• 대한한의학회지
• /
• 제26권2호
• /
• pp.95-104
• /
• 2005

Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

• 한국임상약학회지
• /
• 제8권1호
• /
• pp.1-12
• /
• 1998

Rheumatoid arthritis (RA) is a common systemic inflammatory disease which DMARDS have been widely used as a treatment modality both as monotherapy and combination therapy Bucillamine, one of newer DMARDS, has recently proven its efficacy as monotherapy in the treatment of RA. The objective of this study was to compare the efficacy and the safety of bucillamine monotherapy and bucillamine plus methotrexate combination therapy in the treatment of rheumatoid arthritis. Forty-nine mild RA patients were enrolled in this prospective, open-trial and were assigned to receive bucillamine 200 mg/day (n=18) or bucillamine 200 mg/day and methotrexate 7.5-15 mg/week (n=31) orally for 16 weeks. Concomitant use of NSAID and prednisolone <5 mg/day or equivalent dose of steroid were allowed. Both monotherapy group and combination therapy group have shown significant improvement in disease activities (Ritchie index, painful joints, swollen joints, morning stiffness, grip strength, ESR, RF, CRP, patient's self assessment of pain, physician's global assessment of disease activity) from the baseline. However, there was no statistically significant difference between two groups. The adverse effects were more frequently shown in combination therapy group than monotherapy group. In conclusion, in patients with mild RA monotherapy has shown to be equally efficacious as combination therapy with less side effects.

• 대한한의학회지
• /
• 제40권2호
• /
• pp.119-132
• /
• 2019

Purpose: This study was conducted to collect and analyze real world data to evaluate the effectiveness and safety of comprehensive traditional Korean Medicine treatment on quality of life, anorexia and cachexia of cancer patients. Methods: We analyzed medical records of 62 cancer patients admitted to O-I Dang Korean Medicine Hospital from February 2018 to February 2019. The primary outcome was a change score in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes were Functional Assessment of Cancer Therapy-General (FACT-G), Trial Outcome Index(TOI) of FAACT, 11 point Pain Intensity Numeric Rating Score (11 PI-NRS) and Patient Global Impression of Change (PGIC) and adverse event. Results: Cachexia and quality of life in cancer patients assessed by FAACT, increased by $5.59{\pm}14.83$ (p=0.004) after treatment. PI-NRS was reduced by $2.10{\pm}1.81$ (p<0.001) and TOI and FACT-G total scores were increased by $5.17{\pm}11.70$ (p=0.001) and $3.59{\pm}10.94$ (p=0.012), respectively. These results were also clinically meaningful assessed via minimal clinically important difference (MCID). There was no severe adverse event. Conclusion: These findings suggest that comprehensive traditional Korean Medicine treatment might be effective and safe strategy for improving quality of life, anorexia, cachexia and pain of cancer patients. Further advanced studies with controlled group and more participants with rigorous design are needed to ensure these findings.

• Yonsei Medical Journal
• /
• 제59권9호
• /
• pp.1107-1114
• /
• 2018

Purpose: This study investigated the effectiveness of meaning-centered psychotherapy (MCP), which is known to be a helpful psychotherapeutic intervention in distressing conditions, for patients with pancreatobiliary cancer. Materials and Methods: We recruited 37 patients with pancreatobiliary cancer from three university general hospitals and assessed their psychological characteristics. Patients who reported clinically significant emotional distress were recommended to undergo MCP. Patients who consented to MCP were provided four sessions of the therapy. Patient psychological characteristics were assessed again 2 months after MCP. For statistical comparison, outcome variables included anxiety, depression, mental adjustment to cancer, and quality of life (QoL), as well as the degree of stress and physical symptoms. Results: Sixteen patients completed the MCP and the final assessment 2 months later. In the initial assessment, the patients receiving MCP showed higher levels of anxiety and depression than those not receiving MCP, and QoL was also lower in terms of role function, emotional function, social function, and global QoL. At the 2-month follow-up, the MCP group showed a significant improvement in anxiety (p=0.007), depression (p=0.010), and anxious preoccupation (p<0.001). In addition, QoL significantly improved in the MCP group, while there was no significant change in the non-MCP group. Conclusion: In this study, MCP showed potential therapeutic benefits against emotional distress in patients with pancreatobiliary cancer, improving their QoL.

• 한국산학기술학회논문지
• /
• 제12권1호
• /
• pp.318-326
• /
• 2011

본 연구는 절차기술의 객관구조화 진료시험(Objective Structured Clinical Examination)에서 표준화환자가 평가자의 역할을 수행할 수 있는지 알아보기 위해 신뢰도를 평가하는데 그 목적이 있다. 시험의 주제는 남성 도뇨관삽관과 창상드레싱 2가지로 정하고, 2년 이상의 객관구조화 진료시험 채점 경력이 있는 표준화환자와 교수 각 4명을 2명씩 짝을 지워 한 주제 당 표준화환자 그룹과 교수 그룹이 동시에 채점하게 하였다. 표준화환자들에게는 술기의 정의, 방법, 주의점, 후유증에 대한 교육이 이루어졌으며 동영상이 포함된 강의, 교수의 시연 후 표준화환자가 직접 실습해보고 교수로부터 되먹임을 받는 순서로 총 8시간( 주제당 4시간)의 교육이 시행되었다. 8명의 평가자 모두 객관구조화 진료시험 전날 모여 기존의 동영상자료를 이용한 가상 채점으로 1시간동안 채점 표준화를 이루었다. 채점표는 체크리스트 14문항과 총괄평가 1문항으로 이루어졌다. 한 학생당, 주제당 5분간의 시험 후 2분간의 평가가 이루어졌다. 표준화환자와 교수간의 분석은 GENOVA program을 이용하였다. 연구 결과 주제 전체에서 G상수는 0.839, 평가자의 신뢰도는 0.946으로 매우 높았다. 표준화환자그룹과 교수그룹 사이의 평가자간 일치도는 체크리스트에서 0.949, 총괄평가에서 0.908이었다. 따라서 적절한 교육이 선행되어진다면 표준화환자도 절차기술의 객관화진료시험에 신뢰할 만한 평가자로 이용되어질 수 있을 것이다.

• 대한한방내과학회지
• /
• 제41권6호
• /
• pp.1255-1264
• /
• 2020

Objective: The purpose of this study was to report the effect of Korean medicine on a patient with non-small cell lung cancer with pleural metastasis who had been treated with afatinib. Method: A 61-year old female patient with non-small cell lung cancer with pleural metastasis was treated with acupuncture and herbal medicines, including Yijung-tang, Haengso-tang, Samchulkunbi-tang, Paeamju-bang (Feiai zhu fang), to control various symptoms caused by afatinib. The degree of pain was assessed by a numeric rating scale (NRS) and the quality of life was determined with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) and the EORTC 13-item lung cancer-specific module (EORTC LC-13). Results: After receiving acupuncture and herbal medicines, the patient showed improvement in her back and chest pain, according to the NRS score. Similarly, the Korean medicinal treatments significantly relieved her nausea, vomiting, diarrhea, hemoptysis, and alopecia. However, the EORTC QLQ-C30 assessment suggested that Korean medicinal treatments did not significantly improve the global health status of this patient. Conclusion: Korean medicine could be useful in relieving some of the symptoms occurring after conventional afatinib treatments.

• 대한한방내과학회지
• /
• 제30권1호
• /
• pp.144-152
• /
• 2009

Background : Ephedra (Ephedra sinica) has been widely used to treat respiratory disease in traditional medicine of East Asia for over a hundred years. Despite safety concerns raised by some, the use of ephedra in traditional medicine is documented over more than 1,800 years. It is well established that ephedra is one of the central medicines in Korean 'Seseng constitution' medicine. In Sasang constitution medicine, all humans can be divided into one of four types: Soeumin, Soyangin, Taeumin or Taeyangin, and each constitution type has their own typical characteristics. Accordingly, it is hypothesized that the adverse effects of ephedra differ depending on the Sasang constitution classification. Objectives : The aim of this study was to determine adverse effects of ephedra which is classified as a Taeumin herb, and to observe whether the response differs or not. according to Sasang constitution classification. Methods : The study design was a double-blind randomized controlled trial. The subjects were healthy adults 20 - 50 years old who agreed to participate in this study. They were allocated through randomization to either ephedra group (N=55) or placebo group (N=24). where ephedra extract (6 g of dried ephedra) and placebo with similar opaque capsules were given twice for one day. To compare the adverse events of ephedra according to Sasang constitution classification, we analyzed blood pressure (systolic and diastolic), pulse rate, the morning questionnaire, and patient's global assessment scale score for well known adverse events: palpitation, headache, sweating, tiredness, dyspepsia, and dry mouth. Results : After ingestion of ephedra, the pulse rate had a significant increase in all constitution types. The changes of diastolic pressure in Soeumin and the changes of pulse rate in Soeumin, Soyangin and Taeumin had a significant increase in the ephedra over the control group. In the ephedra group, the palpitation and dyspepsia score of the patients' global assessment scale had a significant increase in Soeumin, with palpitation and sweating score increasing in Soyangin. Others observations were insignificant results. Conclusion : The results of this study may confirm that the physical responses or adverse effects of herbs differ for each type of Sasang constitution. Future studies using other herbs will be required to ascertain the herbal drug reaction of Sasang constitutions.

• 대한한방내과학회지
• /
• 제37권5호
• /
• pp.796-805
• /
• 2016

Objective: To examine the effects of Gagam-Samryoungbeakchul-san (加減 蔘苓白朮散) on a premature ventricular contraction patient with dizziness and chest discomfort. Methods: A patient diagnosed with premature ventricular contraction was treated with herbal medicine and acupuncture. The period of admission was 15 days, and we measured the electrocardiogram before and after treatment. We evaluated the improvement in symptoms by Global Assessment (G/A), and checked the pulse rate by oximetry three times a day. We estimated the efficacy of treatment by analyzing the relationship between the average pulse rate and symptoms. Results: After Gagam-Samryoungbeakchul-san treatment and acupuncture therapy, the average pulse rate increased from 36.5 to 58. This increase in average pulse rate was accompanied by a reduction in dizziness of 40%, chest discomfort of 30%, and frequency of bigeminy in the electrocardiogram. Conclusions: This case report confirmed the effectiveness of Gagam-Samryoungbeakchul-san on premature ventricular contraction, but further study is warranted.

• 대한한방내과학회지
• /
• 제39권6호
• /
• pp.1306-1312
• /
• 2018

Objectives: This study presented the case of a 49-year-old Korean female with phantom limb pain after below right knee amputation and aimed to assess the effectiveness of Korean medicine treatment. Methods: The patient was treated with scalp acupuncture, electroacupuncture and herbal medicine. We executed a numerical rating scale (NRS), conducted a global assessment (G/A), administrated a Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) and measured total daily sleep time to evaluate symptom improvement. Results: The patient's G/A scores decreased from 10 to 2 and SF-MPQ-2 points decreased from 20 to 6 after treatment. The total daily sleep time did not changed due to anxiety. Conclusions: This study suggests that Korean medicine treatment could be effective in treating phantom limb pain after amputation. Further studies are needed.

• 대한중풍순환신경학회지
• /
• 제16권1호
• /
• pp.25-34
• /
• 2015

■ Objectives The purpose of this case report is to show the effect of korean medicine on a progressive supranuclear palsy patient with gait disturbance and dizziness. ■ Methods A patient with gait disturbance and dizziness diagnosed as progressive supranuclear palsy was treated with herbal medicine, acupuncture, electro-acupuncture, moxibustion. The period of admission is 16 days and we evauated the improvements of symptoms by the Unified Parkinson's Disease Rating Scale(UPDRS), Numeric Rating Scale(NRS) and Global Assessment(G/A). ■ Results After taking Modified Bosimhwan andbeing treated by acupuncture therapy, improvements of gait disturbance and dizziness are observed. ■ Conclusion This case report proved the effect of Korean medicine on progressive supranuclear palsy.