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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...

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: Bufonis venonum (BV) is the dried white secretions of the auricular and skin glands of the toads Bufo bufo gargarizans or Bufo melanosticus Schneider. This study was performed to evaluate the toxicity of intramuscularly- administered Bufonis venonum pharmacopuncture (BVP) and to calculate its approximate lethality through a single-dose test with Sprague-Dawley (SD) rats. Methods: Twenty male and 20 female 6-week-old SD rats were injected intramuscularly 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 at 0.5 mL/animal, the low-dosage group injected with 0.125 mL/animal of BVP, the medium-dosage group injected with 0.25 mL/animal of BVP and the high-dosage group injected with 0.5 mL/animal of BVP. All injections were in the left thighs of the rats. After administration, we conducted clinical observations everyday and body weight measurements on days 3, 7 and 14 after the injection. We also carried out hematology, serum biochemistry, and histological observations on day 15 after treatment. Results: No mortalities were observed in any experimental group. No significant changes in weight, hematology, serum biochemistry, and histological observations that could be attributed to the intramuscular injection of BVP were observed in any experimental group. Conclusion: Lethal dose of BVP administered via intramuscular injection in SD rats is over 0.5 mL/animal.

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 aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 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 : The purpose of 29 case series is to report the possibility that a hand acupuncture is effective in relieving headache. Methods : After approval from the Institutional Review Board (IRB), I analyzed 29 cases medical records of outpatients with headache, who visited OO oriental medical hospital from December 2008 to December 2010, who have taken a hand acupuncture's treatment without other intervention, and who were diagnosed with one disease of international classification of headache disease second version (ICHD-2). The data was analyzed with Wilcoxon signed rank test to determine whether a hand acupuncture's treatment differed between before and after treatment's Visual Analogue Scale(VAS) according to types of headache and syndrome differentiation. Statistics program was used SPSS 18.0. Differences were considered significant at P

Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.

Objectives : The objective of this study is to report the change of progress in symptoms and various scales after treated with Mountain Ginseng Pharmacopuncture(MGP) on the patients of Amyotrophic Lateral Sclerosis(ALS). Methods : The three ALS patients who treated with MGP, were checked the change of progress by ALS Functional Rating Scale(ALSFRS), ALS Severity Score(ALSSS), grasping power on both arms and circumference of both thighs and calves. Results : After MGP treatment on three ALS patients, first case did not grow worse during MGP treated whereas she got worse rapidly during none treated period. Second case did not grow worse during treated period and third case got worse in progress by slow degrees despite of MGP treatment. Conclusions : Although MGP could not control the progress of ALS completely, MGP may help the improving of quality of life(QOL) in ALS patients and have the effect of delayed ALS progression.

Objective: This case was to report a case of Partial Tear of Triangular Fibrocartilage Complex treated by Intra-articular bee venom Pharmacopuncture. Methods: The patient was treated by Intra-articular bee venom Pharmacopuncture. The Effect of Treatment was evaluated by Visual Analog Scale(VAS) and Modified Mayo Wrist Score(Wrist Score). Results & Conclusions: After Treatment, Patient's VAS decreased and Wrist Score increased. For this results, Intra-articular Bee Venom Pharmacopuncture may be effective for Partial Tear of Triangular Fibrocartilage Complex.

Objective : Sjogren's Syndrome is a chronic inflamatory disorder characterized by lymphocytic infiltration of lacrimal and salivary gland. It may be associated with renal disease such as tubulonephritis or glomerulonephritis. Proteinuria is a kidney disorder resulting in an abnormally high amount of protein in the urine. When the glomeruli are damaged, proteins of various sizes pass through them and are excreted in the urine. This report is a case of proteinuria with Sjogren's Syndrome. Methods : The patient was diagnosed as kidney yang deficiency syndrome and treated with Woogyu-eum, Sa-am acupuncture therapy and bee venom acupuncture therapy. Visual Analog Scale was used to estimate the clinical symptoms. Results : Clinical symptoms and proteinuria were improved without steroid therapy. Conclusion Therefore, we concluded that oriental medical therapy may be useful to treat proteinuria with Sjogren's Syndrome.

Objectives Mountain ginseng pharmacopuncture (MGP) is a pharmacopuncture made by distilling extract from mountain cultivated ginseng or mountain wild ginseng. This pharmacopuncture is injected intravenously, which is a quick, lossless way of strongly tonifying Qi function. The present study was undertaken to evaluate a 4-week, repeated, intravenous injection, toxicity test of MGP in Sprague-Dawley (SD) rats. Methods Twenty male and female 6-week-old SD rats were used as subjects. We divided the SD rats into 4 groups: the high-dosage (10 mL/kg), medium-dosage (5 mL/kg), low-dosage (2.5 mL/kg) and control (normal saline) groups. MGP or normal saline was injected intravenously into the caudal vein of the rats once daily for 4 weeks. Clinical signs, body weights, and food consumption were monitored during the observation period, and hematology, serum biochemistry, organ weight, necropsy, and histological examinations were conducted once the observations had been completed. Results No mortality was observed in any of the groups during the observation period. No changes due to MGP were observed in the experimental groups regarding clinical signs, body weights, food consumption, hematology, serum biochemistry, organ weight and necropsy. No histological changes due to MGP were observed in any of the male or female rats in the high-dosage group. Conclusion During this 4-week, repeated, intravenous injection, toxicity test of MGP in SD rats, no toxic changes due to MGP were observed in any of the male or female rats in the high-dosage group. Thus, we suggest that the high and the low doses in a 13-week, repeated test should be 10 mL/kg and 2.5 mL/kg, respectively.

Objectives: Mountain ginseng pharmacopuncture (MGP) is an extract distilled from either mountain cultivated ginseng or mountain wild ginseng. This is the first intravenous injection of pharmacopuncture in Korea. The word intravenous does not discriminate between arteries, veins, and capillaries in Oriental Medicine, but only the vein is used for MGP. The aim of this study is to evaluate the intravenous injection toxicity of MGP through a single-dose test in Sprague-Dawley (SD) rats. Methods: Male and female 6-week-old SD rats were injected intravenously with MGP (high dosage of 20 mL/kg or low dosage of 10 mL/kg). Normal saline was injected into the rats in the control group by using the same method. After the rats has treated, we conducted clinical observations, body-weight measurements and histological observations. Results: In this study, no mortalities were observed in any of the experimental groups. Also, no significant changes by the intravenous injection of MGP were observed in the body weights, or the histological observations in any of the experimental groups compared to the control group. The lethal dose for intravenous in jection of MGP was found to be over 20 mL/kg in SD rats. Conclusion: Considering that the dosage of MGP generally used each time in clinical practice is about 0.3 mL/kg, we concluded with confidence that MGP is safe pharmacopuncture.

Herbal prescription, Danggui-Sayuk-Ga-Osuyu-Saenggang-tang (DSGOST), has long been used to treat Raynaud’s phenomenon (RP) in traditional Chinese medicine (TCM). However, a biological mechanism by which DSGOST ameliorates RP is yet deciphered. In this study, we demonstrate that DSGOST inhibits cold-induced activation of RhoA, in both vascular smooth muscle cells (VSMC) and endothelial cells (EC), and blocks endothelin-1-mediated paracrine path for cold response on vessels. While cold induced RhoA activity in both cell types, DSGOST pretreatment prevented cold-induced RhoA activation. DSGOST inhibition of cold-induced RhoA activation further blockedα2c-adrenoreceptor translocation to the plasma membrane in VSMC. In addition, DSGOST inhibited endothelin-1-mediated RhoA activation andα2c-adrenoreceptor translocation in VSMC. Meanwhile, DSGOST inhibited cold-induced or RhoA-dependent phosphorylation of FAK, SRC, and ERK. Consistently, DSGOST inhibited cold-induced endothelin-1 expression in EC. Therefore, DSGOST prevents cold-induced RhoA in EC and blocks endothelin-1-mediated paracrine path between EC and VSMC. In conclusion, our data suggest that DSGOST is beneficial for treating RP-like syndrome.

Background Gyejibongnyeong-hwan (GJBNH) is one of the most popular Korean medicine formulas for menstrual pain of dysmenorrhea. The concept of blood stagnation in Korean medicine is considered the main factor of causing abdominal pain, or cramps, during menstrual periods. To treat the symptoms, GJBNH is used to fluidify the stagnated blood and induce the blood flow to be smooth, reducing pain as the result. The purpose of this trial is to identify the efficacy of GJBNH in dysmenorrhea caused by blood stagnation. Methods This study is a multi-centre, randomised, double-blind, controlled trial with two parallel arms: the group taking GJBNH and the group taking placebo. 100 patients (women from age 18 to 35) will be enrolled to the trial. Through randomization 50 patients will be in experiment arm, and the other 50 patients will be in control arm. At the second visit (baseline), all participants who were already screened that they fulfil both the inclusion and the exclusion criteria will be randomised into two groups. Each group will take the intervention three times per day during two menstrual cycles. After the treatment for two cycles, each patient will be followed up during their 3rd, 4th and 5th menstrual cycles. From the screening (Visit 1) through the second follow-up (Visit 6) the entire process will take 25 weeks. Discussion This trial will provide evidence for the effectiveness of GJBNH in treating periodical pain due to dysmenorrhea that is caused by blood stagnation. The primary outcome between the two groups will be measured by changes in the Visual Analogue Score (VAS) of pain. The secondary outcome will be measured by the Blood Stagnation Scale, the Short-form McGill questionnaire and the COX menstrual symptom scale. Analysis of covariance (ANCOVA) and repeated measured ANOVA will be used to analyze the data analysis. Trial registration Current Controlled Trials: ISRCTN30426947

Background Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence and rising costs. It has a clear impact on a patient's quality of life. Many patients are worried about the use of usual care techniques, such as corticosteroids and antihistamine due to the widespread fear of adverse effects. Complementary and alternative medical approaches have been employed to relieve symptoms of Atopic Dermatitis. Hwangryunhaedoktang is among the most strongly preferred and widely used herbal medicines for Atopic Dermatitis in Korea, as it causes very few serious adverse effects. We aim to establish basic clinical efficacy and safety data for Hwangryunhaedoktang, which is approved as an herbal medication by the Korean Food and Drug Administration, in adult patients with Atopic Dermatitis. Methods/Designs This study is a randomised, double blind, placebo-controlled, two-centre trial with two parallel arms (Hwangryunhaedoktang and a placebo). The diagnosis of Atopic Dermatitis will be made according to the criteria of Hanifin and Rajka by two different Oriental medicine doctors. We will include participants experiencing typical conditions of intermittent or continuous Atopic Eczema for six or more months. Participants will receive Hwangryunhaedoktang or a placebo-drug for eight weeks. The total duration of each arm is eleven weeks. Each participant will be examined for signs and symptoms of Atopic Dermatitis before and after taking medication. A follow-up to evaluate the maintenance of safety will be performed two weeks after the final administration of medication. Discussion This trial will utilize high quality trial methodologies in accordance with consolidated standards of reporting trials guidelines. It will provide evidence for the clinical efficacy and safety evaluation of Hwangryunhaedoktang in adult patients with Atopic Dermatitis. Moreover, we will also employ health-related quality of life questionnaires to assess the changes in quality of life. Trial registration Current Controlled Trials ISRCTN26218532

Objectives: Radix Ginseng has been traditionally used as an adaptogen that acts on the adrenal cortex and stimulates or relaxes the nervous system to restore emotional and physical balance and to improve well-being in cases of degenerative disease and/or old age. Radix Ginseng has been used for a long time, but the safety of ginseng pharmacopuncture needs testing. This study was done to analyze the single-dose toxicity of water-soluble ginseng pharmacopuncture (GP) intramuscular injections in rats. Methods: All experiments were performed at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). Each group contained 10 Sprague-Dawley rats, 5 males and 5 females. GP was prepared in a sterile room at the Korean Pharmacopuncture Institute under regulations of Good Manufacturing Practice (GMP). GP dosages were 0.1, 0.5 and 1.0 mL for the experimental groups; normal saline was administered to the control group. The animals general condition was examined daily for 14 days, and the rats were weighed on the starting day and at 3, 7 and 14 days after administration of the pharmacopuncture. Hematological and biochemistry tests and autopsies were done to test the toxicological effect of GP after 14 days. This study was performed with approval from the Institutional Animal Ethics Committee of Biotextech. Results: No deaths were found in this single-dose toxicity test of intramuscular injections of GP, and no significant changes in the general conditions, body weights, hematological and biochemistry tests, and autopsies were observed. The local injection site showed no changes. Based on these results, the lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results suggest that GP is relatively safe. Further studies, including a repeated toxicity test, are needed to provide more concrete evidence for the safety of GP.

Objectives: The present study evaluated the effects of sa-am acupuncture (SAA) simpo-jeongkyeok (SPJK) treatment on the blood pressure (BP), pulse rate (PR), and body temperature (BT) of patients with hwa byung (HB). Methods: This patient assessor blind, randomized, placebo controlled trial included 50 volunteers, divided randomly into two groups. The treatment group underwent SPJK (PC9, LR1, PC3, KI10) while the control (sham) group received minimal needle insertion at non acupoints. The BP in both arms, PR, and BT at several acupoints were measured before and after treatment at the 1 st , 2 nd , 3 rd , and 4 th visits and before treatment at the follow-up visit. We analyzed data by using the repeated measured analysis of variance (RM ANOVA), Mann-Whitney U, and wilcoxon signed rank tests; differences at P < 0.05 were considered significant. Results: No significant differences in the systolic blood pressure (SBP), diastolic blood pressure (DBP) and PR between the treatment and control group were observed at each visit. However, the decrease in the SBP for the treatment group before and after each visit was significantly higher than it was in the control group. The SBP in both arms in the treatment group was decreased between visits 1 and 2, 1 and 3, 1 and 4, and 1 and follow-up. The DBP in both arms and in the right arm between visits 1 and 3 in the treatment group showed decreases. A minimal BT increase for treatment at CV06 and CV12 and a minimal BT decrease for treatment at CV17 and (Ex) Yintang were found. Patients in the treatment group who visited more frequently experienced a greater decrease in the PR, but that effect was not maintained. Conclusion: The results suggest that SAA SPJK treat ment has instant positive effects on the BP, PR, and BT in patients with HB, but the effects on the BP and PR are not maintained.