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Article ; Online: Quality improvement in juvenile idiopathic arthritis: a mixed-methods implementation pilot of the CAPTURE-JIA dataset.

McErlane, Flora / Anderson, Chris / Lawson-Tovey, Saskia / Lee, Barbara / Lee, Chris / Lunt, Laura / McDonagh, Janet E / Smith, Andrew D / Smith, Nicola / Cleary, Gavin

Pediatric rheumatology online journal

2022 Volume 20, Issue 1, Page(s) 43

Abstract: ... with juvenile idiopathic arthritis (JIA) do not achieve inactive disease during the first two years following diagnosis. Refinements ... the CAPTURE-JIA dataset, and to explore patient and clinician-reported feasibility and acceptability data ... data collection system (the Agileware system), with a subsequent electronic pilot informing the final CAPTURE-JIA ...

Abstract	Background: A significant proportion of children and young people with juvenile idiopathic arthritis (JIA) do not achieve inactive disease during the first two years following diagnosis. Refinements to clinical care pathways have the potential to improve clinical outcomes but a lack of consistent and contemporaneous clinical data presently precludes standard setting and implementation of meaningful quality improvement programmes. This study was the first to pilot clinical data collection and analysis using the CAPTURE-JIA dataset, and to explore patient and clinician-reported feasibility and acceptability data. Methods: A multiphase mixed-methods approach enabled prospective collection of quantitative data to examine the feasibility and efficacy of dataset collection and of qualitative data informing the context and processes of implementation. An initial paper pilot informed the design of a bespoke electronic data collection system (the Agileware system), with a subsequent electronic pilot informing the final CAPTURE-JIA data collection tool. Results: Paper collection of patient data was feasible but time-consuming in the clinical setting. Phase 1 paper pilot data (121 patients) identified three themes: problematic data items (14/62 data items received >40% missing data), formatting of data collection forms and a clinician-highlighted need for digital data collection, informing Phase 2 electronic data collection tool development. Patients and families were universally supportive of the collection and analysis of anonymised patient data to inform clinical care. No apparent preference for paper / electronic data collection was reported by families. Phase 3 electronic pilot data (38 patients) appeared complete and the system reported to be easy to use. Analysis of the study dataset and a dummy longitudinal dataset confirmed that all eleven JIA national audit questions can be answered using the electronic system. Conclusions: Multicentre CAPTURE-JIA data collection is feasible and acceptable, with a bespoke data collection system highlighted as the most satisfactory solution. The study is informing ongoing work towards a streamlined and flexible national paediatric data collection system to drive quality improvement in clinical care.
MeSH term(s)	Adolescent ; Arthritis, Juvenile/diagnosis ; Arthritis, Juvenile/therapy ; Child ; Data Collection ; Humans ; Longitudinal Studies ; Prospective Studies ; Quality Improvement
Language	English
Publishing date	2022-06-18
Publishing country	England
Document type	Journal Article
ZDB-ID	2279468-2
ISSN	1546-0096 ; 1546-0096
ISSN (online)	1546-0096
ISSN	1546-0096
DOI	10.1186/s12969-022-00697-4
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Article: Herbal Medicine (Sihogayonggolmoryeo-Tang or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang) for Treating Hypertension:A Systematic Review and Meta-Analysis.

Lee, Boram / Kwon, Chan-Young

Evidence-based complementary and alternative medicine : eCAM

2020 Volume 2020, Page(s) 9101864

Abstract: Introduction: For situations in which effective and safe natural-derived products to treat hypertension are needed, recent studies suggest that an herbal medicine, Sihogayonggolmoryeo-tang (SYM), can improve both hypertension and concurrent mood ... ...

Abstract	Introduction: For situations in which effective and safe natural-derived products to treat hypertension are needed, recent studies suggest that an herbal medicine, Sihogayonggolmoryeo-tang (SYM), can improve both hypertension and concurrent mood symptoms. We aimed to evaluate the effectiveness and safety of SYM in treating hypertension. Methods: Thirteen English, Korean, and Chinese databases were comprehensively searched from their inception to May 2020. Randomized controlled trials (RCTs) using SYM as a monotherapy or adjunctive therapy for hypertension were evaluated. The primary outcome was the systolic and diastolic blood pressure (BP). Descriptive analyses of the relevant data were conducted, and where appropriate data were available, a meta-analysis was performed, and the results were presented as a risk ratio or mean difference with 95% confidence intervals. The risk of bias was assessed using the Cochrane risk of bias tool, and the quality of evidence was evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Results: Seven RCTs with 711 participants were included. Compared with placebo, SYM significantly lowered systolic and diastolic BP and concurrent depression. SYM significantly lowered systolic and diastolic BP compared with active controls; however, subgroup analysis revealed no differences between SYM and antihypertensives. In addition, SYM significantly decreased the level of concurrent depression compared with antidepressants. There was no consistent difference in BP reduction between SYM combined with antihypertensives and antihypertensives alone. No serious adverse events were reported following SYM administration. Most of the included studies had an unclear risk of bias, and the quality of evidence was generally rated "low." Conclusion: Current evidence suggests that SYM may have the potential to lower hypertension and concurrent depressive symptoms without serious adverse events. Additional high-quality, placebo-controlled RCTs should be conducted to confirm the efficacy of SYM.
Language	English
Publishing date	2020-09-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	2171158-6
ISSN	1741-4288 ; 1741-427X
ISSN (online)	1741-4288
ISSN	1741-427X
DOI	10.1155/2020/9101864
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Article ; Online: Current Treatment Modalities of JIA-associated Uveitis and its Complications: Literature Review.

Abu Samra, Khawla / Maghsoudlou, Armin / Roohipoor, Ramak / Valdes-Navarro, Manuel / Lee, Stacey / Foster, C Stephen

Ocular immunology and inflammation

2016 Volume 24, Issue 4, Page(s) 431–439

Abstract: ... complications seen in patients with JIA-associated uveitis, with special attention to the recent diagnostic and ...

Abstract	Uveitis is a common and serious complication of juvenile idiopathic arthritis. Up to 75% of all cases of anterior uveitis in childhood are associated with juvenile idiopathic arthritis. Despite the remarkable progress in early detection and treatment of inflammation, vision-threatening complications of uveitis still occur in almost 60% of patients. Structural complications include band keratopathy, maculopathy (macular edema, macular cysts, and epiretinal membrane), glaucomatous optic neuropathy, and cataracts. The management of complications in juvenile idiopathic arthritis is usually complex and requires early surgical intervention. In this paper, we review the general concepts of common ocular complications seen in patients with JIA-associated uveitis, with special attention to the recent diagnostic and preferred treatment approaches at the Massachusetts Eye Research and Surgery Institution. Received 9 March 2015; revised 30 September 2015; accepted 30 October 2015; published online 14 January 2016.
MeSH term(s)	Arthritis, Juvenile/complications ; Early Diagnosis ; Humans ; Uveitis, Anterior/diagnosis ; Uveitis, Anterior/etiology ; Uveitis, Anterior/therapy ; Visual Acuity/physiology
Language	English
Publishing date	2016-08
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1193873-0
ISSN	1744-5078 ; 0927-3948
ISSN (online)	1744-5078
ISSN	0927-3948
DOI	10.3109/09273948.2015.1115878
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Article ; Online: A phase II trial protocol of Tocilizumab in anti-TNF refractory patients with JIA-associated uveitis (the APTITUDE trial).

Ramanan, Athimalaipet V / Dick, Andrew D / Jones, Ashley P / Guly, Catherine / Hardwick, Ben / Hickey, Helen / Lee, Richard / McKay, Andrew / Beresford, Michael W

BMC rheumatology

2018 Volume 2, Page(s) 4

Abstract: Background: Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children ... Children with JIA are at risk of intraocular inflammation (uveitis). In the initial stages of mild-moderate ... to 18 years with active JIA-associated uveitis, who have taken MTX for at least 12 weeks and have failed ...

Abstract	Background: Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children. Children with JIA are at risk of intraocular inflammation (uveitis). In the initial stages of mild-moderate inflammation uveitis is asymptomatic. Most children with mild-moderate uveitis are managed on topical steroid drops with or without systemic methotrexate (MTX). When children with moderate-severe uveitis are refractory to MTX, monoclonal anti-tumour necrosis factor agents have been trialled, interim analysis data showed positive results. However, several children with severe recalcitrant disease or non-responsive to anti-tumour necrosis factor agents remain and are at greater risk of significant ocular complications and visual loss. Further evidence of alternative therapies is needed with evidence of a potential role of anti-interleukin-6 agents in the management of severe refractory uveitis. Methods: The trial will be conducted following a two-stage Simon design. The trial will register at least 22 patients aged 2 to 18 years with active JIA-associated uveitis, who have taken MTX for at least 12 weeks and have failed an anti-TNF agent. It will take place in 7 centres across the UK. All participants will be treated for 6 months, with follow up of 9 months from registration. Participants will receive a stable dose of MTX and those weighing ≥30 kg will be dosed with 162 mg of Tocilizumab every 2 weeks and participants weighing < 30 kg dosed with 162 mg of Tocilizumab every 3 weeks. Primary outcome is treatment response at 12 weeks. Adverse events will be collected up to 30 calendar days following treatment cessation. Discussion: This is a novel adaptive design study of subcutaneous IL-6 inhibition in anti-TNF refractory JIA associated uveitis which will be able to determine if further research should be conducted. This is the first trial to look at ophthalmology outcomes in the efficacy of Tocilizumab in uveitis.This is the first paediatric clinical trial to assess the clinical effectiveness and safety of tocilizumab with MTX in JIA associated uveitis. Trials registration: The Trial is registered on the ISRCTN registry (ISRCTN95363507) on the 10/06/2015 and EU Clinical Trials Register on the 03/07/2015 (EudraCT Number: 2015-001323-23).
Language	English
Publishing date	2018-02-27
Publishing country	England
Document type	Journal Article
ZDB-ID	2918121-5
ISSN	2520-1026 ; 2520-1026
ISSN (online)	2520-1026
ISSN	2520-1026
DOI	10.1186/s41927-018-0010-2
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Article ; Online: Effects of Sihogayonggolmoryeo-tang (Saikokaryukotsuboreito or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang) for insomnia disorder with prehypertension or stage 1 hypertension: A study protocol for a randomized controlled trial.

Lee, Boram / Jeong, Yeong-Eun / Park, Hyo-Ju / Choi, Young-Eun / Kim, Hoseok / Kim, Bo-Young / Yang, Changsop / Jung, In Chul

Medicine

2020 Volume 99, Issue 29, Page(s) e20980

Abstract: Background: Insomnia and hypertension are diseases with a high prevalence and a known association with each other. Sihogayonggolmoryeo-tang (SYM) is an herbal medicine traditionally used for the treatment of insomnia disorder concurrent with ... ...

Abstract	Background: Insomnia and hypertension are diseases with a high prevalence and a known association with each other. Sihogayonggolmoryeo-tang (SYM) is an herbal medicine traditionally used for the treatment of insomnia disorder concurrent with hypertension. However, no scientific clinical evidence exists supporting the effects of SYM on these disorders. This study aims to explore the feasibility, effectiveness, and safety of SYM for the treatment of insomnia disorder with concurrent prehypertension or stage 1 hypertension. Methods: A prospective, randomized, wait-list controlled, parallel, pilot clinical trial has been designed for a study to be conducted in Daejeon, Republic of Korea. Thirty insomnia disorder patients with prehypertension or stage 1 hypertension will be randomly assigned to a SYM or wait-list group at a 1:1 ratio. The SYM group will be administered SYM granules twice a day for 4 weeks and followed-up for 2 weeks while the wait-list group will not receive SYM granules. All participants in both groups will be given brochures with instructions for maintaining sleep hygiene and lifestyle modifications to reduce hypertension. Data will be collected at baseline and at 2, 4, and 6 weeks after allocation. The primary outcome is the Insomnia Severity Index score at 4 weeks post-treatment. The secondary outcomes will consist of the Pittsburgh Sleep Quality Index, sleep diary, systolic and diastolic blood pressure, brachial-ankle pulse wave velocity, ankle-brachial index, atherosclerosis biomarkers, the Hospital Anxiety and Depression Scale, the 5-level EuroQol-5 dimensions, and the Patient Global Impression of Change. Adverse events and laboratory test results will be monitored to assess the safety. Data will be recorded in electronic case report forms and analyzed using SPSS Statistics, Version 24.0. Discussion: This is the first clinical trial to explore the effectiveness and safety of SYM for the treatment of insomnia disorder concurrent with prehypertension or stage 1 hypertension. The results of this study can form the foundation for a future multicenter, large-scale, confirmatory clinical trial. Trial registration: Clinical Research Information Service, KCT0005001 (registered on May 8, 2020).
MeSH term(s)	Anxiety/diagnosis ; Bupleurum ; Depression/diagnosis ; Drugs, Chinese Herbal ; Humans ; Hypertension/complications ; Phytotherapy ; Prehypertension/complications ; Quality of Life ; Randomized Controlled Trials as Topic ; Sleep Initiation and Maintenance Disorders/complications ; Sleep Initiation and Maintenance Disorders/therapy ; Surveys and Questionnaires ; Visual Analog Scale
Chemical Substances	Drugs, Chinese Herbal ; saiko-ka-ryukotsu-borei-to
Language	English
Publishing date	2020-07-15
Publishing country	United States
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	80184-7
ISSN	1536-5964 ; 0025-7974
ISSN (online)	1536-5964
ISSN	0025-7974
DOI	10.1097/MD.0000000000020980
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Article ; Online: Efficacy and safety of Sihogayonggolmoryeo-tang (Saikokaryukotsuboreito, Chai-Hu-Jia-Long-Gu-Mu-Li-Tang) for post-stroke depression: A systematic review and meta-analysis.

Kwon, Chan-Young / Lee, Boram / Chung, Sun-Yong / Kim, Jong Woo / Shin, Aesook / Choi, Ye-Yong / Yun, Younghee / Leem, Jungtae

Scientific reports

2019 Volume 9, Issue 1, Page(s) 14536

Abstract: This systematic review and meta-analysis aimed to analyze the efficacy and safety of Sihogayonggolmoryeo-tang (SGYMT), a classical herbal medicine consisting of 11 herbs, for treatment of post-stroke depression (PSD). Thirteen databases were ... ...

Abstract	This systematic review and meta-analysis aimed to analyze the efficacy and safety of Sihogayonggolmoryeo-tang (SGYMT), a classical herbal medicine consisting of 11 herbs, for treatment of post-stroke depression (PSD). Thirteen databases were comprehensively searched from their inception dates until July 2019. Only randomized controlled trials (RCTs) using SGYMT as a monotherapy or adjunctive therapy for PSD patients were included. Where appropriate data were available, meta-analysis was performed and presented as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). We assessed the quality of RCTs using the Cochrane risk of bias tool and the Jadad scale. The quality of evidence for each main outcome was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Twenty-one RCTs with 1,644 participants were included. In the comparison between the SGYMT and antidepressants groups, the SGYMT group scored significantly lower on both the Hamilton Depression Scale (HAMD) (8 studies; MD -2.08, 95% CI -2.62 to -1.53, I
MeSH term(s)	Antidepressive Agents/therapeutic use ; Depression/drug therapy ; Drugs, Chinese Herbal/therapeutic use ; Humans ; Medicine, Chinese Traditional ; Plant Extracts/therapeutic use ; Randomized Controlled Trials as Topic ; Severity of Illness Index ; Stroke/complications ; Stroke/psychology
Chemical Substances	Antidepressive Agents ; Drugs, Chinese Herbal ; Plant Extracts ; saiko-ka-ryukotsu-borei-to
Language	English
Publishing date	2019-10-10
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-019-51055-6
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Article ; Online: Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial.

Sul, Jae-Uk / Kim, Myung Kwan / Leem, Jungtae / Jo, Hee-Geun / Yoon, Sang-Hoon / Kim, Jeeyong / Lee, Eun-Jung / Yoo, Jeong-Eun / Park, So Jung / Kim, Young Il / Kim, Eunseok / Jung, In Chul / Jeon, Ju-Hyun / Park, Yang-Chun

Trials

2019 Volume 20, Issue 1, Page(s) 140

Abstract: Background: Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the ... ...

Abstract	Background: Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the contraindications and adverse effects of surgery, the need for a new treatment strategy is emerging. Traditional herbal medicine is a widely used intervention in east Asia to treat knee osteoarthritis. Gyejigachulbutang is one of the frequently prescribed herbal formulae. The aim of our study is to evaluate the efficacy and safety of gyejigachulbutang for knee osteoarthritis. Methods: This study is a randomized, placebo-controlled, patient and assessor blinded, superiority clinical trial. A total of 80 patients with knee osteoarthritis will be enrolled. The participants will be randomly assigned to the gyejigachulbutang or placebo group in a 1:1 ratio in two Korean medical hospitals. Every participant will take gyejigachulbutang or placebo at a dose of 2.5 g three times a day for 4 weeks. Additional follow-up will be conducted 4 weeks after treatment completion. Any concomitant treatment to relive knee pain will not be allowed except for rescue medicine (acetaminophen). The primary outcome will be a comparison of the change in the visual analogue scale score for knee pain from baseline to visit 3 (week 4) for both the treatment and placebo groups. Secondary outcomes include clinical relevance, minimal clinically important difference, disability, quality of life, and safety. Discussion: This protocol presents a research methodology for clinical trials of gyejigachulbutang for knee osteoarthritis. Various secondary outcomes make this trial more informative. Our trial will provide fundamental evidence for knee osteoarthritis management via herbal medicine treatment. Trial registration: Clinical Research Information Service (CRIS), KCT0003024 . Registered on 25 July 2018.
MeSH term(s)	Analgesics/administration & dosage ; Analgesics/adverse effects ; Arthralgia/diagnosis ; Arthralgia/drug therapy ; Arthralgia/physiopathology ; Disability Evaluation ; Drugs, Chinese Herbal/administration & dosage ; Drugs, Chinese Herbal/adverse effects ; Equivalence Trials as Topic ; Humans ; Knee Joint/drug effects ; Knee Joint/physiopathology ; Multicenter Studies as Topic ; Osteoarthritis, Knee/diagnosis ; Osteoarthritis, Knee/drug therapy ; Osteoarthritis, Knee/physiopathology ; Pain Measurement ; Quality of Life ; Republic of Korea ; Time Factors ; Treatment Outcome
Chemical Substances	Analgesics ; Drugs, Chinese Herbal ; keishi-ka-jutsubu-to
Language	English
Publishing date	2019-02-19
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-019-3234-6
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Article ; Online: Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis

Jae-Uk Sul / Myung Kwan Kim / Jungtae Leem / Hee-Geun Jo / Sang-hoon Yoon / Jeeyong Kim / Eun-Jung Lee / Jeong-Eun Yoo / So Jung Park / Young Il Kim / Eunseok Kim / In Chul Jung / Ju-Hyun Jeon / Yang-Chun Park

Trials, Vol 20, Iss 1, Pp 1-

a randomized, placebo-controlled, patient and assessor blinded clinical trial

2019 Volume 9

Abstract: Abstract Background Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the ... ...

Abstract	Abstract Background Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the contraindications and adverse effects of surgery, the need for a new treatment strategy is emerging. Traditional herbal medicine is a widely used intervention in east Asia to treat knee osteoarthritis. Gyejigachulbutang is one of the frequently prescribed herbal formulae. The aim of our study is to evaluate the efficacy and safety of gyejigachulbutang for knee osteoarthritis. Methods This study is a randomized, placebo-controlled, patient and assessor blinded, superiority clinical trial. A total of 80 patients with knee osteoarthritis will be enrolled. The participants will be randomly assigned to the gyejigachulbutang or placebo group in a 1:1 ratio in two Korean medical hospitals. Every participant will take gyejigachulbutang or placebo at a dose of 2.5 g three times a day for 4 weeks. Additional follow-up will be conducted 4 weeks after treatment completion. Any concomitant treatment to relive knee pain will not be allowed except for rescue medicine (acetaminophen). The primary outcome will be a comparison of the change in the visual analogue scale score for knee pain from baseline to visit 3 (week 4) for both the treatment and placebo groups. Secondary outcomes include clinical relevance, minimal clinically important difference, disability, quality of life, and safety. Discussion This protocol presents a research methodology for clinical trials of gyejigachulbutang for knee osteoarthritis. Various secondary outcomes make this trial more informative. Our trial will provide fundamental evidence for knee osteoarthritis management via herbal medicine treatment. Trial registration Clinical Research Information Service (CRIS), KCT0003024. Registered on 25 July 2018.
Keywords	Knee osteoarthritis ; Gyejigachulbutang ; Gui Zhi Jia Shu Fu Tang ; TJ-18 ; Keishikajutsubuto ; Randomized controlled trial ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2019-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
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Article ; Online: Efficacy and safety of Sihogayonggolmoryeo-tang (Saikokaryukotsuboreito, Chai-Hu-Jia-Long-Gu-Mu-Li-Tang) for post-stroke depression

Chan-Young Kwon / Boram Lee / Sun-Yong Chung / Jong Woo Kim / Aesook Shin / Ye-yong Choi / Younghee Yun / Jungtae Leem

Scientific Reports, Vol 9, Iss 1, Pp 1-

A systematic review and meta-analysis

2019 Volume 20

Abstract: Abstract This systematic review and meta-analysis aimed to analyze the efficacy and safety of Sihogayonggolmoryeo-tang (SGYMT), a classical herbal medicine consisting of 11 herbs, for treatment of post-stroke depression (PSD). Thirteen databases were ... ...

Abstract	Abstract This systematic review and meta-analysis aimed to analyze the efficacy and safety of Sihogayonggolmoryeo-tang (SGYMT), a classical herbal medicine consisting of 11 herbs, for treatment of post-stroke depression (PSD). Thirteen databases were comprehensively searched from their inception dates until July 2019. Only randomized controlled trials (RCTs) using SGYMT as a monotherapy or adjunctive therapy for PSD patients were included. Where appropriate data were available, meta-analysis was performed and presented as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). We assessed the quality of RCTs using the Cochrane risk of bias tool and the Jadad scale. The quality of evidence for each main outcome was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Twenty-one RCTs with 1,644 participants were included. In the comparison between the SGYMT and antidepressants groups, the SGYMT group scored significantly lower on both the Hamilton Depression Scale (HAMD) (8 studies; MD −2.08, 95% CI −2.62 to −1.53, I 2 = 34%) and the National Institutes of Health Stroke Scale (NIHSS) (2 studies; MD −0.84, 95% CI −1.40 to −0.29, I 2 = 19%), and significantly higher on the Barthel index (3 studies; MD 4.30, 95% CI 2.04 to 6.57, I 2 = 66%). Moreover, the SGYMT group was associated with significantly fewer adverse events (6 studies; RR 0.13, 95% CI 0.05 to 0.37, I 2 = 0%) than the antidepressants group. In the subgroup analysis, SGYMT treatment consistently reduced HAMD scores within the first 8 weeks of treatment, but thereafter this difference between groups disappeared. Comparisons between SGYMT combined with antidepressants, and antidepressants alone, showed significantly lower scores in the combination group for both HAMD (7 studies; MD = −6.72, 95% CI = −11.42 to −2.01, I 2 = 98%) and NIHSS scores (4 studies; MD −3.03, 95% CI −3.60 to −2.45, I 2 = 87%). In the subgroup analysis, the reductions of HAMD scores in the SGYMT combined with antidepressants group were consistent within 4 weeks of treatment, but disappeared thereafter. The quality of RCTs was generally low and the quality of evidence evaluated by the GRADE approach was rated mostly “Very low” to “Moderate.” The main causes of low quality ratings were the high risk of bias and imprecision of results. Current evidence suggests that SGYMT, used either as a monotherapy or an adjuvant therapy to antidepressants, might have potential benefits for the treatment of PSD, including short-term reduction of depressive symptoms, improvement of neurological symptoms, and few adverse events. However, since the methodological quality of the included studies was generally low and there were no large placebo trials to ensure reliability, it remains difficult to draw definitive conclusions on this topic. Further well-designed RCTs addressing these shortcomings are needed to confirm our results.
Keywords	Medicine ; R ; Science ; Q
Subject code	150
Language	English
Publishing date	2019-10-01T00:00:00Z
Publisher	Nature Publishing Group
Document type	Article ; Online
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Article ; Online: Herbal medicine Sihogayonggolmoryeo-tang or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang for the treatment of post-stroke depression: A protocol for a systematic review and meta-analysis.

Kwon, Chan-Young / Lee, Boram / Chung, Sun-Yong / Kim, Jong Woo / Shin, Aesook / Choi, Ye-Yong / Yun, Younghee / Leem, Jungtae

Medicine

2018 Volume 97, Issue 38, Page(s) e12384

Abstract: ... the efficacy and safety of herbal medicine Sihogayonggolmoryeo-tang (SGYMT) or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang ...

Abstract	Introduction: This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of herbal medicine Sihogayonggolmoryeo-tang (SGYMT) or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang for the treatment of post-stroke depression. Methods and analysis: The following electronic databases will be searched up to July 2018 without language or publication status restrictions: MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing, and Allied Health Literature (CINAHL), and PsycARTICLES. We will also search Korean and Chinese databases. Any clinical randomized controlled trials related to SGYMT treatment for post-stroke depression will be included. Changes in the degree of depression and adverse events will be assessed as primary outcomes. The total effective rate and changes in neurological function, activities of daily living, and quality of life will be evaluated as secondary outcomes. Study selection, data extraction, assessment of study quality, and evaluation of the quality of evidence for the main findings will be performed independently by 2 researchers. The data synthesis and analysis will be performed using RevMan version 5.3. The results will be expressed as a risk ratio for dichotomous data and as the mean difference or standardized mean difference for continuous data. Data will be synthesized by either a fixed-effects or random-effects model according to a heterogeneity test or the number of studies included in the meta-analysis. The methodological quality of the included studies will be evaluated using the Cochrane Collaboration's risk of bias tool. The quality of evidence for each main outcome will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Ethics and dissemination: Ethical approval is not required because individual patient data are not included. The findings of this systematic review will be disseminated through a peer-reviewed publication or conference presentations. Prospero registration number: CRD42018102939.
MeSH term(s)	Adult ; Aged ; Bupleurum/chemistry ; Clinical Protocols ; Depression/drug therapy ; Depression/etiology ; Drugs, Chinese Herbal/therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Phytotherapy/methods ; Stroke/complications ; Stroke/psychology ; Systematic Reviews as Topic ; Treatment Outcome
Chemical Substances	Drugs, Chinese Herbal
Language	English
Publishing date	2018-09-12
Publishing country	United States
Document type	Journal Article ; Meta-Analysis
ZDB-ID	80184-7
ISSN	1536-5964 ; 0025-7974
ISSN (online)	1536-5964
ISSN	0025-7974
DOI	10.1097/MD.0000000000012384
Database	MEDical Literature Analysis and Retrieval System OnLINE

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