TIMolol nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia (HHT) – study protocol of the prospective, randomized, double-blind, controlled cross-over TIM-HHT trial

2021 ◽  
pp. 1-9
Author(s):  
Kornelia E.C. Andorfer ◽  
Caroline T. Seebauer ◽  
Michael Koller ◽  
Florian Zeman ◽  
Mark Berneburg ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Hereditary Hemorrhagic Telangiectasia ◽  
Case Reports ◽  
Treatment Method ◽  
Additional Treatment ◽  
Double Blind ◽  
Safety Outcome ◽  
Arteriovenous Shunts ◽  
Standard Laser

BACKGROUND: Hereditary hemorrhagic telangiectasia (HHT) is an inherited orphan disease, in which the absence of capillary beds between arterioles and venules lead to arteriovenous shunts. Epistaxis is the core symptom. Several case reports have described the nonselective beta-adrenergic receptor antagonist timolol as a successful treatment method of nosebleeds due in HHT patients. OBJECTIVE: TIM-HHT is a single-site, prospective, randomized, placebo-controlled, double-blind, cross-over study to investigate whether the efficacy of standard laser treatment of epistaxis in HHT patients can be increased by the additional use of timolol nasal spray (1 mg/d). METHODS: Twenty patients will be randomly allocated to one of two treatment sequences. Primary outcome is the severity of epistaxis determined by the Epistaxis Severity Score (ESS). Secondary outcomes are subjective satisfaction, quality of life, as well as the hemoglobin, ferritin, and transferrin levels of the participating patients. Safety outcome is assessed by means of pulse, blood pressure, and adverse events. CONCLUSION: TIM-HHT will evaluate the efficacy and safety of timolol as an additional treatment of epistaxis in HHT patients in a three-month trial period. Benzalkonium chloride is used as a placebo, which has no documented positive effect on the nasal mucosa and hence on epistaxis in HHT patients (in contrast to saline). TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00020994. Registered on 10 March 2020

scholarly journals Efficacy of TIMOLOL nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia. A double-blind, randomized, placebo-controlled trial

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Sophie Dupuis-Girod ◽  
Vincent Pitiot ◽  
Cyrille Bergerot ◽  
Anne-Emmanuelle Fargeton ◽  
Marjolaine Beaudoin ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Hereditary Hemorrhagic Telangiectasia ◽  
Controlled Trial ◽  
Double Blind

scholarly journals Colchicine for children with pericarditis: systematic review of clinical studies

2016 ◽  
Vol 101 (10) ◽  
pp. 953-956 ◽  
Author(s):  
Samer Alabed ◽  
Giordano Pérez-Gaxiola ◽  
Amanda Burls
Keyword(s):  
Systematic Review ◽  
Case Reports ◽  
Data Extraction ◽  
Experimental Studies ◽  
Case Series ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Randomised Controlled

ObjectiveTo review the evidence for the efficacy and safety of colchicine in children with pericarditis.DesignSystematic review.Search strategyThe following databases were searched for studies about colchicine in children with pericarditis (June 2015): Cochrane Central, Medline, EMBASE and LILACS.Eligibility criteriaAll observational and experimental studies on humans with any length of follow-up and no limitations on language or publication status were included. The outcomes studied were recurrences of pericarditis and adverse events.Data extractionTwo authors extracted data and assessed quality of included studies using the Cochrane risk of bias tool for non-randomised trials.ResultsTwo case series and nine case reports reported the use of colchicine in a total of 86 children with pericarditis. Five articles including 74 paediatric patients were in favour of colchicine in preventing further pericarditis recurrences. Six studies including 12 patients showed that colchicine did not prevent recurrences of pericarditis.LimitationsNo randomised controlled trials (RCTs) were found.ConclusionsAlthough colchicine is an established treatment for pericarditis in adults, it is not routinely used in children. There is not enough evidence to support or discourage the use of colchicine in children with pericarditis. Further research in the form of large double-blind RCTs is needed to establish the efficacy of colchicine in children with pericarditis.

scholarly journals Medical Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia: A Meta-analysis

2018 ◽  
Vol 160 (1) ◽  
pp. 22-35 ◽  
Author(s):  
Yuan-Pin Hsu ◽  
Chin-Wang Hsu ◽  
Chyi-Huey Bai ◽  
Sheng-Wei Cheng ◽  
Chiehfeng Chen
Keyword(s):  
Quality Of Life ◽  
Tranexamic Acid ◽  
Medical Treatment ◽  
Nasal Spray ◽  
Hereditary Hemorrhagic Telangiectasia ◽  
Randomized Clinical Trials ◽  
Hemoglobin Concentration ◽  
Mean Difference ◽  
Cochrane Library

Objectives The aim of this study (PROSPERO ID: CRD42017081952) was to evaluate medical treatment for epistaxis from hereditary hemorrhagic telangiectasia (HHT). Data Sources PubMed, Embase, Scopus, and Cochrane Library databases were interrogated from their inceptions to November 2017. Review Methods Randomized clinical trials comparing medical treatment with placebo for epistaxis of HHT were included. We used a random-effects model to synthesize overall effects. Heterogeneity was evaluated with the I2 statistic. Results Eight studies were identified after systematic searching. The use of bevacizumab (BV), tranexamic acid, and estrogen, regardless of the route of administration, had no significant influence on frequency of episodes. Tamoxifen was superior to placebo in both frequency and severity of epistaxis. For duration of epistaxis, nasal spray BV, oral or nasal spray tranexamic acid, and nasal spray estrogen had no significant differences versus placebo, but patients receiving submucosal BV showed lower duration of epistaxis (mean difference: −219.00 min/mo, 95% CI: −271.90 to −166.10). Medical treatment for HHT had no significant changes of mean hemoglobin concentration (pooled mean difference: −0.23 mg/dL, 95% CI: −0.65 to 0.20, I2 = 0%) or quality of life (pooled standardized mean difference: 0.07, 95% CI: −0.16 to 0.30, I2 = 0%). Conclusions Only limited evidence provides a benefit on frequency of epistaxis by treatment with tamoxifen and duration of epistaxis by treatment with submucosal BV among patients with HHT. Mean hemoglobin concentration and quality of life were not influenced by medical treatment.

Intranasal Budesonide and Quality of Life in Pediatric Sleep-Disordered Breathing: A Randomized Controlled Trial

2017 ◽  
Vol 158 (4) ◽  
pp. 752-759 ◽  
Author(s):  
Gunnhildur Gudnadottir ◽  
Eva Ellegård ◽  
Johan Hellgren
Keyword(s):  
Quality Of Life ◽  
Nasal Obstruction ◽  
Nasal Spray ◽  
Sleep Disordered Breathing ◽  
Controlled Trial ◽  
Analog Scale ◽  
Double Blind ◽  
The Mean ◽  
Disordered Breathing

Objective To study the efficacy of budesonide nasal spray on the health-related quality of life and symptoms among children with sleep-disordered breathing. Study Design Randomized, parallel, double-blind, placebo-controlled trial. Setting Tertiary referral center. Subjects and Methods Sixty children (ages, 4-10 years) who were referred because of snoring and/or apneas for >3 months were included between January 2015 and June 2016 and randomized in a double-blind design to treatment with 64 μg/mL of budesonide nasal spray (n = 30) or placebo nasal spray (n = 30) twice daily for 6 weeks. The primary outcome measurement was the change in the mean OSA-18 total score from baseline. Other variables examined were individual OSA-18 domains, a visual analog scale for quality of life, symptoms (snoring, apneas, and nasal obstruction), and adenoid and tonsil size. The trial was investigator initiated and not sponsored by the pharmaceutical industry. Results Fifty-five children completed the trial. An intention-to-treat analysis revealed a significantly greater improvement in the mean OSA-18 total score after treatment with budesonide than placebo (19.5 vs 7.5, P = .0014). Intranasal budesonide also improved 2 OSA-18 domains (sleep disturbance, caregivers’ concerns), the visual analog scale score for quality of life, as well as snoring, apneas, and nasal obstruction. No serious adverse events were reported that could be linked to the treatment. Conclusion Among children with sleep-disordered breathing, 6 weeks’ treatment with intranasal budesonide significantly improved quality of life and symptoms as compared with placebo nasal spray.

Quality of life assessment in patients with moderate to severe allergic rhinitis treated with montelukast and/or intranasal steroids: a randomised, double-blind, placebo-controlled study

2014 ◽  
Vol 128 (3) ◽  
pp. 242-248 ◽  
Author(s):  
B-S Goh ◽  
M I M Ismail ◽  
S Husain
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Placebo Group ◽  
Fluticasone Propionate ◽  
Nasal Spray ◽  
Life Assessment ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

AbstractObjective:This study investigated improvements in quality of life associated with eight weeks of montelukast and/or intranasal steroid treatment for moderate to severe allergic rhinitis.Methods:A single-centre, prospective, randomised, double-blind, placebo-controlled study was carried out. Assessments were made using the Rhinoconjunctivitis Quality of Life Questionnaire and symptom scales.Results:A total of 128 patients (aged 13–51 years) were randomly assigned to one of two groups. In the montelukast group, patients were treated with montelukast tablets and fluticasone propionate nasal spray (n = 64). In the placebo group, treatment comprised a placebo and fluticasone propionate. The results showed significant improvements in symptom scores and quality of life scores for both groups after one month and two months of treatment, compared with baseline values; these improvements were significantly greater for the montelukast group compared with the placebo group. The mean number of loratadine tablets taken by each patient during the study period was only 0.73 for the montelukast group compared with 9 for the placebo group.Conclusion:The combination of montelukast tablets and fluticasone propionate nasal spray improved symptom control and overall quality of life for moderate to severe allergic rhinitis patients.

Role of mometasone furoate aqueous nasal spray for management of adenoidal hypertrophy in children

2014 ◽  
Vol 128 (12) ◽  
pp. 1060-1066 ◽  
Author(s):  
R Bhargava ◽  
A Chakravarti
Keyword(s):  
Quality Of Life ◽  
Nasal Spray ◽  
Mometasone Furoate ◽  
Controlled Study ◽  
Control Group ◽  
Score Change ◽  
Double Blind ◽  
Adenoidal Hypertrophy

AbstractObjectives:To study the role of mometasone furoate aqueous nasal spray for the management of adenoidal hypertrophy in children with more than 50 per cent obstruction, and to assess its impact on change in quality of life.Methods:A prospective, randomised, double-blind, interventional placebo-controlled study was conducted. A total of 100 children aged 2–12 years completed treatment and follow up. The symptoms and degree of obstruction were evaluated by nasopharyngoscopy conducted pre-treatment and 24 weeks post-treatment. Subjects received mometasone furoate nasal spray at a daily dose of 200 µg for 8 weeks, followed by a dose of 200 µg on alternate days for 16 weeks. Results were compared with those of a matched control group who were given saline nasal spray.Results:With mometasone treatment, there was an 89.8 per cent reduction in clinical symptom score, and the degree of obstruction dropped from 87 to 72 per cent (p < 0.0001). A statistically significant change in quality of life scores was seen in patients treated with the mometasone nasal spray (score change of 37.47) as compared with those given saline nasal spray (score change of 11.25) (p = 0.0001).Conclusion:Mometasone nasal spray appears to be effective in treating children with obstructive adenoids.

scholarly journals The Opportunities and Challenges of Jati Plus Perhutani

2020 ◽  
Vol 9 (1) ◽  
pp. 1-3
Author(s):  
Corriyanti Corriyanti ◽  
Novinci Muharyani
Keyword(s):  
Color Change ◽  
Treatment Method ◽  
Additional Treatment ◽  
Added Value ◽  
Class Iii ◽  
Fast Growing ◽  
Teak Wood ◽  
Heat Treatment Method ◽  
Chemical Material

The teak breeding program has long been conducted by Perum Perhutani and produced superior teak and was named Teak Plus of Perhutani - Jati Plus Perhutani (JPP). With good silviculture practices, JPP-teak of 9 year-old can produce no less than 100 m³/ha, with ± 60 cm of tree circumstance. The high demand for teak wood is an opportunity to develop JPP-teak with fast growing character. Research shows that the quality of JPP wood of 5 and 10 years of age can be classified into Strength Class III. Although the quality of JPP-teak is not equal as the teak gets older, it can be improved through several methods, such as densification, thermal modification, etc. Durability of fast growing JPP-teak can be enhanced by additional treatment with natural or chemical material preservation. Wood color modification can be done through heat treatment method. The color change of JPP-teak of 5 years of age that looked more brownies with variation in value of color change (ΔE*) of 1.04 to 48.53. Modification technology influenced the properties of teak wood and it is an opportunity of JPP to gain added value as a renewable forest resource product. With teak forest area covering 1.7 million hectares, Perum Perhutani has challenges in developing JPP-teak with more added value.

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