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Aim To investigate the effect of dipeptidyl peptidase-4 inhibitor (DPP-4i) on serum creatinine (Cr) in patients with type 2 diabetes mellitus (T2DM). Methods A systematic search was performed across databases of PubMed, Embase, Cochrane Library and Web of Science, and randomized controlled trials (RCT) of DPP-4i therapy for regulating Cr in T2DM patients was included. A fixed-effect or random-effect model was used for data fitting, heterogeneity was quantitatively evaluated according to the index of I², and sensitivity analysis and publication bias testing were performed by using the standard methods. Results After searching the database through the system, 12 RCTs were included, with a total of 2 276 participants. Due to the potential heterogeneity, a random effect model was used for data fitting. DPP-4i treatment could mildly increase Cr levels in T2DM patients (WMD: 0. 15 mg / L, 95% CI: 0. 03 ~ 0. 27, I² = 18%, P= 0. 02), and the results showed statistical differences. According to sensitivity testing, the results of Meta-analysis were relatively reliable. No publication bias was observed according to Begg’ s and Egger’ s tests. Conclusions The use of DPP-4i for hypoglycemic treatment in T2DM patients may result in mild elevation of blood Cr levels. Further multicenter studies with larger samples are needed in the future to explore the clinical significance of DPP-4i treatment induced changes in Cr levels. [ABSTRACT FROM AUTHOR]

Background Polycystic ovary syndrome with insulin resistance (PCOS-IR) is recognized as one of the most challenging subtypes of PCOS to treat due to its intricate pathogenesis and significant individual variability. Although Metformin, as a first-line medication, can ameliorate blood glucose levels and enhance insulin sensitivity, its efficacy in regulating hormonal imbalances and improving ovarian function is limited. Additionally, its gastrointestinal side effects often hinder patient adherence. Objective To evaluate the efficacy and safety of Yishen Quzhuo Formula compared to metformin in the treatment of PCOS-IR. Methods A prospective study enrolled 102 PCOS-IR patients from June 2022 to October 2023 at the Department of Gynecology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University. Patients were randomly assigned in a 2∶1 ratio to the experimental group (n=68) treated with Yishen Quzhuo Formula or the control group (n=34) treated with metformin. The comparison was made between the two groups in terms of ovulation rate, pregnancy rate, sex hormones [follicle-stimulating hormone (FSH), luteinizing hormone (LH), LH/FSH ratio, testosterone (T), anti-Müllerian hormone (AMH) ], glucose and lipid metabolism indicators, BMI, waist-hip ratio (WHR), and incidence of adverse reactions. Results After treatment, the basal body temperature (BBT) ovulation rate in the experimental group increased compared to before treatment (P0.05). After treatment, both groups showed a decrease in LH/FSH compared to before treatment (P0.05). After treatment, the waist circumference of the control group was lower than that of the experimental group (P0.05). During treatment, adverse reactions such as hypoglycemia, fatigue, epigastric discomfort, and diarrhea occurred in patients, with a lower incidence of adverse reactions in the experimental group (5/68, 7.35%) than in the control group (15/31, 48.39%) (χ2=20.404, P

Background Traditional Chinese medicine (TCM) is effective in the treatment of sepsis-induced acute lung injury (ALI) /acute respiratory distress syndrome (ARDS). However, the lack of standard and uniform outcome indicators in the design of most published clinical trials makes it difficult to combine and compare the results of similar studies, causing the impossibility of generating high-quality evidence to guide clinical decision-making. Objective To analyze the use of outcome indicators in randomized controlled trials on TCM for sepsis-induced ALI/ARDS from 2017 to 2022. Methods CNKI, Wanfang Data, SinoMed, PubMed, Embase, Web of Science and Cochrane Library were searched for RCTs on sepsis-induced ALI/ARDS, with the intervention group treated with TCM combined with other drugs or conventional treatment, and no restrictions in the control group. The ROB.2 tool of the Cochrane Review Group was used to assess the quality of literature and the classification of outcome indicators was summarized. Results 39 papers were included after screening, including 1 (2.56%) with low risk of bias, 3 (7.69%) with high risk of bias and 35 (89.74%) with concerns of bias. The outcome indicators in 5 RCTs were reported with a quality score of ≥5, indicating the complete reporting of outcome indicators. A total of 106 outcome indicators were reported and used for 443 times, including physicochemical testing outcome (55 types, 51.89%), TCM syndrome/sign outcome (2 types, 1.89%), symptom and syndrome outcome (13 types, 12.26%), long-term prognosis outcome (19 types, 17.92%), quality of life outcome (7 types, 6.60%), safety event outcome (8 types, 7.55%) and economic evaluation outcome (2 types, 1.89%). There were four outcome indicators with utilization rate>50%, including oxygenation index (82.05%), Acute Physiology and Chronic Health Evaluation Scoring System (58.97%), mechanical ventilation duration (51.28%) and interleukin-6 (51.28%). The composite outcome indicators of effective rate or TCM syndrome efficacy were used in 21 papers, involving a total of 12 times of effective rate, TCM syndrome score of 8 times and TCM symptom efficacy of 6 times. The total 106 outcome indicators were summarized and categorized sequentially including overall evaluation indicators (36 types, 33.96%), common indicators (36 types, 33.96%) and different focus indicators (34 types, 32.08%) . Conclusion At present, the selection of outcome indicators in RCTs on TCM for sepsis-induced ALI/ARDS is still nonstandard, mainly manifests in unclear differentiation between primary and secondary outcome indicators, trivialization of endpoint indicators, lack of follow-up data and characteristic indicators of TCM. A core outcome set of TCM outcome indicators for septic induced ALI/ARDS should be constructed to promote the high-quality development of TCM in the future.

Objective To evaluate the effectiveness of multimodal prehabilitation among patients with esophageal neoplasm through meta-analysis. Methods Randomized controlled trials （RCTs） reporting the effectiveness of multimodal prehabilitation in patients with esophageal neoplasm were searched from PubMed， Embase， Cochrane Library， Web of Science， CNKI， Wanfang， Chongqing VIP and CBM databases from the inception to October 1， 2023. Meta-analysis was performed by RevMan 5.4 software after quality evaluation. Results Ten RCTs consisting of 930 patients were included in this meta-analysis. The meta-analysis results showed that compared with conventional nursing， multimodal prehabilitation could lower the incidence of postoperative complications （relative risk （RR） =0.62， 95%CI 0.47-0.82）， and shorten the length of hospital stay （mean difference （MD） =-6.15 d， 95%CI -7.87--4.43 d），reduce hospital costs （MD=CNY-17 800， 95%CI -27 600--8 100）， prolong 6-minute walking distance （MD=93.35 m， 95%CI 36.19-150.51 m） and increase serum albumin levels （MD=6.18 g/L， 95%CI 4.08-8.28 g/L） and IgG levels （standardized mean difference （SMD）=1.21， 95%CI 1.01-1.42）， respectively. Conclusions Multimodal prehabilitation can accelerate postoperative recovery， decrease the incidence of postoperative complications， improve partial exercise， nutritional and immunological indexes， shorten the length of hospital stay and reduce hospitalization costs.

Background The prevalence of pelvic floor dysfunction in postmenopausal women is progressively increasing, leading to a significant impact on both physical and mental well-being due to stress urinary incontinence (SUI) . Objective To investigate the impact of menopausal hormone therapy (MHT) in conjunction with Kegel exercises on pelvic floor structure and clinical symptoms in individuals experiencing mild to moderate SUI. Methods A total of 75 patients with menopausal syndrome accompanied by mild to moderate SUI who visited the Menopause Clinic at Beijing Shijitan Hospital, Capital Medical University in 2022 were selected. They were allocated into the MHT group and the control group in a 2∶1 ratio using a random number table method, and the MHT group was further randomly divided into subgroups receiving Tibolone and estrogen combined with progestogen therapy (EPT) in a 1∶1 ratio. Both the control group and the MHT group underwent pelvic floor muscle training (PFMT), commonly referred to as Kegel exercises, for 15-30 minutes per session, 2-3 times daily, and 2-3 d per weekly, over a continuous period of 12 months. The control group received Kuntai capsules orally in combination with PFMT, with 4 capsules taken per dose, 3 times a day, for 12 months. The MHT group received menopausal hormone therapy in conjunction with PFMT. The EPT subgroups include continuous combined estrogen-progestin therapy (1 mg estradiol valerate + 10 mg dydrogesterone, once daily), continuous sequential estrogen-progestin therapy (femoston 12 courses), and the Tibolone subgroup takes tibolone orally, all of which were administered continuously for 12 months. The study examined serum estradiol (E2) and follicle-stimulating hormone (FSH) levels within and between groups and subgroups before and after treatment. In addition, measurements were obtained for urethral rotation angle (URA), bladder detrusor thickness (BDT), posterior vesicourethral angle (PVUA), levator hiatus area (LHA), urinary incontinence quantification, ICI-Q-SF score, clinical efficacy, as well as changes in the modified Kupperman Menopausal Index (KMI) score, and the modified oxford staging (MOS) . Results Upon completion of the study, 7 participants from the MHT group were lost to follow-up (5 in the Tibolone subgroup and 2 in the EPT subgroup), with 3 participants from the control group also lost to follow-up. In the end, a total of 65 participants were included. After 1 year of treatment, there were no statistically significant differences in FSH, E2, and MOS between the MHT group and the control group (P>0.05). After 1 year of treatment, there were no statistically significant differences in PUVA, BDT, and URA between the MHT group and the control group (P>0.05). However, the LHA of the MHT group was significantly lower than that of the control group (P=0.028). After 1 year of treatment, there were no statistically significant differences in PUVA, BDT, URA, and LHA between the EPT and Tibolone subgroups (P>0.05). Statistically significant differences were found in the comparison of clinical efficacy between the control group and the MHT group (P=0.005). Conversely, no statistically significant differences were observed in the comparison of clinical efficacy between the EPT and Tibolone subgroups (P=0.727). After 1 year of treatment, the MHT group showed lower urinary incontinence quantity, ICI-Q-SF score, and KMI score compared to the control group (P0.05) . Conclusion The combination of MHT with PFMT yields a positive effect on the pelvic floor structure and markedly alleviates symptoms of urinary incontinence. Nevertheless, there is no significant differences between EPT and Tibolone in the improvement of pelvic floor structure and alleviation of clinical symptoms in patients.

Background Wrist motor dysfunction is a common sequela at post-stroke, and the wrist has an important role in improving hand practicality. Therefore, improving the range of motion of the wrist can effectively promote the activities of daily life in post-stroke patients. Although repetitive peripheral magnetic stimulations (rPMS) have been shown to have a significant effect on improving the range of motion of the wrist, the therapeutic effect of different stimulation sites still needs to be further explored. Objective To investigate the effect of rPMS on wrist extensor muscle and radial nerve for the motor function of wrist of subacute stroke patients. Methods A total of 60 subacute stroke patients with wrist motor dysfunction admitted to Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine from October 2022 to October 2023 were selected as the study subjects. The included patients were randomly divided into control group (20 cases), muscle stimulation group (20 cases) and nerve stimulation group (20 cases) by simple randomized grouping method using a random number table. Patients in all the three groups received routine rehabilitation training, and those in the muscle stimulation group and nerve stimulation group were additionally managed by rPMS on the wrist extensor muscle and the radial nerve, respectively. Before and after the interventions for 10 times of rPMS, integrated electromyography (iEMG), root mean square (RMS) and median frequency (MF) on the surface of the wrist extensor muscle, the Fugl-Meyer Assessment for upper extremity (FMA-UE), the Action Research Arm Test (ARAT) and the modified Barthel Index (MBI) were measured to assess the upper limb function of the affected side. Results During the intervention period, there were 2 cases of data loss due to voluntary withdrawal or forced termination of the trial, and finally 20 cases were included in the control group, 19 cases in the muscle stimulation group, and 19 cases in the nerve stimulation group. There were no significant differences in iEMG, RMS and MF of wrist extensor muscle among three groups before treatment (P>0.05). After treatment, iEMG, RMS and MF of wrist extensor muscle in muscle stimulation group and nerve stimulation group were significantly higher than those of control group (P0.05). After treatment, FMA-UE, ARAT and MBI scores in muscle stimulation group and nerve stimulation group were significantly higher than those of control group (P

Background Shoulder-hand syndrome is one of the major disabling factors for stroke patients, which seriously affects their physical and psychological health as well as their quality of life. Currently, there are many non-pharmacologic treatments used to treat post-stroke shoulder-hand syndrome, but there is still some confusion about which non-pharmacologic treatment modality is more effective in clinical practice. Objective To provide evidence-based support for clinical decision-making, this network meta-analysis evaluates the efficacy of seven non-pharmacological treatments in improving outcomes for post-stroke shoulder-hand syndrome, pain as measured by the Visual Analogue Scale (VAS), and scores on the simplified Fugl-Meyer Assessment (FMA) . Methods A computerized search of databases including CNKI, Wanfang Data, VIP, China Biomedical Literature Service System, PubMed, Embase, and Cochrane Library was conducted for randomized controlled trials on non-pharmacological treatments for post-stroke shoulder-hand syndrome up to June 2023. Two researchers independently screened the literature and extracted data, performing the network meta-analysis using RevMan 5.3 and Stata 15.0. Results The analysis included 62 studies involving 5 090 patients, assessing interventions such as acupuncture, herbal fumigation, extracorporeal shockwave therapy, moxibustion, herbal hot compress, electrical stimulation, and herbal soak. Results showed that all seven non-pharmacological treatments were superior to the control group in improving overall effectiveness, and FMA scores (P

Background Chronic non-specific low back pain (CNLBP) has become one of the common causes of limited activity, which seriously threatens the physical and mental health and quality of life of patients. According to certain studies, sensitivity and tension in the myofascial tissue play an important role in chronic pain disorders. By releasing fascial tension, myofascial release theropy (MFR) is primarily used to relieve pain; however, there is a lack of high-quality clinical evidence to support this application. Objective To investigates the effectiveness of MFR in CNLBP cases treated non-surgically. Methods From January to December 2022, 56 patients with CNLBP were recruited as study subjects by Chengdu Sports Institute Sports Hospital. The patients were then divided into two groups using a randomised number table. The MFR group received MFR intervention (lumbar-abdominal MFR intervention) and the patients in the control group (CG group) received pseudo-MFR intervention (pseudo-MFR intervention in the same area) for the duration of 4 weeks, once a week for 20 minutes each time. The following variables were measured: Visual Analogue Scale (VAS) scores, Activities of Daily Living (ADL) scores, Oswestry Dysfunction Index (ODI), lumbar joint mobility[including anterior lumbar flexion (ALF), posterior lumbar extension (LR) and lumbar spine rotation (LSR) on both sides], scores on the SAS, and changes in tumour necrosis factor α (TNF-α) . Results A total of 56 subjects were enrolled in this study. Of these, 8 cases were lost, 8 cases were automatically withdrawn and 40 cases -20 in the MFR group and 20 in the CG group eventually completed follow-up. There were no significant difference in VAS scores, ADL scores, ODI scores, ALF scores, SAS scores, SDS scores and TNF-α level between two groups before intervention (P>0.05). LR and LSR in MFR group were lower than those in CG group before intervention (P

Background Chronic atrophic gastritis (CAG) with intestinal metaplasia (IM) is an independent risk factor for gastric cancer. Long-term inflammation and oxidative stress response stimulate the physical and mental state of patients. Under the modern medical model, proton pump inhibitors and gastric mucosal protective agents are increasingly unable to meet the high drug resistance of patients. It is urgent to seek effective new Chinese medicine treatments and multiple methods to treat CAG and IM. Objective To evaluate the clinical efficacy and safety of modified Piwei Peiyuan Decoction combined with acupuncture in the treatment of CAG with IM. Methods From January 2022 to September 2023, 202 patients with CAG and IM diagnosed by gastroscopy and pathological examination in the Department of Spleen and Stomach, the Center for Preventive Treatment of Disease, the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine and the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine were selected. The patients were divided into control group (n=67), treatment group A (n=68) and treatment group B (n=67) by random number table method. All patients participated in 6 weeks of treatment: (1) Control group: aluminum magnesium suspension combined with folic acid tablets (3 times/d) ; (2) Treatment group A: to add and subtract syndrome types of Piwei Peiyuan Decoction (2 times/d) ; (3) Treatment group B: Piwei Peiyuan Decoction (the same as group A) combined with acupuncture (1 time/d), with Zusanli, Liangqiu, Gongsun, Neiguan, Zhongwan as the main points, according to the syndrome type selection of acupoints. Before and 6 weeks after treatment, OLGA, OLGIM staging, gastric mucosal pathological efficacy, gastric mucosal pathological score, clinical symptom score, PRO scale score, drug-related adverse events (AE) and adverse drug reactions (ADR) were recorded. Results A total of 192 patients completed the 6-week course of treatment (62 in the control group, 66 in the treatment group A, and 64 in the treatment group B). The effective rate of the control group was 48.39% (30/62), the effective rate of the treatment group A was 69.70% (46/66), and the effective rate of the treatment group B was 71.88% (46/64). There was a statistically significant difference in the effective rate among the three groups (χ2=9.144, P=0.01). After treatment, the gastric mucosal pathological score, clinical symptom score and PRO scale score in the three groups were lower than those in the same group before treatment (P0.05) . Conclusion The overall clinical efficacy of Piwei Peiyuan Decoction combined with acupuncture is better than that of aluminum magnesium suspension combined with folic acid tablets, which is better than that of traditional antacids and gastric mucosal protective agents.

Background Early hypocapnia in extremely preterm infants is associated with intraventricular hemorrhage (IVH) and bronchopulmonary dysplasia (BPD). The results of foreign studies show that high frequency oscillatory ventilation combined with volume guarantee ventilation (HFOV+VG) has been confirmed to reduce hypocapnia in preterm infants, but less is known of using HFOV+VG in extremely preterm infants born at 0.05) . Conclusion Compared with SIMV ventilation, HFOV+VG ventilation in extremely preterm infants born at

OBJECTIVE: To evaluate the efficacy and safety of Weimaining capsules combined with chemotherapy in the treatment of lung cancer through Meta-analysis. METHODS: CNKI, Wanfang Data, VIP, CBM, PubMed, Embase, Springer, the Cochrane Library databases were retrieved to collect randomized controlled trial ( RCT) of Weimaining capsules combined with chemotherapy in the treatment of lung cancer from the establishment of the database to Jan. 17th, 2024. The chemotherapy regimen was not limited. The observation group was treated with Weimaining capsules combined with chemotherapy, while the control group received conventional chemotherapy. After screening according to inclusion and exclusion criteria, Meta-analysis was performed by using RevMan 5. 4 software. RESULTS: Totally 8 articles and 807 patients were finally enrolled, including 405 patients in observation and 402 patients in control group. Compared with chemotherapy alone, Weimaining capsules combined with chemotherapy could significantly increase the objective response rate (OR = 2. 63,95% CI = 1. 82-3. 80,P<0. 000 01) and disease control rate (OR = 2. 71, 95%CI = 1. 68-4. 35,P<0. 000 1), improve immune function (CD4+ / CD8+ ) (MD = 0. 54, 95%CI = 0. 22-0. 85,P = 0. 000 7) and quality of life (OR = 3. 59,95%CI = 1. 60-8. 06,P = 0. 002), and decrease the incidence of gastrointestinal reactions and bone myelosuppression (incidence of gastrointestinal reactions: OR = 0. 38, 95%CI = 0. 21-0. 69,P = 0. 001; incidence of myelosuppression: OR = 0. 30,95% CI = 0. 15-0. 61,P = 0. 000 8) of patients with lung cancer, the differences were statistically significant. CONCLUSIONS: In the treatment of lung cancer, Weimaining capsules combined with chemotherapy can significantly improve the objective response rate and disease control rate of patients, enhance the immune function, improve the quality of life, and reduce the incidence of adverse drug reactions (gastrointestinal reactions, myelosuppression suppression). However, the conclusions need to be confirmed by more and higher quality RCT. [ABSTRACT FROM AUTHOR]

Objective To determine the efficacy of micro-needle knife therapy versus placebo (sham microneedle knife) for cervicogenic headache. Method A total of 60 eligible patients with cervicogenic headache were assigned to two groups with 30 cases in each group by using a random number table. Treatment group received micro-needle knife therapy and placebo group received sham micro-needle knife. Results After 4 weeks of intervention, the pain index score was significantly lower in the treatment group (1.27 ± 0.583) than that of the placebo group (3.37 ± 0.765); the cervical range of motion was significantly lower in the treatment group A (1.20 ± 0.407) than that of the placebo group (2.47 ± 0.681); the headache duration was significantly lower in the treatment group (3.33 ± 0.661) than that of the placebo group (5.30 ± 0.988); the headache frequency was significantly lower in the treatment group (1.50 ± 0.682) than that of the placebo group (2.73 ± 0.691), and the differences in the data of the two groups were statistically significant. The duration of headache (3.93 ± 0.739) and frequency of headache (1.96 ± 0.556) were significantly lower in the treatment group than that of the placebo group at follow-up, and the difference was statistically significant (P < 0.05). The occurrence of adverse reactions was not statistically significant in the two groups (P > 0.05) Conclusions Micro-needle knife therapy could effectively improve the pain level of cervicogenic headache patients, reduce the headache duration and headache frequency, and improve the mobility of cervical spine. Acupuncture-related adverse events during treatment were infrequent in both groups and it's safe for cervicogenic headache. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To systematically review the efficacy and safety of ivabradine ( IVA) combined with β-blockers in the treatment of chronic heart failure (CHF). METHODS: PubMed, Embase, the Cochrane Library, Web of Science, CNKI, Wanfang Data, VIP and CBM were retrieved to collect randomized controlled trials of IVA combined with β-blockers in the treatment of CHF ( the observation group was treated with IVA combined with β-blocker, while the control group received β-blocker alone). The retrieval time was from the establishment of the database to Apr. 12th, 2023. Meta-analysis was performed by using RevMan 5. 4 and Stata 16 software. RESULTS: A total of 39 studies including 3 794 patients were enrolled. Meta-analysis showed that the total effective rate in the observation group was significantly higher than that in the control group, the heart rate was significantly lower than that in the control group, and the cardiac function indicator was significantly better than that in the control group ( left ventricular ejection fraction was higher than that in the control group, left ventricular end-systolic diameter and left ventricular end-diastolic diameter were lower than that in the control group, 6 min walking distance was longer than that in the control group), and the incidence of adverse reactions was significantly lower than that in the control group, with statistically significant differences (P < 0. 05). CONCLUSIONS: IVA combined with β-blocker has significant efficacy and good safety in improving the total effective rate, reducing heart rate and improving cardiac function in patients with CHF, which is worthy of clinical promotion and application. [ABSTRACT FROM AUTHOR]

Background Traditional Chinese acupuncture has been widely applied for the treatment of knee osteoarthritis (KOA) with outstanding efficacy. However, recognized and unified outcome indicators remain to be absent, which impedes the translation of research into high-quality clinical evidence. Therefore, the establishment of core outcome indicators for acupuncture in KOA is conducive to enhance the scientific rigor, rationality, and feasibility of clinical research programs in traditional Chinese medicine (TCM) , provide higher quality evidence-based basis for clinical research. Objective To analyze the current status of the application of outcome indicators in randomized controlled trials (RCTs) of acupuncture for KOA, so as to provide a basis for the assessment method of clinical efficacy. Methods PubMed, Cochrane Library, Embase, Web of Science, CNKI, Wanfang, VIP and SinoMed were searched for clinical RCTs of acupuncture in the treatment of KOA from 2003 to 2022. Two researchers screened and extracted the characteristics of literature. The indicator domain, measurement tools and the time point of measurement of RCTs of acupuncture for KOA were analyzed. Results A total of 131 papers were included, with a sample size of 22 726 cases and 89 outcome indicators, which were classified into 40 (44.9%) items for symptoms and signs, 22 (24.7%) items for physical and chemical examinations, 5 (5.6%) items for quality of life, 5 (5.6%) items for psychological state, 3 (3.4%) items for satisfaction evaluation, 2 (2.2%) items for safety indicators, and 12 (13.5%) items for other indicators. Among the 131 articles, 23 measurement time points were included in the 131 articles, ranging from 1 hour to 3 years after treatment, 106 (80.9%) articles used "clinical efficacy" as the outcome indicator, 23 (17.6%) articles used safety evaluation and adverse event reports. Conclusion There are some problems in the use of outcome indicators in the RCTs of acupuncture for KOA, such as large variation in the use of outcome indicators, confounding of primary and secondary indicators, abuse of index combination, irregular use of composite indexes, inadequate safety evaluation, irregular measurement time points, insufficient evaluation of long-term prognosis, and failing to reflect the characteristics of TCM intervention of acupuncture. Future research should combine treatment based on syndrome differentiation characteristics of TCM, to evaluate the efficacy of acupuncture in the treatment of KOA by using scientific and reasonable outcome indicators. It is urgent to establish the core indicators set of TCM in the treatment of KOA, and to construct a standardized and recognized COS-TCM.

Background The prevalence of dyslipidemia among adults in China reached 40.4% in 2012, and dyslipidemia is an independent risk factor for atherosclerotic cardiovascular diseases (ASCVD), and the elderly are at high risk for dyslipidemia and chronic diseases. The results of the previous survey showed that the prevalence of dyslipidemia among the elderly in the Malu district of Shanghai was 63%, therefore, it is of great significance to control dyslipidemia effectively. Objective To explore the synergistic effect of using acupoint catgut embedding combined with atorvastatin calcium to intervene in hyperlipidemia among the elderly in Malu district, so as to provide a basis for preventing and treating hyperlipidemia in the elderly and guide clinical practice. Methods As a single-center randomized controlled trial, a total of 120 elderly patients with hyperlipidemia recruited in the outpatient clinic of Malu Community Health Service Center of Jiading District from 2020-05-10 to 2020-08-04 were randomly divided into the treatment (n=59) and control groups (n=60) in a 1∶1 ratio by using simple random digit grouping methods. The treatment group was treated with acupoint catgut embedding combined with atorvastatin calcium, and the embedding was performed once every 2 weeks, 4 times for a course of treatment, while taking 10 mg of oral atorvastatin calcium tablets daily; the control group received only 10 mg of oral atorvastatin calcium tablets daily for 8 weeks of the intervention cycle. The main observational indexes were LDL cholesterol compliance and improvement in lipid levels, and the effect of this treatment regimen in different populations were explored. Results The primary outcome indicators included that the LDL cholesterol compliance rates were 79.5% and 71.4% in the two groups after treatment, respectively; there was no significant difference in the comparison of total cholesterol, triglycerides, low density lipoprotein cholesterol and high density lipoprotein cholesterol before and after treatment and 1 month of follow-up in the two groups (P>0.05). The secondary outcome indicators included that there was no significant difference in the comparison of apolipoprotein A, apolipoprotein B, lipoprotein alpha, fasting blood glucose and glycated albumin before and after treatment between the two groups (P>0.05), the comparison of the difference of BMI in the two groups before and after treatment, after treatment, and 1 month follow-up showed no statistically significant difference (P>0.05) ; the TCM evidence scores of the treatment group were higher than those of the control group after treatment (P

Background Pregnancy and vaginal delivery are important factors leading to pelvic floor dysfunction (PFD) in women, manifested as pelvic organ prolapse (POP), stress urinary incontinence (SUI), and sexual dysfunction. Postpartum pelvic floor function rehabilitation has become a research hotspot in recent years. Stimulating the pelvic floor muscle groups through active exercise and passive contraction can improve detrusor stability and levator muscle function to prevent and treat PFD. Objective To investigate the clinical value of biofeedback electrical stimulation combined with pelvic floor muscle training (PFMT) therapy in the rehabilitation of pelvic floor function after vaginal delivery through a clinical controlled study. Methods Postpartum women with PFD after delivery implemented in Department of Obstetrics and Gynecology, Beijing Shijitan Hospital Affiliated to Capital Medical University from January 2020 to January 2022 were selected as the research subjects, and divided into the observation group and the control group using a random number table method. The observation group was treated with biofeedback electrical stimulation combined with PFMT, while the control group was treated with PFMT alone. The muscle strength of the pelvic floor class Ⅰ and class Ⅱ muscle fibers, the ratio of SUI and POP level of the two groups before and after treatment; postpartum PFMT situation; scores of Pelvic Floor Dysfunction Questionnaire (PFDI-20), Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICI-Q-SF) before and at 3 and 6 months after the treatment. Results A total of 327 cases were included in the observation group and 343 cases in the control group. After the treatment, the strength recovery of type Ⅰ and Ⅱ muscle fibers in the observation group was better than the control group (P0.05). The proportion of PFMT frequency≥5 times/week in the observation group was higher than that in the control group at 3 months and 6 months after treatment (P

Background In recent years, there have been many randomized controlled trials (RCTs) featuring manipulation for frozen shoulder, but there is a lack of new systematic reviews on the efficacy and safety of manipulation for frozen shoulder. Objective To evaluate the efficacy and safety of manipulation in the treatment of frozen shoulder by Meta-analysis, and understand whether "rotation shoulder joint" could affect the effect of manipulative therapy by subgroup. Methods PubMed, Cochrane Library, Embase, Medline, CNKI, China Biomedical Literature Database, Wanfang Data were searched for RCTs on the efficacy and safety of manipulative therapy for frozen shoulder, with manipulative therapy as the intervention of experimental group and non-pharmacological therapy as the intervention of control group from inception to 2023-03-01. Two investigators extracted data and evaluated the quality. Meta-analysis was performed using Revman 5.3 software. Results A total of 12 RCTs were included in this Meta-analysis, with a total of 893 patients with frozen shoulder, including 451 patients in the experimental group and 442 cases in the control group. Results of Meta-analysis showed that the improvement of VAS by manipulative therapy was better than physical therapy, acupuncture therapy and conventional therapy (SMD=1.09, 95%CI=0.81-1.37, P

Background Oral traditional Chinese medicine (TCM) has been widely used in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD), but the outcome measures of relevant clinical trials have not been standardized and regulated. Objective To screen the published randomized controlled trials (RCTs) of oral TCM in the treatment of AECOPD, summarize the literature characteristics and outcome measures, so as to provide reference for the design of clinical trials and the selection of outcome measures for the treatment of AECOPD with TCM. Methods CNKI, Wanfang Data, VIP, SinoMed, PubMed, Embase, Web of Science, Cochrane Library, ClinicalTrials.gov and Chinese Clinical Trial Registry were systematically searched by computer to obtain RCTs and clinical trial registration protocols for the treatment of AECOPD with oral TCM from January 2018 to October 2022. After independent screening of the literature and extraction of data by 2 researchers, qualitative analysis was used to describe the selection of outcome measures in the enrolled studies. Results A total of 578 studies were enrolled, including 574 RCTs with reported trial results and 4 clinical trial registration protocols. A total of 51 508 patients were involved in 574 RCTs. In the inclusion criteria, 88 studies limited the classification of disease, and 361 studies limited the TCM syndrome type, 6 studies reported the blinding method, and 6 studies mentioned the follow-up. A total of 4 030 outcome measures were covered and the number of outcome measures in a single article ranged from 1 to 24. According to the functional attributes, the outcome measures were classified into 8 measure domains: TCM symptoms/syndromes, symptoms/signs, physical and chemical tests, quality of life, long-term prognosis, economic evaluation, safety evaluation and others. The measure domain with the highest reporting rate was physical and chemical tests, and the top 5 outcome measure items reported in terms of frequency were: response rate (11.5%), forced expiratory volume in 1 s (FEV1) (7.5%), TCM symptom/syndrome score (7.0%), FEV1/Forced Vital Capacity (FVC) (6.8%), FVC (4.6%). Four hundred and forty-five studies reported the composition of response rate, and the top 5 measures with reporting rate were symptoms (423), signs (281), TCM syndrome score (203), laboratory tests (89), and pulmonary function (71) . Conclusion The RCTs of oral TCM in the treatment of AECOPD involved a large number and a wide range of outcome measures. The included literature focused on the effects of oral TCM on the symptoms and signs, physical and chemical test indicators, quality of life, long-term prognosis, economic evaluation and safety outcomes of patients with AECOPD in varying degrees. However, the selection of outcome measures remains problematic in multiple ways: unclear prioritization of outcome measures; focusing on clinical endpoints with insufficient attention to clinical endpoints; insufficient attention to health economics indicators; different sources and judgment criterias of reference of response. In the future studies, researchers can design the rational outcome measures by refering to the published core outcome set (COS) to improve the quality of TCM clinical research.

Background Hepatocellular carcinoma (HCC) is characterized by high morbidity and mortality. Early diagnosis and timely intervention in the precancerous stage can effectively reduce the incidence of HCC, which is of great significance for its prevention and treatment. Modern medical treatment of precancerous lesions of HCC has problems such as difficulties to grasp the timing of intervention and single treatment method, traditional Chinese medicine (TCM) may be a simple and effective new approach to prevent and treat precancerous lesion of HCC. Objective To observe the clinical efficacy and safety of Qizhuhuaji formula in the treatment of precancerous lesion of HCC (liver-depression and spleen-deficiency, phlegm and blood stasis syndrome) . Methods Patients with precancerous lesion of HCC who met the TCM syndrome type "liver-depression and spleen-deficiency, phlegm and blood stasis syndrome" admitted in the hepatology clinic of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Weihai Hospital of Traditional Chinese Medicine and Taian Hospital of Traditional Chinese Medicine from October 2019 to March 2020 were included as the study subjects. General information (gender, age, history of HBV-related cirrhosis, family history of HCC, history of alcohol consumption for more than 10 years), the TCM syndrome score, liver function indicators [alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), albumin (ALB), glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) ], tumor marker indexes [alpha-fetoprotein (AFP), alpha-fetoprotein variants-L3 (AFP-L3), des-γ-carboxy-prothrombin (DCP) ], imaging indexes (lesion type, lesion nature, lesion length diameter), safety indexes and adverse reactions were collected. The 64 patients who met the inclusion criteria and completed the study were divided into the observation group (n=34) and the control group (n=30) using the random number tables. The patients in the control group were treated with conventional therapy such as antiviral, anti-inflammatory and liver-protective therapy; the observation group was treated with conventional therapy combined with Qizhuhuaji formula. The treatment course was 48 weeks, and the follow-up period was 48 weeks after drug withdrawal. The incidence of HCC and complications in the treatment cycle and follow-up period of the two group were observed, and the differences in the improvement indexes of TCM syndrome (TCM syndrome scores, total effective rate), liver function indicators, tumor marker indexes, imaging indexes (lesion length diameter, lesion stability rate, lesion improvement rate), and safety index (safety rate) between the two groups before and after treatment. Results After treatment, the TCM syndrome scores, ALT, AST, TBIL, GGT, ALP, and AFP-L3 were lower than those before treatment in both groups, and the ALB level was higher than that before treatment (P0.05) in the rates of lesion improvement (35.3%) and lesion stability (50.0%) in the observation group compared with the control group (20.0%, 43.3%). There was no statistically significant difference in the incidence of HCC between the observation group (8.8%) and the control group (16.7%) at the end of the follow-up period (P>0.05) ; the incidence of complications (8.8%) in the observation group was lower than that of the control group (30.0%) (P0.05) in the safety rate between the observation group (94.1%) and the control group (90.0%) . Conclusion The treatment of precancerous lesions of HCC (liver depression and spleen deficiency, phlegm and blood stasis syndrome) with Qizhuhuaji formula has better clinical efficacy and higher safety in improving TCM syndrome, improving liver function, shrinking lesion nodules, reducing the incidence of long-term HCC and complications of liver cirrhosis.

OBJECTIVE: At present, there are various surgical repair strategies for the lateral stability of chronic ankle instability after the injury of the lateral collateral ligament of the ankle, but the specific repair strategy to maximize the recovery of lateral stability of the ankle still lacks of evidence-based medical evidence. Based on this, for the first time, this paper systematically evaluated the effects of four popular repair strategies to restore the lateral stability of chronic ankle instability using the network meta-analysis method. METHODS: Computer retrieval was conducted on CNKI, WanFang, VIP, PubMed, Embase, Web of Science and Cochrane Library. The retrieval time was from the establishment of each database to December 2022. The randomized controlled trials or clinical controlled trials on different repair strategies to recover chronic ankle instability after injury of the lateral ligament of the ankle were included. The literature was screened and extracted. The literature quality was evaluated and data were analyzed using RevMan 5.4, R4.2 and Stata 14.2 software. RESULTS: Twelve studies (including 10 randomized controlled trials and 2 cohort studies) were included. A total of 673 patients with chronic ankle instability were involved in 4 repair strategies. The observation indicators were: anterior talar translation distance and talar tilt angle of ankle joint stress X-ray film (hereinafter referred to as anterior talar translation distance and talar tilt angle). The results of network meta-analysis showed that: (1) In terms of anterior talar translation distance, the sequence of reticular meta-analysis results from inferior to superior was anatomical repair > anatomical repair + enhancement of inferior extensor retinaculum > internal brake anatomical reconstruction > autologous/allogeneic tendon anatomical reconstruction. (2) In terms of talar tilt angle, the sorting results of reticular meta-analysis from inferior to superior were as follows: anatomical repair > anatomical repair + inferior extensor retinaculum enhancement > internal brace anatomical reconstruction > autologous/allogeneic tendon anatomical reconstruction. CONCLUSION: Anatomical reconstruction strategy of autologous/allogeneic tendon is the first in improving anterior talar translation distance and talar tilt angle, suggesting that this strategy may have the best effect in restoring the stability of chronic joint instability after injury of the lateral ligament of ankle, but more large sample, multicenter, double-blind randomized controlled trials are still needed in the future to further confirm. [ABSTRACT FROM AUTHOR]

BACKGROUND: With the variation of disease treatment modes and the in-depth research on senile osteoporosis in recent years, increasing studies have confirmed that traditional Chinese medicine has a significant effect on the prevention and treatment of senile osteoporosis. OBJECTIVE: To investigate the effect of Yishen Gushu Formula on bone metabolic markers in patients with osteoporosis of kidney deficiency and blood stasis type. METHODS: 102 patients with senile osteoporosis of kidney deficiency and blood stasis type who were treated at Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine from July 2020 to March 2022 were enrolled, including 32 males and 70 females, aged 71-93 years. All patients were randomly divided into two groups, with 51 patients in each group. The control group was treated with calcium carbonate D3 granules and sodium alendronate tablets, while the treatment group was treated with Yishen Gushu Formula beyond the control group. Treatments in each group lasted 3 months. Bone mineral density of the L1-4 lumbar vertebrae and left femoral neck, visual analog scale score, and serum levels of osteocalcin, osteopontin, type I collagen cross-linked C-terminal peptide and tartrate resistant acid phosphatase were measured before and 3 months after treatment. Traditional Chinese medicine syndrome score and therapeutic efficiency were also assessed. RESULTS AND CONCLUSION: After 3 months of treatment, the bone mineral density of the lumbar vertebrae (L1-4) and left femoral neck was significantly increased in both two groups (P < 0.05), and the bone mineral density of the lumbar vertebrae (L1-4) and left femoral neck was significantly higher in the treatment group than the control group (P < 0.05). The visual analog scale scores of both groups after 3 months of treatment were lower than those before treatment (P < 0.05), and the visual analog scores of the treatment group after 3 months of treatment were lower than those of the control group (P < 0.05). After 3 months of treatment, the serum levels of osteocalcin, osteopontin, type I collagen cross-linked C-terminal peptide and tartrate resistant acid phosphatase were significantly improved in both two groups, while compared with the control group, the serum levels of osteocalcin and osteopontin were significantly higher (P < 0.05) and the serum levels of type I collagen cross-linked C-terminal peptide and tartrate resistant acid phosphatase were significantly lower in the treatment group (P < 0.05). After 3 months of treatment, the Traditional Chinese medicine syndrome scores were decreased in both two groups, while the Traditional Chinese medicine syndrome scores in the treatment group were lower than those in the control group. After 3 months of treatment, no significant adverse reactions occurred in both groups. The total effective rate was 88.2% and 70.6% in the treatment and control groups respectively, and there was a significant difference between the two groups (P < 0.05). To conclude, Yishen Gushu Formula combined with anti-osteoporosis drugs can significantly improve the clinical symptoms of patients with senile osteoporosis of kidney deficiency and blood stasis type and prevent disease progression by regulating bone metabolism, increasing bone mineral density, and relieving pain. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To evaluate the efficacy and safety of indobufen in the prevention of venous thrombosis. METHODS: PubMed, Embase, the Cochrane Library, ClinicalTrial. gov, CNKI, Wanfang Data and CBM were searched electronically for randomized controlled trial (RCT) of indobufen in the prevention of venous thrombosis (the interventions were indobuprofen alone or in combination with other conventional drugs, while the control measures were other positive control drugs alone or in combination with other conventional drugs) up to May 2023. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of the included literature. Meta-analysis was performed by using RevMan 5. 3 software. RESULTS: A total of 15 RCT with 2 164 patients were included. There were 1 117 patients in the indobufen group and 1 047 patients in the control group. Efficacy results showed that the there was sufficient evidence-based evidence for Meta-analysis of indobufen in thromboprophylaxis of atrial fibrillation (AF), thromboprophylaxis after major orthopedic surgery, and thromboprophylaxis of idiopathic model nephropathy, and the results were not worse than warfarin or other anticoagulants. In the prevention of thrombosis after AF combined with ischemic cardio-cerebrovascular disease, nephrotic syndrome and superficial varices of lower extremities, indobufen also had some evidence, yet it was not enough for quantitative analysis. Safety outcomes showed that the incidences of bleeding (RR = 0. 18,95% CI = 0. 09- 0. 38, P<0. 000 01) and minor bleeding (RR = 0. 17, 95% CI = 0. 05-0. 52, P = 0. 002) induced by indobufen in prevention of AF thrombosiswas were significantly lower than those in warfarin, with statistically significant differences. CONCLUSIONS: Indobufen has accumulated a certain amount of evidence-based evidence in the prevention of venous thrombosis. The clinical efficacy of indobufen in the prevention of venous thrombosis is not inferior to that of conventional therapy, and the safety of indobufen is better. [ABSTRACT FROM AUTHOR]

Objective To investigate the clinical efficacy of Bagua Abdominal Massage in patients with mild CO- VID-19. Methods A randomized controlled study was conducted on 64 patients with mild COVID - 19. Patients were randomly assigned into two groups: the experimental group (33 cases) received Bagua Abdominal Massage in addition to conventional traditional Chinese medicine (TCM) treatment, while the control group (31 cases) received only convention- al TCM treatment. The study compared the time to negative conversion of nucleic acid, resolution time for fever, cough, abdominal pain, appetite, nasal congestion, and runny nose between the two groups. Symptom scores before and after treatment were evaluated, and treatment outcomes were compared. Results The experimental group showed shorter times for nucleic acid conversion, runny nose, cough, chills, decreased appetite, nausea, and relief of abdominal distension/ pain compared to the control group (P<0.05). There was no statistical difference in symptom scores and nucleic acid positive time between the two groups before treatment (P>0.05). After treatment, the experimental group had lower scores for runny nose, cough, chills, decreased appetite, nausea, and abdominal distension/pain compared to the control group (P<0.05). Conclusion Bagua Abdominal Massage demonstrates significant effectiveness in treating patients with mild COVID - 19, leading to a shortened nucleic acid conversion time and rapid relief of respiratory and digestive symp- toms, contributing to a faster recovery. [ABSTRACT FROM AUTHOR]

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Acupuncture is a comprehensive therapy which takes the theory of traditional Chinese medicine as the core. Currently, there is much controversy surrounding the "placebo effect" of acupuncture： some people argue that acupuncture is a "super placebo", while others believe that the so-called placebo effect is just part of the therapeutic effect of acupuncture. To solve the controversy, this article clarified the definition, composition, and research purposes of "placebo acupuncture", pointed out its differences from "sham acupuncture", elucidated the relationship between the placebo effect and the intrinsic efficacy of acupuncture, distinguished the differences between the "observed placebo effect" and the "real placebo effect" in acupuncture clinical trials, and proposed the dilemmas and prospects of implementing "placebo acupuncture" and "sham acupuncture" contrasts at the current stage, in order to provide clues for optimizing randomized controlled trials of acupuncture.

Network Meta-analysis was performed to compare the efficacy and safety of Chinese patent medicines in treating chronic pulmonary heart disease. CNKI, VIP, Wanfang, SinoMed, PubMed, Web of Science, EMbase, and Cochrane Library were searched for randomized controlled trial(RCT) of treating chronic pulmonary heart disease with Chinese patent medicines with the time interval from inception to December 2023. The Cochrane risk-of-bias tool was used for quality assessment of the included articles. RevMan 5.4 and Stata 17.0 were employed to establish the risk of bias map and perform the network Meta-analysis, respectively. Ultimately, a total of 95 RCTs involving 8 787 cases and 11 different Chinese patent medicines were included. Network Meta-analysis yielded the following results based on the surface under the cumulative ranking curve(SUCRA).(1)In terms of cardiac function improves clinical total effective rate, SUCRA the top three were Wenxin Granules + conventional western medicine, Tongxinluo Capsules + conventional western medicine, and Qishen Yiqi Dropping Pills + conventional western medicine.(2)For improving forced expiratory volume in the first se-cond(FEV1), SUCRA the top three were Danting Feixin Granules + conventional western medicine, Tongxinluo Capsules + conventional western medicine, and Bufei Huoxue Capsules + conventional western medicine.(3)Regarding increasing the FEV1/forced vital capacity(FVC%) value, SUCRA the top three were Qili Qiangxin Capsules + conventional western medicine, Shexiang Baoxin Pills + conventional western medicine, and Qishen Yiqi Dropping Pills + conventional western medicine.(4)In terms of increasing the partial pressure of oxygen(PaO&#95;2), SUCRA the top three were Qili Qiangxin Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(5)In terms of reducing the partial pressure of carbon dioxide(PaCO&#95;2), SUCRA the top three were Tongxinluo Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(6)In terms of increasing left ventricular ejection fraction(LVEF), SUCRA the top three were Bufei Huoxue Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(7)In terms of decreasing brain natriu-retic peptide(BNP), SUCRA the top three were Compound Danshen Dropping Pills + conventional western medicine, Qili Qiangxin Capsules + conventional western medicine, and Tongxinluo Capsules + conventional western medicine.(8)In terms of improving the hematocrit level, SUCRA the top three were Qishen Yiqi Dropping Pills + conventional western medicine, Compound Danshen Dropping Pills + conventional western medicine, and Tongxinluo Capsules + conventional western medicine. In terms of safety, 26 RCTs reported adverse reactions, which primarily involved the circulatory and digestive systems. The combination of Chinese patent medicines with conventional western medicine has demonstrated enhanced therapeutic effects on chronic pulmonary heart disease. However, due to the varying quality and sample sizes of included studies and the absence of direct comparisons between Chinese patent medicines, the conclusions should be further validated by multicenter studies with larger sample sizes and higher methodological rigor.

The efficacy and safety of Shenshao Capsules in combination with conventional western medicine for the treatment of angina pectoris in coronary heart disease were systematically evaluated. Computer search of seven databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library, was conducted to identify randomized controlled trial(RCT) on Shenshao Capsules for the treatment of angina pectoris in coronary heart disease up to December 2023. According to inclusion and exclusion criteria, articles were screened, and data was extracted. Cochrane bias risk assessment tool 2.0(RoB 2.0) was used to evaluate the quality of the included articles. Meta-analysis was performed by RevMan 5.4 and Stata/SE 15.1 software, and evidence quality was rated by the GRADE system. TSA 0.9.5.10 beta software was used for the trial sequential analysis(TSA). Twelve RCTs, with a total of 1 128 participants(567 in the experimental group and 561 in the control group), were included. Meta-analysis showed that Shenshao Capsules + conventional western medicine significantly improved clinical efficacy(RR=1.20, 95%CI[1.15, 1.26], P&lt;0.000 01) and electrocardiogram efficacy(RR=1.16, 95%CI[1.04, 1.30], P=0.01), reduced the frequency of weekly angina pectoris attacks(MD=-2.85, 95%CI[-5.27,-0.43], P=0.02), daily angina pectoris attacks(MD=-0.30, 95%CI[-0.57,-0.03], P=0.03) and the duration of angina pectoris attacks(RR=-2.28, 95%CI[-3.44,-1.12], P=0.000 1). There was no statistically significant difference in adverse reactions between the two groups(RR=1.33, 95%CI[0.71, 2.51], P=0.37). TSA indicated that the cumulative evidence for clinical efficacy exceeded the traditional boundary but did not exceed the TSA boundary, suggesting a potential false positive result. According to GRADE assessment, except for clinical efficacy, which was rated as low-quality evidence, the remaining outcomes were rated as very low-quality evidence. The results indicate that Shenshao Capsules + conventional western medicine may have certain advantages in improving clinical efficacy and electrocardiographic efficacy, reducing the frequency and duration of angina pectoris attacks. However, due to the limitations of this study, more rigorous and high-quality RCT is needed to validate its efficacy and safety.

This study aims to analyze the current situation of outcome indicators in randomized controlled trial(RCT) of traditional Chinese medicine(TCM) treatment for Alzheimer's disease(AD), so as to provide a reference for establishing a core indicator set in this field. The researchers systematically searched CNKI, Wanfang, VIP, Sino Med, EMbase, PubMed, Medline, and Cochrane Library. Independent screening of literature and extraction of information was conducted according to the inclusion and exclusion criteria. In addition, the Ro B 2. 0 tool was used for bias risk assessment. A total of 78 RCTs were included, involving 6 379 patients,with 122 kinds of outcome indicators. According to functional attributes, the outcome indicators could be categorized into seven groups:TCM diseases(3 kinds, 13 times), symptoms and signs(26 kinds, 196 times), physical and chemical tests(68 kinds, 149 times),qua-lity of life(1 kind, 2 times), long-term prognosis(2 kinds, 2 times), economic evaluation(0 kind), safety events(21 kinds,194 times), and other indicators(1 kind, 1 time). The results show that the literature evaluation of RCTs of TCM treatment for AD is generally risky, and there are some problems in the selection of outcome indicators, such as lack of TCM characteristics, insignificant distinction between primary and secondary outcome indicators, lack of long-term prognosis and economic evaluation indicators, and non-standard safety event reports. It is suggested that future researchers should establish a core indicator set for AD that highlights the characteristics of TCM and then work to improve the quality of clinical trials.

Objective: To investigate the effects of intraoperative intravenous administration of dexmedetomidine (DEX) on the recovery quality of donors undergoing pure laparoscopic donor hepatectomy., Methods: A total of 56 liver donors who were going to undergo scheduled pure laparoscopic donor hepatectomy were enrolled and randomly assigned to two groups, a DEX group ( n =28) and a control group ( n =28). Donors in the DEX group received DEX infusion at a dose of 1 μg/kg over 15 minutes through a continuous pump, which was followed by DEX at 0.4 μg/(kg·h) until the disconnection of the portal branch. Donors in the control group were given an equal volume of 0.9% normal saline at the same infusion rate and over the same period of time as those of the dex infusion in the DEX group. The primary outcome was the incidence of emergence agitation (EA). The Aono's Four-point Scale (AFPS) score was used to assess EA. The secondary observation indicators included intraoperative anesthesia and surgery conditions, spontaneous respiration recovery time, recovery time, extubation time, scores for the Ramsay Sedation Scale, the incidence of chills, numeric rating scale (NRS) score for pain, and blood pressure and heart rate after extubation., Results: The incidence of EA was 10.7% and 39.3% in the DEX group and the control group, respectively, and the incidence of EA was significantly lower in the DEX group than that in the control group ( P =0.014). The APFS scores after extubation in the DEX group were lower than those in the control group (1 [1, 1] vs. 2 [1, 3], P =0.005). Compared to the control group, the dosages of intraoperative propofol and remifentanil were significantly reduced in the DEX group ( P <0.05). During the recovery period, the number of donors requiring additional boluses of analgesia, the blood pressure, and the heart rate were all lower in the DEX group than those in the control group ( P <0.05). No significant differences between the two groups were observed in the spontaneous respiration recovery time, recovery time, extubation time, the incidence of chills, NRS score, scores for the Ramsay Sedation Scale, and the length-of-stay in postanesthesia care unit (PACU) ( P >0.05)., Conclusion: DEX can reduce the incidence of EA after pure laparoscopic donor hepatectomy and improve the quality of recovery without prolonging postoperative recovery time or extubation time., Competing Interests: 利益冲突　所有作者均声明不存在利益冲突, (© 2024《四川大学学报（医学版）》编辑部 版权所有Copyright ©2024 Editorial Office of Journal of Sichuan University (Medical Sciences).)

This study employed evidence mapping to systematically sort out the clinical studies about the treatment of premature ventricular contractions with Chinese patent medicines and to reveal the distribution of evidence in this field. The articles about the treatment of premature ventricular contractions with Chinese patent medicines were searched against PubMed, Cochrane Library, Web of Science, CNKI, Wanfang, and VIP with the time interval from January 2016 to December 2022. Evidence was analyzed and presented by charts and graphs combined with text. According to the inclusion and exclusion criteria, 164 papers were included, including 147 interventional studies, 4 observational studies, and 13 systematic reviews. A total of 27 Chinese patent medicines were involved, in which Shensong Yangxin Capsules and Wenxin Granules had high frequency. There were off-label uses in clinical practice. In recent years, the number of articles published in this field showed a decreasing trend. Eight types of outcome indicators were used in interventional studies. Ambulatory electrocardiography, clinical response rate, safety, and echocardiography had high frequency, while the rate of β-blocker decompensation, major cardiovascular events, and pharmaceutical economic indicators were rarely reported. The evaluation was one-sided. The low quality of the included articles reduced the reliability of the findings. In the future, the clinical use of medicines should be standardized, and the quality of clinical studies should be improved. Comprehensive clinical evaluation should be carried out to provide a sound scientific basis for the treatment of premature ventricular contractions with Chinese patent medicines.

An evidence map was established to comprehensively sort out the clinical research in the treatment of post-acute myocardial infarction heart failure(P-AMI-HF) with Chinese patent medicines, so as to reveal the distribution of evidence in this field. CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, and EMbase were searched for the randomized controlled trial(RCT), systematic reviews/Meta-analysis, and guidelines/consensus in this field. The evidence was analyzed and displayed in the form of a combination of text, charts, bubble charts, and bar charts, and the quality of RCT, systematic reviews/Meta-analysis, and guidelines/consensus were evaluated by RoB 1.0, AMSTAR2, and AGREE Ⅱ, respectively. A total of 163 RCTs, 4 systematic reviews/Meta-analysis, 1 network Meta-analysis, 2 observational studies, and 5 guidelines/consensus were included. In recent years, the total number of publications in this field has shown an upward trend. There were a variety of Chinese patent medicines in the treatment of P-AMI-HF, among which Shenfu Injection received the most attention. The clinical RCT and systematic reviews/Meta-analysis generally had poor quality, and the RCT mostly had a small size, a single center, and a short cycle. The outcome indicators mainly included cardiac function indicators, myocardial injury markers, total response rate, hemodynamic indicators, and safety indicators, while the characteristic efficacy indicators of TCM received insufficient attention. The development processes of some guidelines/consensus lack standardization, which compromised their authority and rationality. Chinese patent medicines have advantages in the treatment of P-AMI-HF, while there are also problems, which remain to be solved by more high-quality evidence. That is, more large-sample and multi-center clinical studies should be carried out in the future, and the formulation process of relevant systematic reviews/Meta-analysis and guideline/consensus should be standardized and the quality of evidence should be improved. In this way, the effectiveness and safety of Chinese patent medicines in the treatment of P-AMI-HF can be explored.

This study aims to systematically review the clinical features and outcome indicators in randomized controlled trial(RCT) of traditional Chinese medicine(TCM) intervention in septic kidney injury and provide a reference for optimizing clinical study design and building the core outcome set(COS) of TCM treatment of septic kidney injury. Computer searches were conducted on PubMed, Cochrane Library, EMbase, Web of Science, CNKI, Wanfang, VIP, and SinoMed to find published RCT of TCM intervention in septic kidney injury in the past five years, extract the basic characteristics, intervention measures, outcome indicators, and other data of included studies, and conduct descriptive analysis. 53 RCTs were included, and the sample size was mostly concentrated in 60-80 cases, with abdominal infection being the most common(15 articles, 83.3%) and the TCM syndrome of blood stasis being the most frequent(9 articles, 50.0%). The frequency of intervention methods from high to low were TCM decoction(28 articles, 52.8%), Chinese patent medicine(22 articles, 41.5%), and combined TCM therapy(3 articles, 7.5%); the intervention time of the trial was more than 7 d(34 articles, 69.4%). The risk of bias in included studies was unclear. A total of 84 outcome indicators were involved, which were divided into 9 fields, including 63 physical and chemical tests(305 times, 72.2%), 4 kinds of disease degree(48 times, 11.6%), 4 kinds of clinical effective rate(15 times, 3.6%), 1 kind of quality of life(1 time, 0.2%), 2 kinds of economic evaluation(14 times, 3.3%), 1 kind of TCM disease(9 times, 2.1%), 2 kinds of long-term prognosis(16 times, 3.8%), 2 kinds of safety events(6 times, 1.4%), and 5 other indicators(8 times, 0.7%). The cumulative frequency was 422 times, among which the outcome indicators with higher frequency were inflammatory factors(42 articles, 79.2%) and markers of renal function and kidney injury(40 articles, 75.5%). Only 1(1.9%) of the included articles mentioned primary and secondary outcome indicators, and 6 articles(11.3%) mentioned safety events, 13 articles(24.5%) mentioned economic assessment. The RCT quality of TCM intervention in septic renal injury was generally low, and the reference standards for sepsis, kidney injury, and TCM syndrome diagnosis were not uniform. There are some problems in outcome indicators, such as unclear distinction between primary and secondary indicators, neglect of endpoint indicators, lack of application of TCM characteristic indicators, and insufficient attention to safety events and economic assessment. It is suggested that the quality of clinical research methodology should be improved in the future, and the COS should be constructed to provide high-level evidence-based evidence for TCM intervention in septic kidney injury.

This study assesses the status of outcome measures in the randomized controlled trial(RCT) involving the kidney-tonif-ying and blood-activating method for treating knee osteoarthritis(KOA), aiming to establish a theoretical foundation for the development of a core set of outcome measures in traditional Chinese medicine(TCM) treatment of KOA. The relevant articles were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, in addition to ClinicalTrials.gov and the China Clinical Trial Registration Center, with the time interval from inception to August 2023. The RCT of treating KOA with the kidney-tonifying and blood-activating method was included. Two assessors independently conducted literature screening, data collection, and qualitative analysis to compile the outcome measure results. A total of 350 RCTs were included, involving 165 outcome measures with the total frequency of 1 462. These outcome measures were categorized into six domains: symptom and sign measures(23) with the frequency of 718(49.1%), TCM symptom and syndrome measures(3) with the frequency of 53(3.6%), physical examination measures(130) with the frequency of 506(34.6%), quality of life measures(4) with the frequency of 20(1.3%), long-term efficacy measures(2) with the frequency of 6(0.4%), and safety measures(3) with the frequency of 159(10.9%). Additionally, 53 studies used TCM syndrome and symptom scores as indicators of efficacy, employing eight distinct measurement tools. The RCTs involving the kidney-tonifying and blood-activating method for treating KOA had a variety of problems, such as unclear prio-ritization of outcome measures, diversity in measurement tools, absence of standardized assessment criteria for specific measures, and non-standardized usage. These problems affected the research quality and reliability. Hence, it is advisable to draw upon international expertise, improve research design, and merge TCM efficacy characteristics with clinical research to establish a core set of KOA outcome measures aligned with TCM principles.

This study systematically combed the randomized controlled trial(RCT) of Chinese patent medicines in treatment of type 2 diabetes mellitus(T2DM) in recent five years by using the method of evidence map. It understood the distribution and quality of evidence in this field and found the existing Chinese patent medicines in treatment of T2DM and the problems in its research. The study collected the commonly used Chinese patent medicines for the treatment of T2DM from three drug catalogs, retrieved Chinese and English databases to obtain RCT literature related to Chinese patent medicines in recent five years, and extracted information such as sample size, study drug, combination medication, course of treatment, and outcome indicators from the literature. It also conducted quality evaluation based on the Cochrane collaborative network bias risk assessment tool and used charts to display the analysis results. A total of 19 kinds of Chinese patent medicines are collected, of which 13 kinds of Chinese patent medicines are mentioned in 131 articles related to RCT. The literature concerning Shenqi Jiangtang Capsules/Granules, Jinlida Granules, and Xiaoke Pills accounts for a large proportion. Outcome indicators include blood glucose, blood lipids, pancreatic islet cell function, and clinical symptoms. In terms of literature quality, 75 articles have correct random methods, and 1 article performs allocation hiding and blind methods. Therefore, the clinical orientation of Chinese patent medicines for the treatment of T2DM is broad, failing to reflect their own characteristics and lacking safety information. Insufficient attention has been paid to TCM syndrome scores, quality of life, and blood lipid outcome indicators that reflect the characteristics of traditional Chinese medicine(TCM). The number of studies on the treatment of T2DM by Chinese patent medicines varies greatly among varieties, and the quality of the studies is low. It is suggested that the holders of the marketing license of T2DM Chinese patent medicines should carry out a post-marketing re-evaluation of the varieties of traditional Chinese patent medicines for treating T2DM according to the relevant requirements of the State Food and Drug Administration, standardize the clinical positioning, and revise and improve the safety information in the instructions. It is recommended that researchers construct a core indicator dataset for Chinese patent medicine treatment of T2DM, improve the efficacy evaluation system, and develop an experimental plan based on CONSORT before conducting RCT.

This study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) in the treatment of diabetic foot ulcer(DFU). The aim as provide references for future studies and to enhance the application of clinical evidence. The RCT of DFU treated with Chinese Patent Medicine was obtained and analyzed using the AI-Clinical Evidence Database of Chinese Patent Medicine(AICED-CPM). The analysis was supplemented with data from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science. A total of 275 RCTs meeting the requirements were retrieved, with only 7 of them having a sample size of 200 or more. These trials involved 66 different Chinese patent medicine including 25 oral medications, 24 Chinese herbal injections, and 17 external drugs. Among the 33 different intervention/control designs identified, the most common design was Chinese patent medicine + conventional treatment vs conventional treatment(86 cases, 31.27%). Out of the 275 articles included in the literature, 50 did not provide information on the specific course of treatment(18.18%). A total of 10 counting indicators(with a frequency of 426) and 36 measuring indicators(with a frequency of 962) were utilized. The methodological quality of the RCT for the treatment of DFU with Chinese patent medicine was found to be low, with deficiencies in blind methods, other bias factors, study registration, and sample size estimation. There were noticeable shortcomings in the reporting of allocation hiding and implementation bias(blind method application). More studies should prioritize trial registration, program design, and strict quality control during implementation to provide valuable data for clinical practice and serve as a reference for future investigations.

This study aimed to systematically review the efficacy and safety of Bidouyan Oral Liquid in the treatment of rhinosinu-sitis(RS). CNKI, Wanfang, SinoMed, VIP, Cochrane Library, PubMed, EMbase, Web of Science, and Ovid were searched for the randomized controlled trial(RCT) of Bidouyan Oral Liquid for the treatment of RS patients. Moreover, the reference lists and the grey literature were searched manually. Two researchers independently screened the literature and extracted data. The Cochrane collaboration's tool for assessing risk of bias(RoB 2.0) in randomized trial was used to assess the methodological quality of the included stu-dies. Meta-analysis was performed in RevMan 5.3 and Stata 12.0, and the grades of recommendation, assessment, development and evaluation(GRADE) was employed to evaluate the quality of evidence. A total of 54 RCTs(35 with drug combinations and 19 with single drugs) comprising 7 511 patients(3 973 in the observation group and 3 538 in the control group) were included. Meta-analysis showed that Bidouyan Oral Liquid + conventional treatment was superior to conventional treatment alone in increasing the total response rate(RR=1.19, 95%CI[1.15, 1.24], P&lt;0.000 01) and decreasing the Lund-Kennedy scores(MD=-1.94, 95%CI[-2.61,-1.26], P&lt;0.000 01), Lund-Mackay scores(MD=-2.14, 95%CI[-2.98,-1.31], P&lt;0.000 01), and visual analogue scale(VAS) scores(MD&#95;(total VAS scores)=-1.28, 95%CI[-1.56,-1.01], P&lt;0.000 01; MD&#95;(nasal congestion VAS scores)=-0.58, 95%CI[-0.89,-0.27], P=0.000 2; MD&#95;(runny nose VAS scores)=-0.61, 95%CI[-0.93,-0.29], P=0.000 2; MD&#95;(olfactory dysfunction VAS scores)=-0.43, 95%CI[-0.52,-0.34], P&lt;0.000 01; MD&#95;(head and facial pain VAS scores)=-0.41, 95%CI[-0.57,-0.26], P&lt;0.000 01). Furthermore, the combined treatment outperformed conventional treatment alone in improving the mucociliary transport rate(MTR)(MD=1.64, 95%CI[1.08, 2.20], P&lt;0.000 01) and lowering the levels of inflammatory cytokines{tumor necrosis factor-α(TNF-α)(SMD=-1.95, 95%CI[-2.57,-1.33], P&lt;0.000 01), interleukin-6(IL-6)(SMD=-2.64, 95%CI[-4.08,-1.21], P=0.000 3)} in RS patients. In addition, the combined treatment did not increase the incidence of adverse reactions(RR=0.83, 95%CI[0.44, 1.57], P=0.57). Bidouyan Oral Liquid was superior to conventional treatment in increasing total response rate(RR=1.25, 95%CI[1.18, 1.32], P&lt;0.000 01), decreasing the Lund-Kennedy(P&lt;0.01) and Lund-Mackay scores(P&lt;0.05), alleviating major symptoms(P&#95;(total VAS scores)&lt;0.01; P&#95;(nasal congestion VAS scores)&lt;0.01; P&#95;(runny nose VAS scores)&lt;0.01; P&#95;(olfactory dysfunction VAS scores)&lt;0.05; P&#95;(head and facial pain VAS scores)&lt;0.01), and decreasing adverse reactions(P=0.03). The results showed that either Bidouyan Oral Liquid or Bidouyan Oral Liquid + conventional treatment can increase the total response rate, decrease the Lund-Kennedy and Lund-Mackay scores, and mitigate major symptoms. In addition, Bidouyan Oral Liquid + conventional treatment improved MTR and reduced the expression of TNF-α and IL-6 without causing serious adverse events. However, due to the limited methodological quality of the included studies, large-sample and high-quality RCTs are needed to provide evidence support.