• Title/Summary/Keyword: Randomized Clinical Trials

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The Effect of Traditional Korean Medicine for Chemotherapy-Induced Hand-Foot Syndrome in Cancer Patients: Review (항암 치료 후 발생한 수족증후군에 대한 한의학적 치료의 효과에 대한 고찰)

  • Kim, Eun-ji;Park, Chan-ran;Son, Chang-gue;Cho, Jung-hyo;Lee, Nam-hun
    • The Journal of Internal Korean Medicine
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    • v.42 no.3
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    • pp.340-350
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    • 2021
  • Objectives: Hand-foot syndrome (HFS) is a common adverse effect of chemotherapy in cancer patients. This review synthesizes research results to assess the effect of traditional Korean medicine (TKM) on HFS in cancer patients. Methods: Four databases (PubMed, The Cochrane Central Register of Controlled Trials, Research Information Sharing Service, China National Knowledge Infrastructure) were searched for randomized controlled trials (RCTs) to assess the effects of TKM on HFS. The effects and quality of RCTs were assessed with the Cochrane risk of bias (ROB) tool. Results: Six RCTs met our study criteria. In all six, TKM showed improvement in HFS symptoms as well as quality of life scores when compared to the control group. However, the methodological quality of RCTs was relatively low due to the unclear or high ROB. Conclusions: TKM would be helpful to patients with HFS after chemotherapy. To clarify the clinical efficacy of TKM, well-designed studies are required in the future.

The Effect of Alternative Medicine on Quality-of-Life Outcomes for Dementia Patients: A Systematic Review and Meta-Analysis

  • So Young, Lee;In Chul, Jung;Eun, Cho
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.4
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    • pp.401-424
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    • 2022
  • Objectives: As effective treatments for dementia are lacking in Western medicine, complementary and alternative medicine (CAM) is considered a useful option. While the quality of life (QoL) is a vital outcome for patients with dementia, the QoL of patients receiving CAM for dementia remains ambiguous. This study aimed to determine the effect of CAM on QoL outcomes in dementia patients. Methods: A search was performed using the keywords "dementia," "Alzheimer's," "cognitive impairment," "Chinese," "Korean," "oriental," "herbal," "acupuncture," and "quality of life". All quantitative data were synthesized using R version 4.1.1. Results: Twenty-five randomized controlled trials (RCTs), 16 pre-post trials, and two cohort studies were selected for the systematic review. QoL in Alzheimer's disease (QOL-AD) (n=11, 25.6%) and geriatric QoL in dementia (GQOL-D, n=9, 20.9%) were the most utilized QoL instruments. Significant benefits in QoL were observed after receiving mind, body, combined mind and body, nursing, oriental medicine, and acupuncture therapies. In the meta-analysis, the combined effect was shown to significantly increase QOL-AD compared to before CAM interventions (standardized mean difference, SMD: 0.507; 95% confidence interval (CI), 0.191~0.824; p<0.01). The overall synthesized estimates in the GQOL-D showed a significantly improved QoL (SMD: 0.537, 95% CI: 0.238~0.837 p<0.01; one group; SMD: 1.465, 95% CI: 0.934~1.996, p<0.01). The seven studies assessing the cost-effectiveness of CAM reported uncertain outcomes. Conclusions: This study showed that CAM interventions benefited patients with dementia by improving their QoL. While additional standardized research is required, CAMs are suggested as effective clinical management for patients with dementia. They are also suggested as complementing therapies for these patients.

Effects of Electrical Stimulation on Patients with Non-Specific Low Back Pain : A Meta-Analysis of Domestic Database (비특이적 만성 허리통증 환자에 대한 전기자극의 효과 : 국내 데이터베이스의 메타분석)

  • Lee, Jeong-Woo;Cho, Sung-Hyoun
    • Journal of The Korean Society of Integrative Medicine
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    • v.10 no.3
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    • pp.37-52
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    • 2022
  • Purpose : The purpose of this meta-analysis was to evaluate the effects of electrical stimulation on patients with non-specific low back pain. Methods : Domestic databases were gathered from studies that conducted clinical trials associated with electrical stimulation and its impact on pain of non-specific low back patients. A total of 681 studies were identified, with 12 studies satisfying the inclusion data. The studies consisted of patient, intervention, comparison, outcome, and study design (PICO-SD). The search outcomes were items associated with low back pain. Cochrane risk of bias 2 (RoB 2) was used to evaluate the quality of 12 randomized controlled trials. Effect sizes (Hedges's g) in this study were computed as the corrected standard mean difference (SMD). A random-effect model was used to analyze the effect size because of the high heterogeneity among the studies. Egger's regression and 'trim-and-fill' tests were carried out to analyze the publication bias. Cumulative meta-analysis and sensitivity analysis were conducted to analyze the effect according to the sample size and the consistency of the effect size. Results : The following factors had a large overall effect size (Hedges's g=1.28, 95 % CI=.20~2.36) involving electrical stimulation on non-specific low back pain. The subgroup analysis all showed a statistical difference in the types of study design, electrical stimulation, and assessment tool. No statistically significant difference was found in the meta-regression analysis. Publican bias was found in the data. Conclusion : The findings in this study indicate that electrical stimulation interventions have a positive effect on patients with non-specific low back pain. However, due to the low quality of studies and publication bias, the results of our study should be interpreted cautiously.

Clinical Efficacy of Coptidis Rhizoma for Non-Alcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis (비알콜성 지방간 환자에 대한 베르베린 투여 치료의 임상적 효능 연구: 체계적 문헌 고찰과 메타분석)

  • SongWon Park;MinJee Kim;Seong-Woo Lim
    • Journal of Korean Medicine for Obesity Research
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    • v.22 no.2
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    • pp.158-166
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    • 2022
  • Objectives: The purpose of this meta-analysis was to evaluate the effects of berberine on non-alcoholic fatty liver disease (NAFLD) through a systematic review and meta-analysis. Methods: We searched seven electronic databases for studies through October 2022. All randomized controlled trials (RTCs) of berberine were included. Data extraction and risk of bias assessments were performed by two independent reviewers. The RevMan 5.4.1 program was used for meta-analysis. Results: A total of 279 relevant studies were identified, and 6 eligible RCTs were included to study the efficacy berberine on NAFLD. The six selected trials are studies on the effect between berberine and conventional treatment combined treatment versus conventional treatment. Liver function tests, blood lipid levels, and blood glucose levels were assessed. Combination treatment with berberine, ursodeoxycholate acid, metformin, and monascus purpureus showed statistically significant improvements in liver function levels, blood lipid levels, and blood glucose levels compared to conventional treatment alone. However, there was no significant efficacy of berberine combination dietary, exercise than control group on NAFLD. The meta-analysis results of examining 4 RCTs comparing the therapeutic efficacy of berberine showed statistically significant improvement in the liver function test, blood lipids levels, blood glucose levels. Conclusions: This study suggests that berberine has positive efficacy on blood lipids, blood glucose liver function, fatty liver condition of NAFLD. However, the level of evidence is low because of small effect size,so further investigation is needed.

The feasibility of needleless jet injection versus conventional needle local anesthesia during dental procedures: a systematic review

  • Alreem Ahmed, Alameeri;Hessa AlFandi, AlShamsi;Amel, Murad;Mariam Mahmoud, Alhammadi;Meznah Hamad, Alketbi;Arwa, AlHamwi;Natheer Hashim Al, Rawi;Sausan Al, Kawas;Marwan Mansoor, Mohammed;Shishir Ram, Shetty
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.48 no.6
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    • pp.331-341
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    • 2022
  • This systematic review evaluates current evidence regarding the feasibility of using needleless jet injection instead of a conventional local anesthetic needle. EBSCO, ProQuest, PubMed, and Scopus databases were used to identify relevant literature published in English from 2005 to 2020. Ten studies were selected. Five of them were randomized clinical trials, 3 case-control studies, and 2 equivalence trials. Using the Critical Appraisal Skills Program checklist, 6 studies scored between 67% and 100%, and 4 studies scored between 34% and 66%. According to Jadad's scale, 2 studies were considered strong, and 8 studies were considered moderate in quality. The results of the 10 studies showed differences in patient preference for needleless jet injection. Needleless injection technique has been found to be particularly useful in uncooperative patients with anxiety and needle phobia. Needleless jet injection is not technique sensitive. However, with needleless jet anesthesia, most treatments require additional anesthesia. Conventional needle anesthesia is less costly, has a longer duration of action, and has better pain control during dental extraction. Needleless jet anesthesia has been shown to be moderately accepted by patients with a fear of needles, has a faster onset of action, and is an efficient alternative to conventional infiltration anesthesia technique.

Anesthetic efficacy in vital asymptomatic teeth using different local anesthetics: a systematic review with network meta-analysis

  • Amy Kia Cheen Liew;Yi-Chun Yeh ;Dalia Abdullah ;Yu-Kang Tu
    • Restorative Dentistry and Endodontics
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    • v.46 no.3
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    • pp.41.1-41.23
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    • 2021
  • Objectives: This study aimed to evaluate the efficacy of various local anesthesia (LA) in vital asymptomatic teeth. Materials and Methods: Randomized controlled trials comparing pulpal anesthesia of various LA on vital asymptomatic teeth were included in this review. Searches were conducted in the Cochrane CENTRAL, MEDLINE (via PubMed), EMBASE, ClinicalTrials.gov, Google Scholar and 3 field-specific journals from inception to May 3, 2019. Study selection, data extraction, and risk of bias assessment using Cochrane Risk of Bias Tool were done by 2 independent reviewers in duplicate. Network meta-analysis (NMA) was performed within the frequentist setting using STATA 15.0. The LA was ranked, and the surface under the cumulative ranking (SUCRA) line was plotted. The confidence of the NMA estimates was assessed using the CINeMA web application. Results: The literature search yielded 1,678 potentially eligible reports, but only 42 were included in this review. For maxillary buccal infiltration, articaine 4% with epinephrine 1:100,000 was more efficacious than lidocaine 2% with epinephrine 1:100,000 (odds ratio, 2.11; 95% confidence interval, 1.14-3.89). For mandibular buccal infiltration, articaine 4% with epinephrine 1:100,000 was more efficacious than various lidocaine solutions. The SUCRA ranking was highest for articaine 4% with epinephrine when used as maxillary and mandibular buccal infiltrations, and lidocaine 2% with epinephrine 1:80,000 when used as inferior alveolar nerve block. Inconsistency and imprecision were detected in some of the NMA estimates. Conclusions: Articaine 4% with epinephrine is superior when maxillary or mandibular infiltration is required in vital asymptomatic teeth.

A Review on Clinical Research Trend in Treatment of Chai-Hu-Shu-Gan-San (Sihosogan-San) for Insomnia (불면증에 대한 시호소간산 치료의 임상연구 동향)

  • Lee, Jae-Eun;Kim, Sang-Ho;Kim, Bo-Kyung;Lim, Jung-Hwa
    • Journal of Oriental Neuropsychiatry
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    • v.31 no.1
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    • pp.25-38
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    • 2020
  • Objectives: This review aimed to investigate the effectiveness of Chai-Hu-Shu-Gan-San (CHSGS) for treatment of insomnia. Methods: 9 databases were comprehensively searched from their inception dates until Jan 2020 using keywords like Insomnia, Chai-Hu-Shu-Gan-San and Sihosogan-san. We included randomized controlled trials (RCTs) using CHSGS as the main intervention for insomnia patients. We assessed the quality of RCTs using the Cochrane risk of bias tool and Jadad scale. Results: 5 RCTs were included. The Chinese classification of mental disorders -3 (CCMD-3) was the most frequently used diagnostic criteria. The effective rate was the most frequently used as outcome. All the 5 RCTs that reported CHSGS and CHSGS adjunctive therapy on insomnia were more effective compared to western medication. Only one study reported adverse effects. The methodological quality of the included RCTs were generally poor. Conclusions: This review found that CHSGS may be effective to treating insomnia. However, because of the small number, heterogeneity and very low methodological quality of included studies, we could not draw any definitive conclusions. Therefore, more rigorous randomized control studies are warranted.

Onion peel extract reduces the percentage of body fat in overweight and obese subjects: a 12-week, randomized, double-blind, placebo-controlled study

  • Lee, Ji-Sook;Cha, Yong-Jun;Lee, Kyung-Hea;Yim, Jung-Eun
    • Nutrition Research and Practice
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    • v.10 no.2
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    • pp.175-181
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    • 2016
  • BACKGROUND/OBJECTIVES: The anti-obesity effect of quercetin-rich onion peel extract (OPE) was suggested in rats, but information from human studies is limited. This study aimed to investigate the effects of OPE on the body composition of overweight and obese subjects. MATERIALS/METHODS: In this 12-week, randomized, double-blind, placebo-controlled study, parallel clinical trials were performed in overweight and obese Korean subjects. Randomly assigned subjects were instructed to take daily either the placebo (male, 6 and female, 30) or OPE capsules containing 100 mg of quercetin (male, 5 and female, 31). Body composition was measured by using bioimpedance and dual-energy X-ray absorptiometry (DXA). Resting energy expenditure (REE) and respiratory quotient (RQ) were evaluated by using indirect calorie measurement methods. Fasting blood levels of glucose, insulin, lipids, and leptin were determined. RESULTS: Quercetin-rich OPE supplementation significantly reduced the weight and percentage of body fat as measured by DXA (P = 0.02). These effects were not shown in the control group. Levels of blood glucose (P = 0.04) and leptin (P = 0.001 for placebo, P = 0.002 for OPE) decreased in both groups. Significant increases in REE and RQ were observed in both groups (P = 0.003 for placebo, P = 0.006 for OPE) and in the OPE group alone (P = 0.02), respectively. CONCLUSIONS: Quercetin-rich OPE supplementation changed the body composition of the overweight and obese subjects. This result suggests a beneficial role of the anti-obesity effect of OPE human subjects.

Systematic Review of External Qigong Therapy for Joint Pain (관절 통증에 대한 외기 방사 기공 요법의 체계적 문헌고찰)

  • Lee, Hyeon-Yeop;Hwang, Man-Suk;Heo, In;Shin, Byung-Cheul;Heo, Kwang-Ho;Hwang, Eui-Hyoung
    • Journal of Korean Medicine Rehabilitation
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    • v.24 no.4
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    • pp.187-193
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    • 2014
  • Objectives The aim of this study is to analyze the therapeutic effect of external Qigong therapy for treatment of other people's disease on joint pain. Methods We searched articles from Pubmed, Chinese Academic Journals (CAJ) and Oasis online databases. Searching keywords were 'external qigong', 'external qi gong', 'qi therapy', '外气', '关节' and '기공'. After searching the articles, we performed quality assessment using Cochrane risk of bias (RoB) tool and risk of bias assessment tool for non-randomized study (RoBANS). Results Among the 117 articles were searched, 2 randomized controlled clinical trials (RCTs) and 2 single-group before and after studies were finally selected. All of 4 studies showed that external Qigong therapy has significant effect on joint pain. Conclusions Although external Qigong therapy has therapeutic effect on joint pain, it is not common therapy yet. However, external Qigong therapy requires more interests and studies in the future, because it is faithful therapy for Korean medicine theory.

Effects of Dignity Interventions on Psychosocial and Existential Distress in Terminally ill Patients: A Meta-analysis (존엄중재가 말기 환자의 심리적.실존적 디스트레스에 미친 효과: 메타분석)

  • Oh, Pok Ja;Shin, Sung-Rae
    • Journal of Korean Academy of Nursing
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    • v.44 no.5
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    • pp.471-483
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    • 2014
  • Purpose: This study was done to evaluate the effects of dignity interventions on depression, anxiety and meaning of life in terminally ill patients. Methods: PubMed, Cochrane Library CENTRAL, EMBASE, CINAHL and several Korean databases were searched. The main search strategy combined terms indicating dignity intervention, presence of terminal illness and study design. Methodological quality was assessed using Cochrane's Risk of Bias for randomized studies and Risk of Bias Assessment tool for non randomized studies. Data were analyzed by the RevMan 5.2.11 program of Cochrane Library. Results: Twelve clinical trials met the inclusion criteria with a total of 878 participants. Dignity intervention was conducted for a mean of 2.2 weeks, 2.8 sessions and an average of 48.7 minutes per session. Effect sizes were heterogeneous and subgroup analysis was done. Dignity interventions had a significant effect on depression (ES= -1.05, p<.001, $I^2$=15%) and anxiety (ES= -1.01, p<.001, $I^2$=0). For meaning of life, dignity interventions were effective (ES= -1.64, p=.005) and effect sizes were still heterogeneous. Conclusion: Results support findings that dignity interventions can assist terminal ill patients in reducing emotional distress and improving meaning of life. Further well-designed dignity studies will lead to better understanding of the effects of treatments on spiritual well-being.