scholarly journals Efficacy of Curcuma longa in treatment of postprandial distress syndrome: An open-label randomized-controlled trial

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1827
Author(s):  
Nicharat Sawangroj ◽  
Jiratha Budkaew ◽  
Bandit Chumworathayi
Keyword(s):  
Randomized Controlled Trial ◽  
Distress Syndrome ◽  
Curcuma Longa ◽  
Controlled Trial ◽  
Symptom Scale ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Postprandial Distress Syndrome ◽  
Clinical Trials Registry

Background: Proton pump inhibitors are effective for functional dyspepsia but ineffective in relieving postprandial distress syndrome. Curcuma longa might be effective for postprandial distress syndrome. The objective of this study was to compare the efficacy of Curcuma longa and simethicone for postprandial distress syndrome in an open-label randomized-controlled trial. Methods: This trial was conducted between July 2018 and February 2019. In total, 78 patients were randomly assigned to receive 4 weeks of treatment with 750 or 1,500 mg oral Curcuma longa per day or 240 mg simethicone per day. The patients assessed their symptoms using the dyspepsia Global Overall Symptom scale at baseline, week 2, and week 4. After stopping medication for 2 weeks, the patients assessed recurrent symptoms and day of recurrence by themselves at the end of week 6. Results: In total, 78 patients underwent randomization (27 in 750 mg Curcuma longa, 26 in 1500 mg Curcuma longa, and 25 in simethicone groups). After 2 weeks, there were no significant differences in all mean changes of symptoms scores (95%CI) of postprandial distress syndrome [-4.1 (-4.5, -2.6) vs -4.3 (-5.2, -3.3) vs -4.2 (-4.8, -3.5), P=0.954]. Over a period of 4 weeks, the reduction in mean scores was greater among participants receiving simethicone (although not statistically significant) compared with two intervention groups [-4.6 (-5.7, -3.6) vs -5.4 (-6.6, -4.1) vs -6.2 (-7.2, -5.2), P=0.122]. The rate of recurrence was significantly lower in simethicone than the two Curcuma longa groups (42.9 vs 45.5 vs 13.6%, P=0.047). There was no serious adverse event reported in all three groups. Conclusions: Curcuma longa had a similar effect on treatment outcomes to simethicone after 2 and 4 weeks, but the recurrence rate of symptoms was significantly higher without serious adverse events. Registration: Registered with the Thai Clinical Trials Registry on 31 January 2018; TCTR20180131001.

scholarly journals Comparative maternal outcomes of oral nifedipine and intravenous labetalol for severe hypertension during pregnancy: an open label randomized controlled trial

2020 ◽  
Vol 9 (7) ◽  
pp. 2847
Author(s):  
Monika Sharma ◽  
Sita Thakur ◽  
Kamal Singh ◽  
Shashank Shekhar
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Health Care Providers ◽  
Severe Hypertension ◽  
Controlled Trial ◽  
Care Providers ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Hypertensive Diseases

Background: Hypertensive diseases are commonly seen during pregnancy and remain one of the leading causes of maternal morbidity and mortality. Mostly commonly preferred drugs by health care providers for treatment of severe hypertension during pregnancy are labetalol and hydralazine. However, they require proper storage, intravenous access, and adequately trained staff for usage. Oral nifedipine in contrast is easier to use and widely available.  Objective of this study was to report the efficacy and safety of oral nifedipine as compared to intravenous labetalol for treatment of severe hypertension during pregnancy.Methods: It was an open label randomized controlled trial in which 100 women with severe hypertension during pregnancy were enrolled. They were randomized to receive either incremental doses of intravenous labetalol every 20 minutes (total 300 mg) or 10 mg oral nifedipine every 20 minutes (up to 50 mg) to lower the blood pressure to safer levels.Results: Women receiving oral nifedipine took significantly less time to achieve target blood pressure [(37.6±23.3) minutes (SD) as compared to those receiving intravenous labetalol (52.0 minutes±27.95 (SD)]. Women receiving nifedipine for treatment also required significantly lesser doses to control the blood pressure [mean dose 1.8±1.1 (SD) versus 2.6±1.2 (SD) p=0.006]. There were two failures in labetalol group and one failure in nifedipine group. No serious adverse events were reported in either group.Conclusions: Oral nifedipine is equally efficacious to I.V. labetalol for treatment of severe hypertension during pregnancy and is easier to use in low resource settings.

scholarly journals Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial

2021 ◽  
Author(s):  
Philippe Bégin ◽  
Jeannie Callum ◽  
Erin Jamula ◽  
Richard Cook ◽  
Nancy M. Heddle ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Harmful Effect ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Negative Results

AbstractThe efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset (NCT04348656). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm—relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94–1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02–1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57–0.95 and OR = 0.66, 95% CI 0.50–0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14–2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

Sign in / Sign up

Export Citation Format

Share Document