Effects of Perceived Treatment on Quality of Life and Medical Outcomes in a Double-blind Placebo Surgery Trial

Cynthia McRae, Eva Cherin, T. Gayle Yamazaki, Gretchen Diem, Alexander Vo, Dan Russell, J. Heiner Ellgring, Stanley Fahn, Paul Greene, Sandra Dillon, Hal Winfield, Kimberly B. Bjugstad, Curt R. Freed

Research output: Contribution to journalArticle

194 Citations (Scopus)

Abstract

Context: This study was part of a large double-blind sham surgery-controlled trial designed to determine the effectiveness of transplantation of human embryonic dopamine neurons into the brains of persons with advanced Parkinson's disease. This portion of the study investigated the quality of life (QOL) of participants during the 1 year of double-blind follow-up. Objectives: To determine whether QOL improved more in the transplant group than in the sham surgery group and to investigate outcomes at 1 year based on perceived treatment (the type of surgery patients thought they received). Design: Participants were randomly assigned to receive either the transplant or sham surgery. Reported results are from the 1-year double-blind period. Setting: Participants were recruited from across the United States and Canada. Assessment and surgery were conducted at 2 separate university medical centers. Participants: A volunteer sample of 40 persons with idiopathic Parkinson's disease participated in the transplant ("parent") study, and 30 agreed to participate in the related QOL study: 12 received the transplant and 18 received sham surgery. Interventions: Interventions in the parent study were transplantation and sham brain surgery. Assessments of QOL were made at baseline and 4, 8, and 12 months after surgery. Main Outcome Measures: Comparison of the actual transplant and sham surgery groups and the perceived treatment groups on QOL and medical outcomes. We also investigated change over time. Results: There were 2 differences or changes over time in the transplant and sham surgery groups. Based on perceived treatment, or treatment patients thought they received, there were numerous differences and changes over time. In all cases, those who thought they received the transplant reported better scores. Blind ratings by medical staff showed similar results. Conclusions: The placebo effect was very strong in this study, demonstrating the value of placebo-controlled surgical trials.

Original languageEnglish (US)
Pages (from-to)412-420
Number of pages9
JournalArchives of General Psychiatry
Volume61
Issue number4
DOIs
StatePublished - Apr 2004
Externally publishedYes

Fingerprint

Placebos
Quality of Life
Transplants
Therapeutics
Parkinson Disease
Transplantation
Placebo Effect
Dopaminergic Neurons
Medical Staff
Brain
Canada
Volunteers
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Effects of Perceived Treatment on Quality of Life and Medical Outcomes in a Double-blind Placebo Surgery Trial. / McRae, Cynthia; Cherin, Eva; Yamazaki, T. Gayle; Diem, Gretchen; Vo, Alexander; Russell, Dan; Ellgring, J. Heiner; Fahn, Stanley; Greene, Paul; Dillon, Sandra; Winfield, Hal; Bjugstad, Kimberly B.; Freed, Curt R.

In: Archives of General Psychiatry, Vol. 61, No. 4, 04.2004, p. 412-420.

Research output: Contribution to journalArticle

McRae, C, Cherin, E, Yamazaki, TG, Diem, G, Vo, A, Russell, D, Ellgring, JH, Fahn, S, Greene, P, Dillon, S, Winfield, H, Bjugstad, KB & Freed, CR 2004, 'Effects of Perceived Treatment on Quality of Life and Medical Outcomes in a Double-blind Placebo Surgery Trial', Archives of General Psychiatry, vol. 61, no. 4, pp. 412-420. https://doi.org/10.1001/archpsyc.61.4.412
McRae, Cynthia ; Cherin, Eva ; Yamazaki, T. Gayle ; Diem, Gretchen ; Vo, Alexander ; Russell, Dan ; Ellgring, J. Heiner ; Fahn, Stanley ; Greene, Paul ; Dillon, Sandra ; Winfield, Hal ; Bjugstad, Kimberly B. ; Freed, Curt R. / Effects of Perceived Treatment on Quality of Life and Medical Outcomes in a Double-blind Placebo Surgery Trial. In: Archives of General Psychiatry. 2004 ; Vol. 61, No. 4. pp. 412-420.
@article{8550046d77094d679d60b7d1104c0c48,
title = "Effects of Perceived Treatment on Quality of Life and Medical Outcomes in a Double-blind Placebo Surgery Trial",
abstract = "Context: This study was part of a large double-blind sham surgery-controlled trial designed to determine the effectiveness of transplantation of human embryonic dopamine neurons into the brains of persons with advanced Parkinson's disease. This portion of the study investigated the quality of life (QOL) of participants during the 1 year of double-blind follow-up. Objectives: To determine whether QOL improved more in the transplant group than in the sham surgery group and to investigate outcomes at 1 year based on perceived treatment (the type of surgery patients thought they received). Design: Participants were randomly assigned to receive either the transplant or sham surgery. Reported results are from the 1-year double-blind period. Setting: Participants were recruited from across the United States and Canada. Assessment and surgery were conducted at 2 separate university medical centers. Participants: A volunteer sample of 40 persons with idiopathic Parkinson's disease participated in the transplant ({"}parent{"}) study, and 30 agreed to participate in the related QOL study: 12 received the transplant and 18 received sham surgery. Interventions: Interventions in the parent study were transplantation and sham brain surgery. Assessments of QOL were made at baseline and 4, 8, and 12 months after surgery. Main Outcome Measures: Comparison of the actual transplant and sham surgery groups and the perceived treatment groups on QOL and medical outcomes. We also investigated change over time. Results: There were 2 differences or changes over time in the transplant and sham surgery groups. Based on perceived treatment, or treatment patients thought they received, there were numerous differences and changes over time. In all cases, those who thought they received the transplant reported better scores. Blind ratings by medical staff showed similar results. Conclusions: The placebo effect was very strong in this study, demonstrating the value of placebo-controlled surgical trials.",
author = "Cynthia McRae and Eva Cherin and Yamazaki, {T. Gayle} and Gretchen Diem and Alexander Vo and Dan Russell and Ellgring, {J. Heiner} and Stanley Fahn and Paul Greene and Sandra Dillon and Hal Winfield and Bjugstad, {Kimberly B.} and Freed, {Curt R.}",
year = "2004",
month = "4",
doi = "10.1001/archpsyc.61.4.412",
language = "English (US)",
volume = "61",
pages = "412--420",
journal = "JAMA Psychiatry",
issn = "2168-622X",
publisher = "American Medical Association",
number = "4",

}

TY - JOUR

T1 - Effects of Perceived Treatment on Quality of Life and Medical Outcomes in a Double-blind Placebo Surgery Trial

AU - McRae, Cynthia

AU - Cherin, Eva

AU - Yamazaki, T. Gayle

AU - Diem, Gretchen

AU - Vo, Alexander

AU - Russell, Dan

AU - Ellgring, J. Heiner

AU - Fahn, Stanley

AU - Greene, Paul

AU - Dillon, Sandra

AU - Winfield, Hal

AU - Bjugstad, Kimberly B.

AU - Freed, Curt R.

PY - 2004/4

Y1 - 2004/4

N2 - Context: This study was part of a large double-blind sham surgery-controlled trial designed to determine the effectiveness of transplantation of human embryonic dopamine neurons into the brains of persons with advanced Parkinson's disease. This portion of the study investigated the quality of life (QOL) of participants during the 1 year of double-blind follow-up. Objectives: To determine whether QOL improved more in the transplant group than in the sham surgery group and to investigate outcomes at 1 year based on perceived treatment (the type of surgery patients thought they received). Design: Participants were randomly assigned to receive either the transplant or sham surgery. Reported results are from the 1-year double-blind period. Setting: Participants were recruited from across the United States and Canada. Assessment and surgery were conducted at 2 separate university medical centers. Participants: A volunteer sample of 40 persons with idiopathic Parkinson's disease participated in the transplant ("parent") study, and 30 agreed to participate in the related QOL study: 12 received the transplant and 18 received sham surgery. Interventions: Interventions in the parent study were transplantation and sham brain surgery. Assessments of QOL were made at baseline and 4, 8, and 12 months after surgery. Main Outcome Measures: Comparison of the actual transplant and sham surgery groups and the perceived treatment groups on QOL and medical outcomes. We also investigated change over time. Results: There were 2 differences or changes over time in the transplant and sham surgery groups. Based on perceived treatment, or treatment patients thought they received, there were numerous differences and changes over time. In all cases, those who thought they received the transplant reported better scores. Blind ratings by medical staff showed similar results. Conclusions: The placebo effect was very strong in this study, demonstrating the value of placebo-controlled surgical trials.

AB - Context: This study was part of a large double-blind sham surgery-controlled trial designed to determine the effectiveness of transplantation of human embryonic dopamine neurons into the brains of persons with advanced Parkinson's disease. This portion of the study investigated the quality of life (QOL) of participants during the 1 year of double-blind follow-up. Objectives: To determine whether QOL improved more in the transplant group than in the sham surgery group and to investigate outcomes at 1 year based on perceived treatment (the type of surgery patients thought they received). Design: Participants were randomly assigned to receive either the transplant or sham surgery. Reported results are from the 1-year double-blind period. Setting: Participants were recruited from across the United States and Canada. Assessment and surgery were conducted at 2 separate university medical centers. Participants: A volunteer sample of 40 persons with idiopathic Parkinson's disease participated in the transplant ("parent") study, and 30 agreed to participate in the related QOL study: 12 received the transplant and 18 received sham surgery. Interventions: Interventions in the parent study were transplantation and sham brain surgery. Assessments of QOL were made at baseline and 4, 8, and 12 months after surgery. Main Outcome Measures: Comparison of the actual transplant and sham surgery groups and the perceived treatment groups on QOL and medical outcomes. We also investigated change over time. Results: There were 2 differences or changes over time in the transplant and sham surgery groups. Based on perceived treatment, or treatment patients thought they received, there were numerous differences and changes over time. In all cases, those who thought they received the transplant reported better scores. Blind ratings by medical staff showed similar results. Conclusions: The placebo effect was very strong in this study, demonstrating the value of placebo-controlled surgical trials.

UR - http://www.scopus.com/inward/record.url?scp=11144353880&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=11144353880&partnerID=8YFLogxK

U2 - 10.1001/archpsyc.61.4.412

DO - 10.1001/archpsyc.61.4.412

M3 - Article

VL - 61

SP - 412

EP - 420

JO - JAMA Psychiatry

JF - JAMA Psychiatry

SN - 2168-622X

IS - 4

ER -