• Title/Summary/Keyword: safety of herbal medicine

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A Clinical Study to Assess the Safety of GyoGam-Dan (교감단의 안정성과 임상적 적용에 대한 연구)

  • Kang, Hyung-Won;Kim, Ji-Hwon;Kim, Jin-Heong;Lee, Chung-Sik;Lee, Sang-Eon;Kim, Tae-Heon;Kim, Tae-Heon
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.3
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    • pp.195-203
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    • 2008
  • Objective: 'GyoGam-Dan' is known as a medicine to cure depression in Donguibogam (traditional Korean oriental medicine book). GyoGam-dan which is composed of Cyperi Rhizoma L. and Poria cum Radix pini has been used by basic prescription of asymptom related to all kinds of Qi(氣) disease. Although it has been clinically used for a long time, its safety have never been proved till now. Methods: We had collected data of 610 cases of patients taking 'GyoGam-Dan' at Wonkwang univ. oriental medical center for a period of three years (2005.3.09-2008.04.30). On the patients' blood, the levels of LFT and RFT were examined and the residual levels of heavy metals and pesticides were measured. Results: There were 610 patients who had taken GyoGam-Dan for about three years. In the patients, the most common diseases is depression, followed by palpitation, and then insomnia. Among the patients' estimations on its effectiveness, there were many of positive ones. The blood analyses of patients who had taken GyoGam-Dan did not show any problems and moreover there was not any problems in the levels of residual heavy metals and agricultural pesticides. Taken together, GyoGam-Dan was proved to be a safe medicine for health. Conclusions: Our clinical and chemical studies show that GyoGam-dan has the anti-stress effect and is a safe medicine of which side effect does not exist. Hereafter, Nigorous clinical trial on GyoGam-dan is required.

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A Clinical Practice Guideline for Ma-huang(Ephedra sinica) Prescription in Obesity (비만치료 및 체중감량에서의 적절한 마황 사용에 대한 임상 진료지침 개발)

  • Kim, Ho-Jun;Han, Chang-Ho;Lee, Eui-Ju;Song, Yun-Kyung;Shin, Byung-Cheul;Kim, Yun-Kyung
    • Journal of Korean Medicine for Obesity Research
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    • v.7 no.2
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    • pp.27-37
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    • 2007
  • Background Clinical practice guidelines (CPG) are systematically developed statements to assist practitioners and patients on healthcare decisions. They provide recommendations for the average patient, which should take into account individual clinical judgment and the patient's values and expectations. Ephedra has sympathomimetic effect and has been used for weight loss worldwide. However, its safety is controversial especially in autonomic and cardiovascular systems. Therefore, the need of appropriate CPG for ephedra prescription in obesity was advocated in Korean Traditional Medicine. Methods The committee comprised of specialists of obesity, oriental herbology, oriental cardiology, constitutional medicine. The committee collected all relevant references about adverse effect and safety of ephedra in the forms of meta-analysis, systematic review, randomized controlled trial, case-control study and observational study from international and domestic databases and paper journals. 11 English- and 5 Korean-language references were gathered and categorized by PICO (Patient, Intervention, Comparison, Outcome) method. We could not complete strength of recommendation which should be clarified according to the evidence grade estimation. Result The first version of CPG for ephedra prescription in obesity was issued by Korean Oriental Association for Study of Obesity. It includes topics of introduction, pharmacokinetics, side effects and adverse events, constitutional aspect and recommendations for dose, indication and contraindication. Conclusion There should be periodic upgrade of this CPG from now on. Although there are some drawbacks in this version of CPG, it has significance as the first CPG in Korean Traditional Medicine.

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Simultaneous determination of illegal galactagogue adulterants in supplement diets by LC-MS/MS

  • Lee, Ji Hyun;Cho, So-Hyun;Park, Han Na;Park, Hyoung Joon;Kim, Nam Sook;Park, Sung Kwan;Kang, Hoil
    • Analytical Science and Technology
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    • v.31 no.4
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    • pp.171-178
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    • 2018
  • Recently, for successful lactation, many breastfeeding mothers seek various products, including herbal medicine, dietary supplements, and prescribed medicines, to improve milk production. As demand for galactogogues grows, it is highly possible that pharmaceutical galactogogues may be adulterated with illegal products to maximize their efficacy. For continuous control and supervision of illegal products, we developed and validated a simple and sensitive LC-MS/MS method capable of simultaneously determining five galactogogues. Chromatographic separation was conducted using an Agilent Poroshell $120SB-C_{18}$ column with a mobile phase consisting of 20 mM ammonium formate (pH 5.4) and 100 % acetonitrile. The total run time was 13 min per analyte. The proposed method was performed according to the guidelines of the International Conference of Harmonization and it produced reliable results. This method showed high sensitivity and specificity, with a limit of detection (LOD) and limit of quantitation (LOQ) of 0.01-0.82 ng/mL and 0.02-2.45 ng/mL, respectively, for the solid- and liquid-type samples. Specificity was evaluated by analyzing matrix-blank samples spiked with the target compounds at LOQ levels, which provided a good separation of all peaks without interference. Additionally, the repeatability and intermediate precision were typically <15 %, whereas the recovery was 80-120 % of the values obtained using blank samples. Thus, we concluded that this method could be used for the identification and quantification of galactogogues in food or herbal products.

Compilation of 104 Experimental Theses on the Antitumor and Immuno-activating therapies of Oriental Medicine (한의학의 항종양 면역치료에 관한 연구 -1990년 이후 발표된 실험논문을 중심으로-)

  • Kang Yeon Yee;Kim Tai Im;Park Jong Ho;Kim Sung Hoon;Park Jong Dai;Kim Dong Hee
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.17 no.1
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    • pp.1-24
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    • 2003
  • This study was done to compile 104 experimental theses which are related to the antitumor and immuno-activating therapies between February 1990 through February 2002. Master's and doctoral theses were dassified by schools, degrees, materials, effects, experimental methods of antitumor and immunoactivity, and results. The following results were obtained from this study : 1. Classifying the theses by the school, 34.6% were presented by Daejeon University, 29.8% by Kyung-hee University and 11.5% by Won-kwang University. Of all theses, 51.0% were aimed for the doctoral degree and 43.3% were for the master's degree. All of three universities have their own cancer centers. 2. Classifying the theses by herb materials, complex prescription accounted for 60.3%, single herb accounted for 24.8% and herbal acupuncture accounted for 14.2%. Considering the key principles of the traditional medicine, complex prescription was much more thoroughly studied than single herb prescription. The results showed that the complex prescription had both antitumor activity and immuno-activating activity, which might reflects on multi-activation mechanisms by complex components. 3. Classifying the theses by the efficacy of herbs examined, in single herb, invigorating spleen and supplementing was 35.5%, expelling toxin and cooling was 29.0%, activating blood flow and removing blood stasis was 12.9%. In herbal acupuncture, invigorating spleen and supplementing was 52.9%, expelling toxin and cooling was 29.4%. In complex prescription, pathogen-free status was 41.9%, strengthening healthy qi to eliminate pathogen was 35.5%, strengthening healthy qi was 22.6%. It is presumed that the antitumor and immunoactivating therapy based on syndrome differentiation is the best way to develop oriental oncology. 4. Classifying the theses by antitumor experiments, cytotoxic effect was 48.1 %, survival time was 48.1 % and change of tumor size was 42.3%. Survival rate was not necessarily correlated with cytotoxicity. These data reflect the characteristic, wholistic nature of the oriental medicine which is based on BRM (biological response modifier). 5. Classifying the theses by immunoactivating experiments, hemolysin titer was 51.0%, hemagglutinin titer was 46.2% and NK cell's activity was 44.2%. In the future studies, an effort to elucidate specific molecular and cellular mechanisms of cytokine production in the body would be crucial. 6. Classifying the theses according to the data in terms of antitumor activity, 50% was evaluated good, 24.0% was excellent, and 15.5% have no effect. In an evaluation of immuno-activating activity, 35.9% was excellent and 18.0% showed a little effect. The index point, as described here, may helps to use experimental data for clinical trials. Changes in index points by varying dosage implicate the importance of oriental medical theory for prescription. 7. In 167 materials, IIP (immunoactivating index point, mean : 3.12±0.07) was significantly higher than AIP(antitumor index point, mean : 2.83±0.07). These data demonstrate that the effect of herb medicine on tumor activity depends more on immunoactivating activity than antitumor activity. This further implies that the development of herbal antitumor drugs must be preceded by the mechanistic understanding of immunoactivating effect. 8. After medline-searching tumor and herb-related articles from NCBI web site, we conclude that most of the studies are primarily focused on biomolecular mechanisms and/or pathways. Henceforth, we need to define the biomolecular mechanisms and/or pathways affected by herbs or complicated prescriptions. 9. Therefore, the most important point of oriental medical oncology is to conned between experimental results and clinical trials. For the public application of herbal therapy to cancer, it is critical to present the data to mass media. 10. To develop the relationship of experimental results and clinical trials, university's cancer clinic must have a long-range plan related to the university laboratories and, at the same time, a regular consortium for this relationship is imperative. 11. After all these efforts, a new type herbal medicine for cancer therapy which is to take care of the long-term administering and safety problem must be developed. Then, it would be expected that anti-tumor herbal acupuncture can improve clinical symptoms and quality of life (QOL) for cancer patients. 12. Finally, oriental medical cancer center must be constructed in NCC (National Cancer Center) or government agency for the development of oriental medical oncology which has international competitive power.

Effect and Safety of Combined Treatment of Gambihwan and Garcinia Cambogia on Weight Loss: A Retrospective Observational Study (감비환과 가르시니아 캄보지아 병용 투여의 체중감량 효과와 안전성: 후향적 관찰연구)

  • Yoon, Sang-Hoon;Lee, Eunji;Jo, Hyunjung;Han, Yeji;Kim, Hyunho;Yun, Younghee;Choi, Ye-yong;Park, Jongseung;Leem, Jungtae
    • Journal of Korean Medicine for Obesity Research
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    • v.20 no.1
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    • pp.31-39
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    • 2020
  • Objectives: Obesity is becoming more popular disease worldwide. Because of the side effects of conventional obesity treatment modality, herbal medicine treatment is becoming more preferred. Gambihwan which including Ephedra sinica Staph is widely used in traditional Korean Medicine practice for obesity treatment. Garcinia cambogia is a kind of health functional food that has body fat reducing effect. Nowadays, ephedra and Garcinia cambogia are often used simultaneously in clinical practice of Korean Medicine. However, the effectiveness and safety of combination therapy in obesity treatment is not well established. Methods: We conducted retrospective observational study to explore effectiveness and safety of combination therapy. We evaluated effect of combined treatment of Gambihwan and Garcinia cambogia on body weight, body mass index, body fat mass, and waist hip ratio reduction. We also assessed safety via liver function test and adverse event. Results: Finally, 23 patients were included. In paired t-test, body weight significantly decreased from 64.50±14.50 kg to 62.94±13.85 kg (P<0.001) and body mass index were also significantly decreased from 24.43±3.79 kg/㎡ to 23.83±3.59 kg/㎡ (P<0.001). Body fat mass was also reduced. Aspartate transaminase and alanine aminotransferase were not significantly increased. There were no drug-induced liver injury and no severe adverse event. Conclusions: In our retrospective review, we found combination therapy of Gambihwan and Garcinia cambogia reduce body weight, body mass index and body fat mass. There were no severe adverse event and drug induced liver injury which indicated safety of combination therapy in obesity treatment.

Review of Randomized Controlled Trials of Korean Medicine for Chronic Urinary Tract Infections (만성 요로감염의 한약 치료에 관한 무작위 대조군 임상 연구 분석)

  • Lee, Ji-Won;Kim, Dong-Chul
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.4
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    • pp.113-126
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    • 2020
  • Objectives: This study aimed to review randomized controlled trials on the effectiveness of korean medicine for chronic urinary tract infections. Methods: We analyzed the randomized controlled trials that intervented korean medicine treatment on chronic urinary tract infections retrieved using seven databases. Literature search was conducted on August 10, 2020. Results: Of the 188 studies searched, 8 studies were finally selected. In all studies, the treatment group was treated with korean medicine and the control group was treated with western medicine. Although the evaluation index was different for each study, all the indexes in the treatment group were significantly improved compared to the control group. Conclusions: Korean medicine treatment for chronic urinary tract infections had a significant effect compared to the western medicine treatment. Further high quality randomized controlled trials should be carried out to verify the strong evidence and safety of herbal medicine treatment.

Efficacy and Safety of Banhahubak-Tang for Depression Treatment: Study Protocol for a Randomized, Waitlist-Controlled Trial

  • Seung-Ho, Lee;Yunna, Kim;Dohyung, Kwon;Seung-Hun, Cho
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.4
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    • pp.389-400
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    • 2022
  • Objectives: Depression is a highly prevalent disease, and the market for antidepressant drugs continues to grow at a steady rate. Although current antidepressants are reported to be effective, because of their low remission rate and side effects, new antidepressants are needed. The use of Banhahubak-tang (BHT) to treat the symptoms of depression is supported by experimental evidence. The proposed study will evaluate the efficacy and safety of BHT in treating depression. Methods: A randomized, waitlist-controlled, parallel clinical trial will be conducted to assess the efficacy of BHT in depression. A total of 84 participants with depression will be randomized into the intervention group or waitlist-control group at a 1:1 ratio. Patients in the intervention group will be administered BHT three times a day for four weeks and followed up for four more weeks after therapy completion. Patients in the waitlist-control group will undergo the same intervention and follow-up after a four-week waiting period. The primary outcome is change in the Korean version of the Hamilton Depression Rating Scale (K-HDRS) scores for major depressive disorders after four weeks. The secondary outcomes include scores on the K-HDRS, Korean Symptom Check List 95 (KSCL-95), Insomnia Severity Index (ISI), State-Trait Anxiety Inventory-Korean version (STAI-K), State-Trait Anger Expression Inventory-Korean version (STAXI-K), and the Instrument on Pattern Identifications for Depression and EuroQol-5 Dimension (EQ-5D). Conclusions: This trial will provide high-quality clinical evidence of the efficacy and safety of BHT in the management of depression.

Evaluation of Pyunkang-tang® Administration on Hematological, Biochemical, and Protein and Lipid Profiles in Dogs

  • Park, Won-Keun;Park, Sung-Jae;Kim, Seung-Gon;Kang, Min-Hee;Park, Hee-Myung
    • Journal of Veterinary Clinics
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    • v.33 no.5
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    • pp.255-260
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    • 2016
  • $Pyunkang-tang^{(R)}$ is a kind of herbal medicine and has been used for the treatment of atopy and allergic disease in humans over forty years. The purpose of this study was to evaluate the hematological, biochemical, and protein and lipid electrophoresis profiles after the oral administration of $Pyunkang-tang^{(R)}$ in healthy dogs. Fifteen clinically healthy beagle dogs were selected and orally administered either 33 ml of $Pyunkang-tang^{(R)}$ (group I, n = 5), 16.5 ml of $Pyunkang-tang^{(R)}$ (group II, n = 5), or 33 ml of distilled water (group III, n = 5) 3 times a day for 4 weeks. The results of the hematological, serum biochemical, and urine analysis did not differ significantly among the 3 groups. The oral administration of $Pyunkang-tang^{(R)}$ for 4 weeks was associated with significant changes in the serum globulin levels and an elevation in the high-density lipoprotein (HDL) concentrations in groups I and II (p < 0.05), compared to group III. The ${\alpha}1-globulin$ and ${\gamma}-globulin$ levels were significantly increased in group I, and the ${\alpha}1-globulin$ and ${\beta}-globulin$ levels were significantly increased in group II. The ${\alpha}2-globulin$ levels were significantly decreased in both groups. During the short-term evaluation of $Pyunkang-tang^{(R)}$ administration, we did not detect any specific adverse effects in the dogs. However, further evaluation of the safety and efficacy of $Pyunkang-tang^{(R)}$ for the treatment of atopic disease in dogs is needed.

Anti-oxidation and Anti-atopic Dermatitis Effect of Herbal Wood Vinegar (한방목초액의 항산화 및 항 아토피 효과)

  • Kim, Tagon;Nho, Hwa Jung;Jun, Sang Hui;Kim, Kang Bae;Kim, Donguk
    • Korean Chemical Engineering Research
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    • v.48 no.6
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    • pp.690-694
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    • 2010
  • In this study, herbal wood vinegar including Bambusoideae, Cinnamomi Cortex, Zingiberis Rhizoma was tested to see possibility for cosmetic or skin related medicine. Anti-oxidation effect of herbal wood vinegar was tested by DPPH free radical scavenging activity, and showed 97% inhibition rate at $50{\mu}g/ml$. Anti-bacterial effect was tested by disc diffusion method, and it indicated strong anti-bacterial activity against normal skin flora Staphylococcus aureus. Whitening effect was measured by tyrosinase inhibition assay, and it was lower compared with vitamin C. Stability test was done by MTT assay, and cell toxicity was relatively high. Stability was also checked, and there was not significant change in color, aroma, appearance and pH during storage. Anti-atopic dermatitis test was done by hairless mouse and herbal wood vinegar recovered damaged skin to almost normal condition after 9 days of application. IgE concentration in herbal wood vinegar treated mouse was also reduced 30% compared with control. From the study, herbal wood vinegar showed good anti-oxidation, anti-bacterial and anti-atopic dermatitis effect, and had promising application in cosmetic or skin related medicine.

Research Trend in Korean Medicine Treatment for Hemifacial Spasm

  • Hyang Gi Lim;Eun Sil Heo;Sang Ha Woo;Jung Hee Lee;Jae Soo Kim;Seong Hun Choi;Hyun-Jong Lee
    • Journal of Acupuncture Research
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    • v.40 no.3
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    • pp.201-213
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    • 2023
  • This study reviewed clinical papers reported on hemifacial spasm (HFS). Six online databases were searched for clinical papers published between January 2000 and December 2022. This study reviewed 14 studies, including 13 case reports and 1 combination of case reports and randomized controlled trials (RCTs). The most frequently used acupoints were ST7 and TE17, and the stomach meridian was the most frequently selected. Herbal medicine, pharmacopuncture, thread embedding acupuncture, cupping, moxibustion, and physical therapy were combined with acupuncture. The most frequently used evaluation method is Scott's scale. Out of 95 cases, 82 reported improved HFS symptoms after treatment. Our findings indicated the effectiveness of Korean Medicine treatment in treating HFS. However, evidence of efficacy and safety remains insufficient. Large-scale and well-designed investigations will be required in the future to corroborate these results. We believe that this paper will serve as the foundation for future RCTs.