• Asian Pacific Journal of Cancer Prevention
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• v.17 no.4
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• pp.2049-2053
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• 2016

Background: The LigaSure vessel sealing system has been proposed to save operation time and reduce intraoperative blood loss for various surgeries. However, its usage for gastric cancer is still controversial. The aim of the present meta-analysis was to compare the effectiveness of LigaSure with conventional surgery in gastrectomy. Materials and Methods: Sources were retrieved from the Cochrane Library, MEDLINE, EMBASE, SCOPUS and Google Scholar until February, 2015. All randomized controlled trials comparing LigaSure with conventional surgery in curative gastric cancer resection were selected. After data extraction, statistics were performed by Review Manager 5.1 software. Results: Three eligible randomized controlled trials were evaluated, with a total of 335 patients. The quality of the included trials was good, yet some methodological and clinical heterogeneity existed. There were no significant differences between the LigaSure and conventional groups in operative time (weighted mean difference [WMD], -22.95 minutes; 95% confidence interval [CI], [-59.75, 13.85]; P = 0.22), blood loss (WMD, -45.8 ml; 95% CI, [-134.5, 42.90]; P = 0.31), nor the incidence of surgical complications (odds ratio, 1.18; 95% CI, [0.68, 2.05]; P = 0.54). But there was a longer duration of hospital stay in LigaSure group (WMD, 1.41 days; 95% CI, [0.14, 2.68]; P = 0.03). Conclusions: All available randomized evidence has been summarized. LigaSure does not confer significant advantage over conventional surgery for curative gastric cancer resection. The usefulness of the device may be limited in gastrectomy. But, more trials are needed for further assessment of the LigaSure system for gastric cancer.

• The Journal of Pediatrics of Korean Medicine
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• v.37 no.3
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• pp.75-93
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• 2023

Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

• Journal of Acupuncture Research
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• v.24 no.1
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• pp.209-216
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• 2007

Objectives : To review and summarize the existing evidence on acupuncture treatment for cancer and cancer related symptoms. Methods: Literature searches were made through domestic and international databases. Data were extracted according to pre-defined criteria. The methodological quality was assessed using the Modified Jadad scale. Results: Seven studies were included. Two of the studies were high in methodological quality. One study concerning acupuncture treatment for cancerous dyspnea reported insignificant differences between the treatment group and placebo group. The other study concerning auricular acupuncture for cancer related pain showed significant pain relief compared with the control group. All the other studies were non-blinded or uncontrolled trials. Conclusion : The hypothesis that acupuncture may be effective for the treatment of cancer is not supported by the data in recent clinical trials. More accurately designed randomized control trials (RCT) are needed.

• Herbal Formula Science
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• v.28 no.2
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• pp.199-209
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• 2020

Objectives : The purpose of this systematic review is to confirm whether Gwibitang is beneficial in chronic fatigue syndrome (CFS). Methods : Clinical trials were searched from databases including Pubmed, Embase, Central Cochrane, CNKI, Wanfang, CQVIP, CiNii, OASIS, Koreamed, and NDSL. The eligible study design was limited into randomized controlled trial, quasi-randomized controlled trial and controlled clinical trial. The outcomes included general effectiveness as nominal scale, and fatigue severity, insomnia severity and quality of life as interval or ratio scale. The meta-analysis and assessment of risk of bias was performed based on the data extracted from the selected trials. Results : The results of eight randomized controlled trials (n=596) were included in the meta-analysis. The results of the synthesis showed Gwibitang is beneficial substantially for relieving and managing the general symptoms, and its heterogeneity was not in important level (RR 0.26 [95% CI 0.17, 0.39], Z=6.47, P<0.00001, I²=0%). Gwibitang was beneficial for alleviating fatigue (SMD -0.78 [95% CI -1.27, -0.30], Z=3.17, P=0.002), but its certainty was low. In case of insomnia, too few trials had been found and their risk of bias was substantial, so no conclusions had been brought to. Conclusions : We found an evidence that Gwibitang could be beneficial for managing and alleviating main symptoms in CFS patients.

• The Journal of Pediatrics of Korean Medicine
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• v.36 no.1
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• pp.38-56
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• 2022

Objectives The purpose of this study was to analyze the trend of recent randomized controlled trials (RCTs) that used herbal medicine for the treatment of tic disorders in China and to evaluate the efficacy and safety of the treatment. Methods RCTs published from January 2017 to December 2021 were searched for using the China National Knowledge Infrastructure (CNKI). These were then analyzed using herbal medicine treatment methods and their results. Results A total of 35 randomized controlled trials were selected and analyzed. In most studies, evaluation indicators such as the Yale tic symptom scale and total effective rate were significantly improved in the herbal medicine treatment group compared to the control group. The most commonly used herb for tic disorder was Uncaria Rhynchophylla (釣鉤藤), followed by Glycyrrhizae Radix (甘草), Gastrodiae Rhizoma (天麻), Paeoniae Radix Alba (白芍藥), Batryticatus (白殭蠶), Poria (茯笭), and Bupleuri Radix (柴胡). In all studies that reported adverse events, herbal medicine was identified as a relatively safe treatment with fewer adverse reactions or no significant difference compared with the control group. Conclusions Based on the results of RCTs, herbal medicine has been shown to be safe and effective for the treatment of intellectual disability. However, additional well-designed large-scale clinical trials are needed to confirm these findings.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.4
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• pp.61-78
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• 2023

Objectives This systematic review aimed to analyze the effectiveness, safety and the reporting quality of scalp acupuncture (SA) treatment for musculoskeletal disease (MSD). Methods Eleven databases were systematically searched up to July 12th 2023. Randomized controlled trials (RCTs) of SA treatment for MSD were selected manually by the inclusion criteria. The risk of bias of RCTs was assessed using the Cochrane's Risk of Bias (RoB) 1.0 and the reporting quality of studies was evaluated using Consolidated Standards of Reporting Trials (CONSORT) 2010 statement and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) 2010 checklist. Results Ten clinical studies were met the inclusion criteria. Most of studies reported SA treatment significantly alleviated pain and functional disability of MSD patients and no serious adverse effects were reported. In RoB assessment, blinding of participants and personnel was found to have the highest RoB and allocation concealment was found to have the most unclear RoB. In CONSORT 2010 statement evaluation, all studies reported 15.3 items (41.4%) on average. In STRICTA 2010 checklist evaluation, all studies reported 11.2 items (65.9%) on average. Conclusions The systematic review found that SA treatment may alleviate pain and functional disability of MSD patients and have little severe adverse effect. The reporting quality of included studies was mainly low, therefore, further studies with strict adherence to the CONSORT and STRICTA checklist should be encouraged.

• Journal of Acupuncture Research
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• v.26 no.5
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• pp.105-116
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• 2009

The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

• The Journal of Korean Medicine
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• v.38 no.3
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

• Journal of Korean Medicine Rehabilitation
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• v.28 no.3
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• pp.55-66
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• 2018

Objectives To evaluate the evidence supporting the effectiveness of bee venom acupuncture for ankle sprain. Methods We conducted search across 11 electronic databases (Pubmed, EMBASE, Cochrane CENTRAL [CENTRAL], KoreaMed, Kmbase, Koreanstudies Information Service System [KISS], National Digital Science Library [NDSL], Korea Institute of Science and Technology Information [KISTI], China National Knowledge Infrastructure [CNKI], Wanfang and Chinese Scientific Journals Database [VIP] database) to find clinical trials that used bee venom acupuncture as treatment for ankle sprain. The methodological quality of randomized controlled clinical trials (RCTs) were assessed using the Cochrane Risk of Bias (RoB) tool, while non-randomized controlled clinical trials (NRCTs) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Four RCTs and one nRCT met our inclusion criteria. Almost studies showed that bee venom acupuncture has positive effect on ankle sprain. 4 studies of same intervention and control included in the meta-analysis. When comparing bee venom acupuncture and acupuncture with acupuncture, the effect size of standardized mean difference (SMD) was -0.19 (95% confidence interval [CI]: -1.95~1.56, Z=0.55, p=0.83). And when comparing bee venom acupuncture with acupuncture, the effect size of SMD was -0.17 (95% CI: -0.65~0.31, Z=0.71, p=0.48). Conclusions Although our systematic review found encouraging but limited evidence of bee venom acupuncture for ankle sprain, most of the studies included in the analysis were evaluated as methodologically high risk of bias. From now on further well-designed RCTs should be encouraged.

• The Journal of Korean Physical Therapy
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• v.26 no.5
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• pp.331-343
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• 2014

Purpose: The purpose of this study is to assess the effectiveness of short-wave therapy (SWT) for treatment of knee osteoarthritis (OA) as compared to placebo and control, and to assess the question of whether the effects are related to the mode, dosage, and application method. Methods: We searched randomized, placebo-controlled trials using electronic databases. We also manually reviewed sources in order to identify additional relevant studies. Results: Eight studies (597 participants) with OA were included in the meta-analysis. Pulse SWT had a significant effect on pain relief compared with control treatment, while did not favour compared with the placebo group. Pulse SWT had a significant effect on functional improvement compared with control and placebo treatment. Continuous SWT had no effect on pain relief and functional improvement. Capacitive SWT a significant effect on pain relief, functional improvement, and muscle strength. Continuous and capacitive SWT had increased muscle strength significantly. We found no clinical significance of all outcomes except pain and functional improvement in pulsed SWT with low dose. There was no difference in adverse events. None of the participants experienced any serious adverse events. Conclusion: Low dose pulsed SWT provided a short-term clinical benefit for pain relief and functional improvement. Pulsed SWD with low and high dose had effects on pain and function. There seems to be a placebo effect. We found significant effects on pain and function in capacitive SWT. Despite some positive findings, this analysis lacked data on how effectiveness is affected by mode, dosage, and application method of SWT. Further well-designed clinical studies are required in order to confirm the effectiveness of SWT.