• Title/Summary/Keyword: Randomized Clinical Trials

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Comparison of pregnancy outcomes using a time-lapse monitoring system for embryo incubation versus a conventional incubator in in vitro fertilization: An age-stratification analysis

  • Chera-aree, Pattraporn;Thanaboonyawat, Isarin;Thokha, Benjawan;Laokirkkiat, Pitak
    • Clinical and Experimental Reproductive Medicine
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    • v.48 no.2
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    • pp.174-183
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    • 2021
  • Objective: The aim of this study was to compare the pregnancy outcomes of in vitro fertilization with embryo transfer between embryos cultured in a time-lapse monitoring system (TLS) and those cultured in a conventional incubator (CI). Methods: The medical records of 250 fertilized embryos from 141 patients undergoing infertility treatment with assisted reproductive technology at a tertiary hospital from June 2018 to May 2020 were reviewed. The study population was divided into TLS and CI groups at a 1 to 1 ratio (125 embryos per group). The primary outcome was the live birth rate. Results: The TLS group had a significantly higher clinical pregnancy rate (46.4% vs. 27.2%, p=0.002), implantation rate (27.1% vs. 12.0%, p=0.004), and live birth rate (32.0% vs. 18.4%, p=0.013) than the CI group. Furthermore, subgroup analyses of the clinical pregnancy rate and live birth rate in the different age groups favored the TLS group. However, this difference only reached statistical significance in the live birth rate in women aged over 40 years and the clinical pregnancy rate in women aged 35-40 years (p=0.048 and p=0.031, respectively). The miscarriage rate, cleavage rate, and blastocyst rate were comparable. Conclusion: TLS application improved the live birth rate, implantation rate, and clinical pregnancy rate, particularly in the advanced age group in this study, while the other reproductive outcomes were comparable. Large randomized controlled trials are needed to further explore the ramifications of these findings, especially in different age groups.

Suggestions for Potentially Useful Herbal Medicines for Treating Insomnia in COVID-19 Era: A Mini-Review

  • Suh, Hyo-Weon;Kwon, Chan-Young;Kim, Jong Woo
    • Journal of Oriental Neuropsychiatry
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    • v.32 no.2
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    • pp.95-109
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    • 2021
  • Objectives: The coronavirus disease 2019 (COVID-19) has become a global pandemic. Mental sequelae occurring in patients with COVID-19 and the general population are important concerns. In Korea, herbal medicine is used nationwide to respond to this pandemic. It can be prescribed by COVID-19 telemedicine center of Korean medicine (KM). Among some herbal medicines, Gamiguibi-tang is the only herbal medicine prescribed for individuals with mental health, especially for those with insomnia. In this mini-review, the objective of this study was to summarize the evidence of some promising herbal medicines available for treating primary insomnia based on existing clinical and preclinical studies. Methods: A research team was formed for KM clinical practice guidelines for insomnia (version 1.0). Team members were provided with a list of references of relevant herbal medicines for insomnia. To gather evidence from clinical studies with appropriate sample sizes, among the list of references, randomized controlled trials for primary insomnia that included 50 subjects or more per arm and used herbal medicine were included in the final analysis. Moreover, pre-clinical studies examining the mechanism of action of each herbal medicine and studies on herb-drug interactions, were searched and summarized. Results: Four herbal medicines (Ondam-tang, Sanjoin-tang, Guibi-tang, and Hyeolbuchugeo-tang) were reviewed based on existing clinical and preclinical studies. Based on findings of existing studies, some suggestions of herbal medicines for insomnia in the COVID-19 era in Korea were suggested. Conclusions: Data of this study could be used to prepare a future revision of the manual of COVID-19 telemedicine center of KM.

A Systematic Review on the Treatment of Post-Stroke Patients Based on Sasang Constitutional Medicine (사상의학적 중풍 후유증 치료에 대한 체계적 문헌 고찰)

  • Oh, Hyunjoo;Lee, Jeongyun;Lee, Hyeri;Lee, Junhee
    • Journal of Sasang Constitutional Medicine
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    • v.34 no.2
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    • pp.48-64
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    • 2022
  • Objectives The purpose of this study was to review and evaluate the clinical evidence of the efficacy and safety of treatment based on Sasang constitutional medicine (SCM) for post-stroke patients by systematic review and meta-analysis. Methods Randomized controlled trials (RCTs), published in 10 electronic databases up to December 2020, were searched. For the included studies, Cochrane's risk of bias assessment was performed to analyze the methodological quality. The strength of evidence was evaluated using the grading of recommendations assessment, development, and evaluation system based on the results of analyses. All review processes were performed by two independent researchers. Results Five RCTs were finally included. All included RCTs were conducted for one month on post-stroke patients in 60-80s, four studies on Tae-Eum patients and one study on So-Yang patients. Four types of constitution-specific herbal medicine (Chungpyesagan-tang, Cheongsimsanyak-tang, Yeoldahanso-tang, and Yangkyuksanhwa-tang) and constitution-specific acupuncture therapy were identified as interventions. More than half of the included studies were evaluated as low quality due to the high-risk of bias in selection, performance, and detection. The combination of constitution-specific herbal medicine, acupuncture, and conventional treatment was more effective in improving the patients' motor impairment, dysphagia, aphasia, and depression than conventional treatment alone. No serious adverse events by SCM treatment were reported. Conclusions SCM treatment may improve the sequelae of post-stroke patients safely in combination with conventional treatment. Since the quality of clinical evidence included in this study was low, higher quality clinical evidence obtained in well-designed clinical studies will be needed.

A Scoping Review of Herbal Medicine for Depression in Adolescents and Young Adults (청소년기 우울증의 한약치료에 관한 주제범위 문헌고찰)

  • Kim, Ye Ji;Seo, Hae Sun;Kim, Sang Min;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.2
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    • pp.26-39
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    • 2022
  • Objectives The purpose of this study was to collect reported but scattered data on herbal medicine treatment for depression in adolescents and young adults and to establish future research directions for this topic. Methods Using the scoping review method, 10 Korean and foreign databases were searched for studies published up to March 22, 2022. Studies targeting children and adolescents diagnosed with depression, studies using herbal medicine treatments, and clinical studies were included. Results Twelve randomized clinical trials, two chart reviews, and six case reports were identified. Frequently used Korean medical patterns, treatment methods, herbal medicines, decoctions, treatment periods, and post-treatment evaluation results were analyzed. Differences in the confirmed results from actual clinical settings were reviewed, and the direction of follow-up research on this topic was suggested. Conclusions This study outlined the results of various levels of clinical research on herbal medicine treatment for depression in adolescents and young adults, showed the clinical availability of herbal medicine, and provided a foundation for future research.

The effects of maternal-child nursing clinical practicum using virtual reality on nursing students' competencies: a systematic review (가상현실을 이용한 모아간호 실습교육이 간호 대학생의 실습역량에 미치는 영향: 체계적 문헌고찰)

  • Hwang, Sungwoo;Kim, Hyun Kyoung
    • Women's Health Nursing
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    • v.28 no.3
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    • pp.174-186
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    • 2022
  • Purpose: This study aimed to investigate the effects of virtual reality used in maternal-child nursing clinical practicums on nursing students' competencies through a systematic review. Methods: The inclusion criteria were peer-reviewed papers in English or Korean presenting analytic studies of maternal-child nursing practicums using virtual reality. An electronic literature search of the Cochrane Library, CINAHL, EMBASE, ERIC, PubMed, and Research Information Sharing System databases was performed using combinations of the keywords "nursing student," "virtual reality," "augmented reality," "mixed reality," and "virtual simulation" from February 4 to 15, 2022. Quality appraisal was performed using the RoB 2 and ROBINS-I tools for randomized controlled trials (RCTs) and non-RCTs, respectively. Results: Of the seven articles identified, the RCT study (n=1) was deemed to have a high risk of bias, with some items indeterminable due to a lack of reported details. Most of the non-RCT studies (n=6) had a moderate or serious risk of bias related to selection and measurement issues. Clinical education using virtual reality had positive effects on knowledge, skills, satisfaction, self-efficacy, and needs improvement; however, it did not affect critical thinking or self-directed learning. Conclusion: This study demonstrated that using virtual reality for maternal-child nursing clinical practicums had educational effects on a variety of students' competencies. Considering the challenges of providing direct care in clinical practicums, virtual reality can be a viable tool that supplements maternal-child nursing experience. Greater rigor and fuller reporting of study details are required for future research.

Acupuncture and Moxibustion for Cancer-related Fatigue: a Systematic Review and Meta-analysis

  • He, Xi-Ran;Wang, Quan;Li, Ping-Ping
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.5
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    • pp.3067-3074
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    • 2013
  • Background: Faced with highly prevalent and recalcitrant cancer-related fatigue (CRF), together with the absence of any official guidelines on management, numerous groups have been striving to seek and test alternative therapies including acupuncture and moxibustion. However, different patients have various feedbacks, and the many clinical trials have given rise to varied conclusions. In terms of the therapeutic effect of acupuncture and moxibustion, there exist vast inconsistencies. Objective: The aim of the study was to evaluate the auxiliary effectiveness of acupuncture and moxibustion in the treatment of CRF, and to provide more reliable evidence to guide clinical practice. Methods: Randomized controlled trials (RCTs) published before December 2012 were all aggregated, focusing on evaluation of acupuncture or moxibustion for CRF. The quality of the included studies was assessed basing on Cochrane handbook 5.1.0, and the available data were analyzed with RevMan software (version 5.2.0). Descriptive techniques were performed when no available data could be used. Results: A total of 7 studies involving 804 participants were eligible. With real acupuncture versus sham acupuncture, subjects receiving true acupuncture benefited more in the reduction of fatigue. With real acupuncture versus acupressure or sham acupressure, fatigue level appeared 36% improved in the acupuncture group, but 19% in the acupressure group and only 0.6% with sham acupressure. When real acupuncture plus enhanced routine care was compared with enhanced routine care, the combination group improved mean scores for general fatigue, together with physical and mental fatigue. With real acupuncture versus sham acupuncture or wait list controls, the real acupuncture group displayed significant advantages over the wait list controls at 2 weeks for fatigue improvement and better well-being effects at 6 weeks. When moxibustion plus routine care was compared with routine care alone, the meta-analyses demonstrated the combination had a relatively significant benefit in improving severe fatigue and QLQ-C30. Conclusion: Up to the search date, there exist few high quality RCTs to evaluate the effect of acupuncture and moxibustion, especially moxibustion in English. Yet acupuncture and moxibustion still appeared to be efficacious auxiliary therapeutic methods for CRF, in spite of several inherent defects of the included studies. Much more high-quality studies are urgently needed.

Root coverage using a coronally advanced flap with or without acellular dermal matrix: a meta-analysis

  • Guan, Wei;Liao, Haiqing;Guo, Li;Wang, Changning;Cao, Zhengguo
    • Journal of Periodontal and Implant Science
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    • v.46 no.1
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    • pp.22-34
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    • 2016
  • Purpose: Gingival recession is a major esthetic concern and may lead to root sensitivity during periodontal treatment. Coronally advanced flaps (CAFs) with and without acellular dermal matrix (ADM) are widely used in root coverage procedures. The aim of this study was to analyze the efficacy of CAF in combination with ADM in the treatment of gingival recession. Methods: PubMed, The Cochrane Library, and Embase were used to identify relevant articles. The articles were screened, data were extracted, and the quality of the studies was assessed by three reviewers with expertise in clinical practice, trials, statistics, and biomedical editing. The clinical endpoints of interest included changes in recession, probing depth (PD), clinical attachment level (CAL), and keratinized tissue (KT). Results: Ten randomized controlled trials were identified, including six studies that compared CAFs with ADM and CAFs using connective tissue grafting (CTG) and four studies that compared CAFs with or without ADM. No statistically significant differences were found between the use of ADM and CTG, whereas statistically significant differences were found between groups in which ADM and CAF were combined and groups that underwent CAF alone with regard to recession coverage, CAL, and KT. The combination of CAF with an ADM allograft achieved more favorable recession coverage and recovery of CAL and KT than CAF alone. Conclusions: The results from the ADM and CTG groups suggest that both procedures may be equally effective in clinical practice. Given the limitations of this study, further investigation is needed to clarify the effectiveness of ADM and CAF in clinical practice.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • v.23 no.6
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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A Systematic Review on the Reporting Quality of Acupuncture Treatment for Carpal Tunnel Syndrome (손목터널증후군에 사용된 침 치료 보고의 질 평가)

  • Hyun, Ji-Yoon;Shin, Joo-eun;Im, Chae-Jeong;Park, Ji-Yeun
    • Korean Journal of Acupuncture
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    • v.37 no.3
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    • pp.131-144
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    • 2020
  • Objectives : The aim of this study is to analyze the details of acupuncture treatment methods and the reporting quality of acupuncture on Carpal Tunnel Syndrome (CTS). Methods : Search was conducted in Pubmed, EMBASE, and Cochrane Library for acupuncture studies on CTS. The reporting quality of acupuncture treatment was assessed using the following guidelines: Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) for analyzing the method of acupuncture treatment, Consolidated Standards of Reporting Trials (CONSORT) for analyzing study design and study process, and Risk of Bias (ROB) for analyzing bias. The number of reported items was calculated and evaluated as a proportion. The reported proportion of each study was classified into three grades: Grade A (% score ≥75), Grade B (50≤ % score <75), and Grade C (% score <50). Results : A total of 9 Randomized Controlled Trials (RCTs) were included in this study. All trials reported 12 items (66.67%) on average in STRICTA guidelines. Five studies were conducted with manual acupuncture and 3 studies were conducted with electroacupuncture. PC7 (Daereung) was most frequently used to treat CTS. In STRICTA guideline evaluation, 3 studies were classified as Grade A, 5 studies were classified as Grade B, and 1 study was classified as Grade C. In the CONSORT statement assessment, all trials reported an average of 20.56 items. Of the 9 RCTs, 6 studies were classified as Grade B and 3 studies were classified as Grade C. In ROB assessment, most studies showed a low (63.49%) or unclear (26.98%) risk of bias. The selective reporting bias and the incomplete outcome data bias were found to have the lowest risk of bias, and the allocation concealment of selection bias was found to have the most unclear risk of bias. Conclusions : Recent acupuncture studies on CTS showed moderate reporting quality. However, more detailed reports on acupuncture are still needed to establish more solid evidence of acupuncture treatment.

Role of Multislice Computerized Tomographic Angiography in Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

  • Park, Dong-Mook;Kim, Young-Don;Hong, Dae-Young;Choi, Gi-Hwan;Yeo, Hyung-Tae
    • Journal of Korean Neurosurgical Society
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    • v.39 no.5
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    • pp.347-354
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    • 2006
  • Objective : We evaluate the role of multislice computerized tomographic angiography[MCTA] in the diagnosis of intracranial vasospasm following subarachnoid hemorrhage[SAH] in patients suspected of having vasospasm on clinical ground. Methods : Between October 2003 and June 2005, patients with ruptured cerebral aneurysms of the anterior circulation clipped within 3 days of the onset were included. We performed follow-up MCTAs in patients who were suspected to have vasospasm on transcranial doppler sonography[TCD] findings and clinical grounds. Based on the clinical presentation of symptomatic vasospasm, we investigated the correlation between clinical, TCD, and MCTA signs of vasospasm and evaluated the role of MCTA in vasospasm. Results : One hundred one patients met the inclusion criteria and symptomatic vasospasm developed in 25 patients [24.8%]. We performed follow-up MCTAs in 28 patients. MCTA revealed spasm in the vessels of 26 patients. The sensitivity of MCTA was 100%. Among the 26 patients with MCTA evidence of vasospasm, 3 patients had TCD signs of vasospasm after symptomatic vasospasm presentation. Another 3 patients with symptomatic vasospasm had no TCD signs of vasospasm in daily serial recordings. Six other patients without symptomatic vasospasm showed MCTA evidence of vasospasm [false positive result] but these patients had also positive TCD signs of vasospasm. Volume rendering[VR] images tended to show significantly more exaggerated vasospasm than maximum intensity projection[MIP] images. The mean cerebral blood flow velocity of both proximal segment of the middle cerebral artery [M1] was significantly correlated with each reduced M1 diameter on MCTA [P<005]. Conclusion : MCTA could be a useful tool for evaluation and planning management of critically ill patients suspected of having vasospasm; however, more randomized controlled trials are necessary to assess these points definitively.