• Title/Summary/Keyword: safety of herbal medicine

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Herbal Medicine for the Treatment of Non-Erosive Reflux Disease: A Systematic Review and Meta-Analysis Protocol

  • Minjeong Kim;Chaehyun Park;Jae-Woo Park;Jinsung Kim;Seok-Jae Ko
    • The Journal of Internal Korean Medicine
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    • v.44 no.6
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    • pp.1176-1185
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    • 2023
  • Introduction: Non-erosive reflux disease (NERD) is the most common subtype of gastroesophageal reflux disease (GERD). This study aims to synthesize evidence on the efficacy and safety of various herbal medicines for the treatment of NERD. Methods and analysis: Ten electronic databases will be examined: MEDLINE (via PubMed), Cochrane Central Register of Controlled Trials, Embase, Allied and Complementary Medicine Database, China National Knowledge Infrastructure Database, Citation Information by Nii, Korean Medical Database, Korean Studies Information Service System, National Digital Science Library, and Oriental Medicine Advanced Searching Integrated System. All randomized controlled trials published from inception to May 2023 that meet the eligibility criteria will be selected. Two independent researchers will extract data, such as publication year, study design, intervention details, outcome measures, main results, and adverse events. The risk of bias and quality of evidence will be assessed, and subgroup analyses will be performed according to the type of control intervention and herbal medicine. The analysis process will be conducted using Review Manager 5.4 software. Discussion: This review will present a summary and rationale for herbal medicine's effectiveness in treating NERD. The findings of this review can help those who want to apply herbal medicine to the treatment of NERD.

ADR of Herbal Medicines (한약물의 ADR)

  • Ko Seong-Gyu;Jang Byoung Eun;Choi Jae Sun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.18 no.4
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    • pp.957-964
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    • 2004
  • Herbal medicines are increasingly used to treat various diseases and lots of studies have been reported that they had benefits in treating and preventing of diseases. But organic toxicity is increasingly recognized as herbal medicines become more popular in industrialized countries. Some herbal products potentially benefit people with lots of diseases, however these benefits remain generally unproved in humans, and a greater awareness for potential adverse effects is required. A herb containing a wide variety of, mostly unknown, substances may well include some with unwanted effects. This review focuses on emerging organic toxicities that have been observed associated with various herbal preparations involving the liver, kidney, and heart, and patterns of organ injury, potential risk factors for organic toxicities. In addition to the potential for organic toxicities, drug drug interactions between herbal medicines and conventional agents may affect the efficacy and safety of concurrent medical therapy. Appropriate reporting and regulatory system to monitor herbal toxicity are required, in conjunction with ongoing scientific evaluation of the potential benefits of phytotherapy.

A Retrospective Study on the Effect of Herbal Extracts Combined with Conventional Therapy on Blood Glucose in Type 2 Diabetes Mellitus (제2형 당뇨병 환자에게 한방의료보험용 혼합엑기스산제와 경구혈당강하제 병용요법이 혈당 변화에 미치는 영향)

  • Jeong, Su-min;Noh, Ji-won;Lee, Min-seung;Yang, Hee-gwon;Ahn, Young-min;Ahn, Se-young;Lee, Byeong-chul
    • The Journal of Internal Korean Medicine
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    • v.41 no.6
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    • pp.1231-1244
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    • 2020
  • Objective: This study was conducted to report the glucose-lowering effect and safety of herbal extracts in patients with type 2 diabetes mellitus. Methods: We investigated 21 patients with type 2 diabetes mellitus who were administered Daeshiho-tang, Bojungikgi-tang, Jowiseunggi-tang, and Hoechunyanggyeok-san at Kyung-Hee University Korean Medical Hospital from 2014 to 2019. The hypoglycemic effect of the herbal extracts was assessed by comparing blood glucose levels, including fasting blood sugar (FBS) and 2-hour postprandial glucose (PP2) levels. For safety assessment, the effects of herbal extracts on liver and kidney function were analyzed by liver function tests, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), and γ-glutamyltransferase (GGT), and kidney function tests, including blood urea nitrogen (BUN) and creatinine (Cr). Patients were stratified according to their glycated hemoglobin (<6.5 or >6.5) levels and the kind of herbal extract used for treatment. Results: After administration of herbal extracts, FBS and PP2 significantly decreased to 20.24 mg/dL and 35.0 mg/dL respectively. Subgroup analysis revealed that, regardless of the glycated hemoglobin level, FBS and PP2 were significantly reduced in both groups. The safety profile showed no significant difference before and after taking herbal extracts. Conclusions: Daeshigo-tang, Bojungikgi-tang, Jowiseunggi-tang, and Hoechunyanggyeok-san may show the further glucose-lowering effects on patients with type 2 diabetes mellitus who have already treated with anti-hyperglycemic agents.

Assessment of Combined Administration of Hypoglycemic Agents and Herbal Extracts (Pyeongwi-san or HyangsaPyongwi-san) on Blood Glucose Levels in Type 2 Diabetes Mellitus: A Retrospective Study (표준 치료를 받고 있는 제2형 당뇨병 환자에서 혈당강하제와 평위산 및 향사평위산 병용 투여가 혈당에 미치는 영향 및 안정성 연구)

  • Woo-nyoung Jung;Seung-hyun Oh;Mee-ryoung Song;Ji-won Noh;Young-min Ahn;Se-young Ahn;Byung-cheol Lee
    • The Journal of Internal Korean Medicine
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    • v.44 no.4
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    • pp.661-674
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    • 2023
  • Abstract: This retrospective study delved into the effects and safety considerations associated with the concomitant usage of hypoglycemic agents and herbal extracts, specifically Pyeongwi-san (PWS) or HyangsaPyongwi-san (HSPWS) in the context of type 2 diabetes mellitus management. Methods: The investigation involved 38 inpatients with type 2 diabetes mellitus who received PWS or HSPWS treatment at Kyung Hee University Korean Medical Hospital from January 2012 to December 2022. By investigating clinical attributes and conducting laboratory assessments, this study aimed to discern the impact of these herbal extracts on blood glucose levels, encompassing fasting blood sugar (FBS) and mean 2-hour postprandial glucose (PP2) levels. Furthermore, the safety profile of the herbal extracts was assessed by comparing liver function indicators, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), and γ-glutamyl transferase (GGT), alongside kidney function markers, such as blood urea nitrogen (BUN) and creatinine (Cr). Results: Following the administration of the herbal extracts, no statistically significant alterations in FBS and mean PP2 levels emerged compared to the baseline levels. Notably, the safety evaluation revealed no significant differences in liver and kidney function parameters following herbal extract administration. Conclusion: The results of this research indicate that using PWS or HSPWS alongside hypoglycemic medications could be a beneficial additional method for addressing digestive symptoms in individuals with type 2 diabetes mellitus. Notably, this combination seems to have no negative interactions with other drugs.

Effects of High Frequency Herbal Medication Administrations on the Renal Functions in Rats -Focusing on Sipjeondaebotang, Bojunikgitang, Ojeoksan and Yukmijihwangtang- (다용 한약처방 투여가 흰쥐의 신장기능에 미치는 영향 -십전대보탕, 보증익기탕, 오적산 및 육미지황탕을 중심으로-)

  • Shin, Gyu-Won;Lee, Sun-Dong;Park, Hae-Mo;Jeon, Sung-Jin;Byun, Jin-Seok
    • Journal of Society of Preventive Korean Medicine
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    • v.9 no.1
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    • pp.119-133
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    • 2005
  • Traditional herbal medicine is widely used among the Korean people, and other eastern Asian countries employ similar therapies as well. In recent years, due to increasing interest in herbal medicines, many researches have been made on the toxicity and side effects of herbal medications. Through private and public media, there have been many opinions suggesting taking herbal medicines is very harmful, especially on the liver and kidney functions. This assertion has been mainly presented by the doctors that practice western medicine, But this assertion is never based on adequate knowledge of herbal medicine. This study aims to provide the evidences that taking herbal medicines is safe on the renal functions. Four frequently used herbal medications(Sipjeondaebotang, Bojungigitang, Ojeoksan, and Yukmijihwangtang) were used to test the toxicity of herbal medicine oh the lab animal model(SD-Rat). There is no significant difference in body weight and kidney weight after herbal medication for 1 month. In all experimental groups, no abnormal findings were observed in histological study, and lab renal function index(BUN, creatinine, uric acid). These results say that four herbal multi-used-medicines, when medicated, is safe from the renal toxicity in lab animal model.

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Status Analysis of Adulterated Herbal Medicine (국내외 위변조 한약 현황 분석)

  • Lee, Soojin
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.34 no.5
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    • pp.215-221
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    • 2020
  • Adulterated herbal medicine is intentionally added with undeclared improper or inferior ingredients which should not be in herbal medicine. The contamination with potentially hazardous substances such as heavy metal, pesticides, fungus, and microorganism sometimes can be regarded as one of adulteration in a broad sense. The problem of adulteration is that adulterated herbal medicine shows poor quality and/or can cause adverse events. Therefore, it is important to control adulteration issues for quality assurance and qualitative improvement of herbal medicines. This study aims to summarize and make a reference how to control adulterated herbal medicine. In this process, this study is to investigate studies about adulterated herbal medicine via searching Korean and foreign electronic databases such as PubMed, NDSL and OASIS. Finally eighteen papers were included to this study and analyzed according to the type of study, the category and efficacy of adulterants, the type of analysis methodologies and possible adverse events of adulterants. Phosphodiesterase type 5 (PDE-5) inhibitors for male sexual enhancement and anorexic, laxative, diuretic agents for weight loss and treating obesity has been used frequently as adulterants. The range of adverse event caused by adulterated herbal medicine were very wide from mild symptoms such as diarrhea, constipation, dizziness and blurred vision to very severe symptoms such as heart failure, hypoglycemia and renal impairment. This study showed the recent trend on the research of adulterated herbal medicine and this will be the ground to develop more detailed systems to control adulterated herbal medicine.

Analysis of Existing Guidelines and Controlled Clinical Trials for Development of [Guideline of Clinical Trials with Herbal Medicinal Products for Colorectal Cancer] (결장직장암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 대조군 임상시험 고찰)

  • Park, Eunjoo;Seong, Sin;Kim, Sungsu;Kim, Jinsung;Park, Jae-Woo;Ko, Seok-Jae;Han, Gajin
    • The Journal of Korean Medicine
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    • v.40 no.1
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    • pp.124-152
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

A Clinical Case of Liver Injury Induced by Chungsim Yeonja-tang (청심연자탕 투여후 발생한 약물 유인성 간손상 치험 1례)

  • Sun, Teh-Cheng;Jang, Hae-Jin;Song, Woo-Sup;Yoon, Yeo-Kwang
    • The Journal of Internal Korean Medicine
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    • v.25 no.3
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    • pp.539-544
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    • 2004
  • Herbal medicine has been used in the Eastern world for 2,000 years, and is beneficial for numerous diseases. There have been reports pertaining to the safety of herbal medicine, but there have been few reports about herbal medicine induced liver injury in Eastern or Western medicine. Most are descriptions of hepatotoxicity of certain toxic herbs. We experienced one case of drug induced liver injury in the treatment of cerebral infarction with Chungsim Yeonja-tang. Although the patient had not used medication and Chungsim Yeonja-tang has no toxic herbs in it. patient's ALP, AST, ALT, GGT was twice elevated after 20 days on medication. This was diagnosed as drug induced liver injury, possibly due to incorrect diagnosis of Sasang constitution. So no herbal medicine was given for seven days. Then Gagam Saeng Gan-tang was given. Gagam Saeng Gan-tang have been used to treat hepatic disease and have been known to have beneficial effects. After 25 days on medication, the clinical symptoms and liver function improved. So, this case is presented to bring more attention to the toxicity of herbal medicines.

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Systematic Review on Herbal Treatment for Obesity in Adults (성인비만의 한약치료 임상연구에 대한 체계적 고찰)

  • Han, Kyungsun;Lee, Myeong-Jong;Kim, Hojun
    • Journal of Korean Medicine Rehabilitation
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    • v.26 no.4
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    • pp.23-35
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    • 2016
  • Objectives This systematic review is to support the effectiveness of herbal medicine for the treatment of simple obesity in adults. Methods A total of 8 electronic databases were searched in English, Chinese and Korean. Standard methodologies for the systematic review were used to search, analyze and synthesize data based on NECA's guideline for undertaking systematic review and meta-analyses for intervention. Results After screening 1781 potential articles, we identified 13 randomized controlled trials (RCTs). We conducted a meta-analysis for the study using Bangpungtongsung-san and Taeeumjowi-tang to evaluate the effectiveness of herbal medicines on weight loss compared to placebo control. Both herbs showed positive effect in weight, body mass index and waist circumference. In an analysis comparing herbal effects considering constitutions showed that proper treatment can lower adverse events. Conclusions Our results provide evidence that herbal medicine can be an effective treatment for the obesity compare to placebo or to conventional medicine without serious adverse events. Further study is needed to evaluate effectiveness of herbal medicines considering personalized treatment and its safety.

A Study Of Effects on Renal Function from Continuous Long-Term Herbal Medication (단일 한약 복합 처방의 장기간 연용 투여가 신기능에 미치는 영향에 대한 전향적 연구)

  • Yoon, Yeo-Kwang;Sun, Teh-Cheng;Song, Woo-Sup;Kwon, Su-Kyung;Jang, Hae-Jin
    • The Journal of Internal Korean Medicine
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    • v.25 no.4
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    • pp.300-305
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    • 2004
  • Background : Due to increased interest in herbal medicines is recent years, medical circles have made studies of toxicity and side effects of herbal medicines. Particularly the kidney is sensitive to toxicity. A few reports concerning the side effects and toxicity of herbal medicine have been presented recently. This has bought on some distrust in herbal medicines among patients and western doctors. Objectives : The purpose of this study is to determine what effects long-term prescription of one herbal medicine may have on renal function. Methods : Nineteen patients took herbal medicine for eight weeks. Tests of their Blood Urea Nitrogen(BUN), Creatinine of blood plasma, and urine (chemical and microscopic) were taken before taking medicine and at the 2nd, 4th, 8th weeks. Results : After taking a herbal medicine, BUN and Creatinine decreased significantly or remained the same in comparison with the prior interval. Chemical and microscopic examination of urine showed no changes. Conclusions : The results suggest that taking this herbal medicine for a long time does not induce nephrotixicity. Further study is needed for investigating safety and toxicity of herbal medicines.

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