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.
Get full access to this article
View all access options for this article.
References
1.
EzzoJM, RichardsonMA, VickersA, Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting. Cochrane Database Syst Rev2006;19:CD002285.
2.
JohnstonePA, PolstonGR, NiemtzowRC, Integration of acupuncture into the oncology clinic. Palliat Med2002;16:235-9.
3.
NystromE, RidderstromG, LefflerAS. Manual acupuncture as an adjunctive treatment of nausea in patients with cancer in palliative care-a prospective, observational pilot study. Acupunct Med2008;26:27-32.
4.
ChooSP, KongKH, LimWT, Electroacupuncture for refractory acute emesis caused by chemotherapy. J Altern Complement Med2006;12:963-9.
5.
MolassiotisA, HelinAM, DabbourR, The effects of P6 acupressure in the prophylaxis of chemotherapy-related nausea and vomiting in breast cancer patients. Complement Ther Med2007;15:3-12.
6.
XiaYS, WangJH, ShanLJ. Acupuncture plus ear-point press in preventing vomiting induced by chemotherapy with cisplatin. Int J Clin Acupunct2000;11:145-8.
7.
DundeeJW, GhalyRG, FitzpatrickKT, Acupuncture prophylaxis of cancer chemotherapy-induced sickness. J R Soc Med1989;82:268-71.
8.
MelchartD, Ihbe-HeffingerA, LepsB, Acupuncture and acupressure for the prevention of chemotherapy-induced nausea-a randomised crossover pilot study. Support Care Cancer2006;14:878-82.
9.
ShenJ, WengerN, GlaspyJ, Electroacupuncture for control of myeloablative chemotherapy-induced emesis: A randomized controlled trial. JAMA2000;284:2755-61.
10.
StreitbergerK, Friedrich-RustM, BardenheuerH, Effect of acupuncture compared with placebo-acupuncture at P6 as additional antiemetic prophylaxis in high-dose chemotherapy and autologous peripheral blood stem cell transplantation: a randomized controlled single-blind trial. Clin Cancer Res2003;9:2538-44.
11.
FeyerPC, MaranzanoE, MolassiotisA, Radiotherapy-induced nausea and vomiting (RINV): antiemetic guidelines. Support Care Cancer2005;13:122-8.
12.
EnblomA, BergiusAxelsson B, SteineckG, One third of patients with radiotherapy-induced nausea consider their antiemetic treatment insufficient. Support Care Cancer2009;17:23-32.
13.
IGARR (the Italian Group for Antiemetic Research in Radiotherapy). Radiation-induced emesis: a prospective observational multicenter Italian trial. Int J Radiat Oncol Biol Phys1999;44:619-25.
14.
MystakidouK, KatsoudaE, LinouA, Prophylactic tropisetron versus rescue tropisetron in fractionated radiotherapy to moderate or high emetogenic areas: a prospective randomized open label study in cancer patients. Med Oncol2006;23:251-62.
15.
BörjesonS, HurstiTJ, TishelmanC, Treatment of nausea and emesis during cancer chemotherapy. Discrepancies between antiemetic effect and wellbeing. J Pain Symptom Manage2002;24:345-58.
16.
ShunSC, ChiouJF, LaiYH, Changes in quality of life and its related factors in liver cancer patients receiving stereotactic radiation therapy. Support Care Cancer2008;16:1059-65.
17.
VazAF, Pinto-NetoAM, CondeDM, Quality of life and acute toxicity of radiotherapy in women with gynecologic cancer: a prospective longitudinal study. Arch Gynecol Obstet2008;278:215-23.
18.
MolassiotisA, Fernadez-OrtegaP, PudD, Use of complementary and alternative medicine in cancer patients: a European survey. Ann Oncol2005;16:655-63.
19.
KolstadA, RisbergT, BremnesY, Use of complementary and alternative therapies: a national multicentre study of oncology health professionals in Norway. Support Care Cancer2004;12:312-18.
20.
ZhanS, OttenbacherKJ. Single subject research designs for disability research. Disabil Rehabil2001;23:1-8.
21.
BackmanCL, HarrisSR, ChisholmJA, Single-subject research in rehabilitation: a review of studies using AB, withdrawal, multiple baseline, and alternating treatments designs. Arch Phys Med Rehabil1997;78:1145-53.
22.
MillerFG, EmanuelEJ, RosensteinDL, Ethical issues concerning research in complementary and alternative medicine. JAMA2004;291:599-604.
23.
FilshieJ, HesterJ.Guidelines for providing acupuncture treatment for cancer patients-a peer-reviewed sample policy document. Acupunct Med2006;24:172-82.
24.
MacPhersonH, AltmanDG, HammerschlagR, Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med2010;7:e1000261.
25.
HuiKK, NixonEE, VangelMG, Characterization of the “deqi” response in acupuncture. BMC Complement Altern Med2007;7:33.
26.
ParkJ, WhiteA, LeeH, Development of a new sham needle. Acupunct Med1999;17:110-12.
27.
EnblomA, HammarM, SteineckG, Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle. Complement Ther Med2008;16:288-94.
28.
ParkJ, WhiteAR, JamesMA, Acupuncture for subacute stroke rehabilitation: a Sham-controlled, subject- and assessor-blind, randomized trial. Arch Intern Med2005;165:2026-31.
29.
StreitbergerK, KleinhenzJ.Introducing a placebo needle into acupuncture research. Lancet1998;352:364-5.
30.
BonomiAE, CellaDF, HahnEA, Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res1996;5:309-20.
31.
CellaDF, TulskyDS, GrayG, The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol1993;11:570-9.
32.
Ashing-GiwaKT, KimJ, TejeroJS. Measuring quality of life among cervical cancer survivors: preliminary assessment of instrumentation validity in a cross-cultural study. Qual Life Res2008;17:147-57.
33.
BörjesonS, HurstiTJ, PetersonC, Similarities and differences in assessing nausea on a verbal category scale and a visual analogue scale. Cancer Nurs1997;20:260-6.
34.
BoogaertsJG, VanackerE, SeidelL, Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand2000;44:470-4.
35.
BengaliMK, OttenbacherKJ. The effect of autocorrelation on the results of visually analyzing data from single-subject designs. Am J Occup Ther1998;52:650-5.
36.
DincerF, LindeK.Sham interventions in randomized clinical trials of acupuncture-a review. Complement Ther Med2003;11:235-42.
TakakuraN, TakayamaM, KawaseA, Double blinding with a new placebo needle: a further validation study. Acupunct Med2010;28:144-8.
39.
ParienteJ, WhiteP, FrackowiakRS, Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture. Neuroimage2005;25:1161-7.
40.
HuiKK, LiuJ, MarinaO, The integrated response of the human cerebro-cerebellar and limbic systems to acupuncture stimulation at ST 36 as evidenced by fMRI. Neuroimage2005;27:479-96.
41.
OnelövE, SteineckG, NybergU, Measuring anxiety and depression in the oncology setting using visual-digital scales. Acta Oncol2007;46:810-6.
42.
JennsK.Importance of nausea. Cancer Nurs1994;17:488-93.
43.
RhodesVA, McDanielRW. Nausea, vomiting, and retching: complex problems in palliative care. CA Cancer J Clin2001;51:232-48; quiz 249-52.
44.
PerdicesM, TateRL. Single-subject designs as a tool for evidence-based clinical practice: Are they unrecognised and undervalued. Neuropsychol Rehabil2009;19:904-27.
45.
SagarSM. Acupuncture as an evidence-based option for symptom control in cancer patients. Curr Treat Options Oncol2008;9:117-26.
46.
MarklundI, KlässboM.Effects of lower limb intensive mass practice in poststroke patients: single-subject experimental design with long-term follow-up. Clin Rehabil2006;20:568-76.
47.
BernhardssonS, KlintbergIH, WendtGK. Evaluation of an exercise concept focusing on eccentric strength training of the rotator cuff for patients with subacromial impingement syndrome. Clin Rehabil2011;25:69-78.
48.
HoriotJC, AaproM.Treatment implications for radiation-induced nausea and vomiting in specific patient groups. Eur J Cancer2004;40:979-87.
