BACKGROUND: Retinitis pigmentosa (RP) is an inherited disease characterized by a progressive loss of rod photoreceptors of the eye, leading to irreversible blindness. To date, to our knowledge, no clinical prospective studies have been undertaken that could document the effect of interventions that could reverse or reduce the progression of this disease. The application of microcurrent stimulation (ES) of the eye in the treatment of chronic eye diseases such as glaucoma and age-related macular degeneration has been used over several decades and has been reported to have beneficial effects to reduce the progression of these blinding diseases and has been supported by animal studies and smaller clinical studies, but to date, no large randomized clinical trials on the use of microcurrent therapy have been published. More recent clinical reports have also shown beneficial effects of ES on slowing the progression of RP but also lacks data from robust prospective clinical outcome studies. To our knowledge, this is the first prospective randomized study to evaluate the safety and clinical effectiveness of transpalpebral electrical stimulation (TpES) on the progression of RP.
METHODS: Randomized prospective study using N-of-1 trial 3 single-blind, crossover comparisons. The intervention period of each comparison is divided into treatment period and control period which are randomized arranged. Twelve participants will be strictly recruited in N-of-1 trial by the researcher in accordance with the inclusion and exclusion criteria. The main outcome of interest examined after each cycle of the 8-week intervention period is the assessment of the visual field (VF). Other variables of interest are best corrected visual acuity (BCVA), retinal function using electroretinogram (ERG), and visual function using NEI VFQ-25 questionnaire. Objective assessments of retinal changes will be undertaken using optical coherence tomography (OCT) and fundus autofluorescence (FAF).
CONCLUSIONS: The trial will evaluate the efficacy and safety of microcurrent stimulation on RP and provide high-quality evidence for clinical application through N-of-1 trial.
BACKGROUND: Chinese Clinical Trial Registry; ChiCTR2300067357; https://www.chictr.org.cn/showproj.html?proj=174635 . Registered on 5 January 2023.

The role of different types and quantities of macronutrients on human health has been controversial, and the individual response to dietary macronutrient intake needs more investigation.
We aimed to use an \'n-of-1\' study design to investigate the individual variability in postprandial glycemic response when eating diets with different macronutrient distributions among apparently healthy adults.
Thirty apparently healthy young Chinese adults (women, 68%) aged between 22 and 34 y, with BMI between 17.2 and 31.9 kg/m2, were provided with high-fat, low-carbohydrate (HF-LC, 60-70% fat, 15-25% carbohydrate, 15% protein, of total energy) and low-fat, high-carbohydrate (LF-HC, 10-20% fat, 65-75% carbohydrate, 15% protein) diets, for 6 d wearing continuous glucose monitoring systems, respectively, in a randomized sequence, interspersed by a 6-d wash-out period. Three cycles were conducted. The primary outcomes were the differences of maximum postprandial glucose (MPG), mean amplitude of glycemic excursions (MAGE), and AUC24 between intervention periods of LF-HC and HF-LC diets. A Bayesian model was used to predict responders with the posterior probability of any 1 of the 3 outcomes reaching a clinically meaningful difference.
Twenty-eight participants were included in the analysis. Posterior probability of reaching a clinically meaningful difference of MPG (0.167 mmol/L), MAGE (0.072 mmol/L), and AUC24 (13.889 mmol/L·h) between LF-HC and HF-LC diets varied among participants, and those with posterior probability >80% were identified as high-carbohydrate responders (n = 9) or high-fat responders (n = 6). Analyses of the Bayesian-aggregated n-of-1 trials among all participants showed a relatively low posterior probability of reaching a clinically meaningful difference of the 3 outcomes between LF-HC and HF-LC diets.
N-of-1 trials are feasible to characterize personal response to dietary intervention in young Chinese adults.

Background: Both anxiety and depression in family caregivers (FCs) of advanced cancer patients are common, and they have a negative influence on both the FCs and the patients. Some studies suggested that a variety of interventions could alleviate the psychological symptoms of FCs. However, there is no consensus on much more effective methods for intervention, and relatively high-quality research is blank in psychological problems of these population in China. The validity of mindfulness-based stress reduction (MBSR) and psychological consultation guided by the needs assessment tool (NST) in the psychological status of caregivers will be compared in this study to select a more suitable intervention for the FCs of advanced cancer patients in China. Methods and Analysis: A randomized N-of-1 trial would be conducted at the Cancer Hospital, Chinese Academy of Medical Sciences. Fifty eligible FCs of advanced cancer patients will be recruited, and all will receive three cycles of psychological intervention treatment, with each cycle including both of MBSR and psychological consultation guided by the NST. MBSR and psychological consultation guided by the NST will be compared with each other in each cycle, and the intervention sequence will be based on the random number table generated after the informed consent has been completed. Each treatment period is 2 weeks, and the interval between different treatment cycles or treatment periods is 1 week. The self-reported scales are measured at the beginning and end of each treatment period, including the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Distress Thermometer (DT), Zarit Burden Interview (ZBI), Chinese version of the Medical Outcomes Study 12-item Short Form (C-SF-12), and Family Carer Satisfaction with Palliative Care scale (FAMCARE-2). Dissemination: The protocol of the study was approved by the Institutional Review Board of the Ethical Committee of the Cancer Hospital, Chinese Academic of Medical Science. The results will be published in a peer-reviewed medical journal. The study is registered at Chinese Clinical Trials Registry with the trial registration number chiCTR2000033707. This study employs an innovative methodological approach on the effectiveness of MBSR and psychological consultation guided by the NST for psychological status of FCs of advanced cancer patients. The findings of the study will be helpful to provide high-quality evidence-based medical data for psychological intervention of FCs of advanced cancer patients, and guide clinicians on best quality treatment recommendations.

BACKGROUND: Modified Sijunzi decoction (SJZD) has been used to treat ulcerative colitis (UC) in remission. However, more rigorous clinical trials are necessary to evaluate its effectiveness. Therefore, a series of single-case randomised controlled trials (N-of-1 trials) is proposed to compare the efficacy of modified SJZD with mesalazine for treating UC in remission.
METHODS: This is a single-site, hospital-based, double-blind N-of-1 trial for 10 single subjects. Three cycles of N-of-1 trials are planned. There are two treatment periods in each cycle. Modified SJZD combined with mesalazine placebo or mesalazine combined with modified SJZD placebo will be randomised during each 8-week treatment period. There is no washout period in the study. Subjects will be selected by the researcher strictly in accordance with the inclusion and exclusion criteria.
CONCLUSIONS: Paired t tests and mixed-effect models will be used to analyse the visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses. The findings will be interpreted with caution. We anticipate that the results will show that modified SJZD is effective for patients with UC in remission.
BACKGROUND: Chinese Clinical Trial Register, ID: ChiCTR1900024086. Registered on 24 June 2019.

BACKGROUND: N-of-1 trial is a desired and appropriate approach to assessing the efficacy and safety of traditional Chinese medicine (TCM) interventions. There have been an increasing number of N-of-1 trials for TCM published. However, a lack of preferred reporting guidance led in the general poor reporting quality of these trials. Due to the unique characteristics of TCM, the working group developed this CONSORT Extension for reporting N-of-1 Trials for Traditional Chinese Medicine (CENT for TCM) to assist TCM researchers in reporting N-of-1 trials for TCM.
METHODS: We registered CENT for TCM at the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network (available at equator-network.org). The development was a comprehensive process through collection of the initial reporting items, two-round scientific Delphi consensus survey with 17 panelists, revision and formation of the final reporting checklist.
RESULTS: The checklist includes 25 items within six domains, eight items in which were extended and elaborated on the items of the CENT 2015 checklist. Explanation of the items were listed adequately considering the nature of TCM, introducing the concept of TCM syndrome differentiation and TCM interventions.
CONCLUSIONS: CENT for TCM can be used to assess the completeness of the reporting of N-of-1 trials for TCM. The working group expect that CENT for TCM could be a practical tool to enhance the comprehensiveness and transparency of the design, implementation and reporting of N-of-1 trials for TCM.

N-of-1 trials can be aggregated to estimate population treatment effects using hierarchical Bayesian models. It is very important to report core items in hierarchical Bayesian analysis. In this study, we assessed reporting of items in hierarchical Bayesian analysis for aggregating N-of-1 trials to estimate population treatment effects.
This was a systematic literature review of aggregating N-of-1 trials by hierarchical Bayesian models to estimate population treatment effects. A comprehensive search was performed to collect eligible articles. Pilot studies, formal N-of-1 trials and reports in which the data were reanalyzed using hierarchical Bayesian methods, were included. The information of reported items related with hierarchical Bayesian analysis was extracted by two independent reviewers. The guideline \"ROBUST,\" developed for reporting Bayesian analysis of clinical studies, was published in Journal of Clinical Epidemiology in 2005. We assessed the included reports using ROBUST criteria and 18 other important items.
After careful screening, 11 studies were identified to be eligible for inclusion. There were three pilot studies, four formal trials, and four reports in which the data were reanalyzed using hierarchical Bayesian methods. The number of reported items in ROBUST criteria ranged from six to seven, with a median number of six. Five of eleven included articles reported all items of the ROBUST criteria. But for justification and sensitivity analysis in prior distribution items, other items were reported in all of the included articles. Software and analysis data set items were reported the most frequently in additional items excluded from the ROBUST criteria. Less than half of the studies reported the other additional items.
Reporting of core items in hierarchical Bayesian analysis for aggregating N-of-1 trials to estimate population treatment effects is suboptimal. A PRISMA-like guidance on reviews of Bayesian N-of-1 trials may be required in the future.