• Title/Summary/Keyword: randomized clinical trials

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Investigation of Various Remedies of Ovarian Cyst except Oral Decoction of Medical Ingredients in Chinese Medicine Journals (경구탕액요법(經口湯液療法)을 제외한 난소낭종의 다양한 치료법에 대한 조사 연구 - 중의학 논문을 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.3
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    • pp.152-168
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    • 2009
  • Purpose: The purpose of this study is to examine remedies suggested in the papers of ovarian cyst in Chinese Medicine Journals and to establish the further direction. Methods: The papers published between 1994 and 2009 in China Academic Journal were reviewed. Results: 1. It was on Bo-Ryu Enema that main focus of investigation was placed. A variety of randomized controlled trials and case series were found. As a result, a lot of proper manual arts and prescriptions were provided out of them. 2. Acupuncture is reported as significant in reducing the size of ovarian cyst and improving clinical symptoms, which covers electrical acupuncture, enlongated needle and moxibustion, burning acupuncture. 3. External application was verified as an effective therapy for the case of a combined treatment with oral medicine. 4. Modern medical equipments such as ultra short wave medical cure, TDP could improve the efficiency of traditional remedies like Bo-Ryu Enema, external application. Conclusion: It would be necessary to practically come up with a diversity of remedies besides oral decoction of medical ingredients, and establish standard of evidence of them.

Can Sodium Citrate Effectively Improve Olfactory Function in Non-Conductive Olfactory Dysfunction? (Sodium Citrate가 효과적으로 비전도성 후각장애에 치료효과를 보일 수 있을지에 대한 문헌 고찰)

  • Kim, Subin;Kang, Haram;Jin, Ho Jun;Hwang, Se Hwan
    • Korean Journal of Otorhinolaryngology-Head and Neck Surgery
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    • v.62 no.2
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    • pp.75-81
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    • 2019
  • The objective of this study was to perform a systematic review of the literature for application of intranasal sodium citrate in the patients with olfactory dysfunction to help determine the sodium citrate treatments for this condition. Two authors independently searched the data base (Medline, Scopus, and the Cochrane database) for relevant studies from inception to January 2018. Included studies were randomized controlled studies published in English comparing topical sodium citrate application (treatment group) with saline (control group) in patients who had olfactory dysfunction. Outcomes of interest included the change of olfactory identification and threshold during 2 hours post-treatment. Three studies were enrolled in the meta-analysis. Compared with control group, treatment group did not increase posttreatment score of olfactory identification [standardized mean difference (SMD)=-0.03; 95% confidence interval (CI)=-0.29-0.24; I2=0%] and olfactory threshold (SMD=0.18; 95% CI=-0.09-0.45; I2=0%) significantly. In the degree of pre-post improvement of two outcomes, although treatment group statistically showed the significant improvement in olfactory threshold (SMD=0.30; 95% CI=0.05-0.55; I2=17%), the clinical significance of this outcome was meaningless. Similarly, there was no significant difference in olfactory identification between two groups (SMD=0.17; 95% CI=-0.11-0.45; I2=22%). Unlike the recent favorable results, our summated results presented the uselessness for the local application of sodium citrate in improving patient's olfactory function. However, we also had some limitation such as small sample size and inconsistent application methods. Therefore, larger trials and standardized methodology are needed to reach more stronger and exact results.

Prognosis of Unrepaired Ascending Aorta after the Surgical Replacement of Bicuspid Aortic Valves

  • Hong Ju Shin;Wan Kee Kim;Dong Kyu Kim;Ho Jin Kim;Joon Bum Kim
    • Journal of Chest Surgery
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    • v.56 no.4
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    • pp.255-261
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    • 2023
  • Background: The surgical threshold for bicuspid aortic valve (BAV)-related aortopathy is a matter of debate due to its uncertain etiology and prognosis. This study investigated the prognosis of unrepaired BAV aortopathy in patients undergoing surgical aortic valve replacement (SAVR). Methods: We retrospectively analyzed data from 720 patients (age, 60.8±11.5 years; 246 women) who underwent SAVR for BAV disease without aortic repair between 2005 and 2020 at Asan Medical Center. The clinical endpoints were defined as occurrences of sudden death, aortic dissection or rupture, and elective aortic repair. To estimate postoperative changes in the dimensions of the unrepaired aorta, the individual annual aortic expansion rate was calculated. Multiple linear regression models were used to evaluate the risk of aortic expansion. Results: The mean ascending aortic diameter was 39.5±4.6 mm, and 299 patients (41.5%) had a baseline ascending aorta diameter >40 mm. During 70.0±68.3 months of follow-up, the mean annual aortic expansion rate was 0.39±1.96 mm/yr, no aortic dissection or rupture was observed, and sudden deaths were reported in 12 patients (0.34% per person-year). Linear regression analysis revealed no significant correlation between the baseline ascending aortic diameter and postoperative aortic expansion (R2=0.004, β=-0.84, p=0.082). Conclusion: In selected patients undergoing SAVR for a BAV (<55 mm), the risk of adverse aortic events was very low. As this observation contradicts current practice guidelines advocating for proactive aortic replacement in dilated ascending aortas measuring >45 mm, the study results need further validation by studies involving larger populations or randomized controlled trials.

The Effects of Digital Therapy for Stroke Patients in Korea: Meta-analysis (국내 뇌졸중 환자를 위한 디지털 치료의 효과: 메타분석)

  • Jae-Hun Jung
    • Journal of The Korean Society of Integrative Medicine
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    • v.11 no.4
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    • pp.1-15
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    • 2023
  • Purpose : This study investigates the effectiveness of digital therapy for stroke patients in Korea. Methods : A comprehensive database search was performed using KCI, Science on, e-article, RISS, KISS and Korea OpenMed databases for randomized controlled trials (RCTs) that studied the effects of digital therapy on patients who had a stroke. This study includes RCTs published from January 2000 to July 15, 2022, which fulfilled the inclusion and exclusion criteria. A total 697 studies were screened and 30 studies were included in the final analysis. Methodological quality was assessed with the Cochrane's RoB (risk of bias) tool. Meta-analysis was performed using CMA 4.0 software. Results : A total of 56 effect sizes were calculated from the 30 selected studies. As a result of the analysis, the overall effect size of digital therapy was .59 (95 % CI=.43-.74). When classified according to type of intervention, VR (virtual reality) (g=.58, 95 % CI=.40-.75), and CACR (computer assisted cognitive rehabilitation) (g=.62, 95 % CI=.30-.95) were statistically significant. VR showed medium to large effect sizes in cognitive function (g=.78, 95 % CI=.20-1.37), psychosocial function (g=.63, 95 % CI=.20-1.07), and physical function (g=.61, 95 % CI=.38-.83). In the CACR, there was a large effect size in cognitive function (g=.84, 95 % CI=.52-1.15), but there was no significant difference in psychosocial function. Also, there was no significant difference between the two interventions in activities of daily living and no significant difference in the effect size of both interventions according to the intervention session. Furthermore, medium to large effect sizes were found for subacute and chronic stroke patients according to the duration of disease. Conclusion : This study presents evidence that digital therapy has a positive effect on various functions of stroke patients in Korea. The researchers expect to actively accept the new paradigm of digital therapy and continue to apply digital therapy in clinical practice.

Hybrid argon plasma coagulation in Barrett's esophagus: a systematic review and meta-analysis

  • Sagar N. Shah;Nabil El Hage Chehade;Amirali Tavangar;Alyssa Choi;Marc Monachese;Kenneth J. Chang;Jason B. Samarasena
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.38-49
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    • 2023
  • Background/Aims: Patients with Barrett's esophagus are at increased risk of developing esophageal adenocarcinoma. Endoscopic therapies aim to eradicate dysplastic and metaplastic tissues. Hybrid argon plasma coagulation (hybrid-APC) utilizes submucosal fluid injection to create a protective cushion prior to ablation that shields the submucosa from injury. We performed a pooled meta-analysis to evaluate the safety and efficacy of hybrid-APC. Methods: We conducted a systematic search of major electronic databases in April 2022. Studies that included patients with dysplastic and non-dysplastic Barrett's esophagus undergoing treatment with hybrid-APC were eligible for inclusion. Outcome measures included complete remission of intestinal metaplasia (CR-IM), stricture formation, serious adverse events, and number of sessions necessary to achieve CR-IM. Results: Overall pooled CR-IM rate for patients undergoing hybrid-APC was 90.8% (95% confidence interval [CI], 0.872-0.939; I2=0%). Pooled stricture rate was 2.0% (95% CI, 0.005-0.042; I2=0%). Overall serious adverse event rate was 2.7% (95% CI, 0.007-0.055; I2=0%). Conclusions: Results of the current meta-analysis suggest that hybrid-APC is associated with high rates of CR-IM and a favorable safety profile. Interpretation of these results is limited by the inclusion of retrospective cohort and case series data. Randomized controlled trials that standardize treatment and outcome evaluation protocols are necessary to understand how this treatment option is comparable to the current standards of care.

A Systematic Review of Traditional Herbal Medicine Treatments for Metabolic Syndrome in Patients Receiving Antipsychotic Drugs (항정신병약물 복용 환자의 대사증후군에 대한 한약치료의 체계적 문헌고찰)

  • Sun-Woo Lim;O-Reun Park;So-Hyeon Park;Sung-Youl Choi;Bo-Kyung Kim;Jung-Hwa Lim
    • Journal of Oriental Neuropsychiatry
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    • v.35 no.1
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    • pp.69-99
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    • 2024
  • Objectives: This study aimed to systematically review the effectiveness and safety of traditional herbal medicine treatments for metabolic syndrome (MS) in patients receiving antipsychotic drugs (APs). Methods: We searched 11 domestic and foreign databases for randomized controlled trials (RCTs) using traditional herbal medicines for MS in patients receiving APs. Results: Twenty RCTs conducted in China were included in the analysis. The most common disease among the participants was schizophrenia. Most studies used the 2004 Chinese Diabetes Society (CDS) standards as the diagnostic criteria for MS. The most used prescription was Yukultang (Liuyu-tang). The most used herbal material was Pinelliae Rhizoma, followed by Poria, Citri Reticulatae Pericarpium, and Glycyrrhizae Radix et Rhizoma. Traditional herbal medicines were mostly reported to improve the symptoms of MS. Conclusions: Traditional herbal medicines may be effective in improving the symptoms of MS in patients receiving APs. However, the quality of the included studies was low, and the studies were heterogeneous. Methodologically rigorous clinical studies on traditional herbal medicine treatments for MS in patients receiving APs are needed.

Does computer-aided diagnostic endoscopy improve the detection of commonly missed polyps? A meta-analysis

  • Arun Sivananthan;Scarlet Nazarian;Lakshmana Ayaru;Kinesh Patel;Hutan Ashrafian;Ara Darzi;Nisha Patel
    • Clinical Endoscopy
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    • v.55 no.3
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    • pp.355-364
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    • 2022
  • Background/Aims: Colonoscopy is the gold standard diagnostic method for colorectal neoplasia, allowing detection and resection of adenomatous polyps; however, significant proportions of adenomas are missed. Computer-aided detection (CADe) systems in endoscopy are currently available to help identify lesions. Diminutive (≤5 mm) and nonpedunculated polyps are most commonly missed. This meta-analysis aimed to assess whether CADe systems can improve the real-time detection of these commonly missed lesions. Methods: A comprehensive literature search was performed. Randomized controlled trials evaluating CADe systems categorized by morphology and lesion size were included. The mean number of polyps and adenomas per patient was derived. Independent proportions and their differences were calculated using DerSimonian and Laird random-effects modeling. Results: Seven studies, including 2,595 CADe-assisted colonoscopies and 2,622 conventional colonoscopies, were analyzed. CADe-assisted colonoscopy demonstrated an 80% increase in the mean number of diminutive adenomas detected per patient compared with conventional colonoscopy (0.31 vs. 0.17; effect size, 0.13; 95% confidence interval [CI], 0.09-0.18); it also demonstrated a 91.7% increase in the mean number of nonpedunculated adenomas detected per patient (0.32 vs. 0.19; effect size, 0.05; 95% CI, 0.02-0.07). Conclusions: CADe-assisted endoscopy significantly improved the detection of most commonly missed adenomas. Although this method is a potentially exciting technology, limitations still apply to current data, prompting the need for further real-time studies.

Middle meningeal artery embolization for chronic subdural hematoma in elderly patients at high risk of surgical treatment

  • Jin Hoo Seok;Jong Hyun Kim;Taek Hyun Kwon;Joonho Byun;Won Ki Yoon
    • Journal of Cerebrovascular and Endovascular Neurosurgery
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    • v.25 no.1
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    • pp.28-35
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    • 2023
  • Objective: The purpose of this study was to evaluate the effectiveness of middle meningeal artery embolization (MMAE) in elderly high-risk patients with symptomatic chronic subdural hematoma (CSDH) in terms of reduction in hematoma volume and recurrence rate. Methods: We retrospectively reviewed data prospectively collected from nine patients who underwent 13 MMAE for CSDH between June 2017 and May 2022. The volume of the subdural hematoma was measured using a computer-aided volumetric analysis program. Hematoma volume changes during the follow-up period were analyzed and clinical outcomes were evaluated. Results: The mean follow-up period was 160 days (range, 46-311 days). All procedures were technically successful and there were no procedure-related complications. Of the 13 MMAE, 84% (11 out of 13 hemispheres) showed mean 88% of reduction on follow-up volumetric study with eight cases of complete resolution. There was one refractory case with MMAE which had been performed multiple burr-hole trephinations, for which treatment was completed by craniotomy and meticulous resection of multiple pseudomembranes. There was no recurrent case during the follow-up period, except for refractory case. Conclusions: MMAE for CSDH in selected high-risk elderly patients and relapsed patients might be effective. Despite the small cohort, our findings showed a high rate of complete resolution with no complications. Further prospective randomized trials are warranted to evaluate its usefulness as a primary treatment option for CSDH.

A Randomized trial to investigate the effect of Asparagus racemosus root tablet in Relieving Postmenopausal Hot Flashes

  • K.M. Hina Fatima;Mariyam Roqaiya;Nawazisha
    • CELLMED
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    • v.14 no.10
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    • pp.10.1-10.6
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    • 2024
  • Background and Objectives: As per the available data, 75% peri and postmenopausal women experience hot flashes having negative effect on their quality of life. Using herbal medicines are stepping forward to alleviate hot flashes as the available hormonal medications have been reported the presence of side effects. This study was planned with the intention to investigate the effect of Asparagus racemosus root in the treatment of postmenopausal hot flashes in comparison to the placebo. Methods: This prospective patient blinded clinical trial randomly assigned 40 postmenopausal women with symptoms of hot flashes to receive either test drug (n=20) comprising Asparagus racemosus tablet of 1g in the dosage of 2 tablet thrice in a day for the duration of 60 days continuously or to receive placebo tablet prepared from roasted wheat flour in the same dosage and duration as test drug. The efficacy was determined by reduction in the frequency and intensity of hot flashes assessed by daily diary along with the improvement in quality of life assessed through Hot Flash-Related Daily Interference Scale. Statistical analysis was accomplished by student t test and Chi-square/Fisher Exact test. Results: Test drug significantly (p <0.001) reduced the intensity and frequency of hot flashes as well as improved the quality of life without showing any side effect. Discussion & Conclusion: According to Unani scriptures, the treatment is to treat the underlying cause, such as aberrant temperament and psychological and environmental issues. Unani drugs have emmenagogue, anti-inflammatory, analgesic, and neuroprotective qualities that can help alleviate premenstrual symptoms. Unani herbs such as C. sativus, Vitex, agnus castus, P. vulgare, N. Jatamansi, M. officinalis, and Z. officinalis have been clinically demonstrated to be effective in PMS. Thus, traditional knowledge authentication and conservation are vital for future research and appreciated for application in the modern day. Furthermore, randomised controlled trials, comprehensive reviews, and meta-analyses are suggested.

A Systematic Review of Non-pharmacological Intervention for Depression in Korean Middle-aged Women (한국 중년여성의 비약물적 우울중재연구: 체계적 문헌고찰)

  • Chae, Myung-Ock;Jeon, Hae Ok;Kim, Ahrin
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.3
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    • pp.638-651
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    • 2016
  • The purpose of this study was to review the literature and examine the effects on non-pharmacological depression intervention for middle-aged women in Korea. This systematic review analyzed the literature from 2006 to September, 2015. The existing literature was searched in the electronic databases in RISS, KISS and DBPia using the following key words: middle-aged women and depression, menopause and depression, climacterium and depression. Two hundred eighty studies were found through the database. According to PICOTS-SD, twelve studies were included for analysis. Among the twelve studies, four studies were conducted in the nursing field. Six studies were randomized controlled trials. Aerobic exercise, laughter therapy, meditation, aroma massage, counseling and art therapy were performed as non-pharmacological interventions for depression in Korean middle-aged women. The length of each session ranged from 20 to 120 minutes. The intervention period varied from 2 to 24 weeks, and the total number of the interventions ranged from 8 to 72 times. They influenced not only depression, but also physical aspects that are associated with obesity and psychosocial variables, such as anxiety, quality of life, life satisfaction, etc.