As evidence-based medicine advances and the number of published acupuncture clinical trials in international journals increases,the quality of these trials has become a major focus.The inherent diversity,complexity,and individualization of acupuncture treatments pose unique challenges for quality control in multicenter clinical studies,particularly in Investigator-Initiated Trial(IIT).Refined quality control is essential for the successful conduct of multicenter clinical trials in acupuncture.This study uses the multicenter clinical trials of acupuncture led by our research group as a case study to summarize the quality control experiences throughout the entire process of multicenter IITs.It synthesizes quality control strategies across the trial lifecycle,examines the management of key elements such as participants,materials,data,and specimens,and discusses project design,process management,protocol adherence,and subject safety.These insights are intended to enhance the scientific rigor and reliability of the trials,providing a reference and point of view for researchers in future similar studies.

Objective:A preliminary trial is conducted to explore whether perioperative(preoperative,intraoperative,and postoperative)electroacupuncture is more effective than postoperative electroacupuncture in improving gastrointestinal function for colorectal cancer patients.Methods and analysis:The study proposes a randomized,parallel-controlled,single-center trial involving 30 colorectal cancer patients aged 18-79 requiring elective surgery.Participants are randomly assigned to two groups,with equal allocation,where one group receives perioperative electroacupuncture,and the other group receives postoperative electroacupuncture.The treatment duration spans from preoperative to postoperative 72 h,with a subsequent 28-day follow-up period.The primary outcome is the time of first postoperative defecation.The secondary outcomes include the recovery time of postoperative bowel sounds,time of the first flatus,dietary recovery,postoperative gastrointestinal dysfunction frequency,quality of life scale,postoperative pain degree,time of the first ambulation,length of hospital stay,gastrointestinal hormone indicators,and adverse events.The coagulation function test,liver and renal function,and stool and blood routine serve as security biomarkers.The statistical analysis includes the t-test,rank-sum test,Chi-square test,and analysis of variance.A two-sided significance level is set at 5%.Discussion:This study aims to evaluate the feasibility and preliminary effectiveness of perioperative electroacupuncture for gastrointestinal function recovery following colorectal cancer surgery.The study's strengths include its randomized design,well-defined intervention periods,and multi-dimensional outcome assessment.Nevertheless,limitations,such as the small sample size and single-center setting,may affect external validity.The findings will guide protocol refinement and sample size estimation for future large-scale multi-center randomized controlled trials.

Objective:A preliminary trial is conducted to explore whether perioperative(preoperative,intraoperative,and postoperative)electroacupuncture is more effective than postoperative electroacupuncture in improving gastrointestinal function for colorectal cancer patients.Methods and analysis:The study proposes a randomized,parallel-controlled,single-center trial involving 30 colorectal cancer patients aged 18-79 requiring elective surgery.Participants are randomly assigned to two groups,with equal allocation,where one group receives perioperative electroacupuncture,and the other group receives postoperative electroacupuncture.The treatment duration spans from preoperative to postoperative 72 h,with a subsequent 28-day follow-up period.The primary outcome is the time of first postoperative defecation.The secondary outcomes include the recovery time of postoperative bowel sounds,time of the first flatus,dietary recovery,postoperative gastrointestinal dysfunction frequency,quality of life scale,postoperative pain degree,time of the first ambulation,length of hospital stay,gastrointestinal hormone indicators,and adverse events.The coagulation function test,liver and renal function,and stool and blood routine serve as security biomarkers.The statistical analysis includes the t-test,rank-sum test,Chi-square test,and analysis of variance.A two-sided significance level is set at 5%.Discussion:This study aims to evaluate the feasibility and preliminary effectiveness of perioperative electroacupuncture for gastrointestinal function recovery following colorectal cancer surgery.The study's strengths include its randomized design,well-defined intervention periods,and multi-dimensional outcome assessment.Nevertheless,limitations,such as the small sample size and single-center setting,may affect external validity.The findings will guide protocol refinement and sample size estimation for future large-scale multi-center randomized controlled trials.

As evidence-based medicine advances and the number of published acupuncture clinical trials in international journals increases,the quality of these trials has become a major focus.The inherent diversity,complexity,and individualization of acupuncture treatments pose unique challenges for quality control in multicenter clinical studies,particularly in Investigator-Initiated Trial(IIT).Refined quality control is essential for the successful conduct of multicenter clinical trials in acupuncture.This study uses the multicenter clinical trials of acupuncture led by our research group as a case study to summarize the quality control experiences throughout the entire process of multicenter IITs.It synthesizes quality control strategies across the trial lifecycle,examines the management of key elements such as participants,materials,data,and specimens,and discusses project design,process management,protocol adherence,and subject safety.These insights are intended to enhance the scientific rigor and reliability of the trials,providing a reference and point of view for researchers in future similar studies.

Three patients with systemic lupus erythematosus(SLE) were admitted in Lanzhou University Second Hospitalbetween May 2013 and October 2017, the patients were treated with hydroxychloroquine(HCQ) for SLE. Patients had no neuropsychiatric symptoms before HCQ treatment, depressive symptoms occurred in 2 cases when the SLE was stable, and 1 case had renal function damage and depressive symptoms. The diagnosis of depression was confirmed in all 3 cases. The treatment for neuropsychiatric lupus was given but of no effect, while the symptoms disappeared after withdraw of HCQ. There is no difference in clinical manifestations between HCQ-caused depressive disorder and depression in neuropsychiatric lupus, but the treatment is different.The literature was searched from 1992 to 2018, and 4 cases of neuropsychiatric disorders caused by HCQ were reported, of which 3 were diagnosed as SLE, and 1 case was chronic Q fever. When depression appears in SLE patients receiving HCQ, HCQ would be the cause and the medication of HCQ should be withdrawn if necessary.