• 제목/요약/키워드: Adverse events

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소아 식욕부진에 대한 이공산(異功散) 치료의 효과 : 체계적 문헌고찰 및 메타분석 (Effects of Yigong-san for the Treatment of Anorexia in Children: A Systematic Review and Meta-Analysis)

  • 이보람;하다정;허태영;박상은;이선행;장규태
    • 대한한방내과학회지
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    • 제43권4호
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    • pp.542-558
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    • 2022
  • Objectives: The purpose of this study was to assess the effect of Yigong-san on anorexia in children by conducting a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: Eleven electronic databases were searched on May 30, 2022 to collect relevant studies. All studies published up to the search date were considered. RCTs reporting the effect of Yigong-san on the treatment of anorexia in children were included. The primary outcome was an improvement in clinical anorexia symptoms after treatment. In this meta-analysis, continuous and binary outcomes were assessed, and the data were presented as the mean difference and risk ratio with their 95% confidence intervals. The risk of bias was assessed using the Cochrane Collaboration's risk of bias tool. Results: A total of nine studies were included in this systematic review. The treatment group (Yigong-san only or Yigong-san plus conventional treatment) showed a statistically significant effect compared to the control group (conventional treatment only) in total effective rate (Yigong-san only: RR 1.26, 95% CI 1.17, 1.36, I2=0%; Yigong-san plus conventional treatment: RR 1.32, 95% CI 1.18, 1.47, I2=0%), clinical symptoms, some of the anthropometric outcomes, and biological markers related to appetite and growth in children with anorexia. No serious adverse events related to Yigong-san were reported. Conclusions: Yigong-san showed statistically significant effects as a treatment for anorexia in children. However, the number of studies included in the meta-analysis was insufficient, and the herbs contained in the Yigong-san used in the included studies were not standardized. Future research should focus on the implementation of methodologically robust clinical research.

위암 수술 후 장마비에 대한 한의학적 치료의 효과 : 체계적 문헌 고찰 및 메타분석 (The Effectiveness of Traditional Korean Medicine for Treating Postoperative Ileus in Gastric Cancer Patients: A Systematic Review and Meta-Analysis)

  • 배혜리;김은지;서현식;이남헌
    • 대한한방내과학회지
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    • 제43권4호
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    • pp.625-642
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    • 2022
  • 목적: 본 연구는 위암 수술 후 장마비의 한의학적 치료 효과를 평가하기 위해 수행하였다. 방법: 2007년 1월 1일부터 2022년 5월 11일까지 출판된 연구들을 6개의 데이터베이스를 통해 수집하였다. 수술 후 한의학적 치료를 받은 위암 환자를 장마비 관련 지표들을 통해 관찰한 연구들을 선정하였다. 결과: 한약, 침, 뜸, 전기혈위자극, 이혈요법, 족삼리혈의 약물 주입을 수술 후 장마비 치료법으로 사용한 27편의 연구를 선정하였다. 한약, 한약과 침 병용요법, 침, 뜸, 전기혈위자극, 이혈요법, 족삼리혈의 네오스티그민 주입 치료군에서 수술 후 첫 가스 배출까지의 시간이 감소하였고 (p<0.00001), 수술 후 첫 배변까지의 시간이 한약. 한약과 침 병용요법, 침, 뜸, 전기혈위자극, 이혈요법, 족삼리혈의 네오스티그민 주입 치료군에서 유의미하게 감소하였다 (p<0.00001). 심각한 이상반응은 나타나지 않았다. 결론: 한의학적 치료는 위절제술 후 위암 환자에게 수술 후 장마비의 예방과 치료법으로 활용될 수 있으며 수술 후 장마비 치료의 임상적 효과를 명확히 하기 위해 후속 연구가 필요하다.

배암차즈기의 투여가 고형암환자에 미치는 영향을 평가하기 위한 선행적 인체적용시험 (Effect of Salvia plebeia Extract on Patients with Solid Cancer: A Preliminary Clinical Trial Protocol)

  • 이보람;표숙진;김애란;곽은빈;최장기;유화승;정환석;조종관
    • 대한한의학방제학회지
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    • 제30권4호
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    • pp.241-248
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    • 2022
  • Objective : The purpose of this trial is to observe the preliminary effects of Salvia plebeia (SP) extract on quality of life in patients with solid cancer. Methods : This is a prospective, open-label, single-arm, and single-dose clinical trial. Twenty participants who have been diagnosed with solid cancer between the ages of 20 and 65 will be included. All participants will be administered SP granules for 12 weeks. Data will be collected at 4, 8, and 12 weeks after enrollment. The primary outcome is quality of life, using the Korean version of the Functional Assessment Cancer Therapy-General questionnaire. Secondary outcomes include tumor markers in blood tests for each cancer type, soluble programmed death-ligand 1, the percentage of natural killer cells among lymphocytes, ratio of T-helper and T-suppressor cells, ratio of total T, T-helper, T-suppressor, and B cells in lymphocytes, level of C-reactive protein, and tumor size via radiology examination. Safety will be assessed by clinical laboratory tests and monitoring of adverse events. Discussion : This study aims to observe the effects of an oral administration of SP preparations in patients with solid cancer on changes in quality of life and an improvement in immune function. It is expected to provide objective evidence of the effect and safety of SP for patients with solid cancer. Trial registration: KCT0007315 (Clinical Research Information Service)

곰피추출물의 간기능 개선 효과 평가를 위한 12주, 무작위배정, 이중맹검, 위약-대조 인체적용시험 (The Effects of Ecklonia stolonifera Extracts on Improvement of Hepatic Function: a Double-Blind, Randomized, Placebo-Controlled Clinical Study)

  • 김정희;김은진;강다혜;김형빈;장재영;엄애선;김종욱
    • 한국식품위생안전성학회지
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    • 제37권3호
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    • pp.198-205
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    • 2022
  • 본 연구에서는 경증 또는 중등도 간기능 이상 소견자를 대상으로 ESE의 간기능 개선 효과를 평가하기 위해 시험식품군과 대조식품군으로 나누어 단일기관, 위약대조, 무작위배정, 이중눈가림 평행 인체적용시험으로 연구를 수행하였다. 12주간 ESE 420 mg(210 mg/포, 1일 2회)을 함유한 시험식품 또는 대조식품을 섭취하였을 때 ESE의 간 기능 개선 유효성과 안전성을 평가하였다. 유효성 평가 결과, 섭취 후 시험식품군은 대조식품군과 비교하여 ALT, AST, γ-GT 수준이 유의하게 감소하였다. 반면, 지질대사 지표는 두 군간의 의미 있는 차이를 보이지 않았다. 또한, 비알콜성 시험대상자군을 대상으로 분석하였을 때도 ALT 및 AST 수준이 유의하게 감소하였으며 γ-GT의 경우 감소하는 경향성을 보였다. 안전성 평가로서 혈액, 소변, 활력 징후를 검사한 결과 대부분 항목에서 시험식품군과 대조식품군 군간 차이가 없었으며 몇몇 유의성이 나타난 지표도 임상적 의미는 없었다. 따라서 ESE는 간기능 개선에 도움을 줄 수 있을 것으로 보이며 안전한 식품 소재로 판단된다.

한의원 진료환경에서 비만환자 대상 한의통합치료의 체중 감량 효과 및 안전성에 관한 연구: 후향적 차트 리뷰 (A Study on Weight Loss Effect and Safety of Integrated Korean Medicine Treatment on Obese Patients in Local Clinics: A Restrospective Chart Review)

  • 권오진;양창섭;김용진;구원회;이원구;김기병;제갈경환
    • 한방비만학회지
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    • 제22권2호
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    • pp.125-135
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    • 2022
  • Objectives: A restrospective chart review were conducted to investigate the overall weight loss effect of the integrated Korean medicine treatment on obese patients (body mass index [BMI] ≥25 kg/m2) in Korean medicine clinic and analyze the difference in the effect according to lifestyle behaviors. Methods: The medical records of 43 obese patients were retrospectively analyzed including body weight, BMI, waist circumference, hip circumference, and body composition who received integrated Korean medicine treatment for 4 weeks at 24 Korean medicine clinics in Daejeon metropolitan city. All outcome measures were evaluated again 8 weeks after the end of treatment at week 12 for follow-up. EuroQol-5D (EQ-5D), the Korean version of the obesity-related quality of life scale (KOQOL) and patient's satisfaction were also evaluated. The analysis was divided according to the treatment period and observation period, and subgroup analysis was performed according to drinking and exercise habits. Results: Body weight, body fat, waist circumference, hip circumference, body fat were significantly reduced at week 4 and week 12. Theses weight reduction effects were significantly greater within treatment period (0 to 4 week) than observation period (4 to 12 week). Especially in the non-exercise group, the changes in body fat mass and body fat percent showed a significant difference between the treatment period and the observation period. KOQOL were also significantly improved at 12 week, but not in EQ-5D. No severe adverse events were observed. Conclusions: The integrated Korean medicine treatment could be effective to treat obesity including weight loss. It is necessary to prevent additional weight regain through regular exercise even after Korean medicine treatment.

뇌혈관질환 환자에 대한 청심연자탕(淸心連子湯), 도담탕(導痰湯), 혈부축어탕(血府逐瘀湯), 보신익뇌탕(補腎益腦湯)의 간기능과 신기능 안전성 평가 : 후향적 연구 (Hepatic/Renal Safety Evaluation of Cheongsimyeonja-tang (Qīngxīn Liánzǎo Tāng), Dodam-tang (Táodàn Tāng), Hyeolbuchukso-tang (Xuè Fǔ Zhú Yū Tāng), and Boshiniknai-tang (Bǔ Shèn Yì Nǎo Tāng) for Cerebrovascular Diseases : A Retrospective Study)

  • 김민화;조임학;남이랑;김마리아;구기범;이세연;권정남;이인;홍진우;윤영주;김소연;한창우;박소정;최준용;신현규
    • 대한한방내과학회지
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    • 제44권3호
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    • pp.439-454
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    • 2023
  • Objectives: As Korea transitions into an aging society, the incidence of cerebrovascular disease is expected to increase. Herbal medicine is commonly used in Oriental medicine to treat cerebrovascular disease. However, there is insufficient clinical evidence to actively support the safety of herbal medicine in clinical practice. Therefore, the aim of this study was to determine the toxicity and safety of four herbal medicines (Cheongsimyeonja-tang, Dodam-tang, Hyeolbuchukso-tang, and Boshiniknai-tang) in patients with cerebrovascular disease. Methods: This study used electronic medical records to analyze patients admitted to an oriental medicine hospital from April 1, 2017, to December 31, 2020. Liver and renal function values at the time of admission and discharge were compared. Results: A total of 25 patients were included in this study. We found no significant differences in various variables, such as complete blood count, liver-renal function test, and urine, before and after the administration of the four herbal medicines. Additionally, no significant adverse events related to herbal medicine were observed. Conclusions: This study confirmed the safety of the four herbal medicines in patients with cerebrovascular disease who were hospitalized in a single Oriental medicine hospital.

금연에 대한 침술 병용 치료의 효과 및 안전성 : 체계적 검토를 위한 프로토콜 (The effectiveness and safety of acupuncture combination treatment on smoking cessation: A protocol for systematic review)

  • 최인서;성원석;조민기;김정현;박연철;김은정;백용현;김근우;서병관
    • 대한융합한의학회지
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    • 제3권1호
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    • pp.5-13
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    • 2022
  • Objectives: Smoking had a long negative impact on public health. The ingredients of a cigarette are major risk factors for several diseases. Owing to the problems about economic and quality of life, we need to ensure smoking cessation (SC). There are several approaches for SC including pharmacological therapy, nicotine replacement therapy, education, and behavioral intervention. However, due to some limitations, other alternative approaches are gaining popularity. Acupuncture has been reported to have few side effects and be more effective than some conventional treatments in several articles. However, there are no systematic reviews on the comparison of acupuncture combination treatment with other conventional monotherapies. Methods: Randomized controlled trials that used acupuncture as an adjunct treatment for SC will be searched and data will be summarized according to the predefined criteria. The primary outcome will be the abstinence rate, and secondary outcomes will be adverse events and biochemical indicators. We will use Review Manager to perform a meta-analysis, Cochrane Collaboration Risk of Bias tool for the risk of bias assessment, and the Grades of Recommendation, Assessment, Development and Evaluation approach to determine the quality of evidence. We will investigate the efficacy and safety of acupuncture combination treatment for SC with this study. Ethics and dissemination: This study will provide reliable clinical evidence on additional effect of acupuncture on smoking cessation. We will publish our results in a peer-review journal.

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

  • 서지인;이윤재;고서림;김누리;김정훈;손미주;김영은;김안나;이은희
    • 대한한방부인과학회지
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    • 제36권4호
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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.

2022년도 경기도 한의약 난임지원사업 결과 분석 연구 (Analysis of the Results of the 2022 Gyeonggi-do Korean Medicine Infertility Support Project)

  • 이혜성;정효정;최수지;김동일
    • 대한한방부인과학회지
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    • 제36권4호
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    • pp.78-95
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    • 2023
  • Objectives: This study aims to analyze the results of the 2022 Gyeonggi-do Oriental Medicine Fertility Treatment Support Project, review the outcomes and satisfaction of Oriental Medicine fertility support initiatives, and propose progressive fertility treatment support strategies by comparing them with the results of the past three years. Methods: Total of 242 women and 205 spouses participated in the Korean Medicine fertility treatment support project, which encompassed herbal medicine, acupuncture, and counseling treatments over a 3-month period, followed by a 3-month post-treatment follow-up. Data pertaining to patients' general, demographic, and fertility-related characteristics were collected before treatment initiation. During treatment, information regarding the treatments administered by Korean medical doctors was recorded, along with post-treatment outcomes and satisfaction levels. Safety assessments included pre- and post-treatment blood tests and monitoring for adverse events. Results: Among the 242 female subjects, 209 successfully completed the treatment program. Of these, 35 (16.7%) achieved pregnancy, with 30 (15%) attaining pregnancy through herbal monotherapy. Out of the 35 pregnancies, 17 were maintained, while 10 resulted in miscarriage. Notably, 83.8% of patients expressed satisfaction with the treatment outcomes. An analysis spanning three years revealed a continuous increase in the average age of patients, surpassing 38 years in 2022, a critical point in fertility decline age. Additionally, there was a notable rise in the prevalence of patients with a history of gynecological issues, advanced spouse age, and semen abnormalities, which is assumed to have contributed to the decrease in the pregnancy success rate. Conclusions: This study compares the clinical results of the 2022 Gyeonggi-do Korean Medicine Fertility Treatment Support Project with those of the past three years. Based on these findings, recommendations are made to enhance the project, including stricter age criteria for patient selection, enhanced specialized treatment tools for medical doctors, and combining Korean Medicine treatment and medical assisted reproductive technologies, all aimed at increasing pregnancy success rates. These results provide a foundation for the development of fertility support projects and related policies.