To Evaluate The Randomized Crossover Test And Methodological Study On The Effects Of Different Acupuncturist Acupuncture Manipulations On Curative Effect

ObjectiveTo evaluate the clinical effects of acupuncture treatments provided by senior acupuncturist and junior acupuncturist in CINV patients when the level of acupuncture prescriptions and doctor-patient communication was controlled, and to explore the relation between clinical effects and real practice acupuncture manipulation skills, and to further discuss methodological issues related to this topic.MethodThis is a randomized cross-over trial. Participants were hospitalized patients who were diagnosed with cancer from oncology department in Xiyuan hospital of China Academy of Chinese Medical Sciences. Cancer patients who received at least two continuous cycle of cisplatin chemotherapy and used 5-HT3 as an anti-emetic treatment were enrolled. Eligible participants were randomly allocated to two groups(A,B). In this study, a senior acupuncturist (clinical experience>15 years) and a junior acupuncturist (<5 years) provided manual acupuncture treatments to patients once per day,5 days per cycle. The senior acupuncturist determined all the treatment regimens (selection of acupoints, methods of needle manipulation and needle retention time). In group A, patients were treated by senior in the first cycle and by junior in the second cycle. In group B, the sequence was vice versa. There was a washout period (21 days) between two cycles. National Cancer Institute nausea and vomiting rating scale (NCI) is the primary outcome. Rhodes Scale (measured 1-5d), Acupuncture Expectancy Scale (AES) and patient communication satisfaction scale were adopted. Differences between treatment effects of senior acupuncturist and junior acupuncturist were compared. Paired-Sample T test and Wilcoxon test were used to compare the effects. This trial has been registered in Clinicaltrail.gov (ID:NCT02127255), and approved Xiyuan hospital ethics committee (ID:2013XL030-2).Result44 participants were screened and 39 were randomized (group A, n=20; group B, n=19). Thirty nine patients were included in analysis. There was no significant difference between group A and B as to baseline age, Karnofsky Performance Scale (KPS), anxiety and depression level, acupuncture expectancy and confidence for acupuncture treatment. There were more males in group B (15/19) than in group A (9/20). Symptoms of nausea and vomiting aggravated gradually and reached peak on day 3 during chemotherapy. NCI scores showed a significant difference between treatment effects of two acupuncturists on the third day during chemotherapy in vomiting (Z=-0.264, P=0.017) when the symptoms were the most severe. No statistical difference was found in the other four days. NCI nausea scores had no significant difference in all the five days. Rhode scores (both nausea and vomiting domain) of patients treated by senior acupuncturist were significantly lower than the scores of patients treated by junior acupuncturist on the third day. A total of eight items of Rhode scores had significant differences, which were symptoms experience scores (Z=-2.117,.P=0.029), symptoms appearance scores (F=-1.968, P=0.049), symptoms suffering scores (Z=-2.639, P=0.008), vomiting experience scores (Z=-2.426, P=0.015), vomiting appearance scores (Z=-2.212, P=0.027), vomiting suffering scores (Z=-2.417, P=0.016), retching suffering scores (Z=-2.017, P=0.044) and nausea suffering scores (F=-2.561, P=0.017). Acupuncture expectancy, confidence for acupuncture treatment and patient communication satisfaction, showed no significant difference between two acupuncturists. Four adverse events were reported and considered to be uncorrelated with acupuncture treatments. There were 16 drop-outs,3 people dropped out in the first cycle,10 in wash-out period and 3 in the second cycle.ConclusionWhen possible prognostic factors, including participants, expertise of selection of acupoints and needle manipulation methods and doctor-patient communication, were controlled to the possibly largest extent, senior acupuncturist controlled vomiting in CINV patients better than junior acupuncturist on the third day of chemotherapy when symptoms were most severe. There was no significant difference in outcomes of nausea. However limited by only two practicing acupuncturists, small sample size, high drop-out/withdrawal rate and insufficient blinding of participants, our conclusion re the treatment effects is of low certainty. This study could provide some methodological references for future acupuncture clinical trials, that is, as an undiminishable prognostic factor, the expertise of acupuncturists and their practicing needling skills should be sufficiently considered in the phase of designing the trial, analyzing data and reporting of results.