scholarly journals Strategies for discontinuation of proton pump inhibitors (PPIs) in patients with long-term PPI administration: a randomized controlled trial

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Mariko Hojo ◽  
Daisuke Asaoka ◽  
Yuji Shimada ◽  
Shuko Nojiri ◽  
Akihito Nagahara
Keyword(s):  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Parallel Group ◽  
Abrupt Discontinuation ◽  
Group A ◽  
Group B

Abstract Background Proton pump inhibitors (PPIs), including potassium ion-competitive acid blocker, are widely used worldwide and are often used for long periods of time. However, in recent years, potential side effects associated with long-term PPI use have been reported. Many patients take PPI for a long period of time, even though it is unnecessary, and it is necessary to discontinue PPI administration in such patients. However, sudden discontinuation may cause symptoms to recur and discontinuation may be unsuccessful. A strategy for safe and secure PPI discontinuation has not yet been established. The purpose of this study is to determine whether PPI can be safely discontinued by tapering the PPI dose or by abrupt discontinuation of PPI, and to establish a strategy for safe and secure PPI discontinuation. Methods The evaluation will be conducted as a multicenter, randomized, parallel-group clinical trial with five assessment points at the start of the study and 2 weeks, 4 weeks, 6 months, and 12 months after the start of the study. One intervention group is the group in which PPI administration is abruptly discontinued (Group A), and the second group is the group in which the PPI dose is gradually tapered and then PPI administration is discontinued (Group B). The primary outcome and secondary outcome are the proportion of patients who successfully discontinued the PPI at 6 months and at 12 months after the start of the study in groups A and B, respectively. Discussion We predict that the proportion of patients who successfully discontinue PPI will be higher in the group in which PPI administration was gradually tapered than in the group in which PPI administration was abruptly discontinued. On the other hand, we expect that many participants will succeed in discontinuing PPI regardless of the discontinuation strategy due to the explanation that discontinuation is necessary. Trial registration Japan Registry of Clinical Trials, jRCT1031180383. Registered 20 March 2019, https://jrct.niph.go.jp/latest-detail/jRCT1031180383.

scholarly journals Induction of Labor Using Misoprostol With or Without Mifepristone in Intrauterine Deat

2014 ◽  
Vol 52 (194) ◽  
pp. 785-790 ◽  
Author(s):  
Ajay Agrawal ◽  
Pritha Basnet ◽  
Achala Thakur ◽  
Pappu Rizal ◽  
Rubina Rai
Keyword(s):  
Fetal Death ◽  
Controlled Trial ◽  
Induction Of Labor ◽  
Intrauterine Fetal Death ◽  
Secondary Outcome ◽  
Group A ◽  
Pre Treatment ◽  
Vaginal Misoprostol ◽  
Group B ◽  
Rapid Expulsion

Introduction: Rapid expulsion of fetus in intrauterine fetal death is usually requested without any medical grounds for it. So an efficient, safe method for induction of labor is required. The objective of this study is to determine if pre-treatment with mifepristone followed by induction of labor with misoprostol in late intrauterine fetal death is more efficacious. Methods: We conducted a randomized controlled trial in 100 patients in B.P.Koirala Institute of Health Sciences, Nepal from June 2011 to May 2013. Group A women received single oral dose of 200 mg mifepristone, followed by induction with vaginal misoprostol after 24 hours. Group B women were induced only with vaginal misoprostol. In each group, five doses of misoprostol was used four hourly. If first cycle was unsuccessful, after break of 12 hour, second course of misoprostol was started. The primary outcome was a measure of induction to delivery time and vaginal delivery within 24 hours. Secondary outcome was to measure need of oxytocin and complications. Results: Maternal age, parity and period of gestation were comparable between groups. Number of misoprostol dose needed in group A was significantly less than group B. Mann Whitney U test showed, women in group A had significantly earlier onset of labor, however total induction to delivery interval was not significant. In group A, 85.7% delivered within 24 hours of first dose of misoprostol while in group B 70% delivered within 24 hours (p=0.07). More women in Group B required oxytocin. Conclusions: Pretreatment with mifepristone before induction of labor following late intrauterine fetal death is an effective and safe regimen. It appears to shorten the duration of induction to onset of labor.  Keywords:  induction of labor; intrauterine fetal death; mifepristone; misoprostol. 

scholarly journals An intervention for improving the lifestyle habits of kindergarten children in Israel: a cluster-randomised controlled trial investigation

2014 ◽  
Vol 18 (9) ◽  
pp. 1537-1544 ◽  
Author(s):  
Liat Lerner-Geva ◽  
Elinor Bar-Zvi ◽  
Gila Levitan ◽  
Valentina Boyko ◽  
Brian Reichman ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Nutritional Knowledge ◽  
Intervention Programme ◽  
Cluster Randomised ◽  
Daily Energy ◽  
Group A ◽  
Group B ◽  
Randomised Controlled

AbstractObjectiveTo assess the effectiveness of an intervention programme to improve kindergarten children's eating and leisure habits in Israel.DesignA cluster-randomised controlled trial.SettingSix full-day kindergartens in Israel were randomly divided into three groups. Group A received the full intervention programme, which included lessons on good eating habits and daily physical exercise. Group B received a partial intervention of lessons only. Group C, the reference group, did not receive any intervention.SubjectsChildren aged 4–6 years (n 204) were recruited for the study.MethodsObjective data for weight and height were collected to calculate BMI Z-scores. Activity, sedentary time, sleeping hours and daily energy intake were assessed via a parental questionnaire. Nutritional knowledge was assessed by a single dietitian using a questionnaire addressed to the children. Assessments were done at baseline and at the end of the intervention.ResultsAfter adjustment for baseline levels we observed a significant reduction in daily energy intake for the full intervention group A (P = 0·03). A positive intervention effect was demonstrated on nutritional knowledge in the partial intervention group B (P = 0·03), although no significant change was demonstrated for BMI Z-score.ConclusionsThe study supports the incorporation of education on healthy lifestyle habits and physical activity into the curricula of kindergartens.

Plaque Removal Efficacy of Dental floss Compare to Water Jet Following Single Use

2021 ◽  
Vol 15 (12) ◽  
pp. 3439-3441
Author(s):  
Syed Midhat Batool ◽  
Madiha Rasheed ◽  
Kawish Syed ◽  
Afaq Farooq ◽  
Zain Ayub ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Water Jet ◽  
Tooth Brushing ◽  
Control Group ◽  
Dental Floss ◽  
Plaque Removal ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Dental plaque (biofilm) is a well-known contributor to the onset and progression of many dental illnesses. Plaque is a natural biofilm that develops on oral surfaces and contains a wide variety of organisms. As a result, it is critical to control plaque formation, particularly in the young population, by implementing effective preventive strategies. Objective: To assess and compare plaque removal efficacy of water flosser and string floss in patients. Study design: Randomized controlled trial Place and Duration of study: Department of Periodontology, Sardar Begum Dental College, Gandhara University from 1st March 2019 to 31st May 2019. Methodology: Seventy patients were enrolled. Patients were randomly allocated to one of two groups, group A (using dental floss) as the control group and group B (using waterpik) as the intervention group, using the lottery technique. Patients were randomly allocated to one of two groups, group A (control group), using dental floss and group B (intervention group), using waterpik utilizing the lottery technique. All participants were taught correct brushing technique utilizing the Modified Bass technique and manufacturer's instructions for using waterpik as well as normal flossing instructions for using Dental floss. Results: The mean age presentation was 34.23±6.78 years. The females were 42 (60%) males were 28 (40%). The mean percentage showed that those using water flosser with tooth brushing had low plaque score than using string floss with tooth brushing. The independent t test showed that water flosser is significantly more effective (p=0.001) in plaque reduction than conventional string floss. Conclusion: A water flosser coupled with hand brushing is more effective in eliminating plaque than string floss. Plaque removal was 20-30% higher in the group that used a water flosser. Key words: Efficacy, Dental floss, Water jet

Ziv-aflibercept versus bevacizumab administration prior to diabetic vitrectomy: a randomised and controlled trial

2019 ◽  
pp. bjophthalmol-2018-313313
Author(s):  
Isaac Aleman ◽  
Javier Castillo Velazquez ◽  
Sloan W Rush ◽  
Ryan B Rush
Keyword(s):  
Postoperative Period ◽  
Controlled Trial ◽  
Intraoperative Complications ◽  
Secondary Outcome ◽  
Interval Group ◽  
Treatment Groups ◽  
Study Interval ◽  
Group A ◽  
Group B

PurposeTo compare the effectiveness of intravitreal ziv-aflibercept (IVZ) to intravitreal bevacizumab (IVB) administered preoperatively to patients undergoing pars plana vitrectomy (PPV) for severe manifestations of proliferative diabetic retinopathy (PDR).DesignRandomised clinical trial (RCT).MethodsTwo hundred and six patients with PDR-related complications requiring PPV were randomised into one of two treatment groups: Group A received IVZ (1.25 mg/0.05 mL) 1–10 days before PPV, while Group B received IVB (1.25 mg/0.05 mL) 1–10 days before PPV. The primary outcome was best-corrected visual acuity (BCVA) at 6 months follow-up. Secondary outcome measures were perioperative tractional retinal detachment (TRD) rates, surgical times, intraoperative and postoperative complications and incidence of unplanned PPV during the 6 month study interval.ResultsOne hundred and seventy three subjects underwent PPV and completed the 6-month follow-up interval. Group A subjects had better BCVA at 6 months (p=0.0035), shorter surgical times (p=0.0013) and were less likely to have a recurrence of vitreous haemorrhaging in the postoperative period (p=0.0101) when compared with subjects in Group B. There were no significant differences among the treatment groups with regards to baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV during the 6 month study interval.ConclusionsThis RCT demonstrated better final visual outcomes, shorter operating times and less vitreous haemorrhage recurrences in the postoperative period when subjects received IVZ compared to IVB prior to PPV for the treatment of PDR-related complications.

scholarly journals VITAMIN D AND PNEUMONIA

2018 ◽  
Vol 25 (04) ◽  
pp. 532-537
Author(s):  
Muhammad Shamaoon ◽  
Dr Maryam ◽  
Muhammad Ahsan ◽  
Rahman Ahmad
Keyword(s):  
Vitamin D ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Hospital Treatment ◽  
Randomized Controlled ◽  
Inflammatory Conditions ◽  
Group A ◽  
Group B

Background: Pneumonia is lower respiratory tract infection (LRTI) andrepresents inflammatory conditions of the lungs i.e of the lower respiratory tracts, air sacs andlung parenchyma.1 Objectives: To determine the role of vitamin D supplementation in reducingmorbidity in children with pneumonia. Study Design: Randomized Controlled trial. Place andDuration of Study: Pediatric Department, Mayo Hospital Lahore from December 2014 to May2015. Patient & Methods: Two hundred children of age 2 – 59 months with pneumonia (fever,cough, tachypnea, and subcostal recessions) and low vitamin D level (< 20 ng/ml) were includedin the study. One Hundred pneumonia patients received antibiotics (group A) and vitamins D(100,000 IU) while another group of hundred patients received only antibiotics without vitaminsupplementation (group B). When respiratory distress settled, length of stay in hospital wascalculated at the time of discharged. All patients were followed in pediatric OPDs for 3 monthsafter in-hospital treatment to pick recurrence of pneumonia symptoms (if any). Results: Themean recovery time for vitamin D group (5.7 +2.8 days) and non-vitamin D (6.1+2.8 days)was almost same with P=0.29. But the frequency of repeated episodes of pneumonia within30 days of treatment was lower in intervention group n=4 (2%) than the non-intervention groupn=18 (9%) (P = 0.002). Conclusion: 100,000 IU of vitamin D given once during treatment ofpneumonia decreases the chances of recurrence in the next 30 days.

scholarly journals Comparison of efficacy of needling and a combination of needling and platelet rich plasma in relieving pain and improving function in patients of tennis elbow: a prospective, randomized, double blinded, placebo controlled clinical trial

2021 ◽  
Vol 7 (2) ◽  
pp. 258
Author(s):  
Vikram Sharma ◽  
Vivek Chandak
Keyword(s):  
Tennis Elbow ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Lateral Epicondylitis ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Group A ◽  
Group B ◽  
Double Blinded

<p><strong>Background: </strong>Lateral epicondylitis is a common musculoskeletal disorder for which an effective treatment strategy remains unknown. Aim of the study was to examine whether a single injection of platelet-rich plasma (PRP) with needling is more effective than needling with placebo in reducing pain in adults with lateral epicondylitis. Study design used was randomized controlled trial.    </p><p><strong>Methods: </strong>A total of 66 patients with chronic lateral epicondylitis were randomized (1:1) to receive either a blinded injection of PRP (group A) or saline (placebo) group B. The primary end point was a change in pain using the VAS and patient-rated tennis elbow evaluation (PRTEE) questionnaire. The secondary outcome being improvement in function (PRTEE scores).<strong></strong></p><p><strong>Results: </strong>The VAS score and PRTEE score improved significantly in both the groups at all 3 follow-up examinations. Group A had significantly better results than the group B.</p><p><strong>Conclusions: </strong>PRP injection are safe and effective management strategy for lateral epicondylitis</p>

scholarly journals Design of a Mobile Application and Evaluation of Its Effects on Psychological Parameters of Covid-19 Inpatients: A Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Shokoufeh Aalaei ◽  
Farnaz Khoshrounejad ◽  
Lahya Afshari Saleh ◽  
Mahnaz Amini
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Care Providers ◽  
Psychological Conditions ◽  
Parallel Group ◽  
High Prevalence ◽  
Group A ◽  
Discharge From Hospital

Background: Panic of the disease and the associated concerns can lower the quality of life and physical performance. As long as the COVID-19 pandemic is ever on the rise, the psychological pandemic of the disease is on the rise, too. The high prevalence of COVID-19 has further increased physicians' work pressure. Patients' needs are not met adequately by physicians. It seems essential to use aids to monitor patients' needs and serve them properly. Thus, in the present research, suggestions are made on how to evaluate patients' physical and psychological conditions during the treatment via a mobile application.Methods and Analysis: The present research is a randomized, two parallel-group, controlled trial. One-hundred-twelve inpatients diagnosed with the coronavirus will be assigned randomly to the control and intervention groups. In the intervention group, a mobile application will be provided to educate patients, establish two-way interactions between patients and care providers and record patients' symptoms. Those in the control group will receive the usual care. The primary outcome is the change to the depression anxiety stress scales-21 (DASS-21) score from the baseline to 2 weeks after discharge from hospital. It will be measured at the baseline, at the time of discharge, and two weeks later.Ethics and Dissemination: The Ethics committee of Mashhad University of Medical Sciences' approval date was 2020-04-19 with IR.MUMS.REC.1399.118 reference code. Thus far, participants' recruitment has not been completed and is scheduled to end in March 2021. The results will be disseminated in a peer-reviewed journal.Trial Registration: IRCT20170922036314N4 (https://www.irct.ir/trial/47383).

scholarly journals A randomized control study of titrated and oral misoprostol solution for induction of labor at term

2021 ◽  
Vol 10 (11) ◽  
pp. 4206
Author(s):  
Barbie Sharma ◽  
Tapasya Dhar ◽  
Sunita Goyal
Keyword(s):  
Controlled Trial ◽  
Tertiary Care ◽  
Induction Of Labor ◽  
Drop Out ◽  
Secondary Outcome ◽  
Tertiary Care Centre ◽  
Maternal Complications ◽  
Oral Misoprostol ◽  
Group A ◽  
Group B

Background: Quest for an induction method with safety, efficacy, feasibility, low cost, and patient preference is a constant pursuit for all obstetricians. Oral misoprostol is one such method which has been shown to be effective in achieving vaginal birth and has been recommended by WHO (2011) and FIGO (2012) for induction of labor. This study aimed to evaluate effectiveness and safety of hourly titrated oral misoprostol solution in comparison with two hourly static-dose oral misoprostol solution for induction of labor at term.Methods: Single centre interventional single-blinded randomized controlled trial conducted in a tertiary care centre in Ludhiana. 264 term pregnant women were randomly given titrated (group A) or static oral misoprostol solution (group B) till the onset of active labor. Induction to delivery time was the primary outcome measure while the secondary outcome measures pertained to efficacy and safety of the regimens.Results: 268 women were randomized, 4 patients were excluded from analysis because of drop out, leaving 264 women for intention to treat analysis. The mean interval between induction and delivery was 16.19±10.48 hours in group A and 15.28±8.34 hours in group B (p>0.10, NS). 71 women (53.8%) in group A and 72 women (54.5%) in group B had vaginal delivery within 24 hours (p>0.10, NS). 40.9% women in group B required more than 8 hours to receive the required number of doses as compared with 8.3% women in dose group A (p<0.01, SS). Oxytocin requirement was significantly higher in group A (76.5%) as compared to group B (59.8%) (p<0.05, SS). Incidence of fetal and maternal complications, rate of cesarean section and instrumental delivery was comparable between the two groups (p>0.10, NS).Conclusions: Titrated oral misoprostol, considering its efficacy, safety and time saving is comparable to WHO recommended static oral misoprostol.

scholarly journals Effect of Different Volumes on Pain Relief in Patient Receiving Fluoroscopic Guided Interlaminar Lumbar Epidural Steroid Injection

2018 ◽  
Vol 1 (21;1) ◽  
pp. 243-249 ◽  
Author(s):  
Jeetinder Kaur Makkar
Keyword(s):  
Pain Relief ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Secondary Outcome ◽  
Double Blind ◽  
Iodinated Contrast ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Epidural Steroid

Background: Epidural steroids injections (ESI) are frequently used to treat lumbar radicular pain. Although different volume have been used for interlaminar ESI in adults, there is no controlled trial comparing the effect of different volumes on pain relief for the same dose of steroid . Objective: To compare the effect of increase in volume of epidural drug on pain relief in lumbar ESI . Study design: Randomized double blind trial Settings: Pain OR of a tertiary care centre Methods: Sixty patients were randomly allocated to 1 of 3 groups: Group A (4 mL), Group B (6 mL), and Group C (8 mL). Pain was evaluated using visual analog scale (VAS) and improvement in disability using modified Oswestry Disability Questionnaire scores (MODQS) at 2, 4, 8, 12, and 24 weeks. Patients having less than 50% pain relief from baseline received an additional epidural injection of the same volume with a maximum of 3 injections at least 15 days apart. The primary objective of the study was incidence of patients attaining more than 50% pain relief at 6 months. Secondary outcome included MODQS and pattern of spread of iodinated contrast on fluoroscopy. Results: At the end of 6 months, there was no significant difference in the effective pain relief between the 3 groups (Group A-16/22 (72.7%), Group B-15/20 (75%), Group C-13/18 (72.2%); P = 0.98, chi- square test). All groups demonstrated a significant reduction in mean VAS scores. There was no significant intergroup difference in VAS sores and MODQS at all the time intervals. The pattern of contrast spread did not differ between the 3 groups. Limitation: Not a placebo controlled trial Conclusions: An increase in volume of the injectate from 4 mL to 8 mL did not increase the efficacy of interlaminar ESI. Key words: Epidural steroid, volume, low back pain, interlaminar:

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