A Severe Cervical Spondylotic Myelopathy Patient Treated with Integrative Korean Medicine Including Acupuncture, Bee Venom Pharmacopuncture and Herbal Medicine: a case report.

Cervical spondylotic myelopathy (CSM) is common in elderly people and severe CSM patients are recommended to receive surgery. However, in some cases, surgery may fail to improve the patients' symptoms. An 80-year-old man diagnosed with CSM complained of right hemiplegia and right arm and leg pain with the presence of a Foley catheter, despite treatment with laminectomy and laminoplasty. Acupuncture, bee venom pharmacopuncture, and herbal medicine were administered for 129 days. As a result, manual muscle testing (MMT) and the Modified Barthel Index (MBI) improved, the pain in his right arm and leg decreased, and he was able to urinate by himself. This case report implies that integrative Korean medicine (IKM) can be an option for patients suffering from muscular weakness resulting from myelopathy.

Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study.

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.

Efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet: Study protocol clinical trial (SPIRIT Compliant).

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).

The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial.

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 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: ClinicalTrials.gov, NCT03374345 . Registered on 15 February 2018.

Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study.

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.

Single-dose Intravenous Injection Toxicity of Water-soluble Danggui Pharmacopuncture (WDP) in Sprague-Dawley Rats.

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.

The definition and diagnosis of cold hypersensitivity in the hands and feet: Finding from the experts survey.

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.

Pigmented Purpuric Dermatosis in Adults Treated with Herbal Medicine: Report of Five Cases.

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.

The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial.

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.

Characteristics of Herbal Medicine Users and Adverse Events Experienced in South Korea: A Survey Study.

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.

Inhibitory effect of Angelica gigas on cold­induced RhoA activation in vascular cells.

The herbal extract Angelica gigas (AG) has been applied as a vasodilating agent for patients suffering from vascular diseases for many years; however, the underlying mechanism has not been fully elucidated. The present study hypothesized that the anti­vasoconstrictive effect of AG may be effective in the treatment of abnormal cold­mediated vasospasms that occur in Raynaud's phenomenon (RP). The effect of AG on the activity of ras homolog gene family member A (RhoA) was investigated in cold­exposed vascular cells. Vascular cells were pretreated to AG, followed by a warm (37˚C) or cold (25˚C) incubation for 30 min and investigated with western blotting, ELISA and confocal microscopy. Cold treatment induced the activation of RhoA in pericytes and vascular endothelial cells, however this was reduced by treatment with AG. Furthermore, AG treatment reduced the endothelin­1 (ET­1)­mediated RhoA activation in pericytes; however, cold­induced ET­1 production by vascular endothelial cells was not affected by treatment with AG. In addition, AG treatment suppressed the formation of stress fibers and focal adhesion complexes, and the cold­induced phosphorylation of focal adhesion kinase, proto­oncogene tyrosine­protein kinase Src and extracellular signal­related kinase. Therefore, AG treatment demonstrated an ability to reduce cold­induced RhoA activation in pericytes and vascular endothelial cells, and attenuated ET­1­mediated RhoA activation in pericytes. In conclusion, the present study indicated that AG may be useful for the treatment of RP.

Smoking cessation programmes using traditional medicine in Korea.

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.

Danggui­Sayuk­Ga­Osuyu­Senggang­Tang ameliorates cold­induced vasoconstriction in vitro and in vivo.

Danggui-Sayuk-Ga-Osuyu-Senggang-Tang (DSGOST), one of the traditional Chinese medicines, has long been prescribed for patients suffering from Raynaud phenomenon (RP) in Northeast Asian countries, including China, Japan and Korea. Although a previous in vitro study from our laboratory revealed that DSGOST prevents cold (25˚C)­induced RhoA activation and endothelin­1 (ET­1) production in endothelial cells (ECs), the mechanisms by which DSGOST is able to alleviate the symptoms of RP have yet to be fully elucidated. The present study aimed to demonstrate that DSGOST regulates RhoA­mediated pathways in cold­exposed pericytes. In pericytes, DSGOST amplified cold­induced RhoA activation, while markedly reducing ET­1­induced RhoA activation. Additionally, DSGOST­mediated regulation of RhoA was closely associated with Rho­associated, coiled­coil­containing protein kinase 1 (ROCK1)/testis­specific kinase 1 (TESK1)/PDXP, but not with LIM domain kinase 1/2 (LIMK1/2), cofilin and myosin light chain (MLC). Thus, DSGOST activation of RhoA/ROCK1/TESK1/PDXP in cold­exposed pericytes appeared to be crucial for treating vessel contraction. In addition, the DSGOST effect on the RhoA­mediated pathway in cold­induced human umbilical vein endothelial cells or human dermal microvascular endothelial cells was similar to that in ET­1­treated pericytes, but not in cold­induced pericytes. The results of the present study further confirmed that DSGOST inhibits cold­induced contraction of the mouse tail vein in vivo. Furthermore, DSGOST treatment reduced cold­induced expression of the α2c­adrenergic receptor in mouse tail vessels. Therefore, the data in the present study suggest that DSGOST may be useful for the treatment of RP­like disease.

History of Research on Pharmacopuncture in Korea.

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.

Study of Intravenous Single-Dose Toxicity Test of Bufonis venonum Pharmacopuncture in Sprague-Dawley Rats.

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.

Anti-Proliferation Effects of Garlic (Allium sativum L.) on the Progression of Benign Prostatic Hyperplasia.

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.

A manual acupuncture treatment attenuates common cold and its symptoms: a case series report from South Korea.

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 themediandurationsofcompletelyrecovery (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.

Erratum: The Effects of Sa-am Acupuncture Simpo-jeongkyeok Treatment on the Blood Pressure, Pulse Rate, and Body Temperature.

[This corrects the article DOI: 10.3831/KPI.2015.18.013.].

Single-dose Intramuscular-injection Toxicology Test of Water-soluble Carthami-flos and Cervi cornu parvum Pharmacopuncture in a Rat Model.

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.

The Effects of Sa-am Acupuncture Simpo-jeongkyeok Treatment on the Blood Pressure, Pulse Rate, and Body Temperature.

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 treatment 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.