• Title/Summary/Keyword: randomized controlled trials (RCTs)

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Chuna Manual Therapy for Postpartum Low Back Pain: Systematic Review (출산 후 요통에 대한 추나요법의 효과: 체계적 문헌고찰)

  • Cho, Ju-chan;Park, In-hwa;Hwang, Man-Suk;Heo, In
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.2
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    • pp.1-8
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    • 2021
  • Objectives This study aimed to evaluate the effect of chuna manual therapy (CMT) for postpartum low back pain using a systematic review. Methods We performed a literature search using 12 electronic databases up to the end of September 2021. We included randomized controlled trials (RCTs) that evaluated the effect of CMT in the treatment of postpartum low back pain. The risk of bias was evaluated using the Cochrane risk-of-bias tool. Results Four randomized controlled trials were reported statistically significant effect in pain VAS, ODI and JOA of chuna manual therapy compared with moxibution, electro acupuncture, hyperthermia or usual care. As a result of assessing the risk of bias tool, most of the contents of the evaluation items were not identified, so it was evaluated as an uncertain risk. Conclusions CMT may be effective in treating postpartum low back pain. However, evidence was limited due to the small sample size, lack of well-designed RCTs and regional bias. Further well-designed studies are required to obtain stronger evidence.

Herbal Medicine (Hyeolbuchukeo-tang, Xuefu Zhuyu Decoction) for Insomnia Disorder: A Systematic Review and Meta-analysis of Randomized Controlled Trials (불면장애에 대한 혈부축어탕의 체계적 문헌 고찰 및 메타분석 연구)

  • Kim, Dong-Hee;Lee, Seung-Hwan;Lim, Jung-Hwa;Kim, Sang-Ho;Lee, Sang-Hyup;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.4
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    • pp.319-332
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    • 2017
  • Objectives: The present study aimed to provide clinical evidence on the effect of herbal medicine, Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia using a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: This study included RCTs that verified the effects of Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia. Literature searches of English, Chinese and Korean databases were performed, and the selected literature was assessed for investigating the risk of bias. Results: The analysis included 10 RCTs. The Chinese Classification of Mental Disorders-3 was most frequently used to define the diagnostic criteria for Hyeolbuchukeo-tang or Xuefu Zhuyu decoction intervention in patients with primary insomnia. The effective rate was the most commonly used outcome measure. A meta-analysis revealed that the effective rate, the Pittsburgh Sleep Quality Index, and the Athens Insomnia Scale in the Modified Xuefu Zhuyu decoction (MXZD) group were higher compared to Western Medicine (WM) group (RR: 1.17, 95% Cl: 1.08 to 1.26, p<0.0001, $I^2$=0/MD: -1.29, 95% Cl: -2.09 to -0.49, p=0.002, $I^2$=0%/MD: -0.99, 95% Cl: -1.81 to -0.18, p=0.02, $I^2$=15%). The effective rate of the MXZD+WM group was significantly different compared to the WM group (RR: 1.28, 95% Cl: 1.11 to 1.47, p=0.0006, $I^2$=2%). The included RCTs were of relatively poor quality and had small sample sizes. Conclusions: Treatment with Hyeolbuchukeo-tang or Xuefu Zhuyu decoction was found to be effective in treating primary insomnia. However, the included RCTs were of relatively poor quality and had small sample sizes. It is hypothesized that this study could serve as a foundation for further clinical studies on the development of diagnosis and treatment methods for primary insomnia based on Korean medicine.

Chuna Manual Therapy for Nocturnal Crying; A Systematic Review (소아 야제에 대한 추나요법 효과; 체계적 문헌고찰)

  • Hwang, Man-Suk;Shin, Byung-Cheul;Heo, Kwang-Ho;Heo, In;Kim, Byung-Jun;Kim, Ki-Bong;Cheon, Jin-Hong;Park, Jae-Hong;Hwang, Eui-Hyoung
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.3
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    • pp.51-57
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    • 2015
  • Objectives To evaluate the evidence supporting the effectiveness of Chuna manual therapy for nocturnal crying. Methods We conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for nocturnal crying. The methodological quality of each RCTs was assessed using the Cochrane Risk of Bias tool and nRCTs was assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study tool. Results Two RCTs and three nRCTs met our inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy in terms of the efficacy rate when compared to medication treatments alone. Positive results were also obtained, in terms of the efficacy rate, when comparing Chuna manual therapy combined with acupoint application therapy to Chuna manual therapy alone, but was not statistically significant. Conclusions Our systematic review found encouraging but limited evidence of Chuna manual therapy for nocturnal crying. We recommend clinical trials which compare the effectiveness of Chuna manual therapy with usual care to obtain stronger evidence without the demerits of trial design.

Effects of Chuna Manual Therapy(CMT) on Rotator Cuff Disorder: A Systematic Review (회전근개 질환에 대한 추나 치료의 효과: 체계적 문헌 고찰)

  • Hong, Su-Min;Do, Ki-Won;Yoon, Kwang-Sik
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.1
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    • pp.1-11
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    • 2021
  • Objectives This study aimed to evaluate the efficacy of Chuna manual therapy(CMT) in the treatment of rotator cuff disorder. Methods We searched th following nine online databases without language restriction (MEDLINE/PubMed, Cochrane library, Ebscohost, CNKI, RISS, NDSL, KMBASE, and KISS) to identify randomized controlled trials (RCTs) that used CMT in the treatment of rotator cuff disorder. The methodological quality of each RCT was assessed using the Cochrane risk-of-bias tool. Results Four RCTs were included. in the meta-analysis. CMT resulted in a significant reduction in symptoms in these trials. However, there was a high risk of bias in the RCTs. Conclusions We reviewed RCTs that studied the effects of CMT for rotator cuff disorder. While the studies indicate that CMT has favorable effects on rotator cuff disorder. But the risk of bias for most of the studies was high. Therefore, high-quality studies are required to make further conclusions.

A Systematic Review and Meta-Analysis of Moxibustion Treatment for Knee Osteoarthritis

  • Park, Jang Mi;Lee, Cham Kyul;Kim, Kyung Ho;Kim, Eun Jung;Jung, Chan Yung;Seo, Byung-Kwan;Goo, Bon Hyuk;Baek, Yong Hyeon;Lee, Eun Yong
    • Journal of Acupuncture Research
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    • v.37 no.3
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    • pp.137-150
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    • 2020
  • The purpose of this study was to evaluate the evidence supporting the effectiveness of moxibustion treatment for osteoarthritis. There were 9 databases used to retrieve randomized controlled trials (RCTs) that used moxibustion as treatment for osteoarthritis. The quality of methodology for the RCTs was assessed using the Cochrane Risk of Bias tool [Review Manager (RevMan) Version 5.3 Windows, The Nordic Cochrane Centre, Copenhagen, Denmark]. The inclusion criteria for this review was met by 27 RCTs. All studies were conducted in China. A 4-week moxibustion treatment period was the most common. EX-LE4 and SP10 and GB34 acupoints were most frequently selected in the treatment of osteoarthritis. The most commonly used evaluation index was the visual analog scale (VAS). All studies, including a meta-analysis showed that moxibustion treatments were statistically significantly effective at treating knee osteoarthritis. However, well-designed randomized RCTs without a high risk of bias should be designed in the future.

Chuna Manual Therapy for Primary Insomnia; A Review of Clinical Study (일차성 불면증의 추나 치료에 대한 문헌 연구 보고)

  • Hwang, Man-Suk
    • Journal of Korean Medicine Rehabilitation
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    • v.26 no.3
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    • pp.79-84
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    • 2016
  • Objectives To evaluate the evidence supporting the effectiveness of Chuna manual therapy for primary insomnia. Methods The researcher conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for primary insomnia. Results Four RCTs met inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy in terms of the PSQI when compared to medication treatments alone. Positive results were also obtained, in terms of the PSQI, when comparing Chuna manual therapy combined with acupuncture therapy to acupuncture therapy alone, but was not statistically significant. Conclusions The review found encouraging but limited evidence of Chuna manual therapy for primary insomnia. We recommend clinical trials which compare the effectiveness of Chuna manual therapy with usual care to obtain stronger evidence without the demerits of trial design.

Using of the "Consolidated Standards of Reporting Trials:CONSORT" to heighten quality of Medical Education study (의학교육연구의 질을 향상시키기 위한 '연구보고의 표준' 의 활용)

  • Yoo, Ji-Soo
    • Korean Medical Education Review
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    • v.10 no.2
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    • pp.25-44
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    • 2008
  • Objectives: Through using of the strong research method like a Randomized Controlled Trial: RCT, we have to heighten quality of Medical Education study. I'd like to introduce "CONSORT", which stands for Consolidated Standards of Reporting Trials. Contents: Preventive Service Task Force(200l) in USA proposed Levels of evidence for enlarging evidence-based Practice: EBP. And the CONSORT was introduced, which encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials (RCTs). the CONSORT has 13 guides like these: 1. How participants were allocated to interventions 2. Scientific background and explanation of rationale 3. Eligibility criteria for participants. The settings and locations where the data were collected. 4. Precise details of the interventions intended for each group and how and when they were actually administered 5. Specific objectives and hypotheses 6. Clearly defined primary and secondary outcome measures, When applicable. any methods to enhance the quality of measurements (e.g., multiple observations, training of assessors) 7. How sample size was determined. When applicable, explanation of any interim analyses and stopping rules 8. Method used to generate the random allocation sequence, Details of any restriction [of randomization] 9. Method used to implement the random allocation sequence 10. Who generated the allocation sequence, who enrolled participants. and who assigned participants to their groups 11. Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated 12. Statistical methods used to compare groups for primary outcome(s), Methods for additional analyses, such as subgroup analyses and adjusted analyses 13. Flow of participants through each stage (a diagram is strongly recommended) Specifically, for each group report the numbers of participants randomly assigned. receiving intended treatment, completing the study protocol. and analyzed for the primary outcome. Results and Conclusion: Randomized Controlled Trial: RCT guided of CONSORT will contribute to do stronger evidence-based medical studies.

Fulvestrant 250mg versus Anastrozole 1 mg in the Treatment of Advanced Breast Cancer: a Meta-Analysis of Randomized Controlled Trials

  • Gong, Dan-Dan;Man, Chang-Feng;Xu, Juan;Fan, Yu
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.5
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    • pp.2095-2100
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    • 2014
  • Objective: Most patients with advanced breast cancer experience resistance to endocrine treatment and eventual disease progression. This meta-analysis was designed to compare the efficacy and tolerability of fulvestrant 250mg with anastrozole 1mg in postmenopausal women with advanced breast cancer. Methods: Electronic literature databases (Cochrane Library, Medline, and Embase) were searched for randomized controlled trials (RCTs) published prior to August 2013. Only RCTs that compared fulvestrant 250mg to anastrozole 1mg in postmenopausal women with advanced breast cancer were selected. The main outcomes were time to treatment failure (TTF), time to progression (TTP), duration of response (DOR), clinical benefit rate, and tolerability. Results: Four RCTs covering 1,226 patients (fulvestrant, n=621; anastrozole, n=605) were included in the meta-analysis. Fulvestrant increased the DOR compared to anastrozole (HR =1.31, 95% confidence interval [CI] 1.13-1.51). There was no statistically significant difference between fulvestrant and anastrozole in terms of TTF (HR=1.02, 95%CI 0.89-1.17), complete response (RR=1.79, 95%CI, 0.93-3.43), and partial response (RR=0.91, 95%CI 0.69-1.21). As for safety, there was no statistical significance between the two groups for common adverse events. Conclusion: Fulvestrant 250mg is as effective and well-tolerated as anastrozole 1mg treatment for advanced breast cancer in postmenopausal women whose disease progressed after prior endocrine treatment. Thus, fulvestrant may serve as a reasonable alternative to anastrozole when resistance is experienced in breast cancer cases.

Banhabaeckchulchunma-tang for Benign Paroxysmal Positional Vertigo: A Systematic Review and Meta-analysis (양성 발작성 자세변환성 현훈에 대한 반하백출천마탕(半夏白朮天麻湯)의 효과: 체계적 문헌고찰과 메타분석)

  • Kim, Geun-Lip;Hong, Chul-Hee;Lee, Kyou-Young
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.34 no.4
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    • pp.71-89
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    • 2021
  • Objectives : The purpose of this study is to evaluate the effect of Banhabaeckchulchunm a-tang(BBCT) for Benign Paroxysmal Positional Vertigo(BPPV) Methods : We searched randomized controlled trials(RCTs) which assess the effect of BB CT for BPPV through 8 electronic databases from their inception to July 2021. RevMan 5.4 was used to evaluate the risk of bias. Results : 12 RCTs with 901 subjects were included. The BBCT treatment group had significantly higher total effetive rate(TER) than the western medicine treatment group(P=0.0001), and the Dizziness Handicap Inventory(DHI) score(P=0.003), traditional chinese medicine syndrome(TCM syn.) score(P<0.00001), and Visual analog scale(VAS)(P=0.0006) were significantly lower than the western medicine treatment group. The combined treatment of BBCT and canalith repositioning procedure(CRP) group had significantly higher TER than only CRP treatment group(P=0.02), and there was no significant difference in DHI score(P=0.12). TG(P=0.006) and TC(P=0.04) were significantly lower, and ApoA1 was significantly higher(P=0.0001). There was no significant difference in LDL(P=0.24). Conclusions : These results demonstrate that BBCT could be effective for BPPV especially after CRP. However, because of limits of included studies such as high heterogeneity between the literatures, unclear risk of bias, insufficient reports of adverse events(AEs), a well-designed RCTs with a low risk of bias in more diverse countries are needed in the future.

A Systematic Review and Meta Analysis of Randomized Controlled Trials of the Clinical Effect on Taking a Herbal Medicine on Postpartum Lactation (한약 복용이 산후 유즙분비에 미치는 효과에 대한 체계적 문헌고찰)

  • Lee, Hye-Jung;Lee, Su-Jeong;Hwang, Deok-Sang;Lee, Chang-Hoon;Jang, Jun-Bock;Lee, Jin-Moo
    • The Journal of Korean Obstetrics and Gynecology
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    • v.34 no.3
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    • pp.137-156
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    • 2021
  • Objectives: The purpose of this study is to assess the effect of taking herbal medicine for the postpartum lactation. Methods: We searched 9 databases for recent three years, that contained four english, two chinese, one japanese and two korean database from September 17, 2016 to December 31, 2020. Randomized controlled trials (RCTs) were eligible. Measurement of outcome included total curative effective rate, volume of lactation, volume of milk supplement, and serum prolactin concentration. The risk of bias was assessed by two independent authors using the Cochrane risk of bias tool. Results: Total 725 of studies was screened, 11 RCTs were finally selected. Number of participants per study ranged from 60 to 257. The treatment group of taking a herbal medicine is effective for improving total curative effective rate, volume of lactation, volume of milk supplement, and serum prolactin concentration compared with control group. Because most of the studies had considerable heterogeneity in terms of type of intervention and comparison for outcome measurement, meta analysis for quantitative analysis was impossible. Conclusions: This studies showed that taking a herbal medicine is effective on increasing volume of lactation and speeding up the start of the first breastfeeding. However, included studies suffered from incomplete reporting, high or unclear risk of bias and substantial heterogeneity between studies. In the Future, further high-quality RCTs are needed to prove effectiveness of herbal medicine for breastfeeding and reduce the risk of bias.