To evaluate the application of outcome indicators in randomized controlled trials(RCTs) concerning the treatment of tension-type headache(TTH) with traditional Chinese medicine(TCM) in recent five years, so as to provide a basis for the study of core outcome set(COS) for TCM intervention in TTH. The RCTs on TCM treatment of TTH in recent five years were systematically retrieved from CNKI, Wanfang, VIP, CBM, EMbase, PubMed, Cochrane Library, Web of Science, ClinicalTrials.gov and China Clinical Trial Registry. After literature screening, data extraction and evaluation of the risk of bias, the outcome indicators in the included RCTs were subjected to qualitative analysis. The preliminary search yielded 19 042 articles, and 10 983 were left after the elimination of duplication. Finally, 52 RCTs(48 in Chinese and 4 in English) were included for qualitative analysis. The outcome indicators of RCTs included in this study were classified into seven domains: TCM syndrome, symptom and sign, physical and chemical detection, quality of life, long-term prognosis, economic evaluation, and safety event. The findings demonstrated that headache characteristic index in the symptom and sign domain was the index with the highest reporting frequency and reporting rate. Seventeen RCTs used TCM syndrome score as the outcome indicator. Further analysis revealed that there existed such problems in research design as non-distinction between primary and secondary outcome indicators, great difference in the adopted measurement tools for outcome indicators, and the neglect of measurement time of outcome indicators. Moreover, the syndrome indicators reflecting TCM advantages, objective evaluation indicators, safety and health-economic indicators were lacking. These limitations have affected the quality and reliability of RCTs on TTH treatment with TCM. It is suggested that the efficacy and characteristics of TCM should be combined into current clinical research, and the COS in RCTs regarding TCM treatment of TTH should be established according to internationally recognized standard procedures.
Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional ; Quality of Life ; Randomized Controlled Trials as Topic ; Reproducibility of Results ; Tension-Type Headache/drug therapy*

The efficacy of gastrodin as a Chinese herbal medicine extract in the treatment of tension-type headache has been confirmed. This paper systematically reviewed the efficacy and safety of gastrodin in the treatment of tension-type headache, aiming to provide a new choice for the treatment of this disease. In this study, four Chinese databases, four English databases and two trial registries were searched from the date of establishment to September 2020. The related randomized controlled trials(RCTs) were screened out according to the predetermined criteria. The bias risk assessment tool developed by Cochrane collaboration was used to evaluate the quality of the reports. RevMan 5.4.1 was used for Meta-analysis, and GRADE system for the evidence-based evaluation on the quality of outcome indicators. A total of 177 articles were retrieved and 8 articles were finally included for analysis, with a total sample size of 1 091 cases, which included 565 cases in the treatment group and 526 cases in the control group. The overall quality of included stu-dies was not high. The results of Meta-analysis are as follows:(1)In terms of headache frequency, gastrodin group was better than wes-tern medicine group(MD=-2.90, 95%CI[-3.76,-2.03], P<0.000 01).(2)In terms of number of abnormal blood vessels in TCD, gastrodin group was better than western medicine group(MD=-88.96, 95%CI[-102.36,-75.55], P<0.000 01).(3)In terms of effective rate, gastrodin group was better than western medicine group(RR=1.47, 95%CI[1.29, 1.68], P<0.000 01). The results of subgroup analysis are as follows:(1)Effective rate based on age, for the patients upper age limit 40-46 years old, gastro-din group was better than western medicine group(RR=1.69, 95%CI[1.50, 1.90], P<0.000 01); for the patients upper age limit 55-60 years old, gastrodin group was better than western medicine group(RR=1.27, 95%CI[1.16, 1.38], P<0.000 01).(2)Effective rate based on dosage form, both the gastrodin capsules and injection groups were better than western medicine group(RR_(capsules)=1.42, 95%CI[1.08, 1.88], P=0.01; RR_(injection)=1.50, 95%CI[1.26, 1.77], P<0.000 01). GRADE evaluation showed that the above outcomes had low quality of evidence. Only one article detailed the occurrence of adverse reactions and thus the present study cannot make a positive conclusion on the safety of gastrodin in the treatment of tension-type headache. The small number and low quality of the included reports affected the reliability of the results. In the future, more high-quality randomized controlled trails are needed to improve the evaluation on the efficacy and safety of gastrodin in the treatment of tension-type headache.
Adult ; Benzyl Alcohols/therapeutic use* ; Drugs, Chinese Herbal/adverse effects* ; Glucosides ; Humans ; Middle Aged ; Reproducibility of Results ; Tension-Type Headache

This study aims to systematically evaluate the clinical efficacy and safety of Toutongning Capsules in the treatment of tension-type headache(TTH), so as to provide a corresponding basis for clinical treatment. Eight commonly used medical research databases and two clinical trial registration systems were retrieved with the time interval from the establishment of the database or system to November 2020. The randomized controlled trials of Toutongning Capsules in the treatment of TTH were screened out according to the pre-set criteria. The quality of the included papers was evaluated by the bias risk assessment tool in Cochrane Reviewers Handbook 6.1 and the data were statistically analyzed by RevMan v5.4 provided by Cochrane collaboration. A total of 13 studies were included and the quality of methodology was generally low. Meta-analysis showed that Toutongning Capsules assisted with western medicine therapy can effectively reduce the pain intensity(MD_(VAS)=-1.94,95%CI[-2.50,-1.38],P<0.000 01;MD_(NRS)=-0.83,95%CI[-0.86,-0.80],P<0.000 01), headache duration(SMD=-0.98,95%CI[-1.17,-0.79],P<0.000 01), headache frequency(MD=-1.01,95%CI[-1.16,-0.85],P<0.000 01), headache index(MD=-11.13,95%CI[-12.10,-10.16],P<0.000 01), anxiety and depression scale score(MD_(HAMA)=-4.02,95%CI[-6.58,-1.46],P=0.002;MD_(HAMD)=-2.67,95%CI[-4.04,-1.29],P=0.000 1), while Toutongning Capsules as monotherapy only reduced the headache score(MD=-2.24,95%CI[-2.97,-1.51],P<0.000 01). The available clinical studies demonstrate that Toutongning Capsules combined with western medicine in the treatment of TTH can improve the related outcome indicators, but the clinical safety and efficacy of Toutongning Capsules alone remain unclear. Due to the small number and low quality of the included studies, large-sample, multi-center, high-quality and strictly designed randomized controlled trials are still needed to verify the clinical efficacy in the future.
Capsules ; Databases, Factual ; Drugs, Chinese Herbal ; Humans ; Tension-Type Headache/drug therapy* ; Treatment Outcome

In this study, the evidence mapping methodology was used to systematically retrieve and sort out the clinical research evidence of Chinese patent medicines in the treatment of tension-type headache(TTH), and to understand the distribution of evidence in this field and the basis and quality of evidence. Chinese and English articles on the 28 Chinese patent medicines for TTH, which were recorded in National Essential Medicines List(2018), Medicine Catalogue for National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance(2020), and Chinese Pharmacopoeia(2020), were retrieved from China National Knowledge Infrastructure(CNKI), Wanfang, VIP, China Biology Medicine disc(CBMdisc), PubMed, EMbase, and Cochrane Library from the establishment to June 2021, followed by descriptive analysis. Then, tables and bubble charts were plotted to analyze the distribution characteristics of evidence. A total of 129 eligible articles were yielded: 126 randomized/non-randomized controlled trials, and 3 systematic reviews. The functions, indications, and composition of the 28 medicines, as well as the proportion of related articles, publication trends, intervention measures, and outcome indicators were compared and analyzed. The results showed that the 28 Chinese patent medicines, composed of 128 Chinese medicinals, can be classified into six categories in terms of function: reinforcing healthy Qi, tranquilizing mind, dispelling stasis, regulating Qi, treating wind, and resuscitating. There are ongoing efforts to study the treatment of TTH with Chinese patent medicine in China, despite of little evidence. The clinical positioning of Chinese patent medicine for TTH is not clear, and clinical research fails to highlight the advantages of Chinese medicine. In addition, the outcome indicators have not been standardized and unified, and there is a lack of evidence on the long-term efficacy of Chinese patent medicine for TTH. This study is the first exploratory application of evidence maps to compare the characteristics and clinical research progress of 28 Chinese patent medicines for TTH, which can provide a reference for research on the optimization of Chinese medicine strategies for TTH.
Asians ; Drugs, Chinese Herbal ; Female ; Humans ; Medicine, Chinese Traditional ; Medicine, East Asian Traditional ; Nonprescription Drugs ; Pregnancy ; Tension-Type Headache

BACKGROUND AND PURPOSE: Cluster headache (CH) is frequently either not diagnosed or the diagnosis is delayed. We addressed this issue by developing the self-administered Cluster Headache Screening Questionnaire (CHSQ). METHODS: Experts selected items from the diagnostic criteria of CH and the characteristics of migraine. The questionnaire was administered to first-visit headache patients at nine headache clinics. The finally developed CHSQ included items based on the differences in responses between CH and non-CH patients, and the accuracy and reliability of the scoring model were assessed. RESULTS: Forty-two patients with CH, 207 migraineurs, 73 with tension-type headache, and 18 with primary stabbing headache were enrolled. The CHSQ item were scored as follows: 3 points for ipsilateral eye symptoms, agitation, and duration; 2 points for clustering patterns; and 1 point for the male sex, unilateral pain, disability, ipsilateral nasal symptoms, and frequency. The total score of the CHSQ ranged from 0 to 16. The mean score was higher in patients with CH than in non-CH patients (12.9 vs. 3.4, p < 0.001). At a cutoff score of >8 points, the CHSQ had a sensitivity, specificity, positive predictive value, and negative predictive value of 95.2%, 96%, 76.9%, and 99.3%, respectively. CONCLUSIONS: The CHSQ is a reliable screening tool for the rapid identification of CH.
Cluster Headache* ; Diagnosis ; Dihydroergotamine ; Headache ; Headache Disorders, Primary ; Humans ; Male ; Mass Screening* ; Migraine Disorders ; Prevalence ; Sensitivity and Specificity ; Tension-Type Headache

OBJECTIVE: We aimed to develop the clinical guideline for headache by the systematic review and synthesis of existing evidence-based guidelines. The purpose of developing the guideline was to improve the appropriateness of diagnosis and treatment of headache disorder, and consequently, to improve patients’ pain control and quality of life. The guideline broadly covers the differential diagnosis and treatment of tension-type headache, migraine, cluster headache, and medication-overuse headache. METHODS: This is a methodological study based on the ADAPTE methodology, including a systematic review of the literature, quality assessment of the guidelines using the Appraisal of Clinical Guidelines for REsearch & Evaluation II (AGREE II) Instrument, as well as an external review using a Delphi technique. The inclusion criteria for systematic search were as follows: topic-relevant, up-to-date guidelines including evidence from within 5 years, evidence-based guidelines, guidelines written in English or Korean, and guidelines issued by academic institutions or government agencies. RESULTS: We selected five guidelines and conducted their quality assessment using the AGREE II Instrument. As a result, one guideline was found to be eligible for adaptation. For 13 key questions, a total of 39 recommendations were proposed with the grading system and revised using the nominal group technique. CONCLUSION: Recommendations should be applied to actual clinical sites to achieve the ultimate goal of this guideline; therefore, follow-up activities, such as monitoring of guideline usage and assessment of applicability of the recommendations, should be performed in the future. Further assessment of the effectiveness of the guideline in Korea is needed.
Cluster Headache ; Delphi Technique ; Diagnosis ; Diagnosis, Differential ; Follow-Up Studies ; Government Agencies ; Headache Disorders ; Headache ; Korea ; Methods ; Migraine Disorders ; Quality of Life ; Tension-Type Headache

PURPOSE: Obesity and headache are two highly prevalent diseases both in childhood and adolescent. In this study, we assessed the prevalence of obesity in pediatric headaches patients in a single institution in Korea, and differences according to age, sex, headache type, frequency, intensity, and disability. METHODS: We retrospectively reviewed the medical records of 340 subjects (6–18 years of age) who visited the Pediatric Headache Clinic of Bucheon St. Mary's Hospital during the period from January 2015 through March 2018. Data on age, sex, height and weight, as well as headache type, frequency, intensity and disability, were collected. Body Mass Index (BMI) percentile was calculated based on the 2017 Korean Children Adolescence Growth Chart. RESULTS: 17.6% of the pediatric headache patients were obese. The prevalence of obesity in male patients was higher than females (Male 23.8% VS Female 11.6%, P=0.002). There were no significant differences in obesity rate according to age, headache type, frequency, intensity, and disability. CONCLUSION: The prevalence of obesity in the pediatric headache population was 17.6% which is higher than 10.1% in general population (Korea National Health and Nutrition Examination Survey, KNHANES, 2013).
Adolescent ; Body Mass Index ; Child ; Female ; Growth Charts ; Gyeonggi-do ; Headache* ; Humans ; Korea ; Male ; Medical Records ; Migraine Disorders ; Nutrition Surveys ; Obesity* ; Prevalence* ; Retrospective Studies ; Tension-Type Headache

PURPOSE: This study examined the effects of the forward head posture and tension type headache on neck movement among office workers. METHODS: The subjects were 6 male and 21 female patients composed of a forward head posture group, forward head posture group with a tension type headache and a normal group. Each group consisted of 2 males and 7 females. The cranio-vertebral angle of the head and the angle of motion of the neck were measured. SPSS 23.0 was used for data analysis and one-way ANOVA was performed for the mean comparison of the neck movements in the three groups. RESULTS: The participants had a limitation in the movement of all necks between the forward head posture group and forward head posture with tension type headache group compared to the normal subjects. The forward head posture with tension headache group had limited neck extension and lateral bending compared to the forward head posture group. CONCLUSION: Office workers have limitations in the movement of the neck when they are accompanied by forward head posture and tension headache. In particular, when accompanied with a tension headache, there is a restriction on the neck extension and side bending. This study is expected to provide basic data for the relief of tension headache and the treatment of forward head posture in office workers.
Female ; Head* ; Humans ; Male ; Neck* ; Posture* ; Statistics as Topic ; Tension-Type Headache*

BACKGROUND AND PURPOSE: Sufficient sleep is an essential part of good health and well-being. Tension-type headache (TTH) is the most common type of primary headache and has negative impacts on the quality of life and work performance. We aimed to determinethe relationship between TTH and insufficient sleep in the general population. METHODS: This study used data from the Korean Headache Sleep Study, which was a population-based survey about headache and sleep among Korean adults. Insufficient sleep was defined when the discrepancy between sleep need and average sleep duration was at least 1 hour. RESULTS: Among the 2,695 included subjects, 570 (21.2%) and 727 (27.0%) were classified as having TTH and insufficient sleep, respectively. The prevalence of insufficient sleep was significantly higher among subjects with TTH than among those without headaches (28.8% vs. 20.4%). For subjects with TTH, the scores on a visual analogue scale (4.7±1.8 vs. 4.3±1.9, mean±SD) and the Headache Impact Test-6 (44.9±7.0 vs. 43.6±6.1) were much higher in subjects with insufficient sleep than in those without insufficientsleep. Multivariable analyses revealed that insomnia [odds ratio (OR)=2.1], poor sleep quality (OR=1.7), and short sleep duration (OR=6.9) were significantly associated with insufficient sleep in subjects with TTH. CONCLUSIONS: Our findings suggest that insufficient sleep is prevalent among subjects with TTH and is linked to an exacerbation of TTH. Therefore, the proper evaluation and management of sleep may lead to the better management of TTH.
Adult ; Epidemiology ; Headache ; Humans ; Prevalence ; Quality of Life ; Sleep Deprivation ; Sleep Initiation and Maintenance Disorders ; Tension-Type Headache* ; Work Performance

PURPOSE: Headache is a common symptom during childhood. It is usually persistent and requires special care. This study aimed to identify the characteristics of headache in children < 7 years of age. METHODS: We reviewed 3 years of clinical files on children < 7 years of age with a chief complaint of headache. RESULTS: This study included 146 children (66 males, 80 females; mean age, 5.5±1.0 years). Mean symptom duration was 5.8±7.9 months. Attack durations were longer than 2 hours in 31 patients, shorter than 2 hours in 70 patients, and unchecked in 45 patients. Attack frequency was 15.1±10.6 times per month. Pain locations and characteristics were also variable. Mean pain severity score was 5.1±2.2 on the visual analog scale. Of 38 patients who underwent electroencephalography, 9 showed positive findings. Of 41 who underwent brain magnetic resonance imaging, 20 showed positive findings. The diagnoses were migraine (including probable migraine) in 34, tension-type headache in 5, and congenital malformations in 3. Medications were used in 29 patients: acetaminophen in 17, ibuprofen in 8, naproxen sodium in 1, and topiramate or amitriptyline in 3. CONCLUSION: In children aged < 7 years, headache has a relatively benign course, but detailed history taking is needed for more accurate diagnosis.
Acetaminophen ; Amitriptyline ; Brain ; Child* ; Diagnosis ; Electroencephalography ; Female ; Headache* ; Humans ; Ibuprofen ; Magnetic Resonance Imaging ; Male ; Migraine Disorders ; Naproxen ; Tension-Type Headache ; Visual Analog Scale