scholarly journals The Effect of Intravenous Metoclopramide on Pain, Nausea, Discomfort, and Ease of Insertion of Nasogastric Tube in Emergency Department: A Double-blind Randomized Clinical Trial

2021 ◽  
Author(s):  
Seyed Mohammad Hosseininejad ◽  
Farzad Bozorgi ◽  
Asieh Khodami ◽  
Hamed Aminiahidashti ◽  
Mohammad Hajizade Juybari
Keyword(s):  
Emergency Department ◽  
Placebo Group ◽  
Nasogastric Tube ◽  
Controlled Trial ◽  
Intervention Group ◽  
Routine Procedure ◽  
Mazandaran Province ◽  
Double Blind ◽  
Patient Reported ◽  
Convenience Sampling

Background: Placement of nasogastric tube (NGT) is a routine procedure in the emergency departments, which can be uncomfortable, painful, and cause nausea. The aim of this study was to investigate the effect of intravenous metoclopramide on the ease of NGT insertion, as well as reduction of patients’ pain, nausea, and discomfort during NGT insertion in the emergency department. Methods: In this randomized, double-blind, placebo-controlled trial, 80 patients referred to Imam Khomeini Hospital, Mazandaran Province, Iran were enrolled. Data were collected from December 2015 to March 2016. Participants were selected via convenience sampling and randomly divided into two equal groups (placebo and intervention groups). In metoclopramide and placebo groups, 10 mg of metoclopramide and 10 mg of normal saline solution were administered, respectively. All of the NGT was inserted 15–20 mins after the intravenous infusion. Patient-reported pain, discomfort, and nausea were evaluated using visual analogue scale (VAS), at four time points including before (T0), immediately (T1), 30 min after (T2), and 1 hr after the NGT placement (T3). The ease of NGT insertion was evaluated as easy, moderate, and difficult to pass. Results: None of the patients had pain, nausea, and discomfort in T0. Additionally, for those who received intravenous metoclopramide, pain intensity significantly decreased compared with the placebo group in T1 (37.7 vs 55.0), T2 (26.2 vs 41.7), and T3 (20.5 vs 33.7), respectively (P < 0.001). Nausea intensity decreased significantly over time among patients in the intervention group compared with the placebo group in T1 (32.7 vs 43.2), T2 (19.5 vs 31.2), and T3 (9.0 vs 21.7), respectively (P < 0.001). The intensity of patients’ discomfort decreased significantly among patients in the intervention group compared with the placebo group in T1 (39.5 vs 54.0), T2 (28.7 vs 40.2), and T3 (26.2 vs 39.6), respectively (P < 0.001). Patients in the intervention group had easier placement of NGT compared with the placebo group (Easy: 40.0% vs 0.0%, Moderate: 45.0% vs 62.5%, and Difficult: 15.0% vs 37.5%; P < 0.001). Conclusion: Based on the results of the present study, it seems that intravenous metoclopramide can be used as a promising modality for improving the ease of NGT placement and reducing patients’ pain, nausea, and discomfort during NGT insertion in the emergency department.

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks.Participants, design and intervention: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. Outcome measurements and statistical analysis: The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events.Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the intervention group and 18.91 (102.27) in the placebo group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups.Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation.Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2nd November 2017, code NCT03343275, and URL:https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks.Methods: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events.Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation.Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2nd November 2017, code NCT03343275, and URL:https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks. Methods: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events. Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation. Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2nd November 2017, code NCT03343275, and URL: https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1 Keywords: double J stent; encrustation; nutraceutical; L-methionine; phytin; pH.

scholarly journals Effect of vitamin D supplementation on selected inflammatory biomarkers in older adults: a secondary analysis of data from a randomised, placebo-controlled trial

2015 ◽  
Vol 114 (5) ◽  
pp. 693-699 ◽  
Author(s):  
Mary Waterhouse ◽  
Bich Tran ◽  
Peter R. Ebeling ◽  
Dallas R. English ◽  
Robyn M. Lucas ◽  
...  
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Post Intervention ◽  
Double Blind ◽  
Specific Patient ◽  
Significant Difference

AbstractObservational studies have suggested that 25-hydroxyvitamin D (25(OH)D) levels are associated with inflammatory markers. Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups. Thus, we aimed to determine the effect of supplementary vitamin D using secondary data from a population-based, randomised, placebo-controlled, double-blind trial (Pilot D-Health trial 2010/0423). Participants were 60- to 84-year-old residents of one of the four eastern states of Australia. They were randomly selected from the electoral roll and were randomised to one of three trial arms: placebo (n 214), 750 μg (n 215) or 1500 μg (n 215) vitamin D3, each taken once per month for 12 months. Post-intervention blood samples for the analysis of C-reactive protein (CRP), IL-6, IL-10, leptin and adiponectin levels were available for 613 participants. Associations between intervention group and biomarker levels were evaluated using quantile regression. There were no statistically significant differences in distributions of CRP, leptin, adiponectin, leptin:adiponectin ratio or IL-10 levels between the placebo group and either supplemented group. The 75th percentile IL-6 level was 2·8 pg/ml higher (95 % CI 0·4, 5·8 pg/ml) in the 1500 μg group than in the placebo group (75th percentiles:11·0 v. 8·2 pg/ml), with a somewhat smaller, non-significant difference in 75th percentiles between the 750 μg and placebo groups. Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation, we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels, with the possible exception of IL-6.

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks. Participants, design and intervention: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. Outcome measurements and statistical analysis: The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events. Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the intervention group and 18.91 (102.27) in the placebo group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation. Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2 nd November 2017, code NCT03343275, and URL: https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1 Keywords: double J stent; encrustation; nutraceutical; L-methionine; phytin; pH.

scholarly journals The effectiveness of Kinesio Taping® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial

2020 ◽  
Vol 34 (7) ◽  
pp. 877-889 ◽  
Author(s):  
Venta Donec ◽  
Raimondas Kubilius
Keyword(s):  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Outpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Kinesio Taping ◽  
Patient Reported ◽  
Double Blinded

Objective: To evaluate the effectiveness of the Kinesio Taping® method for mobility and functioning improvement for patients with knee osteoarthritis (KO). Design: Randomized, double-blinded, controlled trial. Setting: Outpatient rehabilitation department. Subjects: A total of 187 subjects with symptomatic I–III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n = 81 (123 knees); control group, n = 76 (114 knees). Intervention: The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month. Main measures: Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants’ experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was p < 0.05. Results: The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was –2.2 ± 3.2 seconds, at follow-up –2.4 ± 3.1 seconds; in control group –2.8 ± 3.6 seconds, and –2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16), χ2 = 7.5, df = 2, p = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p < 0.005). Conclusion: Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.

Effects of Curcuminoids Plus Piperine on Glycemic, Hepatic and Inflammatory Biomarkers in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blind Placebo-Controlled Trial

Drug Research ◽  
2018 ◽  
Vol 68 (07) ◽  
pp. 403-409 ◽  
Author(s):  
Yunes Panahi ◽  
Nahid Khalili ◽  
Ebrahim Sahebi ◽  
Soha Namazi ◽  
Luis Simental-Mendía ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Placebo Group ◽  
Controlled Trial ◽  
Intervention Group ◽  
Inflammatory Biomarkers ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Hs Crp ◽  
The Impact

Abstract Introduction Curcuminoids have been shown to reduce glycemia and related complications in diabetes. In the present study, we evaluated the impact of curcuminoids plus piperine administration on glycemic, hepatic and inflammatory biomarkers in type 2 diabetes (T2D) patients. Methods T2D patients aged 18–65 years were enrolled in a randomized double-blind placebo-controlled trial and randomly allocated to standard-of-care treatment and dietary advises plus either curcuminoids (daily dose of 500 mg/day co-administered with piperine 5 mg/day) or placebo for a period of 3 months. Glycemic, hepatic and inflammatory parameters were measured at baseline and final conditions. Results A total of 100 subjects (50 in each group) completed the 3-month period of trial. A significant reduction was found in serum levels of glucose (−9±16 mg/dL vs. −3±11 mg/dL in curcuminoids and placebo groups, respectively; p=0.048), C-peptide (−0.6±0.8 ng/mL vs. 0.02±0.6 ng/mL; p<0.001) and HbA1c (−0.9±1.1% vs. −0.2±0.5%; p<0.001) after curcuminoids supplementation versus placebo group. Additionally, participants in the intervention group showed lower serum alanine aminotransferase (−2±6 vs. −1±5; p=0.032) and aspartate aminotransferase (−3±5 vs. −0.3±4; p=0.002) levels compared with the placebo group. Finally, no significant differences in high-sensitivity C-reactive protein (hs-CRP) concentrations were observed between curcuminoids and placebo groups (p>0.05). Conclusion The results of the present trial revealed a beneficial effect of curcuminoids plus piperine supplementation on glycemic and hepatic parameters but not on hs-CRP levels in T2D patients.

scholarly journals Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy

Neurology ◽  
2018 ◽  
Vol 90 (14) ◽  
pp. e1212-e1221 ◽  
Author(s):  
Amel Karaa ◽  
Richard Haas ◽  
Amy Goldstein ◽  
Jerry Vockley ◽  
W. Douglas Weaver ◽  
...  
Keyword(s):  
Placebo Group ◽  
Mitochondrial Myopathy ◽  
Controlled Trial ◽  
Cardiopulmonary Exercise Testing ◽  
Inner Mitochondrial Membrane ◽  
Double Blind ◽  
Therapeutic Benefits ◽  
Patient Reported ◽  
Efficacy Measure ◽  
Patient Reported Measures

ObjectiveTo assess the safety and efficacy of elamipretide, an aromatic-cationic tetrapeptide that readily penetrates cell membranes and transiently localizes to the inner mitochondrial membrane where it associates with cardiolipin, in adults with primary mitochondrial myopathy (PMM).MethodsA Study Investigating the Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy (MMPOWER) was a phase I/II multicenter, randomized, double-blind, placebo-controlled trial of elamipretide in 36 participants with genetically confirmed PMM. Participants were randomized to intravenous elamipretide (0.01, 0.1, and 0.25 mg/kg/h or placebo for 2 hours in a dose-escalating sequence). The primary efficacy measure was the change in distance walked in the 6-minute walk test (6MWT) after 5 days of treatment. Other efficacy measures included changes in cardiopulmonary exercise testing parameters, in participant-reported symptoms, and in serum and urinary biomarkers. Safety, tolerability, and pharmacokinetics were also measured.ResultsParticipants who received the highest dose of elamipretide walked a mean of 64.5 m farther at day 5 compared to a change of 20.4 m in the placebo group (p = 0.053). In addition, there was a dose-dependent increase in distance walked on the 6MWT with elamipretide treatment (p = 0.014). In a model that adjusted for additional covariates possibly affecting response, the adjusted change for the highest dose of elamipretide was 51.2 vs 3.0 m in the placebo group (p = 0.0297). No significant differences were observed in other efficacy and safety endpoints.ConclusionsElamipretide increased exercise performance after 5 days of treatment in patients with PMM without increased safety concerns. These findings, as well as additional functional and patient-reported measures, remain to be tested in larger trials with longer treatment periods to detect other potential therapeutic benefits in individuals affected by this condition.Classification of evidenceThis trial provides Class I evidence that for patients with PMM, elamipretide improved the distance walked on the 6MWT.

scholarly journals Identifying and Treating Opioid Side Effects

2019 ◽  
Vol 130 (1) ◽  
pp. 142-148 ◽  
Author(s):  
Jonathan Moss
Keyword(s):  
Placebo Group ◽  
Transit Time ◽  
Methadone Maintenance ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treated Group ◽  
Opioid Withdrawal ◽  
University Hospital ◽  
Double Blind ◽  
Opioid Administration

Abstract Methylnaltrexone Reverses Chronic Opioid-induced Constipation: A Randomized, Controlled Trial. By Yuan CS, Foss JF, O’Connor M, Osinski J, Karrison T, Moss J, Roizen MF. JAMA 2000; 130:142–8. Reprinted with permission. Context Constipation is the most common chronic adverse effect of opioid pain medications in patients who require long-term opioid administration, such as patients with advanced cancer, but conventional measures for ameliorating constipation often are insufficient. Objective To evaluate the efficacy of methylnaltrexone, the first peripheral opioid receptor antagonist, in treating chronic methadone-induced constipation. Design Double-blind, randomized, placebo-controlled trial conducted between May 1997 and December 1998. Setting Clinical research center of a university hospital. Participants Twenty-two subjects (9 men and 13 women; mean [SD] age, 43.2 [5.5] years) enrolled in a methadone maintenance program and having methadone-induced constipation. Main Outcome Measures Laxation response, oral-cecal transit time, and central opioid withdrawal symptoms were compared between the 2 groups. Results The 11 subjects in the placebo group showed no laxation response, and all 11 subjects in the intervention group had laxation response after intravenous methylnaltrexone administration (P&lt;.001). The oral-cecal transit times at baseline for subjects in the methylnaltrexone and placebo groups averaged 132.3 and 126.8 minutes, respectively. The average (SD) change in the methylnaltrexone-treated group was −77.7 (37.2) minutes, significantly greater than the average change in the placebo group (−1.4 [12.0] minutes; P&lt;.001). No opioid withdrawal was observed in any subject, and no significant adverse effects were reported by the subjects during the study. Conclusions Our data demonstrate that intravenous methylnaltrexone can induce laxation and reverse slowing of oral cecal-transit time in subjects taking high opioid dosages. Low-dosage methylnaltrexone may have clinical utility in managing opioid-induced constipation.

scholarly journals Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Hailong Zhang ◽  
Jiansheng Li ◽  
Xueqing Yu ◽  
Suyun Li ◽  
Haifeng Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Chinese Medicine ◽  
Short Form ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Acute Exacerbations

Abstract Background The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. AECOPD have been effectively treated with Chinese medicine for a long time. The aim of this proposed trial is to assess the therapeutic effect of Chinese medicine (CM) on AECOPD. Methods/design This proposed study is a multicenter, double-blind, parallel-group randomized controlled trial (RCT). We will randomly assign 378 participants with AECOPD into two groups in a 1:1 ratio. On the basis of health education and conventional treatment, the intervention group will be treated with CM, and the control group is given CM placebo according to CM syndrome. Patients are randomized to either receive CM or placebo, 10 g/packet, twice daily. The double-blind treatment lasts for 2 weeks and is followed up for 4 weeks. The main outcome is the COPD Assessment Test; secondary outcomes are treatment failure rate, treatment success rate, length of hospital stay, AECOPD readmission rate, intubation rate, mortality, dyspnea, the 36-item Short Form Health Survey, and the COPD patient-reported outcome scale. We will document these outcomes faithfully at the beginning of the study, 2 weeks after treatment, and at the 4 weeks follow-up. Discussion This high-quality RCT with strict methodology and few design deficits will help to prove the effectiveness of CM for AECOPD. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD. Trial registration ClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.

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