This study delves into the pivotal factors influencing the consensus process within traditional Chinese medicine guideline development, with the objective of augmenting the quality of this process through methodological recommendations aimed at elevating standardization.

Semi-structured qualitative interviews were used to interview guideline leaders, working groups and consensus groups to explore the pertinent elements impacting the credibility of consensus and gather insights into the constitution and progression of the consensus methodology.

The study encompassed interviews with 26 participants, yielding 212 codes that were subsequently categorized into five domains: establishment of the consensus group, integration of patient participation, adeptness of the meeting moderator, preparation for consensus formulation, and overarching factors influencing consensus. The research distilled three fundamental phases for forming a consensus group and delineated 17 fundamental tenets for applying the consensus methodology.

In forthcoming guideline development endeavors, it is advisable to bolster methodological training ahead of the consensus process while ensuring comprehensive engagement of methodologists. Encouraging experts to navigate differences judiciously and prioritizing meticulous methodology and evidentiary groundwork are recommended. The process should involve openly disclosing the selection of consensus group members, heightening the involvement of patients, and effective management and disclosure of conflicts of interest. This collective approach helps curtail bias, enhance transparency, bolster reliability, and fortify the scientific rigor of consensus outcomes.

Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions, including nausea, vomiting, and diarrhea, which make it challenging for them to adhere to treatment. As an effective traditional Chinese medicine, the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.

To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy. This statistical analysis plan (SAP) is intended to enhance the transparency and research quality of our randomized controlled trial.

Our study is a multicenter, double-blind, randomized controlled clinical trial. This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula. To attenuate possible selection bias in the final report, we declared the overall trial design, outcome measures, subgroup analyses, and safety measures. Also, we described the data management and statistical analysis methods in detail.

The SAP provides more detailed information than the trial protocol for data management and statistical analysis methods. Further post-hoc analyses can be performed by referring to the SAP, and possible selection bias can be attenuated.

To systematically evaluate the effectiveness and safety of Chinese herbal medicine (CHM) plus nucleotide analogues (NAs) for treating compensated HBV-related cirrhosis, the early stage of cirrhosis.

PubMed, Cochrane library, China Network Knowledge Infrastructure Database (CNKI), Chinese Scientific Journals Database (VIP), Wan Fang Database and Sino-Med Database were searched. Randomized controlled trials (RCTs) and quasi-RCTs comparing NAs and NAs plus CHM therapy on patients with compensated HBV-related cirrhosis were included. Two reviewers independently extracted information and assessed the methodological quality of the trials. Different CHM herbal formulas used in the trials were considered. Primary meta-analysis was conducted when there were at least two trials comparing the same CHM formula.

Forty-five trials comprising 3497 participants were included. The quality of most of the trials was moderate or low. Twenty-six herbal formulations were identified. A meta-analysis was conducted for compound Biejia Ruangan (FFBJ), Dahuang Zhechong (DHZC), and Fuzheng Huayu (FZHY). The results of the subgroup analysis showed a beneficial effect of FFBJ plus entecavir (ETV), and DHZC plus adefovir dipivoxil (ADV) on hyaluronic acid (HA); FFBJ plus ADV on laminin (LN); and FZHY plus ADV on HA, LN, and precollagen type Ⅲ (PC-Ⅲ). The results from other studies suggested significant benefits of CHM plus NAs compared with NAs alone, except those on albumin (ALB). None of the trials evaluated the quality of life or reported severe adverse events.

A positive effect was found for FFBJ plus ETV, DHZC plus ADV, and FZHY plus ADV on HA; FZHY plus ADV and FFBJ plus ADV on LN; and FZHY plus ADV on PCIII compared with the effects of NAs used alone.