scholarly journals Have the IHS Guidelines for controlled trials of acute treatment of migraine attacks been followed? Laying the ground for the 4th edition

Cephalalgia ◽  
2020 ◽  
Vol 40 (8) ◽  
pp. 778-787
Author(s):  
Alicia Alpuente ◽  
Cristina Tassorelli ◽  
Hans-Christoph Diener ◽  
Stephen D Silberstein ◽  
Patricia Pozo-Rosich
Keyword(s):  
Clinical Trials ◽  
Acute Treatment ◽  
International Headache Society ◽  
Scientific Data ◽  
Controlled Trials ◽  
Double Blind ◽  
Critical Areas ◽  
Efficacy Measure ◽  
Update Process

Background The International Headache Society (IHS) has published four editions of Guidelines for acute clinical trials in migraine in the past 28 years. This continuous update process has been driven by the increasing amount of scientific data in the field of migraine and by the need to continuously improve the quality of trials. Objectives To illustrate: i) the results of the analysis on the adherence of published trials to the 3rd edition published in 2012, in order to identify the critical areas that needed to be addressed in the 4th edition and ii) the changes introduced in this latter edition for improving adherence and methodology robustness. Methods We searched and reviewed all controlled trials on acute treatment of migraine published in the period 2012–2018 and we assessed their adherence to the 3rd edition of the IHS Guidelines using a score system based on the most important recommendations. Afterwards, we compared the two editions of the Guidelines and assessed the changes between them. Results We included data from 24 controlled clinical trials. Most trials had a randomized double-blind controlled (RDB) design, while a minority (16.7%) were non-randomized double-blind trials. Less than half (44.6%) of the RDB trials used the recommended “pain-free at 2 hours” endpoint as the primary efficacy measure. Trial design and evaluation of results were the areas that diverged the most from the recommendations. Conclusion Adherence to IHS guidelines for clinical trials has been suboptimal so far. The new edition has been adapted and optimized to facilitate uptake and strengthen the quality of evidence.

scholarly journals Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition

Cephalalgia ◽  
2019 ◽  
Vol 39 (6) ◽  
pp. 687-710 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Cristina Tassorelli ◽  
David W Dodick ◽  
Stephen D Silberstein ◽  
Richard B Lipton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Treatment ◽  
International Headache Society ◽  
Evidence Base ◽  
Controlled Trials ◽  
Headache Disorders ◽  
Fourth Edition ◽  
Standing Committee ◽  
Randomised Controlled

The quality of clinical trials is an essential part of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for controlled trials of drugs in migraine. Scientific and clinical developments in headache medicine led to second and third editions in 2000 and 2012, respectively. The current, fourth edition of the Guidelines retains the structure and much content from previous editions. However, it also incorporates evidence from clinical trials published after the third edition as well as feedback from meetings with regulators, pharmaceutical and device manufacturers, and patient associations. Its final form reflects the collective expertise and judgement of the Committee. These updated recommendations and commentary are intended to meet the Society's continuing objective of providing a contemporary, standardized, and evidence-based approach to the conduct and reporting of randomised controlled trials for the acute treatment of migraine attacks.

scholarly journals Efficacy and safety of guselkumab for the treatment of patients with moderate-to-severe plaque psoriasis: A metaanalysis of randomized clinical trials

2020 ◽  
Vol 19 (2) ◽  
pp. 433-440
Author(s):  
Xing-Bao Tao ◽  
Yin-Qiu Huang ◽  
Yi-Hong Zhou ◽  
Lv-Lang Zhang ◽  
Yao-Kai Chen
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Adverse Events ◽  
Plaque Psoriasis ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Double Blind ◽  
Severe Plaque Psoriasis ◽  
Central Registry

Purpose: To conduct a systematic analysis on data from randomized controlled trials (RCTs) on different doses of guselkumab, and provide high-quality evidence for its use in the treatment of patients with moderate-to-severe plaque psoriasis (PsO). Methods: Related studies were searched using online search engines including MEDLINE, PubMed, and central registry of Cochrane controlled trials from January 2001 to October 2017. Only randomized, placebo-controlled, double-blind clinical trials involving guselkumab- and placebo-treated PsO subjects were included. Results: Five eligible double-blind, randomized, and placebo-controlled trials involving patients with moderate-to-severe PsO subjects treated with guselkumab were included. Compared with the placebo groups, the proportion of patients with improvements in Psoriasis Area and Severity Index (PASI) 75 (RR= 12.14; 95% CI= 9.11-16.16; p < 0.001); PASI 90 (RR= 23.26; 95% CI =14.57-37.13; p < 0.001), and PASI 100 (RR = 37.66; 95% CI = 15.81-89.69; p < 0.001) were significantly higher than those in guselkumab-treated groups. Furthermore, the guselkumab-treated groups showed significant decreases in Physician’s Global Assessment (PGA) score (RR = 10.46; 95% CI = 7.96-13.83; p < 0.001) and the Dermatology Life Quality Index (DLQI) score (SMD = -1.3; 95% CL = -1.4 to -1.19; p < 0.001), when compared with the placebo groups. However, there were no significant differences in adverse events (AEs) (RR = 1.01; 95% CL = 0.93-1.11; p > 0.05); severe adverse events (SAEs) (RR = 1.32; 95% CI =0.69-2.54; p > 0.05) and study discontinuations (RR = 0.79; 95% CI = 0.42-1.48; p > 0.05) between the two groups. Conclusion: This meta-analysis summarizes available evidence for the use of guselkumab in psoriasis. The results suggest that guselkumab is superior to placebo in moderate-to-severe psoriasis, and is welltolerated, effective, and safe in improving the severity of disease and quality of life. Keywords: Guselkumab, Effectiveness, Safety, Plaque psoriasis, Meta-analysis, Quality of life

Guidelines for Controlled Trials of Drugs in Tension-Type Headache: Second Edition

Cephalalgia ◽  
2009 ◽  
Vol 30 (1) ◽  
pp. 1-16 ◽  
Author(s):  
L Bendtsen ◽  
ME Bigal ◽  
R Cerbo ◽  
HC Diener ◽  
K Holroyd ◽  
...  
Keyword(s):  
Clinical Trials ◽  
International Headache Society ◽  
Tension Type Headache ◽  
Controlled Trials ◽  
Controlled Clinical Trials ◽  
Trial Methodology ◽  
New Information ◽  
Drug Treatments ◽  
Type Headache

The Clinical Trials Subcommittee of the International Headache Society published its first edition of the guidelines on controlled trials of drugs in tension-type headache in 1995. These aimed ‘to improve the quality of controlled clinical trials in tension-type headache’, because ‘good quality controlled trials are the only way to convincingly demonstrate the efficacy of a drug, and form the basis for international agreement on drug therapy’. The Committee published similar guidelines for clinical trials in migraine and cluster headache. Since 1995 several studies on the treatment of episodic and chronic tension-type headache have been published, providing new information on trial methodology for this disorder. Furthermore, the classification of the headaches, including tension-type headache, has been revised. These developments support the need for also revising the guidelines for drug treatments in tension-type headache. These Guidelines are intended to assist in the design of well-controlled clinical trials in tension-type headache.

Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic migraine in adults

Cephalalgia ◽  
2020 ◽  
Vol 40 (10) ◽  
pp. 1026-1044 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Cristina Tassorelli ◽  
David W Dodick ◽  
Stephan D Silberstein ◽  
Richard B Lipton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Treatment ◽  
International Headache Society ◽  
Preventive Treatment ◽  
Evidence Base ◽  
Episodic Migraine ◽  
Controlled Trials ◽  
Headache Disorders ◽  
Standing Committee ◽  
New Research

Clinical trials are a key component of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for Controlled Trials of Drugs in Migraine. Advances in drugs, devices, and biologicals, as well as novel trial designs, have prompted several updates over the nearly 30 years since, including most recently the Guidelines for controlled trials of preventive treatment of chronic migraine (2018), the Guidelines for controlled trials of acute treatment of migraine attacks in adults (2019), and Guidelines for controlled trials of preventive treatment of migraine in children and adolescents (2019). The present update incorporates findings from new research and is intended to optimize the design of controlled trials of preventive pharmacological treatment of episodic migraine in adults. A guideline for clinical trials with devices will be published separately.

Guidelines for Controlled Trials of Prophylactic Treatment of Chronic Migraine in Adults

Cephalalgia ◽  
2008 ◽  
Vol 28 (5) ◽  
pp. 484-495 ◽  
Author(s):  
S Silberstein ◽  
P Tfelt-Hansen ◽  
DW Dodick ◽  
V Limmroth ◽  
RB Lipton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chronic Migraine ◽  
Prophylactic Treatment ◽  
International Headache Society ◽  
Current Trend ◽  
Episodic Migraine ◽  
Controlled Trials ◽  
Controlled Clinical Trials ◽  
Methodological Issues

In 1991 the Clinical Trials Subcommittee of the International Headache Society (IHS) developed and published its first edition of the Guidelines on controlled trials of drugs in episodic migraine because only quality trials can form the basis for international collaboration on drug therapy, and these Guidelines would ‘improve the quality of controlled clinical trials in migraine’. With the current trend for large multinational trials, there is a need for increased awareness of methodological issues in clinical trials of drugs and other treatments for chronic migraine. These Guidelines are intended to assist in the design of well-controlled clinical trials of chronic migraine in adults, and do not apply to studies in children or adolescents.

scholarly journals Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ismail Zul Khairul Azwadi ◽  
Mohd Noor Norhayati ◽  
Mohd Shafie Abdullah
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Obstructive Uropathy ◽  
Meta Analysis ◽  
Percutaneous Nephrostomy ◽  
Procedural Pain ◽  
Controlled Trials ◽  
Failure Rates ◽  
Ureteral Stenting

AbstractAcute obstructive uropathy is associated with significant morbidity among patients with any condition that leads to urinary tract obstruction. Immediate urinary diversion is necessary to prevent further damage to the kidneys. In many centres, the two main treatment options include percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS). The purpose of this study if to compare the efficacy and safety of PCN and RUS for the treatment of acute obstructive uropathy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov. We also searched the reference lists of included studies to identify any additional trials. We included randomised controlled trials and controlled clinical trials comparing the outcomes of clinical improvement (septic parameters), hospitalisation duration, quality of life, urinary-related symptoms, failure rates, post-procedural pain [measured using a visual analogue scale (VAS)] and analgesics use. We conducted statistical analyses using random effects models and expressed the results as risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). Seven trials were identified that included 667 patients. Meta-analysis of the data revealed no difference in the two methods in improvement of septic parameters, quality of life, failure rates, post-procedural pain (VAS), or analgesics use. Patients receiving PCN had lower rates of haematuria and dysuria post-operatively and longer hospitalisation duration than those receiving RUS. PCN and RUS are effective for the decompression of an obstructed urinary system, with no significant difference in most outcomes. However, PCN is preferable to RUS because of its reduced impact on the patient’s post-operative quality of life due to haematuria and dysuria, although it is associated with slightly longer hospitalisation duration.

scholarly journals Combine therapy as a modern approach to treatment of allergic rhinitis

2021 ◽  
Vol 93 (8) ◽  
pp. 986-990
Author(s):  
Alexander V. Emelyanov
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Allergic Rhinitis ◽  
Suboptimal Control ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Double Blind ◽  
Modern Approach ◽  
Dose Combination

Allergic rhinitis (AR) is one the most common allergic diseases affecting from 10 to 40% of the population in different countries, including Russia. AR is a risk factor of bronchial asthma, other upper airway disease and may decrease patient quality of life, their productivity, increase probability of occupational traumatism, depression and anxiety. AR also presents a substantial economic burden. The rationale to use fixed dose combination of intranasal steroids and topical H1 antihistamines includes suboptimal control of symptoms by monotherapy, its complementary pharmacologic activity and the results of clinical trials. This review focused on fixed dose combination of intranasal mometasone furoate and olopataine. Double blind placebo-controlled and open clinical trials have confirmed that this combination decreased severity of nasal and ocular symptoms of seasonal and perennial AR, improved patient quality of life and had a good tolerability. Its efficacy was higher than those of monotherapy. Fast onset of action and sustainable effect on symptoms (during 1 yr) may improve adherence patients to the treatment and control of symptoms of AR.

scholarly journals The effects of pharmacological interventions on quality of life and fatigue in sarcoidosis: a systematic review

2020 ◽  
Vol 29 (155) ◽  
pp. 190057 ◽  
Author(s):  
Roeland Vis ◽  
Ewoudt M.W. van de Garde ◽  
Jan C. Grutters ◽  
Ingrid H.E. Korenromp
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Minimal Important Difference ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Qualitative Synthesis ◽  
Pharmacological Interventions ◽  
Open Label ◽  
Double Blind

AimsMany sarcoidosis patients experience a reduction in health-related quality of life (HRQoL) and a majority of patients report fatigue. Historically, drug trials in sarcoidosis have focused on changes in chest radiographs, lung function parameters and biomarkers, while HRQoL and fatigue have not been the main outcomes examined. We performed a systematic review of the literature to evaluate the existing evidence on the effects of pharmacological interventions on HRQoL and fatigue outcomes.MethodsThe systematic search was performed in Medline and Embase and yielded 15 records covering seven randomised controlled trials and seven single-arm open label studies, which were included in a qualitative synthesis (the results of one study were included in two publications). 12 studies evaluated immunosuppressive and/or immunomodulatory therapies and two studies evaluated stimulants.ResultsNine out of the 14 studies observed positive treatment effects from the interventions on HRQoL and/or fatigue, exceeding the minimal important difference. The risk of bias was generally high with only three studies rated as having a low risk of bias. The results suggest a potential for improvement in HRQoL and/or fatigue in patients with active disease who are either untreated or treated but not yet fully stabilised or therapy refractory.ConclusionMore randomised, double-blind and placebo-controlled trials are needed to expand the evidence base on these important outcome parameters.

scholarly journals Adverse Event Burden Score—A Versatile Summary Measure for Cancer Clinical Trials

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3251
Author(s):  
Jennifer G. Le-Rademacher ◽  
Shauna Hillman ◽  
Elizabeth Storrick ◽  
Michelle R. Mahoney ◽  
Peter F. Thall ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Treatment Cycle ◽  
Controlled Trials ◽  
Cancer Clinical Trials ◽  
Weighted Sum ◽  
Summary Measure ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Over Time

This article introduces the adverse event (AE) burden score. The AE burden by treatment cycle is a weighted sum of all grades and AEs that the patient experienced in a cycle. The overall AE burden score is the total AE burden the patient experienced across all treatment cycles. AE data from two completed Alliance multi-center randomized double-blind placebo-controlled trials, with different AE profiles (NCCTG 97-24-51: 176 patients, and A091105: 83 patients), were utilized for illustration. Results of the AE burden score analyses corroborated the trials’ primary results. In 97-24-51, the overall AE burden for patients on the treatment arm was 2.2 points higher than those on the placebo arm, with a higher AE burden for patients who went off treatment early due to AE. Similarly, in A091105, the overall AE burden was 1.6 points higher on the treatment arm. On the placebo arms, the AE burden in 97-24-51 remained constant over time; and increased in later cycles in A091105, likely attributable to the increase in disease morbidity. The AE burden score enables statistical comparisons analogous to other quantitative endpoints in clinical trials, and can readily accommodate different trial settings, diseases, and treatments, with diverse AE profiles.

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