• 제목/요약/키워드: Adverse Event

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A Clinical Trial to Assess the Efficacy of Acupuncture on Hot Flashes in Postmenopausal Women;Focusing on the comparison of the effects of Traditional Korean medical acupuncture (TKMA) and Minimal Acupuncture (MA)

  • Kim, Dong-Il;Roh, Jin-Ju;Choi, Min-Sun;Lee, Seung-Deok;Roh, Ju-Won;Yoon, Sang-Ho;Ahn, Hong-Yup;Oh, Dal-Seok;Choi, Sun-Mi
    • 대한한의학회지
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    • 제28권4호
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    • pp.74-85
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    • 2007
  • Objective : In this study we wanted to confirm if proper stimulation and de-Qi of traditional Korean medical acupuncture could increase hot flash relief efficacy. Design : A randomized controlled, single blind study. We used two modalities of acupuncture, one with optimal stimulation [Study group; Korean medical acupuncture (TKMA)] and one with minimal stimulation [Control group; Minimal acupuncture (MA)]. Same acupoints [PC6(內關), HT8(少府), HT7(神門), LI4(合谷), ST36(足三里), SP6(三陰交), Ren4(關元)] were used in both groups. Fifty-two patients were treated twice a week for 8 weeks, and follow up was done after 4 weeks from the last treatment. Patients were checked hot flash VAS (visual analog scale), frequency and duration every time they visited. Results : Hot flash relief efficacy by 100mm hot flash VAS was obvious in both groups. Hot flash VAS scores of study group were smaller than the scores of control group at the early stage (3rd, $4^{th}$ and $8^{th}$ visit), but there wasn't a remarkable difference between study and control group at the end of the trial. Besides, diminution of hot flash VAS was faster and more even in the study group than control group by visualization using 'Box plot'. We compared frequency and duration of hot flash, 100mm sweating, palpitation, sleep disturbance VAS, and Kupperman Index, MENQOL, Patient's global assessment score. Both groups showed definite decrease from the baseline, but the difference was not statistically significant. There wasn't any adverse event. Hot flash relief efficacy was kept in most patients after 4 weeks' follow-up. Conclusion : Acupoint combination by Traditional Korean medical theory is effective on hot flashes and hot flash relief efficacy was faster and more even in optimal stimulation than minimal stimulation.

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Efficacy and Safety of Miniscalpel Acupuncture on Knee Osteoarthritis - A randomized controlled pilot trial -

  • Jun, Seungah;Lee, Jung Hee;Gong, Han Mi;Choi, Seong Hun;Bo, Min Hwang;Kang, Mi Suk;Lee, Geon-Mok;Lee, Hyun-Jong;Kim, Jae Soo
    • 대한약침학회지
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    • 제21권3호
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    • pp.151-158
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    • 2018
  • Objectives: We investigated the efficacy and safety of miniscalpel acupuncture (MA) for knee osteoarthritis (KOA) in an assessor-blinded randomized controlled pilot trial; this would provide information for a large-scale randomized controlled trial. Methods: Participants (n = 24) were recruited and randomly allocated to the MA group (experimental) or acupuncture group (control). The MA group received treatment once a week for 3 weeks (total of 3 treatments), while the acupuncture group received treatment two times per week for 3 weeks (total of 6 treatments). The primary outcome was pain as assessed by a visual analogue scale (VAS). The secondary outcomes (intensity of current pain, stiffness, and physical function) were assessed using the short-form McGill Pain Questionnaire (SF-MPQ) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Assessments were performed at baseline, 1, 2, and 3 during treatment and at week 5 (2 weeks after the end of treatment). Results: Of the 24 participants, 23 completed the study. Both groups showed significant improvements in VAS, SF-MPQ, and WOMAC. However, there were no significant differences between the MA and acupuncture groups. No serious adverse event occurred and blood test results were within normal limits. Conclusion: Our results suggest that although both MA and acupuncture provide similar effects with regard to pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to further clarify these findings.

The Ratio of Descending Aortic Enhancement to Main Pulmonary Artery Enhancement Measured on Pulmonary CT Angiography as a Finding to Predict Poor Outcome in Patients with Massive or Submassive Pulmonary Embolism

  • Park, Chi-Young;Yoo, Seung-Min;Rho, Ji-Young;Ji, Young-Geon;Lee, Hwa-Yeon
    • Tuberculosis and Respiratory Diseases
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    • 제72권4호
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    • pp.352-359
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    • 2012
  • Background: The purpose of this study was to evaluate whether measuring the ratio of descending aortic enhancement (DAE) to main pulmonary artery enhancement (MPAE) on pulmonary computed tomography angiography (PCTA) can predict poor outcome in patients with acute massive or submassive pulmonary embolism (PE). Methods: We retrospectively, reviewed computed tomgraphy findings and charts of 37 patients with acute PE and right ventricular dysfunction. We divided the enrolled patients into 3 groups; group Ia (n=8), comprised of patients with major adverse event (MAE); group Ib (n=5), consisted of those with PE-related MAE; and group II (n=29), those without MAE. We analyzed the right ventricular diameter (RVD)/left ventricular diameter (LVD) and DAE/MPAE on PCTA. Results: For observer 1, RVD/LVD in group Ia ($1.9{\pm}0.36$ vs. $1.44{\pm}0.38$, p=0.009) and group Ib ($1.87{\pm}0.37$ vs. $1.44{\pm}0.38$, p=0.044) were significantly higher than that of group II. For observer 2, RVD/LVD in group Ia ($1.71{\pm}0.18$ vs. $1.41{\pm}0.47$, p=0.027) was significantly greater than that of group II, but RVD/LVD of group Ib was not ($1.68{\pm}0.2$ vs. $1.41{\pm}0.47$, p=0.093). For both observers, there was a significant difference of DAE/MPAE between group Ib and group II ($0.32{\pm}0.15$ vs. $0.64{\pm}0.24$, p=0.005; $0.34{\pm}0.16$ vs. $0.64{\pm}0.22$, p=0.004), but no significant difference of DAE/MPAE between group Ia and group II ($0.51{\pm}0.3$ vs. $0.64{\pm}0.24$, p=0.268; $0.53{\pm}0.29$ vs. $0.64{\pm}0.22$, p=0.302). Intra-class correlation coefficient (ICC) for the measurement of DAE/MPAE (ICC=0.97) was higher than that of RVD/LVD (ICC=0.74). Conclusion: DAE/MPAE measured on PCTA may predict PE-related poor outcomes in patients with massive or submassive PE with an excellent inter-observer agreement.

Effect of a Proton Pump Inhibitor on Tumor Bleeding Prevention in Unresectable Gastric Cancer Patients: a Double-Blind, Randomized, Placebo-Controlled Trial

  • Kim, Young-Il;Kim, Mi-Jung;Park, Sook Ryun;Kim, Hark Kyun;Cho, Soo-Jeong;Lee, Jong Yeul;Kim, Chan Gyoo;Kim, Gwang Ha;Park, Moo In;Nam, Byung-Ho;Park, Young Iee;Choi, Il Ju
    • Journal of Gastric Cancer
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    • 제17권2호
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    • pp.120-131
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    • 2017
  • Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).

만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구 (Efficacy and Safety of Miniscalpel Acupuncture, Non-Steroidal Anti-Inflammatory Drugs or Combined Treatment for Chronic Neck Pain: An Assessor-Blinded Randomized Controlled Pilot Study)

  • 공한미;전승아;정연중;김주란;이정희;이현종;박정아;김재수
    • Korean Journal of Acupuncture
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    • 제37권1호
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    • pp.14-23
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    • 2020
  • Objectives : We investigated the efficacy and safety of miniscalpel acupuncture (MA) treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain (CNP) in an assessor-blinded randomized controlled pilot trial to establish a basis for larger-scale randomized controlled studies on this subject. Methods : Participants (n=36) were recruited and randomly allocated to the MA group, NSAIDs and combined treatment group. The MA group received MA three times over three weeks. The NSAIDs group was administered orally with zaltoprofen 80mg t.i.d. over three weeks. The combined treatment group received MA and zaltoprofen in the same manner as MA and NSAIDs groups. The primary outcome was pain as assessed by a visual analogue scale (VAS) and the secondary outcomes were assessed using the Neck Disability index (NDI), EuroQol 5-dimension questionnaire (EQ-5D), and Patients' Global Impression of Change scale (PGIC). Assessments were made at week 0 (baseline), 1, 2, 3 (primary end point) during treatment and at week 7 (4 weeks after the end of treatment). Results : 35 participants completed the study. No serious adverse event occurred and blood test results were within normal limits. The improvement of VAS and NDI was significantly greater in combined and MA group than that in NSAIDs group (p<0.017). The combined group showed better outcomes in EQ-5D at visit 2 and 5, in PGIC at visit 4 than the NSAIDs group (p<0.017). No significant differences were found between combined and MA group. Conclusions : Our results suggest that both combined and MA group can be more effective in improving pain control than NSAIDs group. A large-scale clinical study is warranted to further clarify these findings.

Prognostic impact of chromogranin A in patients with acute heart failure

  • Kim, Hong Nyun;Yang, Dong Heon;Park, Bo Eun;Park, Yoon Jung;Kim, Hyeon Jeong;Jang, Se Yong;Bae, Myung Hwan;Lee, Jang Hoon;Park, Hun Sik;Cho, Yongkeun;Chae, Shung Chull
    • Journal of Yeungnam Medical Science
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    • 제38권4호
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    • pp.337-343
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    • 2021
  • Background: Chromogranin A (CgA) levels have been reported to predict mortality in patients with heart failure. However, information on the prognostic value and clinical availability of CgA is limited. We compared the prognostic value of CgA to that of previously proven natriuretic peptide biomarkers in patients with acute heart failure. Methods: We retrospectively evaluated 272 patients (mean age, 68.5±15.6 years; 62.9% male) who underwent CgA test in the acute stage of heart failure hospitalization between June 2017 and June 2018. The median follow-up period was 348 days. Prognosis was assessed using the composite events of 1-year death and heart failure hospitalization. Results: In-hospital mortality rate during index admission was 7.0% (n=19). During the 1-year follow-up, a composite event rate was observed in 12.1% (n=33) of the patients. The areas under the receiver-operating characteristic curves for predicting 1-year adverse events were 0.737 and 0.697 for N-terminal pro-B-type natriuretic peptide (NT-proBNP) and CgA, respectively. During follow-up, patients with high CgA levels (>158 pmol/L) had worse outcomes than those with low CgA levels (≤158 pmol/L) (85.2% vs. 58.6%, p<0.001). When stratifying the patients into four subgroups based on CgA and NT-proBNP levels, patients with high NT-proBNP and high CgA had the worst outcome. CgA had an incremental prognostic value when added to the combination of NT-proBNP and clinically relevant risk factors. Conclusion: The prognostic power of CgA was comparable to that of NT-proBNP in patients with acute heart failure. The combination of CgA and NT-proBNP can improve prognosis prediction in these patients.

외상후 스트레스장애 치료에 대한 한의학 임상연구 동향 (A Review on Clinical Research Trends in the Treatment of Post Traumatic Stress Disorder (PTSD) in Korean Medicine)

  • 주성준;권정은;권찬영;이보람;김상호
    • 동의신경정신과학회지
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    • 제30권3호
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    • pp.251-263
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    • 2019
  • Objectives: The purpose of this study was to review the clinical research trends in the treatment of post traumatic stress disorder (PTSD) in Korean medicine (KM). Methods: We searched MEDLINE, CENTRAL, EMBASE, Google Scholar and five Korean databases through May 2019, for studies on KM to treat PTSD. Clinical research that conducted KM treatment of PTSD patients were included. Two researchers independently conducted study selection and data extraction process. Results: Totally, eight studies were included in this review. Types of traumatic events that patients experienced included physical violence/threatening, traffic accidents, sexual violence and personal tragic events. KM interventions performed included acupuncture, moxibustion, herbal medicine, physical therapy, and KM-based psychotherapy. Treatment duration varied from two days to more than five months. Follow-up began at least one week to three months after the end of treatments. It was reported that the major psychological and/or somatic symptoms of PTSD, such as anxiety, depression, insomnia, and musculoskeletal pain, subjectively improved, as well as other objective outcomes: Impact Event Scale-Revised Korean version (IES-R-K), Beck's Depression Inventory (BDI), State-Trait Anxiety Inventory, Hwabyung Symptoms/characters, Electroencephalography (EEG) change, etc. Statistical studies were conducted in three studies only. Outcomes such as Visual Analogue Scale (VAS), BDI, and IES-R-K showed statistically significant improvement after KM treatments. There was no study reporting adverse events during or after the interventions. Conclusions: According to this review, diverse types of KM treatments have been used among PTSD patients in eight studies. The KM treatments effectively improved psychological and somatic symptoms of PTSD patients. However, the lack of high quality research as well as the lack of standardization of KM treatments for PTSD are limitations. Further methodologically robust clinical trials should be performed, and the standardization of KM treatments for PTSD should be sought.

의료기기 안전성 정보 모니터링에 대한 한병병원 및 병원 종사자의 인지도 조사연구 (A Study on the Cognizance of Hospital and oriental Hospital Workers for Medical Device Safety Information Monitoring)

  • 김지현;남기창;김호준;남연교;김유진;조은혜;권범선
    • 대한의용생체공학회:의공학회지
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    • 제42권3호
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    • pp.86-93
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    • 2021
  • Purpose: The purpose of this study is to find out the cognizance of medical device safety information (MDSI) monitoring in the hospital and oriental hospital workers, and the different aspect of MDSI between oriental medical devices and medical devices. Methods: The survey was performed both in the oriental medicine hospital and general hospital. The survey had 16 items; 2 items basic questions, 5 items in the awareness of MDSI, 5 items in the education of MDSI, 4 items in the necessity of defining oriental medical devices and differences between general and oriental medical devices. A total of 120 hospital worker were participated; 60 oriental medicine hospital workers and 60 general hospital workers. They had worked in the oriental medicine or general hospital associated with 'Medical Device Safety Monitoring Center, Dongguk University Ilsan Hospital' in 2019 and 2020. Results: The cognizance of MDSI was high both in oriental medicine hospital and general hospital workers and there were no significant differences between oriental medicine and general hospital workers. When we divided the hospital workers into the senior workers who had worked for over 3 years and junior workers for less than 3 years, the senior workers had higher awareness of MDSI than junior workers. However, the cognizance of education of MDSI was high which was not different between senior and junior workers. Both hospital workers thought that it was necessary to define oriental medicine device legally and the oriental medical device might have low risk and less side effect than medical device. Conclusion: The cognizance of MDSI was high and there was no significant differences between oriental medicine and general hospital workers. Because the senior hospital workers had higher recognition of MDSI, we need to provide the continuous education program for junior hospital workers. Although oriental medical device are thought to be safer than medical device, we need to have a legal definition.

Effect of Hominis Placenta Pharmacopuncture for a Patient with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial

  • Kim, Yunna;Eom, Yoon Ji;Kwon, Dohyung;Lee, Jae Hyok;Jung, In Chul;Cho, Eun;Lee, Ji Eun;Cho, Seung-Hun
    • 동의신경정신과학회지
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    • 제32권2호
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    • pp.81-93
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    • 2021
  • Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

한방 치료로 고안드로겐혈증을 개선한 다낭성 난소 증후군 연속증례연구 (A Case Series of Polycystic Ovary Syndrome with Improved Hyperandrogenism Treated with Korean Medicine)

  • 신혜규;배지용;지영근;안해인;윤영흠;김남권
    • 대한한방부인과학회지
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    • 제34권3호
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    • pp.175-191
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    • 2021
  • Objectives: This study aims to analyze the medical record of eight cases of polycystic ovary syndrome (PCOS) in a local Korean medicine clinic, in order to provide evidence on Korean medicine treatment of PCOS and to suggest the direction of future studies. Methods: The medical records of eight cases diagnosed with PCOS based on 2003 Rotterdam Criteria and whose total testosterone level was 0.53 ng/ml and over were retrospectively analyzed. The primary outcome was total testosterone level, and the secondary outcomes included luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels, LH/FSH ratio, weight, last mentrual period (LMP), numerical rating scale (NRS) score of dysmenorrhea, and other associated symptoms pre- and post-treatment. Korean medicine treatment consists of the complex herbal prescription consisting of Yukmijihwang-tang, Baekho-tang, Daesiho-tang, and Gyejibokryeong-hwan, modified according to symptoms; acupuncture and electroacupuncture on 中脘 (CV12), 下脘 (CV10), 關元 (CV4), 石門 (CV5), 合谷 (LI4), 太衝 (LR3), 三陰交 (SP6), and 懸鍾 (GB39); and indirect moxibustion on 神闕 (CV8). Results: The average total testosterone level lowered statistically significantly after the treatment. The average FSH and LH levels lowered with insignificance, while the average LH/FSH ratio and weight lowered statistically significantly. During the treatment period of three to six months, every patient had the menstrual cycle shortened except for one case; and two cases with infertility problem succeeded in being pregnant. There was no adverse event. Conclusions: The Korean medicine treatment was found effective in treating PCOS, especially regarding hyperandrogenism, amenorrhea or oligomenorrhea, and infertility.