scholarly journals Montelukast as an Alternative to Low-Dose Inhaled Corticosteroids in the Management of Mild Asthma (The SIMPLE Trial): An Open-Label Effectiveness Trial

2009 ◽  
Vol 16 (suppl a) ◽  
pp. 11A-16A ◽  
Author(s):  
R Andrew McIvor ◽  
Alan Kaplan ◽  
Caroline Koch ◽  
John S Sampalis
Keyword(s):  
Asthma Control ◽  
Outcome Measures ◽  
Low Dose ◽  
Inhaled Corticosteroids ◽  
Symptom Control ◽  
Physician Satisfaction ◽  
Mild Asthma ◽  
Secondary Outcome ◽  
Open Label ◽  
Number Of Patients

OBJECTIVE: To evaluate the effectiveness of montelukast as monotherapy for patients with mild asthma who remain uncontrolled or unsatisfied while on inhaled corticosteroid (ICS) monotherapy.DESIGN: A multicentre, open-label study. Patients (six years of age or older) had ICS therapy discontinued and were treated with orally administered montelukast once daily for six weeks.MAIN OUTCOME MEASURES: The primary outcome measure was the rate at which asthma symptom control was achieved or maintained after six weeks of treatment. The secondary outcome measures were to compare compliance and physician satisfaction, and to further assess the safety and tolerability of montelukast.RESULTS: Of the 534 patients enrolled, 481 (90.1%) completed the study. Mean (± SD) age was 27.8±19.0 years. The number of patients with uncontrolled symptoms decreased from 455 (85.2%) at baseline to 143 (26.8%) at week 6 (P<0.001), and mean Asthma Control Questionnaire score decreased from 1.4±0.8 to 0.6±0.6 (P<0.001), representing a clinically significant improvement. Of the 79 patients with controlled asthma symptoms at baseline, 73.4% maintained asthma control at week 6. Compliance to asthma therapy increased from 41% at baseline for ICS to 88% at week 6 for montelukast (P<0.001). Physician satisfaction with treatment increased from 43% to 85% (P<0.001) and patient satisfaction increased from 45% at baseline to 94% at week 6. No serious adverse events were reported over the course of the study.CONCLUSION: Montelukast is an effective and well-tolerated alternative to ICS treatment in patients with mild asthma who are uncontrolled or unsatisfied with low-dose ICS therapy.

scholarly journals Montelukast as an Alternative to Low-Dose Inhaled Corticosteroids in the Management of Mild Asthma (the SIMPLE Trial): An Open-Label Effectiveness Trial

2009 ◽  
Vol 16 (suppl a) ◽  
pp. 11A-16A ◽  
Author(s):  
R Andrew McIvor ◽  
Alan Kaplan ◽  
Caroline Koch ◽  
John S Sampalis
Keyword(s):  
Asthma Control ◽  
Outcome Measures ◽  
Low Dose ◽  
Inhaled Corticosteroids ◽  
Symptom Control ◽  
Physician Satisfaction ◽  
Mild Asthma ◽  
Secondary Outcome ◽  
Open Label ◽  
Number Of Patients

OBJECTIVE: To evaluate the effectiveness of montelukast as monotherapy for patients with mild asthma who remain uncontrolled or unsatisfied while on inhaled corticosteroid (ICS) monotherapy.DESIGN: A multicentre, open-label study. Patients (six years of age or older) had ICS therapy discontinued and were treated with orally administered montelukast once daily for six weeks.MAIN OUTCOME MEASURES: The primary outcome measure was the rate at which asthma symptom control was achieved or maintained after six weeks of treatment. The secondary outcome measures were to compare compliance and physician satisfaction, and to further assess the safety and tolerability of montelukast.RESULTS: Of the 534 patients enrolled, 481 (90.1%) completed the study. Mean (± SD) age was 27.8±19.0 years. The number of patients with uncontrolled symptoms decreased from 455 (85.2%) at baseline to 143 (26.8%) at week 6 (P<0.001), and mean Asthma Control Questionnaire score decreased from 1.4±0.8 to 0.6±0.6 (P<0.001), representing a clinically significant improvement. Of the 79 patients with controlled asthma symptoms at baseline, 73.4% maintained asthma control at week 6. Compliance to asthma therapy increased from 41% at baseline for ICS to 88% at week 6 for montelukast (P<0.001). Physician satisfaction with treatment increased from 43% to 85% (P<0.001) and patient satisfaction increased from 45% at baseline to 94% at week 6. No serious adverse events were reported over the course of the study.CONCLUSION: Montelukast is an effective and well-tolerated alternative to ICS treatment in patients with mild asthma who are uncontrolled or unsatisfied with low-dose ICS therapy.

Fluticasone versus Salmeterol/Low-Dose Fluticasone for Long-Term Asthma Control

2002 ◽  
Vol 36 (12) ◽  
pp. 1944-1949 ◽  
Author(s):  
Catherine A Heyneman ◽  
Rachel Crafts ◽  
Jerry Holland ◽  
Aaron D Arnold
Keyword(s):  
Fluticasone Propionate ◽  
Asthma Control ◽  
Low Dose ◽  
Inhaled Corticosteroids ◽  
Symptom Control ◽  
Persistent Asthma ◽  
Forced Expiratory Volume ◽  
Combination Drug ◽  
Medium Dose

OBJECTIVE: To evaluate the relative clinical superiority of increasing the dose of fluticasone propionate versus the addition of salmeterol to low-dose fluticasone propionate for long-term asthma control. DATA SOURCES: Literature was identified by a MEDLINE search (1966–October 2002). Key search terms included asthma, inhalation, corticosteroid, β-adrenergic agonist, and combination drug therapy. DATA SYNTHESIS: Current guidelines for long-term control of asthma include treatment with either inhaled corticosteroids (medium dose) or inhaled corticosteroids (low to medium dose) in combination with a long-acting bronchodilator. Previous studies evaluating salmeterol or formoterol combination therapy with beclomethasone or budesonide have generally produced superior results compared with increasing the dose of the inhaled corticosteroid. Four recent controlled clinical trials have compared the clinical utility of fluticasone propionate monotherapy versus salmeterol/low-dose fluticasone propionate for long-term asthma control in patients with moderate to severe persistent asthma. Based on spirometry data, rescue albuterol use, and symptom scores, the addition of salmeterol to low-dose fluticasone propionate was superior to increasing the dose of fluticasone propionate. CONCLUSIONS: Based on improvements in forced expiratory volume in 1 second, peak expiratory flow, and symptom control, the addition of salmeterol to low-dose fluticasone propionate provides better control of asthma than increasing the dose of fluticasone propionate.

scholarly journals Analgesic effects of intravenous ketamine after spinal anaesthesia for non-elective caesarean delivery: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e044168
Author(s):  
Prahlad Adhikari ◽  
Asish Subedi ◽  
Birendra Prasad Sah ◽  
Krishna Pokharel
Keyword(s):  
Postoperative Pain ◽  
Adverse Effects ◽  
Outcome Measures ◽  
Caesarean Delivery ◽  
Low Dose ◽  
Saline Group ◽  
Secondary Outcome ◽  
Pain Scores ◽  
Intravenous Ketamine ◽  
Elective Caesarean Delivery

ObjectivesThis study aimed to determine if low dose intravenous ketamine is effective in reducing opioid use and pain after non-elective caesarean delivery.DesignProspective, randomised, double-blind.SettingTertiary hospital, Bisheshwar Prasad Koirala Institute of Health Sciences, Dharan, NepalParticipants80 patients undergoing non-elective caesarean section with spinal anaesthesia.InterventionsPatients were allocated in 1:1 ratio to receive either intravenous ketamine 0.25 mg/kg or normal saline before the skin incision.Primary and secondary outcome measuresThe primary outcome was the total amount of morphine equivalents needed up to postoperative 24 hours. Secondary outcome measures were postoperative pain scores, time to the first perception of pain, maternal adverse effects (nausea, vomiting, hypotension, shivering, diplopia, nystagmus, hallucination) and neonatal Apgar score at 1 and 5 min, neonatal respiratory depression and neonatal intensive-care referral.ResultsThe median (range) cumulative morphine consumption during the first 24 hours of surgery was 0 (0–4.67) mg in ketamine group and 1 (0–6) mg in saline group (p=0.003). The median (range) time to the first perception of pain was 6 (1–12) hours and 2 (0.5–6) hours in ketamine and saline group, respectively (p<0.001). A significant reduction in postoperative pain scores was observed only at 2 hours and 6 hours in the ketamine group compared with placebo group (p<0.05). Maternal adverse effects and neonatal outcomes were comparable between the two groups.ConclusionsIntravenous administration of low dose ketamine before surgical incision significantly reduced the opioid requirement in the first 24 hours in patients undergoing non-elective caesarean delivery.Trial registration numberNCT03450499.

scholarly journals Effects of Collagen Hydrolysates on Human Brain Structure and Cognitive Function: A Pilot Clinical Study

Nutrients ◽  
2019 ◽  
Vol 12 (1) ◽  
pp. 50
Author(s):  
Seiko Koizumi ◽  
Naoki Inoue ◽  
Fumihito Sugihara ◽  
Michiya Igase
Keyword(s):  
Cognitive Function ◽  
Outcome Measures ◽  
Brain Structure ◽  
Short Form ◽  
Gray Matter Volume ◽  
Rank Correlation ◽  
Secondary Outcome ◽  
Open Label ◽  
Associate Learning ◽  
Collagen Hydrolysates

This study investigated the effects of collagen hydrolysates (CH) on language cognitive function and brain structure. In this open-label study, 5 g CH was administered once a day for 4 weeks to 30 healthy participants aged 49–63 years. The primary outcome measures were the brain healthcare quotients based on gray matter volume (GM-BHQ) and fractional anisotropy (FA-BHQ). The secondary outcome measures were changes in scores between week 0 and week 4 for word list memory (WLM) and standard verbal paired associate learning (S-PA) tests as well as changes in the physical, mental, and role/social component summary scores of the Short Form-36(SF-36) quality of life instrument. CH ingestion resulted in significant improvements in FA-BHQ (p = 0.0095), a measure of brain structure, as well in scores for the WLM (p = 0.0046) and S-PA (p = 0.0007) tests, which measure cognitive function. There were moderate correlations between the change in WLM score and the change in GM-BHQ (r = 0.4448; Spearman’s rank correlation) and between the change in S-PA score and the change in FA-BHQ (r = 0.4645). Daily ingestion of CH changed brain structure and improved language cognitive function.

scholarly journals Douching With Water Works Device for Perceived Vaginal Odor With or Without Complaints of Discharge in Women With No Infectious Cause of Vaginitis: A Pilot Study

2006 ◽  
Vol 2006 ◽  
pp. 1-4 ◽  
Author(s):  
Ashwin J. Chatwani ◽  
Sarmina Hassan ◽  
Salma Rahimi ◽  
Stacey Jeronis ◽  
Vani Dandolu
Keyword(s):  
Pilot Study ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Open Label ◽  
Significant Change

Objective. To determine if douching with Water Works device for 1 month can (1) lower or eliminate perceived vaginal odor by subject; (2) have any effects on vaginal ecosystem.Methods. Ten women with perceived vaginal odor with or without discharge, douched every day for 4 weeks in an open-label, nonrandomized pilot study. Primary outcome measures included perceived vaginal odor by subject, lactobacilli score from Nugent slide, and acceptance of the Water Works douching system. Secondary outcome included the safety of using this douching device.Results. At week 4, there was improvement in vaginal odor (P=.0006) and there was no significant change in lactobacilli score.Conclusion. Douching with Water Works device is associated with reduction or elimination of vaginal odor without adversely affecting the vaginal ecosystem.

scholarly journals Low dose niacin versus placebo in the treatment of Parkinson’s Disease:  A Randomized Controlled Trial

2021 ◽  
Author(s):  
Chandramohan Wakade ◽  
Raymond Chong ◽  
Marissa Seamon ◽  
Sharad Purohit ◽  
Banabihari Giri ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Open Label ◽  
Double Blind ◽  
One Year ◽  
Time Point

Abstract BackgroundParkinson’s Disease (PD) patients have lower niacin levels compared to their spouses. The main objective was to study low-dose daily niacin supplementation versus placebo on motor symptoms in Parkinson’s disease subjects.MethodsA randomized, placebo-controlled, double-blind, single-center clinical trial in Parkinson’s disease patients was performed in Augusta, GA, between September 2016 to September 2019. Randomized participants were 47 PD patients who received either low-dose niacin (N = 21 ) or placebo (N = 26) for the first six months (mean age 68.4 SD, 8.7; mean duration of disease 5.8 SD 4.9; H&Y scores between 0.5 to 4; 64% subjects were Veterans). The Veterans Affairs Pharmacy generated the randomized sequence. After the double-blind phase, all participants received open-label niacin for the next six months. All patients were evaluated at baseline, six months, and one year of treatment. The main outcome measure was the Unified Parkinson’s Disease Rating Scale III (UPDRS III) scores. Secondary outcome measures were depression, sleep quality, mental flexibility and cognition, and physical fatigue.Results39 subjects were analyzed with low-dose niacin (N = 18) and placebo (N = 21) for the completion of the first six months (randomized, double-blind), and 31 subjects were analyzed for the completion of the next six months (open-label) with low-dose niacin (N = 14) and placebo (N = 17). Niacin treatment was not tolerated by two subjects. The baseline mean UPDRS III score was 21.3 ± 15.8 for the niacin group and 22.4 ± 11.8 for placebo. The change with six months of placebo was 0.05 [95% CI, -2.4 to 2.32], and niacin was 1.06 [95% CI, -3.68 to 1.57]. From six to twelve months, the average UPDRS III score decreased for the placebo group by 4.58 [95% CI, -0.85 to 8.30] and the niacin group by 4.63 [95% CI, 1.42 to 7.83]. Eight subjects withdrew from the study before the 6-month time point and eight more before the one-year time point due to voluntary discontinuation, flushing, or inability to continue (SARS-CoV-2 shut-down).ConclusionLow-dose niacin supplementation may be helpful as an adjunct therapy in improving motor function in PD.Trial registrationClinicaltrials.gov, NCT03462680. Registered 12 March 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03462680?term=gpr109A&draw=2&rank=1

Efficacy of Pregabalin in the Treatment of Trigeminal Neuralgia

Cephalalgia ◽  
2007 ◽  
Vol 28 (2) ◽  
pp. 174-181 ◽  
Author(s):  
M Obermann ◽  
MS Yoon ◽  
K Sensen ◽  
M Maschke ◽  
HC Diener ◽  
...  
Keyword(s):  
Pain Relief ◽  
Trigeminal Neuralgia ◽  
Facial Pain ◽  
Secondary Outcome ◽  
Open Label ◽  
Day Range ◽  
Number Of Patients ◽  
Poor Treatment ◽  
Reduction Of Pain ◽  
Poor Treatment Outcome

This prospective, open-label study aimed to evaluate the efficacy of pregabalin treatment in patients suffering from trigeminal neuralgia with and without concomitant facial pain. Fifty-three patients with trigeminal neuralgia (14 with concomitant chronic facial pain) received pregabalin (PGB) 150-600 mg daily and were prospectively followed for 1 year. The primary outcome was number of patients pain free or with reduction of pain intensity by > 50% and of attack frequency by > 50% after 8 weeks. Secondary outcome was sustained pain relief after 1 year. Thirty-nine patients (74%) improved after 8 weeks with a mean dose of 269.8 mg/day (range 150-600 mg/day) PGB: 13 (25%) experienced complete pain relief and 26 (49%) reported pain reduction > 50%, whereas 14 (26%) did not improve. Patients without concomitant facial pain showed better response rates (32 of 39, 82%) compared with patients with concomitant chronic facial pain (7 of 14, 50%, P = 0.020). Concomitant chronic facial pain appears to be a clinical predictor of poor treatment outcome. PGB appears to be effective in the treatment of trigeminal neuralgia.

Efficacy and Safety of Traditional Chinese Medicine in COVID-2019: A Study Protocol for an Open-Label, Multicenter Randomized Controlled Trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Zhengzhong Yuan ◽  
Xiaoqiong Pan ◽  
Jizhou Zhang ◽  
Jiahui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Lung Injury Score ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Introduction: The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. It directly leads to high morbidity and mortality, but also results in a devastating effect on the global economy. Unfortunately, there are no effective therapies or vaccines for it. Hence, we designed a randomized trial to evaluate the efficacy and safety of Traditional Chinese Medicine for treating patients with COVID-19.Methods and analysis: This is an open-label, multicenter randomized controlled clinical trial. One hundred and twelve patients infected by SARS-CoV-2 will be randomly assigned to the experimental or the control group in an equal ratio. The patients in control group will accept routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in the experimental group will be asked to take traditional Chinese medicine depending on the different stages of the disease for consecutive 14 days in addition to supportive care. All data will be gathered at baseline and on days 3, 7, 10 and 14. The primary outcome measures will be the time of Reverse Transcription PCR testing of respiratory tract sample turns to be negative. Secondary outcome measures will include Murray lung injury score, MuLBSTA score and TCM ( Traditional Chinese Medicine ) Syndrome Scoring System. A laboratory test will be taken before and after treatment to assess the safety of TCM.Discussion: The study may help to identify the the efficacy and safety of Traditional Chinese Medicine in treating COVID-2019.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030759.Registered on March 13th 2020-Retrospectively registered, http://www.chictr.org.cn/.

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