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Article: A novel sham moxibustion device: A randomized, placebo-controlled trial

TitleA novel sham moxibustion device: A randomized, placebo-controlled trial
Authors
Issue Date2006
PublisherChurchill Livingstone. The Journal's web site is located at http://www.elsevier.com/locate/issn/09652299
Citation
Complementary Therapies In Medicine, 2006, v. 14 n. 1, p. 53-60 How to Cite?
AbstractObjectives: (1) Develop a sham moxibustion device; (2) determine whether volunteer participants and practitioners can distinguish the sham procedure from real moxibustion during treatment for prevention of the common cold; and (3) assess the feasibility of conducting a larger clinical trial of the device. Design: Double-blinded, randomized, placebo-controlled clinical trial. Setting: A community outpatient health station in Chaoyang district, Beijing, China, from early November through late December 2003. Methods: Sham and real moxibustion pillars were made by affixing moxa cones onto special collar bases. These pillars resemble each other in appearance, burning procedure and residue, but the base of the sham pillar isolates the moxa-produced heat and smoke and prevents them from radiating to the skin. These devices were tested in a pilot clinical trial in which patients received moxibustion at Zusanli (ST 36) for prevention of the common cold. Volunteers (n = 71) aged 55-75 years were given pre-treatment questionnaires to assess their knowledge of moxibustion and their expectations and motives for participating in the trial, randomized into treatment (n = 36) and placebo-controlled (n = 35) groups, and treated once every 2 days for 1 month. Questionnaires assessing the effectiveness of the blinding were given to the volunteers at the end of the trial and to practitioners after each treatment session. Result: There were no significant differences between the two groups of patients in past moxibustion experience, knowledge of moxibustion, expectations and motivation. The number of volunteers in the treatment group and the placebo group who believed they received: (1) real moxibustion; (2) sham moxibustion; and (3) were uncertain as to which they received is 30, 0, 5; 29, 0, 4, respectively. The results show no significant statistical differences (P = 1.000). The number of volunteers in the treatment group and the placebo group who were believed, by the two practitioners who provided the treatments, to have received: (1) real moxibustion; (2) sham moxibustion; and (3) and an undisclosed treatment were 10, 6, 19; 9, 4, 20 and 11, 7, 17; 12, 5, 16, respectively. There were no statistically significant differences between the practitioners (P = 0.811 and 0.840). Conclusion: The sham moxibustion device was successfully validated in the present study. The results demonstrate that these specially designed real and sham moxibustion pillars can be used together to provide an effective placebo-control in moxibustion research and can successfully fulfill the double blinding protocol in moxibustion clinical trials. © 2005 Elsevier Ltd. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/188578
ISSN
2015 Impact Factor: 1.935
2015 SCImago Journal Rankings: 0.649
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorZhao, Ben_US
dc.contributor.authorWang, Xen_US
dc.contributor.authorLin, Zen_US
dc.contributor.authorLiu, Ren_US
dc.contributor.authorLao, Len_US
dc.date.accessioned2013-09-03T04:10:25Z-
dc.date.available2013-09-03T04:10:25Z-
dc.date.issued2006en_US
dc.identifier.citationComplementary Therapies In Medicine, 2006, v. 14 n. 1, p. 53-60en_US
dc.identifier.issn0965-2299en_US
dc.identifier.urihttp://hdl.handle.net/10722/188578-
dc.description.abstractObjectives: (1) Develop a sham moxibustion device; (2) determine whether volunteer participants and practitioners can distinguish the sham procedure from real moxibustion during treatment for prevention of the common cold; and (3) assess the feasibility of conducting a larger clinical trial of the device. Design: Double-blinded, randomized, placebo-controlled clinical trial. Setting: A community outpatient health station in Chaoyang district, Beijing, China, from early November through late December 2003. Methods: Sham and real moxibustion pillars were made by affixing moxa cones onto special collar bases. These pillars resemble each other in appearance, burning procedure and residue, but the base of the sham pillar isolates the moxa-produced heat and smoke and prevents them from radiating to the skin. These devices were tested in a pilot clinical trial in which patients received moxibustion at Zusanli (ST 36) for prevention of the common cold. Volunteers (n = 71) aged 55-75 years were given pre-treatment questionnaires to assess their knowledge of moxibustion and their expectations and motives for participating in the trial, randomized into treatment (n = 36) and placebo-controlled (n = 35) groups, and treated once every 2 days for 1 month. Questionnaires assessing the effectiveness of the blinding were given to the volunteers at the end of the trial and to practitioners after each treatment session. Result: There were no significant differences between the two groups of patients in past moxibustion experience, knowledge of moxibustion, expectations and motivation. The number of volunteers in the treatment group and the placebo group who believed they received: (1) real moxibustion; (2) sham moxibustion; and (3) were uncertain as to which they received is 30, 0, 5; 29, 0, 4, respectively. The results show no significant statistical differences (P = 1.000). The number of volunteers in the treatment group and the placebo group who were believed, by the two practitioners who provided the treatments, to have received: (1) real moxibustion; (2) sham moxibustion; and (3) and an undisclosed treatment were 10, 6, 19; 9, 4, 20 and 11, 7, 17; 12, 5, 16, respectively. There were no statistically significant differences between the practitioners (P = 0.811 and 0.840). Conclusion: The sham moxibustion device was successfully validated in the present study. The results demonstrate that these specially designed real and sham moxibustion pillars can be used together to provide an effective placebo-control in moxibustion research and can successfully fulfill the double blinding protocol in moxibustion clinical trials. © 2005 Elsevier Ltd. All rights reserved.en_US
dc.languageengen_US
dc.publisherChurchill Livingstone. The Journal's web site is located at http://www.elsevier.com/locate/issn/09652299en_US
dc.relation.ispartofComplementary Therapies in Medicineen_US
dc.subject.meshAgeden_US
dc.subject.meshCommon Cold - Prevention & Controlen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshFemaleen_US
dc.subject.meshHealth Knowledge, Attitudes, Practiceen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshMoxibustion - Instrumentationen_US
dc.subject.meshQuestionnairesen_US
dc.titleA novel sham moxibustion device: A randomized, placebo-controlled trialen_US
dc.typeArticleen_US
dc.identifier.emailLao, L: lxlao1@hku.hken_US
dc.identifier.authorityLao, L=rp01784en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1016/j.ctim.2005.06.003en_US
dc.identifier.pmid16473754-
dc.identifier.scopuseid_2-s2.0-32244433046en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-32244433046&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume14en_US
dc.identifier.issue1en_US
dc.identifier.spage53en_US
dc.identifier.epage60en_US
dc.identifier.isiWOS:000239334500008-
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridZhao, B=55469024300en_US
dc.identifier.scopusauthoridWang, X=12239794300en_US
dc.identifier.scopusauthoridLin, Z=26433004200en_US
dc.identifier.scopusauthoridLiu, R=35324632500en_US
dc.identifier.scopusauthoridLao, L=7005681883en_US

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