• Title/Summary/Keyword: Randomized Clinical Trials

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Investigation of Clinical Research of Acupuncture Intervention in Assisted Reproductive Technology in Pubmed (보조생식술에 있어서 침의 중재에 대한 임상연구 동향 - Pubmed를 중심으로 -)

  • Bae, Geung-Mee;Cho, Hye-Sook;Lee, Seung-Hwan;Lee, In-Sun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.22 no.4
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    • pp.65-82
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    • 2009
  • Purpose: The purpose of this study is to examine acupuncture intervention suggested in the papers of assisted reproductive technology(ART, hereafter) in medicine journals and to establish the further direction. Methods: The papers published between 1996 and 2009 in Pubmed were reviewed. Results: 1. A variety of randomized controlled trials and case series were found in Pubmed concerning influence of acupuncture in ART. It was investigated into improvement of pregnancy rate, analgesic effect during oocyte retrieval, change of serum hormone, and reduction of anxiety. 2. It was on clinical pregnancy rate that main focus of the investigation was placed and the improvement of pregnancy rate differed from studies. 3. For the analgesic effect during oocyte retrieval, the electro acupuncture was mainly used and the studies reported the reduced pain rate, tiredness, and nausea. 4. Acupuncture was reported as significant in improving the state of anxiety during ART. Conclusion: It would be necessary to further study the period of acupuncture intervention, the selection of acupoint through well-designed study, and establish standard of evidence of them.

Effectiveness and Safety of Traditional East Asian Herbal Medicine as Monotherapy for Major Depressive Disorder: A Systematic Review and Meta-Analysis (주요우울장애에 대한 한약 단독치료의 효과와 안전성: 체계적 문헌고찰 및 메타분석)

  • Seung, Hye-Bin;Kwon, Hui-Ju;Kim, Sang-Ho
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.1
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    • pp.79-111
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    • 2022
  • Major depressive disorder (MDD) causes a persistent feeling of sadness and loss of interest. It can lead to emotional and physical problems. Treatments such as antidepressant and cognitive behavioral therapy for MDD have many limitations. Traditional East Asian Herbal Medicine (TEAM) is a representative modality of Complementary and Integrative Medicine (CIM) which can be used for MDD. However, no study has systematically reviewed the efficacy or safety of TEAM for MDD so far. Therefore, we performed a systematic review and meta-analysis to evaluate effectiveness and safety of TEAM as a monotherapy for MDD. We only included TEAM that could be used in context of clinical setting in Korean Medicine. Outcomes were the Hamilton Depression Rating Scale (HAMD) and total effective rate (TER). After comprehensive electronic search of 11 databases, we included 28 randomized controlled trials (RCTs) that compared HM as monotherapy with antidepressant for MDD. Meta-analysis showed that TEAM had significant benefits in reducing HAMD (MD=-0.40, 95% CI: -0.67 to -0.13, p=0.003, I2=85%) and improving TER (RR=1.06, 95% CI: 1.02 to 1.10, p=0.003, I2=0%). It also appeared to be safer than antidepressant in terms of adverse effects. Methods used for RCTs were poor and the quality of evidence was graded 'low' or 'moderate'. These findings indicate that the use of HM as a monotherapy might have potential benefits in MDD treatment as an alternative to antidepressant. However, considering the methodological quality of included RCTs, the clinical evidence is uncertain. Further well-designed RCTs are required to confirm these findings.

Efficacy and Cardiovascular Safety of Romosozumab: A Meta-analysis and Systematic Review (Romosozumab의 효과 및 심혈관계 안전성: 체계적 문헌고찰 및 메타분석)

  • Seo-Yong Choi;Jeong-Min Kim;Sang-Hyeon Oh;Seunghyun Cheon;Jee-Eun Chung
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.2
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    • pp.128-134
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    • 2023
  • Background: This systematic review and meta-analysis aimed to evaluate the efficacy and cardiovascular safety of romosozumab compared with placebo. Methods: Randomized controlled trials (RCTs) were searched from Medline, EMBASE, Cochrane Central, and Web of Science until July 2022. Primary outcomes included the change in bone mineral density (BMD) from baseline at month 6. The secondary outcomes were the change of bone turnover markers (N-terminal propeptide of type 1 procollagen (P1NP); C-terminal telopeptide of type 1 collagen (CTX)) from baseline at month 3, and the incidence of cardiovascular adverse events for the total follow-up period. Results: A total of 7 RCTs on 8,370patients were included. Romosozumab showed better effects in improving BMD in both lumbar spine and femoral neck at month 6 (standardized mean difference, SMD 2.20 [95% CI: 1.89-2.52], SMD 0.63 [95% CI: 0.41-0.86]). In contrast to placebo, romosozumab significantly increased PINP levels and reduced CTX levels at month 3 (SMD 0.93 [95% CI: 0.65-1.22], SMD -1.03 [95% CI: -1.23~ -0.82]. However, there was no significant difference in the composite incidence of cardiovascular adverse events and major adverse cardiovascular events (OR 1.16 [95% CI: 0.82-1.65], OR 1.08 [95% CI: 0.75-1.56]). Conclusion: This analysis showed that romosozumab significantly improved BMD compared to placebo and was beneficial for change in bone turnover markers. There is no significant difference in the incidence of cardiovascular adverse events compared to placebo.

The Effect of Yijung-tang for Chronic Gastritis: A Systemic Review and Meta-Analysis (만성 위염에 대한 이중탕(理中湯)의 효과 : 체계적 문헌 고찰 및 메타 분석)

  • Ye-seul Kim;Yeong-seo Lee;Kyoung-min Kim;Myung-ho Jin
    • The Journal of Internal Korean Medicine
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    • v.44 no.4
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    • pp.675-702
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    • 2023
  • Objective: This study assessed the effectiveness of using Yijung-tang to treat chronic gastritis through a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: The search was conducted using keywords such as "gastritis", "Lizhong", "Yijung", and "Chronic gastritis" on July 31, 2023. A meta-analysis was conducted according to outcome measurements, such as total effective rate (TER), Traditional chinese medicine symptom score (TSS), gastric hormones, and symptom relief time, using the Review Manager website. Results: A total of 11 RCT studies were selected. The treatment group (Yijung-tang-gagam or Yijung-tang-gagam+Western medicine) showed significant improvement effects in terms of TER, TSS, serum gastrointestinal hormones (motilin (MTL), gastrin (GAS), and somatostatin (SS)), and symptom relief time compared to the control group (Western medicine). TER-RR : 1.20, 95% CI : 1.11 to 1.30, P≤0.00001, RR : 1.21, 95% CI : 1.14 to 1.28, P≤0.00001; MTL-MD : 35.99, 95% CI : 30.79 to 41.20, P≤0.00001); GAS-MD : 103.33, 95% CI : 97.62 to 109.04, P≤0.00001); SS : MD : -37.19, 95% CI : -41.75 to -32.64, P≤0.00001; symptom relief time (nausea)-MD : -1.96, 95% CI : -2.47 to -1.45, P≤0.00001; symptom relief time (colic)-MD : -1.75, 95% CI : -2.31 to -1.18, P≤0.00001. Conclusion: This study suggests that Yijung-tang is effective against chronic gastritis. However, the number of studies was insufficient, and the diagnosis and evaluation criteria were not standardized. Furthermore, because of the low quality of the included studies, more clinical studies need to be conducted to increase the possibility of clinical use.

Effect of Hwanggigyejiomul-tang on Postoperative Breast Cancer-related Lymphedema (BCRL): A Systematic Review and Meta-analysis (수술 후 발생한 유방암 연관 림프 부종(BCRL)에 대한 황기계지오물탕(黃芪桂枝五物湯)의 효과 : 체계적 문헌 고찰 및 메타 분석)

  • Yeong-seo Lee;Ye-seul Kim;Young-kyun Kim;Kyoung-min Kim
    • The Journal of Internal Korean Medicine
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    • v.45 no.1
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    • pp.31-54
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    • 2024
  • Objectives: This study assessed the effectiveness of Hwanggigyejiomul-tang for postoperative breast cancer-related lymphedema (BCRL) by a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: A search was conducted using keywords such as "breast cancer", "lymphedema", "edema", "Huangqi Guizhi Wuwu decoction", "Huangqi Guizhi Wuwu tang", and "Hwanggigyejiomul tang" in 10 databases (PubMed, Cochrane, ScienceDirect, CNKI, CiNii, RISS, KISS, ScienceON, OASIS, DBpia) on February 11, 2024. There were no limits on the publication period and language, and the quality of the studies was evaluated using Cochrane's risk of bias tool. A meta-analysis was performed based on the outcome measurements, such as total effective rate (TER), increase in shoulder joint mobility (flexion, extension, abduction, adduction), Fugl-Meyer assessment (FMA), and visual analog scale (VAS) using Review Manager Web. Results: Eleven RCTs were selected. The treatment group (Hwanggigyejiomul-tang-gagambang or hapbang with control group intervention) showed a more statistically significant effect compared with the control group (physical therapy or western medicine) in TER (upper limb circumference change), TER (upper limb edema grade change), increase in flexion angle, increase in extension angle, increase in adduction angle, FMA, and VAS. Conclusions: Hwanggigyejiomul-tang is effective in treating postoperative BCRL. However, because of the low quality of the included studies, more clinical studies are required to increase the possibility of clinical use.

Therapeutic Effects of Acupuncture for Shoulder Impingement Syndrome: A Systematic Review and Meta-Analysis (어깨충돌증후군에 대한 침치료의 효과: 체계적 문헌고찰 및 메타분석)

  • Jeong Hoon Ahn;Gun Hee Bae;Byung-Jun Kim;In-Hwa Park;In Heo;Yun-Yeop Cha
    • Journal of Korean Medicine Rehabilitation
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    • v.34 no.1
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    • pp.83-95
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    • 2024
  • Objectives This review was conducted to evaluate the therapeutic effects of manual acupuncture (MA) for shoulder impingement syndrome (SIS). Methods We searched 12 electronic databases (DBpia, Korean studies Information Service System [KISS], Oriental Medicine Advanced Searching Integrated System [OASIS], Research Information Sharing Service [RISS], China National Knowledge Infrastructure [CNKI], CINAHL, Clinical Key, Cochrane Library, Embase, JAMA, PubMed, Web of Science) to find randomized-controlled clinical trials (RCTs) investigating therapeutic effects of MA for treating SIS. Shoulder Pain and Disability Index scores and numeric pain rating scale or visual analogue scale were analyzed as the main evaluation criteria. Results Among 181 studies, 169 were screened and only 12 RCTs were eligible in our review. Finally, 11 RCTs could be statistically analyzed. MA was more effective than sham treatment and physical therapy in terms of reducing pain (p=0.003, p=0.0007 each). Electroacupuncture (EA) showed more significant effect than physical therapy (PT) for improving shoulder pain (p<0.00001) and shoulder functionality (p<0.00001). Conclusions These results suggest that MA and EA could be superior option for treating SIS than sham treatment or PT. However this review has its limitations due to the small sample size and lack of well-designed RCTs that were included in the study. Further well-designed RCTs are necessary to provide high-level evidence.

Trends in Research on Patients With COVID-19 in Korean Medical Journals

  • Heejeong Choi;Seunggwan Song;Heesang Ahn;Hyobean Yang;Hyeonseong Lim;Yohan Park;Juhyun Kim;Hongju Yong;Minseok Yoon;Mi Ah Han
    • Journal of Preventive Medicine and Public Health
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    • v.57 no.1
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    • pp.47-54
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    • 2024
  • Objectives: This study was conducted to systematically summarize trends in research concerning patients with coronavirus disease 2019 (COVID-19) as reported in Korean medical journals. Methods: We performed a literature search of KoreaMed from January 2020 to September 2022. We included only primary studies of patients with COVID-19. Two reviewers screened titles and abstracts, then performed full-text screening, both independently and in duplicate. We first identified the 5 journals with the greatest numbers of eligible publications, then extracted data pertaining to the general characteristics, study population attributes, and research features of papers published in these journals. Results: Our analysis encompassed 142 primary studies. Of these, approximately 41.0% reported a funding source, while 3.5% disclosed a conflict of interest. In 2020, 42.9% of studies included fewer than 10 participants; however, by 2022, the proportion of studies with over 200 participants had increased to 40.6%. The most common design was the cohort study (48.6%), followed by case reports/series (35.2%). Only 3 randomized controlled trials were identified. Studies most frequently focused on prognosis (58.5%), followed by therapy/intervention (20.4%). Regarding the type of intervention/exposure, therapeutic clinical interventions comprised 26.1%, while studies of morbidity accounted for 13.4%. As for the outcomes measured, 50.7% of studies assessed symptoms/clinical status/improvement, and 14.1% evaluated mortality. Conclusions: Employing a systematic approach, we examined the characteristics of research involving patients with COVID-19 that was published in Korean medical journals from 2020 onward. Subsequent research should assess not only publication trends over a longer timeframe but also the quality of evidence provided.

A Comparative Study on the Clinical Efficacy and Safety between Combination Therapy with CDK 4/6 Inhibitor and AI Versus AI Monotherapy in HR+/HER type2- Advanced Breast Cancer: Updated Meta-analysis (메타분석을 이용한 호르몬 수용체 양성/인체 상피세포 성장 인자 수용체 음성 진행성 유방암에서 사이클린 의존성 인산화효소 4/6 억제제와 방향화효소 억제제 병용요법과 방향화효소 억제제 단독요법의 임상적 유효성 및 안전성 비교 연구)

  • Kim, Min Ji;Kim, Kyung;Cho, MoonKyoung;Sohn, KieHo;Baek, In-hwan
    • Korean Journal of Clinical Pharmacy
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    • v.30 no.1
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    • pp.1-10
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    • 2020
  • Objective: The aim of the study was to perform a meta-analysis of randomized clinical trials to compare the clinical efficacy and safety between combination of cyclin-dependent kinase (CDK) 4/6 inhibitors with aromatase inhibitors (AIs) and AIs alone in patients with hormone receptor+/human epidermal growth factor receptor type2-(HR+/HER2-) advanced breast cancer. Methods: Published clinical studies were identified through electronic database searches until February 2019. Literature qualities were assessed by the Scottish Intercollegiate Guidelines Network Checklist. Key endpoints of efficacy were progression-free survival (PFS), objective response rate (ORR), and clinical benefit (CB). Endpoints of safety were adverse events (AEs) (neutropenia, leukopenia, any grade 3/4 AEs, and serious AEs) and on-treatment death. Meta-analysis was performed using the RevMan 5.3 software. Results: The selected five studies were evaluated as "good" in quality assessment. Compared to AIs alone, the combination therapy significantly improved PFS (pooled hazard ratio=0.55; 95% confidence interval (CI) 0.49-0.62), ORR (odds ratio=1.78; 95% CI=1.49-2.13), and CB (odds ratio=1.86; 95% CI=1.51-2.28). The prevalence of AEs was significantly higher in the combination group than in the AIs alone group. On-treatment death was greater in the combination group than in the AIs alone group, although insignificant. Conclusion: The combination therapy of CDK4/6 inhibitors with AIs was more effective for the treatment of HR+/HER2- advanced breast cancer, but less safe than AIs alone. The combination therapy should be effectively managed through patient monitoring, and further studies are needed to reduce AEs in the combination therapy of CDK4/6 inhibitors with AIs.

Review of Clinical Research Literatures on Effect of Traditional Chinese Medicine for Pediatric Night Crying (야제 (夜啼)의 한의학 치료에 대한 최신 중의학 임상 연구 동향 -2000년대 이후 발표된 임상 연구 논문을 중심으로-)

  • Kim, Sang Min;Lee, Jin Yong;Lee, Sun Haeng;Doh, Tae Yun
    • The Journal of Pediatrics of Korean Medicine
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    • v.32 no.3
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    • pp.100-118
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    • 2018
  • Objectives The purpose of this study is to analyze some of the TCM (traditional Chinese medicine) clinical research literatures about pediatric night crying in order to learn clinical application of Korean medicine treatment for pediatric night crying. Methods We searched clinical trial literatures about TCM treatment of pediatric night crying from the CNKI (China National Knowledge Infrastructure) (January 2000 to June 2018). We analyzed the literature in regards to the treatment methods and the results. Results Among the 459 searched studies, 13 randomized controlled trials and 41 case studies were selected and analyzed. In most of the studies, the effectiveness of TCM in treating patients was significantly high, so we confirmed the effectiveness of TCM on pediatric night crying. The most commonly used pattern differentiations (辨證) were Spirit damage due to fright and fear (驚恐傷神), Spleen deficiency and cold (脾虛寒) and Heart fire heat (心火熱). Methods of treatment include herbal medicines (internal medicine and external application), massage therapy (Tuina methods), acupuncture and other treatments (bloodletting). The most commonly used herb medicines were Cicadidae Periostracum (蟬?), Poria Cocos (茯?), Glycyrrhizae Radix (甘草), Uncariae Ramulus et Uncus (釣鉤藤), Junci Medulla (燈心草), Fossilia Ossis Mastodi (龍骨), Atractylodis Rhizoma Alba (白朮), Cinnabaris (朱砂), and Coptidis Rhizoma (黃連). The most commonly used massage methods were Clearing Liver Channel (淸肝經), Clearing Heart Channel (淸心經), Kneading $Xi{\check{a}}oti{\bar{a}}nx{\bar{i}}n$ (?小天心), Supplementing Spleen Channel (補脾經), Clearing $Ti{\bar{a}}nh{\acute{e}}shu{\check{i}}$ (淸天河水), and Rubbing Abdomen (摩腹). Conclusions Based on the results of clinical studies from China, the use of Korean medicine for the treatment of pediatric night crying has been shown to be effective in relieving symptoms. Based on the results of this study, it is possible to widen the scope of Korean medicine by additionally reviewing clinical and experimental studies on pediatric night crying.

Research Trends of Fermented Medicinal Herbs - Based on Their Clinical Efficacy and Safety Assessment (발효한약의 최근 연구 동향 - 안전성과 유효성 기반)

  • Choi, Yun-Kyung;Sul, Jae-Uk;Park, Seoul-Ki;Yu, Sun-Nyoung;Kim, Sang-Hun;Rhee, Moon-Soo;Ahn, Soon-Cheol;Shin, Mi-Sook
    • Journal of Life Science
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    • v.22 no.12
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    • pp.1729-1739
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    • 2012
  • The aim of this study was to evaluate the clinical efficacy and safety of fermented medicinal herbs. A search of the China National Knowledge Infrastructure (CNKI), PubMed databases and Korean Journal of Oriental Medicine in 2000-2011 located 11 randomized controlled trials (RCTs) that investigated the clinical efficacy of fermented medicinal herbs. Domestic RCTs reported clinical efficacy on improvement of immune responses and clinical safety on usage of fermented medicinal herbs in subjects suffering from cerebral hemodynamics. Countries other than Chinareported studies on the cause of esophageal cancer and on local inflammatory reactions. In China, studies were reported on the effectiveness of fermented medicinal herbs on scapulohumeral periarthritis of the stasis type, chronic superficial gastritis, dysuria induced by benign prostatic hyperplasia of deficiency of kidney yang, diabetic nephropathy, essential hypertension, and benign prostate hyperplasia. These results indicate that fermented medicinal herbs have obvious clinical effects in some diseases and no adverse reactions. Therefore, we need to initiate more fermentation research with useful bacteria, fungi, and mushrooms to produce fermented medicinal herbs. Both governments and research authorities should focus on research involving fermentation of medicinal herbs.