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 Adherence to the 2008 IHS guidelines for controlled trials of drugs for the preventive treatment of chronic migraine in adults

Cephalalgia ◽  
2019 ◽  
Vol 39 (8) ◽  
pp. 1058-1066 ◽  
Author(s):  
Marie Deen ◽  
Daniele Martinelli ◽  
Judith Pijpers ◽  
Hans-Christoph Diener ◽  
Stephen Silberstein ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chronic Migraine ◽  
International Headache Society ◽  
A Priori ◽  
Preventive Treatment ◽  
Controlled Clinical Trials ◽  
Trial Quality ◽  
Definition Of ◽  
Double Blinded

Introduction Since the definition of chronic migraine as a new disease entity in 2004, numerous clinical trials have examined the efficacy of preventive treatments in chronic migraine. Our aim was to assess the adherence of these trials to the Guidelines of the International Headache Society published in 2008. Methods We searched PubMed for controlled clinical trials investigating preventive treatment for chronic migraine in adults designed after the release of the Guidelines and published until December 2017. Trial quality was evaluated with a 13-item scoring system enlisting essential recommendations adapted from the Guidelines. Results Out of 3352 retrieved records, we included 16 papers in the analysis dealing with pharmacological treatment of chronic migraine. The median score was 6.5 (range 2–13). All trials were randomized, the large majority (81.25%) were placebo-controlled and double-blinded (87.5%). Adherence was lowest on i) a priori definition of outcomes (31.25%), ii) primary endpoint definition (37.5%%) and iii) trial registration (37.5%). Discussion Most clinical trials adhered to the recommendations of the IHS, whereas adherence to migraine-specific recommendations was lower. Greater awareness and adherence to the guidelines are essential to improve the quality of clinical trials, validity of publications and the generalizability of the results.

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 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.

Economic Analysis Alongside Clinical Trials: Revisiting the Methodological Issues

1991 ◽  
Vol 7 (4) ◽  
pp. 561-573 ◽  
Author(s):  
Michael F. Drummond ◽  
Linda Davies
Keyword(s):  
Clinical Trials ◽  
Economic Analysis ◽  
Resource Use ◽  
Trial Design ◽  
Outcome Data ◽  
Medical Evidence ◽  
Controlled Clinical Trials ◽  
Methodological Issues ◽  
Health Care Interventions

AbstractControlled clinical trials are recognized as the best source of data on the efficacy of health care interventions and technologies. Because economic evaluation is dependent on the quality of the underlying medical evidence, clinical trials have increasingly been viewed as a natural vehicle for economic analysis. However, the closer integration of economic and clinical research raises many methodological issues. This paper discusses these issues in trial design, collection of resource use data, collection of outcome data, and interpretation and extrapolation of results. Some guidelines are suggested for economic analysts wishing to undertake evaluations alongside clinical trials.

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.

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 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.

The Effect of Qigong Exercise on Immunity and Infections: A Systematic Review of Controlled Trials

2012 ◽  
Vol 40 (06) ◽  
pp. 1143-1156 ◽  
Author(s):  
Chong-Wen Wang ◽  
Siu-Man Ng ◽  
Rainbow T.H. Ho ◽  
Eric T.C. Ziea ◽  
Vivian C.W. Wong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Infectious Diseases ◽  
Clinical Evidence ◽  
Clinical Symptoms ◽  
Controlled Trials ◽  
Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Induced Immunity ◽  
Quality Of Research

The objective of this review was to summarize and critically evaluate the clinical evidence of the effect of qigong exercise on immunity and its efficacy in the prevention or treatment of infectious diseases. Thirteen databases were searched from their respective inceptions through January 2011, and all controlled clinical trials of qigong exercise on immunity and infections were included. Quality and validity of the included studies were evaluated using standard scales. Seven studies including two randomized controlled trials (RCTs), two controlled clinical trials (CCTs) and three retrospective observational studies (ROSs) met the inclusion criteria. One study focused on functional measures of immunity (antigen-induced immunity) and six studies on enumerative parameters of immunity. No study on clinical symptoms relevant to infectious diseases could be identified. Overall, the included studies suggested favorable effects of qigong exercise on immunity, but the quality of research for most of the studies examined in this review was poor. Further rigorously designed studies are required, which should adhere to accepted standards of methodology for clinical trials.

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.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

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