scholarly journals Vonoprazan-Based Regimen Is More Useful than PPI-Based One as a First-LineHelicobacter pyloriEradication: A Randomized Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Masafumi Maruyama ◽  
Naoki Tanaka ◽  
Daisuke Kubota ◽  
Masayuki Miyajima ◽  
Takefumi Kimura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Eradication Rate ◽  
Controlled Trial ◽  
Eradication Therapy ◽  
Group Versus ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Primary Endpoints ◽  
H Pylori

Background. A new agent, potassium-competitive acid blocker vonoprazan (VPZ) has potent acid-inhibitory effects and may offer advantages over conventionalH. pylorieradication therapies. We aimed to compare the eradication rate between VPZ-based treatment and PPI-based one.Methods. This randomized controlled trial was designed to assign 141 patients withH. pylori-positive gastritis to VPZ group (VPZ 20 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days) or PPI group (rabeprazole 20 mg or lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days). Primary endpoints were eradication rates and adverse events.Results. Seventy of 72 patients in VPZ group and 63 of 69 patients in PPI group completed the treatment after 7 days. The eradication rate was significantly higher in VPZ group than PPI group by intention-to-treat analysis (95.8% versus 69.6%,P=0.00003, 95% confidence interval [CI] 88.3-99.1% versus 57.3-80.1%) and per-protocol analysis (95.7% versus 71.4%,P=0.0002, 95% CI 88.0-99.1% versus 58.7-82.1%). The incidence of adverse events was not different between the groups (26.3% in VPZ group versus 37.7% in PPI group,P=0.15).Conclusion. VPZ-based regimen is more useful than that PPI-based regimen as a first-lineH. pylorieradication therapy.

High eradication rate of H. pylori with moxifloxacin-based treatment: a randomized controlled trial

2007 ◽  
Vol 119 (11-12) ◽  
pp. 372-378 ◽  
Author(s):  
Petra Bago ◽  
Aleksandar Vcev ◽  
Monika Tomic ◽  
Marjan Rožankovic ◽  
Marinko Marušić ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Eradication Rate ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
H Pylori

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

Water exchange-assisted vs. carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial

Endoscopy ◽  
2021 ◽  
Author(s):  
Shaopeng Liu ◽  
Tao Dong ◽  
Yupeng Shi ◽  
Hui Luo ◽  
Xianmin Xue ◽  
...  
Keyword(s):  
Carbon Dioxide ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Water Exchange ◽  
Controlled Trial ◽  
Control Group ◽  
Balloon Enteroscopy ◽  
Randomized Controlled ◽  
Single Balloon ◽  
Single Balloon Enteroscopy

<b>Background and study aims</b> Single-balloon enteroscopy (SBE) is a valuable but difficult modality for the diagnosis and treatment of small-bowel diseases. The water exchange (WE) method has the advantage of facilitating intubation during colonoscopy. Here, we evaluated the effects of WE on procedure-related variables related to SBE. <b>Patients and methods</b> This randomized controlled trial was conducted in a tertiary-care referral center in China. Patients with attempt at total enteroscopy (ATE) were randomly allocated to undergo WE-assisted (WE group) or carbon dioxide-insufflated enteroscopy (CO<sub>2</sub> group). All patients were planned to undergo both antegrade and retrograde procedures. The primary outcome was the total enteroscopy rate (TER). Secondary outcomes included maximal insertion depth, positive findings, procedural time and adverse events. <b>Results</b> In total, 110 patients were enrolled, with 55 in each group. Baseline characteristics between the two groups were comparable. TER was achieved in 58.2% (32/55) of the WE group and 36.4% (20/55) of the control group (p=0.022). The estimated intubation depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the CO<sub>2</sub> group (p=0.037). The insertion time was prolonged in the WE group compared with CO<sub>2</sub> group (178.9±45.1 min vs. 154.2±27.6 min, p<0.001). Endoscopic findings and adverse events were comparable between the two groups. <b>Conclusions</b> The WE method improved TER and increased intubation depth during SBE. The use of WE did not increase complications of enteroscopy. Clinical trial registation: https://clinicaltrials.gov/， NCT01942863.

Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures

2015 ◽  
Vol 8 (7) ◽  
pp. 756-763 ◽  
Author(s):  
Avery J Evans ◽  
Kevin E Kip ◽  
Waleed Brinjikji ◽  
Kennith F Layton ◽  
Mary L Jensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vertebral Body ◽  
Controlled Trial ◽  
Vertebral Compression Fractures ◽  
Compression Fractures ◽  
Time Points ◽  
Randomized Controlled ◽  
Primary Endpoints ◽  
Average Pain ◽  
Registration Number

BackgroundWe present the results of a randomized controlled trial evaluating the efficacy of vertebroplasty versus kyphoplasty in treating vertebral body compression fractures.MethodsPatients with vertebral body compression fractures were randomly assigned to treatment with kyphoplasty or vertebroplasty. Primary endpoints were pain (0–10 scale) and disability assessed using the Roland–Morris Disability Questionnaire (RMDQ). Outcomes were assessed at 3 days, 1 month, 6 months, and 1 year following the procedure.Results115 subjects were enrolled in the trial with 59 (51.3%) randomly assigned to kyphoplasty and 56 (48.7%) assigned to vertebroplasty. Mean (SD) pain scores at baseline, 3 days, 30 days, and 1 year for kyphoplasty versus vertebroplasty were 7.4 (1.9) vs 7.9 (2.0), 4.1 (2.8) vs 3.7 (3.0), 3.4 (2.5) vs 3.6 (2.9), and 3.0 (2.8) vs 2.3 (2.6), respectively (p>0.05 at all time points). Mean (SD) RMDQ scores at baseline, 3 days, 30 days, 180 days, and 1 year were 17.3 (6.6) vs 16.3 (7.4), 11.8 (7.9) vs 10.9 (8.2), 8.6 (7.2) vs 8.8 (8.5), 7.9 (7.4) vs 7.3 (7.7), 7.5 (7.2) vs 6.7 (8.0), respectively (p>0.05 at all time points). For baseline to 12-month assessment in average pain and RMDQ scores, the standardized effect size between kyphoplasty and vertebroplasty was small at −0.36 (95% CI −1.02 to 0.31) and −0.04 (95% CI −1.68 to 1.60), respectively.ConclusionsOur study indicates that vertebroplasty and kyphoplasty appear to be equally effective in substantially reducing pain and disability in patients with vertebral body compression fractures.Trial registration numberNCT00279877.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

Abstract MP72: Feasibility, Safety and Acceptability of Soy-Based Diet for Pregnant Women: Preliminary Results From a Pilot Randomized Controlled Trial

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Ling Shi ◽  
Vidya Iyer ◽  
Errol Norwitz ◽  
Tiffany A Moore Simas ◽  
Nirupa Matthan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Pregnant Women ◽  
Health Effects ◽  
Cardiometabolic Risk ◽  
Controlled Trial ◽  
Cardiometabolic Health ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial ◽  
Whole Foods

Introduction: Previous evidence suggests that soy containing foods may have beneficial effects on lipid and glycemic metabolism due to their biologically active components, including soy protein and isoflavones. Pregnancy is associated with changes in glucose and lipid metabolism, partially attributable to elevated estrogen concentrations. We have previously reported a significant, inverse association between urinary excretion of isoflavones and cardiometabolic risk markers in pregnant women, using data from the National Health and Nutrition Examination Survey (NHANES). Further studies are needed to determine the cardiometabolic health effects of soy intake in pregnant women. Hypothesis: We hypothesize that consumption of soy-based whole foods is safe and acceptable for pregnant women and has beneficial cardiometabolic health effects. Methods: A pilot randomized controlled trial (RCT) was conducted in 30 pregnant women who received counseling to consume either a high-soy or low-soy foods containing diet. Assessments (physical and anthropometric measurements, food frequency questionnaires, fasting blood samples) were conducted at 14 and 28 weeks of pregnancy, and 6 weeks’ postpartum. Monthly follow-up calls were conducted by research team coordinator to assess safety and encourage adherence. Results: Both the high-soy and low-soy groups demonstrated high adherence (80-90%), defined as consuming soy foods ≥ 15 days in the past four weeks for high-soy group and ≤ 5 days for low-soy group. Five subjects in the high-soy group reported adverse events (nausea, vomiting, diarrhea, itchy mouth); all were transient and resolved without sequelae. No adverse events were reported in the low-soy group. Skinfold thickness decreased (-4.8 mm) in the high-soy group and increased (+3.6 mm) in the low-soy group (p=0.04). There was a trend towards lower BMI in the high-soy compared to low-soy group at 28 weeks (+1.4 vs. +3.6 kg/m 2 , respectively, p=0.15) and postpartum (-1.2 vs. +0.6 kg/m 2 , respectively, p=0.14). This decrease in BMI was predominantly a loss of body fat and not lean mass. There were no significant differences between groups in fasting glucose, HDL-C, LDL-C, TG, or VLDL concentrations. Conclusions: In conclusion, results from this pilot RCT support the acceptability and safety of consuming soy-based whole foods during pregnancy. A larger-scale RCT is needed to further elucidate the effects of soy-based foods on cardiometabolic risk factors during pregnancy, as well as the transgenerational effects on their offspring.

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