability after surgery was higher in the control group (MD: 4.84 vs MD: 9.58; p < .01) with differences in the analysis of repeated measures (p<.001), but not in group interaction (p =.26). Changes were found in adductor strength in the experimental group (MD: -2.48; p<.001 in the left adductor; MD: -1.48; p<.01 in right adductor) and control group (MD: -1.68; p<.001 in the left adductor; MD: -2.05; p<.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p<.001) and right (p<.001) adductor strength.Conclusions. An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength and flexibility, while improvements are maintained at four weeks follow-up. Trial Registration Number: NCT03617887.

Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

2021 ◽  
Vol 104 (6) ◽  
pp. 887-894
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Energy Conservation ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

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