• Title/Summary/Keyword: Randomized controlled clinical trials

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Clinical Effectiveness of Traditional Herbal Medicine in the Treatment of Chemotherapy-induced Leukopenia: A Systematic Review and Meta-analysis of Randomized Clinical Trials (항암화학요법 유발 백혈구감소증에 대한 한약치료의 효과 : 체계적 고찰 및 메타분석(2007-2017))

  • Kim, Min-serh;Jung, Yu-jin;Hong, Sang-hoon
    • The Journal of Internal Korean Medicine
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    • v.39 no.4
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    • pp.520-549
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    • 2018
  • Objectives: We performed a systematic review and meta-analysis to explore the recent clinical research trends regarding the effects of traditional herbal medicine (THM) on chemotherapy-induced leukopenia. Methods: Randomized controlled trials that verified effects of herbal medicine treating chemotherapy induced leukopenia were included in the study. A literature search was performed in the English, Chinese, and Korean databases for papers published from January 1, 2007, to September 1, 2017. The selected literature was assessed by Cochrane's Risk of Bias (RoB). Results: Forty-two of 232 randomized controlled trials met the inclusion criteria. The most commonly used herbal prescriptions called '升白湯 (shengbai decoction)' which means elevating the numbers of White blood cells (WBCs). And the mostly included herbs such as Astragali Radix, Angelicae Gigantis Radix, Atractylodis Rhizoma Alba, Codonopsis Pilosulae, Glycyrrhizae Radix, Ligustri Lucidi Fructus are commonly used to elevate qi, blood and yin. The count of WBC in peripheral blood, the level of leukopenia presented in WHO (World Health Organization), and clinical symptoms were used to evaluate the treatments. The effective rate was 68.6-98.18% and the effectiveness was significantly higher in the intervention group than in the control group in 38 articles (p<0.05). No serious adverse events were reported. Only five articles (5/42, 11.9%) were rated as having adequate methodological quality with a low level of bias. Conclusion: Some traditional herbal medicines may be effective as therapeutic treatments for chemotherapy-induced leukopenia, but the majority of reviewed studies were of poor quality. The present findings need to be confirmed by rigorously conducted high-quality trials, including pharmacokinetic studies, to confirm the absence of interactions between traditional herbal medicine agents and chemotherapy.

Systematic Review of Bee Venom Therapy for Traumatic Injury (임상에서 흔히 접하는 외상성 손상에 대한 봉독약침요법의 체계적 문헌고찰)

  • Lee, Jae-Eun;Lee, Chi-Ho;Lee, Eun-Jung;Lee, Jung-Min;Oh, Min-Seok
    • Journal of Korean Medicine Rehabilitation
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    • v.26 no.3
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    • pp.67-77
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    • 2016
  • Objectives To evaluate the evidence supporting the effectiveness of Bee Venom therapy for traumatic injury. Methods We conducted search across 3 electronic databases (Pubmed, CAJ and Oasis) to find clinical trials that used Bee Venom therapy as treatment for traumatic injury. The methodological quality of RCTs (Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 87 articles that were searched, 10 RCTs and 19 NRCTs were finally selected. Among 19 selected studies, all studies showed that Bee Venom therapy has significant effect on traumatic injury. Conclusions Our systematic review found encouraging but limited evidence of Bee Venom therapy for traumatic injury. We recommend clinical trials which compare the effectiveness of Bee Venom therapy with other pharmacopuncture therapies to clarify the effectiveness of Bee Venom therapy from other pharmacopuncture therapies.

Clinical Effectiveness of Traditional Herbal Medicine in the Treatment of Central Post-Stroke Pain and Thalamic Syndrome: a Systemic Review and Meta-analysis of Randomized Clinical Trials Based on Traditional Chinese Medicine Journals (뇌졸중 후 중추성 통증 및 시상증후군에 대한 한약치료의 효과 : 체계적 고찰 및 메타분석 - 중의학 저널을 중심으로)

  • Jung, Yu-jin;Kang, Eun-jin;Hong, Sang-hoon
    • The Journal of Internal Korean Medicine
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    • v.40 no.3
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    • pp.295-311
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    • 2019
  • Objectives: This research aimed to investigate Chinese clinical studies on the treatment of central post-stroke pain (CPSP) and thalamic syndrome after stroke with traditional herbal medicine (THM). Methods: Randomized controlled trials verifying the effects of herbal medicine on treating CPSP and thalamic syndrome after stroke were included in the study. Electrical and hand search were conducted in the China National Knowledge Infrastructure (CNKI), National Discovery for Science Leaders (NDSL), Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (Oasis) for CPSP and thalamic syndrome after stroke. A literature search was performed in the Chinese and Korean databases for papers published from January 1, 2010 to October 1, 2018. The selected literature was assessed by Cochrane's risk of bias. Results: Twelve reports on randomized controlled trials met the inclusion criteria from the 227 identified reports. Effective rate, comparison of visual analogy scale, present pain intensity, pain grading index, recurrence rate, follow-up, and a 36-item short form survey instrument were used to evaluate the treatments. The effective rate of the treatment group was significantly higher than that of the control group in all papers. Side effects occurred less frequently in the treatment group than in the western medicine control group. Conclusions: The treatment of CPSP and thalamic syndrome after stroke with THM was shown to be highly effective. Additional well-designed clinical trials are needed. This study can be used as a basis for further research on the treatment of CPSP and thalamic syndrome after stroke.

Barriers to Participation in a Randomized Controlled Trial of Qigong Exercises Amongst Cancer Survivors: Lessons Learnt

  • Loh, Siew Yim;Lee, Shing Yee;Quek, Kia Fatt;Murray, Liam
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.12
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    • pp.6337-6342
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    • 2012
  • Background: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial. Materials and Method: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197). Results: Multiple barriers were identified, and were regrouped as patient-related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. Conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

Efficacy and Safety of Gabapentin in the Treatment of Chronic Cough: A Systematic Review

  • Shi, Guanglin;Shen, Qin;Zhang, Caixin;Ma, Jun;Mohammed, Anaz;Zhao, Huan
    • Tuberculosis and Respiratory Diseases
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    • v.81 no.3
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    • pp.167-174
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    • 2018
  • Despite recent clinical guidelines, the optimal therapeutic strategy for the management of refractory chronic cough is still a challenge. The present systematic review was designed to assess the evidence for efficacy and safety of gabapentin in the treatment of chronic cough. A systematic search of PubMed, Embase, Cochrane Library databases, and publications cited in bibliographies was performed. Articles were searched by two reviewers with a priori criteria for study selection. Seven relevant articles were identified, including two randomized controlled trials, one prospective case-series designed with consecutive patients, one retrospective case series of consecutive patients, one retrospective case series with unknown consecutive status, and two case reports comprising six and two patients, respectively. Improvements were detected in cough-specific quality of life (Leicester Cough Questionnaire score) and cough severity (visual analogue scale score) following gabapentin treatment in randomized controlled trials. The results of prospective case-series showed that the rate of overall improvement of cough and sensory neuropathy with gabapentin was 68%. Gabapentin treatment of patients with chronic cough showed superior efficacy and a good safety record compared with placebo or standard medications. Additional randomized and controlled trials are needed.

The Effect of Manual Stretching and Positioning and Developmental Treatment in Congenital Muscular Torticollis: randomized Controlled Trials (선천성 근성 사경 환아에서 수기신장과 자세와 발달을 이용한 치료의 효과에 대한 무작위 연구)

  • Lee, In-Hee
    • Physical Therapy Korea
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    • v.16 no.1
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    • pp.34-41
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    • 2009
  • The purpose of this study is to compare the outcomes of manual stretching treatment with those of motor development and positioning physical therapy (MDPPT) for congenital muscular torticollis (CMT). This study was designed to be randomized controlled trials and to evaluate the outcomes of 43 consecutive patients with CMT who were first seen when they were average 26 days old. Before treatments, the patients were unintentionallv classified into two clinical groups along with the treatment methods. Among the 43 patients, 22 were classified to the manual stretching group and 21 to the MDPPT group. By means of independent t-test on the result. the duration of treatment according to methods was not significantly different in two groups (p>.05). The duration of treatment in accordance with head tilt level was not significantly different in two groups (p>.05). There was change of mass diameter, between at the beginning day of treatment and after treatment in manual stretching group with a strong positive linear correlation (p=.000, r=.734), but slightly positive linear correlation in MDPPT group. The result of this study indicates that two therapeutic methods make little difference in effectiveness.

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Traditional Herbal Medicine for Dysfunctional Uterine Bleeding versus Western Medicine: A Systematic Review of Randomized Controlled Trials (기능성 자궁출혈에 대한 한약치료 : 체계적 문헌 고찰)

  • Park, Eo-Jin;Jo, Hee-Geun;Choi, Ji-Hyun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.31 no.4
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    • pp.110-127
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    • 2018
  • Objectives: To evaluate the effectiveness and safety of traditional herbal medicine (THM) in the treatment of dysfunctional uterine bleeding (DUB) versus conventional western medicine. Methods: Randomized Controlled Trials (RCTs) comparing THM vs. conventional western medicine for DUB, were obtained from PubMed, Cochrane Library, Embase, CNKI, RISS, NDSL, KISS and OASIS. The risk of bias was assessed by using Cochrane's risk of bias tool. Results: 16 RCTs with 1,659 patients were identified and reviewed. 10 RCTs reported THM was statistically effective than control group in effective rate. Also recurrent rate was estimated in 6 RCTs and was lower than control group. 7 studies observed adverse events (AEs) and severe AEs were not reported. Conclusions: Despite several limitations, this review suggested that THM was safe and effective in the treatment of DUB. THM may also decrease the recurrence rate. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more sternly designed trials are warranted.

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.

Effect of Acupuncture and Moxibustion for Vitiligo: A Scoping Review of Randomized Controlled Trials (백반증의 침구(鍼灸) 치료 효과: 무작위 대조 시험에 대한 주제 범위 문헌 고찰)

  • Do Kyung Han;Jeewon Shon;Won Gun An
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.4
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    • pp.145-155
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    • 2023
  • Objectives : The aim of this study is to review the effect of acupuncture/moxibustion on vitiligo. Methods : Using 5 databases(Pubmed, EMBASE, Cochrane Library, RISS, OASIS) clinical studies about effect of acupuncture/moxibustion on vitiligo were searched. Only randomized controlled trials(RCTs) were selected to analyze. Results : Total 235 studies were searched. After screening those studies 5 studies were selected from china and Iran. 3 studies used effective rate to measure the effect of acupuncture for vitiligo. 1 study used Vitiligo Area Scoring Index(VASI) and 1 study assessed 4 grade of repigmentation to prove acupuncture's effect on vitiligo. All studies showed repigmentation in acupuncture/moxibustion group. Adverse effects reported in the five studies were temporary erythema, itching, and dryness. Conclusions : These findings suggest that acupuncture and moxibustion can be considered a safe treatment for vitiligo. However, due to the small number of RCTs conducted on acupuncture and moxibustion for vitiligo, more RCTs should be conducted to confirm the effectiveness of acupuncture and moxibustion for vitiligo.

Acupuncture Treatment for Restless Legs Syndrome: A Review of Randomized Controlled Trials

  • Go Eun Chae;Hyun Woo Kim;Hye Jeong Jo;Ahra Koh;Young Jin Lee;Ji Eun Choi;Woo Young Kim
    • Journal of Acupuncture Research
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    • v.40 no.4
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    • pp.308-318
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    • 2023
  • To determine the effectiveness of acupuncture in treating restless legs syndrome (RLS), we conducted a literature review of randomized controlled trials (RCTs) that utilized acupuncture as an intervention for patients diagnosed with RLS. Relevant clinical studies (n = 158) from seven databases (the Cochrane Library, PubMed, Embase, CNKI, KISS, RISS, and OASIS) were included based on the inclusion and exclusion criteria and analyzed. Moreover, 6 RCTs were selected for review. In all six studies, it was indicated people who underwent acupuncture treatment showed significant improvements in their overall health. An increase in the treatment efficacy rate, sleep quality, and quality of life indicators after the acupuncture treatment was confirmed. The severity of pain as assessed using the visual analog scale (VAS) scores and International RLS Study Group Rating Scale (IRLSRS) scores and the severity of RLS symptoms were significantly reduced. Any significant side effects were not reported. Acupuncture is suggested as an effective and safe treatment method for RLS. However, further large-scale RCT studies are needed to confirm our findings.