• Title/Summary/Keyword: randomized controlled trial(RCT)

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Application of Traditional East Asian Herbal Medicine for Atrophic Vaginitis: A Systematic Review of Randomized Controlled Trials (위축성 질염에 대한 한약 투약의 효과 : 체계적 문헌 고찰)

  • Park, Eo-Jin;Jo, Hee-Geun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.3
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    • pp.227-244
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    • 2019
  • Objectives: To evaluate the effectiveness and safety of application of Traditional East Asian Herbal Medicine (TEAM) in the treatment of Atrophic Vaginitis (AV). Methods: Randomized Controlled Trials (RCTs) were obtained from PubMed, Cochrane Library, Embase, CNKI, RISS, NDSL, and KISS. The risk of bias was assessed by using Cochrane's risk of bias tool, and RevMan 5.3 software was used. Results: 26 RCTs with 3,162 patients were identified and reviewed. Among them, 21 RCTs observe the effect of integrated traditional Chinese and Western medicine. 23 RCTs reported treatment groups was statistically effective than control groups in the study. Also, the recurrence rate was estimated in 10 RCTs and was lower than control groups. 12 studies observed adverse events (AEs) and severe AEs were not reported. Conclusions: This review suggested that TEAM was safe and effective in the treatment of AV. TEAM may also decrease the recurrence rate. However, this could not be proven conclusively. To ensure evidence-based clinical practice, well-designed trials with larger sample sizes are needed.

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.

A Review on Clinical Studies of the Acupuncture and Moxibustion Therapy for Gastroesophageal Reflux Disease in China by Searching CAJ (CAJ 검색을 통해 살펴 본 중국에서의 역류성 식도질환 침구치료 임상연구 동향에 대한 고찰)

  • Kang, Sei-Young
    • Korean Journal of Acupuncture
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    • v.32 no.1
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    • pp.1-12
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    • 2015
  • Objectives : The purpose of this study was to review the acupuncture and moxibustion therapy for gastroesophageal reflux disease(GERD) in China. Methods : The literatures were searched using the database-China Academic Journals(CAJ)(~2015.1.). Clinical studies of acupuncture and moxibustion therapy for GERD such as randomized controlled trial(RCT), non-randomized controlled trial(NRCT), case series, or case report were included. Results : Thirty studies met our inclusion criteria: 24 RCTs, 4 NRCTs, 1 case series, 1 case report. Various kinds of treatment such as body acupuncture, abdominal acupuncture, acupuncture therapy with finger on back-shu point, electroacupuncture, acupoint injection, auricular acupuncture, and moxibustion were used in the clinical studies. The treatment groups take herbal medicines at the same time in 16 studies, and proton pump inhibitor(PPI) and histamine 2 receptor antagonist were used as a comparative treatment in the most of studies. Acupuncture or moxibustion treatments were done daily or 2~3 times a week for 5 days~18 weeks. All of studies reported higher effective rate in the acupuncture or moxibustion treatment group compared to the western medication control group. Conclusions : The results of this study could be used for the future practice and the clinical research about the acupuncture and moxibustion therapy for GERD.

Acupuncture for Parkinson's Disease in China (중국에서의 파킨슨병 침치료 임상연구 동향)

  • Kim, Lak-Hyung;Jang, In-Soo;Kang, Sei-Young
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.147-158
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    • 2011
  • Objectives : The purpose of this study was to obtain some knowledge about the acupuncture treatments on Parkinson's disease for the future practice and the research from the clinical studies in China. Methods : The literatures were searched using the data base-China Academic Journals (CAJ) (1994-2011). Clinical studies of acupuncture for Parkinson's disease such as randomized controlled trial (RCT), non-randomized controlled trial (NRCT), case series, case report were included. Results : Of 145 articles, 52 Clinical studies met our inclusion criteria: 20 RCTs, 7 NRCTs, 22 case series and 3 case reports. Various kinds of acupuncture treatments such as scalp acupuncture, body acupuncture, abdominal acupuncture, acupoint injection, eye acupuncture and thick needle acupuncture (粗鍼) were used in the clinical studies. The treatment and control groups take Madopa Tablet (Levodopa + Benserazide HCl) in the same time in many studies, and Madopa treatment was used as a comparative treatment in the most of studies. Acupuncture treatment was done daily or 2~3 times a week for 2~20 weeks. All of studies reported high effective rate in the treatment group compared to control group. Conclusions : The results of this study could be used for the future study about the acupuncture therapy for Parkinson's disease.

A Review on Treatment of Somatization Disorder in Traditional Chinese Medicine (신체화 장애에 대한 중의학 연구동향)

  • Kim, Hyo-seop;Bae, Jin-soo;Lee, Seung-Hwan;Lim, Jung-Hwa;Seong, Woo-Yong
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.3
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    • pp.217-230
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    • 2017
  • Objectives: This study was conducted to review studies on somatization disorder in traditional Chinese medicine. Methods: We reviewed studies in the China National Knowledge Infrastructure (CNKI) to 2017. Keywords were 軀體化障碍, Somatization disorder, somatic symptom disorder. We included Randomized Controlled Trial (RCT), and excluded non-Randomized Controlled Trial (nRCT), non-related somatization disorder or traditional Chinese medicine, non-clinical trials, dissertations for degrees. Jadad scale and Cochrane Library's Risk of Bias (RoB) were used for assessment of the quality of studies. Results: Twelve studies were selected. The Chinese Classification of Mental Disorders-3 (CCMD-3) was most frequently used as diagnostic criteria for somatization disorder. As for outcome measurement, Hamilton Rating Scale for Depression (HAMD) was used most commonly. Meta-analysis of 10 studies revealed effective rate of Chinese Herbal Medicine groups (CHM) was significantly higher than Western Medicine groups (WM) (RR: 1.14, 95% CI: 1.02 to 1.27, p=0.02, $I^2=40%$). There was no significant difference in effective rate of CHM+WM and WM (RR: 1.12, 95% CI: 0.84 to 1.49, p=0.46, $I^2=83%$). And also, effective rate of Acupuncture group (Acu) revealed no significant difference compared to that of WM (RR: 1.17, 95% CI: 0.95 to 1.44, p=0.13, $I^2=84%$). For HAMD, there was significant difference in CHM vs, WM group and Acu vs. WM group. Quality of selected 12 RCTs was low. Conclusions: Therapies practiced in traditional Chinese medicine may be effective options for somatization disorder. treatment. For further clinical studies in Korean medicine, this study could be groundwork for development of diagnosis and treatment on somatization disorder.

Evidence based practice within the complementary medicine context

  • McLean, Lisa;Micalos, Peter Steve;McClean, Rhett;Pak, Sok Cheon
    • CELLMED
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    • v.6 no.3
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    • pp.15.1-15.4
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    • 2016
  • Evidence based practice (EBP) is a system of applying the most current and valid high quality evidence to support clinical decision making in a healthcare setting. In the twenty five years since its inception, EBP has become the accepted benchmark for excellence in healthcare. Although the system emerged within the biomedical sciences, in the years since EBP has become normative across all healthcare modalities from dentistry, allied health to complementary and alternative medicine (CAM). Practicing evidence based medicine within any modality potentially offers the patient the best available care based on high quality evidence. Yet it is the nature of the evidence that provokes some questions about the suitability of EBP across all modalities of healthcare. The meta analysis of randomized controlled trial (RCT) stands at the pinnacle of the hierarchy of evidence in EBP. This forms a challenge to CAM due to the difficulty in reducing the elementals of a holistic naturopathic assessment of a patient into an answerable question to be tested within a RCT. On one level this makes EBP paradigmatically incompatible with CAM, yet on another level it presents the opportunity to redefine the parameters of what is considered high level evidence. EBP has become a tool, and at times a weapon wielded by governments and health insurance companies to direct healthcare funding and policy. The implications of the nature of accepted evidence are becoming far reaching. The pursuit of the best available healthcare for each individual is the focus of EBP. However, the injudicious use of this system to direct health policy is fraught with biomedical bias and dominance. This issue raises the challenge to CAM to present high level evidence according to the rules of evidence, or face the annihilation of centuries of empirical knowledge.

Acupuncture Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Controlled Pilot Trial

  • Kim, Jung-Eun;Kim, Sung-Phil;Kim, Ae-Ran;Park, Hyo-Ju;Kwon, Ojin;Jung, So-Young;Cho, Jung-Hyo;Kim, Joo-Hee;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.35 no.3
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    • pp.120-128
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    • 2018
  • Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.

Overview for clinical use of coffee enema using literatures (커피관장요법의 임상적용에 대한 문헌적 고찰)

  • Oh, Soo-Jung;Cho, Jung-Hyo;Son, Chang-Gue
    • Journal of Haehwa Medicine
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    • v.22 no.2
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    • pp.37-45
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    • 2014
  • Recently, interest in detoxification therapies is increasing. Coffee enema has been most frequently used as one of detoxification therapies. However, there is lack of scientific basis for coffee enema, regarding its clinical efficacy and safety respectively. This study aimed to produce the general features of coffee enema such as definition, protocols, clinical applications and efficacies, and side effects. Total 37 articles coffee enema were collected from 7 databases including PubMed, and reviewed thoroughly. The majority of papers were review studies or case reports for effects/side-effects of coffee enema. The quality of papers was generally poor, and no randomized controlled clinical trial (RCT) was exist. This study shows the current status of coffee enema-related study, and suggests the demand for RCT study to develop the evidence-based detoxification therapy using coffee enema.

Individualized Acupuncture versus Standardized Acupuncture in Symptomatic Treatment of Osteoarthritis of the Knee-a Randomized Controlled Trial (ISRCTN 40706107) (퇴행성 슬관절염에 대한 맞춤형 침 치료 효과 검증 무작위 대조군 임상연구(RCT) (ISRCTN 40706107))

  • Byun, Hyuk;Kim, Sun-Woong;Ahn, Ji-Hyun;Kim, Yong-Suk;Seo, Jung-Chul;Choi, Sun-Mi;Park, Ji-Eun;K., Kawakita;N., Takahashi;E., Sumiya;Lee, Seung-Deok
    • Journal of Acupuncture Research
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    • v.24 no.4
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    • pp.183-195
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    • 2007
  • Objectives : To determine whether individualized acupuncture (IA) provides greater pain relief and improved function compared with standardized acupuncture (SA) in patients with osteoarthritis of the knee. Methods: Design is a randomized single blind controlled trial with two intervention arms (IA vs SA) of 6 weeks' duration and 3 months follow up. An orthopedist diagnosed 50 patients' symptoms as knee osteoarthritis. Interventions were applied by 2 residents studying the acupuncture and moxibustion specially in Dongguk University International Hospital. Primary outcome measure is pain as measured by visual analogue scale (VAS). Secondary measures of pain and disability include WOMAC, SF-36, LFI and KHAQ. Results : The 50 participants were well matched for age, sex, bad side, VAS, WOMAC, SF-36, LFI and KHAQ scores at the baseline. 3 participants dropped out. There have not been any adverse events in both groups. Participants in both groups experienced great improvement in all measures except SF-36at 3 and 6 weeks. At 18 weeks, the IA group experienced significantly greater improvement than the SA group in VAS but not in WOMAC, SF-36, LFI and KHAQ. Conclusions : Manipulation of IA seems to provide pain relief longer for osteoarthritis of the knee when compared with SA.

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Systematic Review of Chuna Manipulative Treatment for Ankle Sprain

  • Kwak, Min Kyung;Kim, Min Wook;Jeong, Sang Jun;Kim, Shin Ae;Jeong, Mi Young;Kim, Jae Hong
    • Journal of Acupuncture Research
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    • v.35 no.2
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    • pp.61-68
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    • 2018
  • Background: This study was performed to review the efficacy of national and international randomized controlled trials (RCT) investigating Chuna manipulative treatment for ankle sprains. Methods: Online databases (PubMed, Cochrane, EMBASE, CNKI, NDSL, OASIS), were searched for studies where Chuna treatment was performed for ankle sprains up to October 12th, 2017. Only RCT were selected that fulfilled the inclusion/exclusion criteria. Data were analyzed using the Cochrane risk of bias tool. Results: There were 676 studies retrieved from the databases, resulting in analysis of 24 RCT. There was an average of 7 treatment visits over a 7 day period and the most frequent evaluation tool used was efficacy rate, with drug therapy being the most common control used in the trials. In 15 RCT, several Chuna methods were used in combination, amongst which, the osteopathic technique was most common. Statistically significant improvement in evaluation indices was reported in 19 RCT, and in 3 RCT, statistically significant improvement was reported, but not for all indices. In the remaining 2 RCT, there were no significant differences in any of the evaluation indices. No adverse reactions were reported in any of the RCT, although it was unknown whether all the trial protocols indicated that adverse reactions should be monitored, and for this reason, the risk of bias was unclear. Conclusion: The review of 24 studies suggest that Chuna manipulative treatment for ankle sprains was effective in most cases, although, potential bias in these studies was difficult to evaluate.