Electroacupuncture for post-stroke urinary incontinence: a systematic review and meta-analysis with trial sequential analysis.

Background: The evidence for the effectiveness of electroacupuncture (EA) for post-stroke urinary incontinence (PSUI) patients remains unclear. Therefore, the purpose of this systematic review and meta-analysis was to assess the efficacy of EA for PSUI. Methods and analysis: Eight English and Chinese databases were searched from their inception until 1 August 2023 to collect randomized controlled trials (RCTs) that investigated the effect of EA on PSUI. Two reviewers independently selected studies that met the eligibility criteria, extracted the necessary data, and assessed the risk of bias for included studies using Cochrane Handbook version 5.1.0. Meta-analysis was performed using Review Manager software (version 5.4.1). Publication bias detection was conducted using STATA (version 16.0). Sequential analysis was performed using TSA 0.9.5.10 Beta. The Grading of Recommendations Assessment, Development, and Evaluation System (GRADE) was used for assessing the certainty of evidence. Results: We included 15 RCTs involving a total of 1,414 patients. The narrative analysis revealed that compared with sham EA, genuine EA exhibited greater efficacy in reducing occurrences of 24-h urinary incontinence while also enhancing maximum cystometric capacity (MCC). Moreover, this effect remained significant even during the 3-month follow-up period. Fourteen studies were encompassed within the quantitative analysis. In contrast to active interventions, EA did not yield an improvement in the responder rate (RR 1.53, 95% CI 0.61 to 3.80, p = 0.36). When compared with basic treatments, the combination of EA with them led to a reduction in 24-h urinary incontinence occurrences (MD -0.56, 95% CI -0.60 to -0.52, p < 0.00001), an improvement in MCC (MD 43.23, 95% CI 28.86 to 57.60, p < 0.00001), and a decrease in residual urine volume (RUV; MD -19.99, 95% CI -29.75 to -10.23, p < 0.0001). However, it did not lead to an increase in the responder rate (RR 1.39, 95% CI 0.88 to 2.20, p = 0.16). In comparison to basic treatments combined with active interventions, the amalgamation of EA and them led to an increase in the responder rate (RR 1.24, 95% CI 1.14 to 1.35, p < 0.00001), a reduction in 24-h urinary incontinence occurrences (MD -2.90, 95% CI -5.26 to -0.55, p = 0.02), a decrease in International Consultation on Incontinence Questionnaire-Short Form scores, and an improvement in both MCC (MD 42.11, 95% CI 23.26 to 60.96, p < 0.0001) and RUV (MD 42.11, 95% CI 23.26 to 60.96, p < 0.0001). Furthermore, all reported adverse effects associated with EA were mild. The trial sequential analysis suggested that a sufficient sample size was available to yield results. However, the level of evidence was predominantly assessed as low or very low. Conclusion: Electroacupuncture improved post-stroke urinary incontinence with no serious adverse effects. Caution is warranted due to methodological issues, and more high-quality studies are required to confirm its efficacy and safety.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023449599, Identifier CRD42023449599.

Auricular acupressure for constipation in adults: a systematic review and meta-analysis.

Introduction: Auricular acupressure (AA) has been widely utilized in the management of constipation, with several studies suggesting its efficacy in treating constipation patients. However, the safety and effectiveness of AA in constipation remain uncertain. Hence, the aim of this study was to assess the effectiveness and safety of AA for constipation. Methods and analysis: A total of eight electronic databases and three clinical trial registration platforms were searched from their inception to April 2023 for randomized controlled trials (RCTs) of AA for constipation. The included studies were appraised for quality using the Cochrane Collaboration's Risk of Bias Assessment tool. The quality of evidence was assessed by two independent reviewers employing the Grading of Recommendations Assessment, Development, and Evaluation System (GRADE) evaluation tool. Meta-analysis of data and assessment of publication bias were performed using RevMan 5.4 and STATA 13.0 software, respectively. Results: This review included 34 randomized controlled trials conducted between 2007 and 2023, involving 2,465 participants. The findings of the study indicate that overall, AA is significantly associated with improved CSBMs (MD = 1.22, 95% CI [0.68, 1.77], p < 0.0001, I2 = 0%), BSF (MD = 0.72, 95%CI: [0.15,1.28], p = 0.01, I2 = 82%), CAS (MD = -3.28, 95%CI: [-5.95, -0.60], p = 0.02, I2 = 80%), responder rate (RR = 1.27, 95%CI: [1.16, 1.38], p < 0.00001, I2 = 79%), cure rate (RR = 1.84, 95% CI [1.56, 2.15], p < 0.00001, I2 = 0%), and PAC-QOL (MD = -2.73, 95% CI: [-3.41, -2.04], p < 0.00001, I2 = 98%) compared to the control group. However, no difference in PAC-SYM (MD = -0.15, 95%CI: [-0.38,0.07], p = 0.19, I2 = 67%) was found between the two groups. Additionally, there was no significant difference in adverse events (RR = 0.53, 95% CI: [0.24, 1.21], p = 0.13, I2 = 38%). Conclusion: Based on the available evidence, auricular acupressure appears to be a potentially safe and effective intervention for managing constipation in adults. Nonetheless, the overall quality of evidence for the identified outcomes was assessed as low to very low, highlighting the need for additional high-quality randomized controlled trials to further validate these findings. Systematic Review Registration: https://www.crd.york.ac.uk/prospero, identifier CRD42023425033.

[Acupoint selection rules of acupuncture for pseudobulbar palsy dysphagia].

OBJECTIVE: To analyze the acupoint selection rules of acupuncture for pseudobulbar palsy dysphagia using data mining technology. METHODS: The literature of acupuncture for pseudobulbar palsy dysphagia published from January 1, 1990 to May 1, 2021 was retrieved from CNKI, SinoMed, Wanfang, VIP, and PubMed databases. Acupuncture prescription database was established. The frequency of acupoint selection was analyzed by Microsoft Excel 2016; Apriori algorithm was used to analyze the association rules and draw the high-frequency acupoint co-occurrence network diagram; SPSS21.0 was used to perform clustering analysis. RESULTS: A total of 87 literature was included, involving 89 acupuncture prescriptions and 71 acupoints. Fengchi (GB 20) was the most frequently-used acupoint; the commonly-selected meridians were gallbladder meridian, conception vessel, governor vessel and stomach meridian; the acupoints located at the neck were the most frequently-used acupoints; the crossing points were commonly selected among the special acupoints. The most commonly-used acupoint combination was Jinjin (EX-HN 12) plus Yuye (EX-HN 13). CONCLUSION: The modern acupuncture for pseudobulbar palsy dysphagia usually selects local acupoints, especially the neck acupoints such as Fengchi (GB 20) and Lianquan (CV 23). The acupoints in the front and back are concurrently selected with needles towards the disease location.

CACA Guidelines for Holistic Integrative Management of Breast Cancer.

Purpose: Breast cancer is now the most common malignant tumor worldwide. About one-fourth of female cancer patients all over the world suffer from breast cancer. And about one in six female cancer deaths worldwide is caused by breast cancer. In terms of absolute numbers of cases and deaths, China ranks first in the world. The CACA Guidelines for Holistic Integrative Management of Breast Cancer were edited to help improve the diagnosis and comprehensive treatment in China. Methods: The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to classify evidence and consensus. Results: The CACA Guidelines for Holistic Integrative Management of Breast Cancer include the epidemiology of breast cancer, breast cancer screening, breast cancer diagnosis, early breast cancer treatment, advanced breast cancer treatment, follow-up, rehabilitation, and traditional Chinese medicine treatment of breast cancer patients. Conclusion: We to standardize the diagnosis and treatment of breast cancer in China through the formulation of the CACA Guidelines.

Effect of an Artificial Intelligence Clinical Decision Support System on Treatment Decisions for Complex Breast Cancer.

PURPOSE: To examine the impact of a clinical decision support system (CDSS) on breast cancer treatment decisions and adherence to National Comprehensive Cancer Center (NCCN) guidelines. PATIENTS AND METHODS: A cross-sectional observational study was conducted involving 1,977 patients at high risk for recurrent or metastatic breast cancer from the Chinese Society of Clinical Oncology. Ten oncologists provided blinded treatment recommendations for an average of 198 patients before and after viewing therapeutic options offered by the CDSS. Univariable and bivariable analyses of treatment changes were performed, and multivariable logistic regressions were estimated to examine the effects of physician experience (years), patient age, and receptor subtype/TNM stage. RESULTS: Treatment decisions changed in 105 (5%) of 1,977 patients and were concentrated in those with hormone receptor (HR)-positive disease or stage IV disease in the first-line therapy setting (73% and 58%, respectively). Logistic regressions showed that decision changes were more likely in those with HR-positive cancer (odds ratio [OR], 1.58; P < .05) and less likely in those with stage IIA (OR, 0.29; P < .05) or IIIA cancer (OR, 0.08; P < .01). Reasons cited for changes included consideration of the CDSS therapeutic options (63% of patients), patient factors highlighted by the tool (23%), and the decision logic of the tool (13%). Patient age and oncologist experience were not associated with decision changes. Adherence to NCCN treatment guidelines increased slightly after using the CDSS (0.5%; P = .003). CONCLUSION: Use of an artificial intelligence-based CDSS had a significant impact on treatment decisions and NCCN guideline adherence in HR-positive breast cancers. Although cases of stage IV disease in the first-line therapy setting were also more likely to be changed, the effect was not statistically significant (P = .22). Additional research on decision impact, patient-physician communication, learning, and clinical outcomes is needed to establish the overall value of the technology.

Efficacy, Safety, and Tolerability of Pertuzumab, Trastuzumab, and Docetaxel for Patients With Early or Locally Advanced ERBB2-Positive Breast Cancer in Asia: The PEONY Phase 3 Randomized Clinical Trial.

Importance: Prospective assessment of treatments known to benefit patients in global clinical trials in specific racial groups is essential. Objective: To compare the efficacy, safety, and tolerability of adding pertuzumab to trastuzumab and docetaxel vs placebo, trastuzumab, and docetaxel in Asian patients with ERBB2-positive early or locally advanced breast cancer. Design, Setting, and Participants: This multicenter, double-blind, placebo-controlled phase 3 trial enrolled 329 women with ERBB2-positive early (T2-3, N0-1, M0) or locally advanced breast cancer (T2-3, N2 or N3, M0; T4, any N, M0) and primary tumor larger than 2 cm from March 14, 2016, to March 13, 2017. Analysis of the primary end point was performed on an intention-to-treat basis. Interventions: Before surgery, patients received 4 cycles of intravenous pertuzumab (840-mg loading dose and 420-mg maintenance doses), trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance doses), and docetaxel (75 mg/m2) or intravenous placebo, trastuzumab, and docetaxel every 3 weeks. After surgery, patients received 3 cycles of intravenous fluorouracil, epirubicin, and cyclophosphamide followed by 13 cycles of the same intravenous anti-ERBB2 therapy (pertuzumab and trastuzumab or placebo and trastuzumab) for up to 1 year. Main Outcomes and Measures: The primary end point was independent review committee-assessed total pathologic complete response rate. The 2-sided Cochran-Mantel-Haenszel test, stratified by disease category and hormone receptor status, was used to compare rates between treatment groups. Results: In total, 329 female patients were randomized (pertuzumab, 219; and placebo, 110; mean [SD] age, 48.8 [9.5] years). In the intention-to-treat population, total pathologic complete response rates were 39.3% (86 of 219) in the pertuzumab group and 21.8% (24 of 110) in the placebo group (difference, 17.5% [95% CI, 6.9%-28.0%]; P = .001). Of the most common grade 3 or higher adverse events, there was a higher incidence of neutropenia in the pertuzumab group (83 of 218 [38.1%] vs 36 of 110 [32.7%]). Serious adverse events were reported in 10.1% of patients (22 of 218) in the pertuzumab group and 8.2% of patients (9 of 110) in the placebo group. Conclusions and Relevance: Treatment with pertuzumab, trastuzumab, and docetaxel resulted in a statistically significant improvement in the total pathologic complete response rate vs placebo, trastuzumab, and docetaxel for the neoadjuvant treatment of ERBB2-positive early or locally advanced breast cancer in Asian patients. Safety data were in line with the known pertuzumab safety profile and generally comparable between treatment groups. The PEONY trial adds to the totality of data showing the benefit of the pertuzumab regimen. Trial Registration: ClinicalTrials.gov identifier: NCT02586025.

Artificial Intelligence Treatment Decision Support For Complex Breast Cancer Among Oncologists With Varying Expertise.

PURPOSE: The aim of the current study was to assess treatment concordance and adherence to National Comprehensive Cancer Network breast cancer treatment guidelines between oncologists and an artificial intelligence advisory tool. PATIENTS AND METHODS: Study cases of patients (N = 1,977) who were at high risk for recurrence or who had metastatic disease and cell types for which the advisory tool was trained were obtained from the Chinese Society for Clinical Oncology cancer database (2012 to 2017). A cross-sectional observational study was performed to examine treatment concordance and guideline adherence among an artificial intelligence advisory tool and 10 oncologists with varying expertise-three fellows, four attending physicians, and three chief physicians. In a blinded fashion, each oncologist provided treatment advice on an average of 198 cases and the advisory tool on all cases (N = 1,977). Results are reported as rates and logistic regression odds ratios. RESULTS: Concordance for the recommended treatment was 0.56 for all physicians and higher for fellows compared with chief and attending physicians (0.68 v 0.54; 0.49; P = .001). Concordance differed by hormone receptor subtype-TNM stage, with the lowest for hormone receptor-positive human epidermal growth factor receptor 2/neu-positive cancers (0.48) and highest for triple-negative breast cancers (0.71) across most TNM stages. Adherence to National Comprehensive Cancer Network guidelines was higher for oncologists compared with the advisory tool (0.96 v 0.82; P < .003) and lower for fellows compared with attending physicians (0.93 v 0.98; 0.96; P = .04). CONCLUSION: Study findings reflect a complex breast cancer case mix, the limits of medical knowledge regarding optimum treatment, clinician practice patterns, and use of a tool that reflects expertise from one cancer center. Additional research in different practice settings is needed to understand the tool's scalability and its impact on treatment decisions and clinical and health services outcomes.

A meta-analysis of clinical benefit rates for fulvestrant 500 mg vs. alternative endocrine therapies for hormone receptor-positive advanced breast cancer.

BACKGROUND: Fulvestrant, a selective estrogen receptor degrader, is approved for first- and second-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer (ABC). METHODS: Meta-analysis of randomized controlled trials (RCTs) evaluating fulvestrant 500 mg in postmenopausal hormone receptor-positive ABC, to evaluate differences in clinical benefit rate (CBR; proportion of patients experiencing best overall response of complete response, partial response, or stable disease for ≥ 24 weeks) between fulvestrant 500 mg and comparator endocrine therapies. Odds ratios (OR) and 95% confidence intervals (CI) for CBR were calculated; fixed effects (FE) models were constructed (first- and second-line data, alone and combined). RESULTS: Six RCTs were included. Four studies evaluated fulvestrant 500 mg vs. fulvestrant 250 mg; two evaluated fulvestrant 500 mg vs. anastrozole 1 mg. In total, 1054 and 534 patients were included (first- and second-line treatment, respectively). Analysis of OR and 95% CI of CBR by therapy line favored fulvestrant 500 mg vs. comparator therapy. Assessing all results combined in the FE model indicated significant improvement in CBR with fulvestrant 500 mg vs. comparator treatments (OR 1.33; 95% CI 1.13-1.57; p = 0.001). Restricting the FE model to therapy line demonstrated significant improvement in CBR vs. comparator treatments (OR 1.33; 95% CI 1.02-1.73; p = 0.035) for first-line, and a trend to improvement vs. comparator treatments (OR 1.27; 95% CI 0.90-1.79; p = 0.174) for second-line. CONCLUSIONS: In postmenopausal patients with hormone receptor-positive ABC, fulvestrant 500 mg first-line was associated with significantly greater CBR (more patients benefiting from treatment) vs. comparator endocrine therapy.

Switching to anastrozole plus goserelin vs continued tamoxifen for adjuvant therapy of premenopausal early-stage breast cancer: preliminary results from a randomized trial.

PURPOSE: To assess the efficacy, safety, and quality-of-life impact of switching adjuvant treatment in hormone receptor-positive primary breast cancer patients who are still premenopausal after 2-3 years of tamoxifen therapy to anastrozole plus goserelin as compared with continuing tamoxifen over a total period of 5 years. PATIENTS AND METHODS: Hormone receptor-positive, premenopausal, lymph node-positive, or tumor size ≥4 cm breast cancer patients who had received tamoxifen for 2-3 years were randomly assigned to continue tamoxifen treatment (TAM group) or switch to adjuvant anastrozole plus goserelin (ADD group) and continue treatment for another 2-3 years (total treatment duration 5 years). Endpoints evaluated were adverse events (AEs), changes in bone mineral density, quality of life, and disease-free survival-related events. RESULTS: A total of 62 patients (33 in the ADD group and 29 in the TAM group) were evaluated. Grade 3-4 drug-related AEs occurred in five patients (15.2%) in the ADD group vs none in the TAM group. In the ADD group, arthralgias were the most common AEs (5/33 patients; 15.2%), and three patients in this group were discontinued because of AEs. Treatment was temporarily suspended due to AEs in three patients (9.1%) in the ADD group and one patient (3.4%) in the TAM group. Compared with continuing TAM therapy, switching to anastrozole plus goserelin did not result in any worsening of bone mineral density or quality of life. During a median follow-up of 34 months, five patients (15.2%) in the ADD group had disease-free survival events vs four patients (13.8%) in the TAM group. CONCLUSION: For early-stage breast cancer patients who remain premenopausal following 2-3 years of adjuvant tamoxifen therapy, switching to anastrozole plus goserelin therapy was safe with tolerable adverse effects. However, it did not show superior efficacy compared to remaining on tamoxifen treatment. TRIAL REGISTRATION: ClinicalTrials.gov (identifier NCT01352091).

Predicting Neoadjuvant Chemotherapy in Nonconcentric Shrinkage Pattern of Breast Cancer Using 1H-Magnetic Resonance Spectroscopic Imaging.

OBJECTIVE: The aim of this study was to explore the response to neoadjuvant chemotherapy (NAC) in nonconcentric shrinkage pattern of breast cancer (BC) patients using H-magnetic resonance spectroscopy. METHODS: Twenty-five BC patients were the study cohort. All patients received AT-based regimen as first-line treatment. Tumor response to chemotherapy was evaluated after the second and fourth cycles using magnetic resonance imaging and magnetic resonance spectroscopy. Final histopathology following surgery after 4 to 8 cycles of NAC served as a reference. Changes in total choline integral* (tCho) and tumor size in response versus nonresponse groups were compared using the 2-way Mann-Whitney nonparametric test. Receiver operating characteristic (ROC) analyses were undertaken, and the area under the ROC curve compared among them. RESULTS: H-magnetic resonance spectroscopy revealed a negative tCho integral* in 6 cases at the first follow-up and 14 cases at the second follow-up. Based on pathology (Miller-Payne system), there were 16 cases of response, and 9 cases of nonresponse. The tCho integral* was significantly different between the response and nonresponse groups at the second follow-up (P = 0.027). The tumor size changes were not significantly different in the response and nonresponse groups at the second follow-up study (P > 0.05). The comparison of ROC curves among the change in tCho integral* and tumor size at baseline and both follow-ups revealed the maximum area under the ROC curve of the change in tCho integral* to be 0.747 at the second follow-up, sensitivity to be 93.75%, and positive predictive value to be 78.9%. CONCLUSIONS: In nonconcentric shrinkage pattern after NAC of BC, when tumor size is difficult to reflect the response, tCho integral* reduction may be a predictive marker.

[Single-agent Xeloda in the treatment of recurrent and metastatic breast cancer].

OBJECTIVE: To evaluate the efficacy and adverse reactions of Xeloda in the treatment of recurrent and metastatic breast cancer. METHODS: This clinical study was designed to treat 69 patients with recurrent and metastatic breast cancer with Xeloda, 2500 mg/m(2)/d, twice daily for 2 weeks followed by a 1-week rest period, repeated every 3 weeks. RESULTS: Sixty-nine patients received Xeloda for more than 1 cycle. The overall response rate (CR + PR) was 16.0%, clinical benefit rate (CR + PR + SD > or = 24 months) was 27.5%, disease control rate (CR + PR + SD) was 75.4%. The median time to failure (TTF) was 3 months (range: 0.7 - 11 months). The median time to progression (TTP) was 2 months (range: 0.7 - 11 months). The median duration of response (CR + PR) was 6 months (range: 4 - 11 months). The most common treatment-related adverse events were hand-foot syndrome (HFS) that occurred in 60.8% (42/69) patients mostly as grade I-II. Fifty-five percent (22/40) of patients who had received high dose preventive Vit B6 developed HFS without grade III; while 69% (20/29) of patients who had not received such treatment did develop HFS including 2 patients with grade III. However, there was not significant difference between the two groups. CONCLUSION: Xeloda is an effective and well tolerated treatment in patients with recurrent and metastatic breast cancer. The symptoms of HFS may be relieved by high dose Vit B6 as prevention.

[Clinical trial on ibandronate in patients with tumor-associated hypercalcemia].

OBJECTIVE: Ibandronate, a third generation bisphosphonate, inhibits bone resorption in human and animal studies. This study is to evaluate the efficacy and safety of ibandronate as a single agent in patients with tumor-associated hypercalcemia. METHODS: An open, multicenter, non-controlled clinical trial was conducted in 22 patients. The patients received 2 mg ibandronate intravenously if the corrected calcium was less than 3.0 mmol/L but more than 2.7 mmol/L; they received 4 mg ibandronate iv if corrected calcium was more than 3.0 mmol/L. RESULTS: There was 100% efficacy in these two dose groups but the calcium correcting effect was more pronounced in the 4-mg dose group than the 2-mg dose group. The most common adverse reactions were fever and skin itching with an incidence of 4.5%. CONCLUSION: Ibandronate is active in patients with tumor-associated hypercalcemia and the adverse effects are well tolerated.