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 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 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.

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.

Erenumab in prophylaxis of migraine – pilot study

Ból ◽  
2020 ◽  
Vol 20 (4) ◽  
pp. 1-4
Author(s):  
Marcin Kopka
Keyword(s):  
Chronic Migraine ◽  
Primary Endpoint ◽  
Migraine Headache ◽  
Critical Role ◽  
Preventive Treatment ◽  
Tolerability Profile ◽  
Good Tolerability ◽  
New Class ◽  
Calcitonin Gene

The aim of preventive treatment of episodic and chronic migraine is to reduce the frequency and severity of attacks and thereby improve patient’s quality of life. It is suggested that calcitonin gene related peptide (CGRP) plays a critical role in migraine patophysiology. In last few decades a new class of drugs was developed – monoclonal antibodies against CGRP. One of them is erenumab, which has been available in Poland since November 2018. The aim of this study was to assess the efficacy and tolerability of erenumab in migraine prophylaxis in polish patients with episodic and chronic migraine. Adult patients diagnosed with migraine (according to ICHD 3) with at least 4 migraine headache days in month were included in this study. The primary endpoint was the proportion of patients with more than 50% reduction in number of migraine headache days after the first month of treatment. From December 2018 to April 2019 9 women (24–66 years; average 43.8 years) were included. The average migraine headache days in this study group was 9 (5–20). The participants were treated with subcutaneously delivered erenumab in daily dose of 70 mg. After the first month of treatment in 7 from 9 women (77.5 %) primary endpoint was reached. In 3 of 9 (30%) patients itch was noted. The results of this study suggest efficacy and good tolerability profile of erenumab in polish patients with episodic and chronic migraine. The future study are needed with larger groups of participants.

scholarly journals Systematic qualitative review of randomised trials conducted in nonsmall cell lung cancer with a noninferiority or equivalence design

2014 ◽  
Vol 45 (2) ◽  
pp. 511-524 ◽  
Author(s):  
Marianne Paesmans ◽  
Bogdan Grigoriu ◽  
Sebahat Ocak ◽  
Martine Roelandts ◽  
Jean-Jacques Lafitte ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Cell Lung Cancer ◽  
A Priori ◽  
Nonsmall Cell Lung Cancer ◽  
Phase Iii ◽  
Randomised Clinical Trials ◽  
Randomised Trials ◽  
Definition Of ◽  
Methodological Aspects

The use of noninferiority randomised trials for patients with advanced non-small cell lung cancer has emerged during the past 10–15 years but has raised some issues related to their justification and methodology. The present systematic review aimed to assess trial characteristics and methodological aspects.All randomised clinical trials with a hypothesis of noninferiority/equivalence, published in English, were identified. Several readers extracted a priori defined methodological information. A qualitative analysis was then performed.We identified 20 randomised clinical trials (three phase II and 17 phase III), 11 of them being conducted in strong collaboration with industry. We highlighted some deficiencies in the reports like the lack of justification for both the noninferiority assumption and the definition of the noninferiority margin, as well as inconsistencies between the results and the authors' conclusions. CONSORT guidelines were better followed for general items than for specific items (p<0.001).Improvement in the reporting of the meth"odology of noninferiority/equivalence trials is needed to avoid misleading interpretation and to allow readers to be fully aware of the assumptions underlying the trial designs. They should be restricted to limited specific situations with a strong justification why a noninferiority hypothesis is acceptable.

Effectiveness and safety of endoscopic thoracic sympathectomy for excessive sweating and facial blushing: A systematic review

2007 ◽  
Vol 23 (1) ◽  
pp. 54-62 ◽  
Author(s):  
Antti Malmivaara ◽  
Pekka Kuukasjärvi ◽  
Ilona Autti-Ramo ◽  
Niina Kovanen ◽  
Marjukka Mäkelä
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Side Effects ◽  
Quality Data ◽  
Controlled Clinical Trials ◽  
Endoscopic Thoracic Sympathectomy ◽  
Excessive Sweating ◽  
Thoracic Sympathectomy ◽  
Facial Blushing

Objectives:Despite controversies, endoscopic thoracic sympathectomy (ETS) has been used as a treatment for excessive sweating of hands and face and for facial blushing. This study aims to evaluate the effectiveness of ETS for the current indications in a systematic review.Methods:Controlled clinical trials and cohort studies with more than 100 patients were included. Abstracts were searched from MEDLINE and CCTR from 1966 to June 2004. Two reviewers extracted the data and assessed study quality. Data on effectiveness and safety were synthesized qualitatively.Results:We did not find any controlled clinical trials. Fifteen prospective studies were included. The internal and external quality of these studies were poor overall. Follow-up was commonly less than 2 years, during which time excessive sweating and facial blushing seemed to decrease among most patients. Immediate complications related to thoracoscopy occurred in up to 10 percent of patients. Compensatory sweating below breast level was reported in up to 90 percent of the patients. Other common side effects included dryness of face and hands, gustatory sweating, and neuralgic pain. Several other less common side effects were reported.Conclusions:The evidence of the effectiveness of ETS is weak due to a lack of randomized trials. The intervention leads to severe immediate complications in some of the patients, and to persistent side-effects for many of the patients.

Knowledge Representation for Computer-Aided Planning of Controlled Clinical Trials: the PATriCIa Project

1997 ◽  
Vol 36 (03) ◽  
pp. 172-178 ◽  
Author(s):  
U. Haag
Keyword(s):  
Clinical Trials ◽  
Knowledge Representation ◽  
Formal Representation ◽  
Controlled Clinical Trials ◽  
Knowledge Based ◽  
Study Protocols ◽  
Representation Method ◽  
Computer Aided Planning ◽  
Research Structure

The main thesis of the PATriCIa project is that a knowledge-based system can provide efficient and reliable support for biometricians as well as physicians involved in planning of controlled clinical trials, resulting in a higher quality of medical research. Structure and contents of study protocols are analyzed, and an object-oriented method for formally representing biometric knowledge is proposed. A study protocol can be generated from this formal representation. The programming language Prolog is used to realize the system based on a blackboard architecture. It is concluded that the knowledge representation method developed in the PATriCIa project is well suited for the purpose of generating study protocols for controlled clinical trials.

The clinical and public health implications and risks of widening the definition of chronic migraine

Cephalalgia ◽  
2019 ◽  
Vol 40 (4) ◽  
pp. 407-410 ◽  
Author(s):  
Martina Guglielmetti ◽  
Alberto Raggi ◽  
Raffaele Ornello ◽  
Simona Sacco ◽  
Domenico D’Amico ◽  
...  
Keyword(s):  
Public Health ◽  
Chronic Migraine ◽  
High Frequency ◽  
Episodic Migraine ◽  
Headache Frequency ◽  
Allocation Of Resources ◽  
Independent Entity ◽  
Definition Of ◽  
The Impact

Background The definition of chronic migraine has long been debated. Recently, it was suggested to define subjects with at least 8/migraine days as chronic migraine; that is, incorporating so-called high frequency episodic migraine (eight or more migraine days but less than 15 headache days per month). Methods We addressed the possible problems that might arise based on this proposal accounting for clinical, pathophysiological, impact and public health aspects. Results and conclusions Defining chronic migraine on the basis of headache frequency alone does not account for clinical and pathophysiological aspects, as well as for the impact of chronic migraine in terms of disability and quality of life. Moreover, it is potentially harmful for patients in terms of allocation of resources. These issues are discussed in the present manuscript, and we support the idea of defining high frequency episodic migraine as an independent entity as a viable path to follow.

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