A Preliminary Trial in the Efficacy of Yokukansankachimpihange on REM Sleep Behavior Disorder in Dementia With Lewy Bodies

Manabe, Yuta

doi:10.3389/fnut.2020.00119

Cited by 5 publications

(18 citation statements)

References 19 publications

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“…In addition to the included RCTs, all other studies (Iwasaki et al, 2005;Shinno et al, 2007;Xu et al, 2007;Shinno et al, 2008;Hayashi et al, 2010;Kawanabe et al, 2010;Guo et al, 2011b;Iwasaki et al, 2012;Nagata et al, 2012;Yang et al, 2012;Sumiyoshi et al, 2013;Kudoh et al, 2016;Ohsawa et al, 2017;Meguro and Yamaguchi, 2018;Xu, 2018;Manabe, 2020) have reported that HM improved BPSD in at least one indicator.…”

Section: Results From Other Included Studiesmentioning

confidence: 99%

“…Thirty-four studies ( Chen et al, 1997 ; Chen et al, 2013 ; Chen, 2020 ; Du et al, 2015 ; Fang et al, 2018 ; Gu et al, 2018 ; Guo et al, 2011a ; Han, 2018 ; Hu et al, 2015 ; Huang and Xu, 2019 ; Li, 2020 ; Li et al, 2018 ; Lin et al, 2016 ; Liu et al, 2015 ; Motohashi, 2006 ; Pan et al, 2014 ; Pu et al, 2014 ; Shen, 2013 ; Shen et al, 2019 ; Shen et al, 2018 ; Shi et al, 2020 ; Yao et al, 2014 ; Zhang et al, 2015a ; Zhang et al, 2018 ; Zhang, 2012 ; Zhou, 2018 ; Zhou, 2015 ; Zhou and Wei, 2015 ; Zhu et al, 2019 ; Zuo, 2017 ; Xu, 2018 ; Guo et al, 2011b ; Xu et al, 2007 ; Yang et al, 2012 ) were published in China, and 18 studies ( Furukawa et al, 2017 ; Mizukami et al, 2009 ; Monji et al, 2009 ; Okahara et al, 2010 ; Teranishi et al, 2013 ; Terasawa et al, 1997 ; Kudoh et al, 2016 ; Meguro and Yamaguchi, 2018 ; Hayashi et al, 2010 ; Iwasaki et al, 2012 ; Iwasaki et al, 2005 ; Kawanabe et al, 2010 ; Manabe, 2020 ; Nagata et al, 2012 ; Ohsawa et al, 2017 ; Shinno et al, 2008 ; Sumiyoshi et al, 2013 ; Shinno et al, 2007 ) were published in Japan. The type of dementia was Alzheimer’s disease, vascular dementia, two or more types of dementia, and dementia with Lewy bodies in 26 ( Chen, 2020 ; Fang et al, 2018 ; Furukawa et al, 2017 ; ...…”

Section: Resultsmentioning

confidence: 99%

“…In a total of 13 studies ( Chen et al, 2013 ; Guo et al, 2011a ; Han, 2018 ; Hu et al, 2015 ; Huang and Xu, 2019 ; Lin et al, 2016 ; Pu et al, 2014 ; Yao et al, 2014 ; Zhang et al, 2018 ; Zhou, 2015 ; Zhu et al, 2019 ; Guo et al, 2011b ; Yang et al, 2012 ), participants were recruited according to pattern identification, of which blood stasis was the most common (six studies) ( Chen et al, 2013 ; Hu et al, 2015 ; Pu et al, 2014 ; Yao et al, 2014 ; Zhu et al, 2019 ; Yang et al, 2012 ), followed by phlegm (five studies) ( Chen et al, 2013 ; Hu et al, 2015 ; Lin et al, 2016 ; Zhu et al, 2019 ; Yang et al, 2012 ) or kidney deficiency (five studies) ( Chen et al, 2013 ; Guo et al, 2011a ; Hu et al, 2015 ; Huang and Xu, 2019 ; Guo et al, 2011b ). The treatment period ranged from 2 weeks to 2 years, of which 4 weeks (1 month) was the most common in 20 studies ( Chen et al, 2013 ; Chen, 2020 ; Furukawa et al, 2017 ; Guo et al, 2011a ; Li, 2020 ; Mizukami et al, 2009 ; Okahara et al, 2010 ; Zhou, 2018 ; Xu, 2018 ; Guo et al, 2011b ; Hayashi et al, 2010 ; Iwasaki et al, 2012 ; Iwasaki et al, 2005 ; Kawanabe et al, 2010 ; Manabe, 2020 ; Nagata et al, 2012 ; Shinno et al, 2008 ; Sumiyoshi et al, 2013 ; Yang et al, 2012 ; Shinno et al, 2007 ), followed by 8 weeks (2 months) in 12 studies ( Chen et al, 1997 ; Fang et al, 2018 ; Huang and Xu, 2019 ; Lin et al, 2016 ;…”

Section: Resultsmentioning

confidence: 99%

“…After completion of treatment, the follow-up was performed in four studies ( Fang et al, 2018 ; Pan et al, 2014 ; Zhang et al, 2015a ; Kawanabe et al, 2010 ), of which the duration was 4 weeks in two studies ( Fang et al, 2018 ; Kawanabe et al, 2010 ) and 5 ( Pan et al, 2014 ) and 24 weeks ( Zhang et al, 2015a ) in one study each. Eighteen studies ( Furukawa et al, 2017 ; Lin et al, 2016 ; Mizukami et al, 2009 ; Monji et al, 2009 ; Okahara et al, 2010 ; Pan et al, 2014 ; Shi et al, 2020 ; Teranishi et al, 2013 ; Zhang et al, 2015a ; Kudoh et al, 2016 ; Meguro and Yamaguchi, 2018 ; Hayashi et al, 2010 ; Iwasaki et al, 2012 ; Manabe, 2020 ; Nagata et al, 2012 ; Ohsawa et al, 2017 ; Shinno et al, 2008 ; Sumiyoshi et al, 2013 ) were approved by the institutional review board before the study began, and 37 studies ( Chen, 2020 ; Du et al, 2015 ; Furukawa et al, 2017 ; Gu et al, 2018 ; Han, 2018 ; Hu et al, 2015 ; Huang and Xu, 2019 ; Li, 2020 ; Lin et al, 2016 ; Liu et al, 2015 ; Mizukami et al, 2009 ; Monji et al, 2009 ; Okahara et al, 2010 ; Pan et al, 2014 ; Pu et al, 2014 ; Shen, 2013 ; Shen et al, 2019 ; Shen et al, 2018 ; Shi et al, 2020 ; Teranishi et al, 2013 ; Terasawa et al, 1997 ; Zhang et al, 2015a ; Zhang et al, 2018 ; Zhou, 2018 ; Zhou, 2015 ; Zhu et al, 2019 ; Zuo, 2017 ; Kudoh et al, 2016 ;…”

Section: Resultsmentioning

confidence: 99%

“…Various types of HMs were used in the included studies, of which Yokukansan was the most frequently used in 13 studies ( Iwasaki et al, 2005 ; Shinno et al, 2007 ; Shinno et al, 2008 ; Mizukami et al, 2009 ; Monji et al, 2009 ; Hayashi et al, 2010 ; Kawanabe et al, 2010 ; Okahara et al, 2010 ; Iwasaki et al, 2012 ; Nagata et al, 2012 ; Sumiyoshi et al, 2013 ; Teranishi et al, 2013 ; Furukawa et al, 2017 ), followed by Xiaoyaosan (four studies) ( Zhou, 2015 ; Zhou and Wei, 2015 ; Shen et al, 2018 ; Shen et al, 2019 ) and Liuweidihuang pill (three studies ( Shen, 2013 ; Du et al, 2015 ; Gu et al, 2018 ). In terms of dosage form, powder was most often used in 18 studies ( Terasawa et al, 1997 ; Iwasaki et al, 2005 ; Shinno et al, 2007 ; Mizukami et al, 2009 ; Monji et al, 2009 ; Hayashi et al, 2010 ; Kawanabe et al, 2010 ; Okahara et al, 2010 ; Iwasaki et al, 2012 ; Nagata et al, 2012 ; Sumiyoshi et al, 2013 ; Teranishi et al, 2013 ; Zhou and Wei, 2015 ; Kudoh et al, 2016 ; Furukawa et al, 2017 ; Ohsawa et al, 2017 ; Meguro and Yamaguchi, 2018 ; Manabe, 2020 ), followed by decoction (16 studies) ( Guo et al, 2011a ; Guo et al, 2011b ; Yang et al, 2012 ; Zhang, 2012 ; Pu et al, 2014 ; Yao et al, 2014 ; Zhang et al, 2015a ; Hu et al, 2015 ; Zhou, 2015 ; Zuo, 2017 ; Han, 2018 ; Li et al, 2018 ; Zhou, 2018 ; Huang and Xu, 2019 ; Zhu et al, 2019 ;…”

Section: Resultsmentioning

confidence: 99%

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Herbal Medicine for Behavioral and Psychological Symptoms of Dementia: A Systematic Review and Meta-Analysis

Kwon

Lee

2021

Front. Pharmacol.

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Background: Dementia is a global health concern, causing serious health and socioeconomic burdens with population aging. The associated symptoms of dementia, called behavioral and psychological symptoms of dementia (BPSD), are factors contributing to the socioeconomic burden of dementia. Recently, herbal medicine (HM) has attracted attention as a potential complementary therapy for BPSD. Therefore, this systematic review was aimed at analyzing the effectiveness (or efficacy), safety, and research status of HM in BPSD management through a comprehensive review.Methods: Thirteen electronic databases were searched comprehensively. Related clinical studies published until December 28, 2020, were collected. The methodological quality was evaluated using tools such as the Cochrane Collaboration’s risk of bias tool according to the study design. The effectiveness (or efficacy) was analyzed for randomized controlled trials (RCTs) only, and when sufficient homogeneity was assured, effect estimates were presented as mean difference (MD) and risk ratio (RR), with 95% confidence interval (CIs), through a meta-analysis.Results: A total of 52 clinical studies, including 36 RCTs, were included in this review. As an adjunctive therapy, HM showed statistically significant benefits in BPSD severity assessed by the Behavior Pathology in Alzheimer’s Disease Rating Scale (combined with psychotropic drugs: MD = −3.48, 95% CI: −3.96 to −2.99; with anti-dementia drugs: MD = −2.81, 95% CI: −3.17 to −2.45) and Neuropsychiatric Inventory (with anti-dementia drugs: MD = −3.23, 95% CI: −4.06 to −2.40). Adverse events were significantly less frequent in the HM group (RR = 0.50; 95% CI: 0.28 to 0.88). However, the methodological quality of the RCTs included in this systematic review was not optimal overall.Conclusion: According to the findings of this review, HM may be associated with additional benefits in BPSD treatment, particularly when used as an adjunct to conventional medications, including psychotropic and anti-dementia drugs. However, considering the methodological quality of the included RCTs, this clinical evidence is not robust. Nevertheless, dementia is a global health concern, and considering the limitations of conventional psychotropic drugs for BPSD, a major cause of the disease burden, HM appears to be a promising complementary therapy that warrants further research.

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Section: Results From Other Included Studiesmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Herbal Medicine for Behavioral and Psychological Symptoms of Dementia: A Systematic Review and Meta-Analysis

Kwon

Lee

2021

Front. Pharmacol.

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Sleep disturbances in Lewy body dementia: A systematic review

Elder

Lázár

Alfonso‐Miller

et al. 2022

Int J Geriat Psychiatry

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Background: Lewy body dementia (LBD) refers to both dementia with Lewy bodies (DLB) and Parkinson's disease with dementia (PDD). Sleep disturbances are common in LBD, and can include poor sleep quality, excessive daytime sleepiness (EDS), and rapid eye movement behaviour disorder (RBD). Despite the high clinical prevalence of sleep disturbances in LBD, they are under-studied relative to other dementias. The aim of the present systematic review was to examine the nature of sleep disturbances in LBD, summarise the effect of treatment studies upon sleep, and highlight specific and necessary directions for future research. Methods: Published studies in English were located by searching PubMED and PSYCArticles databases (until 10 June 2022). The search protocol was preregistered in PROSPERO (CRD42021293490) and performed in accordance with PRISMA guidelines. Results: Following full-text review, a final total of 70 articles were included. These included 20 studies focussing on subjective sleep, 14 on RBD, 8 on EDS, 7 on objective sleep, and 1 on circadian rhythms. The majority of the 18 treatment studies used pharmacological interventions (n = 12), had an open-label design (n = 8), and were of low-to-moderate quality. Most studies (n = 55) included only patients with DLB. Due to the heterogeneity of the studies, we reported a narrative synthesis without meta-analysis. Conclusions: At least one form of sleep disturbance may be present in as many as 90% of people with LBD. Subjectively poor sleep quality, excessive daytime sleepiness, and RBD are more common and severe in LBD relative to other dementias.

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Clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations

Rodríguez‐Porcel

Wyman‐Chick

Ruiz

et al. 2022

Transl Neurodegener

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The selection of appropriate outcome measures is fundamental to the design of any successful clinical trial. Although dementia with Lewy bodies (DLB) is one of the most common neurodegenerative conditions, assessment of therapeutic benefit in clinical trials often relies on tools developed for other conditions, such as Alzheimer’s or Parkinson’s disease. These may not be sufficiently valid or sensitive to treatment changes in DLB, decreasing their utility. In this review, we discuss the limitations and strengths of selected available tools used to measure DLB-associated outcomes in clinical trials and highlight the potential roles for more specific objective measures. We emphasize that the existing outcome measures require validation in the DLB population and that DLB-specific outcomes need to be developed. Finally, we highlight how the selection of outcome measures may vary between symptomatic and disease-modifying therapy trials.

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A Preliminary Trial in the Efficacy of Yokukansankachimpihange on REM Sleep Behavior Disorder in Dementia With Lewy Bodies

Cited by 5 publications

References 19 publications

Herbal Medicine for Behavioral and Psychological Symptoms of Dementia: A Systematic Review and Meta-Analysis

Herbal Medicine for Behavioral and Psychological Symptoms of Dementia: A Systematic Review and Meta-Analysis

Sleep disturbances in Lewy body dementia: A systematic review

Clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations

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