The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues

Placebo-controlled trials are controversial when individuals might be denied existing beneficial medical interventions. In the case of malaria, most patients die in rural villages without healthcare facilities. An artesunate suppository that can be given by minimally skilled persons might be of valu...

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Main Authors:	Kitua, A., Folb, P., Warsame, M., Binka, F., Faiz, A., Ribeiro, I., Peto, T., Gyapong, J., Yunus, E. B., Rahman, R., Baiden, F., Clerk, C., Mrango, Z., Makasi, C., Kimbute, O., Hossain, A., Samad, R., Gomes, M.
Format:	Journal Article
Language:	EN
Published:	2012
Subjects:	Rectal Administration Antimalarials Artemisinins Health Services Accessibility Humans Malaria Medication Adherence Placebos Randomized Controlled Trials as Topic Referral and Consultation Rural Health Suppositories
Online Access:	http://hdl.handle.net/10986/5100

id	okr-10986-5100
recordtype	oai_dc
spelling	okr-10986-51002021-04-23T14:02:21Z The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues Kitua, A. Folb, P. Warsame, M. Binka, F. Faiz, A. Ribeiro, I. Peto, T. Gyapong, J. Yunus, E. B. Rahman, R. Baiden, F. Clerk, C. Mrango, Z. Makasi, C. Kimbute, O. Hossain, A. Samad, R. Gomes, M. Rectal Administration Antimalarials Artemisinins Health Services Accessibility Humans Malaria Medication Adherence Placebos Randomized Controlled Trials as Topic Referral and Consultation Rural Health Suppositories Placebo-controlled trials are controversial when individuals might be denied existing beneficial medical interventions. In the case of malaria, most patients die in rural villages without healthcare facilities. An artesunate suppository that can be given by minimally skilled persons might be of value when patients suddenly become too ill for oral treatment but are several hours from a facility that can give injectable treatment for severe disease. In such situations, by default, no treatment is (or can be) given until the patient reaches a facility, making the placebo control design clinically relevant; alternative bioequivalence designs at the facility would misrepresent reality and risk incorrect conclusions. We describe the ethical issues underpinning a placebo-controlled trial in severe malaria. To protect patients and minimise risk, all patients were referred immediately to hospital so that each had a higher chance of prompt treatment through participation. There was no difference between artesunate and placebo in patients who reached clinic rapidly; among those who could not, a single artesunate suppository significantly reduced death or permanent disability, a finding of direct and indirect benefit to patients in participating villages and elsewhere. 2012-03-30T07:31:16Z 2012-03-30T07:31:16Z 2010 Journal Article J Med Ethics 1473-4257 (Electronic) 0306-6800 (Linking) http://hdl.handle.net/10986/5100 EN http://creativecommons.org/licenses/by-nc-nd/3.0/igo World Bank Journal Article
repository_type	Digital Repository
institution_category	Foreign Institution
institution	Digital Repositories
building	World Bank Open Knowledge Repository
collection	World Bank
language	EN
topic	Rectal Administration Antimalarials Artemisinins Health Services Accessibility Humans Malaria Medication Adherence Placebos Randomized Controlled Trials as Topic Referral and Consultation Rural Health Suppositories
spellingShingle	Rectal Administration Antimalarials Artemisinins Health Services Accessibility Humans Malaria Medication Adherence Placebos Randomized Controlled Trials as Topic Referral and Consultation Rural Health Suppositories Kitua, A. Folb, P. Warsame, M. Binka, F. Faiz, A. Ribeiro, I. Peto, T. Gyapong, J. Yunus, E. B. Rahman, R. Baiden, F. Clerk, C. Mrango, Z. Makasi, C. Kimbute, O. Hossain, A. Samad, R. Gomes, M. The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues
relation	http://creativecommons.org/licenses/by-nc-nd/3.0/igo
description	Placebo-controlled trials are controversial when individuals might be denied existing beneficial medical interventions. In the case of malaria, most patients die in rural villages without healthcare facilities. An artesunate suppository that can be given by minimally skilled persons might be of value when patients suddenly become too ill for oral treatment but are several hours from a facility that can give injectable treatment for severe disease. In such situations, by default, no treatment is (or can be) given until the patient reaches a facility, making the placebo control design clinically relevant; alternative bioequivalence designs at the facility would misrepresent reality and risk incorrect conclusions. We describe the ethical issues underpinning a placebo-controlled trial in severe malaria. To protect patients and minimise risk, all patients were referred immediately to hospital so that each had a higher chance of prompt treatment through participation. There was no difference between artesunate and placebo in patients who reached clinic rapidly; among those who could not, a single artesunate suppository significantly reduced death or permanent disability, a finding of direct and indirect benefit to patients in participating villages and elsewhere.
format	Journal Article
author	Kitua, A. Folb, P. Warsame, M. Binka, F. Faiz, A. Ribeiro, I. Peto, T. Gyapong, J. Yunus, E. B. Rahman, R. Baiden, F. Clerk, C. Mrango, Z. Makasi, C. Kimbute, O. Hossain, A. Samad, R. Gomes, M.
author_facet	Kitua, A. Folb, P. Warsame, M. Binka, F. Faiz, A. Ribeiro, I. Peto, T. Gyapong, J. Yunus, E. B. Rahman, R. Baiden, F. Clerk, C. Mrango, Z. Makasi, C. Kimbute, O. Hossain, A. Samad, R. Gomes, M.
author_sort	Kitua, A.
title	The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues
title_short	The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues
title_full	The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues
title_fullStr	The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues
title_full_unstemmed	The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues
title_sort	use of placebo in a trial of rectal artesunate as initial treatment for severe malaria patients en route to referral clinics : ethical issues
publishDate	2012
url	http://hdl.handle.net/10986/5100
_version_	1764393943658659840

The Use of Placebo in a Trial of Rectal Artesunate as Initial Treatment for Severe Malaria Patients En Route to Referral Clinics : Ethical Issues

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