| Background:In recent years, with the progress of science and technology, the increasingly frequent international exchanges, evidence-based medicine has been widely accepted in the field of medicine in our country; however, as one of the complex non pharmacological interventions, there are still many challenges in the evaluation of clinical efficacy of acupuncture. Nowadays, the methods of effect evaluation mainly include systematic review, randomized controlled trial (RCT), cohort study, case series and case report. Among them, RCT is recognized as the gold standard. Expertise based RCT (ERCT) is one type of the RCTs developed and used to evaluate the effectiveness of non pharmaceutical interventions, such as surgeries. The core idea of ERCT is fully considering the effect of the intervention attributed to different personal expertise on the treatment. The subjects are randomly assigned to the different intervention providers, rather than groups of different medications (or acupuncture points, in acupuncture trials).Objective:To cimplement an exploratory ERCT of the acupuncture treatment for chemotherapy-induced nausea and vomiting (CINV) in cancer patients, discussing whether different acupuncturists with their particular skills and expertise would impact the clinical therapeutic effect; to further compare the manipulation parameters of acupuncturists in detail based on experimental data; and to find out their respective understanding and attitudes to those existed diversity. Our tudy is aimed to provide new idea for design and quality control of future clinical trials.Methods:ERCT:Inclusion criteria:cancer patients receiving cisplatin chemotherapy and 5-HT3 as anti emetic treatment. Exclusion criteria:patients with serious cardiovascular or renal diseases, or nausea and vomiting due to other reasons, or receiving concurrent radiotherapy, hormone therapy and acupuncture treatment. Patients who met the criteria were randomly allocated into 4 groups. All groups received the preventative basic treatment which combined cisplatin chemotherapy with conventional 5-HT3 antagonist. Group A adopted an individualized treatment based on syndrome differentiation given by senior experienced acupuncturists, without any restriction in acupoints selecting and manipulation; group B adopted an individualized treatment based on syndrome differentiation given by junior acupuncturists, without any restriction in acupoints selecting and manipulation; group C only acupunctured P6 (Neiguan), using even manipulating method; group D did not receive any acupuncture intervention. Additional antiemetics like 5-HT3 receptor antagonists were allowed in case of severe vomiting. The NCI scale and the Rhodes scale scores during the process of treatments were the prespecified primary outcomes. Generalized estimating equations (GEE) was used to compare the effects between four groups. Global evaluation of effectiveness by patients, the changes of their confidence towards acupuncture, additional consumption of antiemetics were the secondary outcome measures. Parameters of acupuncture manipulation were compared between senior and junior acupuncturists. Face to face indepth interviews were conducted (four participants) to explore the understandings and attitudes of acupuncturists towards the existed manipulation descrepencies. Results:(1) We randomized 102 participants in this study,101 were included in statistical analysis. One patient who did not receive any acupuncture intervention and provide data of efficacy evaluation outcome was excluded in the analysis. The study found that the NCI scores in group A was significantly lower than group B (estimated value:-1.1076, P=0.0096) and group D (estimated value:-1.2117, P=0.0066), but had no significant difference with group C (estimated value is:-0.7622, P=0.0591). The scores of NCI vomiting scale, Rhodes total scale and each subscale, global self rating scale, change of acupuncture confidence, consumption of additional antiemetic and safety outcomes showed no significant differences between four groups(P>0.05). (2) No significant difference was found in symptom pattern flexibility, and acupoints selection flexibility. As to needling depth of ST36 (Zusanli) senior acupuncturists reported deeper distance than juniors. For retaining time of needling RN12 (Zhongwan), senior acupuncturists mostly prefered 20 minute, juniors usually chose 20 to 30 minutes. As needling P6 (Neiguan) senior acupuncturists, besides using even method, inclined to use reinforcing method than juniors. (3) When analyzing interview transcriptions, we classified 88 codes into 7 domains, we noted that seniors focused more on the overall conditions of patients and were more flexible in acupoints selection; Seniors declared that they received rigorous training of acupuncture manipulation, Deqi were requirements from both the patients and acupuncturists; in addition, about the confidence of acupuncture manipulation, feeling of deqi, and the enthusiasm for trying new treatment, seniors and juniors might be different. Conclusion:Different expertise of acupuncturists might have a certain influence on the clinical curative effect. The results of this study cannot providing supporting evidence for junior acupuncturists. Existing evidence suggested that after chemotherapy, treatment provided by senior acupuncturists produced better effects for relieving nausea than no acupuncture intervention and junior acupuncturists, but had no significant difference compared to Neiguan group. For the delayed nausea, senior acupuncturists provided better curative effect treatments than no acupuncture intervention, but not significantly different with junior group and Neiguan group. In addition, the clinical effects of acupuncture might be impacted by different needle manipulation, insertion depth and retaining duration more than symptom differentiation and points selected for the treatment of CINV. We illustrated a new methodological frame that combined ERCTs with qualitative research methods. We suggest that in the future, we need to consider the treatment adequacyof acupuncture interventions at the beginning of study design when evaluating clinical effectiveness of acupuncture. The parameters of acupuncture intervention include clinical experience and operating habits of acupuncturists, as well as the adherence of acupuncturists to the treatment protocols of the trials. Future RCTs should strictly control the parameters of acupuncture intervention according to the protocols, so that it can better guarantee the validity, producibility and generalbility of the RCTs.
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