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 mechanismscited as placebo and if acupuncture or sham reduces radiotherapy-inducedemesis more than standard care.

Methodology/Principal Findings

Cancer patients receiving radiotherapy over abdominal/pelvic regions wererandomized to verum (penetrating) acupuncture (n = 109;99 provided data) in the alleged antiemetic acupuncture point PC6 or shamacupuncture (n = 106; 101 provided data) performed witha telescopic non-penetrating needle at a sham point 2–3 times/weekduring the whole radiotherapy period. The acupuncture cohort was compared toa reference cohort receiving standard care (n = 62; 62provided data). The occurrence of emesis in each group was compared after amean dose of 27 Gray. Nausea and vomiting were experienced during thepreceding week by 37 and 8% in the verum acupuncture group, 38 and7% in the sham acupuncture group and 63 and 15% in thestandard care group, respectively. The lower occurrence of nausea in theacupuncture cohort (verum and sham) compared to patients receiving standardcare (37% versus 63%, relative risk (RR) 0.6, 95 %confidence interval (CI) 0.5–0.8) was also true after adjustment forpotential confounding factors for nausea (RR 0.8, CI 0.6 to 0.9). Nauseaintensity was lower in the acupuncture cohort (78% no nausea,13% a little, 8% moderate, 1% much) compared to thestandard care cohort (52% no nausea, 32% a little, 15%moderate, 2% much) (p = 0.002). The acupuncturecohort expected antiemetic effects from their treatment (95%).Patients who expected nausea had increased risk for nausea compared topatients 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 andvomiting compared to patients receiving standard care, possibly through ageneral care effect or due to the high level of patient expectancy.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00621660","term_id":"NCT00621660"}}NCT00621660