• Title/Summary/Keyword: Herbal medicine safety

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The Study of Safety of Herbal Medicine Including Fuzi(附子) on High Range of LFT, RFT Patients (간, 신장수치 이상 환자에 부자(附子) 배합 처방 투여가 미치는 영향)

  • Lee, Young-Jun;Hwang, Won-Duk;Lee, Jae-Wook;Jeong, Hui-Jin;Bae, Su-Hyun;Kim, Kyu-Gon
    • Herbal Formula Science
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    • v.19 no.2
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    • pp.179-189
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    • 2011
  • Objectives : Aconiti Lateralis Preparata Radix(fuzi, 附子) and its class herbs(chaunwu, caowu etc.) are necessary for some clinical conditions, such as cold pain, chilling etc,. But, they has some poison component. And, they have been known to cause liver and kidney injury, and dangerous in the patients who has abnormal range of LFT and RFT. This study shows the consequences for aspartate aminotransferase(AST), alanine aminotransferase(ALT), blood urea nitrate(BUN), and Creatinine were analyzed using samples from patients who took the decoction containing fuzi. Methods : Blood samples for Experiment Group(E) were collected from 63 patients, who took the decoction containing fuzi, admitted into the 6th internal medicine department of Dong Eui Oriental Medical Hospital between from January 2007 to March 2011. In compared to those of experiment group, blood samples as Control Group(C) were collected from 64 patients, who took the decoction not containing fuzi, admitted into the same hospital from January 2009 to April 2011. Results and Conclusions : 1. AST No changed : E 4.17%, C 2.63%, Increased : E 12.5%, C 28.95%, Decreased : E 80.33%, C 68.42% 2. ALT No changed : E2.94%, C5.13%, Increased : E 8.82%, C 20.51%, Decreased : E 88.24%, C 74.36% 3. BUN No changed : E 0%, CG 7.14%, Increased : E 32.25%, CG 14.29% Decreased : EG 67.65%, CG 78.57% 4. Creatinine No changed : EG 5.00%, CG 0%, Increased : EG 35.00%, CG 54.55% Decreased : EG 60.00%, CG 45.45% 5. The results suggest that the decoction containing fuzi isn't harmful AST, ALT, BUN, Cr of the patients who has high range of them.

Toxicological Effect of Samultang (Herbal Medicine) Administration in the Pregnant Rats and Fetuses - Focusing on dose-response Relationship - (사물탕의 용량별 투여가 임신 랫드와 태자에 미치는 독성학적 연구)

  • Jeon, Sung-Jin;Shin, Heon-Tae;Kim, Kyung-Tae;Park, Hae-Mo;Lee, Sun-Dong
    • Journal of Society of Preventive Korean Medicine
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    • v.14 no.3
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    • pp.1-12
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    • 2010
  • Objective : Samulatang (herbal description) is much used for women's disease in Korean Traditional Medicine. The aim of this study is to evaluate reproductive toxic effect by Samultang in pregnant rats and fetuses, and ascertain a dose-response relationship Method : Pregnant Sprague-Dawley rats were administered with the Samultang at single, double and quadruple dose for 20 days, orally. Pregnant rats were sacrificed at 20th day of gestation, and observed internal and reproductive organs. Live fetuses of gestation were randomly selected and fixed in 95% ethanol. Fetuses were stained with alcian blue and alizarin red S. We observe maternal body weight,, index associated pregnancy, and skeletal malformations in fetus Result : Maternal body weight of Samultang treated group has increased, side effect was not found in maternal body compared to that of control group. There were no significant difference in internal and reproductive organs. Double concentration administered group had lowest value in number of implantation, live fetuses, implantation rate and delivery rate, Also double concentration administered group showed higher early and late resorption rate than the other group. But, these are not significant. In the sex ratio, number of females, bigger than number of males in all Samultang administered groups. The fetuses of dams treated with Samultang didn't showed external and skeletal malformation. Vertebral and sternal variations were observed in single, double and quadruple concentration administered group but, compared to the control, those variations were insignificant. There were no significant changes in number of ribs, cervical, thoracic, lumber, sacral and caudal vertebrae Conclusion : Samultang is not expected to affect on pregnant rats and fetus about maternal body weight and number of live fetuses. There were no significant changes in organ weight, reproductive organs. Although skeletal variations were showed in vertebrae and sternum, treated groups were shown insignificant changes in skeletal variation

Herbal Medicine for Premenstrual Syndrome: A Systematic Review and Meta-analysis (월경전증후군에 대한 한약 치료의 효과 : 체계적 문헌 고찰과 메타 분석)

  • Ji-In Seo;Yun-Jae Lee;Seo-Lim Ko;Nu-Ree Kim;Jeong-Hun Kim;Mi-Ju Son;Young-Eun Kim;An-Na Kim;Eun-Hee Lee
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.4
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    • pp.96-120
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    • 2023
  • Objectives: This study reports the findings that support the efficacy of herbal medicine (HM) for premenstrual syndrome (PMS). Methods: We conducted meta-analysis of findings from randomized controlled trials (RCTs) for PMS treated with HM. The articles were published before July 2022, located using 9 databases (Pubmed, EMBASE, Cochrane Library, CINAHL, CNKI, CiNii, SCIENCE ON, KoreaMed, OASIS). Results: We observed 2,034 studies, of which 23 RCTs met our inclusion criteria. The risk of bias in the included studies was relatively unclear or high. Meta-analysis of 3 RCTs showed that HM group had a significantly higher total effective rate than the western medicine group (RR 1.20 [95% CI 1.06, 1.36, p=0.004]). Meta-analysis of 1 RCT showed that HM group had a significantly lower symptom score (MD -3.04 [95% CI -5.36, -0.72, p=0.01]), while there was no significant difference in daily record of severity of problems scale (MD -20.52 [95% CI -49.33, 8.29, p=0.16]). Conclusions: HM significantly improved PMS symptoms than general treatment and no serious adverse events were reported. However, the evidence on the effectiveness and safety of HM for PMS was not enough to provide reliable results due to the small number and low quality of included studies. We believe that rigorous RCTs will lead to more reliable evidence of the intervention.

Case Report on the Five-year Survival and Complete Response of a Patient with Pancreatic Cancer Treated with Integrative Medicine (통합 의학 치료로 5년 생존 및 완전 관해에 도달한 췌장암 증례 보고 1례)

  • Yu-jin Jung;Jisoo Kim;Kyung-Dug Park;Yoona Oh;Beom-Jin Jeong;Sunhwi Bang
    • The Journal of Internal Korean Medicine
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    • v.44 no.3
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    • pp.562-577
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    • 2023
  • Objectives: This is a five-year survival and complete response (CR) report on pancreatic cancer treated with western medicine and Korean traditional medicine. Method: A 59-year-old woman diagnosed with pancreatic cancer visited ○○ Korean traditional medicine hospital after neoadjuvant chemotherapy and pylorus-preserving pancreaticoduodenectomy. She was treated with Korean traditional medicine, including acupuncture, abdominal moxibustion, wild ginseng pharmacopuncture, and herbal medicine, which was based on integrated medicine therapy (IMT), from March 2018 to September 2022. The tumor size was measured by scanning with computed tomography (CT), magnetic resonance imaging, and positron-emission tomography/CT. Adverse events were evaluated using laboratory conclusion and National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Result: During four years and three months of treatment, IMT maintained safety. The patient finally reached five-year survival without any recurrence or complication (CR) on October 26, 2022. Conclusion: We suggest that an integrative approach including Korean traditional medicine can be a meaningful treatment option for pancreatic cancer. Further studies should be performed to establish the proper treatment protocol of integrative medicine for pancreatic cancer.

Traditional Korea Medicine for Enhanced Recovery after Surgery (ERAS) in Inpatients after Gynecological Surgery: Retrospective Analysis (부인과 수술 후 한방 조기 회복 치료를 받은 입원 환자에 대한 후향적 분석)

  • Kim, Hae-Won;Yoo, Jeong-Eun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.3
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    • pp.142-161
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    • 2019
  • Objectives: The purpose of this study is to report the effect and safety of traditional Korean medicine (TKM) for enhanced recovery after surgery (ERAS) after gynecological surgery. Methods: The study is conducted by analyzing the medical records of the hospitalized patients in TKM hospital. Eighty-six patients were enrolled who received TKM for ERAS after gynecological surgery from January 2015 to April 2018. We performed statistical analysis by using SPSS ver. 25.0. To prove the effect and safety of TKM for ERAS, we analyzed symptoms and Hemoglobin (Hb), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and serum creatinine (Cr) with glomerular filtration rate (GFR). In addition, we checked other adverse reactions that the patients complained to prove the safety of TKM for ERAS. Results: Among symptoms of pain, there was a statistically significant decrease in abdominal pain, lower back pain, and shoulder pain. Other symptoms showed statistically significant improvement in fatigue, abdominal tympanosis, operation-site discomfort, dizziness, urinary discomfort, throat discomfort, constipation, dyspepsia and colporrhagia. Anemia in both ferritin combination treatment group and herbal medicine only group showed significant improvement. There was no liver damage or renal damage by TKM. Conclusions: The result has shown that TKM for ERAS after gynecological surgery is effective and safe. The further study of TKM for ERAS with more patients is needed.

Anti-inflammatory and Cartilage Protection Effects of Daeganghwal-tang in MIA-induced Osteoarthritis at Rats (대강활탕(大羌活湯)이 흰쥐에서 MIA로 유발된 골관절염에 미치는 항염증 및 연골 보호 효과)

  • Kim, Ju-ran;Lee, Jung Hee;Lee, Yun Kyu;Lee, Hyun-Jong;Kim, Jae Soo
    • Herbal Formula Science
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    • v.29 no.3
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    • pp.127-145
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    • 2021
  • Objectives : The purpose of this study was to evaluate the effects of Daeganghwal-tang on knee cartilage in monosodium iodoacetate(MIA)-induced osteoarthritis rats. Methods : Forty SD rats were randomly divided into five groups(n=8/group): normal group was SD rats group injected with normal saline at left knee joint and administrated orally distilled water, control group was MIA-induced osteoarthritis SD rats group administrated orally distilled water, Indomethacin group was MIA-induced osteoarthritis SD rats group administrated orally indomethacin 2 mg/kg, DGHT(L) group was MIA-induced osteoarthritis SD rats group administrated orally 1280 mg/kg of Daeganghwal-tang, and DGHT(H) group was MIA-induced osteoarthritis SD rats group administrated orally 2560 mg/kg of Daeganghwal-tang. After orally administration of drugs for 4 weeks, gross appearance and histological analysis were used to evaluate the degree of knee cartilage damage. In addition, pro-inflammatory cytokines, bone degrade factor and bone defence factors were analyzed to investigate the anti-inflammatory and cartilage protection effects of Daeganghwal-tang. Also, hematological test, biochemical test, and liver and kidney tissue were analyzed to determine the safety of Daeganghwal-tang. Results : Daeganghwal-tang inhibited the damage of the knee cartilage, and significantly prevented the reduction in cartilage thickness. In addition, the pro-inflammatory cytokines and the bone degrade factor significantly decreased, and the bone defence factors significantly increased. In the safety assessment of Daeganghwal-tang, there were no significant differences among the experimental groups and no abnormal findings were observed. Conclusions : Daeganghwal-tang has anti-inflammatory effect, inhibits cartilage damage, and protects cartilage in MIA-induced osteoarthritis rats.

Safety of Bojungikgi-tang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study (보중익기탕연조엑스의 1회 경구투여 후 안전성 평가에 관한 단일기관 연구)

  • An, Sung-Hu;Jeong, Yeong-jin;Kim, Jong-gyu;Shin, Hyeryung;Kwon, Young-Dal
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.4
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    • pp.157-166
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    • 2021
  • Objectives This study is designed to evaluate the safety of Bojungikgi-tang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times - screening, pre administration, post administration and follow up-during the whole trial. The difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.

Effect of Nokyongdaebo-tang on chronic anemia in Taeumin wiwansuhan-pyohan disease (胃脘受寒表寒病) patient: a case report

  • Ha, Su-Jeong;Jung, Hee Tae;Song, Si Yeon;Ko, Myung-Hyun;Park, Ji-Hye;Yoo, Hwa-Seung;Park, So-Jung
    • The Journal of Korean Medicine
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    • v.41 no.4
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    • pp.112-119
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    • 2020
  • Objectives: The present study reports a case of chronic anemia patient who was significantly improved after taking Nokyongdaebo-tang (NYDBT) Methods: A 48-year-old male patient diagnosed with iron deficiency anemia (IDA) visited the Daejeon Korean medicine Hospital of Daejeon University on June 2018. The patient was treated with Korean medicine for 23 months including acupuncture, herbal medicine and Sasang constitutional medicine prescription. Improvement of anemia was assessed by changes of Hemoglobin value. Laboratory analysis was used to evaluate the safety of treatment. Results: Chronic anemia has significantly improved since taking NYDBT on 9 days (2019.12.09-2019.12.17). The Hb value has been maintained in the normal range since it first entered the normal range on January 18, 2020. The patient had become transfusion-free and this condition persisted for 6 months after stopping the transfusion. Conclusion: This case demonstrates the therapeutic potential of Sasang constitutional medicine for chronic anemia as a personalized medicine.

Standardization of Hippocastani Semen Extract (서양칠엽수종자엑스 기준및시험법 비교 및 규격 설정)

  • Kim, Seung-Hyun;Kim, Dae-Hyun;Park, Jin-Ho;Cho, Chang-Hee;Lee, Jong-Pill;Kang, Shin-Jung;Lee, Mi-Na;Sung, Sang-Hyun
    • Journal of Pharmaceutical Investigation
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    • v.40 no.1
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    • pp.59-61
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    • 2010
  • This study was carried out to establish standard analytical method of Hippocastani Semen extract. Each standard analytical methods were covered for exact and efficient analytical method. Consequently, analytical method of Deutsches Arzneibuch has been adopted for Hippocastani Semen extract. Analytical methods established in this study could be applied to a reasonable and unified quality control of Hippocastani Semen extract.

Safety of red ginseng and herb extract complex (RHC) in menopausal women: A randomized, double-blind, placebo-controlled trial

  • Hyun, Sun Hee;Han, Chang-Kyun;So, Seung-Ho;Park, Soo Kyung;Park, Chae-Kyu;In, Gyo;Lee, Ji Young
    • Journal of Ginseng Research
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    • v.46 no.4
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    • pp.601-608
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    • 2022
  • Background: Various treatments are used to relieve menopausal symptoms for women. However, herbal substances are frequently used as complementary and alternative therapies as other treatments can increase ovarian and breast cancer risk. While the herbal substances' therapeutic effect is essential, the safety of their use is considered more important. This study aims to confirm the safety of red ginseng and herb extract complex (RHC), which are used to relieve menopausal symptoms. Methods: This randomized, double-blind, placebo-controlled clinical study recruited and divided 120 women experiencing menopausal symptoms into the RHC and placebo groups (60 women per group). Subjects were administered with 2 g RHC or placebo daily for 12 wk. Adverse reactions, female hormonal changes, and uterine thickness were observed and recorded on wk 0, 6, and 12. Hematologic and blood chemistry tests were also conducted. Results: The reactions of the subjects who received RHC or placebo at least once were analyzed. A total of six adverse reactions occurred in the RHC group, while nine occurred in the placebo group; common reactions observed in both groups were genital, subcutaneous tissue, and vascular disorders. However, there was no statistically significant difference between the administration groups (p = 0.5695), and no severe adverse reactions occurred in both groups.