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Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle?
Linköping University, Faculty of Health Sciences. Linköping University, Department of Medical and Health Sciences, Division of Nursing Science.
Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
Department of Oncology-Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institute, Stockholm, Sweden.
Linköping University, Department of Medical and Health Sciences, Nursing Science. Linköping University, Faculty of Health Sciences. (Centre of Surgery and Oncology, Department of Oncology, Link¨oping University Hospital, Link¨oping, Sweden)ORCID iD: 0000-0002-9786-7326
2008 (English)In: Complementary Therapies in Medicine, ISSN 0965-2299, E-ISSN 1873-6963, Vol. 16, no 5, 288-94 p.Article in journal (Refereed) Published
Abstract [en]

A control treatment in acupuncture research must be credible, regardless if the needling is performed by one or by several therapists.

Objective: To investigate if individuals could identify whether needling had been given with an acupuncture needle or a sham needle and if the therapist influenced this ability.

Design: Eighty individuals were randomized to one single needling given by one of four physiotherapists using either an invasive needle or a non-penetrating telescopic sham needle.

Results: An equal proportion of individuals, 27 (68%), in the acupuncture group and the sham group answered incorrectly or was not sure at all regarding needling type but the proportion varied between the therapists from 55 to 80% (ns). Bang's blinding index was 0.20 (95% CI 0.03-0.36) in the acupuncture group and 0.10 (95% CI 0.09-0.29) in the sham group (interpretation: 20 and 10% identified needling type beyond statistical chance). Acupuncture was on a four-grade scale rated as median "mildly painful" and sham as "not painful" (ns). Pain ratings varied from median "not" to "mildly painful" in the therapists (p = 0.01).

Conclusions: Two thirds of individuals needled by acupuncture as well as sham could not identify needling type and only 10-20% of the individuals were unblinded beyond chance. The therapists, not the needling type, influenced how painful the needling was perceived. IMPLICATIONS: To achieve blinding success in acupuncture efficacy studies using the sham needle, the needling procedure must be strictly standardized in order to minimize differences between the therapists.

Place, publisher, year, edition, pages
2008. Vol. 16, no 5, 288-94 p.
Keyword [en]
Acupuncture therapy, Blinding, Research methodology, Reliability, Sham
National Category
Medical and Health Sciences Nursing
URN: urn:nbn:se:liu:diva-17231DOI: 10.1016/j.ctim.2008.02.012PubMedID: 19186344OAI: diva2:207638
Available from: 2009-03-12 Created: 2009-03-12 Last updated: 2013-09-12Bibliographically approved
In thesis
1. Nausea and vomiting in patients receiving acupuncture, sham acupuncture or standard care during radiotherapy
Open this publication in new window or tab >>Nausea and vomiting in patients receiving acupuncture, sham acupuncture or standard care during radiotherapy
2008 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background and aim: Many patients with cancer experience emesis (nausea and vomiting) during radiotherapy. The overall aim of this thesis was to improve the situation for patients with risk for emesis during radiotherapy, by evaluating emesis in patients receiving verum (genuine) acupuncture, sham (simulated) acupuncture or standard care during radiotherapy.

Methods: In study I, a cross-sectional sample (n=368) treated with radiotherapy over various fields answered a study-specific questionnaire. In study II, 80 healthy volunteers were randomized to receive needling with verum acupuncture or non-penetrating telescopic sham needles by one of four physiotherapists. In study III, 215 patients were randomly allocated to verum (n=109) or non-penetrating telescopic sham (n=106) acupuncture during their entire radiotherapy period over abdominal or pelvic fields. The same 215 patients were also included in study IV. They were compared to 62 patients irradiated over abdominal or pelvic fields, selected from study I.

Results: In study I, the weekly prevalence of nausea was 39 % in all radiotherapy-treated patients and 63 % in abdominal or pelvic irradiated patients. Age younger than 40 years and previous experience of nausea in other situations were characteristics associated with an increased risk for nausea. Of the 145 nauseous patients, 34 % considered their antiemetic treatment as insufficient. Patients with nausea reported lower level of quality of life compared to patients free from nausea. In study II, most individuals needled with verum (68 %) or sham (68 %) acupuncture could not identify needling type, and that blinding result varied from 55 to 80 % between the four therapists. In study III, nausea was experienced by 70 % (mean number of days=10.1) and 25 % vomited during the radiotherapy period. In the sham group 62 % experienced nausea (mean number of days=8.7) and 28 % vomited. Ninety five percent in the verum and 96 % in the sham group believed that the treatment had been effective for nausea. In both groups, 67 % experienced other positive effects, on relaxation, mood, sleep or pain-reduction, and 89 % were interested in receiving the treatment again. In study IV, the weekly prevalence of nausea and vomiting was 38 and 8 % in the verum group, 37 and 7 % in the sham group and 63 and 15 % in the standard care group. The nausea difference between the acupuncture and the standard care cohort was statistically significant, also after overall adjustments for potential confounding factors. The nausea intensity in the acupuncture cohort was lower compared to the standard care cohort (p=0.002). Patients who expected nausea had increased risk for nausea compared to patients who expected low risk for nausea (Relative risk 1.6).

Conclusions and implications: Nausea was common during abdominal or pelvic field irradiation in patients receiving standard care. Verum acupuncture did not reduce emesis compared to sham acupuncture, while reduced emesis was seen in both patients treated with verum or sham acupuncture. Health-care professionals may consider identifying and treating patients with increased risk for nausea in advance. The telescopic sham needle was credible. Researchers may thus use and standardize the sham procedure in acupuncture control groups. The choice of performing acupuncture during radiotherapy cannot be based on arguments that the specific characters of verum acupuncture have effects on nausea. It is important to further study what components in the acupuncture procedures that produce the dramatic positive but yet not fully understood antiemetic effect, making it possible to use those components to further increase quality of care during radiotherapy.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2008. 69 p.
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1088
Acupuncture, Cancer, Emesis, Placebo, Radiotherapy
National Category
Medical and Health Sciences
urn:nbn:se:liu:diva-17237 (URN)978-91-7393-754-2 (ISBN)
Public defence
2008-12-05, Berzeliussalen, Campus US, Linköpings universitet, Linköping, 13:00 (English)
Available from: 2009-03-12 Created: 2009-03-12 Last updated: 2013-09-03Bibliographically approved

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