• Title/Summary/Keyword: Controlled clinical trials, randomized

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Current Status of N-of-1 Trials for Herbal Medicine -Literature Review (한약에 대한 N-of-1 임상시험의 현황 - 문헌 고찰)

  • Jeung, Chang-woon;Jeon, Sun-woo;Jo, Hee-Geun
    • The Journal of Korean Medicine
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    • v.41 no.1
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    • pp.107-116
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    • 2020
  • Objectives: To overcome the limitations of randomized controlled trials, many other trials design is tested. The n-of-1 trial is a promising research method in the field of Korean medicine because of this methodology can examine the optimal treatment for each patient strictly. Therefore, we reviewed the status of N-of-1 studies on herbal medicine. Methods: A systematic literature review was conducted based on the pubmed database. The search term were 'N-of-1 Trial', 'Chinese Medicine', 'Herbal Medicine', 'Kampo'. There was no restriction in year. Results: Four clinical trials have been identified to demonstrate the effectiveness of herbal medicines for Kidney-yin-deficiency syndrome, bronchiectasis and gastric cancer. These studies suggest that the N-of-1 design is a study that encourages patient involvement, demonstrates the effectiveness of herbal medicines and helps reduce unnecessary medication. Conclusion: The N-of-1 clinical trial may be a rigorous methodology suitable for the clinical setting and may help the development of evidence-based Korean medicine. Attention is also needed in this research method in Korea.

Clinical Usefulness of Gastric Residual Volume as An Indicator to Provide Approximately Enteral Nutrition for Patients in Intensive Care Units: A Systematic Literature Review (중환자의 경관영양 공급 지표로서 위 잔여량의 임상적 효용성: 체계적 문헌고찰)

  • Kim, Hyunjung;Chang, Sun Ju
    • Journal of Korean Biological Nursing Science
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    • v.16 no.4
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    • pp.267-275
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    • 2014
  • Purpose: The practice of enteral nutrition with gastric residual volumes (GRVs) as a clinical indicator is poorly standardized in intensive care units. This study aims to summarize the results from studies that evaluated the clinical outcomes related to the GRVs. Methods: This systematic review study analyzed 11 studies consisting of four randomized controlled trials, one non-randomized controlled trial, and six observational studies. Results: No consistent relationship between GRV thresholds and clinical outcomes was observed. Higher GRVs were not consistently correlated with clinical outcomes such as higher gastrointestinal complications, aspiration pneumonia, or mortality. Higher GRVs significantly generate complications more often. Findings show that a single GRV more than 200 mL or two consecutive GRVs more than 150 mL should raise concern about negative consequences. Conclusion: Critical care nurses need to monitor GRVs closely during their practice of enteral nutrition. For critically ill patients receiving enteral nutrition, a GRV threshold of 200 ml would be a desirable limit to provide safe and adequate nutrition with a conservative approach.

Recent Clinical Research on Effect of Acupuncture for Strabismus (사시의 침치료에 대한 최근 임상 연구 동향)

  • Lee, Ji Na;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.2
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    • pp.23-30
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    • 2016
  • Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for strabismus in Korea and other countries. We have analyzed 10 years (from 2006 to 2015) of case studies and randomized controlled trials (RCT) on effect of acupuncture for strabismus. Methods The search database includes Oasis, KTKP (Korean Traditional Knowledge Portal), Medline, Embase, and Cochrane library. To narrow the search, the following key search terms were used: 'strabismus, acupuncture'. The search was limited to the publication date from 2006 to 2015. 7 case studies and 5 control studies were selected for analysis. Results and Conclusions 1. The acupuncture treatment is effective for paralytic strabismus 2. The studies used BL1, GB1, ST2, TE23, GB15, EX-HN5, ST1, and LI4 acupoints and also an electroacupuncture treatment, which is 15 minutes of extraocular muscle stimulation, was used. 3. Degree of strasbismus was tested by Ocular motor range test, Corneal light reflex test, Ocular abducent scale test (Scott and Kraft, Diploptic range test).

The Metformin Use and Gastric Cancer Risk (메트포르민의 사용과 위암 발생)

  • Kim, Young-Il
    • Journal of Digestive Cancer Reports
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    • v.8 no.2
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    • pp.97-101
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    • 2020
  • Metformin is a widely used first-line anti-diabetic drug worldwide. Epidemiologic studies using the large population-based cohort database have shown the association between metformin uses and reduced risk of various type cancers including gastric cancer. In the gastric cancer prevention, metformin use was associated with the significant reduction of gastric cancer risk, especially for long-term metformin users. However, there is no well-designed randomized controlled clinical trial investigating the effect of metformin as a chemopreventive drug for gastric cancer. Therefore, further well-designed clinical trials will be needed to implement metformin for chemoprevention of gastric cancer.

A Review of Clinical Studies about Acupuncture Therapy for Whiplash Associated Disorder (교통사고로 인한 편타 손상의 침 치료에 대한 임상연구의 국내외 동향)

  • Jeon, Jun-Young;Yoo, Duk-Joo;Maeng, Tae-Ho;Shim, Jae-Woo;Cho, Woo-Young;Kim, Hyungsuk;Lim, Woong-jin;Lee, Jong-soo
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.4
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    • pp.47-54
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    • 2015
  • Objectives This study aimed to research current trends of acupuncture treatment of whiplash associated disorder (WAD). Methods Clinical studies about acupuncture therapy on WAD were searched in 7 databases. The included studies were classified according to their publication dates, methods, interventions, outcome measures. Interventions were analyzed by accompanied intervention, acupoint, acupuncture retaining time and treatment period. Results 14 articles were included. The number of studies on acupuncture for WAD shows increasing tendency since 1990. The included studies consist of 6 randomized controlled trials (RCTs), 2 non-randomized controlled trials (nRCTs), 2 cohort studies, 1 before and after study, 1 case study and 2 case reports. Most studies used visual analogue scale (VAS) as primary outcome. Conclusions This review demonstrates that further clinical studies need to be carried out under the formal clinical practice guidelines of acupuncture therapy for WAD in order to support clinical treatment objectively.

Effects of Neuromuscular Electrical Stimulation on Muscle Wasting with Cancer Patient: Study Protocol for a Systematic Review (신경근전기자극치료가 암환자의 근육 손실에 미치는 영향: 체계적 문헌고찰을 위한 프로토콜)

  • Eun Soo Park;Jong Hee Kim;Soo Dam Kim;Dong Hyun Kim;Min Seok Oh;Eun Jung Lee;Hwa Seung Yoo
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.2
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    • pp.49-55
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    • 2023
  • Objectives The purpose of this study is to analyze randomized controlled trials about neuromuscular electrical stimulation for muscle wasting with cancer patient and evaluate it's motor functionality effect. Methods Studies will be searched from 7 online databases (PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure [CNKI], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]). Participants will be cancer patients with muscle loss, regardless of cause, gender, race or age, interventions will be neuromuscular electrical stimulation. Other treatments than interventions will be the control group and the main outcome will be reviewed by motor functionality effect. Results Randomized controlled trials about neuromuscular electrical stimulation for muscle wasting should be included in the study. Primary outcomes include motor functionality effect. Secondary outcomes evaluate adverse event. The data uses Review Manager Software 5.4. Conclusions The conclusion of this study will provide a basis for determining whether neuromuscular electrical stimulation treatment for muscle wasting with cancer patient treatment is an effective and safe treatment method in clinical practice.

A Systematic Review of Clinical Trials on Alternative Medicine (대체의학의 임상실험 현황에 대한 체계적 고찰)

  • Cho, Hyun;Yoo, Jin-Yeong;Park, Soo-Hee
    • Proceedings of the KAIS Fall Conference
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    • 2010.11b
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    • pp.603-606
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    • 2010
  • 본 논문은 근거중심 대체의학의 현황과 범위를 알아보기 위한 것이다. 연구방법: 2000년부터 2010년 3월까지 Pubmed에 게재된 논문 중 alternative medicine으로 검색하여 체계적 고찰을 하였다. 2000년부터 2010년 현재까지 근거중심 대체의학에 대한 다양한 연구결과을 통합하기 위해 체계적 문헌고찰을 실시하였다. 682편의 연구 중 대체의학에 관한 임상연구는 19개였으며 연구전체 대상자는 2,573명이었다. 논문분석 결과 RCT(Randomized Controlled Trial) 실험 설계연구가 44%였으며 CCT(Controlled Clinical Trials)가 16%, OD(efficacy studies with either a controlled or an Other than controlled Design) 40%였다. 가장 많은 임상실험이 시행된 중재 방법은 Acupuncture과 Massage 였다. 대상 질병군 분포는 근골격계 및 결합조직의 질환과 관련된 '통증 완화'에 대한 임상연구가 20%, 다음으로 특정 감염성 및 기생충성 질환, 신생물이 각각 15% 순이었다. 근거중심 대체의학 현황을 파악하고자 체계적으로 고찰한 결과 대체의학을 통한 중재가 질병치료에 효과가 있는지에 대한 과학적 근거를 제시한 임상연구가 부족하다. 대체의학의 품질, 안정성, 유효성 확보를 위해 대체의학에 대한 질 높은 연구필요하며 근거중심 대체의학의 활성화가 필요할 것으로 생각된다.

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Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for gastric cancer] (위암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Gajin;Seong, Sin;Kim, Sungsu;Kim, Jinsung;Park, Jae-Woo
    • 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].

Trends in Chinese Clinical Research on Herbal Medicine Treatment in Adolescent Polycystic Ovary Syndrome - Focusing on Randomized Controlled Clinical Trials - (청소년 다낭성 난소증후군 한약치료에 대한 중의학 임상연구 동향 -무작위 대조군 임상연구를 중심으로-)

  • Kim Hyo Eun;Jang Su Bi;Kim Ki Bong;Cheon Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.2
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    • pp.53-67
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    • 2024
  • Objective This study aimed to assess the trend of randomized clinical trials conducted in China involving oral herbal medicine for treating adolescent polycystic ovary syndrome (PCOS). Methods We used the China National Knowledge Infrastructure as our primary resource and conducted a search using keywords such as "PCOS", "多囊卵巢" and "多囊卵巢综合征". We identified and analyzed seven RCTs. Results 1. The group receiving herbal medicine treatment demonstrated significant improvements in total efficiency, sex hormone levels, and ultrasound-measurable values compared to the control group. 2. Epimedii Herba (淫羊藿), Alviae Miltiorrhizae Radix (丹參), and Angelicae Gigantis et Acutilobae Radix (當歸) were among the most used herbs in Traditional Chinese medicine decoctions for treating PCOS. Conclusions The findings suggest that oral herbal medicine is an effective treatment for patients with PCOS. This study provides a foundation for future research on the use of oral herbal medicine in PCOS treatment.

Review on randomized controlled trials of acupuncture for postmenopausal symptoms in the search site, Pub Med. - focusing on hot flush (Pub Med 검색을 통한 폐경기 증상의 침구 임상시험에 대한 고찰 - 안면홍조를 중심으로)

  • Kim, Ro-Sa;Lee, Jin-Moo;Cho, Jung-Hoon;Jang, Jun-Bock;Lee, Kyung-Sub;Lee, Chang-Hoon
    • The Journal of Korean Obstetrics and Gynecology
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    • v.20 no.4
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    • pp.148-159
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    • 2007
  • Purpose: Vasomotor symptoms including hot flash are very common to postmenopausal women. Estrogen therapy was regarded as the best option for relieving menopausal symptoms until 2002, when the Women#s Health Initiative(WHI) reported the side effect of the therapy. Consequently, studies on the complementary and alternative medical herbs and therapy for the management of menopausal symptoms have followed. And so we have reviewed some international clinical studies about the management of postmenopausal symptoms with acupuncture therapy. Methods: "Menopause and acupuncture" was designated as a key word in the search site. Pub Med, and nine papers dealing with hot flash among the relevant RCTs were selected, and then, the effect of acupuncture on hot flash and the way the researches had been done was examined. Results : The intensity of hot flash reduced significantly and the frequency of hot flash was inclined to reduce, but not significantly, compared to the controlled group. Conclusion: Each clinical test has its limitations in point of the number of the required samples. However, it still shows the possibility that acupuncture itself will be effective enough to reduce the intensity of hot flash to a certain degree. It is believed that extensive clinical tests on the effect of acupuncture on hot flash will need to be done hereafter. And when the tests are carried out, it is required to exclude placebo effect, do blind test, and carefully select and control the methods.

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