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A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia
The effectiveness and safety of yokukansan (TJ-54), a traditional Japanese medicine (kampo) for the treatment of the behavioural and psychological symptoms of dementia (BPSD), were evaluated in 106 patients diagnosed as having Alzheimer's disease (AD) (including mixed-type dementia) or dementia...
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| Published in: | The international journal of neuropsychopharmacology 2009-03, Vol.12 (2), p.191-199 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
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| container_end_page | 199 |
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| container_title | The international journal of neuropsychopharmacology |
| container_volume | 12 |
| creator | Mizukami, Katsuyoshi Asada, Takashi Kinoshita, Toru Tanaka, Katsuaki Sonohara, Kazuki Nakai, Ryuhei Yamaguchi, Kiyoshi Hanyu, Haruo Kanaya, Kiyoshi Takao, Tetsuya Okada, Masakatsu Kudo, Sumio Kotoku, Hayato Iwakiri, Masahiko Kurita, Hirofumi Miyamura, Toshihiro Kawasaki, Yosuke Omori, Koji Shiozaki, Kazumasa Odawara, Toshinari Suzuki, Tatsuya Yamada, Shizuru Nakamura, Youichi Toba, Kenji |
| description | The effectiveness and safety of yokukansan (TJ-54), a traditional Japanese medicine (kampo) for the treatment of the behavioural and psychological symptoms of dementia (BPSD), were evaluated in 106 patients diagnosed as having Alzheimer's disease (AD) (including mixed-type dementia) or dementia with Lewy bodies. Patients were randomly assigned to group A (TJ-54 treatment in period I and no treatment in period II; each period lasting 4 wk) or group B (no treatment in period I and TJ-54 treatment in period II). BPSD and cognitive functions were evaluated using the Neuropsychiatric Inventory (NPI) and the Mini-Mental State Examination (MMSE), respectively. Activities of daily living (ADL) were evaluated using Instrumental Activities of Daily Living (IADL) in outpatients and the Barthel Index in in-patients. For the safety evaluation, adverse events were investigated. Significant improvements in mean total NPI score associated with TJ-54 treatment were observed in both periods (Wilcoxon test, p=0.040 in period I and p=0.048 in period II). The mean NPI scores significantly improved during TJ-54 treatment in groups A and B (p=0.002 and p=0.007, respectively) but not during periods of no treatment. Among the NPI subscales, significant improvements were observed in delusions, hallucinations, agitation/aggression, depression, anxiety, and irritability/lability. The effects of TJ-54 persisted for 1 month without any psychological withdrawal symptoms in group A. TJ-54 did not show any effect on either cognitive function or ADL. No serious adverse reactions were observed. The present study suggests that TJ-54 is an effective and well-tolerated treatment for patients with BPSD. |
| doi_str_mv | 10.1017/S146114570800970X |
| format | article |
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Patients were randomly assigned to group A (TJ-54 treatment in period I and no treatment in period II; each period lasting 4 wk) or group B (no treatment in period I and TJ-54 treatment in period II). BPSD and cognitive functions were evaluated using the Neuropsychiatric Inventory (NPI) and the Mini-Mental State Examination (MMSE), respectively. Activities of daily living (ADL) were evaluated using Instrumental Activities of Daily Living (IADL) in outpatients and the Barthel Index in in-patients. For the safety evaluation, adverse events were investigated. Significant improvements in mean total NPI score associated with TJ-54 treatment were observed in both periods (Wilcoxon test, p=0.040 in period I and p=0.048 in period II). The mean NPI scores significantly improved during TJ-54 treatment in groups A and B (p=0.002 and p=0.007, respectively) but not during periods of no treatment. Among the NPI subscales, significant improvements were observed in delusions, hallucinations, agitation/aggression, depression, anxiety, and irritability/lability. The effects of TJ-54 persisted for 1 month without any psychological withdrawal symptoms in group A. TJ-54 did not show any effect on either cognitive function or ADL. No serious adverse reactions were observed. The present study suggests that TJ-54 is an effective and well-tolerated treatment for patients with BPSD.</description><identifier>ISSN: 1461-1457</identifier><identifier>EISSN: 1469-5111</identifier><identifier>DOI: 10.1017/S146114570800970X</identifier><identifier>PMID: 19079814</identifier><language>eng</language><publisher>Cambridge, UK: Cambridge University Press</publisher><subject>Aged ; Aged, 80 and over ; Behavioral Symptoms - drug therapy ; Behavioral Symptoms - etiology ; Behavioral Symptoms - psychology ; Bias ; Cross-Over Studies ; Dementia - complications ; Dementia - psychology ; Drug Evaluation ; Drugs, Chinese Herbal - therapeutic use ; Female ; Humans ; Japan - epidemiology ; Male ; Medicine, Chinese Traditional ; Mental Status Schedule ; Middle Aged ; Neuropsychological Tests ; Statistics, Nonparametric</subject><ispartof>The international journal of neuropsychopharmacology, 2009-03, Vol.12 (2), p.191-199</ispartof><rights>Copyright © 2008 CINP</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c469t-6a3f0950b4084ffd71d89c085d65bb32d8a5c66298b77921345c22a4987743603</citedby><cites>FETCH-LOGICAL-c469t-6a3f0950b4084ffd71d89c085d65bb32d8a5c66298b77921345c22a4987743603</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19079814$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mizukami, Katsuyoshi</creatorcontrib><creatorcontrib>Asada, Takashi</creatorcontrib><creatorcontrib>Kinoshita, Toru</creatorcontrib><creatorcontrib>Tanaka, Katsuaki</creatorcontrib><creatorcontrib>Sonohara, Kazuki</creatorcontrib><creatorcontrib>Nakai, Ryuhei</creatorcontrib><creatorcontrib>Yamaguchi, Kiyoshi</creatorcontrib><creatorcontrib>Hanyu, Haruo</creatorcontrib><creatorcontrib>Kanaya, Kiyoshi</creatorcontrib><creatorcontrib>Takao, Tetsuya</creatorcontrib><creatorcontrib>Okada, Masakatsu</creatorcontrib><creatorcontrib>Kudo, Sumio</creatorcontrib><creatorcontrib>Kotoku, Hayato</creatorcontrib><creatorcontrib>Iwakiri, Masahiko</creatorcontrib><creatorcontrib>Kurita, Hirofumi</creatorcontrib><creatorcontrib>Miyamura, Toshihiro</creatorcontrib><creatorcontrib>Kawasaki, Yosuke</creatorcontrib><creatorcontrib>Omori, Koji</creatorcontrib><creatorcontrib>Shiozaki, Kazumasa</creatorcontrib><creatorcontrib>Odawara, Toshinari</creatorcontrib><creatorcontrib>Suzuki, Tatsuya</creatorcontrib><creatorcontrib>Yamada, Shizuru</creatorcontrib><creatorcontrib>Nakamura, Youichi</creatorcontrib><creatorcontrib>Toba, Kenji</creatorcontrib><title>A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia</title><title>The international journal of neuropsychopharmacology</title><addtitle>Int J Neuropsychopharmacol</addtitle><description>The effectiveness and safety of yokukansan (TJ-54), a traditional Japanese medicine (kampo) for the treatment of the behavioural and psychological symptoms of dementia (BPSD), were evaluated in 106 patients diagnosed as having Alzheimer's disease (AD) (including mixed-type dementia) or dementia with Lewy bodies. Patients were randomly assigned to group A (TJ-54 treatment in period I and no treatment in period II; each period lasting 4 wk) or group B (no treatment in period I and TJ-54 treatment in period II). BPSD and cognitive functions were evaluated using the Neuropsychiatric Inventory (NPI) and the Mini-Mental State Examination (MMSE), respectively. Activities of daily living (ADL) were evaluated using Instrumental Activities of Daily Living (IADL) in outpatients and the Barthel Index in in-patients. For the safety evaluation, adverse events were investigated. Significant improvements in mean total NPI score associated with TJ-54 treatment were observed in both periods (Wilcoxon test, p=0.040 in period I and p=0.048 in period II). The mean NPI scores significantly improved during TJ-54 treatment in groups A and B (p=0.002 and p=0.007, respectively) but not during periods of no treatment. 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The present study suggests that TJ-54 is an effective and well-tolerated treatment for patients with BPSD.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Behavioral Symptoms - drug therapy</subject><subject>Behavioral Symptoms - etiology</subject><subject>Behavioral Symptoms - psychology</subject><subject>Bias</subject><subject>Cross-Over Studies</subject><subject>Dementia - complications</subject><subject>Dementia - psychology</subject><subject>Drug Evaluation</subject><subject>Drugs, Chinese Herbal - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Japan - epidemiology</subject><subject>Male</subject><subject>Medicine, Chinese Traditional</subject><subject>Mental Status Schedule</subject><subject>Middle Aged</subject><subject>Neuropsychological Tests</subject><subject>Statistics, Nonparametric</subject><issn>1461-1457</issn><issn>1469-5111</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><recordid>eNqFkd1qFTEUhYMotlYfwBsJXohCR5NMfi9L8ZeCFyp4N2SSTE96JpMxyRTGp_FRzbQHCoqYm4Sdb63N3guApxi9xgiLN18w5RhTJpBESAn0_R44riXVMIzx_Zs3brb_I_Ao5yuECGUtfwiOsEJCSUyPwa8zmPRkY_A_nYUmxZybeO0SzGWxK4wD1LAkbX3xcdIj_KRnPbnsYHDWGz85-HKvwxxfncI17pe9nrKeTqGfYNm5qnS6BDeVzWgr9G6nr31cUrWqbeGcV7OLY7z0plbyGuYSQ95o6zad14_Bg0GP2T053Cfg27u3X88_NBef3388P7toTB24NFy3A1IM9RRJOgxWYCuVQZJZzvq-JVZqZjgnSvZCKIJbygwhmiopBG05ak_Ai1vfOcUfi8ulCz4bN4513LjkjnNFWybEf0GCGCaUywo-_wO8qoPXJVamHkkYoxXCt9DN6pMbujn5oNPaYdRtIXd_hVw1zw7GS19juFMcUq1AezDVoU_eXrq71v-2_Q2kFbI8</recordid><startdate>20090301</startdate><enddate>20090301</enddate><creator>Mizukami, Katsuyoshi</creator><creator>Asada, Takashi</creator><creator>Kinoshita, Toru</creator><creator>Tanaka, Katsuaki</creator><creator>Sonohara, Kazuki</creator><creator>Nakai, Ryuhei</creator><creator>Yamaguchi, Kiyoshi</creator><creator>Hanyu, Haruo</creator><creator>Kanaya, Kiyoshi</creator><creator>Takao, Tetsuya</creator><creator>Okada, Masakatsu</creator><creator>Kudo, Sumio</creator><creator>Kotoku, Hayato</creator><creator>Iwakiri, Masahiko</creator><creator>Kurita, Hirofumi</creator><creator>Miyamura, Toshihiro</creator><creator>Kawasaki, Yosuke</creator><creator>Omori, Koji</creator><creator>Shiozaki, Kazumasa</creator><creator>Odawara, Toshinari</creator><creator>Suzuki, Tatsuya</creator><creator>Yamada, Shizuru</creator><creator>Nakamura, Youichi</creator><creator>Toba, Kenji</creator><general>Cambridge University Press</general><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7TK</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>20090301</creationdate><title>A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia</title><author>Mizukami, Katsuyoshi ; Asada, Takashi ; Kinoshita, Toru ; Tanaka, Katsuaki ; Sonohara, Kazuki ; Nakai, Ryuhei ; Yamaguchi, Kiyoshi ; Hanyu, Haruo ; Kanaya, Kiyoshi ; Takao, Tetsuya ; Okada, Masakatsu ; Kudo, Sumio ; Kotoku, Hayato ; Iwakiri, Masahiko ; Kurita, Hirofumi ; Miyamura, Toshihiro ; Kawasaki, Yosuke ; Omori, Koji ; Shiozaki, Kazumasa ; Odawara, Toshinari ; Suzuki, Tatsuya ; Yamada, Shizuru ; Nakamura, Youichi ; Toba, Kenji</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c469t-6a3f0950b4084ffd71d89c085d65bb32d8a5c66298b77921345c22a4987743603</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Behavioral Symptoms - 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Academic</collection><jtitle>The international journal of neuropsychopharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mizukami, Katsuyoshi</au><au>Asada, Takashi</au><au>Kinoshita, Toru</au><au>Tanaka, Katsuaki</au><au>Sonohara, Kazuki</au><au>Nakai, Ryuhei</au><au>Yamaguchi, Kiyoshi</au><au>Hanyu, Haruo</au><au>Kanaya, Kiyoshi</au><au>Takao, Tetsuya</au><au>Okada, Masakatsu</au><au>Kudo, Sumio</au><au>Kotoku, Hayato</au><au>Iwakiri, Masahiko</au><au>Kurita, Hirofumi</au><au>Miyamura, Toshihiro</au><au>Kawasaki, Yosuke</au><au>Omori, Koji</au><au>Shiozaki, Kazumasa</au><au>Odawara, Toshinari</au><au>Suzuki, Tatsuya</au><au>Yamada, Shizuru</au><au>Nakamura, Youichi</au><au>Toba, Kenji</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia</atitle><jtitle>The international journal of neuropsychopharmacology</jtitle><addtitle>Int J Neuropsychopharmacol</addtitle><date>2009-03-01</date><risdate>2009</risdate><volume>12</volume><issue>2</issue><spage>191</spage><epage>199</epage><pages>191-199</pages><issn>1461-1457</issn><eissn>1469-5111</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>ObjectType-Article-2</notes><notes>ObjectType-News-1</notes><notes>ObjectType-Feature-3</notes><abstract>The effectiveness and safety of yokukansan (TJ-54), a traditional Japanese medicine (kampo) for the treatment of the behavioural and psychological symptoms of dementia (BPSD), were evaluated in 106 patients diagnosed as having Alzheimer's disease (AD) (including mixed-type dementia) or dementia with Lewy bodies. Patients were randomly assigned to group A (TJ-54 treatment in period I and no treatment in period II; each period lasting 4 wk) or group B (no treatment in period I and TJ-54 treatment in period II). BPSD and cognitive functions were evaluated using the Neuropsychiatric Inventory (NPI) and the Mini-Mental State Examination (MMSE), respectively. Activities of daily living (ADL) were evaluated using Instrumental Activities of Daily Living (IADL) in outpatients and the Barthel Index in in-patients. For the safety evaluation, adverse events were investigated. Significant improvements in mean total NPI score associated with TJ-54 treatment were observed in both periods (Wilcoxon test, p=0.040 in period I and p=0.048 in period II). The mean NPI scores significantly improved during TJ-54 treatment in groups A and B (p=0.002 and p=0.007, respectively) but not during periods of no treatment. Among the NPI subscales, significant improvements were observed in delusions, hallucinations, agitation/aggression, depression, anxiety, and irritability/lability. The effects of TJ-54 persisted for 1 month without any psychological withdrawal symptoms in group A. TJ-54 did not show any effect on either cognitive function or ADL. No serious adverse reactions were observed. The present study suggests that TJ-54 is an effective and well-tolerated treatment for patients with BPSD.</abstract><cop>Cambridge, UK</cop><pub>Cambridge University Press</pub><pmid>19079814</pmid><doi>10.1017/S146114570800970X</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1461-1457 |
| ispartof | The international journal of neuropsychopharmacology, 2009-03, Vol.12 (2), p.191-199 |
| issn | 1461-1457 1469-5111 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_66943577 |
| source | Oxford Academic Journals (OUP) |
| subjects | Aged Aged, 80 and over Behavioral Symptoms - drug therapy Behavioral Symptoms - etiology Behavioral Symptoms - psychology Bias Cross-Over Studies Dementia - complications Dementia - psychology Drug Evaluation Drugs, Chinese Herbal - therapeutic use Female Humans Japan - epidemiology Male Medicine, Chinese Traditional Mental Status Schedule Middle Aged Neuropsychological Tests Statistics, Nonparametric |
| title | A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-09-21T20%3A04%3A35IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20randomized%20cross-over%20study%20of%20a%20traditional%20Japanese%20medicine%20(kampo),%20yokukansan,%20in%20the%20treatment%20of%20the%20behavioural%20and%20psychological%20symptoms%20of%20dementia&rft.jtitle=The%20international%20journal%20of%20neuropsychopharmacology&rft.au=Mizukami,%20Katsuyoshi&rft.date=2009-03-01&rft.volume=12&rft.issue=2&rft.spage=191&rft.epage=199&rft.pages=191-199&rft.issn=1461-1457&rft.eissn=1469-5111&rft_id=info:doi/10.1017/S146114570800970X&rft_dat=%3Cproquest_cross%3E66943577%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c469t-6a3f0950b4084ffd71d89c085d65bb32d8a5c66298b77921345c22a4987743603%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=222282554&rft_id=info:pmid/19079814&rft_cupid=10_1017_S146114570800970X&rfr_iscdi=true |