scholarly journals Omalizumab for the treatment of allergic rhinitis: a systematic review and meta-analysis

2021 ◽  
Vol 0 (0) ◽  
pp. 0-0
Author(s):  
S. Tsabouri ◽  
G. Ntritsos ◽  
F. Koskeridis ◽  
E. Evangelou ◽  
P. Olsson ◽  
...  

Background: Allergic rhinitis (AR), an IgE mediated inflammatory disease, significantly impacts quality of life of a considerable proportion of the general population. Omalizumab, a humanized monoclonal antibody against IgE, has been evaluated for both seasonal and perennial AR. We aimed to assess the efficacy and safety of omalizumab in randomized controlled trials (RCTs) in inadequately controlled AR. Methods: We conducted a systematic literature search of RCTs evaluating the safety and efficacy of omalizumab in AR. We synthesized evidence for clinical improvement of AR symptoms, quality of life, reduction of the use of rescue medication, and adverse events. Results: The systematic search returned 289 articles, of which 12 RCTs were eligible for data extraction and meta-analysis. Omalizumab reduced the Daily Nasal Symptom Severity Score (DNSSS) by a summary standardized mean difference of -0.41 points with large heterogeneity; omalizumab significantly reduced the DNSSS both in the 3 cedar pollen-induced AR trials by -0.97 points and to a lower extent in the remaining five non-cedar trials by -0.19 points. Omalizumab also improved the Daily Ocular Symptom Severity Score (DOSSS) by a summary standardized mean difference of -0.30 points with large heterogeneity; the Rhino-conjunctivitis Quality of Life Questionnaire by a summary standardized mean difference of -0.45 points with no heterogeneity and the mean daily consumption of rescue antihistamines by a summary standardized mean difference of -0.21 with large heterogeneity. No statistically significant difference in the occurrence of adverse events was observed between omalizumab and placebo. Conclusion: Our findings further support the efficacy and safety of omalizumab in the management of patients with allergic rhinitis inadequately controlled with a conventional treatment.

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0244295
Author(s):  
Ponco Birowo ◽  
Ervandy Rangganata ◽  
Nur Rasyid ◽  
Widi Atmoko

Purpose Chronic pelvic pain syndrome (CPPS) is one of the most common outpatient urological diagnoses, and its incidence is increasing. Extracorporeal shockwave therapy (ESWT) has been suggested for relieving local perineal symptoms associated with chronic prostatitis/CPPS. Despite several treatment methods, no causal or standardized treatment is available for CPPS. This study aimed to investigate the efficacy and safety profile of ESWT for the treatment of chronic non-bacterial prostatitis. Materials and methods Studies were collected using four search engines (Pubmed, Cochrane, ScienceDirect, and EBSCOHost), on May 16, 2020; and assessed based on predetermined inclusion and exclusion criteria. Two reviewers performed study selection. Studies were then analyzed using Review Manager 5.3 for the meta-analysis. Results Seventy-four publications were initially retrieved, and three studies were considered for both qualitative and quantitative analyses. From these studies, we found that the use of ESWT was significantly associated with decreased pain domain (mean difference: -3.93; 95% confidence interval [CI] -5.13, -2.73; p<0.001), improved urinary score (mean difference: -1.79; 95% CI -2.38, -1.21; p<0.001), improved quality of life (mean difference: -1.71; 95% CI -2.12, -1.31; p<0.001), and improved National Institutes of Health chronic prostatitis symptom index (NIH-CPSI) score (mean difference: -5.45; 95% CI -5.74, -5.16; p<0.001) after 12 weeks of treatment. Conclusion ESWT is efficacious and safe in reducing pain and improving urinary condition, NIH-CPSI score, and quality of life in patients with chronic non-bacterial prostatitis.


2021 ◽  
Vol 42 (4) ◽  
pp. 283-292 ◽  
Author(s):  
Michael T. Werner ◽  
John V. Bosso

Background: Only a fraction of patients with allergic rhinitis receive allergen-specific immunotherapy (AIT). AIT is most commonly delivered subcutaneously in a series of injections over 3‐5 years. Common obstacles to completing this therapy include cost and inconvenience. Intralymphatic immunotherapy (ILIT) has been proposed as a faster alternative, which requires as few as three injections spaced 4 weeks apart. Objective: This systematic review and meta-analysis evaluated the current evidence that supports the use of ILIT for allergic rhinitis. Methods: Clinical trials were identified in the published literature by using an electronic search strategy and were evaluated by using a risk of bias tool. Treatment outcome (symptom scores, medication scores, and combined symptom and medication scores) and provocation testing results (nasal provocation and skin-prick testing) were included in a meta-analysis of standardized mean difference with subgrouping by using a random-effects model. Overall adverse event rates were tabulated, and overall risk ratios were calculated by using a random-effects model. Results: We identified 17 clinical trials that met eligibility criteria. The standardized mean difference of ILIT on the symptom and medication score was ‐0.72 (95% confidence interval [CI], ‐0.98 to ‐0.46; p < 0.0001) (n = 10). The standardized mean difference of ILIT on nasal provocation and skin-prick testing was ‐1.00 (95% CI, ‐1.38 to ‐0.61; p < 0.0001) (n = 7) and ‐0.73 (95% CI, ‐0.99 to ‐0.47; p < 0.0001) (n = 7), respectively. No statistically significant heterogeneity was detected. The overall adverse event rate was 39.5% for ILIT and 23.5% for placebo. Also, 98.4% of adverse events were mild. Conclusion: Our meta-analysis demonstrated that ILIT was safe, conferred desensitization to seasonal and nonseasonal allergens, alleviated allergic rhinitis symptoms, and reduced medication use. A larger randomized, double-blind, placebo controlled trial will be necessary for wider adaptation of this form of AIT.


Arthritis ◽  
2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Yasser El Miedany ◽  
Maha El Gaafary ◽  
Sally Youssef ◽  
Ihab Ahmed

Objectives. To assess the validity, reliability, and responsiveness to change of a patient self-reported questionnaire combining the Widespread Pain Index and the Symptom Severity Score as well as construct outcome measures and comorbidities assessment in fibromyalgia patients. Methods. The PROMs-FM was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction were achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included the modified ACR criteria main items (Symptom Severity Score and Widespread Pain Index), in addition to assessment of functional disability, quality of life (QoL), review of the systems, and comorbidities. Every patient completed HAQ and EQ-5D questionnaires. Results. A total of 146 fibromyalgia patients completed the questionnaire. The PROMs-FM questionnaire was reliable as demonstrated by a high standardized alpha (0.886–0.982). Content construct assessment of the functional disability and QoL revealed significant correlation (p<0.01) with both HAQ and EQ-5D. Changes in functional disability and QoL showed significant (p<0.01) variation with diseases activity status in response to therapy. There was higher prevalence of autonomic symptoms, CVS risk, sexual dysfunction, and falling. Conclusions. The developed PROMs-FM questionnaire is a reliable and valid instrument for assessment of fibromyalgia patients. A phased treatment regimen depending on the severity of FMS as well as preferences and comorbidities of the patient is the best approach to tailored patient management.


2022 ◽  
Vol 12 ◽  
Author(s):  
Aranjit Singh Randhawa ◽  
Norhayati Mohd Noor ◽  
Mohd Khairi Md Daud ◽  
Baharudin Abdullah

Bilastine is a non-sedating second generation H1 oral antihistamine (OAH) for treating allergic rhinitis (AR) patients. The effect of bilastine has not previously been evaluated in a meta-analysis. The aim of this review was to determine the efficacy and safety of bilastine in treating AR. An electronic literature search was performed using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Science Direct and Google Scholar up to March 2021. Randomized controlled trials comparing bilastine with placebo and standard pharmacotherapy were included. The included studies must have diagnosis of AR established by clinicians and the outcomes must have a minimum of 2 weeks of follow-up period. The primary outcomes assessed were total symptom score (TSS), nasal symptom score (NSS) and non-nasal symptom score (NNSS). The secondary outcomes were discomfort due to rhinitis, quality of life (QOL) and adverse events. The risk of bias and quality of evidence for all studies were appraised. The meta-analysis was done using Review Manager 5.3 software based on the random-effects model. The search identified 135 records after removal of duplicates. Following screening and review of the records, fifteen full-text articles were assessed for eligibility. Five trials involving 3,329 patients met the inclusion criteria. Bilastine was superior to placebo in improving TSS, NSS, NNSS, rhinitis discomfort score and QOL but has comparable efficacy with other OAHs in TSS, NSS, NNS, rhinitis discomfort score and QOL. There was no difference in adverse effects when bilastine was compared against placebo and other OAHs except for somnolence. Bilastine has fewer incidence of somnolence compared to cetirizine. The overall quality of evidence ranged from moderate to high quality. Bilastine is effective and safe in treating the overall symptoms of AR with comparable efficacy and safety with other OAHs except somnolence. Whilst bilastine has similar efficacy to cetirizine, somnolence is notably less in bilastine.


2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Guo-wei Qin ◽  
Tong-tong Xu ◽  
Xiang-wei Lv ◽  
Shi-min Jiang ◽  
Ke-jia Zhang ◽  
...  

Objective. To perform a systematic evaluation of the efficacy and safety of combined treatment of Shenmai injection and chemotherapy for lung cancer. Methods. A literature search for randomized controlled trials (RCTs) describing the treatment of lung cancer by Shenmai injection and chemotherapy or chemotherapy alone was performed using the PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Value In Paper (VIP), China BioMed, and Wanfang databases. The databases were searched for entries published before September 1, 2019. Results. Thirty-seven RCTs, comprising a total of 2808 cases, were included in the present meta-analysis. Of these, 1428 cases were treated by Shenmai injection plus chemotherapy, and 1380 cases were treated only by chemotherapy. The results of meta-analysis showed that the combined treatment (Shenmai injection plus chemotherapy) increased the short-term efficacy of treatment (relative risk [RR] = 1.183, 95% confidence interval [CI] = 1.043–1.343, P < 0.01 ) and improved patients’ quality of life (RR = 1.514, 95%CI = 1.211–1.891, P < 0.01 ) compared with chemotherapy alone. With regard to the adverse effects, the combined treatment markedly reduced the incidence of white blood cell (WBC) reduction (RR = 0.846, 95%CI = 0.760–0.941, P < 0.01 ), platelet reduction (RR = 0.462, 95% CI = 0.330–0.649, P < 0.01 ), and hemoglobin reduction (RR = 0.462, 95% CI = 0.330–0.649, P < 0.01 ) and alleviated drug-induced liver injury (RR = 0.677, 95%CI = 0.463–0.990, P < 0.05 ). However, it did not offer a significant protective effect (RR = 0.725, 95%CI = 0.358–1.468, P < 0.05 ). The effect of the combined treatment on the occurrence of vomiting was considerable (RR = 0.889, 95%CI = 0.794–0.996, P < 0.05 ), and the combined treatment markedly increased the immunity of patients with lung cancer. Conclusion. The combined treatment of Shenmai injection plus chemotherapy enhanced the short-term efficacy of chemotherapy, improved the patient quality of life, alleviated the adverse effects of chemotherapeutics, and increased the patient immunity. These results should be confirmed by large-scale, high-quality RCTs.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030713 ◽  
Author(s):  
Dacheng Li ◽  
Li Zhu ◽  
Daming Liu

IntroductionRefractory gastro-oesophageal reflux disease (rGORD) is a common disease, affecting patients’ quality of life. Since conventional medicines have limitations, like low effective rates and adverse events, acupuncture may be a promising therapy for rGORD. While no related systematic review has been published, the present study is designed to evaluate the efficacy and safety of acupuncture for rGORD.Methods and analysisPubMed, the Cochrane Central Register of Controlled Trials and Chinese electronic databases, including China National Knowledge Infrastructure, Wan Fang database, VIP, SinoMed and the Chinese Clinical Trial Registry, will be searched from establishment of the database to 31 August 2019. There will be no limitations on language, and all articles will be screened and collected by two reviewers independently. RevMan V.5.3.5 software will be used for meta-analysis, and the conduction of study will refer to the Cochrane Handbook for Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines. The efficacy and safety of acupuncture for rGORD will be evaluated based on outcomes, including global symptom improvement, oesophageal sphincter function test measured by high-resolution manometry, quality of life, recurrence rate and adverse events.Ethics and disseminationThere is no necessity for this study to acquire an ethical approval, and this review will be disseminated in a peer-reviewed journal or conference presentation.Trial registration numberCRD42018111912.


2019 ◽  
Vol 57 (1) ◽  
pp. 8-17 ◽  
Author(s):  
Tom A Rayner ◽  
Sean Harrison ◽  
Paul Rival ◽  
Dominic E Mahoney ◽  
Massimo Caputo ◽  
...  

Summary Limited uptake of minimally invasive surgery (MIS) of the aorta hinders assessment of its efficacy compared to median sternotomy (MS). The objective of this systematic review is to compare operative and perioperative outcomes for MIS versus MS. Online databases Medline, EMBASE, Cochrane Library and Web of Science were searched from inception until July 2018. Both randomized and observational studies of patients undergoing aortic root, ascending aorta or aortic arch surgery by MIS versus MS were eligible for inclusion. Primary outcomes were 30-day mortality, reoperation for bleeding, perioperative renal impairment and neurological events. Intraoperative and postoperative timing measures were also evaluated. Thirteen observational studies were included comparing 1101 MIS and 1405 MS patients. The overall quality of evidence was very low for all outcomes. Mortality and the incidence of stroke were similar between the 2 cohorts. Meta-analysis demonstrated increased length of cardiopulmonary bypass (CPB) time for patients undergoing MS [standardized mean difference 0.36, 95% confidence interval (CI) 0.15–0.58; P = 0.001]. Patients receiving MS spent more time in hospital (standardized mean difference 0.30, 95% CI 0.17–0.43; P &lt; 0.001) and intensive care (standardized mean difference 0.17, 95% CI 0.06–0.27; P &lt; 0.001). Reoperation for bleeding (risk ratio 1.51, 95% CI 1.06–2.17; P = 0.024) and renal impairment (risk ratio 1.97, 95% CI 1.12–3.46; P = 0.019) were also greater for MS patients. There was substantial heterogeneity in meta-analyses for CPB and aortic cross-clamp timing outcomes. MIS may be associated with improved early clinical outcomes compared to MS, but the quality of the evidence is very low. Randomized evidence is needed to confirm these findings.


2014 ◽  
Vol 35 (4) ◽  
pp. 338-345 ◽  
Author(s):  
David P. Skoner ◽  
Craig F. LaForce ◽  
Robert A. Nathan ◽  
Eduardo R. Urdaneta ◽  
Michael A. Zielinski ◽  
...  

2019 ◽  
Author(s):  
JM Dahanayake ◽  
Pathirage Kamal Perera ◽  
P Galappaththy ◽  
D Samaranayake

Abstract Background: Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and it’s ready to use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis. Study design: This is a three arm, open label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratidine Patients with symptoms of AR will be allocated randomly into the 3 arms after a 1 week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the 3 arms prior to visit 1, at the end of 28 days, end of the and second months of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion: This clinical trial will be able to provide evidence based scientific data on Ayurvedic dosage form, TMD12 and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions. Trial registration:ISRCTN18149439 (06 May 2019) Keywords: Allergic rhinitis, Ayurvedic dosage forms, Tamalakyadi decoctions, Randomized controlled trial


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038705
Author(s):  
Qiongshuai Zhang ◽  
Guangcheng Ji ◽  
Fang Cao ◽  
Yihan Sun ◽  
Guanyu Hu ◽  
...  

IntroductionSpasticity is a common complication of poststroke, tuina is a widely used rehabilitation treatment, although there is a lack of supportive evidence on efficacy and safety for patients with poststroke spasticity. The aim of this systematic review is to assess and synthesis evidence of efficacy and safety of tuina for spasticity of poststroke.Methods and analysisA comprehensive electronic search of EMBASE, MEDLINE, Cochrane Library, Web of Science, Wiley, Springer, PEDro, Chinese Science Citation Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific and Journal Database (VIP), Wanfang Database (Wanfang), Japanese medical database (CiNii), Korean Robotics Institute Summer Scholars and Thailand Thai-Journal Citation Index Centre will be conducted to search literatures of randomised controlled trials of tuina for spasticity of poststroke survivors range from the establishment to 1 January 2020.There is no time of publication limitations. The primary outcome will be measured with the Modified Ashworth Scale, and the second outcome will include Fugl-Meyer Assessment Scale, surface electromyogram RMS value, the Modified Barthel Index, Stroke Specific Quality of Life Scale, quality of life 36-Item Short-Form Health Survey and Visual Analogue Scale. Cochrane Handbook for Systematic Reviews of Interventions will be used to assess the risk of bias, and GRADE will be used to access the confidence in cumulative evidence. The protocol will be conducted according to approach and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015.Ethics and disseminationEthical approval will not be required, for no primary data of individual patients were collected. We will publish the findings in a peer-reviewed journal.PROSPERO registration numberCRD42020163384.


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