• Title/Summary/Keyword: randomized comparative trial

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The effect of acupuncture on hot flushes : A study protocol of multi-center randomized controlled clinical trial (갱년기 여성의 안면홍조에 대한 침치료 다기관 임상시험 : 프로토콜)

  • Park, Ji-Eun;Oh, Dal-Seok;Kang, Kyung-Won;Kim, Dong-Il;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.24 no.3
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    • pp.33-45
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    • 2007
  • Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

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Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Atopic Dermatitis (아토피 피부염의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구)

  • Gwon, Ji-Yae;Seon, Ji-Hye;Yun, Hwa-Jeong;Kim, Nam-Kwen
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.30 no.1
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    • pp.17-28
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    • 2017
  • Objectives : The aim of this study is reviewing the literature to extracting the key parameter and finding the calibration parameter for the clinical study with economical assessment protocol on atopic dermatitis. Methods : Literature search is performed using PUBMED for literature published from Janurary 2000 to December 2016. We included randomized controlled trials(RCTs) with economic assessment in which human participants. Results : Among the articles published from January 2000 to December 2016, The 1464 articles were found. After reviewing the title, abstract and full text, the five articles were selected. Selected articles are classified 3 CEA(cost effective analysis)study, 1 CMA(cost minimizing analysis)study and 1 cost analysis study. Conclusions : We found highly reliable key parameters and calibration parameters, which might be necessary factors for developing research protocol of economic evaluation alongside clinical trial about atopic dermatitis patients.

A Comparative study of Warm needling and Bee Venom Pharmacopuncture on Osteoarthritis of the Knee - a Randomized Controlled Trial - (퇴행성슬관절염에 대한 봉약침과 온침효과 비교)

  • Yang, Ka-Ram;Song, Ho-Sueb
    • Journal of Pharmacopuncture
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    • v.11 no.2
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    • pp.21-31
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    • 2008
  • Objective This study was performed to investigate whether Bee Venom Pharmacopuncture(BVP) could be a more effective modality than Warm Needling(WN) in relieving pain and symptoms of knee osteoarthritis(OA). Design Prospective, randomized and controlled clinical trial. Setting Single center trial in Korea Patients 49 volunteers with knee OA participated in the study. All the participants were screened through an inclusion and exclusion criteria. 33 participants were completed the clinical trial. Intervention The subjects were randomly assigned to one of two groups. One group received BVP(n=18), while the other group received WN(n=15). Sixteen sessions of BVP or WN were given at the pain region of the problematic knee for 8 weeks. Primary outcome measure is the Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index scores(Korean WOMAC, KWOMAC). Secondary outcome measure is the physical health scores based on the 36-Item Short-Form Health Survey(SF-36) and Patient Global Assessment(PGA). KWOMAC and SF-36 were measured third (baseline, 4 and 8 weeks). PGA was measured twice(4 and 8 weeks). Results BVP group showed significant decrease compared to WN group in pain, function and total scores of KWOMAC according to the Mann-Whitney U-test. In the PGA, BVP group, compared to WN group, showed a significant increase. Conclusions BVP was more effective in relieving pain of knee OA than WN. These findings suggest that BVP is a promising alternative for treating knee OA.

The effects of Sa-am Acupuncture Simpojeongkyeok Treatment on Hwa-byung : Randomized, patient-assessor blind, placebo-controlled acupuncture, pilot clinical trial (화병에 대한 사암침 심포정격의 치료 효과 : 환자-평가자 눈가림, 무작위배정 대조군 임상시험)

  • Choi, Woo-Jin;Lee, Seung-Gi;Son, In-Bong;Sun, Seung-Ho
    • Journal of Oriental Neuropsychiatry
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    • v.22 no.2
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    • pp.1-13
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    • 2011
  • Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.

The Effects of Acupuncture Treatment on Hwa-byung patient's Insomnia: Patient-assessor blind, Randomized, Placebo-controlled Clinical trial (화병환자의 불면증상에 대한 침치료 유효성 평가연구: 환자-평가자 눈가림, 무작위배정, 일반대조군 임상시험)

  • Lee, Go-Eun;Kim, Nam-Kwon;Kim, Hang-Yi;Kang, Hyung-Won
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.1
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    • pp.31-48
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    • 2012
  • Objectives: The purpose of this research is to examine the effects of acupuncture treatment on Hwa-byung patient's insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors and analysts were unaware of individuals who were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. 18 subjects were placed into a trial group and 19 subjects into a control group by a randomization table. The trial group was treated on bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI(Insomnia Severity Scale) was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by a Likert scale for major symptoms of Hwa-byung, PSQI, Hwa-byung scale, BDI, STAI, and STAXI. Results: In the ISI, PSQI, and the Likert scale regarding major symptoms of Hwa-byung, Hwa-byung scale, BDI, and STAI, more significant decreases were found in those concerning the trial group compared to those of the control group from a statistical perspective. However, in the STAXI, regarding the trial group, there was no significant decrease compared to the control group. Conclusions: The results suggest that acupuncture treatment is effective in the treatment regarding Hwa-byung patients who suffer from insomnia.

A Comparative Clinical Study on an Electronic Moxibustion with Acupuncture for Dry Eye Syndrome (건성안 증후군에 대한 전자뜸과 침의 효과 비교 임상연구)

  • Ji-Shik Park;Ji-Hoon Song;Min-Yeong Jung;Jung-Hwa Choi;Soo-Yeon Park
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.1
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    • pp.64-77
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    • 2023
  • Objectives : Recently, the number of patients with dry eye syndrome has been steadily increasing. However, established treatment for it does not yet exist. This study compared electronic moxibustion with acupuncture for patients with dry eye in terms of efficacy and safety. Methods : This trial was designed as an investigator-initiated, single-blinded, comparative, randomized controlled trial. Thirty patients with dry eye were randomized to the electronic moxibustion treatment group(EMG) or the acupuncture treatment group(AG) in equal proportion. The participants who assigned to the EMG were treated with electronic moxibustion to ten acupoints including both sides of BL2, GB14, TE23, and LI4 for 12 minutes. The participants who were assigned to the AG were treated with acupuncture to the same acupoints for 15 minutes. Over 4 weeks, each intervention was carried out twelve times in total. The primary outcome was the ocular surface disease index(OSDI). The secondary outcomes were the subjective symptoms visual analog scale(VAS), quality of life(QoL), Schirmer I test(SIT), and general assessment. Adverse events and vital signs were also investigated for safety assessment. Results : In intragroup comparisons, both the EMG and the AG significantly improved the OSDI scores, the subjective symptoms VAS scores, the QoL scores, and the SIT results after 4 weeks of the trial. However, there were no statistical differences in intergroup comparisons between the two groups after 4 weeks. The safety of electronic moxibustion and acupuncture was confirmed by no occurrence of serious adverse events. Conclusions : Both electronic moxibustion and acupuncture were effective for dry eye syndrome, and they were safe. Electronic moxibustion and acupuncture can be used for dry eye syndrome as equivalent treatments.

Pregabalin versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated with Failed Back Surgery Syndrome

  • Laith Thamer Al-Ameri;Mohammed Emad Shukri;Ekhlas Khalid Hameed;Ahmed Abed Marzook
    • Journal of Korean Neurosurgical Society
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    • v.67 no.2
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    • pp.202-208
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    • 2024
  • Objective : Failed back surgery syndrome (FBSS) is a common long-term complication following spine surgeries characterized by chronic persistent pain; different strategies of management were employed to deal with it. This clinical trial aims to compare the efficacy of Pregabalin and Gabapentin in the management of this condition. Methods : A double-blind, randomized, comparative study (clinical trial registry NCT05324761 on 11th April 2022) with two parallel arms with Pregabalin and Gabapentin were used in arms one and two, respectively. Visual analog scale was used for basal and endpoint assessment of pain. T-test and analysis of covariance were used to deal with different variables. A pairwise test was used to compare pairs of means. Results : Of 66 patients referred to the trial, 64 were eligible, with 60 patients completing the 30 days trial. Both pregabalin and gabapentin effectively reduce pain, with significant p-values of 0.001 for each group. However, the pregabalin group was superior to gabapentin in pain reduction (p=0.001). Gender was an insignificant factor (p=0.574 and p=0.445 for the pregabalin and gabapentin groups, respectively, with a non-significant reduction (p=0.393) for both groups in total. Location of stenosis before surgery and type of surgery performed show non-significant effect on pain reduction for both groups. Conclusion : Both pregabalin and gabapentin effectively and safely relieve neuropathic pain associated with FBSS; pregabalin was significantly more effective irrespective of the patients' gender.

Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Facial palsy (얼굴마비의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구)

  • Gong, Na-Gyeong;Seo, Eunsung;Seon, Ji-Hye;Kim, Nam-Kwen
    • The Journal of Korean Medicine
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    • v.38 no.1
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    • pp.46-55
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    • 2017
  • Objectives: The aim of this study is reviewing the literature to extract the key parameter, study design, perspective, cost-effectiveness index and find the calibration parameter for the clinical study with economical evaluation protocol on facial palsy. Methods: Literature search is performed using PUBMED for literature published from January 2000 to December 2016. We included randomized controlled trials(RCTs) and modelling study with economic assessment in which human participated. Results: As a result of literature search, the 198 articles were found. After reviewing the title, abstract and full text, the 5 articles were selected. Selected articles are classified into 4 RCT studies dealing with quality of life and 1 CEA(cost-effectiveness analysis) study. Conclusions: We found reliable key parameters, calibration parameters and elements of economical assessment study, which might be necessary factors for developing research protocol of clinical trial with economic evaluation about facial palsy patients.