• The Journal of Internal Korean Medicine
• /
• v.37 no.1
• /
• pp.90-108
• /
• 2016

Objectives: This study aimed to learn what should be considered in the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) by analyzing the existing guidelines and clinical trials.Methods: The development committee searched the existing guidelines for herbal medicinal products or GERD. Then, clinical trials related to GERD using herbal medicine were selected. The chosen trials were analyzed in terms of their inclusion and exclusion of participants, intervention, comparators, outcome, and trial design. Then, we compared the results of the analysis according to the regulations and guidelines of the Ministry of Food and Drug Safety to suggest the issues that we will have to consider when developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).Results: As a result, few guidelines for GERD and clinical trials with herbal medicinal products were located in the national institution homepage. In addition, 8 articles were found using the following combination of search terms: “Gastroesophageal reflux disease”, “GERD”, “herbal medicine”, “herbal therapy”, “Korean Medicine”, “Traditional Chinese Medicine”, and “TCM”. Even though all trials had their own unique research questions, all studies were performed using a randomization method. Most trials included participants with reflux esophagitis, but two trials targeted proton pump inhibitor-refractory GERD. The type of intervention varied, such as decoction, granules, and capsules. Additionally, individualized herbal medicines were used in two studies. Comparators were diverse, such as placebo, Western medicine, and electro-acupuncture. The most frequently used outcome for efficacy was the effectiveness rate. In addition, the outcome for evaluating quality of life, esophageal mucosa and pressure, esophageal acid reflux, and recurrence rates were used. Safety was investigated by recording adverse events and carrying out laboratory tests.Conclusions: We identified some issues by reviewing the existing guidelines and comparing them with clinical trials for GERD and herbal medicinal products. These results will be utilized for developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).

• The Journal of Pediatrics of Korean Medicine
• /
• v.35 no.3
• /
• pp.53-66
• /
• 2021

Objective The purpose of this study is to evaluate whether herbal bath shortens the duration of pediatric fever. Methods Databases, such as Medline, EMBASE, Cochrane library, OASIS, KISS, KMBASE, CNKI, Wanfang Med Online were used to search randomized controlled trials. Those trials that included children younger than 18-year-old were evaluated for the clinical efficacy of herbal bath in fever by analyzing 'body temperature (BT) drop start time' and 'time to return to normal BT'. Results 12 studies or 1306 participants were analyzed in the study. When applying herbal bath in combination with the controlled treatment, 'BT drop start time' was decreased by 0.11 hours, and 'time to return to normal BT' was decreased by 10.94 hours compared to the controlled group. When comparing herbal bath with tepid bath, 'time to return to normal BT' was reduced by 8.19 hours in herbal bath group. In regards to safety, 3 studies out of 12 studies mentioned about its adverse events: 2 studies did not have any adverse events, and a minor needle-shaped bleeding had occurred in one of the studies. Conclusion Use of herbal bath as a treatment of fever in children was associated with shortened duration of fever. However, cautious interpretation is necessary due to its limited safety data.

• Journal of Acupuncture Research
• /
• v.31 no.4
• /
• pp.71-79
• /
• 2014

Objectives : The aim of this study is to evaluate the safety of acupuncture therapy when applied to patients who are undergoing anticoagulants / antiplatelet medication therapy combined with herbal medicine using a retrospective, case-control study. Methods : 428 charts of patients were reviewed in this study. Odds ratio between case of bleeding-related adverse event and control was calculated as main analysis. Exposures were anticoagulants / antiplatelet medication, Hwalhyeolgeoeo herbal medicine and combination of both drugs. Additionally, odds ratios were calculated according to the severity of bleeding-related adverse events. Results : The results were as following: 1. Analysis of all bleeding-related adverse events showed there was no increased risk of combined therapy compared with other exposures and control group. 2. Analysis of only clinically significant adverse events showed there was no increased risk of combined therapy compared with other exposure and control group. 3. Hwalhyeolgeoeo herbal medicine group showed a tendency of increased risk of bleeding-related adverse events in all analysis but was not statistically significant. Conclusions : The results suggest that Hwalhyeolgeoeo herbal medicine-anticoagulant / antiplatelet medication combined therapy may not increase risk of bleeding-related adverse events in acupuncture therapy. By executing various modules of analysis, it was possible to acquire useful data for possible future studies. Further research is needed to confirm such results.

• The Journal of Internal Korean Medicine
• /
• v.44 no.5
• /
• pp.1017-1024
• /
• 2023

Objectives: The aim of this study is to report the effectiveness and safety of herbal medicine treatment for abdominal pain with acute kidney injury. Methods: A 80-year-old female patient presented with abdominal pain. Blood test results showed increased blood urea nitrogen, serum creatinine, amylase, and lipase. The patient was treated with acupuncture and herbal medicine, specifically Hyangsayukgunja-tang-gahwangryeon for 4 days and Gagam-gunbi-tang for 11 days. Gastrointestinal symptoms were assessed using the Numerical Rating Scale, Gastrointestinal Symptom Rating Scale, and abdominal examination. Results: Gastrointestinal symptoms improved after taking Korean herbal medicine. Additionally, blood urea nitrogen, serum creatinine, amylase, and lipase levels showed improvement compared to values before treatment. Conclusions: Korean medicine treatment can improve clinical symptoms without damaging the kidneys of patients with acute kidney injuries.

• Journal of Korean Medicine for Obesity Research
• /
• v.9 no.1
• /
• pp.71-78
• /
• 2009

Objectives Bangpungtongsung-san(Fangfengtongsheng-san) has been traditionally prescribed a a restorative medicine. Methods In this study, we investigated the acute toxicity of water-extracted Bangpungtongsung-san(Fangfengtongsheng-san). 20 male and 20 female mice were orally treated of Bangpungtongsung-san(Fangfengtongsheng-san) at the respective doses of 0 (control group), 1250, 2500 and 5000mg/kg for 14days. Results We observed survival rates, general toxicity, change of body weight and examined microscopic changes of some organs. Conclusions Compared with the control group, we could no find any toxic alteration in all treated groups (1250, 2500 and 500mg/kg). $LD_{50}$ of Bangpungtongsung-san(Fangfengtongsheng-san) might be over 5000mg/kg and it was very safe to ICR mice.

• Journal of Physiology & Pathology in Korean Medicine
• /
• v.26 no.1
• /
• pp.47-52
• /
• 2012

The aim of this study was to investigate the acute toxicity and safety of fermented Soshiho-tang extract using male and female ICR mice. Mice were treated with fermented Soshiho-tang extract once orally at 1250, 2500 or 5000 mg/kg and observed for two weeks. At the doses used, no mortality or abnormal clinical signs in animals were shown during at the observation period. In addition, no differences were found between control and treated groups in body weight, hematology and biochemical analysis, and other findings. Above data strongly suggest that no observed adverse effect level of fermented Soshiho-tang extract might be over 5000 mg/kg/day in this study.

• The Journal of Korean Medicine
• /
• v.35 no.2
• /
• pp.47-59
• /
• 2014

Objectives: Most drug interactions are attributed to the inhibition or induction of the activity of cytochrome P450s (CYP450). Although the regulation of CYP450s by drugs has been widely reported, there have been few studies on influence of traditional herbal formulas on the drug-metabolizing enzymes. Because herbal formulas have been used traditionally to treat various diseases and because herb-drug interactions are crucial factors determining therapeutic efficacies, a systematic evaluation of the effects of herbal formulas is important. Methods: The effects of Galgeun-tang (GGT, gegen tang), Gumiganghwal-tang (GMGHT, jiuweiqianghuo tang), Insampaedok-san (ISPDS, renshenbaidu powder), Samsoeum (SSE, shensu drink), Socheongryong-tang (SCRT, xiaoqinglong-tang) and Sosiho-tang (SSHT, xiaochaihu tang) that are traditional herbal formulas used to treat common cold, on drug-metabolizing enzymes were evaluated through an in vitro CYP3A4, CYP2D6, CYP2C19 and CYP2E1 inhibition assay to assess its interaction potential with synthetic drugs. The inhibitory effects of herbal formulas were characterized with $IC_{50}$ values. Results: These six herbal formulas inhibited the activities of CYP3A4, 2C19, 2D6 and 2E1, in a concentration-dependent manner. Among the six herbal formulas, GGT critically inhibited CYP2C19, CYP2D6 and CYP2E1. GMGHT also inhibited CYP2D6 and CYP2E1 to a greater extent than the other CYP450 isozymes. Additionally, SSE and SSHT may change the effects of medicines that depend primarily on the CYP2C19 and CYP2E1 pathways. On the other hand, ISPDS and SCRT were not inhibited CYP3A4, CYP2C19, CYP2D6 and CYP2E1-mediated metabolism. Conclusions: These findings provide useful information regarding the safety and effectiveness of herbal formulas.

• Toxicological Research
• /
• v.22 no.1
• /
• pp.47-54
• /
• 2006

One of the main attractions of treatment with herbal medicine is its apparent lack of side effects compared with the drug therapies used in allopathic medicine. However, evidence from various countries suggest that Asian herbal medicine carry a significant risk of contamination with toxic heavy metals at levels that may seriously threaten health. The aims of this study were to analyze and compare concentrations of heavy metals in urine and hair from 184 patients taking herbal medicines in the form of decoctions and/or pills in comparison to 101 control subjects taking either Western or no medications. Levels of metal concentrations exceeding WHO reference values were observed in a number of hair and urine samples for all subjects. After adjusting for potential confounders, taking decoctions or pills was associated with higher levels of some metals (such as Cu, Pb in urine), as well a higher odds ratio of exceeding the upper limit of reference ranges for Pb, Hg in hair. In contrast, taking decoctions or pills was associated with lower levels of some metals (such as Cu in urine and Cd, Cu, Hg, Pb in hair), suggesting that some herbal medicines may have a chelating effect on heavy metals in the body. Overall, the results obtained in the study show a mixed picture and suggest that heavy metals contamination in herbs is sometimes present, but may also be counteracted by the potential for some herbal medicines to act as chelating agents. Further study must be followed to obtain more concrete evidence.

• The Journal of Pediatrics of Korean Medicine
• /
• v.33 no.3
• /
• pp.82-102
• /
• 2019

Objectives The purpose of this study is to investigate clinical studies on the efficacy and safety of herbal medicine inhalation therapy in children by analyzing recent randomized controlled trials conducted in China. Methods We searched the clinical studies from the China Academic Journal (CAJ) in China National Knowledge Infrastructure (CNKI) using a by key word '霧化吸入' and specific criteria from 1st January 2010 to 2nd July 2019. Data regarding years of publication, demographic information, target diseases or symptoms, treatment methods, outcome measure, results and adverse events are collected for this study. Results Total of 44 randomized controlled trials were selected and analyzed. Respiratory diseases and symptoms (84.1%) were the most frequent target diseases that herbal medicine inhalation therapy was used. Acute stomatitis was another disease state that the therapy was used. In most of the studies, the herbal medicine inhalation in children showed significant efficacies. The most commonly used herbal medicines were Ephedrae Herba (麻黃), Lonicera Flos (金銀花), Armeniacae Semen (杏仁), Glycyrrhizae Radix et Rhizoma (甘草), Scutellaria Radix (黃芩), Forsythia Fructus (連翹) etc. Hardly any adverse effects were reported from the trials selected. Conclusions Based on the results of the clinical studies from China, herbal medicine inhalation therapy in children can be an effective and safe option for treatment and symptom improvement.

• Journal of Society of Preventive Korean Medicine
• /
• v.19 no.1
• /
• pp.83-93
• /
• 2015

Objective : There are many documents that explain efficacy of herbal medicine products (HMP), however, explanations on efficacy are not consistent with the clinical use. The objective of this study is to identify the differences between herbal medicines used in clinics and Korean Medicine literatures. The disease was restricted in low back pain (LBP). Method : In order to investigate HMP for the treatment of LBP, we selected five Korean medical documents as reference and searched for key words related to LBP. Five databases were Information on Herbal prescription published by Ministry of Food and Drug Safety, 56 Herbal Medicines covered with Health Insurance, Guideline for prescribing herbal medicines announced by Ministry Health & Welfare, Explanation on Herbal Medicines published by Korean Pharmaceutical Association, website of Korea Pharmaceutical Information Center (http://www.health.kr/). The keywords were 'low back pain', 'lumbar', 'pain', 'myalgia', 'neuralgia', 'arthralgia', 'arthroneuralgia', and 'sciatica'. We also utilized the result of retrospective cross-sectional study in five university hospitals to investigate HMP used in practice for LBP. Results : From five databases, the number of searched HMP was 25, 12, 40, 12 and 38 respectively and 83 remained after removing duplications. There were 43 kinds of HMP used in clinical practice and only 20 (46.51 %) were included in one or more databases. Conclusion : This study suggests the necessity for reorganizing efficacy of herbal medicine. Standardizing explanation on herbal medicine should reflect the clinical conditions in further study.