Pilot testing of methods for evaluation of acupuncture for emesis during radiotherapy: a randomised single subject experimental design.

BACKGROUND Many acupuncture studies are of weak methodological quality, possibly due to lack of pilot testing. This pilot study tested design features, including test of feasibility, compliance to treatment and data collection, level of blinding success and the patients' potential perceived effects of the treatment, in preparation for an efficacy study. METHOD A modified single subject experimental design was conducted. 10 cancer patients were randomised to verum penetrating acupuncture or non-penetrating sham needles for 30 min 2-3 times/week during radiotherapy over abdomen/pelvis. They answered test-retested emesis questions (r=0.527-1.0) covering nausea, vomiting, use of antiemetics, wellbeing and activities of daily living. RESULTS Overall, the patients completed 98% of the 345 emesis-questionnaire days and 101 of the 115 offered treatments. All patients believed they received verum acupuncture. 10 patients experienced antiemetic effects, seven relaxation, five pain-reduction and five experienced sleep improvement. Two types of nausea questions showed absolute concordance (r=1.0) (n of observations=456). Nausea was experienced by one of five verum acupuncture treated patients (duration median 0% of the radiotherapy-days) and four of five sham acupuncture treated patients (duration median 24% of the radiotherapy-days). Patients experiencing nausea rated decreased wellbeing and performance of daily activities compared to patients free from nausea. CONCLUSIONS All patients were blinded, complied with verum/sham treatments and data-collection, and believed they had effects of the received treatment. The methods for verum/sham treatment and data collection may thus be used in an adequately powered randomised controlled study of the effect of acupuncture for radiotherapy-induced emesis.