• Title/Summary/Keyword: randomized clinical

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A comprehensive quality analysis of randomized controlled clinical trials of Asian ginseng and American ginseng based on the CONSORT guideline

  • Chen, Weijie;Li, Xiuzhu;Chen, Zhejie;Hao, Wei;Yao, Peifen;Li, Meng;Liu, Kunmeng;Hu, Hao;Wang, Shengpeng;Wang, Yitao
    • Journal of Ginseng Research
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    • v.46 no.1
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    • pp.71-78
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    • 2022
  • Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

A Review of Clinical Studies for External Washing on Seborrheic Dermatitis - Focused on Chinese Randomized Controlled Trials - (지루 피부염 (Seborrheic Dermatitis)의 외세요법에 대한 최신 연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 -)

  • Ryu Eui Seong;Lee Min Yeong;Jang Su Bi;Choi Il Shin;Kin Ki Bong;Cheon Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.37 no.2
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    • pp.28-42
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    • 2023
  • Objective This study aimed to analyze the efficacy and safety of external washing therapy for seborrheic dermatitis based on randomized controlled clinical studies in China. Methods We used the China National Knowledge Infrastructure (CNKI) as a data resource and conducted a search using the following key words: "Seborrheic Dermatitis" and "外洗" Seven randomized controlled clinical studies were identified and analyzed in this study. Results 1. The external washing treatment group showed significant changes in total efficiency, relapse rates, Quality of life, and Hamilton depression rating scale, compared with the control group. 2. The most commonly used herbal medicines were Sophorae Radix (苦蔘), Thujae Orientalis Folium (側柏葉), Impatiens balsamina L. (透骨草), Phellodendri Cortex (黃柏), and Stemonae Radix (百部根). Conclusions The results indicate that external washing treatment is effective for patients with seborrheic dermatitis. Futher research on external washing treatment of seborrheic dermatitis in the future may be useful.

A Systematic Review and Meta-Analysis of Randomized Controlled Trials on Acupuncture for Improving Post-Operative Cognitive Dysfunction (POCD) and Chemotherapy-Related Cognitive Impairment (CRCI)

  • Kim, Ju-Young;Cho, Han-Byul;Kim, Man-Gi;Koo, Byung-Su;Kim, Geun-Woo
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.1
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    • pp.49-78
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    • 2022
  • Objectives: This study was conducted to evaluate the efficacy of Korean Medicine Therapy (KMT) for the treatment of Chemotherapy-induced Cognitive Impairment (CICI) through systematic review and meta-analysis of randomized controlled trials (RCTs) as proceeding research to further research the efficacy of KMT for CICI patients. Methods: We conducted a systematic review and meta-analysis according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines (PRISMA). The RCTs on the efficacy of KMT for treatment of CICI were searched by structured search strategies in MEDLINE, EMBASE, Cochrane library, CAJD, KISS, NDSL, KoreaMed, and OASIS. The searched RCTs were screened by inclusion and exclusion criteria. We evaluated the quality of the method in the included studies using the Jadad score and Cochran ROB tool. The efficacy outcomes were the Visual Analogue Scale (VAS) and the Clinical total Effective Rate (CER) of CICI. They were analyzed using mean difference for continuous variable or Relative Risk (RR) for Dichotomous variable in the random-effect model. The RevMan 5.3 program was used for meta-analysis. Results: We included 19 RCTs, including 653 participants, in the systematic review and meta-analysis. There were favorable results for the KMT group after the intervention compared with the pharmacotherapy group, physiotherapy group, and combined treatment group. KMT group showed improvement using CER and VAS compared with exercises, but their heterogeneities were slightly significant. KMT was more effective compared to the Rehabilitation program in CER and the subgroup analysis results showed that KMT had a significant difference compared to other therapies in VAS, to Medication therapy in CER. Conclusions: KMT presented reasonable evidence on improving the Clinical total Effective Rate and Visual Analogue Scale in CICI patients. However, further evaluation in future research is required.

Manual Therapy for Plantar Fasciitis: A Review of Clinical Study (족저근막염의 수기요법에 대한 문헌 연구 보고)

  • In-hwa Park;Yun-Yeop Cha;Min-Jeong Kim;In Heo;Byung-Jun Kim
    • Journal of Korean Medicine Rehabilitation
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    • v.34 no.3
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    • pp.53-63
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    • 2024
  • Objectives This study aims to analyze the effectiveness of manual therapy for the treatment of plantar fasciitis by reviewing existing randomized controlled trials. Specifically, it seeks to identify various manual therapy techniques and evaluate their applicability in clinical settings. Methods The study reviewed literature from six databases (PubMed, the Cochrane Library, China National Knowledge Infrastructure, ScienceON, Research Information Sharing Service, Korean studies Information Service System) up to April 2024. Studies were selected based on criteria including randomized controlled trials involving manual therapy for plantar fasciitis. Results An analysis of ten studies involving 714 patients revealed the use of techniques such as joint mobilization, muscle relaxation, and pressure point techniques. Manual therapy was found to be more effective in reducing pain than both extracorporeal shock wave therapy and routine physical therapy alone. However, caution is needed in generalizing these results due to the limited number of studies analyzed. No significant adverse effects were reported. Conclusions Manual therapy demonstrates potential as an effective treatment for plantar fasciitis, offering benefits in pain management and functional recovery. However, further high-quality randomized controlled trials are necessary to strengthen the clinical evidence and establish standardized treatment protocols.

Effects of Soy Bread on Cardiovascular Risk Factor, Inflammation and Oxidative Stress in Women With Active Rheumatoid Arthritis: A Randomized Double-Blind Controlled Trial

  • Afsaneh Sayyaf;Ehsan Ghaedi;Fatemeh Haidari;Elham Rajaei;Kambiz Ahmadi-engali;Bijan Helli
    • Clinical Nutrition Research
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    • v.13 no.1
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    • pp.22-32
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    • 2024
  • Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disorder with widespread synovitis. Isoflavones, the main active component of soy, have been reported to have potent anti-inflammatory effects; the previous RA animal models showed the promising effect of soy supplementation. We aimed to evaluate the effect of soy bread on inflammatory markers and lipid profiles in RA patients. The present study was designed as a randomized controlled trial. RA patients were randomly allocated to obtain soy bread (n = 22) or placebo bread (n = 22) for 8 weeks. Fasting serum levels of lipid profile, total antioxidant capacity (TAC), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and DAS28 were checked. Findings showed that there were no significant differences between the two groups in physical activity and dietary intake at the beginning of the study and the end of the study. There were no significant differences between the two groups in measured lipid profile markers, including high-density lipoprotein, low-density lipoprotein, total cholesterol, triglyceride, and very low-density lipoprotein, at the end of the trial. In addition, TAC and CRP also were not significant at the end of the trial between the 2 groups (0.66 and 0.12, respectively). However, the serum levels of TNF-α reduced significantly in the soy bread group at the end of the intervention (p < 0.000) and compared with the control group (p < 0.019). Soy bread consumption only decreased circulating TNF-α serum concentration. Other outcome measures were not changed following supplementation. Future long-term, well-designed studies are needed to confirm these findings.

Trend of Clinical Trials for Intradermal Acupuncture Treatment on Dry Eye Syndrome (건성안 증후군의 피내침 치료에 대한 임상연구 동향)

  • Song, Ji-Hoon;Park, Soo-Yeon
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.33 no.2
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    • pp.12-22
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    • 2020
  • Objectives : The aim of this study is to review the trend of clinical trials conducted with the intradermal acupuncture treatment on dry eye syndrome. Methods : Through 4 foreign online databases(PubMed, Cochrane Library, EMBASE, and CNKI) and 3 domestic online databases(NDSL, RISS, and OASIS), we searched for clinical studies performed acupuncture treatment for dry eye syndrome from 2000 to 2020. Only randomized controlled trials(RCT) were selected and analyzed with the research method. Results : A total of 4 studies were reviewed. Cuanzu(攢竹, BL2), Taiyang(太陽, EX-HN5), and Sibai(四白, ST2) were the most frequently used acupoints in the studies. Among the evaluation indexes, Schirmer I test(SIT), tear film break-up time(BUT) were the most frequently used outcomes. In the most of the 4 studies, intradermal acupuncture treatment showed significant therapeutic effects for dry eye syndrome. Conclusions : These results suggest that it is necessary to develop more detailed standards for intradermal acupuncture treatment method as the method of intradermal acupuncture is getting more diverse, and objective tools are needed to evaluating dry eye syndrome.

Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Facial palsy (얼굴마비의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구)

  • Gong, Na-Gyeong;Seo, Eunsung;Seon, Ji-Hye;Kim, Nam-Kwen
    • The Journal of Korean Medicine
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    • v.38 no.1
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    • pp.46-55
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    • 2017
  • Objectives: The aim of this study is reviewing the literature to extract the key parameter, study design, perspective, cost-effectiveness index and find the calibration parameter for the clinical study with economical evaluation protocol on facial palsy. Methods: Literature search is performed using PUBMED for literature published from January 2000 to December 2016. We included randomized controlled trials(RCTs) and modelling study with economic assessment in which human participated. Results: As a result of literature search, the 198 articles were found. After reviewing the title, abstract and full text, the 5 articles were selected. Selected articles are classified into 4 RCT studies dealing with quality of life and 1 CEA(cost-effectiveness analysis) study. Conclusions: We found reliable key parameters, calibration parameters and elements of economical assessment study, which might be necessary factors for developing research protocol of clinical trial with economic evaluation about facial palsy patients.

Efficacy of proton pump inhibitors and H2 blocker in the treatment of symptomatic gastroesophageal reflux disease in infants

  • Azizollahi, Hamid Reza;Rafeey, Mandana
    • Clinical and Experimental Pediatrics
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    • v.59 no.5
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    • pp.226-230
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    • 2016
  • Purpose: Gastroesophageal reflux disease (GERD) occurs in pediatric patients when reflux of gastric contents presents with troublesome symptoms. The present study compared the effects of omeprazole and ranitidine for the treatment of symptomatic GERD in infants of 2-12 months. Methods: This study was a clinical randomized double-blind trial and parallel-group comparison of omeprazole and ranitidine performed at Children Training Hospital in Tabriz, Iran. Patients received a standard treatment for 2 weeks. After 2 weeks, the patients with persistent symptoms were enrolled in this randomized study. Results: We enrolled 76 patients in the present study and excluded 16 patients. Thirty patients each were included in group A (ranitidine) and in group B (omeprazole). GERD symptom score for groups A and B was $47.17{\pm}5.62$ and $51.93{\pm}5.42$, respectively, with a P value of 0.54, before the treatment and $2.47{\pm}0.58$ and $2.43{\pm}1.15$, respectively, after the treatment (P=0.98). No statistically significant differences were found between ranitidine and omeprazole in their efficacy for the treatment of GERD. Conclusion: The safety and efficacy of ranitidine and omeprazole have been demonstrated in infants. Both groups of infants showed a statistically significant decrease in the score of clinical variables after the treatment.

A Randomized single blind controlled clinical trial on safety and efficacy of a Unani formulation (Itrifal-e-Sagheer) in dyslipidemia

  • Alam, Sazid;Alam, MD Anzar;Quamri, MA;Sofi, Ghulamuddin;Khan, Mohd. Qudratullah;Ansari, Shabnam
    • CELLMED
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    • v.10 no.1
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    • pp.8.1-8.7
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    • 2020
  • Aim:'Itrifal-e-Sagheer', a compound Unani formulation has been indicated in disease conditions simulating dyslipidemia. The present study was done to substantiate the efficacy of 'Itrifal-e-Sagheer' in dyslipidemia on scientific parameters. Materials and methods: A randomized, single blind, controlled, clinical trial was carried out on 30 patients of dyslipidemia who were randomly allocated into test (n = 15) or control (n = 15) groups. The test drug, Itrifal-e-Sagheer and control drug, Abana® were given to respective group for 45 days along with lifestyle modification. Results: The test drug significantly alleviated the symptoms of subjective parameters (palpitation, breathlessness and weight gain) (p<0.05). There was statistically significant reduction in lipid profile of the patients in test group (p<0.05) than control drug treatment. Conclusion: The study evidenced that Itrifal-e-Sagheer is potentially effective and safe in the treatment of dyslipidemia. However, a multicentric study with robust study design is required to generalize the results.

Trend for Acupuncture treatment Clinical Trial on Atopic Dermatitis (아토피피부염의 침 치료 임상연구 동향)

  • Park, Soo-Yeon;Choi, Jung-Hwa;Jeong, Min-Yeong;Lee, Gi-Hyun
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.33 no.1
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    • pp.45-55
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    • 2020
  • Objectives : The objective of this study is to review the Trend of clinical trials conducted with the acupuncture treatment on Atopic Dermatitis. Methods : Through 4 foreign online databases(PubMed, Cochrane library, EMBASE, CNKI) and 3 domestic online databases(NDSL, RISS, OASIS), we searched for clinical studies performed acupuncture treatment for Atopic Dermatitis from 2010 to December 2019. Only randomized controlled trials(RCT) was selected and anlayzed according to the research method. Results : A total 4 studies were reviewed. LI11, ST36, SP10 were most frequently used acupoints in acupuncture treatment. Among the evaluation indexes, SCORAD, VAS, DLQI were used most. In most of the 4 studies, acupuncture treatment showed significant therapeutic effects. Conclusions : These results suggest that it is necessary to develop more detailed standards about Acupuncture treatment method as the method of acupuncture is getting more diverse, and objective tools are needed in evaluating Atopic Dermatitis.