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The observational clinical study of the placebo effect and development to counseling therapy of medicine

Research Project

Project/Area Number 24590631
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical sociology
Research InstitutionKeio University

Principal Investigator

ISAWA Minae  慶應義塾大学, 薬学部, 研究員 (10338006)

Co-Investigator(Kenkyū-buntansha) NAKASHIMA Emi  慶應義塾大学, 薬学部, 教授 (90115254)
SAKATANI Kaoru  日本大学, 工学部, 教授 (90244350)
辻井 岳雄  日本大学, 医学部, 研究員 (80424216)
Project Period (FY) 2012-04-01 – 2015-03-31
Project Status Completed (Fiscal Year 2014)
Budget Amount *help
¥5,330,000 (Direct Cost: ¥4,100,000、Indirect Cost: ¥1,230,000)
Fiscal Year 2014: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2013: ¥2,730,000 (Direct Cost: ¥2,100,000、Indirect Cost: ¥630,000)
Fiscal Year 2012: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Keywordsプラセボ / 服薬カウンセリング / 脳科学的研究 / NIRS / カウンセリング / SERT遺伝子多型 / プラセボ効果 / セロトニン輸送担体遺伝子多型 / 条件付け / 認知 / ブレインモニタリング / NIRS
Outline of Final Research Achievements

An explanation to patients of the anticipated pharmacological effects of drugs may serve to improve compliance and to enhance treatment benefit via subjective factors. Factors influencing the placebo effect may include expectation, cognition and conditioning. Therefore, counseling may influence the magnitude of the placebo effect.
Here, we aimed to examine the effectiveness of counseling (advice to subjects about its expected efficacy) as a means of improving the stress-reducing efficacy of aromatherapy and a revitalizing medicinal product, using both subjective and objective indicators. They completed a self-reported questionnaire and multi-dimensional fatigue inventory-20 (MFI-20) as subjective indicators, and blood flow in the inferior frontal cortex was evaluated by means of near-infrared spectroscopy (NIRS) as an objective indicator. Overall, the results indicated that counseling intervention increased the effectiveness of both aromatherapy and the revitalizing medicinal product.

Report

(4 results)
  • 2014 Annual Research Report   Final Research Report ( PDF )
  • 2013 Research-status Report
  • 2012 Research-status Report
  • Research Products

    (15 results)

All 2015 2014 2013 2012

All Journal Article (4 results) (of which Peer Reviewed: 3 results,  Acknowledgement Compliant: 2 results) Presentation (10 results) Book (1 results)

  • [Journal Article] Influence of counseling intervention on the effectiveness of aromatherapy with bergamot oil in healthy women volunteers measured with a brain monitoring system.2014

    • Author(s)
      Isawa M, Inoue S, Itoh H, Nishimura T, Tomi M, Shimada H, Saito H, Nakashima E
    • Journal Title

      J Jpn Cosumet soc

      Volume: 38 Pages: 81-86

    • NAID

      130005089544

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Influence of counseling intervention on the effectiveness of a revitalizing medicinal product in healthy volunteers, using a brain monitoring system2014

    • Author(s)
      Isawa M, Shimizu A, Miyashita E, Itoh H, Nishimura T, Tomi M, Shimada H, Saito H, Nakashima E
    • Journal Title

      Jpn J Pharm Health Care Sci.

      Volume: 40 Pages: 558-566

    • NAID

      130005103177

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] 脳が決める効果:プラセボ効果の要因解析からわかること2013

    • Author(s)
      井澤美苗、信野明美、西村友宏、登美斉俊、中島恵美
    • Journal Title

      日本香粧品学会誌

      Volume: 37 Pages: 197-200

    • NAID

      130004703405

    • Related Report
      2013 Research-status Report
  • [Journal Article] Effectiveness of Aromatherapy Evaluated with Subjective and Objective Cognitive Indicators: A clinical trial on young adults using near-infrared spectroscopy.2012

    • Author(s)
      Shinno A, Isawa M, Itoh H, Kose N, Ishino H, Nishimura T, Tomi M, Tsujii T, Shimada H, Saito H, Nakashima E
    • Journal Title

      Jpn J Pharm Health Care Sci

      Volume: 38(4)

    • NAID

      130004502733

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Presentation] 芳香療法におけるカウンセリング併用効果2015

    • Author(s)
      国府里紗子、成瀬千明、井澤美苗、伊藤博之、西村友宏、登美斉俊、中島恵美
    • Organizer
      日本薬学会第135年会
    • Place of Presentation
      神戸
    • Year and Date
      2015-03-26
    • Related Report
      2014 Annual Research Report
  • [Presentation] カフェインによるプラセボ効果とセロトニントランスポーター遺伝子多型との関連性2015

    • Author(s)
      成瀬千明、国府里紗子、井澤美苗、田代亮太、伊藤博之、西村友宏、登美斉俊、中島恵美
    • Organizer
      日本薬学会第135年会
    • Place of Presentation
      神戸
    • Year and Date
      2015-03-26
    • Related Report
      2014 Annual Research Report
  • [Presentation] カフェインを用いたプラセボ効果の臨床研究2014

    • Author(s)
      成瀬千明、国府里紗子、田代亮太、伊藤博之、井澤美苗、西村友宏、登美斉俊、中島恵美
    • Organizer
      第58回日本薬学会関東支部大会
    • Place of Presentation
      東京
    • Year and Date
      2014-10-04
    • Related Report
      2014 Annual Research Report
  • [Presentation] 薬理効果に及ぼす心理的要因の解析:カウンセリング介入によるアロマセラピー効果の変動2014

    • Author(s)
      国府里紗子、成瀬千明、井上志保、井澤美苗、西村友宏、登美斉俊、中島恵美
    • Organizer
      医療薬学フォーラム2014 第22回クリニカルファーマシーシンポジウム
    • Place of Presentation
      東京
    • Year and Date
      2014-06-29
    • Related Report
      2014 Annual Research Report
  • [Presentation] プラセボ効果の要因解析と臨床応用に関する研究2014

    • Author(s)
      田代亮太、井澤美苗、西村友宏、登美斉俊、望月眞弓、中島恵美
    • Organizer
      日本薬学会第134年会
    • Place of Presentation
      熊本
    • Related Report
      2013 Research-status Report
  • [Presentation] Effect of counseling intervention on aromatherapy in healthy women volunteers measured by brain monitoring system2013

    • Author(s)
      Minae Isawa, Shiho Inoue, Tomohiro Nishimura, Masatoshi Tomi, Mayumi Mochizuki, and Emi Nakashima
    • Organizer
      World Congress of Pharmacy and Pharmaceutical Sciences 2013, 73rd International Congress of FIP
    • Place of Presentation
      Dublin, Ireland
    • Related Report
      2013 Research-status Report
  • [Presentation] Statistical analysis of the placebo effect in clinical trials2013

    • Author(s)
      46. Isawa M, Kato A, Tashiro R, Itoh H, Nishimura T, Tomi M, Uchida H, Nakashima E
    • Organizer
      Asian Federation for Pharmaceutical Sciences 2013
    • Place of Presentation
      Jeju, Republic of Korea
    • Related Report
      2013 Research-status Report
  • [Presentation] 臨床試験におけるプラセボ効果の主観的及び客観的評価の要因解析2013

    • Author(s)
      31. 加藤亜也、田代亮太、井澤美苗、伊藤博之、西村友宏、登美斉俊、内田裕之、中島恵美
    • Organizer
      医療薬学フォーラム2013 第21回クリニカルファーマシーシンポジウム
    • Place of Presentation
      金沢
    • Related Report
      2013 Research-status Report
  • [Presentation] アロマテラピーの臨床研究情報と薬物療法への応用に関する薬剤師意識調査2012

    • Author(s)
      井上志保、信野明美、井澤美苗、登美斉俊、佐々木琢也、中島恵美
    • Organizer
      第22回日本医療薬学会年会
    • Place of Presentation
      新潟
    • Related Report
      2012 Research-status Report
  • [Presentation] 臨床効果と心的制御機構に関する研究:服薬カウンセリングの現状調査とドリンク剤臨床試験における検討2012

    • Author(s)
      清水絢子、宮下恵里、信野明美、井澤美苗、登美斉俊、中島恵美
    • Organizer
      第22回日本医療薬学会年会
    • Place of Presentation
      新潟
    • Related Report
      2012 Research-status Report
  • [Book] 今日のOTC薬‐解説と便覧・改訂第3版‐2015

    • Author(s)
      中島恵美、伊藤明彦監修、井澤美苗(共著)
    • Total Pages
      741
    • Publisher
      南江堂
    • Related Report
      2014 Annual Research Report

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Published: 2013-05-31   Modified: 2019-07-29  

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