Partially randomized patient preference trial: Comparative evaluation of fibromyalgia between acupuncture and cupping therapy (PRPP-FACT).

BACKGROUND: and purpose The aim of this study was to investigate the feasibility of applying a partially randomized patients' preference (PRPP) trial in the clinical evaluation of acupuncture versus cupping therapy for fibromyalgia. MATERIALS AND METHODS: The final study included 126 participants. Participants without a treatment modality preference were randomly assigned to either the cupping therapy group or the acupuncture group. Patients with strong preferences were assigned to their treatment modality of choice. Ashi points were used for treatment. Outcome measures were both qualitative (patient expectation and satisfaction) and quantitative (drop-out rate, pain intensity, quality of life, depression assessment). RESULTS: The recruitment of the non-randomized participants was completed 8 months before the randomized participants were recruited. There was no statistical difference related to the grouping method in the adjusted drop-out rate, patient expectation, and satisfaction. CONCLUSION: The PRPP model is suitable for use in the clinical evaluation of non-pharmaceutical therapies.

Factors influencing participant compliance in acupuncture trials: An in-depth interview study.

INTRODUCTION: Little is known of acupuncture patients' experiences and opinions of clinical trials, and what may influence their compliance when participating in an acupuncture trial. OBJECTIVES: To explore the potential factors that influence patients' choice and determinants to participate in acupuncture clinical trials. METHODS: Ten qualitative, in-depth interviews were conducted with patients from acupuncture clinics in Beijing, who had previously participated in acupuncture clinical trials. RESULTS: Four main themes emerged from the interview data: effectiveness of the treatment, convenience of participating in a trial, doctor-participant communication, and participant acceptance of the treatment (or the trial). Effectiveness of acupuncture in treating the health condition was the most important factor for participant adherence. Pragmatics of treatment schedules, travel and attendance burden, together with confidence in the doctor's ability additionally influenced trial and treatment compliance. CONCLUSIONS: In-depth interviews suggest that treatment effectiveness, the pragmatics of attending treatment sessions, and the expertise and attitudes of acupuncturists are determining factors of participation and compliance in acupuncture clinical trials. Participants' confidence in, and expectation of, acupuncture may facilitate compliance, while their fear of acupuncture and negative perceptions of the trial's purpose may reduce treatment compliance. Compliance may be facilitated by enhanced doctor-patient communication, personalized treatment programs, and feedback on treatment outcomes.

Attitude and willingness of attendance for participating in or completing acupuncture trials: a cross-sectional study.

OBJECTIVE: To explore the influence of patients' participation in and completing the acupuncture clinical trials through a cross-sectional survey. In addition, we explored potential factors involved in improving patient's compliance to treatment, thus enhancing the quality of acupuncture clinical studies. METHODS: A survey was conducted at outpatient department of acupuncture and metabolic diseases in two hospitals in Beijing. The semi-structured questionnaire was designed based on literature review and Delphi methods. It contains 15 questions related to patients' experience and attitude. SPSS 22.0 was used for analyses. OR and 95% CI were used for dichotomous outcomes. Logistic regression analysis (LRA) and multi-LRA were used to explore the factors influencing patients' participation or completion and the relationship between demographic characteristics and potential factors. RESULTS: A survey was conducted from April to September 2016. Five hundred patients were consecutively sampled to fill semi-structured questionnaires regardless of their types of disease. The participants (75.2% were female) were in the age range of 15-85 years and all of them completed the survey. The effect and safety of acupuncture therapy were considered to be the deciding factors by 92% and 96% of the respondents, respectively. Only 40 of the surveyed participants (8.0%) had previously participated in the clinical trials. The LRA showed they paid more attention to treatment regimen (frequency and session of treatment) when deciding whether or not to participate in the trials (OR 1.54, 95% CI 1.02-2.34). Multivariate LRA showed that elder people considered cost (OR 1.36, 95% CI 1.09-1.70) to be an important factor, while the participants having medical insurance (OR 1.45, 95% CI -0.20-0.93) thought informed consent was important. Meanwhile, participants with higher education preferred regular follow-up (OR 1.16, 95% CI 0.02-0.28). CONCLUSION: After providing adequate information regarding the potential benefits and harms of the acupuncture treatment, completion of the treatment within the specific time regimen was found to be the most important factor affecting patient's compliance. Other factors, such as cost and regular follow-up, should also be given special consideration.

Effect of Acupotomy on FAK-PI3K Signaling Pathways in KOA Rabbit Articular Cartilages.

OBJECTIVE: By observing the needle-knife of KOA rabbit morphology, knee joint cartilage p-FAK, p-PI3K, Aggrecan gene, and protein expression, to study the effect of needle-knife to promote cartilage cell synthesis metabolism mechanism. METHOD: 49 male New Zealand rabbits, randomly divided into normal group (Z), model group (M), model-inhibitors (MP), needle-knife group (D), needle-knife inhibitors group (DP), electroacupuncture group (E), and electroacupuncture inhibitors (EP). RT-PCR and Western Blot were used to test each animal cartilage p-FAK, p-PI3K, and Aggrecan gene and protein expression level. RESULTS: Compared with N group, p-FAK and p-PI3K protein and mRNA expression of M group, D group, and E group increased (P < 0.05), while the protein and mRNA expression of Aggrecan reduced (P < 0.05). Compared with M group, p-FAK, p-PI3K, Aggrecan protein, and mRNA of E and D group increased (P < 0.05). Compared with E group, p-FAK, p-PI3K, Aggrecan protein, and mRNA expression of D group increased (P < 0.05); after adding inhibitors, p-FAK, p-PI3K, Aggrecan protein, and mRNA expression reduced (P < 0.05). CONCLUSION: Needle-knife therapy can promote the repairment of cartilage cells by activating FAK-PI3K signaling pathways, promoting the synthesis of cartilage cell metabolism.

[Effect of electroacupuncture intervention at different phases of post-operation on bladder function in patients undergoing cervical cancer operation].

OBJECTIVE: To observe the effect of electroacupuncture (EA) at different time-points after cervical carcinoma surgery on urinary bladder function of uroschesis patients so as to determine the optimum time of acupuncture intervention. METHODS: Sixty cervical cancer post-operation patients with catheter due to uroschesis were randomly and equally divided into late treatment group (acupuncture intervention was given from the over 15th day on after surgery) and early treatment group (acupuncture was given from the 7th day to the 14th day after surgery). Bilateral Shangliao (BL 31), Ciliao (BL 32), Zhongliao (BL 33), Xialiao (BL 34), Zhibian (BL 54), Yinlingquan (SP 9) and Sanyinjiao (SP 6) were punctured with filiform needles combined with electrical stimulation of bilateral BL 31 and BL 34 for 30 min, once daily for 10 sessions. The residual urine volume was measured before treatment and after 5 and 10 sessions of treatment separately. RESULTS: After 5 and 10 sessions of treatment, the average residual urine volumes of both late treatment and early treatment groups were decreased significantly ( P< 0.05), and the residual urine volume level of the early treatment group was markedly lower than that of the late treatment group (P < 0.05). After 5 sessions of acupuncture treatment, of the two 30 cases in the late treatment and early treatment groups, 8 and 17 had an automatic micturition, 22 and 13 needed catheter retention, and following 10 sessions of treatment, 22 and 27 had an automatic micturition, and 8 and 3 still needed catheter retention, respectively. Regarding the functional recovery state of the urinary bladder, of the two 30 cases in the late treatment and early treatment groups, 6 and 14 were good, 24 and 16 poor respectively following 5 sessions of treatment; 15 and 22 were good, 15 and 8 were poor respectively following 10 sessions of treatment. The therapeutic effects of the early treatment group were apparently superior to those of the late treatment group. The number of the treatment sessions for recovering the bladder function was obviously fewer in the early treatment group than in the late treatment group (P < 0.05). CONCLUSION: Early acupuncture intervention is significantly better than late treatment for reducing residual urine volume and promoting bladder function recovery for uroschesis patients undergoing cervical cancer operation.