• Title/Summary/Keyword: Adverse events

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

  • Lee, Bo-ram;Ha, Da-jung;Huh, Tae-young;Park, Sang-eun;Lee, Sun-haeng;Chang, Gyu-tae
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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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.

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

  • Bae, Hye-ri;Kim, Eun-ji;Seo, Hyun-sik;Lee, Nam-hun
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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    • pp.625-642
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    • 2022
  • Objectives: Postoperative ileus (POI) is a common impairment of gastrointestinal motility and causes a delay in postoperative recovery, as well as an increased length of hospital stay, but no single strategy has a significant recuperative effect on POI. Studies of traditional Korean medicine (TKM) have reported improvements in bowel function after surgery. The aim of this systematic review was to assess the effectiveness of TKM on postoperative ileus in gastric cancer patients. Methods: We used six databases to search for studies published from January 1, 2007, until May 11, 2022. The included studies were those reporting gastric cancer patients who received TKM treatment after gastrectomy through indicators related to POI. Results: The search identified 27 RCTs that used herbal medicine (Daegeonjung-tang and Gami-leejoongtang), herbal medicine combined with acupuncture (Sama-tang, Gumiseunggi-tang, Daeseunggi-tang, and Insam-tang), acupuncture, acupuncture and moxibustion, electroacupuncture, warm needling, transcutaneous electroacupuncture (TEA), low-frequency electrical acupoint stimulation (LEAS), moxibustion, auricular acupressure, and ST-36 acupoint injection with neostigmine as treatments for POI. The time to first flatus was shortened by herbal medicine combined with warm needling (Sama-tang, Gumiseunggi-tang, Daeseunggi-tang, and Insam-tang), acupuncture, electroacupuncture, warm needling, TEA, moxibustion, auricular acupressure, and ST-36 acupoint injection with neostigmine (p<0.00001). The time to the first defecation decreased significantly in response to the herbal medicine combined with warm needling (Sama-tang, Gumiseunggi-tang, Daeseunggi-tang, and Insam-tang), acupuncture, electroacupuncture, warm needling, TEA, moxibustion, auricular acupressure, and ST-36 acupoint injection with neostigmine (p<0.00001). No serious adverse events occurred. Conclusions: TKM could be a promising option for preventing and resolving POI in gastric cancer patients after gastrectomy.

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

  • Boram, Lee;Sookjin, Pyo;Ae-Ran, Kim;Eunbin, Kwag;Jang-Gi, Choi;Hwaseung, Yoo;Hwan-Suck, Chung;Jongkwan, Jo
    • Herbal Formula Science
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    • v.30 no.4
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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)

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

  • Kim, Junghee;Kim, Eun Jin;Kang, Dahye;Kim, Hyung-Bin;Jang, Jae Young;Om, Ae-Son;Kim, Jongwook
    • Journal of Food Hygiene and Safety
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    • v.37 no.3
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    • pp.198-205
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    • 2022
  • Hepatic diseases are divided into two types: alcoholic and non-alcoholic. Non-alcoholic liver injury finally induces fatty liver and damages liver function. Many studies have demonstrated that Ecklonia stolonifera has antioxidative, anti-inflammatory, and hepatoprotective activities. We conducted a 12-week double-blind, placebo-controlled, randomized trial to examine the efficacy of E. stolonifera extracts (ESE) on biochemical markers of hepatic function. Sixty-five subjects with mild or moderate liver injuries were randomly allocated to receive either 420 mg/d of ESE or a placebo for 12 weeks. Fifty-five participants completed the trial. No significant adverse events were observed among the subjects during the study. The primary end points were changes in plasma levels of aspartate transaminase (AST), alanine transaminase (ALT), and γ-glutamyltransferase (γ-GT). The secondary end points were changes in lipid profile levels, including total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL). Compared with the baseline, AST and ALT levels decreased significantly in the ESE group compared to those in the placebo group (P<0.001). In addition, γ-GT levels in the ESE group were significantly lower than those in the placebo group (P=0.016). There were no differences in the TC, TG, HDL, and LDL levels between groups. In conclusion, ESE consumption for 12 weeks improved liver parameters in subjects with liver injury. Regular consumption of ESE could maintain liver health in individuals at risk of hepatic damage.

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

  • Ojin Kwon;Changsop Yang;Young Jin Kim;Won Hae Ku;Won Gu Lee;Ki Byung Kim;Kyung Hwan Jegal
    • Journal of Korean Medicine for Obesity Research
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    • v.22 no.2
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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.

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 (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)

  • Min-hwa Kim;Im-hak Cho;I-rang Nam;Maria Kim;Ki-beom Ku;Se-yeon Lee;Jung-nam Kwon;In Lee;Jin-woo Hong;Young-ju Yun;So-yeon Kim;Chang-woo Han;So-jung Park;Jun-yong Choi;Hyeun-kyoo Shin
    • The Journal of Internal Korean Medicine
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    • v.44 no.3
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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.

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

  • In Suh Choi;Won-Suk Sung;Min-gi Jo;Jung-Hyun Kim;Yeon-Cheol Park;Eun-Jung Kim;Yong-Hyeon Baek;Geun-Woo Kim;Byung-Kwan Seo
    • Journal of Convergence Korean Medicine
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    • v.3 no.1
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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.

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.

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

  • Hye-Sung Lee;Hyo-Jung Jung;Su-Ji Choi;Dong-Il Kim
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.4
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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.