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 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 Effects of Neural Mobilization Techniques on Painand Disabilityin PatientsWith Neurodynamic Dysfunction: A Systematic Review of Randomized Controlled Trials

2021 ◽  
Author(s):  
Hasan Shamsi ◽  
Khosro Khademi-Kalantari ◽  
Farshad Okhovatian
Keyword(s):  
Clinical Trials ◽  
Nervous System ◽  
Randomized Clinical Trials ◽  
Tension Type Headache ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Level 3 ◽  
Tunnel Syndrome ◽  
Type Headache

Introduction: Neural mobilization is the most important  technique  used for the treatment  of nervous system dysfunction. This study aimed to systematically review and evaluate the therapeutic efficacy of neural mobilization techniques in nervous system dysfunctions by assessing Randomized Controlled Clinical Trials (RCTs). Materials and Methods: We used all English papers published in five electronic databases from 2000 to 2020 using the following keywords: “neural mobilization”, “nerve mobilization”, “physical therapy”, “nerve glide exercises”, “neural stretching”, “neurodynamics”, and “neural physiotherapy”. The full text of the articles identified was reviewed to select papers specifically discussing neural mobilization as a treatment modality. The PEDro scale was used to assess the quality of these trials. The randomized clinical trials were selected that examined the therapeutic effect of neural mobilization. Results: Twelve RCTs were identified. Five RCTs used the same median nerve tensioning technique in patients  with Carpal Tunnel  Syndrome  (CTS).  In some studies, the methods  of neural mobilization were different. Fourteen papers examined different neurodynamic dysfunctions such as lateral epicondylalgia, radicular neck pain, postoperative spinal surgery, radicular low back pain, and chronic tension-type headache. There is moderate evidence (Level 2) to support distal nerve tensioning and tendon gliding techniques in CTS Also, there was limited (Level 3) and insufficient (Level 4) evidence about using cervical lateral gliding away from their involved side and upper limb tension test mobilization and the use of slump stretches and combinations techniques in the treatment of neurodynamic dysfunction, respectively. Besides, all studies reported a positive effect compared to neutral effects. Conclusion: Although clinicians frequently use neuromobilization techniques for both diagnosis and treatment of nervous system dysfunctions, the quality assessment of 20 RCTs has shown insufficient evidence to support the efficacy of these techniques in the treatment of nervous system dysfunctions.

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.

Diagnosis of Headache in Childhood and Adolescence: A Study in 437 Patients

Cephalalgia ◽  
1995 ◽  
Vol 15 (1) ◽  
pp. 13-21 ◽  
Author(s):  
C Wöber-Bingöl ◽  
C Wöber ◽  
A Karwautz ◽  
C Vesely ◽  
C Wagner-Ennsgraber ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Outpatient Clinic ◽  
International Headache Society ◽  
Tension Type Headache ◽  
Childhood And Adolescence ◽  
Highly Sensitive ◽  
Ihs Criteria ◽  
Type Headache ◽  
Structured Questionnaire

We investigated whether the criteria for idiopathic headache published by the International Headache Society (IHS) are useful in childhood and adolescence and compared the diagnoses according to this classification with those of Vahlquist. We used a semi-structured questionnaire to examine a total of 437 children and adolescents referred consecutively to a headache outpatient clinic. Twenty-eight of 437 patients were excluded because of symptomatic or unclassifiable headache. Of 409 patients with idiopathic headache, 70.4% had definite migraine or tension-type headache (IHS 1.1, 1.2, 2.1, 2.2), 20.5% had a migrainous disorder (IHS 1.7) and 9.1% had headache of the tension-type not fulfilling the criteria (IHS 2.3). In the differential diagnosis of migraine and tension-type headache the intensity of pain, aggravation of headache by physical activity, nausea and vomiting were the most important features. The quality of pain, photo- and phonophobia were less helpful and location least important. The duration of migraine attacks was less than 2 h in 19.0% of the migraine patients. In general, the diagnostic criteria of migraine were highly specific but less sensitive, and those of tension-type headache highly sensitive but less specific. The agreement between IHS criteria and those of Vahlquist was marked (kappa = 0.57). We conclude that the IHS criteria are useful for classifying headache in children and adolescents referred to a headache outpatient clinic. A forthcoming modification of the IHS criteria should consider a reduction of the minimum duration of migraine attacks from 2 h to I h and should try to increase the sensitivity of the criteria for migraine and the specificity of the criteria for tension-type headache.

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.

Quality of Life in Children with Primary Headache in a General Hospital

Cephalalgia ◽  
2009 ◽  
Vol 29 (6) ◽  
pp. 624-630 ◽  
Author(s):  
J Bruijn ◽  
W-F Arts ◽  
H Duivenvoorden ◽  
N Dijkstra ◽  
H Raat ◽  
...  
Keyword(s):  
Quality Of Life ◽  
General Hospital ◽  
International Headache Society ◽  
Primary Headache ◽  
Tension Type Headache ◽  
Healthy Children ◽  
Life Domains ◽  
Paediatric Department ◽  
Type Headache

Knowledge on the quality of life of children with headache is lacking. Until now only a few studies in this field have provided information on a limited number of life domains. The aim of this study was to assess the quality of life in a comprehensive number of life domains in children with primary headache presenting at an out-patient paediatric department in a general hospital. From October 2003 to October 2005 all children referred to the out-patient paediatric department of the Vlietland Hospital because of primary headache were investigated by protocol. A thorough history was taken and a general physical and neurological examination was performed. The International Headache Society criteria were used for classification. Quality of life (QoL) was measured using the Dutch version of the Child Health Questionnaire (CHQ-PF50 Dutch edition) and compared with data from a previously investigated cohort of healthy children from the same region, and with data from a cohort of children from the USA with asthma or with attention deficit hyperactivity disorder (ADHD), investigated with the CHQ-PF50. A total of 70 primary headache patients were included in the study (25 with tension-type headache, 36 with migraine, seven with chronic tension-type headache, two with both tension-type headache and migraine). Their mean age was 10.6 years (range 4–17 years); 37 children were male. On all but one subscale (self-esteem) the QoL of the children with primary headache was decreased compared with the cohort of healthy children, especially on the domains of mental health, parental impact time and family cohesion. Compared with the cohort of children with asthma the QoL was significantly worse for our headache group on seven subscales and significantly better on one subscale (general health perception). Compared with the cohort of children with ADHD, the QoL was significantly worse on six subscales but significantly better on three subscales. There were no significant differences on any QoL subscale between children with tension-type headache and children with migraine. We conclude that the QoL in children with primary headache presenting at the out-patient paediatric department of a general hospital seems to be considerably diminished. Furthermore, we conclude that, in this population there is no difference in QoL between children with tension-type headache and those with migraine.

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.

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