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.

OBJECTIVE: To determine the efficacy of acupuncture for hypertension. METHOD: Seven electronic databases were searched on April 13, 2014 to include eligible randomized controlled trials (RCTs). Data were extracted and risk of bias was assessed. Subgroup analyses and meta- analysis were performed. RESULTS: 23 RCTs involving 1788 patients were included. Most trials had an unclear risk of bias regarding allocation concealment, blinding, incomplete outcome data and selective reporting. Compared with sham acupuncture plus medication, a meta-analysis of 2 trials revealed that acupuncture as an adjunct to medication was more effective on systolic (SBP) and diastolic (DBP) blood pressure change magnitude (n=170, SBP: mean difference (MD)= -7.47,95% confidence intervals (CI):-10.43 to -4.51,I2 =0%; DBP: -4.22,-6.26 to -2.18, 0%).A subgroup analysis of 4 trials also showed acupuncture combined with medication was superior to medication on efficacy rate (n=230, odds ratio (OR)=4.19, 95%CI: 1.65 to 10.67, I2 =0%). By contrast, compared with medication, acupuncture alone showed no significant effect on SBP /DBP after intervention and efficacy rate in the subgroup analysis. (7 trials with 510 patients, SBP: MD=-0.56, 95%CI:-3.02 to 1.89,I2 =60%; DBP: -1.01,-2.26 to 0.24, 23%; efficacy rate: 10 trials with 963 patients, OR=1.14, 95% CI: 0.70 to 1.85, I2 =54%).Adverse events were inadequately reported in most RCTs. CONCLUSION: Our review provided evidence of acupuncture as an adjunctive therapy to medication for treating hypertension, while the evidence for acupuncture alone lowing BP is insufficient. The safety of acupuncture is uncertain due to the inadequate reporting of it. However, the current evidence might not be sufficiently robust against methodological flaws and significant heterogeneity of the included RCTs. Larger high-quality trials are required