Research Of Single Patient (N-of-1) Trial In Traditional Chinese Medicine

Background Single patient (N-of-1) trials, as a product of randomized controlled trials (RCTs) based on the trend of personalized medicine, has the epoch-making significance for Traditional Chinese Medicine (TCM). However, at present, there are still lack of high quality N-of-1 trials and related high visibility of the achievement, which greatly affects the reliability and authenticity, which has impact on the utilization and transformation. Therefore, analysis on current situation of n-of-1 trials, method discussion, practical application and CONSORT Extension for N-of-1 Trials (CENT) on TCM, all are very important to improve and realize the modernization and internationalization of TCM.Objectives and Methods 1. Taking the method of documentation metrology, it made statistical analysis on publications collected in documentation of N-of-1 trials from 1985-2013. To trace hack and sum up the developments on TCM N-of-1 trials, we systematically reviewed Chinese publications in recent 5 years.2. To evaluate the quality of reporting of N-of-1 trials published in the medical literature, we used CENT guidelines and logistic analysis to examine factors that influence reporting quality in these trials.3. Making CENT guidelines for TCM was used by Delphi method.4. To learn the reasons of N-of-1 trials have gained little traction with TCM physicians, we interviewed them on their perceived benefits and drawbacks of clinical trials and factors influencing N-of-1 trial’s perceptions.5. To assess the effectiveness of Astragalus and Dodder with conventional chemotherapy for gastric cancer patient and to determine the superiority and solution of N-of-1 trials for TCM.Results 1. We identified 112 eligible N-of-1 trials published in 87 journals and involving a total of 2278 patients. The published rate has risen from 1985 and most trials were from North America. Above 1/2 of the journals of publication were higher than the median of impact factor. Trials were focused on pharmaceutical interventions related to circulation system, skeletal system, nervous system and psychological disease.6 N-of-1 trials of TCM began in 2010, studied on cancer, hypertension, chronic kidney disease, diabetes and acupuncture intervention by descriptive analysis and l test. Most of trials and reviews were found in CSCD as citations and came from the developed cities,2. Overall agreement between the two evaluators for compliance with CENT criteria was 0.80 (95%CI,0.79 to 0.82). Although 87% of articles described the trial design, reporting of specific CENT elements in the Methods and Results ranged from 29% to 87% and 32% to 93%, respectively. There were 7 trials whose quality score was between 0 and 10,30 trials between 11 and 20 score,41 trials between 21 and 30 score and 34 trials between 31 and 42 score. Quality of reporting was related more with high impact factors (P=0.004) and the published year (P=0.001).3. After two-cycle Delphi discussion, CENT guidelines for TCM containing 38 items have been made.4.106 TCM physicians remarked on two parts of survey on the application of clinical trial and the concept of N-of-1 trial. Most of them have not practiced clinical trials and were unfamiliar with N-of-1 trial, but they readily grasped the fundamental logic and appreciated the potential scientific benefits for TCM.5.6 gastric cancer patients (mean age,52 years [SD,10.38]) participated.4 patients completed 3 treatment pairs and 2 completed 2 pairs. For each trial, only 3 had statistically significant differences on leukocyte reduction. No differences were seen in leukocyte of other 3 patients, and Quality of Life score. The pulse, tongue and looking of 2 patients improved much,2 were not obvious and 2 were no improvement.Conclusions N-of-1 trials have been increased, especially in Canada and America. In China, few reviews were published. All were recognized among TCM, which need physicians and researchers focus on the development of this method and reporting guidelines. The quality of N-of-1 trials reporting was more or less low. Combined with the TCM, we made CENT guidelines for TCM in order to improve the quality of TCM N-of-1 trial. Through the survey, we know that physicians have little knowledge of N-of-1 trials. It is important to generalize the method of N-of-1 trial. In selected patients with gastric cancer, the symptoms in 3 of them are effective with Astragalus and Dodder with conventional chemotherapy. n-of-1 trials may be a useful method for determining the combination method with conventional chemotherapy for gastric cancer patients.