scholarly journals Effectiveness and Quality of Life with Montelukast in Asthma – A double-blind randomized control trial

2019 ◽  
Vol 35 (3) ◽  
Author(s):  
Mirza Saif Ullah Baig ◽  
Rashid Ahmed Khan ◽  
Kamran Khan ◽  
Nadeem Rizvi
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Asthma Control ◽  
Persistent Asthma ◽  
Double Blind ◽  
Once Daily ◽  
The Mean ◽  
Moderate Persistent Asthma

Objective: To determine the role of montelukast – a leukotriene receptor antagonist (LTRA) – in improving the quality of life (QOL) and asthma control of adult patients with mild to moderate persistent asthma. Methods: Randomized, double-blind, placebo-controlled, non-crossover trial was conducted from March 2017 till November 2018 in three hospitals of Karachi and Hyderabad. Adults of age 15 years or more with mild to moderate persistent asthma. Treatment group was administered tablet montelukast 10mg once daily; the other group was given a similar looking placebo; as an adjuvant to the current medication. QOL was assessed with Asthma Quality of Life Questionnaire – Standard (AQLQ-S) before and after the treatment. Asthma control was monitored via Asthma Control Test (ACT). Results: After 4 weeks, the mean ± SD of overall QOL on AQLQ-S improved from 3.74±0.88 to 5.06±0.89 for montelukast group and from 3.58±0.92 to 4.71±0.97 for placebo group (p=0.02). The improvement in sub-domains of symptoms, activity, and emotional functions was not significant; however, the sub-domain “environmental stimuli” significantly improved with 5.06±0.89 for montelukast group and 4.71±0.97 for placebo group (p=0.02). The mean ± SD of ACT, after four weeks, for montelukast group was 18.19±2.91 and for placebo group 17.28±3.36. Only on ACT, Montelukast did not show any statistically insignificant results. Conclusion: The role of montelukast in improving QOL of adult patients with mild to moderate persistent asthma is quite beneficial. It improves patient quality of life. It has the ease of once daily oral administration and also eradicates side effects associated with long-term adherence to steroids. doi: https://doi.org/10.12669/pjms.35.3.42 How to cite this:Baig S, Khan RA, Khan K, Rizvi N. Effectiveness and Quality of Life with Montelukast in Asthma – A double-blind randomized control trial. Pak J Med Sci. 2019;35(3):---------. doi: https://doi.org/10.12669/pjms.35.3.42 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

scholarly journals The Effects of Propolis Extract Administration on HIV Patients Receiving ARV

2021 ◽  
Vol 13 (1) ◽  
pp. 75-83
Author(s):  
Erwin Astha Triyono ◽  
Sarah Firdausa ◽  
Heru Prasetyo ◽  
Joni Susanto ◽  
James Hutagalung ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Cd4 Count ◽  
Controlled Clinical Trial ◽  
Human Immune System ◽  
Hiv Patients ◽  
Double Blind ◽  
Significant Difference

BACKGROUND: Human immunodeficiency virus (HIV) is an infectious disease that targets the human immune system by attacking cluster of differentiation (CD)4 cells. The use of propolis in HIV patients is expected to be safe and beneficial in terms of increasing endurance and immunity by its role in increasing CD4 level. This study aimed to analyze the influence of propolis supplementation in increasing the CD4 level in anti-retroviral (ARV)-treated HIV patients.METHODS: Double-blind randomized controlled clinical trial was conducted in 50 HIV patients who took regular ARV therapy. The subjects were divided into two groups, one group was treated with ARV and propolis, while another one was given ARV and placebo. The CD4 cell count was measured during pre-treatment, in the 3rd month, in the 6th month after treatment. The level of hemoglobin, leukocyte, and platelets were also measured. The SF-12 questionnaire was used to evaluate quality of life of the subject.RESULTS: Out of 50 subjects, 43 subjects completed the study, which were 19 subjects from the propolis group and 24 subjects from the placebo group. After 3-month of treatment, there was a statistically significant difference in the incrwase of CD 44 level in propolis group, while the increment was not significant in the placebo group. After 6-month treatment, the increase of CD4 level was occurred in both groups, propolis and placebo, however the increment was not statistically significant. The levels of hemoglobin, leukocyte, and platelets were not altered by the treatment and remained normal throughout the study. The quality of life was improved during the study; however, it was also not statistically significant. Mild adverse events occurred in 3 subjects which were relieved after the treatment stopped.CONCLUSION: Based on the result of this study, the administration of propolis on HIV patients receiving ARV bring significant difference in the increase of CD4 in propolis group from baseline to 3 month after the treatment. While in placebo group, this increment was not significant. At the end of study, CD4 count continued to rise up, however the increase was not statistically significant. There are no hemoglobin, leukocyte, platelets, and quality of life abnormalities. Therefore, it is necesary to do further research with a spesific CD4 count. However, it may be beneficial in relieving the clinical symptoms and quality of life of patient living with HIV.KEYWORDS: CD4, ARV, HIV, propolis

scholarly journals Assessment of quality of life in asthma patients in 5 to 18 years of children

2020 ◽  
Vol 7 (11) ◽  
pp. 2214
Author(s):  
Nikhil Jain ◽  
Karan Joshi
Keyword(s):  
Quality Of Life ◽  
Asthma Control ◽  
Persistent Asthma ◽  
Tertiary Hospital ◽  
P Value ◽  
Cross Sectional ◽  
Asthmatic Patients ◽  
Asthma Patients ◽  
Severity Of The Disease

Background: Asthma is a common cause of morbidity and mortality with prevalence of 300 million in world. The QOL of asthmatic patients cannot be determined only on the basis the severity of the disease, but requires a measurement of personal perception. This study was conducted with the aim to assess and compare the QOL using PedsQl scale in asthma patients between 5 to 18 years of age with different demographic and clinical variables.Methods: This was a cross-sectional observational study conducted at respiratory clinic in tertiary hospital, Rewa from October 2017 to June 2019. A total number of 150 asthmatic patients and their parents participated. Asthmatic patients (N=150) and their parents, presenting to asthma clinic of Gandhi Memorial Hospital, Rewa (after applying inclusion-exclusion criteria) were assessed for QOL using PedsQl scale 3.0. Statistical analysis was performed by SPSS version 20. Test of significance by student T-test and one way ANOVA.Results: The QOL is severely hampered by asthma with mean of 59 in intermittent asthma, 51 in mild, 44.74 in moderate and 40 in severe persistent asthma, significant p value of <0.05. Younger age, level of asthma control and severity were significantly related to QOL with p value of <0.05. Sex, socioeconomic status, were insignificantly related.Conclusions: QOL is impaired as the grading of asthma increases. Impairment of Quality of life are mostly associated with low level of asthma control, poly-therapy and frequent night attacks.

Dupilumab improves asthma control and quality of life in children with uncontrolled persistent asthma

2021 ◽  
Author(s):  
Alessandro Fiocchi ◽  
Wanda Phipatanakul ◽  
Sandy R. Durrani ◽  
Jeremy Cole ◽  
Xuezhou Mao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Asthma Control ◽  
Persistent Asthma

scholarly journals OR11-03 NT-814, a Non-Hormonal Dual Neurokinin 1,3 Receptor Antagonist Markedly Improves Vasomotor Symptoms in Post-Menopausal Women; Results of a Randomised, Double-Blind, Placebo-Controlled, Dose-Finding Study (SWITCH-1)

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
James Simon ◽  
Richard A Anderson ◽  
Elizabeth Ballantyne ◽  
Hadine Joffe ◽  
Mary Kerr ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Dose Finding ◽  
Vasomotor Symptoms ◽  
Phase 3 ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Vasomotor symptoms (VMS), caused by declining estrogen in menopausal women, are common and debilitating. Hormone therapy is effective in many women but carries risks and may be contraindicated. Biological and clinical evidence shows a modulatory role for neurokinin (NK) receptor antagonists acting primarily via hypothalamic KNDy (kisspeptin, NK, dynorphin) neurons on VMS. NT-814 is an oral non-hormonal dual NK1,3 receptor antagonist which has previously been shown to cause rapid and marked improvements in VMS in post-menopausal women. This Phase-2b trial (SWITCH-1) was undertaken to further evaluate efficacy and safety and to establish the optimum dose(s) for Phase 3 studies. Methods: SWITCH-1 was a double-blind, placebo-controlled, adaptive-randomization, dose-finding trial in 199 post-menopausal women. After a 2-week single-blind placebo run-in to establish symptom stability, women (40 to 65 years) with ≥7 moderate and/or severe VMS per day at baseline were randomized to 12 weeks of once daily treatment with placebo or one of 4 doses of NT-814: 40 mg, 80 mg, 120 mg, 160 mg. Subjects recorded the frequency and severity of VMS in electronic diaries twice daily throughout the study. Patient-reported measures of quality-of-life, sleep and mood were collected periodically. Adverse events (AEs) were recorded at each clinic visit. Results: VMS frequency was reduced in all treatment groups, including placebo. VMS reductions were significantly greater with the 2 higher NT-814 doses at most time-points, as early as the first week of treatment. Least squares mean reductions from baseline in moderate/severe VMS per day at week 4 were: placebo, 2.7; 40 mg, 4.3 (p=0.161 vs placebo); 80 mg, 4.1 (p=0.326); 120 mg, 6.7 (p&lt;0.0001); 160 mg, 5.5 (p=0.007). In week 12 the reductions were: placebo, 4.7; 40 mg, 6.5 (p=0.185); 80 mg, 5.6 (p=0.599); 120 mg, 7.8 (p=0.009); 160 mg, 6.6 (p=0.109). At the 160 mg dose the median reduction in week 12 was significantly greater than placebo (6.9 vs 4.4, p=0.0023), indicating an effect of high outliers on the mean. Average HF severity was also improved in a dose-related manner, with greater reductions compared to placebo with the 2 higher NT-814 doses. Improvements in HF were accompanied by statistically significant benefits on sleep (assessed using the Insomnia Severity Index and Pittsburgh Sleep Quality Index), mood (measured using the Beck Depression Inventory), and all four domains of the MenQoL menopause-specific quality-of-life instrument. NT-814 was well-tolerated; most AEs were mild or moderate and there were no serious AEs related to treatment. Conclusions: NT-814, a once daily non-hormonal NK antagonist, at doses of 120 & 160 mg reduced the frequency and severity of VMS and significantly improved quality of life, mood and sleep, in postmenopausal women. NT-814 was well tolerated, with a safety profile that supports further evaluation in Phase 3 trials.

scholarly journals Observation of the Improvement in Nocturnal Asthma Symptoms with Administration of Once Daily Sustained Released Theophylline

2018 ◽  
Vol 9 (2) ◽  
pp. 74-77
Author(s):  
Mesbahul Karim Ruble ◽  
AKM Rafiqul Bari ◽  
Amar Biswas ◽  
Md Khairul Anam ◽  
Mahbub E Khuda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sustained Release ◽  
Pulmonary Function Tests ◽  
Persistent Asthma ◽  
Nocturnal Asthma ◽  
Once Daily ◽  
Asthma Symptoms ◽  
Sustained Release Theophylline

Objective: The aims and objective of this study to observe the improvement in Nocturnal Asthma symptoms and Quality of Life (QoL) with administration of once daily sustained release theophylline preparation.Background: Nocturnal symptoms are a common part of the asthma. Nocturnal asthma is defined by a drop in forced expiratory volume in 1 second (FEV1) of at least 15% between bedtime and awakening in patients with clinical and physiologic evidence of asthma, which may include improvement in QoL.Methodology: The patient with Chronic Persistent Asthma, both sex, age >18 to 50 years of age and preferably patients with nocturnal exacerbations were included in the study. All patients were diagnosed on the basis of clinical history, physical examination, chest X-ray and pulmonary function tests, in accordance with the clinical criteria for the diagnosis by the GINA. The recruitment period was between March 2017 and August 2017 Shaheed Suhrawardy Medical College Hospital, Dhaka.Results: It was observed that 65(92.85%) was found exacerbation free night and 5(7.15%) patients were found exacerbation with sustained release Theophylline. There are significantly improved qualities of life between 1st follow up to 2nd follow up, 3rd follow up and 4th follow up p<0.001 which was statistically significant. Spirometry test was gradually improved between 1st visit of FEV1 to 2nd, 3rd and 4th visit of FEV1, (p<0.001) that was statistically significant.Conclusion: Most of the patients were found exacerbation free night. There are significantly improved quality of life between 1st follow up to 2nd follow up, 3rd follow up and 4th follow up in Spirometry test. The value of FEV1 was gradually improve in the lst visit, 2nd, 3rd and 4th visit with sustained release Theophylline.J Shaheed Suhrawardy Med Coll, December 2017, Vol.9(2); 74-77

Efficacy of Celecoxib in Treating Symptoms of Viral Pharyngitis: A Double-Blind, Randomized Study of Celecoxib versus Diclofenac

2002 ◽  
Vol 30 (2) ◽  
pp. 185-194 ◽  
Author(s):  
LLM Weckx ◽  
JE Ruiz ◽  
J Duperly ◽  
GA Martínez Mendizabal ◽  
MBG Rausis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Randomized Study ◽  
Specific Inhibitor ◽  
Symptomatic Treatment ◽  
Double Blind ◽  
Once Daily ◽  
Daily Group ◽  
Throat Pain

This study compared the efficacy and safety of the cyclooxygenase-2 specific inhibitor celecoxib with the conventional non-steroidal anti-inflammatory drug diclofenac in the symptomatic treatment of viral pharyngitis. Adult patients from 27 study centers in Latin America were treated with oral doses of celecoxib 200 mg once daily or 200 mg twice daily, or diclofenac 75 mg twice daily for 5 days in a double-blind, randomized study. The primary efficacy assessment was ‘Throat Pain on Swallowing’ on day 3. In addition, secondary quality-of-life assessments were performed on days 3 and 5. All adverse events and treatment-emergent signs and symptoms were recorded. Data from 313 patients were evaluable for efficacy (105 celecoxib 200 mg once daily, 107 celecoxib 200 mg twice daily, 101 diclofenac 75 mg twice daily). The upper 95% confidence limits for the visual analog scale of ‘Throat Pain on Swallowing’ on day 3 for celecoxib 200 mg once daily relative to diclofenac 75 mg twice daily, and celecoxib 200 mg twice daily relative to diclofenac 75 mg twice daily were 9.26 and 7.83, respectively. All secondary efficacy and quality-of-life measures were clinically similar for the three treatment groups, and no statistically significant differences were detected. The incidences of treatment-emergent adverse events and withdrawals due to adverse events were similar for all groups, but numerically higher among patients taking diclofenac than celecoxib. More patients in the diclofenac group reported gastrointestinal complaints (7.3%) compared with those in the celecoxib groups (4.3% in the celecoxib 200 mg once-daily group and 3.4% in the celecoxib 200 mg twice-daily group). In conclusion, 5 days of treatment with celecoxib 200 mg once daily is as effective as diclofenac 75 mg twice daily in the symptomatic treatment of viral pharyngitis. Celecoxib 200 mg once daily is also as effective as celecoxib 200 mg twice daily in this condition.

Randomized, Prospective Clinical Trial of rFVIIa for Secondary Prophylaxis in Hemophilia Patients with Inhibitors.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 766-766 ◽  
Author(s):  
Barbara A. Konkle ◽  
Liselotte S. Ebbesen ◽  
Ute Friedrich ◽  
Raul P. Bianco ◽  
Toshko Lissitchkov ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Secondary Prophylaxis ◽  
Post Treatment ◽  
Factor Vii ◽  
Double Blind ◽  
Once Daily ◽  
On Demand ◽  
Observation Period

Abstract Introduction: Hemophilia patients with inhibitors experience frequent bleeds and reduced quality of life (QoL). This trial evaluated whether once−daily prophylaxis therapy with activated recombinant factor VII (rFVIIa; 90 or 270 μg/kg) for 3 months can effectively reduce bleed frequency compared with on−demand therapy, without compromising safety. Methods: Thirty−eight hemophilia inhibitor patients with frequent bleeds entered a 3−month observation period where on−demand therapy was continued according to local practice. Twenty−two patients with a stable bleed frequency (≥4 bleeds/month) were randomized 1:1 to once−daily dosing with 90 or 270 μg/kg rFVIIa in a double−blind, parallel−group design. To maintain blinding, the same volume was administered in both groups. Patients then entered a 3−month post−treatment observation period, where on−demand therapy was resumed. Results: The number of bleeds per month was significantly reduced by 45% and 59% with 90 or 270 μg/kg rFVIIa prophylaxis, respectively, compared with the observation period (Fig.). Similar reductions were seen for all bleeds, irrespective of site or cause. The majority of this reduced bleeding frequency was maintained in the 3 month post−treatment period (27% and 50% reductions, respectively). There were no treatment− or dose−dependent patterns in the number or type of adverse events. No thromboembolic events or withdrawals due to adverse events or ineffective treatment were reported. The benefits of reducing bleeding frequency in this trial translated into improvements in QoL. Conclusions: These results support the concept of secondary rFVIIa prophylaxis in inhibitor patients with frequent bleeds. Clinically relevant reductions in number of bleeds and improvements in quality of life were observed during prophylaxis compared with conventional on−demand therapy without raising any safety concerns. Figure Figure

scholarly journals Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246871
Author(s):  
Timna Naftali ◽  
Lihi Bar-Lev Schleider ◽  
Fabiana Scklerovsky Benjaminov ◽  
Fred Meir Konikoff ◽  
Shelly Tartakover Matalon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Placebo Group ◽  
Activity Index ◽  
Controlled Trial ◽  
Clinical Effects ◽  
Short Term Treatment ◽  
Double Blind ◽  
Endoscopic Score

Background Cannabis is often used by patients with ulcerative colitis, but controlled studies are few. We aimed to assess the effect of cannabis in improving clinical and inflammatory outcomes in ulcerative colitis patients. Methods In a double-blind, randomized, placebo-controlled trial, patients received either cigarettes containing 0.5 g of dried cannabis flowers with80mgTetrahydrocannabinol (THC)or placebo cigarettes for 8 weeks. Parameters of disease including Lichtiger disease activity index, C reactive protein (CRP), calprotectin, Mayo endoscopic score and quality of life (QOL) were assessed before, during and after treatment. Results The study included 32 patients. Mean age was 30 years, 14 (43%) females. Lichtiger index improved in the cannabis group from 10.9 (IQR 9–14) to5 (IQR 1–7), (p<0.000), and in the placebo group from 11 (IQR 9–13) to 8 (IQR 7–10)(p = 0.15, p between groups 0.001). QOL improved in the cannabis group from 77±4 to 98±20 (p = 0.000) but not in the placebo group (78±3 at week 0 and 78±17 at week 8;p = 0.459; p between groups 0.007). Mayo endoscopic score changed in the cannabis group from 2.13±1 to 1.25±2 (p = 0.015) and in the placebo group from 2.15±1to 1.69±1 (p = 0.367, p between groups 0.17). Conclusion Short term treatment with THC rich cannabis induced clinical remission and improved quality of life in patients with mild to moderately active ulcerative colitis. However, these beneficial clinical effects were not associated with significant anti-inflammatory improvement in the Mayo endoscopic score or laboratory markers for inflammation.(clinicaltrials.gov NCT01040910).

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