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Background Shoulder pain is an uncomfortable feeling in the muscle around the shoulder. The cause of myalgia is the accumulation of lactic acid in muscles and impaired blood circulation, which is called blood stasis in traditional East Asian medicine. This study aimed to explore the therapeutic effect of Gyejibongnyeong-Hwan (GBH) for shoulder discomfort related to blood stasis before and after treatment. Methods/design This study will be a double-centre, randomised, wait-list controlled pilot trial. Participants with shoulder pain and with a visual analogue scale score of 4 or higher out of 10, blood stasis score of 9 or higher, and triglyceride level of ≥150 mg/dl or total cholesterol level of ≥200 mg/dl will be recruited from two university hospitals. A total of 40 participants will be assigned to the immediate and waiting treatment groups. The immediate treatment group will receive GBH for 8 weeks on enrolment while the waiting treatment group will receive GBH for 8–16 weeks after 8 weeks of controlled waiting. The primary outcome is shoulder pain, and the secondary outcomes are the blood stasis score, blood pressure, ankle–brachial pressure index, brachial–ankle pulse wave velocity, body mass index, waist circumference, indexes of oximetry, and levels of blood lipid, blood sugar, resistin, C-reactive protein, serum amyloid P, and D-dimer. Discussion The results of this pilot trial will be the bases for a full-scale clinical trial of GBH. Trial registration Clinical Research Information Service, KCT0003837. Registered on 23 April 2019. https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14258

Background: Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang(SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. Methods: This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19-59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion: This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial. Trial registration: This study is registered at ClinicalTrials.gov, ID: NCT03374345. Registered on (15 February 2018). Keywords: Herbal medicine, Cold Hypersensitivity, Sipjeondaebo-tang, Cold intolerance.

Introduction This study investigated the current status of the Health Promotion Programme using Traditional Korean Medicine (HaPP-TKM). A survey of public health Traditional Korean Medicine (TKM) doctors asked for suggestions on developing the system and programmes so that TKM public health doctors can practice effectively in different circumstances. Methods TKM public health doctors working in health centres in the Republic Korea were asked about the performance status of HaPP-TKM and their opinions on the programme. The questionnaire took about 20 min to complete and included basic information about the respondent, plus performance status and opinions on HaPP-TKM and the TKM public health doctor system. The survey was administered to 908 doctors through SurveyMonkey. Results The response rate was 96.2% (n = 838) of which 31.1% (n = 236) of respondents were administering HaPP-TKM. The top three programmes that TKM doctors implemented were; stroke (23.1%, n = 61), smoking cessation (20.1%, n = 53), and osteoarthritis (14.8%, n = 39). Over 50% of TKM public health doctors reported that the difficulties performing the programmes were a result of insufficient infrastructure, followed by lack of information and training on TKM health promotion programmes (32.6%, n = 86). Conclusion The study results show that TKM is in high demand and appropriate for stroke, smoking cessation, and osteoarthritis. The activation plan for TKM health promotion programmes are as follows: first, well trained human resources, spaces, facilities, and budget are essential, second, programme development and training manual development should run concurrently and last, it is necessary to consider ways to specialize the health promotion programmes and medical treatment according to specialty areas.

In Korea, Gyejibongnyeong-Hwan (GBH), a herbal decoction used to treat blood stasis (BS), is widely used to treat shoulder pain in clinics. Nevertheless, the therapeutic mechanism of GBH in alleviating shoulder pain has not yet been elucidated.In this study, we applied mass spectrometry-based metabolomics to explore the therapeutic mechanism of GBH in BS-induced shoulder pain.We conducted a two-center, randomized, wait-list controlled pilot trial to explore the therapeutic effect of GBH on shoulder discomfort related to BS.A total of 40 participants with shoulder pain were randomly assigned to either the immediate treatment (GBH-Treat; n = 20) or waiting treatment (Wait-List; n = 20) group. A non-targeted metabolomics approach was then applied to investigate the therapeutic mechanism of GBH.After 8 weeks of treatment, the visual analog scale (VAS) scores for shoulder pain decreased significantly in the GBH-Treat and Wait-List groups compared with baseline VAS scores (p = 0.004 and p = 0.013, respectively). However, the VAS and BS scores were significantly more reduced in the GBH-Treat group than in the Wait-List group. The plasma metabolic pattern between GBH-Treat and Wait-List groups also differed significantly, which was shown by the score plot of a partial least-squared-discriminant analysis (RThese results demonstrated that GBH may be a potential treatment option for shoulder pain, and it acts by regulating metabolic patterns. In particular, our study provides evidence for the use of GBH treatment for patients with should pain caused by BS, and we believe that our findings can provide evidence for precision medicine based on traditional Chinese medicine (TCM) or traditional Korean medicine (TKM). We also verified that metabolomics studies provide comprehensive understanding of herbal decoctions in TCM or TKM.

Migraine is a relatively common disease that has a significant effect on the daily activities of affected individuals. The purpose of this study was to explore the effects of herbal medicine (Jodeungsan, JDS) on migraine.Sixty-four patients with migraine were recruited and randomized to either the JDS or placebo group at a 1:1 ratio. The subjects received JDS or placebo daily for four weeks. The primary outcome was a change in the number of headache attack days (HADs), and the secondary outcome measures were the headache impact test (HIT), migraine-specific quality of life (MSQoL), the deficiency and excess pattern identification questionnaire (DEPIQ), the cold and heat pattern identification questionnaire (CHPIQ), and the blood stasis pattern questionnaire (BSPQ).In all, 61 of the 64 patients took the investigational drugs for four weeks. The number of HADs did not significantly differ between the JDS and placebo groups at the end of the study. However, the HIT and MSQoL results showed significant improvement over the baseline in both groups.JDS did not have a significant effect on chronic migraine. Larger studies are needed to confirm this result.Clinical Research Information Service (https://cris.nih.go.kr/): KCT0003121.

The objective of the study was to explore the status of usage of complementary and alternative medicine (CAM) among Korean elite athletes. A survey was emailed to all Korean national sports federations recognized by the International Olympic Committee and the Olympic Council of Asia. A total of 705 Korean elite athletes participated in this study. The athletes had to be any of the following to participate in this survey: elite intercollegiate athletes, professional athletes, and national team athletes. 83.3% of the participants stated that they have previously experienced Korean medicine (KM). Compared to the general population in Korea, athletes had more experience (general population = 73.8%). The participants without experience mentioned that they either did not need any KM treatments (39.8%) or lacked information (39.8%) regarding KM treatments. The primary reason for the utilization of KM was the effectiveness of treatments. Therefore, 70.8% of the participants have mentioned recommending KM to others. Generally, athletes are worrisome that the consumption of herbal medicine may not be doping-free; however, it is vital to note that 62% of the participants expressed that prescribed herbal medicine is safe. Overall, this research demonstrates a high prevalence of KM usage by intercollegiate, professional, and national team athletes in Korea. Hence, this study’s results may serve as the foundation in future research directions for promoting KM among Korean elite athletes.

ObjectivesDementia is common in people over the age of 65 years, with 80% of people with dementia older than 75 years. Previous studies have linked dementia to late-life depression, but the association between dementia and mid-life depression is poorly understood. Depression is a preventable and treatable medical condition, which means it is a modifiable factor that can potentially prevent or delay dementia. This study aimed to identify the association between dementia and depression within the life course.DesignA nationwide, retrospective propensity score matched cohort study associating dementia with depression. Depression diagnosed between the ages of 45 and 64 years was classified as ‘mid-life’ and ‘late-life’ if diagnosed at 65 years or older. Patients were considered to have depression when one or more International Statistical Classification of Diseases and Related Health Problems, 10th revision codes for depression were recorded as primary or secondary diagnosis.SettingNational Health Insurance Service-National Sample Cohort database of the National Health Insurance Service in South Korea, containing patient data from 2002 to 2013.ParticipantsThe study included 1824 and 374 852 patients in the case and control groups, respectively. A logistic regression analysis with complex sampling design was performed after adjusting for covariates, using the propensity score matching method without callipers, with a 1:1 nearest neighbour matching algorithm.Primary and secondary outcome measuresThe association of mid-onset and late-onset depression with dementia in terms of sociodemographic characteristics, such as sex and age, within the Korean population.ResultsDementia was significantly associated with the presence of depression (OR=2.20, 95% CI=1.53–3.14); in particular, female patients with depression and patients aged 45–64 years with depression had increased odds of dementia (OR=2.65, 95% CI=1.78–3.93 and OR=2.72, 95% CI=1.41–5.24, respectively)ConclusionDepression is an associated factor for dementia, especially among people aged 45–64 years (mid-life).

Background Cold hypersensitivity in the hands and feet (CHHF) commonly affects Asian women, especially Korean women, and it negatively impacts the quality of life of the affected individuals. One commonly used herbal prescription for treating CHHF is Onkyeong-tang (OKT). Although OKT is widely used clinically in treating CHHF, no randomized clinical trial has been performed to evaluate the efficacy and safety of OKT in the treatment of cold hypersensitivity in the feet (CHF). This clinical trial aims to provide objective evidence for the basis of using OKT in the treatment of CHF in Korean women. Methods This trial will be a double-blind, randomized, placebo-controlled, parallel-group, multicenter pilot study. A total of 112 participants will be randomly divided into an OKT treatment group or a placebo group with a 1:1 ratio via a web-based randomization system. The OKT and placebo groups will receive prescribed medications orally three times per day (3 g each time) before or between meals for 8 weeks. The primary outcome studied will be the changes in Visual Analog Scale (VAS) scores of CHF from baseline. Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test. Discussion This trial will be the first clinical trial to assess the efficacy and safety of OKT in the treatment of CHF. We anticipate that the findings of the study will provide evidence for the basis of using OKT in treating CHF symptoms and generate basic data for designing a further large-scale randomized clinical trial. Trial registration Clinical Research Information Service (CRIS): KCT0003723. Retrospectively registered on 8 April 2019.

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Additional file 1. SPIRIT 2013 checklist.

Objectives The study was to survey use of electronic medical records in subjects of Korean medicine doctors working for Korean medicine organizations and to contemplate ways to develop utilization of electronic medical records. Methods On August 2017, it conducted online self-reported survey on subjects of Korean medicine doctors at Korean hospitals and clinics who agreed to participate in the study. A total 40 doctors in hospital and 279 doctors in clinic were included. The surveyed contents include kinds of electronic chart, reason for not using electronic medical records and problems with creation of medical records. Results It finds that 100% of those working at Korean medicine hospitals and 86.4% of those at Korean medicine clinics have used electronic medical records. Subjects answered the biggest reason for not using electronic medical records was inconvenience. The most serious problems with creation of electronic medical records at Korean medicine organizations found in the study include there was no method of creation of medical records and no standardized terminology for use in electronic medical records. Conclusion For utilization of electronic medical records at Korean medicine organizations, standardization of terminology, development of EMR in favour of its users and development of strategy that motivates use of EMR are required.

Infertility has long been recognized as a treatable disease, and complementary and alternative medicine treatments, such as acupuncture and moxibustion, have been used in Korea and China. This study describes female infertility treatment programs that used traditional Korean medicine (TKM) and were conducted by local governments in Korea and evaluates its effectiveness and safety.The authors officially requested related information from the report of the infertility treatment programs and related sources from 2006 to 2016 from the HealthWelfare Ministry of Korea and the Association of Korean Medicine (AKOM). Additional information was obtained from six Korean databases. Data including basic information about the programs, participant information, interventions, and outcomes were abstracted.A total of 9 reports, including multiple years of data from 6 programs (total 13 programs), were identified. In these 13 programs, a total of 1023 female subjects participated, and 205 of the 887 subjects who completed the program reported a successful pregnancy, indicating a 23.1% pregnancy rate. The programs lasted 3-9 months, and interventional elements, such as herbal medicine, acupuncture, fumigation, and massage, were identified. Significant adverse effects were not reported.This study suggests that infertility treatment programs with TKM interventions exhibited a positive effect on pregnancy in females with infertility. Thus, the infertility treatment programs with TKM interventions are expected to be useful and might serve as the primary treatment before assisted reproduction techniques.

Introduction Moxibustion therapy has been used in oriental medicine for symptoms of irritable bowel syndrome such as diarrhoea and constipation. This study aimed to evaluate the efficacy and safety of different doses of moxibustion for irritable bowel syndrome (IBS). Methods This study was conducted at Semyung Korean Medical Hospital, Chungbuk, Republic of Korea. Twenty-four patients (12 males, 12 females) aged 18–30 years who were diagnosed with IBS using the Rome III criteria were included. trial In this triple blind randomised controlled trial patients were allocated to receive either 3-cone moxibustion or 1-cone moxibustion. Moxa was applied to Guan Yuan (CV4) for 20 min. The Bowel Symptom Severity Scale (BSSS) score was used as the primary outcome measure; the Irritable Bowel Syndrome Severity Scale – Korean Version (IBSSS-K) score, heart rate variability (HRV), visceral sensitivity questionnaire, and a pattern identification questionnaire were secondary outcome measures. Results There was a significant difference in IBSSS-K scores after moxibustion in both the 3CMG (score: before: 217.50 ± 79.95, after: 137.42 ± 68.70, p = 0.021) and 1CMG groups (score: before: 217.67 ± 98.77, after: 112.25 ± 71.11, p = 0.006). There were no significant differences in the BSSS scores, IBSSS-K scores, Qi stagnation questionnaire scores, or cold-heat pattern questionnaire scores, between the two groups. Conclusions Different doses of moxibustion resulted in similar efficacy levels for the treatment of IBS. These preliminary findings suggest that moxibustion therapy may be effective and can be safe in improving the symptoms of IBS.

Background: Cold hypersensitivity in the hands and feet (CHHF) is a symptom patients usually feel cold in their hands and feet, but not dealt with a disease in western medicine. However, it is often appealed by patients at a clinic of Korean medicine (KM), considered to be a sort of key diagnostic indicator, and actively treated by physicians. Nevertheless, there is no standardized diagnostic definition for CHHF. Therefore, we surveyed KM experts’ opinions to address the clinical definition, diagnostic criteria, and other relevant things on CHHF. Methods: We developed a survey to assess the definition, diagnosis, causes, and accompanying symptoms on CHHF. 31 experts who work at specialized university hospitals affiliated with KM hospitals consented to participation. Experts responded to survey questions by selecting multiple-choice answers or stating their opinions. Results: Vast majority of experts (83.8%) agreed with our definition on CHHF (“a feeling of cold as a symptom; that one's hands or feet become colder than those of average people in temperatures that are not normally perceived as cold”). 77.4% of experts considered subjective symptoms on CHHF were more important than medical instrument results. Constitution or genetic factors (87.1%) and stress (64.5%) were the most common causes reported for CHHF. Conclusions: This study offers an expert consensus regarding the themes, opinions, and experiences of practitioners with CHHF. Our results underscore the need for standardized definitions and diagnostic criteria for CHHF. Keywords: Cold hypersensitivity, Cold extremities, Cold constitution

Aim Raynaud's phenomenon is characterized by prolonged vasoconstriction in cutaneous capillaries on cold stress. RhoA activity would be a therapeutic target for treating Raynaud's phenomenon. A traditional herbal medicine, ucha-shinki-hwan, has been used to promote vasodilation, but the biological mechanism of ucha-shinki-hwan is still unclear. Thus, we hypothesized that ucha-shinki-hwan is able to be used for treatment of Raynaud's phenomenon and that ucha-shinki-hwan inhibits cold-induced vasoconstriction by targeting RhoA GTPase. Methods Human dermal microvascular endothelial cells were pretreated with ucha-shinki-hwan for 30 min, followed by incubation in room temperature (37 ± 2°C) or a lower temperature (25 ± 2°C) for 30 min. Expression of active RhoA was measured on western blot. Endothelin-1 and nitric oxide production were examined on enzyme-linked immunosorbent assay. The formation of stress fiber and focal adhesion complex was analyzed using immunocytochemistry. Results Cold exposure activated RhoA GTPase whereas ucha-shinki-hwan treatment suppressed its activation in human dermal microvascular endothelial cells. Moreover, ucha-shinki-hwan decreased cold-induced endothelin-1 and nitric oxide production. In addition, ucha-shinki-hwan treatment inhibited the formation of stress fiber and focal adhesion complex with downregulation of focal adhesion kinase (FAK), SRC kinase and extracellular regulated kinases (ERK) phosphorylation. Conclusion Ucha-shinki-hwan inhibits contraction of cold-exposed human dermal microvascular endothelial cells by targeting RhoA activation. This in vitro study is therefore the first to suggest that ucha-shinki-hwan is likely to be effective for inhibiting cold-induced response in vascular endothelial cells.

The herbal extract Angelica gigas (AG) has been applied as a vasodilating agent for patients suffering from vascular diseases for many years; however, the underlying mechanism has not been fully elucidated. The present study hypothesized that the anti‑vasoconstrictive effect of AG may be effective in the treatment of abnormal cold‑mediated vasospasms that occur in Raynaud's phenomenon (RP). The effect of AG on the activity of ras homolog gene family member A (RhoA) was investigated in cold‑exposed vascular cells. Vascular cells were pretreated to AG, followed by a warm (37˚C) or cold (25˚C) incubation for 30 min and investigated with western blotting, ELISA and confocal microscopy. Cold treatment induced the activation of RhoA in pericytes and vascular endothelial cells, however this was reduced by treatment with AG. Furthermore, AG treatment reduced the endothelin‑1 (ET‑1)‑mediated RhoA activation in pericytes; however, cold‑induced ET‑1 production by vascular endothelial cells was not affected by treatment with AG. In addition, AG treatment suppressed the formation of stress fibers and focal adhesion complexes, and the cold‑induced phosphorylation of focal adhesion kinase, proto‑oncogene tyrosine‑protein kinase Src and extracellular signal‑related kinase. Therefore, AG treatment demonstrated an ability to reduce cold‑induced RhoA activation in pericytes and vascular endothelial cells, and attenuated ET‑1‑mediated RhoA activation in pericytes. In conclusion, the present study indicated that AG may be useful for the treatment of RP.

Introduction This study is designed to evaluate the efficacy and safety of treating irritable bowel syndrome patients with a proper dose of moxibustion. Methods and analysis This study will be a 4-week-long, randomised controlled pilot clinical trial. Twenty-four patients will be recruited and randomly allocated to 1 of 2 groups: a 3 moxibustion treatment intervention group and a 1 moxibustion treatment control group. Both groups will receive two moxibustion sessions a week for 4 weeks (8 sessions in total). The primary outcome will be measured using the Bowel Symptom Severity Scale. The inclusion criteria are as follows. The patients will be between 18 and 30 years old and of either gender. The patients will have experienced repeated abdominal pain or discomfort (i.e., an uncomfortable sensation not described as pain) at least 3 times per month in association with two or more of the following over the previous 3 months: (a) improvement with defecation; (b) onset associated with a change in the frequency of defecation; (c) onset associated with a change in the form (appearance) of stool. All included patients will have provided written consent to the clinical ethics committee and have agreed with both the clinical trial plan and follow-up observations. Ethics and dissemination This research protocol has been reviewed and approved by the institutional review board of the trial centre (Semyung Korean Medicine Hospital, IRB No. 2016-06-01). The results will be published in a journal and will be disseminated both electronically and in print.

Background. This study aimed to investigate medical records using traditional Korean medicine (TKM) in Sewol Ferry disaster in 2014 and further explore the possible role of traditional medicine in disaster situation. Methods. After Sewol Ferry accident, 3 on-site tents for TKM assistance by the Association of Korean Medicine (AKOM) in Jindo area were installed. The AKOM mobilized volunteer TKM doctors and assistants and dispatched each on-site tent in three shifts within 24 hours. Anyone could use on-site tent without restriction and TKM treatments including herb medicine were administered individually. Results. The total of 1,860 patients were treated during the periods except for medical assistance on the barge. Most patients were diagnosed in musculoskeletal diseases (66.4%) and respiratory diseases (7.4%) and circulatory diseases (8.4%) followed. The most frequently used herbal medicines were Shuanghe decoction (80 days), Su He Xiang Wan (288 pills), and Wuji powder (73 days). Conclusions. TKM in medical assistance can be helpful to rescue worker or group life people in open shelter when national disasters occur. Therefore, it is important to construct a rapid respond system using TKM resources based on experience.

Background The aim of this study was to investigate the clinical practice of Korean medicine doctors (KMDs) for managing menopausal disorders. Methods We conducted a web-based questionnaire for KMDs to respond to recommendations across the three main KM domains: major symptoms of menopausal disorders, herbal prescriptions, and pattern identification. Results We received responses from 227 doctors who have treated menopausal disorders. The major pattern identifications recommended by the doctors for the pre-, peri-, and postmenopausal phases, respectively, were depression of liver energy (59.5%), kidney yin deficiency (49.8%), and kidney yin deficiency (50.7%). The most frequent herbal remedies prescribed for the pre-, peri-, and postmenopausal phases were Jiawei shaoyao-san (58.1%), Jiawei shaoyao-san (48.5%), and Jiawei guipi-decoction (37.9%), respectively. Conclusion The results of our clinical practice survey provide information on KMDs’ clinical experiences of using herbal medicines and their use of pattern identification to manage menopausal disorders.

Background: Most women experiencing menopause have sought out traditional treatment options to relieve their symptoms. The aim of this study, which used a web-based survey, was to investigate perceptions of Korean medicine doctors (KMDs) on managing menopausal symptoms with herbal medicines. Methods: We developed and then sent a questionnaire via email to a total 497 KMDs in obstetrics and gynecology affiliated with the Society of Korean Medicine. The questionnaire consisted of three categories and a total of 26 items focusing on major menopausal symptoms, prescriptions, pattern identification, and background characteristics. Results: Out of the 497 KMDs, we received responses from 48 doctors, a response rate of 9.7%. The most common symptoms of menopausal disorder perceived by responded KMDs were hot flashes (22.9%), sleep disorders (18.2%), systemic fatigue (12.5%), and sweating (12.0%). The herbal medicines reported to be the most effective when treating patients with menopausal disorders were Jiawei shaoyao-san (12.5%), Jiawei guipi-decoction (11.8%). The responding KMDs recommended one to two months of treatment for female menopausal disorder, using two to three doses of herbal medicine per day in combination with traditional Korean medicine (KM) therapies such as acupuncture, moxibustion, cupping, and pharmacopuncture. Conclusion: The results of this survey may provide information about doctor’s perceptions on using herbal medicines to manage patient’s menopausal symptoms. Future studies should be done with a larger sample size to overcome the limitation of this study and to examine how KM is used for treating menopausal symptoms in clinical practice. Keywords: Menopausal symptoms, Herbal medicines, Web-based survey

SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents (PDF 39 kb)

Introduction Migraine is a common and disabling primary headache disorder. Cupping is a traditional medical treatment used in several societies in East Asia and it is frequently used for controlling pain including migraine. There have been no systematic reviews on the treatment effects of cupping on migraine. Furthermore, related studies have had many limitations, making it unclear whether cupping intervention is beneficial for migraine. We propose to conduct a systematic review and meta-analysis to consider the evidence related to the effect of cupping on migraine. Methods We developed a protocol describing the essential reporting items based on the PRISMA for systematic review protocols 2015 (PRISMA-P 2015) (Registration number: CRD42017054979). We will search eight databases and include data from prospective randomized controlled clinical trials or quasi-randomized controlled trials that used cupping interventions for the treatment of migraine. The risk of bias will be assessed with the “Risk of bias” tool from the Cochrane Handbook. Using improved effectiveness and the change in headache pain intensity as graded on the visual analogue scale as the primary outcomes, we will compare these outcomes between the cupping intervention and control groups. Conclusion There have been no systematic reviews of cupping therapy for migraine headaches to date. This systematic review will assess the effectiveness and safety of cupping therapy for migraine. This systematic review will inform and help healthcare practitioners to treat migraine and will be disseminated electronically and in print in a peer-reviewed journal.

Background Cold hypersensitivity in the hands and feet (CHHF) is a common complaint in Asian female population especially in Korea. Due to the symptoms of CHHF the quality of individual's daily life can be degraded. Ucha-Shinki-Hwan (UCHA) is widely used in the treatment of various diseases including CHHF by harmonizing Yin and Yang, and improving the vitality of whole body. However, the efficacy of UCHA as a treatment option of CHHF has not been assessed in trials. Thus, we aimed to investigate the efficacy and safety of UCHA in Korean women with CHHF through this trial. Methods This study will be an exploratory, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Korean women aged 19 to 59 years who complaint with CHHF will be enrolled from 5 university affiliated Korean medicine hospitals. A total of 164 subjects will be randomly assigned to a treatment group (UCHA) or a placebo group at a 1:1 ratio. The subjects will receive 2.5 g of either UCHA or placebo three times a day for 8 weeks. The primary outcome will be evaluated with the visual analog scale score of CHHF. The secondary outcome measures will be changes in skin temperature in extremities as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion This study will be the first trial to explore the efficacy and safety of UCHA for CHHF patient. This will provide meaningful clinical information on herbal medicine treatment of CHHF and a clinical evidence for planning a full randomized clinical trial. Disclosures and acknowledgments The authors report no competing interests. Trial registration This study is registered at ClinicalTrials.gov, ID: NCT03790033. Registered on (31 December 2018) PROTOCOL VERSION:: The final approved version of the trial protocol is V1.3. (25 January 2019).