Saccharomyces boulardii Combined With Quadruple Therapy for Helicobacter pylori Eradication Decreased the Duration and Severity of Diarrhea: A Multi-Center Prospective Randomized Controlled Trial

Background: Whether probiotics helped the Helicobacter pylori (H. pylori) eradication was still highly controversial. The non-bacterial Saccharomyces boulardii (S. boulardii) has demonstrated its efficacy in the treatment of antibiotic-associated and infectious diarrhea. We aimed to evaluate the effects of S. boulardii combined with quadruple therapy for H. pylori eradication and associated side effects.Methods: Three hundred and sixty H. pylori-infected patients were recruited in this multicenter, randomized controlled trial. The patients who underwent H. pylori eradication treatment were randomized in a ratio of 1:1 into two separate groups that received standard quadruple therapy (Group A) and quadruple therapy plus S. boulardii sachets (Group B) for 14 days. The everyday medication and side-effect records were collected for compliance and adverse effect analysis. All patients accepted 13C/14C-urea breath tests 4 weeks after the therapy completion.Results:Saccharomyces boulardii and quadruple therapy-combined intervention significantly reduced the incidences of overall side effects (27.8 vs. 38.5%, p = 0.034) and diarrhea (11.2 vs. 21.2%, p = 0.012) in Group B compared with quadruple therapy alone in Group A, especially reduced the diarrhea duration (5.0 days vs. 7.7 days, p = 0.032) and incidence of severe diarrhea (4.7 vs. 10.1%, p = 0.040). Intention-to-treat (ITT) analysis and per-protocol (PP) analysis both indicated no statistical differences of eradication rate between Groups A and B (ITT: 82.7 vs. 85.8%, p = 0.426; PP: 89.7 vs. 94.2%, p = 0.146). The joint use of S. boulardii and quadruple therapy markedly improved the overall pre-eradication alimentary symptoms (hazard ratio (HR): 2.507, 95% CI: 1.449–4.338) recovery.Conclusion:Saccharomyces boulardii ameliorated H. pylori eradication-induced antibiotic-associated side effects especially reduced the incidence of severe diarrhea and the duration of diarrhea. However, there was no significant effect of S. boulardii on the rate of H. pylori eradication.Trial Registration: The protocol had retrospectively registered at ClinicalTrails.gov, Unique identifier: NCT03688828, date of registration: September 27, 2018; https://clinicaltrials.gov/show/NCT03688828

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Protective Effect of Enterococcus faecium SF68 and Saccharomyces boulardii in Acute Severe Diarrhea in Infants: Randomized Controlled Trial

Esculapio ◽

10.51273/esc20.2516413 ◽

2021 ◽

Vol 16 (4 (oct 2020 - dec 2020)) ◽

Author(s):

Fariha Ahmad Khan ◽

Muhammad Zeeshan Khan ◽

Abdul Mudabbir Rehan ◽

Zoobia Irum ◽

Fouzia Perveen ◽

...

Keyword(s):

Hospital Stay ◽

Enterococcus Faecium ◽

Standard Treatment ◽

Controlled Trial ◽

Length Of Hospital Stay ◽

Saccharomyces Boulardii ◽

Severe Diarrhea ◽

Randomized Controlled ◽

Group A ◽

Group B

Objectives: This study was done to observe the effect of Enterococcus faecium SF68 and Saccharomyces boulardii in acute severe diarrhea in infants. Methods: It was a single blind, randomized controlled clinical trial done in Children Hospital, Lahore. The infants were selected between 6 months to 12 months of age. All the infants were suffering from acute diarrhea with severe dehydration. Total 105 infants were selected and randomly divided into three groups having 35 infants in each group. Infants in group A received standard treatment of diarrhea. Infants in group B and C received Enterococcus faecium SF68 and Saccharomyces boulardii respectively twice daily for five days along with standard treatment of diarrhea. All the infants were monitored for five days. The treatment response was observed in terms of frequency of diarrhea, duration of diarrhea, stool consistency and length of hospital stay. Results: The frequency of diarrhea, duration of diarrhea and length of hospital stay were significantly reduced in both group B and C as compared to group A. Conclusion: Enterococcus faecium SF68 and Saccharomyces boulardii helped to reduce the stool frequency, duration of diarrhea, length of hospital stay and also improved the stool consistency in acute severe diarrhea in infants. Key Words: Probiotics, Enterococcus faecium SF68, Saccharomyces boulardii, Acute severe Diarrhoea How to Cite: Ahmad F.K, Zeeshan M.K, Mudabbir A.R, Irum Z, Perveen F, Chiragh S. Protective Effect of Enterococcus Faecium Sf68 and Saccharomyces Boulardii in Acute Severe Diarrhea in Infants: Randomized Controlled Trial. Esculapio.2020;16(04):59-65.

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Efficacy of Tamsulosin plus Tadalafil versus Tamsulosin as Medical Expulsive Therapy for Lower Ureteric Stones: A Randomized Controlled Trial

Advances in Urology ◽

10.1155/2020/4347598 ◽

2020 ◽

Vol 2020 ◽

pp. 1-5

Author(s):

Diwas Gnyawali ◽

Manish Man Pradhan ◽

Prem Raj Sigdel ◽

Purushottam Parajuli ◽

Sampanna Chudal ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Side Effects ◽

Emergency Room ◽

Controlled Trial ◽

University Teaching ◽

Emergency Room Visits ◽

Medical Expulsive Therapy ◽

Randomized Controlled ◽

Group A ◽

Group B

Introduction. Urolithiasis is one of the common disorder with which about 1/5th is found in the ureter, of which 2/3rd is seen in the lower ureter. Medical expulsive therapy is one of the routine modalities of treatment which uses various drugs acting on the ureter smooth muscle by different mechanism. We aim to compare the efficacy of combination vs. single drug. Methods. This randomized controlled trial was done in 176 consecutive patients over a period of six months (March 2019 to August 2019) in Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching. Participants were divided into two groups (Group A, tamsulosin plus tadalafil, and Group B, tamsulosin) from computer-generated random numbers. Therapy was continued for a maximum of 3 weeks. Stone expulsion rate, time to stone expulsion, analgesic use, number of colic and emergency room visits for pain, early intervention, and adverse effects of drugs were recorded. Results. Among 176 patients who were enrolled in study, 7 were lost to follow-up, and 5 people required immediate intervention. There was a significant higher stone passage rate in group A than group B (64 vs. 50; P=0.025) and shorter expulsion time (1.66 vs. 2.32 weeks P=0.001) and less number of emergency room visits and colic episodes. No significant side effects were noted during study. Conclusion. Tamsulosin plus Tadalafil is more effective than tamsulosin with early passage of stone and decreased number of colic episodes and emergency visits without significant side effects for lower ureteric calculi of 5 mm to 10 mm.

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Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽

10.1177/17085381211010022 ◽

2021 ◽

pp. 170853812110100

Author(s):

Mohamed Shukri Abdelgawad ◽

Amr M El-Shafei ◽

Hesham A Sharaf El-Din ◽

Ehab M Saad ◽

Tamer A Khafagy ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Radiofrequency Ablation ◽

Controlled Trial ◽

Compression Therapy ◽

Randomized Controlled ◽

Venous Ulcers ◽

Group A ◽

Group B ◽

To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

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A Randomized Controlled Trial of Attentional Control Training for Treating Alcohol Use Disorder

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.748848 ◽

2021 ◽

Vol 12 ◽

Author(s):

Angelina Isabella Mellentin ◽

W. Miles Cox ◽

Javad S. Fadardi ◽

Laila Martinussen ◽

Nicolaj Mistarz ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Attentional Control ◽

Alcohol Use Disorder ◽

Controlled Trial ◽

Smartphone Application ◽

Evidence Based ◽

Randomized Controlled ◽

Alcohol Cues ◽

Group A ◽

Group B

Background: There is consistent evidence that community and clinical samples of individuals with an alcohol use disorder (AUD) have attentional biases toward alcohol cues. The alcohol attentional control training program (AACTP) has shown promise for retraining these biases and decreasing alcohol consumption in community samples of excessive drinkers. However, there is a lack of evidence regarding the effectiveness of ACTP in clinical AUD samples. The main aim of the present study is to investigate whether primary pharmacological and psychological, evidence-based alcohol treatment can be enhanced by the addition of a gamified AACTP smartphone application for patients with an AUD.Design and Methods: The study will be implemented as a randomized controlled trial. A total of 317 consecutively enrolled patients with AUD will be recruited from alcohol outpatient clinics in Denmark. Patients will be randomized to one of three groups upon initiation of primary alcohol treatment: Group A: a gamified AACTP smartphone application + treatment as usual (TAU); Group B: a gamified AACTP sham-control application + TAU; or Group C: only TAU. Treatment outcomes will be assessed at baseline, post-treatment, and at 3- and 6-month follow-ups. Repeated measures MANOVA will be used to compare the trajectories of the groups over time on alcohol attentional bias, alcohol craving, and drinking reductions. It is hypothesized that Group A will achieve better treatment outcomes than either Group B or Group C.Perspectives: Because attentional bias for alcohol cues is proportional to the amount of alcohol consumed, and these biases are not addressed within current evidence-based treatment programs, this study is expected to provide new evidence regarding the effectiveness of the gamified AACTP in a clinical population. Furthermore, due to promising results found using AACTP in community samples of excessive drinkers, there is a high probability that the AACTP treatment in this study will also be effective, thereby allowing AACTP to be readily implemented in clinical settings. Finally, we expect that this study will increase the effectiveness of evidence-based AUD treatment and introduce a new, low-cost gamified treatment targeting patients with an AUD. Overall, this study is likely to have an impact at the scientific, clinical, and societal levels.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT05102942?term=NCT05102942&draw=2&rank=1, identifier: NCT05102942.

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Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial

Pharmacy Practice ◽

10.18549/pharmpract.2020.3.2025 ◽

2020 ◽

Vol 18 (3) ◽

pp. 2025

Author(s):

Mariam A. Alameri ◽

Syed A. Syed Sulaiman ◽

Abdullah M. Ashour ◽

Ma’ad F. Al-Saati

Keyword(s):

Randomized Controlled Trial ◽

Patient Education ◽

Risk Stratification ◽

Controlled Trial ◽

Education Programs ◽

Randomized Controlled ◽

Group A ◽

Total Knee ◽

The Mean ◽

Group B

Background: Total knee replacement (TKR) is a major orthopedic surgery that is considered high risk for the development of venous thromboembolism (VTE). Objective: The aim of this study is to evaluate the clinical outcomes that resulted from the use of a new proposed VTE risk stratification protocol for selecting a suitable extended VTE prophylaxis for post TKR surgery patients administered in conjunction with patient education programs. Method: A randomized controlled trial was conducted in two medical centers in Saudi Arabia. A total of 242 patients were enrolled in the study, 121 patients in each group. The experimental group (A) was assessed by using the proposed VTE risk stratification protocol and also took part in patient education programs about TKR and its complications. The control group (B) was assessed by using the 2005 Caprini risk assessment tool and no education programs were given to this group. Both groups were followed for 35 days post operation. Results: The mean age of the participants was 65.86 (SD 8.67) and the majority of them were female 137 (56.6%). The mean body mass index of the study sample was 32.46 (SD 5.51). There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p˂0.05). There were no confirmed pulmonary embolism cases in the study sample and diagnosis of deep-vein thrombosis was confirmed in 12/242 (5.0%) of patients: 1/121 (0.8%) in group A and 11/121 (9.1%) in group B (p˂0.05). The readmission rate for all patients was 2.5% (6/242), all of whom were in group B (p˂0.05). Conclusion: The proposed VTE risk stratification protocol that was applied in conjunction with patient education programs reduced VTE complications and readmission events, post TKR surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04031859.

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Home-based physical activity in breast cancer patients and cardiorespiratory fitness: during and/or after chemotherapy? A three-arm randomized controlled trial (APAC)

10.21203/rs.3.rs-33269/v1 ◽

2020 ◽

Author(s):

Francois Vincent ◽

Elise Deluche ◽

Joelle Bonis ◽

Sophie Leobon ◽

Marie-Thérèse Antonini ◽

...

Keyword(s):

Breast Cancer ◽

Physical Activity ◽

Randomized Controlled Trial ◽

Cardiorespiratory Fitness ◽

Controlled Trial ◽

Categorical Variables ◽

Randomized Controlled ◽

Home Based ◽

Group A ◽

Group B

Abstract ObjectivesAdapted physical activity (APA) program is recommended for breast cancer care. However, their modalities have not been defined. The aim of this study was to determine the best time to begin APA. This randomized controlled trial evaluated at 12 months the effect of home-based APA performed during and/or after treatment on cardiorespiratory fitness. The primary endpoint was peak oxygen consumption (VO2peak) compared at 12 months (group A vs C and B vs C). Secondary endpoints included the 6-min walking test (6MWT), assessment of muscular strength, fatigue, quality of life, anxiety, and depression, and a questionnaire of PA levels. All tests were evaluated at baseline, 6 months, and 12 months.MethodA total of 94 patients with breast cancer were randomized to three different groups: group A, performing 6 months of APA during adjuvant care; group B, 6 months of APA after adjuvant care; and group C, 12 months of APA during and after specific care. The program combined one resistance session and two aerobic sessions per week. Analysis of variance was used for repeated measures, Student’s t-test or the Mann–Whitney U-test for continuous variables, and χ2 test for binary or categorical variables.Results A total of 81 participants were assessed at 6 months and 73 participants at 12 months. The majority of patients completed more than 85% of the exercise sessions. The baseline for VO2peak and secondary outcomes did not differ among the groups. VO2peak increased during the exercise period and decreased during the chemotherapy period without APA, but at 12 months no significant difference was observed. The same variations were observed in the 6MWT, with a significance at 6 months between A+C vs. B (p=0.04), but no difference among the groups at 12 months. In the three groups, no decrease in other studied parameters were noted, except at 6 months in group B without APA. ConclusionsHome-based APA in breast cancer survivors can decrease some of the negative side effects of cancer treatment and has a positive effect on physical function with no differences based on the timing of this program.TRIAL REGISTRATIONClinicalTrials.gouv.fr (NCT01795612). Registered 20 February 2013,https://clinicaltrials.gov/ct2/show/NCT01795612?term=APAC&draw=2&rank=3

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POSTOPERATIVE ANALGESIA IN CHILDREN

The Professional Medical Journal ◽

10.29309/tpmj/2018.25.07.136 ◽

2018 ◽

Vol 25 (07) ◽

pp. 1069-1072

Author(s):

Mohsin Riaz Askri ◽

Shumyala Maqbool ◽

Muhammad Afzal Mirza ◽

Muhammad Rauf

Keyword(s):

Randomized Controlled Trial ◽

Postoperative Analgesia ◽

Controlled Trial ◽

Study Group ◽

Randomized Controlled ◽

Caudal Analgesia ◽

Group A ◽

The Mean ◽

Group B ◽

Independent University

Objectives: To compare the mean duration of pain relief using caudal bupivacainewith and without neostigmine for postoperative analgesia in children undergoing infra-umbilicalsurgery. Study design: Randomized Controlled trial. Settings: Department of AnaesthsiaChildren Hospital/Institute of child health Faisalabad& Independent university hospitalFaisalabad. Duration of Study: Six months from July 2017 to December 2017. Methods: 60patients (30 in each group) were included in this study. Group-A given 1ml/kg of 0.25% caudalbupivacaine and Group-B given 1ml/kg of 0.25% caudal bupivacaine and 2μg/kg neostigmine.Results: Mean age was 4.20±1.09 and 4.13±1.07 years in group-A and B, respectively. Sexdistribution shows, 22 patients (73.3%) in group-A and 9 (30.0%) in group-B were male while 8patients (26.7%) of group-A and 11 patients (36.7%) of group-B were female. Mean duration ofrelief of pain (hours) in group-A was 6.70±2.12 hours and in group-B was 11.97±3.80 hours.Difference between group-A and group-B was considered statistically significant (P<0.001).Conclusion: Neostigmine with bupivacaine caudally in paediatric patients increases theduration of analgesia. However, neostigmine may be used for prolongation of caudal analgesia.

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Improved Analgesic Effect of Paravertebral Blocks before and after Video-Assisted Thoracic Surgery: A Prospective, Double-Blinded, Randomized Controlled Trial

Pain Research and Management ◽

10.1155/2019/9158653 ◽

2019 ◽

Vol 2019 ◽

pp. 1-7 ◽

Cited By ~ 3

Author(s):

Lihua Chu ◽

Xiaolin Zhang ◽

Yaping Lu ◽

Guohao Xie ◽

Shengwen Song ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Thoracic Surgery ◽

Controlled Trial ◽

Analgesic Efficacy ◽

Video Assisted Thoracic Surgery ◽

Randomized Controlled ◽

Video Assisted ◽

Group A ◽

Group B ◽

Double Blinded

Despite being less invasive, patients who underwent video-assisted thoracic surgery (VATS) suffered considerable postoperative pain. Paravertebral block (PVB) was proven to provide effective analgesia in patients with VATS; however, there is no difference in pain relief between preoperative PVB and postoperative PVB. This study was aimed to investigate the analgesic efficacy of combination of preoperative and postoperative PVB on the same patient undergoing VATS. In this prospective, double-blinded, randomized controlled trial, 44 patients undergoing VATS were enrolled, and they received patient-controlled intravenous analgesia (PCIA) with sufentanil plus preoperative PVB (Group A, n = 15) or postoperative PVB (Group B, n = 15), or combination of preoperative and postoperative PVB (Group C, n = 14). The primary outcome was sufentanil consumption and PCIA press times in the first 24 hours postoperatively. Also, data of postoperative use of PCIA and visual analogue scale (VAS) were collected. In the first 24 hours postoperatively, median sufentanil consumption in Group C was 0 (0–34.75) μg, which was much less than that in Group A (45.00 (33.00–47.00) μg, p=0.005) and Group B (36 (20.00–50.00) μg, p=0.023). Patients in Group C pressed less times of PCIA (0 (0–0) times) than patients in Group A (2 (1–6) times, p<0.001) and Group B (2 (1–3) times, p=0.009). Kaplan–Meier analysis showed patients with combination of preoperative and postoperative PVB had a higher PCIA-free rate than patients with either technique alone (p=0.003). The VAS among the three groups was comparable postoperatively. The combination of both preoperative and postoperative PVB provides better analgesic efficacy during the early postoperative period and may be an alternative option for pain control after VATS. This trial is registered with ChiCTR1800017102.

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Effect of Virgin Coconut Oil Application on the Skin of Preterm Newborns: A Randomized Controlled Trial

Journal of Tropical Pediatrics ◽

10.1093/tropej/fmz041 ◽

2019 ◽

Vol 66 (2) ◽

pp. 129-135

Author(s):

Mithun Chandra Konar ◽

Kamirul Islam ◽

Atanu Roy ◽

Taraknath Ghosh

Keyword(s):

Adverse Effect ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Neurodevelopmental Outcome ◽

Coconut Oil ◽

Preterm Neonates ◽

Virgin Coconut Oil ◽

Randomized Controlled ◽

Group A ◽

Group B

Abstract Background Preterm constitutes a major part of neonatal mortality, particularly in India. Due to dermal immaturity, preterm neonates are susceptible to various complications like infection, hypothermia, etc. Emollient application is a traditional practice in our subcontinent. Aims To find out the efficacy of coconut oil application for skin maturity, prevention of sepsis, hypothermia and apnea, its effect on long-term neurodevelopment and adverse effect of it, if any. Material and methods A randomized controlled trial was conducted in the rural field practice area of Department of Community Medicine, Burdwan Medical College from March 2014 to August 2018. Preterm born in the study period was divided into Group A (received virgin coconut oil application) and Group B (received body massage without any application). Neonatal skin condition was assessed on 7th, 14th, 21st and 28th day of life. Neurodevelopmental status was assessed on 3rd, 6th and 12th months. Results A total of 2294 preterm were included in the study. Groups A and B consisted of 1146 and 1148 preterm infants, consecutively. Mean gestational age of the study population was 31.9 ± 3.4 weeks and 50.4% were male. Mean weight loss in first few days was less in group A but mean weight gain per day was higher in group B. Lesser incidences of hypothermia and apnea, and better skin maturity and neurodevelopmental outcome were noted in group A. No significant adverse effect was noted with coconut oil application. Conclusion Use of coconut oil helps in dermal maturity and better neurodevelopmental outcome. Further studies are warranted for universal recommendation.

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Efficacy of haemorrhoidectomy versus haemorrhoidectomy with internal sphincterotomy in treatment of haemorrhoids: a retrospective randomized controlled trial study

International Surgery Journal ◽

10.18203/2349-2902.isj20210913 ◽

2021 ◽

Vol 8 (3) ◽

pp. 839

Author(s):

Rajasekar Selvarajan

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Data Entry ◽

College Hospital ◽

Internal Sphincterotomy ◽

Medical College ◽

Randomized Controlled ◽

Post Operative Pain ◽

Group A ◽

Group B

Background: Role of internal sphincterotomy along with hemorrhoidectomy in reducing the pain among the cases with hemorrhoids is still a debate among most of the surgeons. Hence this study was conducted to compare the efficacy of haemorrhoidectomy with or without internal sphincterotomy in reducing the post-operative pain among the patients with haemorrhoids. Methods: A hospital based randomized controlled trial study was conducted among the patients with haemorrhoids undergoing surgical intervention for the same in department of general surgery in Sri Muthukumaran Medical College Hospital and Research Institute, Chennai, during the study period from July 2017 to December 2019. A total of sixty cases with haemorrhoids were included in the study. Patients in group A (n=30) underwent haemorrhoidectomy alone and group B (n=30) underwent haemorrhoidectomy along with internal sphicterectomy. Data entry was done using Microsoft excel and data was analyzed using Statistical Package for Social Sciences (SPSS) version 17. Results: In the present study, mean pain scores on first three post-operative days and the duration required to resume the normal activities was found to be low in the group who underwent haemorrhoidectomy with internal sphincterectomy compared to the group who underwent haemorrhoidectomy alone. Duration of surgical procedure and the complications were found to be similar in both haemorrhoidectomy with internal sphincterectomy group and haemorrhoidectomy alone, group. Conclusions: Haemorrhoidectomy with lateral Internal Sphincterotomy is better in terms of less pain but the complications were similar in both groups.

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