• Title/Summary/Keyword: Randomized clinical trials

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The effectiveness and safety of acupuncture combination treatment on smoking cessation: A protocol for systematic review (금연에 대한 침술 병용 치료의 효과 및 안전성 : 체계적 검토를 위한 프로토콜)

  • In Suh Choi;Won-Suk Sung;Min-gi Jo;Jung-Hyun Kim;Yeon-Cheol Park;Eun-Jung Kim;Yong-Hyeon Baek;Geun-Woo Kim;Byung-Kwan Seo
    • Journal of Convergence Korean Medicine
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    • v.3 no.1
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    • pp.5-13
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    • 2022
  • Objectives: Smoking had a long negative impact on public health. The ingredients of a cigarette are major risk factors for several diseases. Owing to the problems about economic and quality of life, we need to ensure smoking cessation (SC). There are several approaches for SC including pharmacological therapy, nicotine replacement therapy, education, and behavioral intervention. However, due to some limitations, other alternative approaches are gaining popularity. Acupuncture has been reported to have few side effects and be more effective than some conventional treatments in several articles. However, there are no systematic reviews on the comparison of acupuncture combination treatment with other conventional monotherapies. Methods: Randomized controlled trials that used acupuncture as an adjunct treatment for SC will be searched and data will be summarized according to the predefined criteria. The primary outcome will be the abstinence rate, and secondary outcomes will be adverse events and biochemical indicators. We will use Review Manager to perform a meta-analysis, Cochrane Collaboration Risk of Bias tool for the risk of bias assessment, and the Grades of Recommendation, Assessment, Development and Evaluation approach to determine the quality of evidence. We will investigate the efficacy and safety of acupuncture combination treatment for SC with this study. Ethics and dissemination: This study will provide reliable clinical evidence on additional effect of acupuncture on smoking cessation. We will publish our results in a peer-review journal.

Efficacy and Safety of Trastuzumab Deruxtecan and Nivolumab as Third- or Later-Line Treatment for HER2-Positive Advanced Gastric Cancer: A Single-Institution Retrospective Study

  • Keitaro Shimozaki;Izuma Nakayama ;Daisuke Takahari;Kengo Nagashima;Koichiro Yoshino ;Koshiro Fukuda;Shota Fukuoka ;Hiroki Osumi ;Mariko Ogura ;Takeru Wakatsuki;Akira Ooki ;Eiji Shinozaki;Keisho Chin ;Kensei Yamaguchi
    • Journal of Gastric Cancer
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    • v.23 no.4
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    • pp.609-621
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    • 2023
  • Purpose: Determination of optimal treatment strategies for HER2-positive advanced gastric cancer (AGC) in randomized trials is necessary despite difficulties in direct comparison between trastuzumab deruxtecan (T-DXd) and nivolumab as third or later-line treatments. Materials and Methods: This single-institution, retrospective study aimed to describe the real-world efficacy and safety of T-DXd and nivolumab as ≥ third line treatments for HER2-positive AGC between March 2016 and May 2022. Overall, 58 patients (median age, 64 years; 69% male) were eligible for the study (T-DXd group, n=20; nivolumab group, n=38). Results: Most patients exhibited a HER2 3+ status (72%) and presented metastatic disease at diagnosis (66%). The response rates of 41 patients with measurable lesions in the T-DXd and nivolumab groups were 50% and 15%, respectively. The T-DXd and nivolumab groups had a median progression-free survival of 4.8 months (95% confidence interval [CI], 3.3, 7.0) and 2.3 months (95% CI, 1.5, 3.5), median overall survival (OS) of 10.8 months (95% CI, 6.9, 23.8) and 11.7 months (95% CI, 7.6, 17.1), and grade 3 or greater adverse event rates of 50% and 2%, respectively. Overall, 64% patients received subsequent treatment. Among 23 patients who received both regimens, the T-DXd-nivolumab and nivolumab-T-DXd groups had a median OS of 14.0 months (95% CI, 5.0, not reached) and 19.3 months (95% CI, 9.5, 25.1), respectively. Conclusions: T-DXd and nivolumab showed distinct efficacy and toxicity profiles as ≥ third line treatments for HER2-positive AGC. Considering the distinct features of each regimen, they may help clinicians personalize optimal treatment approaches for these patients.

Analysis of Research Trends in Traditional Chinese Medicine Treatments for Pes Anserine Bursitis from 2014 to 2024: Using the Search Results of China National Knowledge Infrastructure (거위발 점액낭염의 중의학적 치료에 대한 2014-2024년도의 연구 동향 분석: China National Knowledge Infrastructure를 중심으로)

  • Ja-Yean Son;Seok-Gyu Yang;Hea-Ju Kim;Seol Jung;Dong-Gyu Kim;Young-Hoon Lee;Kangmoo Goo;Na-young Kim;Dong Hwan Lee;Yu-Ra Im;Hyun-Woo Cho
    • Journal of Korean Medicine Rehabilitation
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    • v.34 no.2
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    • pp.135-147
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    • 2024
  • Objectives The aim of this study is to investigate the research trends in traditional Chinese medicine (TCM) treatment for pes anserine bursitis using the search results from the China National Knowledge Infrastructure (CNKI). Methods We searched for clinical studies on pes anserine bursitis in the CNKI electronic database. We analyzed the publication year, study type, participant demographics, treatment methods and duration, evaluation criteria, adverse events, and the results of each article. Results Seventeen studies published from January 1, 2014 to January 1, 2024 were selected. Among the 17 selected studies, 14 were randomized controlled trials and 2 were case reports. The most frequently used treatment intervention was acupuncture. Nine types of acupuncture were identified, including electro-acupuncture, pharmacopuncture, acupotomy, floating acupuncture, and other new types of acupuncture. The most commonly used evaluation outcome was effective rate. Conclusions Various TCM treatments for pes anserine bursitis were introduced, and we could identify the effectiveness of TCM in treating pes anserine bursitis. However, it is anticipated that more well-designed and high-quality evaluation studies will be required in the future.

Effect of Helicobacter pylori Eradication on the Prevention of Gastric Cancer in the General Population with or without Precancerous Lesions: A Meta-analysis (일반 인구 집단에서 전암성 병변 유무에 따른 헬리코박터 제균 치료의 위암 예방 효과 연구: 메타분석)

  • Kang, Soo Jin;Shin, Cheol Min;Kang, Seung Joo
    • Journal of Digestive Cancer Research
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    • v.8 no.2
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    • pp.81-90
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    • 2020
  • We performed a comprehensive meta-analysis on whether Helicobacter pylori (H. pylori) eradication can prevent gastric cancer in individuals with precancerous lesions (chronic atrophic gastritis, intestinal metaplasia, and dysplasia). The studies evaluating the effect of H. pylori eradication on gastric cancer were searched from PubMed, KoreaMed, EMBASE, and Cochrane Library. Subgroup analyses by precancerous lesions, regions and follow-up time were performed. Six randomized clinical trials were included. In the overall population, H. pylori eradication significantly decreased the risk of gastric cancer (risk ratio [RR]=0.56; 95% confidence interval [CI]: 0.41-0.77, p<0.01). Eradication therapy significantly reduced the risk of gastric cancer in Asian and group who followed up more than 10 years (RR=0.51; 95% CI: 0.35-0.73, p<0.01; I2=0%, p=0.46). However, subgroup analysis according to the precancerous lesions did not show any significant results (p>0.05). In the general population especially in Asian population, H. pylori eradication can reduce the risk of gastric cancer. The effect of the eradication treatment is remarkable upon the long-term follow-up. In contrast, there is insufficient evidence whether the eradication should be recommended for the individuals with precancerous lesions.

Cognitive Function Effects of Acupuncture Treatment for Mild Cognitive Impairment : Systematic Literature Review and Meta-Analysis (경도인지장애 침치료 인지기능효과 : 체계적 문헌고찰 메타분석)

  • Won Soon Kim
    • Journal of Society of Preventive Korean Medicine
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    • v.28 no.2
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    • pp.151-164
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    • 2024
  • Objectives : Using MMSE and MoCA cognitive tools, this study tried to measure the effect of acupuncture differing by cognitive types. Through the method of PRISMA literature review, this study aimed to understand and improve the acupuncture's effectiveness in its application. Methods : The research method was a literature review and Cochrane meta-analysis of papers on the effectiveness of acupuncture treatments for mild cognitive impairment conducted from 2012 to 2023. The Cochrane risk of bias (RoB) tool was used as a quality analysis tool, and the meta-analysis tool was Cochrane RevMan V5.4.1 software. Results : As a result of the study, a total of 967 subjects were used for analysis, and 16 papers on randomized acupuncture trials were analyzed. The results are as follows: As a result of meta-analysis of acupuncture intervention for mild cognitive impairment, the MMSE score had an average of 1.61 with a 95% confidence interval ranging from 0.14 to 3.07, and a statistically significant result with p<0.001. The Z-score was 2.15, which corresponded to a p-value of 0.03. The MoCA score had an average range between 0.39 and 2.49, also showing statistical significance with p<0.001, and a Z-score of 2.70 (p=0.007). The effect of acupuncture in subjects with mild cognitive impairment was significant. Conclusion : The suggestions and conclusion indicate that acupuncture intervention has a significant effect on mild cognitive impairment. This study propose future experimental research on various types of acupuncture interventions for mild cognitive impairment. The significance of this study is that it presented basic data for the development of a preventive convergence cognitive intervention program for patients with mild cognitive impairment in the community.

Clinical Applications and Efficacy of Korean Ginseng (고려인삼의 주요 효능과 그 임상적 응용)

  • Nam, Ki-Yeul
    • Journal of Ginseng Research
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    • v.26 no.3
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    • pp.111-131
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    • 2002
  • Korean ginseng (Panax ginseng C.A. Meyer) received a great deal of attention from the Orient and West as a tonic agent, health food and/or alternative herbal therapeutic agent. However, controversy with respect to scientific evidence on pharmacological effects especially, evaluation of clinical efficacy and the methodological approach still remains to be solved. Author reviewed those articles published since 1980 when pharmacodynamic studies on ginseng have intensively started. Special concern was paid on metabolic disorders including diabetes mellitus, circulatory disorders, malignant tumor, sexual dysfunction, and physical and mental performance to give clear information to those who are interested in pharmacological study of ginseng and to promote its clinical use. With respect to chronic diseases such as diabetes mellitus, atherosclerosis, high blood pressure, malignant disorders, and sexual disorders, it seems that ginseng plays preventive and restorative role rather than therapeutics. Particularly, ginseng plays a significant role in ameliorating subjective symptoms and preventing quality of life from deteriorating by long term exposure of chemical therapeutic agents. Also it seems that the potency of ginseng is mild, therefore it could be more effective when used concomitantly with conventional therapy. Clinical studies on the tonic effect of ginseng on work performance demonstrated that physical and mental dysfunction induced by various stresses are improved by increasing adaptability of physical condition. However, the results obtained from clinical studies cannot be mentioned in the indication, which are variable upon the scientist who performed those studies. In this respect, standardized ginseng product and providing planning of the systematic clinical research in double-blind randomized controlled trials are needed to assess the real efficacy for proposing ginseng indication. Pharmacological mode of action of ginseng has not yet been fully elucidated. Pharmacodynamic and pharmacokinetic researches reveal that the role of ginseng not seem to be confined to a given single organ. It has been known that ginseng plays a beneficial role in such general organs as central nervous, endocrine, metabolic, immune systems, which means ginseng improves general physical and mental conditons. Such multivalent effect of ginseng can be attributed to the main active component of ginseng,ginsenosides or non-saponin compounds which are also recently suggested to be another active ingredients. As is generally the similar case with other herbal medicines, effects of ginseng cannot be attributed as a given single compound or group of components. Diversified ingredients play synergistic or antagonistic role each other and act in harmonized manner. A few cases of adverse effect in clinical uses are reported, however, it is not observed when standardized ginseng products are used and recommended dose was administered. Unfavorable interaction with other drugs has also been suggested, which the information on the products and administered dosage are not available. However, efficacy, safety, interaction or contraindication with other medicines has to be more intensively investigated in order to promote clinical application of ginseng. For example, daily recommended doses per day are not agreement as 1-2g in the West and 3-6 g in the Orient. Duration of administration also seems variable according to the purpose. Two to three months are generally recommended to feel the benefit but time- and dose-dependent effects of ginseng still need to be solved from now on. Furthermore, the effect of ginsenosides transformed by the intestinal microflora, and differential effect associated with ginsenosides content and its composition also should be clinically evaluated in the future. In conclusion, the more wide-spread use of ginseng as a herbal medicine or nutraceutical supplement warrants the more rigorous investigations to assess its effacy and safety. In addition, a careful quality control of ginseng preparations should be done to ensure an acceptable standardization of commercial products.

Economic Value of the Sirolimus Eluting Stent($CYPHER^{TM}$) in Treating Acute Coronary Heart Disease (관상동맥질환 치료를 위한 시롤리무스 방출 스텐트 ($CYPHER^{TM}$)의 경제성 분석)

  • Lee, Hoo-Yeon;Park, Eun-Cheol;Park, Ki-Dong;Park, Ji-Eun;Kim, Young;Lee, Sang-Soo;Kang, Hye-Young
    • Journal of Preventive Medicine and Public Health
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    • v.36 no.4
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    • pp.339-348
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    • 2003
  • Objective : To quantify the economic value of the Sirolimus fluting Stent ($CYPHER^{TM}$) in treating acute coronary heart disease (CMD), and to assist in determining an adequate level of reimbursement for $CYPHER^{TM}$ in Korea. Methods : A decision-analytical model, developed by the Belgium Health Economics Disease Management group, was used to investigate the incremental cost-effectiveness of $CYPHER^{TM}$ versus conventional stenting. The time horizon was five years. The probabilities for clinical events at each node of the decision model were obtained from the results of large, randomized, controlled clinical trials. The initial care and follow-up direct medical costs were analyzed. The initial costs consisted of those for the initial procedure and hospitalization, The follow-vp costs included those for routine follow-up treatments, adverse reactions, revascularization and death. Defending on the perspective of the analysis, the costs were defined as insurance covered or total medical costs (=sum of insurance covered and uncovered medical costs). The cost data were obtained from the administrative data of 449 patients that received conventional stenting from five participating Korean hospitals during June 2002. Sensitivity analyses were peformed for discount rates of 3, 5 and 7%. Since the major clinical advantage of $CYPHER^{TM}$ over conventional stenting was the reduction in the revascularization rates, the economic value of $CYPHER^{TM}$, in relation to the direct medical costs of revascularization, were evaluated. If the incremental cost of $CYPHER^{TM}$ per revascularization avoided, compared to conventional stenting, was no higher than that of a revascularization itself, $CYPHER^{TM}$ would be considered as being cost-effective. Therefore, the maximum acceptable level for the reimbursement price of $CYPHER^{TM}$ making the incremental cost-effectiveness ratio equal to the cost of a revascularization was identified. Results : The average weighted initial insurance covered and total medical costs of conventional stenting were about 6,275,000 and 8,058,000 Won, respectively. The average weighted sum of the initial and 5-year follow-up insurance covered and total medical costs of conventional stenting were about 13,659,000 and 17,353,000 Won, respectively. The estimated maximum level of reimbursement price of $CYPHER^{TM}$ from the perspectives of the insurer and society were $4,126,897{\sim}4,325,161$ and $4,939,939{\sim}5,078,181$ Won, respectively. Conclusion : By evaluating the economic value of $CYPHER^{TM}$, as an alternative to conventional stenting, the results of this study are expected to provide a scientific basis for determining the acceptable level of reimbursement for $CYPHER^{TM}$.

The Effect of Steroid Therapy in Patients with Late ARDS (후기 급성호흡곤란증후군환자에서 스테로이드의 사용 효과)

  • Huh, Jin Won;Lim, Chae-Man;Jegal, Yang-Jin;Lee, Sang Do;Kim, Woo Sung;Kim, Dong Soon;Kim, Won Dong;Koh, Youn Suck
    • Tuberculosis and Respiratory Diseases
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    • v.52 no.4
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    • pp.376-384
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    • 2002
  • Background : The mortality from acute respiratory distress syndrome(ARDS) in the late stage, which is characterized by progressive pulmonary fibroproliferation, is ${\geq}80%$. Although previous prospective trials failed to show a survival benefit of steroid therapy in early ARDS, recently, a few of reports have described the survival benefit of the long-term use of steroid in patients with late ARDS. In this study, we analyzed the effect of steroid therapy on patients with late ARDS retrospectively in a single. Medral intensive care unit (MICU). Methods : Over a 3-year period, the medical records of 48 ARDS patients who had been on mechanical ventilation more than 8 days were reviewed. 14 patients were treated by the long-term use of methylprednisolone and another 34 patients served as a control. Both groups were comparable regarding clinical and physiologic data lung injury score(LIS), multiple organ failure score, APACHE III and SAPS II score. Because steroid was instituted after 8 days of advanced mechanical ventilatory support in average, we arbitrarily defined the $8^{th}$ day of ARDS as first day of the study. Results : Initially, the groups had similar PF($PaO_2/FiO_2$) ratio, LIS, APACHE III and SAPS II score. By 7th day after the start of steroid therapy, there were significant improvements in PF ratio, LIS, APACHE III and SAPS II score. The mortality in the steroid treated group was significantly lower(42.9% vs 73.5%, p<0.05). Conclusion : Although the data of this study was retrospective and was not randomized, in order to improve the patient's outcomes, steroid therapy should be considered in late ARDS patients. However, prospective trials are needed to define the indication and the effect of steroid therapy in late ARDS.

Literature review and future tasks necessary to establish of Korean Dietary Reference Intake for choline (콜린의 한국인 영양소 섭취기준 제정 검토를 위한 문헌 고찰 및 향후 과제)

  • Shim, Eugene;Park, Jae-Hee;Lee, Yunjung;Park, Eunju
    • Journal of Nutrition and Health
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    • v.55 no.2
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    • pp.211-226
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    • 2022
  • Choline, an essential nutrient for humans, is required for the structural integrity of the cell membranes, methyl-group metabolism, synthesis of the neurotransmitter acetylcholine, synthesis of the membrane phospholipid components of the cell membranes, and the transport of lipids and cholesterol. Choline can be synthesized in the body, but it is insufficient to meet the daily requirements and hence it must be obtained through the diet. In the United States/Canada, Australia/New Zealand, Europe, China, and Taiwan, the adequate intake (AI) and tolerable upper intake level (UL) of choline have been established, while the establishment of the 2020 Dietary Reference Intakes for Koreans (KDRI) for choline was postponed due to the lack of a choline database for Korean foods and studies on the choline intake of Koreans. However, as part of the preparation work for the 2020 DRI revision and finalization, choline intake and the possibility of disease occurrence were verified through analysis of published data. The groundwork for the subsequent establishment of a choline DRI was laid through a literature search, evaluation, and review of the literature reported from 1949 up to 2019. This can be regarded as the culmination of this project. According to the results of randomized controlled trials (RCTs), cohort studies, case-control studies, and cross-sectional observational studies in humans, approximately 400-500 mg/day of choline intake was effective in preventing liver function damage (fatty liver), neural tube damage, cardiovascular disease, breast cancer, and cognitive function improvement. The same amount of choline intake, however, also correlated with the risk of prostate and colorectal cancer. At present, there is limited information available on choline intake and health outcomes, particularly for the Korean population. More human studies, including clinical trials on the requirements and the physiological benefits associated with dietary intake, are needed to establish the KDRI for choline.