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

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A Review of Acupuncture Treatment Methods for Urinary incontinence and Overactive bladder in Postmenopausal Women (폐경 후 여성 요실금과 과민성 방광의 침 치료법에 대한 고찰)

  • Cho, Se-In;Kim, Dong-Il;Choi, Su-Ji
    • The Journal of Korean Obstetrics and Gynecology
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    • v.35 no.4
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    • pp.121-142
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    • 2022
  • Objectives: The purpose of this study is to review the acupuncture treatment Urinary incontinence (UI) and Overactive bladder (OAB) in postmenopausal women. Methods: We searched articles in 8 search engines with keywords related to 'Overactive bladder', 'Urinary incontinence' and 'Menopause' in July 2022. Randomized Controlled Trials (RCT) that used acupuncture on Urinary incontinence (UI) and Overactive bladder (OAB) after menopause were included. Animal studies and non RCT data were excluded. Data on acupuncture treatment such as methods, site, duration, frequency, and period were analyzed. Also, network analysis between acupoints was conducted. Results: 15 articles were selected and analyzed. Studies were conducted using manual acupuncture, electroacupuncture, pharmacopuncture and fire acupuncture. Most studies used more than one acupoint, and there were 32 acupoints selected for acupuncture treatment for UI and OAB after menopause. The most commonly used acupoint was 中極 (CV3) (n=8). In terms of the correlation of acupoints, 太谿 (KI3) had the highest value of degree centrality at 0.75. The mean treatment time, number of treatments, and duration were 26.42±6.10 minutes, 18.71±9.09 times, and 6.87±4.77 weeks. Conclusions: The results of this study could be useful in establishing the evidence for performing standardized acupuncture treatment for Urinary incontinence and Overactive bladder in postmenopausal women.

Comparison of the Effects of Topical Nasal Application on Allergic Rhinitis between Korean and Western Medicine : A Systematic Review of Randomized Controlled Trials (알레르기성 비염에 대한 한약 및 양약 국소비강외용제의 효과 비교 : 체계적 문헌 고찰)

  • Jo, Hyo-Rim;Oh, Se-Hee;Kim, Seon-Hye;Sung, Won-Suk;Hong, Seung-Ug;Kim, Eun-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.4
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    • pp.62-89
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    • 2019
  • Objectives : The purpose of this study is to evaluate the effectiveness and safety of topical nasal application of Herbal medicine compared with Western medicine in the treatment of Allergic Rhinitis(AR). Methods : Electronic databases including Cochrane library, PubMed, EMBASE, CNKI, KMBASE, KISS, NDSL, OASIS, KISS and KJTK(Korean Traditional Knowledge Portal) were searched by the keywords such as 'allergic rhinitis', 'nasal sprays', 'herbal medicine', 'plant extracts', and 'external application'. The quality of each RCTs was assessed by Cochrane Collaboration of 'Risk of bias(RoB) Tool'. Results : 19 RCTs were finally selected from 1419 references screened. 19 RCTs were compared with the effects of topical nasal application of Herbal medicine and Western medicine. Based on the symptom scores from 13 RCTs, topical nasal application of herbal medicine generally has a better effect on relief of AR. The two treatments have similar effects on improving the level of specific factors like IgE, IgG, IL-13, $uLTD_4$ in blood and urine. 8 RCTs showed adverse effects(AEs) in both groups and severe AEs were not reported. Conclusions : This study shows that topical nasal application of herbal medicine can improve symptoms and related factors of allergic rhinitis. Well-designed RCT studies with low risk of bias should be conducted to confirm these findings.

Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination during EBUS-TBNA: A Study Protocol for a Randomized Controlled Trial

  • Kim, Na Young;Park, Jae Hyeon;Park, Jimyung;Kwak, Nakwon;Choi, Sun Mi;Park, Young Sik;Lee, Chang-Hoon;Cho, Jaeyoung
    • Tuberculosis and Respiratory Diseases
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    • v.84 no.4
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    • pp.291-298
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    • 2021
  • Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard diagnostic method for mediastinal and hilar lymphadenopathy. Although rare, fatal infectious complications can occur following EBUS-TBNA. However, to date, there is a lack of effective preventive strategies to reduce these complications. We started a trial to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Methods: This study is a single-center, parallel-group, assessor-blinded randomized controlled trial (RCT). We will enroll 112 adult participants undergoing EBUS-TBNA using a convex probe, and randomly assign them to two groups at a 1:1 ratio. The intervention group will gargle for 1 minute with 100 mL of 0.12% chlorhexidine gluconate before EBUS-TBNA, while the control group will have no mouthrinse before the procedure. Immediately after completion of EBUS-TBNA on all targeted lesions with an aspiration needle, a needle wash sample will be taken by instilling 5 mL of sterile saline into the used needle. The primary outcome is colony forming unit (CFU) counts in aerobic cultures of the needle wash samples. Secondary outcomes are CFU counts in anaerobic cultures, fever within 24 hours after EBUS-TBNA, and infectious complications within 4 weeks after EBUS-TBNA. Conclusion: This trial was designed as the first RCT to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Results from this trial can provide clinical evidence for a simple, safe, and cost-effective strategy to prevent infectious complications following EBUS-TBNA (ClinicalTrials.gov ID: NCT04718922, registered on 22 January 2021).

A Study on the Effect of Proprioceptive Neuromuscular Facilitation Training by Meta-analysis -Focused on Balance and Gait Ability in Patients with Storke

  • Jeun, Young-Ju
    • Journal of the Korea Society of Computer and Information
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    • v.27 no.7
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    • pp.145-152
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    • 2022
  • Stroke results in balance disorders, these directly affect autonomy and gait ability. The aim of this meta-analysis was to determine the efficacy of proprioceptive neuromuscular facilitation on balance and gait. We included all randomized controlled trials assessing the efficacy of proprioceptive neuromuscular facilitation on balance and gait control in patients after stroke. This study was conducted according to the PRISMA guideline. Cochrane library, CINAHL, and PubMed were searched for studies published up to November 2021, and all randomized controlled trails(RCT) assessing PNF therapy were included. This analysis included only RCT. A total of 18 studies were selected from 1091 records obtained from the databases. The meta-analysis was performed using the R project for statistical computing version 4.0.2. The overall intervention effect was middle (standardized mean difference (SMD): 0.56) Additionally, berg balance scale (SMD: 0.48), functional reach test (SMD: 0.51), timed up and go test (SMD: 0.78), 10m walking test (SMD: 0.52), and dynamic gait index (SMD: 0.33) had medium effect sizes. The average Pedro scale was 6.63 out of 18, with a low risk of bias. These findings indicate that PNF is an effective therapy for improving balance gait in stroke patients.

Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

  • Soo-Han Choi;Su-Yeon Yu;Jimin Kim;Miyoung Choi;Youn Young Choi;Jae Hong Choi;Ki Wook Yun;Young June Choe
    • Pediatric Infection and Vaccine
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    • v.31 no.1
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    • pp.12-24
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    • 2024
  • The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22-0.37; I2 =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01-0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97-5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

A Meta-analysis of the Effectiveness of Acupuncture for the Treatment of Essential Tremors (본태성 떨림의 침치료 효과에 대한 메타분석)

  • Sohn, Yu-jin;Jung, Seo-yoon;Kang, Ki-wan;Jeong, Min-jeong;Jang, In-soo
    • The Journal of Internal Korean Medicine
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    • v.38 no.4
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    • pp.419-432
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    • 2017
  • Objectives: This study provides an evaluation of the effectiveness of acupuncture for the treatment of essential tremors (ETs) using randomized controlled trials (RCTs). Methods: Nine databases (PubMed, CINAHL, EMBASE, OASIS, NDSL, CNKI, Wanfang, J-STAGE, and CiNii) and the keywords "Essential tremor", "Benign tremor", "Familial tremor", and "Acupuncture" were used to compile RCTs that used acupuncture to treat ETs. Studies that were not RCTs, such as case studies, reviews, and essays, were excluded. The methodological quality of each RCT was assessed using the Cochrane risk-of-bias tool, and where appropriate, meta-analyses were performed. Results: Initially, 819 studies were found, but 773 were excluded after title and abstract screening. After further screening of the resulting 46 papers, eight RCTs were selected that had been published between 2003 and 2016, and the total effective rate (TER) was used as the primary evaluation method for all eight studies. It was found that the TER was significantly higher in treatment groups (83.33-96.7%) than in control groups (56.5-80.0%), and seven studies included in the meta-analysis showed positive results for acupuncture for ETs (Risk Ratio: 1.43, 95% Confidence Interval: 1.21-1.69, P<0.0001) Confidence Interval. Conclusions: This meta-analysis of clinical trials suggests that acupuncture is effective for treating ET patients; however, further studies are needed or larger populations to prove its effectiveness.

Short-course Versus Long-course Preoperative Radiotherapy plus Delayed Surgery in the Treatment of Rectal Cancer: a Meta-analysis

  • Liu, Shi-Xin;Zhou, Zhi-Rui;Chen, Ling-Xiao;Yang, Yong-Jing;Hu, Zhi-De;Zhang, Tian-Song
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.5755-5762
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    • 2015
  • Background: Short-course preoperative radiation (SCRT) with delayed surgery was found to increase pathologic complete response (pCR) rates in several trials. However, there was no clear answer on whether SCRT or long-course chemo-radiotherapy (LCRT) is more effective. Therefore we conducted this meta-analysis to evaluate the safety and efficacy of SCRT versus LCRT, both with delayed surgery, for treatment of rectal cancer. Materials and Methods: The literature was searched from PubMed, EMBASE, Web of Science, Cochrane Library and clinicaltrials.gov up to November, 2014. Quality of the randomized controlled trials (RCTs) was evaluated according to the Cochrane's risk of bias tool of RCT. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to rate the level of evidence. Review Manager 5.3 was employed for statistical analysis. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. Results: Three RCTs, with a total of 357 rectal cancer patients, were included in this systematic review. Metaanalysis results demonstrated there were no significantly differences in sphincter preservation rate, local recurrence rate, grade 3~4 acute toxicity, R0 resection rate and downstaging rate. Compared with SCRT, LCRT was associated with significant increase in the pCR rate [RR=0.49, 95%CI (0.31, 0.78), P=0.003]. Conclusions: In terms of sphincter preservation rate, local recurrence rate, grade 3~4 acute toxicity, R0 resection rate and downstaging rate, SCRT with delayed surgery is as effective as LCRT with delayed surgery for management of rectal cancer. LCRT significantly increased pCR rate compared with SCRT. Due to risk of bias and imprecision, further multi-center large sample RCTs were needed to confirm this conclusion.

A Review on Clinical Studies of Herbal Treatment for Infertility Caused by Polycystic Ovary Syndrome -Focusing on Chinese Clinical Trials- (다낭성 난소증후군의 난임치료에 대한 한약임상연구 경향 분석 -중국의 임상연구를 중심으로-)

  • Won, An-Na;Choi, Min-Sun;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.27 no.4
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    • pp.43-56
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    • 2014
  • Objectives: The purpose of this study is to review the trend of chinese clinical studies of herbal treatment for infertility caused by Polycystic Ovary Syndrome (PCOS). Methods: We searched the clinical studies published from 1979 to 2013 through CAJ (Chinese Academic Journal) with keywords of "PCOS and 不孕" or "多囊卵 巢綜合證 and 不孕". We analyzed the intervention type of clinical studies. In addition, We researched randomized controlled trials (RCTs) published from 2009 to 2013, assessed the quality of RCTs using the Jadad Scale and reanalyzed the intervention type of RCTs. Results: One hundred and seventeen clinical studies were finally selected. Clinical studies of herbal treatment for infertility caused by PCOS increased remarkably after the 2000s in China. Combined herbal medicine and western medicine was used the most frequently. RCTs published from 2009 to 2013 were fifty. Average of Jadad score of RCTs was 1.2. Combined herbal medicine and western medicine was also the most frequently used as intervention in RCTs. Conclusions: Clinical studies on effect of combined herbal medicine and western medicine for infertility caused by PCOS were mostly published in China. But Quality of studies was generally low. Further research on effect of herbal treatment for infertility caused by PCOS is needed.

Efficacy of Red Ginseng by Oriental Medical Obesity Syndrome Differentiation on Obese women : Randomized, Double-blind, Placebo-controlled Trial (비만 여성에서 한방 비만 변증에 따른 홍삼의 비만 개선 효과 : 무작위 배정, 이중 맹검, 위약 대조 임상시험)

  • Kwon, Dong-Hyun;Lee, Myeong-Jong;Lim, Chi-Yeon;Bose, Shambhunath;Lee, Su-Jin;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.11 no.1
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    • pp.1-14
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    • 2011
  • Objectives This trial was conducted to evaluate the efficacy of Red Ginseng by oriental medical obesity syndrome differentiation on obese women as compared to placebo. Methods 50 obese women were recruited and randomized to receive Korean Red Ginseng(n=24) or placebo(n=26) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure, pulse rate, resting metabolic rate, Korean version of obesity-related quality of life(KOQOL) scale and oriental medical obesity syndrome differentiation questionnaire were measured at baseline and 8 weeks. Adeverse events and safety outcomes variables were also checked during trials. Results and Conclusion There was significant efficacy of Red Ginseng on obese women in body weight, body fat mass, waist-hip ratio, food intake, KOQOL as compared with baseline. But there was no efficacy as compared with placebo group except KOQOL. There was no difference of efficacy compared with the oriental medical obesity syndrome differentiation.

Impact of GNB3, ADRB3, UCP2, and PPAR${\gamma}$-Pro12Ala polymorphisms on Boiogito response in obese subjects : A randomized, double-blind, placebo-controlled trial (방기황기탕의 유전자 다형성에 따른 비만 치료 효과 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Bose, Shambhunath;Lim, Chi-Yeon;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.12 no.2
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    • pp.28-43
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    • 2012
  • Objectives: The aim of the study was to investigate the efficacy of Boiogito for obesity. We examined the efficacy of Boiogito for obese patients and we expected the reaction of Boiogito would vary according to the single nucleotide polymorphism(SNPs). Methods: 111 subjects(body mass index${\geq}25m/kg^2$) were recruited and randomized to receive Boiogito(n=55) or Placebo(n=56) for 8weeks. Anthropometric factors, serum lipid profile, glucose, blood pressure(BP), pulse rate, resting metabolic rate and Korean version of obesity-related quality of life(KOQOL) scale measured at baseline and 8weeks. SNPs(${\beta}3$-adrenergic receptor(ADRB3), G protein ${\beta}3$(GNB3), peroxisome proliferator activated receptor gamma 2 gene(PPAR-${\gamma}2$), uncoupling protein(UCP2)) were conducted at baseline. Adverse reactions and safety outcome variables were also checked during trials. Results: Both groups showed significant improvement on obesity after treatment. Boiogito group decreased triglyceride than did control group and improved KOQOL. Boiogito showed a significant higher efficacy in C/T and T/T genotype of GNB3 gene / in Trp64 and Arg64 genotype of ADRB3 gene / in D/D genotype of UCP2 gene / in Pro/Pro genotype of PPAR-${\gamma}$ gene. Conclusions: Boiogito promoted obesity indexes without severe adverse reactions and proved its safety. Pharmacogenetical studies of Boiogito on obesity could be a effective method for the individualized treatment and prevention of obesity.