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.

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.

scholarly journals Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults

Cephalalgia ◽  
2018 ◽  
Vol 38 (5) ◽  
pp. 815-832 ◽  
Author(s):  
Cristina Tassorelli ◽  
Hans-Christoph Diener ◽  
David W Dodick ◽  
Stephen D Silberstein ◽  
Richard B Lipton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chronic Migraine ◽  
International Headache Society ◽  
Preventive Treatment ◽  
Evidence Base ◽  
Controlled Trials ◽  
Headache Disorders ◽  
Standing Committee

Background Quality clinical trials form 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. In 2008, the Committee published the first specific guidelines on chronic migraine. Subsequent advances in drug, device, and biologicals development, as well as novel trial designs, have created a need for a revision of the chronic migraine guidelines. Objective The present update is intended to optimize the design of controlled trials of preventive treatment of chronic migraine in adults, and its recommendations do not apply to trials in children or adolescents.

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.

Evidence for the Efficacy of Ultra-High Diluted Homoeopathic Medicines in the Management of Influenza-Like Illness: A Narrative Review

2020 ◽  
Vol 33 (04) ◽  
pp. 257-262
Author(s):  
Anupam Mukherjee ◽  
Neeti Sinha ◽  
Joy Kumar Dey ◽  
Arun Bhargav Jadhav
Keyword(s):  
Clinical Trials ◽  
Placebo Group ◽  
Significant Role ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Narrative Review ◽  
Controlled Trials ◽  
Jadad Scale ◽  
Randomised Controlled

Abstract Introduction In view of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the rise in cases of influenza-like illness (ILI), there is urgent need of developing and scientifically establishing treatment strategies. Homoeopathy has been used effectively in various pandemics for a long-time showing potential of combating such outbreaks effectively. This study aims at evaluating the methodological quality of the clinical trials conducted with a motive of assessing the efficacy of homoeopathy in management of ILI. Methods The randomised clinical research manuscripts from various databases were included for the narrative review. In this study, the Jadad scale was applied as an assessment tool with the criteria of randomisation, blinding and withdrawals to evaluate the methodological quality of the selected randomised controlled trials. Results The seven randomised controlled trials fulfilling the inclusion criteria evaluated on Jadad scale lay between the ranges of 2 to 5 with a mean score of 3.71 implicating the efficacy of homoeopathy in ILI. Six studies showed significant role of homoeopathy in the faster recovery of ILI symptoms. One trial, however, reported no noticeable difference in intergroup (treatment and placebo group) improvement but distinct intragroup comparison was observed. Conclusion It was concluded from this narrative review that homoeopathy has significant role in faster recovery of ILI symptoms in comparison to placebo group, and it can be employed as a potential treatment strategy in the recurrent pandemics of ILI and the currently prevailing coronavirus disease 2019 (COVID-19) crisis. It is suggested that more clinical trials with standard methodology should be conducted in this regard.

scholarly journals Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals

2018 ◽  
Vol 5 (1) ◽  
pp. 21
Author(s):  
Mahmood E. Elrggal ◽  
Morooj Al-Muwallad ◽  
Areej Al-Otaibi ◽  
Jomanah Alsiddik ◽  
Alaa Shahbar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Helicobacter Pylori ◽  
Randomized Controlled Trials ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Randomised Controlled

<p class="abstract"><strong>Background:</strong> Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects.<strong> </strong>Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in <em>Helicobacter pylori</em> associated infections by using the CONSORT 2010 checklist.</p><p class="abstract"><strong>Methods:</strong> All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on <em>Helicobacter pylori</em> associated infections were included in the review.</p><p class="abstract"><strong>Results:</strong> 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%).<strong> </strong>The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.</p><p><strong>Conclusions: </strong>The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.</p>

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.

scholarly journals Chair-Based Exercises for Frail Older People: A Systematic Review

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Kevin Anthony ◽  
Katie Robinson ◽  
Philippa Logan ◽  
Adam L. Gordon ◽  
Rowan H. Harwood ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older People ◽  
Evidence Base ◽  
Controlled Trials ◽  
Frail Older People ◽  
Exercise Programmes ◽  
Randomised Controlled ◽  
And Function ◽  
Harmful Effects

Introduction. Frail older people are often unable to undertake high-intensity exercise programmes. Chair-based exercises (CBEs) are used as an alternative, for which health benefits are uncertain.Objective. To examine the effects of CBE programmes for frail older people through a systematic review of existing literature.Method. A systematic search was performed for CBE-controlled trials in frail populations aged ≥65 years published between 1990 and February 2011 in electronic databases. Quality was assessed using the Jadad method.Results. The search identified 164 references: with 42 duplicates removed, 122 reviewed, 116 excluded, and 6 analysed. 26 outcome measures were reported measuring 3 domains: mobility and function, cardiorespiratory fitness, mental health. All studies were of low methodological quality (Jadad score ≤2; possible range 0–5). Two studies showed no benefit, and four reported some evidence of benefit in all three domains. No harmful effects were reported; compliance was generally good.Conclusion. The quality of the evidence base for CBEs is low with inconclusive findings to clearly inform practice. A consensus is required on the definition and purpose of CBEs. Large well-designed randomised controlled trials to test the effectiveness of CBE are justified.

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.

Sign in / Sign up

Export Citation Format

Share Document