Pilot Testing of Methods for Evaluation of Acupuncture for Emesis during Radiotherapy: A Randomised Single Subject Experimental Design

Abstract

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 effi cacy study. Method A modifi ed 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, fi ve pain-reduction and fi ve experienced sleep improvement. Two types of nausea questions showed absolute concordance (r=1.0) (n of observations=456). Nausea was experienced by one of fi ve verum acupuncture treated patients (duration median 0% of the radiotherapy-days) and four of fi ve 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.

Nurses' knowledge and attitudes toward complementary therapies for cancer: A review of the literature

“…The literature reviewed has shown that CTs could alleviate symptoms of chemotherapy, boost immunity and increase the QoL. [13363738] The use of CTs as a complement to conventional cancer treatment can be beneficial; however, adverse effects that could be harmful and interfere with oncological medical therapy should be considered. Thus, it is essential that the integration of conventional treatment and CTs for cancer should be properly managed.…”

“…For instance, herbal medicine, acupuncture, and yoga could alleviate the side effects of chemotherapy. [13363738] Thus, there is the need for further research regarding the efficacy and safety of CTs for cancer treatment.…”

Use of acupuncture to alleviate side effects in radiation oncology: Current evidence and future directions

“…Before starting the study with 215 patients, a pilot study with 10 patients was conducted 24 . Verum and sham acupuncture was delivered close to (before or after) the first RT session for 30 minutes, 3 times per week for the first 2 weeks, then twice weekly for the remaining course of RT.…”

“…All studies have shown that acupuncture is associated with better outcome in relieving disorders than the control groups 20, 21, 22, 23, 24, 25, 29. This effect is observed in the verum acupuncture and in the sham acupuncture arms at least in 3 trials.…”

Complementary and alternative theraphy methods used in the management of chemotherapy induced nausea and vomiting

“…Literatürde akupunkturun kanserde ağrı, yorgunluk, anksiyete, depresyon, bulantı-kusma, ağız kuruluğu, gibi şikayetleri azaltmak, yaşam kalitesini artırmak için kullanılabileceği önerilmektedir. [57] Enblom, Tomasson, Hammar, Steineck ve Borjeson [58] radyoterapi alan hastalarda akapunkturun bulantıyı azalttığını bildirmişlerdir.…”