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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.

Background: Cold hypersensitivity in the hands and feet (CHHF) is defined as the symptom of a sensation of coldness in the extremities under conditions that are not considered cold by an unaffected person. CHHF is common in East Asian women. CHHF can affect the quality of life by placing restrictions on one's daily activities. Although electroacupuncture (EA) and acupuncture have been widely used for treating CHHF, randomized clinical trial (RCT) has not yet been conducted for evaluating the safety and efficacy of EA or acupuncture for the treatment of CHHF. This study aims to evaluate the effects of EA in CHHF patients. Methods: This study is a randomized, multicenter, and parallel design clinical trial. Overall, 72 participants will be randomly assigned to the EA treatment group, acupuncture treatment group, and untreated control group in 1:1:1 ratio via a web-based randomization system. The EA treatment group and acupuncture treatment group will receive EA or acupuncture treatment by visiting ten times at intervals of twice a week for five weeks. Follow-up visits will be made four weeks after the end of treatment. For the untreated control group, three visits will be made. The primary outcome measures will be the CHHF visual analogue scale score. Secondary outcome measures will be the body temperature of hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale abbreviated version, the results of the questionnaire of health-related quality of life, questionnaire of demonstration, and questionnaire of cold hypersensitivity.Discussion: This study will be the first clinical trial to evaluate the efficacy and safety of EA for the treatment of CHHF. We expect this study to provide basic evidence for the treatment of CHHF with EA, future large-scale RCT, and the development of general clinical guidelines for CHHF in the Korean medical field.Trial registration: CRIS, KCT0004306. Registered on October 14, 2019. https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14865

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.

Objective:This study is to evaluate both the single-dose intravenous injection toxicity and the approximate lethal dose of Water-soluble Danggui Pharmacopuncture (WDP) in Sprague-Dawley (SD) rats. Methods: Toxicity experiments were conducted at Good Laboratory Practice (GLP) laboratory in Biotoxtech Co., according to the regulations of GLP. WDP injection of dose 0.125, 0.25, and 0.5 mL/animal were experimental groups and normal saline injection group was control group. WDP and normal saline were injected once to 6- week old 5 male and 5 female SD rats at the tail veins at approximately 2 mL/min. During 14 days after the injection, general symptoms were observed and weight were measured. After the observation period, hematological and blood biochemical examination, macroscopic autopsy, topical resistance test at the injection area were performed. Results: RThe WDP 0.5 mL/animal injection group in 4 cases of male rats and all cases of female rats showed hematuria 30 minutes after the administration. However, after 1 hour, no more abnormal general symptoms were observed. The WDP did not affect weight, hematological and blood biochemical examination, macroscopic autopsy, and topical resistance test at the injection area. Conclusion: WDP single dose intravenous injection results showed that WDP have no toxic effects and a lethal dose of WDP should be over 0.5 mL/animal in male and female rats under the study condition. So WDP may be safe.

Objective: The purpose of this study is to investigate the effect of Cheonmagudeung-eum (CGE) for essential hypertension by systematic review and meta-analysis. Methods: The period of literature search was until October 30, 2016, and 14 electronic databases were utilized as search engines. The evalu...

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

Objectives: This study assessed the application of Oryung-san (Wuling-san or Gorei-san), a common diuretic in traditional medicine, as an antihypertensive agent. Methods: Experimental studies of the pharmacological properties of Oryung-san, including diuretic action and lowering effects on blood pre...

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.

OBJECTIVE To investigate beneficial effects of manual acupuncture on common cold periods and its symptoms depended on the difference onset time of common cold, within 36 h or over than that. To prove effects of manual acupuncture on common cold, a retrospective chart review was conducted. METHODS Chart data for patients with common cold who were treated with only manual acupuncture with fulfilling Jackson scales and satisfaction at the end of each treatment were collected via multi-centers of Oriental hospitals, Oriental medicine clinics and covalent hospital in South Korea. Totally 187 patients were divided into two groups, Group I (115 patients, within 36 h) and Group II (72 patients, onset time of cold over than 36 h). Finally 120 patients were observed until entire resolution of cold symptoms. RESULTS Group I showed significant decreases the median durations of completely recovery (3 days; 95% CI 3.0-4.0) as compared with Group II (6 days; 95% CI 4.0-7.0, P < 0.001). The manual acupuncture beneficially worked for reduction rate of common cold symptoms by 50% after initial treatment, decreased cold symptoms, and reduced cold duration. CONCLUSION Manual acupuncture beneficially affected common cold and its symptoms. Moreover it is more susceptibility on the early time of onset cold.

Objectives Bufonis venonum (BV) is toad venom and is the dried, white secretions of the auricular and the skin glands of toads. This study was performed to evaluate the toxicity of intravenous injection of Bufonis venonum pharmacopuncture (BVP) through a single- dose test with sprague-dawley (SD) rats. Methods Twenty male and 20 female 6-week-old SD rats were injected intravenously in the caudal vein with BVP or normal saline. The animals were divided into four groups with five female and five male rats per group: the control group injected with normal saline, the low-dosage group injected with 0.1 mL/animal of BVP, the medium-dosage group injected with 0.5 mL/ animal of BVP and the high-dosage group injected with 1.0 mL/animal of BVP. We performed clinical observations every day and body weight measurements on days 3, 7 and 14 after the injection. We also conducted hematology, serum biochemistry, and histological observations immediately after the observation period. Results No mortalities were observed in any experimental group. Paleness occurred in the medium- and the high-dosage groups, and congestion on tails was observed in females in the medium- and the high-dosage groups. No significant changes in weight, hematology, serum biochemistry, and histological observations that could be attributed to the intravenous injection of BVP were observed in any experimental group. Conclusion The lethal dose of intravenously-administered BVP in SD rats is over 1.0 mL/animal.

Benign prostatic hyperplasia (BPH) is a urologic disease that affects most of men over the age 50. But until now there is no such perfect cure without side effects. Because of diverse adverse effects, it is desirable to develop effective and long term-safety-herbal medicines to inhibit the progress of BPH. In spite of garlic's large use and a wide spectrum of studies, including anti-hyperlipidemic, cardio-protective, and anti-inflammatory activities, there was none to prove efficacy for BPH. In this study, we evaluated the efficacy of garlic to prove its suppressing effects on BPH. Garlic administration decreased relative prostate weight ratio, suppressed mRNA expression level of AR, DHT serum levels, and the growth of prostatic tissue in BPH-induced rats. Moreover, garlic administration decreased the levels of inflammatory proteins, iNOS, and COX-2 in prostatic tissue. Further investigation showed that garlic induced accumulation of death-inducing signal complex and activation of AMPK and decreased the levels of anti-apoptotic proteins, such as Bcl-2, Bcl-xL, and survivin. These results suggest that garlic may have suppressing effects on BPH and it has great potential to be developed as treatment for BPH. Copyright © 2016 John Wiley & Sons, Ltd.

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).

Background This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet. Methods This study is a multicenter, double-blinded, randomized, placebo-controlled, two-arm, parallel-group pilot clinical trial. A total of 60 participants will be enrolled and randomly assigned to the Ojeok-san treatment group or the placebo control group, in a 1:1 ratio using an Internet-based randomization system. Each group will be administered Ojeok-san or placebo three times per day for 8 weeks. The primary outcome will be the mean change in the Visual Analog Scale scores of cold hypersensitivity in the hands from baseline to week 8. Secondary outcomes will include the mean changes in the skin temperature of the extremities, recovery rate of the skin temperature of hands after cold stress test, and the score of Korean version of the WHO Quality of Life Scale abbreviated version. Discussion The findings of this study should provide meaningful information for a further large-scale, randomized controlled trial to confirm the safety and efficacy of Ojeok-san on cold hypersensitivity in the hands and feet in female patients. Trial registration ClinicalTrials.gov, ID: NCT03083522. Registered on 20 March 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-3013-9) contains supplementary material, which is available to authorized users.

Objectives: This study investigated quality among three herb medicine extract granules(DSGOST) which were made from different companies to check quality control of herb medicine extract granules. Methods: we selected three DSGOST extract granules which were made from different companies. And we experimented extract granules by method from K.P(Korean Pharmacopoeia), K.H.P(Korean Herbal Pharmacopoeia) of KFDA. Results: In qualitative analysis of DSGOST, we indentified Akebiae Caulis (木通), Asari Herba Cum Radix (細 辛), Evodiae Fructus (吳茱萸) in three different DSGOST extract granules. In quantitative analysis of DSGOST, Medication A,B,C contained similar content of Paeoniflorin & Glycyrrhizic acid. However Medication B contains especially lowest value of Cinnamic acid & total Decursin. Conclusions: Herb medicine extract granules have different contents of ingredients although those were made by same prescription. And these differences may influence medicinal effect to patients. So we need to make system of quality control with various research of quantitative & qualitative analysis about herb medicine extract granules.

Objectives: Radix Ginseng has been used for thousands of years to treat a wide variety of diseases. Radix ginseng has also been used as a traditional medicine for boosting Qi energy and tonifying the spleen and lungs. Traditionally, its effect could be obtained orally. Nowadays, a new method, the injection of herbal medicine, is being used. This study was performed to investigate the single-dose intravenous toxicity of water-soluble ginseng pharmacopuncture (WSGP) in Sprague-Dawley (SD) rats. Methods: All experiments were carried out at Biotoxtech, an institute authorized to perform non-clinical studies under the regulation of Good Laboratory Practice (GLP). At the age of six weeks, 40 SD rats, 20 male rats and 20 female rats, were allocated into one of 4 groups according to the dosages they would receive. The WSGP was prepared in the Korean Pharmacopuncture Institute under the regulation of Korea-Good Manufacturing Practice (K-GMP). Dosages of WSGP were 0.1, 0.5 and 1.0 mL/animal for the experimental groups, and normal saline was administered to the control group. The rat's general conditions and body weights, the results of their hematological and biochemistry tests, and their necropsy and histopathological findings were investigated to identify the toxicological effect of WSGP injected intravenously. The effect was examined for 14 days after the WSGP injection. This study was performed under the approval of the Institutional Animal Ethics Committee of Biotoxtech. Results: No deaths were found in this single-dose toxicity test on the intravenous injection of WSGP, and no significant changes in the rat's general conditions and body weights, the results on their hematological and biochemistry test, and their necropsy findings were observed during the test. The local area of the injec tion site showed minial change. The lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results indicate that WSGP is safe at dosages up to 1 mL/animal.

Objectives: The aims of the study were to test the single- dose intravenous toxicity of Daebohwalryeok pharmacopuncture (DHRP) in Sprague-Dawley (SD) rats and to estimate the crude lethal dose. Methods: The experiments were conducted at Biotoxtech Co., a Good Laboratory Practice (GLP) laboratory, according to the GLP regulation and were approved by the Institutional Animal Care and Use Committee of Biotoxtech Co. (Approval no: 110156). The rats were divided into three groups: DHRP was injected into the rats in the two test groups at doses of 10 mL/kg and 20 mL/kg, respectively, and normal saline solution was injected into the rats in the control group. Single doses of DHRP were injected intravenously into 6 week old SD rats (5 male and 5 female rats per group). General symptoms were observed and weights were measured during the 14 day observation period after the injection. After the observation period, necropsies were done. Then, histopathological tests were performed. Weight data were analyzed with a one-way analysis of variance (ANOVA) by using statistical analysis system (SAS, version 9.2). Results: No deaths and no statistical significant weight changes were observed for either male or female SD rats in either the control or the test groups during the observation period. In addition, no treatment related general symptoms or necropsy abnormalities were observed. Histopathological results showed no DHRP related effects in the 20 mL/kg DHRP group for either male or female rats. Conclusion: Under the conditions of this study, the results from single-dose intravenous injections of DHRP showed that estimated lethal doses for both male and female rats were above 20 mL/kg.

Objectives: This study was carried out in order to find both the single-dose intramuscular injection toxicity and the approximate lethal dose of samjeong pharmacopuncture (SP) in Sprague-Dawley (SD) rats. Methods: The SD rats in this study were divided into four groups, one control group (1.0 mL/animal, normal saline) and three experimental groups (0.25, 0.5, and 1.0 mL/animal, SP). All groups consisted of five male and five female rats. SP was injected as a single-dose intramuscularly at the thigh. After the injection, general symptoms and weight were observed for 14 days. After the observations had ended, hematologic and serum biochemical examinations, necropsy and a local tolerance test at the injection site were performed. The experiments were carried out at the Good Laboratory Practice firm, Biotoxtech Co. (Cheongwon, Chungbuk). Animal experiments were approved by the Ethics Committee (Approval Number: 130379). Results: No deaths occurred in any of the three experimental groups. The injection of SP had no effects on the general symptoms, body weights, results of the hematologic, and serum biochemical examinations, and necropsy findings. In local tolerance tests at the injec tion sites, mild inflammation was observed in the exper imental group, but it did not appear to be a treatment related effect. Conclusion: Under the conditions of this test, the results from the injection of SP suggest that the approximate lethal dose of SP is above 1.0 mL/animal for both male and female SD rats. Therefore, the clinical use of SP is thought to be safe.

Objectives: The purpose of the study is to assess both the approximate lethal dose and the single dose intramuscular injection toxicity of Danggui (Angelica gigantis radix) pharmacopuncture (DGP) in Sprague-Dawley (SD) rats. Methods: The experiments were conducted at the good laboratory practice (GLP) laboratory, Biotoxtech Co., which is a laboratory approved by the ministry of food and drug safety (MFDS). The study was performed according to the GLP regulation and the toxicity test guidelines of the MFDS (2009) after approval of the institutional animal care and use committee of Biotoxtech. Single doses of DGP were injected intramuscularly into the rats in three test groups of 6 week old SD rats (5 male and 5 female rats per groups) in the amounts of 0.1, 0.5, and 1.0 mL/animal for groups 2, 3, and 4, respectively, and normal saline solution in the amount of 1.0 mL/animal was injected intramuscularly into the rats (5 male and 5 female rats) in the control group. Observations of the general symptoms and weight measurements were performed during the 14 day observation period after the injection. Hematologic and serum biochemical examination, necropsy, and a local tolerance test at the injection site were done after the observation period. Results: No death was observed in three test groups (0.1, 0.5 and 1.0 mL/animal group). In addition, the injection of DGP had no effect on general symptoms, weights, hematologic and serum biochemical examination, and necropsy. The results from the local toler ance tests at injection site showed no treatment related effects in the SD rats. Conclusion: The results of single dose intramuscular injection of DGP suggest that the approximate lethal dose is above 1.0 mL/animal for both male and female SD rats and that intramuscular injection of DGP may be safe.

Background The purpose of this report is to demonstrate the clinical effect of Korean medicine treatment for pigmented purpuric dermatosis (PPD). Methods Five cases of PPD with skin purpura and blood heat due to blood deficiency were evaluated. All patients had been in a chronic disease state for at least 1 year. The treatment consisted only of the Korean herbal medicine Gami-Samultang (GS). The degree of symptoms that the patients experienced when they first visited our clinic was set at a visual analog scale (VAS) score of 10. Results After treatment, body purpura disappeared in all cases. In contrast, the patients' symptoms had not resolved following previous steroid treatment. All patients were satisfied with the treatment results and showed a VAS score of 0 for purpura. Conclusion This report suggests that GS can be used to effectively treat PPD. Additional clinical studies on PPD are needed to develop more comprehensive treatment guidelines.

Background In recent years, cold hypersensitivity in the hands (CHH) has become a common ailment of women in Korea. It can lead to gynecological problems such as irregular menstruation, miscarriage, and infertility. Traditionally, Korean herbal medicine has been the primary treatment method used to balance thermoregulation in the human body; however, its effectiveness has not been confirmed through systematic study. Thus, in this trial, we will investigate the feasibility of a full randomized clinical trial, Danggui-Sayuk-Ga-Osuyu-Saenggang-tang (DSGOST) in Korean women with CHH. Methods This study will be a pilot, multicenter, double-blind, randomized, parallel-group, two-arm, placebo-controlled clinical trial. A total of 66 participants will be randomly divided into two groups, a DSGOST treatment group and a placebo control group, in a 1:1 ratio using a web-based randomization system. Each group will take DSGOST or placebo three times daily for 6 weeks. The primary outcome will be measured using Visual Analogue Scale (VAS) scores of CHH. Secondary outcomes will include changes in skin temperature of the hands, Clinical Global Impressions (CGI) scale scores, recovery rate of skin temperature of the hands after the cold stress test, and the Korean version of the WHO Quality of Life Scale, abbreviated version (WHOQOL-BREF). Discussion This trial will be the first trial to reflect the newly defined disease range of CHH which was compiled by Korean medicine expert consensus. This study will provide considerable evidence for further large-scale trials and general clinical guidelines for CHH in the Korean medical field. Trial registration This study is registered at ClinicalTrials.gov, ID: NCT02645916. Registered on 30 December 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2002-8) contains supplementary material, which is available to authorized users.

Background. This survey aimed to investigate the characteristics of users and nonusers of herbal medicine and the adverse events experienced due to herbal medicines in South Korea. Methods. The questionnaire consisted of safety, using experience, using type, usage and nonusage reason, purchase location, and adverse events of herbal medicine. The survey was administered by online. Results. Of the total 1,134 respondents, 726 (64.0%) considered herbal medicine safe, and 693 (61.1%) answered that they have taken herbal medicines within the past year. Most common place to purchase them was “TKM hospital or clinic” (63.6%), and most participants (72.2%) took a decoction from a TKM institution. The biggest reason for taking them was for “health improvement” (57.3%), and the reasons for not using them was “medication not necessary” (63.7%). Among those who took herbal medicines, 46 experienced adverse events, and the most frequently reported symptoms were digestive disorders (52.2%). Of the 46 participants who experienced adverse events, 20 (43.5%) were treated by TKM doctors. Conclusions. This study suggests that regulation of herbal medicines is needed in order to resolve problems related to the safety of herbal medicines.

Objectives: The purpose of this study was to investigate the current trends in research on pharmacopuncture in Korea since 2007. Methods: A literature review was performed by using the search engines ‘Science and Technology Society Village’, ‘Korean Studies Information Service System’, ‘National Discovery for Science Leaders’, and ‘Oriental Medicine Advanced Searching Integrated System’ in Korea from January 2007 to December 2013. Searched key words were ‘pharmacopuncture’, ‘herbal acupuncture’, ‘aqua-acupuncture’, and ‘bee venom’. Finally, we selected 457 papers, including Korean experimental studies and clinical studies. Selected papers were classified according to year of publication, type of pharmacopuncture, disease & topic, research type and the publishing journal. Results: One hundred fifty pharmacopunctures were studied in 457 papers. Single compound pharmacopuncture was the most studied pharmacopuncture in experimental studies while animal-based pharmacopuncture was the most studied pharmacopuncture in clinical studies. Bee venom placed first among the various pharmacopunctures, followed by placenta, sweet bee venom, mountain-ginseng, and anti-inflammatory pharmacopunctures. Experimental research on pharmacopuncture has fallen since 2007 when 55 papers were published. However, clinical research has been increasing steadily. In clinical studies, case reports were numerous than randomized clinical trials (RCTs). Musculoskeletal diseases were the most frequently-treated diseases in studies on pharmacopuncture; among the musculoskeletal diseases, rheumatoid arthritis was the most frequently-treated disease in experimental studies and low back pain was the most frequently-treated condition in clinical studies. Since 2007, 45 different journals have published studies on pharmacopuncture, with the Journal of the Korean Acupuncture and Moxibustion Medicine Society having the largest number of papers on pharmacopuncture and the Journal of Pharmacopuncture the second largest number. Conclusion: The trends in research on pharmacopuncture published in studies from 2007 to 2013 were similar to those in studies published before 2006. Many studies on pharmacopuncture focused on bee venom and musculoskeletal diseases. Additional studies on diverse types of and indications for pharmacopuncture are needed.

The aim of this study is to investigate the efficacy of pulsed electromagnetic field (PEMF) on the alleviation of lumbar myalgia. This is a randomized, real-sham, double blind pilot study. 38 patients were divided into the PEMF group and the Sham group, each of which was composed of 19 patients (1 patient dropped out in the Sham group) of randomized allocation. The PEMF group was treated by using the PEMF device and the Sham group by using a sham device on the lumbar muscle and acupuncture points, three times a week for a total of two weeks. Evaluations of Visual Analogue Scale for bothersomeness (VASB), Visual Analogue Scale for pain intensity (VASP), Oswestry Disability Index (ODI), 36-Item Short Form Health Survey Instrument (SF-36), EuroQol-5Dimension (EQ-5D), Beck"s Depression Inventory (BDI) and Roland-Morris Disability Questionnaire (RMDQ), etc. before and 1 week after treatment were carried out. The primary outcome measure was the VASB, measured 1 week after the end of the pulsed electromagnetic therapy. VASB scores for the PEMF group changed by ?2.06 ± 2.12 from the baseline, and that for the Sham group changed by ?0.52 ± 0.82 (p < 0.05). VASP scores for the PEMF group were reduced by ?2.10 ± 2.12 from the base line, and that for the Sham group was reduced by ?0.53 ± 1.50 (p < 0.05). PEMF group showed significant improvements in all VASB, VASP, ODI, SF-36, EQ-5D, BDI and RMDQ scores, while the Sham group showed significant improvements in all scores, except the VASP score. However, the VASB, VASP and RMDQ scores of the PEMF group were much lower than those of the Sham group. The two groups showed no significant difference in ODI, SF-36, EQ-5D and BDI. This study demonstrates the effectiveness of PEMF treatment for alleviating lumbar myalgia.

Objectives: This case report is to present a complete re covery from Kaposi’s varicelliform eruption (KVE) that occurred in a patient with atopic dermatitis by applying Korean Medicine therapies. Methods: Hwangyeonhaedoktang pharmacopuncture (HP), 0.3 mL, and 25% bee venom pharmacopuncture (BVP), 0.1 mL, were injected, 0.2 mL each, at both BL13 acupoints once a day in the morning. Acupuncture was applied at Sama Upper, Middle and Lower of the Master Tung acupuncture points and at ST44 on the left lateral for 30 minutes twice a day. The affected face was gauze dressed with mixture of 2.0 mL HP and 1.0 mL 25% BVP with 20 mL of normal saline twice a day. Herbal Medicine, Seungmagalgeuntang, was administered three times a day after each meal. Results: Rashes and papules on the face were completely cleared after 10 days of treatments. Conclusion: KVE, an acute and urgent dermatitis, can be effectively treated with Korean medicine.

Objectives: The purpose of this study is to report the clinical effect of Korean medicine (KM) treatment for Henoch-Schonlein purpura (HSP). Methods: Five HSP patients who demonstrated a Yin deficiency and who had a history of a previous upper respiratory tract infection were included in this study. Four patients had arthritis and three had severe stomachache. One of them appeared to have proteinuria and hematuria before starting KM treatment. Results: All patients were improved with only herbal medicine, Jarotang (JRT). Purpura in the lower extremities and abdominal pain, which were not treated by using a corticosteroid, disappeared and had not recurred after 6 months. Conclusion: The se cases indicate that JRT may be effec tive in treating HSP in patients who demonstrate Yin deficiency, even though the number of cases was limited to five.

The purpose of this study was to report the effect of a combination of Sa-am five-element acupuncture and eight-principle pharmacopuncture (EPP) for the treatment of an essential tremor (ET). This study reviewed the medical records treated at OO Korean medical hospital for ET by using diverse types of acupuncture without herbal medicine, other types of physical therapy, and western medication related ET or Parkinson’s disease and was performed after the approval of the institutional review board (IRB). The three cases that were finally selected were then extracted and reviewed. The three cases that were finally selected involved three women in their 70s to 80s. The evaluation of the pro gress was made by using the numeric rating scale. A combined treatment, the method of liver excess (肝乘 格), from among Sa-am five-element acupuncture, and Hwangyeonhaedoktang EPP at CV23 and CV17, was applied to all cases. In all three cases, the ET was improved, and recurred ETs improved with the same treatment. The results suggest that the combined treatment of Sa-am five-element acupuncture and Hwangyeonhaedoktang EPP may be effective for treating an ET, even though this conclusion is based on only three cases.

Background There are growing interests in using various methods including traditional and complementary medicines (T&CM) for tobacco control. The study aimed to introduce how traditional Korean medicine (TKM) applied to smoking cessation programmes in Korea and to show the detail information of each programme for designing other smoke cessation programmes. Methods Reports of the smoke cessation programmes in Korea were searched on March 10th, 2016, from the webpages of the related agencies and the databases: the Ministry of Health and Welfare, the Korea Health Foundation, the Association of Korean Medicine, PubMed, Google scholar, the RISS, the KISS, the NDSL, and the OASIS. Smoking cessation programmes, projects, or services using traditional Korean medicine (TKM) were included with no language, implementation site, and year restrictions. Results The three smoking cessation programmes using TKM in South Korea were the public health centre smoking cessation programme (PHC-SCP), the Ministry of Gender Equality & Family smoking cessation programme (MOGEF-SCP), and the National Health Insurance Service smoking cessation treatment project (NHIS-SCP). All programmes included ear acupuncture and counselling. Manual acupuncture was only used in the NHIS-SCP. The MOGEF-SCP and the NHIS-SCP used herbal medicines selectively. The PHC-SCP and MOGEF-SCP provided education programme and other tools such as non-smoking doll, self-writing handbook. They were run at no cost for participants. Treatment period were different for each programmes, 3 weeks, 4 weeks, 8 to 12 weeks, respectively. Treatment frequency was twice a week for PHC-SCP and MOGEF-SCP, and dependent on each clinic for NHIS-SCP. Conclusions This study showed the summaries of the smoking cessation programme that used TKM. The three programmes and the detail information will be a reference for other countries that are going to apply T&CM to their smoking cessation programme. Though TKM integrated smoking cessation programmes had been contributed to stop smoking, persistent efforts are needed to develop more effective and various treatments. In addition, this study suggests that consistent support and systematic reporting system are needed to be successful in non-smoking strategy. Electronic supplementary material The online version of this article (doi:10.1186/s12906-016-1462-9) contains supplementary material, which is available to authorized users.

Objectives: This study introduces the history and types of Korean pharmacopuncture and reports trends of research on Korean pharmacopuncture. Methods: Pharmacopuncture studies were searched from the first year of each search engine to 2014 by using seven domestic and foreign search databases. Selected studies were divided into the history of pharmacopuncture, kinds and features of pharmacopuncture, research types, and experimental and clinic studies and were then classified by year of publication, type of pharmacopuncture, disease, and topic. Results: Pharmacopuncture can be classified into four large groups: meridian field pharmacopuncture (MFP), eight-principles pharmacopuncture (EPP), animal-based pharmacopuncture (ABP) and mountain- ginseng pharmacopuncture, which is a single-co mpound pharmacopuncture (SCP). The largest numbers of studies were reported from 1997 to 2006, after which the numbers decreased until 2014. Of experimental studies, 51.9%, 18.7%. 14.3%, 9% and 3.4% were on SCP, ABP, MFP, formula pharmacopuncture (FP), and EPP, respectively. Of clinical studies, 54.7%, 15.3%. 14.9% 10.0% and 1.5% were on ABP, MFP, EPP, SCP, and FP (1.5%), respectively. Among clinical studies, case reports and case series accounted for 76.5%, followed by randomized controlled trials (RCTs, 16.4%) and non-RCT (13.9%). Musculoskeletal diseases, toxicity and safety tests, anti-cancer effects, and nervous system diseases were mainly treated in experimental studies while musculoskeletal diseases, nervous system diseases, toxicity and safety tests, and autonomic nerve function tests were addressed in clinical studies. Bee venom (BV) was the most frequently-used pharmacopuncture in mechanism studies. Pharmacopuncture was mainly used to treat musculoskeletal diseases. Conclusion: Pharmacopuncture and studies of it have made great progress in Korea. Studies on BV pharmacopuncture and musculoskeletal diseases accounted for most of the studies reported during the review period. Research on the types of pharmacopuncture and diseases has to be expanded. Especially, studies on the use of MFP and EPP for treating patients with various diseases are needed.

Objectives This study was performed to research the biological change after walking program in forest according to Sasang constitution. Methods Twenty four applicants are involved in this study. They were classified into three groups(Soyangin, Taeeumin, Soeumin) by QSCC II and divided into two groups(roadway, forest path) by place. And then they participated in walking program on March 31 in 2012. We performed before and after measurements, including active oxygen, biochemical test(BC), and stress hormones. Results Cortisol decreased in the entire group after walking program, which means the effect of relaxation. Glucose reduced in Soyangin group while increased in Taeeumin and Soeumin group after the program. There was no correlation in the test results between Sasang constitution and walking place. Conclusions Walking program has shown most efficacy in relaxation. However a single positive result within this study should be carefully interpreted. In the future, well-designed studies for Sasang constitutional walking program are needed.