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Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care

BACKGROUND: It is not known whether or not delivering acupuncture triggers mechanisms cited as placebo and if acupuncture or sham reduces radiotherapy-induced emesis more than standard care. METHODOLOGY/PRINCIPAL FINDINGS: Cancer patients receiving radiotherapy over abdominal/pelvic regions were ran...

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Autores principales: Enblom, Anna, Lekander, Mats, Hammar, Mats, Johnsson, Anna, Onelöv, Erik, Ingvar, Martin, Steineck, Gunnar, Börjeson, Sussanne
Formato: Texto
Lenguaje:English
Publicado: Public Library of Science 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063156/
https://www.ncbi.nlm.nih.gov/pubmed/21448267
http://dx.doi.org/10.1371/journal.pone.0014766
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author Enblom, Anna
Lekander, Mats
Hammar, Mats
Johnsson, Anna
Onelöv, Erik
Ingvar, Martin
Steineck, Gunnar
Börjeson, Sussanne
author_facet Enblom, Anna
Lekander, Mats
Hammar, Mats
Johnsson, Anna
Onelöv, Erik
Ingvar, Martin
Steineck, Gunnar
Börjeson, Sussanne
author_sort Enblom, Anna
collection PubMed
description BACKGROUND: It is not known whether or not delivering acupuncture triggers mechanisms cited as placebo and if acupuncture or sham reduces radiotherapy-induced emesis more than standard care. METHODOLOGY/PRINCIPAL FINDINGS: Cancer patients receiving radiotherapy over abdominal/pelvic regions were randomized to verum (penetrating) acupuncture (n = 109; 99 provided data) in the alleged antiemetic acupuncture point PC6 or sham acupuncture (n = 106; 101 provided data) performed with a telescopic non-penetrating needle at a sham point 2–3 times/week during the whole radiotherapy period. The acupuncture cohort was compared to a reference cohort receiving standard care (n = 62; 62 provided data). The occurrence of emesis in each group was compared after a mean dose of 27 Gray. Nausea and vomiting were experienced during the preceding week by 37 and 8% in the verum acupuncture group, 38 and 7% in the sham acupuncture group and 63 and 15% in the standard care group, respectively. The lower occurrence of nausea in the acupuncture cohort (verum and sham) compared to patients receiving standard care (37% versus 63%, relative risk (RR) 0.6, 95 % confidence interval (CI) 0.5–0.8) was also true after adjustment for potential confounding factors for nausea (RR 0.8, CI 0.6 to 0.9). Nausea intensity was lower in the acupuncture cohort (78% no nausea, 13% a little, 8% moderate, 1% much) compared to the standard care cohort (52% no nausea, 32% a little, 15% moderate, 2% much) (p = 0.002). The acupuncture cohort expected antiemetic effects from their treatment (95%). Patients who expected nausea had increased risk for nausea compared to patients who expected low risk for nausea (RR 1.6; Cl 1.2–2.4). CONCLUSIONS/SIGNIFICANCE: Patients treated with verum or sham acupuncture experienced less nausea and vomiting compared to patients receiving standard care, possibly through a general care effect or due to the high level of patient expectancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT00621660
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spelling pubmed-30631562011-03-28 Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care Enblom, Anna Lekander, Mats Hammar, Mats Johnsson, Anna Onelöv, Erik Ingvar, Martin Steineck, Gunnar Börjeson, Sussanne PLoS One Research Article BACKGROUND: It is not known whether or not delivering acupuncture triggers mechanisms cited as placebo and if acupuncture or sham reduces radiotherapy-induced emesis more than standard care. METHODOLOGY/PRINCIPAL FINDINGS: Cancer patients receiving radiotherapy over abdominal/pelvic regions were randomized to verum (penetrating) acupuncture (n = 109; 99 provided data) in the alleged antiemetic acupuncture point PC6 or sham acupuncture (n = 106; 101 provided data) performed with a telescopic non-penetrating needle at a sham point 2–3 times/week during the whole radiotherapy period. The acupuncture cohort was compared to a reference cohort receiving standard care (n = 62; 62 provided data). The occurrence of emesis in each group was compared after a mean dose of 27 Gray. Nausea and vomiting were experienced during the preceding week by 37 and 8% in the verum acupuncture group, 38 and 7% in the sham acupuncture group and 63 and 15% in the standard care group, respectively. The lower occurrence of nausea in the acupuncture cohort (verum and sham) compared to patients receiving standard care (37% versus 63%, relative risk (RR) 0.6, 95 % confidence interval (CI) 0.5–0.8) was also true after adjustment for potential confounding factors for nausea (RR 0.8, CI 0.6 to 0.9). Nausea intensity was lower in the acupuncture cohort (78% no nausea, 13% a little, 8% moderate, 1% much) compared to the standard care cohort (52% no nausea, 32% a little, 15% moderate, 2% much) (p = 0.002). The acupuncture cohort expected antiemetic effects from their treatment (95%). Patients who expected nausea had increased risk for nausea compared to patients who expected low risk for nausea (RR 1.6; Cl 1.2–2.4). CONCLUSIONS/SIGNIFICANCE: Patients treated with verum or sham acupuncture experienced less nausea and vomiting compared to patients receiving standard care, possibly through a general care effect or due to the high level of patient expectancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT00621660 Public Library of Science 2011-03-23 /pmc/articles/PMC3063156/ /pubmed/21448267 http://dx.doi.org/10.1371/journal.pone.0014766 Text en Enblom et al. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Enblom, Anna
Lekander, Mats
Hammar, Mats
Johnsson, Anna
Onelöv, Erik
Ingvar, Martin
Steineck, Gunnar
Börjeson, Sussanne
Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care
title Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care
title_full Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care
title_fullStr Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care
title_full_unstemmed Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care
title_short Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care
title_sort getting the grip on nonspecific treatment effects: emesis in patients randomized to acupuncture or sham compared to patients receiving standard care
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063156/
https://www.ncbi.nlm.nih.gov/pubmed/21448267
http://dx.doi.org/10.1371/journal.pone.0014766
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