• Title/Summary/Keyword: Oriental Medicine Clinical Trial

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뜸을 이용한 RCT임상연구의 경향에 대한 개괄 (Overview for pattern and results of moxibustion-derived clinical trials)

  • 손창규
    • Korean Journal of Acupuncture
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    • 제26권1호
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    • pp.41-49
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    • 2009
  • Objective : To make comprehensive picture of clinical trials using moxibustion and their results by today, then help a strategy for moxibustion-derived clinical studies in the future. Methods : Surveyed literatures containing randomized controled clinical trial (RCT) from PubMed and Korean journals. Analysis was performed according to distribution mainly by study subject, target diseases, study design, and its efficacy. Results : Fifty two literatures were selected according to inclusion criteria of randomized controled clinical study. Moxibustion-derived RCT have been rapidly increased from 2003 since the first was published in China in 1992. The main subjects of RCT are associated with immunity, cancer, arthritis, chronic colitis and urogenital disorders, which are connected to cold-elated pathogenesis. The average number of subjects was 94, and direct-moxibustion was mainly applied. The control groups were set up by giving conventional therapy, herbal medicine, acupuncture or only observation. The most of RCTs showed positive results. Conclusions : This study would be helpful for designing or conducting RCTs to develop the scientific development of moxibustion.

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고혈압 침 임상연구에서 환자의 기대치와 치료효과 간의 상관관계 (The Relationship between Patients' Expectations of Treatment Effect and Clinical Outcome in a Trial of Acupuncture for Hypertension)

  • 김준범;류연;김정은;박지은
    • Journal of Acupuncture Research
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    • 제33권4호
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    • pp.33-38
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    • 2016
  • Objectives : To identify potential correlation between patients' expectations and clinical outcome in a randomized control study of acupuncture. Methods : In a clinical trial of acupuncture for hypertension, 60 participants with pre and mild hypertension were randomized into an acupuncture group and a control group. After randomization, all participants were asked to rate their expectation for the intervention on a scale of 0 to 10. To analyze the effect of expectation on clinical outcome, change of blood pressure was compared between high and low expectation groups. Results : There was no significant difference of baseline blood pressure between low expectation group and high expectation group. Proportion of acupuncture group and control group was also not different between low and high expectation groups (p = 0.638). The change of systolic blood pressure was -1.55 mmHg in low expectation group and -3.07 mmHg in high expectation group, and it was not significantly different (p = 0.54). There was no significant difference in the change of diastolic blood pressure between two groups (p = 0.58), with -3.24 mmHg in low expectation group and -2.34 mmHg in high expectation group. Conclusion : In this study, the expectation of intervention (including acupuncture treatment) was not associated with the effect of intervention.

Acupuncture Treatment in Clinical Studies for Parkinson's Disease : A Literature Review

  • Sohn, Soo Ah;Lee, Kyoung Yun;Kim, Chang Wan;Lee, Yu Jin
    • Journal of Acupuncture Research
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    • 제35권4호
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    • pp.149-157
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    • 2018
  • Background: Parkinson's disease is the second most common degenerative brain disease after Alzheimer's disease. This study reviewed clinical practice of acupuncture and moxibustion treatment for Parkinson's disease to assess the future direction of these treatments. Methods: The literature search used 5 Korean Internet databases. The search terms were "Parkinson's disease." and "Parkinson (Korean)." 36 papers were selected: 27 case reports, 2 respropective studies, 3 uncontrolled clinical trials, 3 randomized controlled trial, 1 non-randomized controlled trial. Results: Filiform needles were used in most of studies. Pharmacopuncture, electro-acupuncture, and auricular acupuncture therapy were also used in combination with Filiform needles. 2. The most commonly used basic acupoints for Parkinson's disease was Saamchimbeop. The most commonly used form of pharmacopuncture involved Bee-venom. Conclusion: It is expected that treatment of Parkinson's disease with a variety of acupuncture and moxibustion therapies will continue to be studied, in addition to treatments that utilize existing Filiform needle treatments in clinical practice.

파킨슨병 변증 유형 및 지표 분포에 대한 전향적 다기관 관찰연구 프로토콜 (An Observational Multi-Center Study Protocol for Distribution of Pattern Identification and Clinical Index in Parkinson's Disease)

  • 조혜연;권오진;서복남;박성욱;유호룡;장정희
    • 대한한방내과학회지
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    • 제45권1호
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    • pp.1-10
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    • 2024
  • Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

국내 데이터 베이스 검색을 통한 오공 약침 시술에 대한 임상 논문고찰 (Narrative Review of Clinical Trial on Scolopendrid Pharmacopuncture in Korean Literature)

  • 조동찬;이진현;김창곤;정우석;문수정;박태용;이정한
    • 한방재활의학과학회지
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    • 제23권4호
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    • pp.73-82
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    • 2013
  • Objectives The purpose of this review is to investigate studies of Scolopendrid pharmacopuncture and the evidence of it's effects in order to suggest a better research method in the future. Methods We retrieved numbers of clinical studies about Scolopendrid pharmacopuncture from 7 Korean web databases, using key words such as 'Scolopendrid', 'Scolopendrid AND Pharmacopuncture'. This study had been conducted from 1st May 2013 to 31th July 2013. Controlled studies and case studies were only used for this study. Clinical studies that we picked from the databases were classified according to the diseases that those studies are about, and from these clinical studies, we are to research what has to be improved generally in clinical researches. Results 18 case studies, 4 controlled studies had been under research. Scolopendrid pharmacopuncture has a therapeutic effect mainly in musculoskeletal and neurological diseases such as herniated intervertebral disc, carpal tunnel syndrome, swollen leg, feeling of cold on legs, wrist ganglion, lateral epicondylitis, radial nerve palsy, cervical myelopathy, cauda equina syndrome, postauricular pain; as an early symptom of Bell's palsy, pain of popliteal part, gout, plantar fasciitis, cellulitis, frozen shoulder, pain of hip adductors. However objectivity and reliability of the Scolopendrid pharmacopuncture studies still remains controversial. Conclusions It has been suggested that there are positive effects of Scolopendrid pharmacopuncture therapy in treating specific diseases (especially neuromusculoskeletal diseases). However, this narrative review can't conclude and prove that the Scolopendrid pharmacopuncture has positive effectiveness on these diseases unlike systematic review. So, in order to put Scolopendrid pharmacopuncture therapy to use for many kinds of diseases in more reasonable ways, it is essential to build well-designed clinical research tools. In the future, abundant case studies, more follow-up trials and randomized controlled trials based on the korean medicine should be done to use Scolopendrid pharmacopuncture for a clinical purpose.

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)

여성 성기능장애 관련 최근 국내외 한의학 연구 동향에 대한 고찰 (A Review of Recent Oriental Medicine Studies on Female Sexual Dysfunction)

  • 최민선;김동일
    • 대한한방부인과학회지
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    • 제24권3호
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    • pp.171-189
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    • 2011
  • Objectives: Female Sexual Dysfuction(FSD) is a common gynecologic condition and its prevalence is more higher than men. Despite its high prevalence and clinical importance, research on FSD is not enough in both of oriental and western medicine. The purpose of this study is to review research tendency of recent oriental medicine studies on FSD and to suggest the following research on FSD. Methods: We searched oriental medicine papers related to FSD published in the last 10 years(2001-2011) through Korean Medicine Gynecology Society database, KISS, RISS, NDSL, CNKI(China National Knowledge Infrastructure), and Pubmed. Results: 26 papers were searched, then 18 papers of them were related to Traditional Chinese Medicine(TCM), 8 papers of them were related to Korean Medicine(KM). In classification according to paper type, 16 papers were clinical study, 1 paper was experimental study, 2 papers were bibliographic study, and 7 papers were the other study. Then 5 papers of clinical study was Randomized Controlled Trial(RCT). Conclusion: There was a lack of oriental medicine research on FSD. On the base of this study, so further research is needed. Especially, Clinical trials such as RCT have strong objective evidence power in the viewpoint of Evidence Based Medicine(EBM) are needed.

월경통의 보완대체의학적 치료에 관한 논문 연구 (Systematic Review on Complementary and Alternative Medicine for Dysmenorrhea)

  • 유성원;윤인환;김영은;이성근;이기상;조한백
    • 대한한방부인과학회지
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    • 제22권1호
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    • pp.279-302
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    • 2009
  • Purpose: The aim of this study was to review systemically clinical trials on the trends of studies for Complementary Alternative Medicine in the treatment of dysmenorrhea. Methods: Through medical websites, foreign clinical literatures about complementary and alternative medicines of dysmenorrhea were searched. And domestic clinical literatures about dysmenorrhea, complementary and alternative treatment and oriental medicine treatment were searched using internet websites or hand-searching in National digital library, National assembly library, KISS, RISS. And then they were assessed by the assessment standard of Jadad scale and Classifying Recommendations. Results: 1. 15 foreign literatures and 36 domestic literatures were selected. 2. 4 foreign and 4 domestic clinical literatures were enough to satisfy over 2 points in Jadad score and recommendation level in Classifying Recommendations. 3. Some clinical trials were rated low in Jadad score since it was not easy to set control groups and keep blinding in clinical trials. 4. Some clinical trials were rated low in Classifying Recommendations since they did not carry out enough study about stability, side effect and follow-ups. Conclusion: To put clinical trials to practical use of Complementary Alternative Medicine in the treatment of dysmenorrhea, scientific and objective-based studies should be needed.

약침제제(藥鍼製劑)의 안전성(安全性)을 위한 임상시험방법(臨床試驗方法)에 대한 연구(硏究) (A Study of clinical trial method for safety of herb-acupuncture)

  • 전금선;남상수;이재동;최도영;안병철;박동석;이윤호;최용태
    • Journal of Acupuncture Research
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    • 제15권2호
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    • pp.183-198
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    • 1998
  • This study was done in order to present clinical trial method for safety of herb-acupuncture. The results were summerized as follow: In case of western medicine, clinical trial divides into four phase 1. Phase I: Investigate safety and drug movement for health people. 2. The first phase II: Investigate safety, effectiveness for the limited patient. The late phase II: Investigate propriety of an applicable disease, the way to use and dose. 3. Phase III: Through the comparative, public trial, investigate a final, applicable disease and side effect. 4. Phase IV: After NDA, investigate safety and effectiveness for the wide patients. In case of herb-acupuncture, we have to investigate the following for safety and effectiveness 1. Drug dose: Decide with 1/2 or 1/3 of oral dosage or a basis of animal's of maximum dosage or a ratio of man and animal. 2. Toxicity: Examine blood, urine, liver function, EKG, after herb-acupuncture during acertain period of time. 3. Regional response: Estimate response of swelling, redness, pruritus. etc 4. Treatment effectiveness: After exactly diagnosis, estimate effectiveness with a objective guide post.

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치매의 한약물 치료에 대한 체계적 임상논문 고찰 - 국내문헌을 중심으로 - (A Systematic Review of Clinical Studies for Herbal Medicine of Dementia - based on Korean Literature -)

  • 권용주;조혜영;황의완;조성훈
    • 동의신경정신과학회지
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    • 제21권4호
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    • pp.151-161
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    • 2010
  • Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.