BackgroundNausea and vomiting during pregnancy (NVP) are common symptoms in early pregnancy. NVP can further affect the physical and mental health of pregnant women. Acupuncture has shown potential clinical value in treating NVP and can be considered a beneficial supplemental therapy for NVP. However, existing systematic reviews (SRs) and meta-analyses (MAs) on the efficacy and safety of acupuncture for NVP have yielded inconsistent conclusions, and their methodological and reporting quality has not yet been systematically and comprehensively evaluated.ObjectiveTo synthesize the existing evidence on the efficacy and safety of acupuncture for the treatment of NVP and to assess the quality and risk of bias of the available SRs/MAs.MethodsTwo researchers independently searched nine databases for relevant literature, screened studies according to predefined inclusion and exclusion criteria, and extracted data from the eligible SRs and MAs. The methodological quality, reporting completeness, risk of bias, and strength of evidence were rigorously evaluated using AMSTAR 2, PRISMA-A, ROBIS, and GRADE, respectively. In addition, the GROOVE tool was used to assess the degree of overlap among the original studies by calculating the corrected covered area (CCA).ResultsWe retrieved a total of 288 studies, and 9 SRs/MAs were ultimately included in this review. The methodological quality of one study was moderate, while two studies were rated as low and the remaining six as critically low. According to the PRISMA-A statement, the reporting items of the included SRs/MAs were relatively complete. Furthermore, it revealed a slight overlap among the original studies, with a CCA of 3.64%. The results based on GRADE showed that of the 52 outcomes, 2 were rated as moderate quality, 20 as low quality, and 30 as very low quality. Descriptive analysis showed that acupuncture combined with medication could reduce the frequency of nausea and vomiting, accelerate the ketonuria-negative rates, and maintain serum electrolyte balance. Acupuncture also appeared to reduce the frequency of nausea and vomiting compared with medication alone.ConclusionsAcupuncture appears to relieve the symptoms of NVP to a certain extent. However, the current evidence is limited by low reliability, methodological flaws, publication bias, and inaccurate data. Therefore, the true efficacy remains unclear. Although acupuncture shows preliminary clinical potential, high-quality randomized controlled trials with standardized outcome indicators are still needed to draw definite conclusions.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier CRD420261326889.
Introduction: Functional dyspepsia (FD) is a prevalent gastrointestinal disorder with complex pathogenesis. Traditional Chinese Medicine (TCM) classifies FD into syndromes such as liver-stomach disharmony, spleenstomach damp-heat, and food and drink retention. This study aims to explore the efficacy and safety of Aurantii Fructus Immaturus Flavonoid Tablets (AFIF) in treating these TCM subtypes. Methods: This multicenter, stratified block-randomized, single-dummy, placebo-controlled study enrolled 270 patients with FD, classified into the three TCM subtypes. Within each subtype, participants were randomized to receive AFIF or placebo in a 2:1 ratio. Patients in the AFIF group received four tablets (0.29 g per tablet) orally, three times daily, approximately 30 min before meals, for 4 consecutive weeks, while the placebo group received matching placebo tablets following the same dosing schedule. The primary endpoint was the improvement in Western medical clinical symptoms after 4 weeks. Secondary endpoints included TCM syndrome efficacy, gastric emptying rate at 3.5 h postprandially, and changes in tongue and pulse features. Results: Of 266 initially enrolled patients, 170 (AFIF=113, placebo=57) were analyzed after excluding two centers due to data quality issues. After 4 weeks, the clinical cure rate was 21.24 % in the AFIF group versus 5.26 % in the placebo group, with a rate difference of 15.98 % (95 % CI: 6.46 %-25.49 %; P = 0.007). The markedly effective rate was 61.06 % versus 28.07 %, with a difference of 32.99 % (95 % CI: 18.26 %-47.72 %; P < 0.001). Among the three TCM syndromes, patients with spleen-stomach damp-heat syndrome showed the greatest benefit from AFIF, with a cure rate of 18.52 % and a markedly effective rate of 47.22 %. AFIF also improved gastric emptying rate at 3.5 h postprandially, although the difference compared with placebo was not statistically significant. No drug-related adverse events were reported. Conclusion: AFIF is safe and effective for treating FD, with the greatest efficacy observed in patients with the spleen-stomach damp-heat TCM subtype.
[This corrects the article DOI: 10.3389/fphar.2026.1776655.].
PURPOSE:Patient-reported outcomes (PROs) assist patients and clinicians in assessing treatment effectiveness and enhancing healthcare quality. This study aims to explore and analyze the application and characteristics of PROs in clinical trials of Traditional Chinese Medicine (TCM). METHODS:This cross-sectional study was based on randomized clinical trials of TCM between January 1, 2010, and December 31, 2022 in International Clinical Trials Registry Platform. For each included trial, data including study phase, design, participant demographics, target diseases, PROs, and PRO measurements were extracted. Trials were categorized into three groups: (1) recorded specified patient-reported outcome tools, (2) referenced patient subjective outcomes without specified tools, and (3) did not mention any PROs. Further descriptive statistical analysis were conducted on the most commonly used PRO tools in different countries and for different diseases. RESULTS:Among a total of 7783 eligible trials, 4858 (62.4%) listed explicit PRO tools, and 850 (10.9%) referenced PROs without specified tools. The most common conditions evaluated by PRO tools were musculoskeletal diseases (935 trials, 19.2%), symptoms (714, 14.7%), and neurological diseases (500, 10.3%). Frequently used PRO tools included the Visual Analogue Scale (VAS), 36-item Short-Form Health Questionnaire, and Pittsburgh Sleep Quality Index. Regionally, most PRO-related trials were in the Western Pacific (3904, 68.4%) and fewest in Africa (8, 0.1%). Countries conducting the most PRO-related trials were China, Iran, the USA, South Korea, and Brazil, focusing on musculoskeletal, symptoms, neurological, genitourinary, and digestive diseases, with varying popular disease-specific PRO tools by country. Musculoskeletal diseases were the primary focus in China, Brazil, and South Korea. CONCLUSIONS:The use of PROs in TCM clinical trials has grown during the study period. However, there was an uneven regional distribution of PRO application and a lack of standardized, reliable PRO tools tailored for TCM. Great efforts are needed to enhance the quality and promote the use of PRO tools in TCM clinical research.
Background Acupuncture is used and studied globally. In 1998, Vickers et al. reported a 100% positive rate for acupuncture trials in certain countries, suggesting publication bias. This review aimed to assess whether this pattern has changed and to analyze the factors associated with positive results. Methods MEDLINE was searched for acupuncture randomized controlled trials (RCTs) with English-language records between July 1, 1995, and June 30, 2025; eligible full texts were published in English or Chinese. Data on citations, study characteristics, design, outcomes, and positive results (classified by two determining methods) were extracted and analyzed using chi-square tests and logistic regression. Results Of the 6406 trials identified, 2,001 trials met the inclusion criteria. The annual output of acupuncture RCTs increased year by year. Mainland China, Japan, Hong Kong, and Taiwan, countries or regions previously reporting 100% positive rates in the study of Vickers et al., now exhibited lower positive rates. However, the overall positive rate remained high (91.8% by the method of Vickers et al.; 88.3% using improved methodology). Positive rates varied significantly according to the following factors including first or corresponding author’s continent, journal impact factor and category, ethics approval, trial registration, sample-size calculation, blinding, shared co-interventions, and specification of primary or secondary outcomes (P < 0.05). Conclusions The overall positive rate in published acupuncture RCTs remains high despite a maturing evidence base. The high rate likely reflects multiple contributing factors; publication bias cannot be excluded. Ensuring trial registration and rigorous methods, as well as sufficient reporting of negative results, may help increase transparency and utility of acupuncture trials.
Background:Attention Deficit Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental disorder in children, with an etiology that remains incompletely understood. Recent studies have suggested that the mode of delivery, particularly cesarean section (C-section), may be associated with an increased risk of ADHD. This study aims to examine whether children born via C-section are at increased risk of developing ADHD using both cohort and case-control data. Methods:We included observational studies (case-control or cohort) that examined the association between mode of delivery and ADHD in children. Inclusion criteria were: (a) ADHD diagnosed using standardized tools; (b) assessment of the relationship between C-section and ADHD; (c) availability of effect estimates (ORs with 95% CIs). Exclusion criteria were: (a) duplicate or overlapping data; (b) unavailable full text; (c) no extractable effect estimates. Literature searches were conducted in PubMed, Web of Science, CNKI, Wanfang, and VIP. Data were extracted using Excel and analyzed in R Studio with the meta, metabias, and metainf packages to pool the adjusted odds ratios (ORs) for the association between C-section and the occurrence of ADHD. Study quality was assessed using the Newcastle-Ottawa Scale (NOS). Results:A total of 14 studies were included, consisting of six case-control and eight cohort studies across 10 countries in Asia, Europe, the Americas, and Australia. ADHD diagnoses were based on DSM-IV or ICD-10. Most studies adjusted for key confounders such as maternal age (57.14%), child's sex (50.00%), and gestational factors (35.71%). The pooled ORs were 1.44 (95% CI [1.04-1.25]) for case-control studies and 1.12 (95% CI [1.10-1.15]) for cohort studies. All studies scored ≥ 7 on the NOS. Conclusions:This meta-analysis suggests that C-section is associated with a moderately increased risk of ADHD in children. Both elective and emergency C-sections showed similar effects. However, limitations such as study heterogeneity, potential publication bias, and lack of genetic or biological mechanism data are to be acknowledged. Further research is needed to clarify causality and explore underlying mechanisms.
Aims:To identify drug-related problems (DRPs) associated with proton pump inhibitors (PPIs) and their influencing factors among hospitalized nephrology patients, thereby providing evidence for the rational use of PPIs. Methods:A retrospective cohort of internal nephrology inpatients who received PPIs between June 2024 and May 2025 was assembled. Clinical pharmacists applied the PCNE classification system (version 9.1) to identify and categorize PPI-related DRPs. Univariate and multivariate logistic regression analyses were performed to explore factors contributing to inappropriate PPIs use. Results:A total of 520 patients were included, of which 241 patients (46.34%) experienced 303 DRPs. The most frequent problems involved drug selection and treatment duration. Multivariate analysis revealed that the following variables were independently associated with inappropriate PPIs use: purpose of PPI application (OR = 0.455, 95% CI 0.305-0.680, p < 0.001), antiplatelet agents (OR = 1.552, 95% CI 1.062-2.268, p = 0.023), anti-infective drugs (OR = 1.922, 95% CI 1.313-2.813, p = 0.001), and peritoneal dialysis (OR = 1.743, 95% CI 1.028-2.955, p = 0.039). Conclusion:Systematic identification of PPI-related DRPs and analysis of their determinants by clinical pharmacists will substantially promote the rational use of PPIs in hospitalized patients with renal disease.
Background Objective performance criteria (OPCs) are critical for evaluating efficacy in single-arm trials. This study aimed to examine current practices and methodological challenges in establishing OPCs in single-arm trials of traditional Chinese medicine (TCM). Methods PubMed, Embase, the Cochrane Library, CNKI, Wanfang, and VIP were searched for TCM single-arm trials using OPCs published up to December 2025. Data on OPC sources, population comparability, uncertainty quantification, and primary outcome alignment were extracted and descriptively analysed. Results Twelve studies (13 publications; 1134 participants) conducted in China (2019-2025) evaluated Chinese herbal decoctions (n=9), proprietary Chinese medicines (n=2), or acupuncture plus rehabilitation (n=1) across kidney, neurological, gynaecological and other conditions. OPCs were derived from prior clinical studies (n=6), meta-analyses (n=5), or a synthesis of clinical experience and literature (n=1). Three studies reported 95% confidence intervals, and four justified population comparability. Ten studies exhibited limited comparability due to differences in disease duration, severity, or assessment timing. One study mentioned expert discussion but provided no details. Eleven studies reported a clear primary outcome, among which ten aligned their OPCs accordingly and one based its OPC on a secondary outcome. Only one study lacked an explicit primary outcome definition. Four studies based their OPCs on non-standardised composite outcomes such as remission rate. Conclusions Current TCM single-arm trials face challenges in establishing OPCs, including incomplete reporting, poor population comparability, inadequate uncertainty quantification, and non-standardised endpoints. Future studies should adopt transparent and contextually appropriate OPC specification guidelines, ensuring methodological rigour in source selection, population comparability, and outcome definition.
BACKGROUND:Endometriosis is an estrogen-dependent, progesterone-resistant gynecological disorder, with dysmenorrhea being the most common manifestation. OBJECTIVE:This study evaluates the efficacy and safety of the Tibetan herbal medication Honghua Ruyi Pill (HHRY) in managing endometriosis-related dysmenorrhea. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS:This is a multi-center, randomized, placebo-controlled, double-blinded clinical trial conducted in seven hospitals in China from July 2021 to January 2023. A total of 164 patients with endometriosis and moderate or severe dysmenorrhea (visual analog scale [VAS] score ≥ 4) were assigned to the treatment or placebo group in a 1:1 ratio by block randomization. Patients received HHRY or placebo twice a day for three consecutive menstrual cycles (MCs) and were followed up for three MCs after stopping the medication. MAIN OUTCOME MEASURES:Primary outcomes were VAS score of the maximum (VASmax) of dysmenorrhea, endometriosis health profile-5 (EHP-5) score, and 5-level EuroQoL 5-dimension version (EQ-5D-5L) score. Secondary outcomes were VASmax of non-menstrual pelvic pain, days of leave taken, emergent use of nonsteroidal anti-inflammatory drugs (NSAIDs) and changes in uterine, cyst and nodule sizes. Safety profiles were assessed based on adverse events, vital signs, serology markers, urinalysis, and liver and kidney function indicators. RESULTS:VASmax of dysmenorrhea, EHP-5 score, EQ-5D-5 L score, and VASmax of non-menstrual pelvic pain were significantly lower in the HHRY group compared to the placebo group at the final follow-up (3.00 vs 5.50, P < 0.001; 4.00 vs 8.00, P < 0.001; 4.00 vs 9.00, P < 0.001; 0.00 vs 1.00, P < 0.001; respectively). The emergent use of NSAIDs for breakthrough pain showed no significant difference between groups (P > 0.999), but the number of patients who had taken time off was significantly different (5.00 vs 14.00, P = 0.028). Sonographic evaluations indicated no significant change in uterine size (P = 0.183) but showed a significant reduction in cyst size (2.09 cm vs 0.20 cm, P = 0.027, sum of 3 diameters of cysts) and nodule size (0.70 cm vs 0.00 cm, P < 0.001, maximum nodule diameter). Safety analysis showed no significant difference in the incidence of adverse events between groups (18.85% vs 28.05%, P = 0.059). CONCLUSION:HHRY can improve dysmenorrhea, chronic pelvic pain, and quality of life in patients with endometriosis. It has a good overall safety profile, and a 3-month treatment can maintain its effects for at least 3 months after the last dose. HHRY may be considered as a new therapeutic option for treating endometriosis-related dysmenorrhea. TRIAL REGISTRATION:Trial registration at ClinicalTrials.gov with registration number: NCT04942015. Please cite this article as: Han M, Liang XF, Gao J, Wang Y, Cao LX, Wang BJ, Wang Y, Zerang Z, Liu JP, Du HL. Honghua Ruyi Pill, a compound herbal medicine, improves endometriosis-related dysmenorrhea: A multicenter randomized, double-blind, placebo-controlled trial. J Integr Med. 2026; 24(2):182-191.
OBJECTIVE: To update the current best evidence on the effectiveness and safety of cupping therapy in pain management. METHODS: The protocol of this systematic review was registered at PROSPERO(CRD42021261308). An updated literature searching in 7 databases was conducted from January 2014 to January 2023. Two authors extracted data and assessed the risk of bias independently. Statistical analysis was performed using RevMan 5.4.1 software(Cochrane Collaboration, London, UK). Meta-analysis with a random effect model was conducted when there was no serious statistical heterogeneity among trials(I 2 ≤ 75%). Grading of Recommendations Assessment, Development, and Evaluation was also conducted to assess the quality of evidence. RESULTS: Seventy-two trials with 5720 participants were included. All included trials were assessed as having high risk of bias. The majority of the included trials reported the benefit of cupping plus other therapy or cupping alone on improving cure rate(average risk ratio more than 1.15) and reducing visual analogue scale [average mean difference(MD) reduction 0.16 to 7.0 cm], improving quality of life, quality of sleep or other symptoms related to pain condition. And there was low/very low quality evidence that the incidence of adverse events in the cupping groups were lower than that in the control groups. Although the heterogeneity between studies and the methodological quality of the study itself lead to the low evidence strength of the current conclusions, the results of this study are a valuable supplement to the founding of previous review. CONCLUSION: Cupping therapy alone or combined with other therapy was considered benefit in relieving pain, improving the quality of life, and increasing the cure rate of patients with pain conditions, though supported by the low quality of evidence. According to the limited evidence, cupping therapy seems to have less harm than drugs when treating pain conditions.
Introduction: Vaginitis is an inflammatory condition of the female reproductive tract influenced by multiple factors, including hormone levels, lifestyle habits, and individual predispositions. In Traditional Chinese Medicine (TCM) theory, different constitution types can influence the onset and progression of vaginitis, as they determine an individual's internal balance of Yin and Yang, Qi, and Blood. This study aims to explore the correlation between lifestyle factors, TCM constitution types, and vaginal microecological abnormalities. Methods: A case-control study was conducted at the Third Affiliated Hospital of Beijing University of Chinese Medicine between August and October 2024, involving women aged 18-45 with a history of sexual activity. The exposure variables encompassed age, lifestyle habits, and TCM constitution types, while the outcome variable focused on vaginal microecological abnormalities. Associations were assessed using logistic regression and Least Absolute Shrinkage and Selection Operator (LASSO) regression, with results reported as odds ratios (ORs) and 95 % confidence intervals (CIs). Results: This study identified several significant risk factors for vaginal microecological imbalance. Univariate analysis showed differences between the abnormal (n = 334) and normal groups (n = 111) in reproductive infection score, sedentary hours, meat and dessert consumption, and TCM constitution types. Multivariate logistic regression confirmed reproductive infection score (OR = 1.2454, P < 0.0001) and sedentary hours (OR = 1.3501, P = 0.0002) as key contributors, with meat consumption nearly doubling the risk (OR = 1.9941, P = 0.0230). Additionally, dampness-heat constitution (DHC) (OR = 6.6673, P = 0.0212) and qi-deficiency constitution (QDC) (OR = 3.9269, P = 0.0420) were associated with significantly higher risks of abnormal vaginal flora. LASSO regression analysis further emphasized the critical roles of reproductive infection score and sedentary hours in driving microecological imbalance. Conclusion: Reproductive infection score and sedentary hours are significant contributors to vaginal microecological imbalance, while dietary habits and TCM constitution types, such as DHC and QDC, further influence the risk. These results provide valuable insights into the multifactorial nature of vaginal microecology and suggest that addressing these factors could improve preventive care and management.
BACKGROUND:This study comprehensively analyzes the diagnostic criteria, eradication indications, treatment, and other information in the latest guidelines published by various countries around the world, so that researchers can have a systematic understanding of Helicobacter pylori and further provide a basis for clinical H. pylori diagnosis and treatment. METHODS:Nine online databases were searched to find the latest version of guidelines for H. pylori worldwide. Two researchers read the included guidelines independently and extracted the eradication indications, diagnostic criteria, and treatment in the guidelines, conducting a summary of them. RESULTS:A total of 25 guidelines or consensus were included. Among all diagnostic methods for H. pylori infection, the urea breath test is widely recommended as the first choice. A total of 20 guidelines mentioned indications for H. pylori eradication. Among them, the indications with a higher proportion of recommendations were long-term use of non-steroidal anti-inflammatory drugs (including low-dose aspirin) in 90% of patients with peptic ulcer history or active peptic ulcer disease 80%; gastric mucosa-associated lymphoid tissue (MALT) lymphoma 75%. It is worth mentioning that 40% of the guidelines pointed out that, as long as H. pylori infection is confirmed, it should be eradicated. A total of 24 guidelines mentioned treatment for H. pylori. Among them, bismuth quadruple therapy (a combination of a bismuth, two antibiotics, and a proton pump inhibitor (PPI)) was the most recommended first-line therapy. Levofloxacin triple therapy (a combining of a bismuth, an antibiotic, and a PPI) was the most recommended second-line therapy. CONCLUSION:Current global Helicobacter pylori management guidelines share foundational consensus, yet exhibit regional variations in diagnostic criteria, eradication indications, and therapeutic regimens due to context-specific epidemiological, socioeconomic, and antimicrobial resistance profiles. Clinical practice should prioritize regionally tailored approaches, integrating local guidelines while maintaining awareness of international recommendations to optimize decision-making. Moreover, health authorities responsible for guideline development must ensure timely updates based on dynamic surveillance of local resistance patterns and socioeconomic realities.
OBJECTIVE: To explore the association between adjuvant therapy with Traditional Chinese Medicine (TCM) and glycemic control in patients with type 2 diabetes mellitus (T2DM) in the real world. METHODS: In this retrospective cohort study, we consecutively collected medical records of T2DM patients enrolled in the Metabolic Management Center (MMC) from October 2021 to April 2024. Patients were divided into two groups based on the presence or absence of a TCM prescription within 6 months after enrollment in MMC management. Propensity score matching (PSM) was used to balance the differences in covariates between the two groups. The independent efficacy of adjuvant TCM therapy on glycemic control was assessed by univariate and multivariate logistic regression, and then further determined by subgroup analysis. RESULTS: Atotal of 580 patients were included, with 441 patients (76.0%) receiving TCM treatment. Before PSM, multivariable logistic regression revealed that adjuvant TCM therapy was significantly associated with a lower incidence of poor glycemic control [odds ratio (OR) = 0.47, 95% confidence interval (CI) (0.30, 0.73)]. After PSM, weighted regression analysis further confirmed this inverse association [OR = 0.60; 95% CI (0.39, 0.92)]. In addition, patients treated with Chinese herbal medicine (CHM) alone [OR = 0.45; 95% CI (0.27, 0.75)], non-drug therapy (NDT) alone [OR = 0.56; 95% CI (0.32, 0.99)], and CHM + NDT [OR = 0.43; 95% CI (0.25, 0.74)] all exhibited a reduced incidence of poor glycemic control compared with those who did not receive TCM treatment. CONCLUSION: The adjuvant TCM therapy is beneficial for achieving optimal glycemic control, suggesting that adjuvant TCM therapy may be embraced as a viable glycemic management approach for T2DM patients with poor glycemic control.
Introduction: Stress urinary incontinence (SUI) is an involuntary loss of urine on physical exertion, sneezing, or coughing. Acupuncture, a worldwide accepted traditional and complementary medicine, has been widely used in China to treat SUI. This review aims to evaluate the effectiveness and safety of acupuncture for women with SUI. Methods: The protocol was registered in PROSPERO (CRD42022361059) and this systematic review (SR) was funded by the National Administration of Traditional Chinese Medicine. Databases including China National Knowledge Infrastructure, Wanfang Database, Chinese Scientific Journal Database, SinoMed, Web of Science, PubMed, The Cochrane Library, and Embase were searched from their inception to October 2023, for relevant randomised controlled trials (RCTs) on the treatment of acupuncture with/without pelvic floor muscle training (PFMT). Study screening and data extraction were carried out independently by two authors. Methodological quality was evaluated using the Cochrane's risk of bias (RoB) tool 2.0. Meta-analysis was performed by RevMan 5.3.5. Results: A total of 31 RCTs with 2885 patients were included in this SR. The results showed that the combination of acupuncture with PFMT had a better effect than PFMT only in decreasing urine leakage (RR = -1.87, 95 % CI [-2.24, -1.49], 13 studies, 956 patients) and Incontinence Questionnaire Short Form (ICI-Q-SF) scores (RR = -2.26, 95 % CI [-2.64, -1.88], 14 studies, 1015 patients) in women with SUI. Acupuncture compared with sham acupuncture demonstrated improvements in urinary leakage (RR = -4.22, 95 % CI [-5.52, -2.93], 5 studies, 286 patients), and ICI-Q-SF scores with MD and 95 % CI of -3.88(-4.59, -3.17), -8.71(-10.85, -6.57), and -3.10(-3.38, -2.82), respectively. Subgroup analyses of manual acupuncture or electroacupuncture and duration of PFMT treatment can appropriately reduce heterogeneity. For the Egger's test of 1-h pad leakage and of ICI-Q-SF scores, suggesting that there was a small possibility of publication bias in this SR (p = 0.1257 and p = 0.8058, respectively). Adverse events appeared in 12 participants in the acupuncture group and 9 in the sham group. (relative risk = 1.33, 95 % CI = [0.56, 3.15], P = 0.70). The quality of RCTs included in this review was generally poor. Conclusion: Acupuncture has potential in the treatment of SUI in women, and no significant adverse events were reported. However, considering issues with the methodological quality of the included studies, the reliability of this review conclusion may be affected to a certain extent.
Objectives To assess the therapeutic effects and safety of Tongxie Yaofang (TXYF) granules vs placebo as an alternative treatment for diarrhoea-predominant irritable bowel syndrome (IBS-D). We hypothesised that TXYF would improve clinical responses among patients with IBS-D.Design A randomised, double-blind, placebo-controlled, phase II, superiority trial.Setting Outpatients attending the Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, China.Participants 96 eligible participants included men and women ranging from late adolescence to middle adulthood (18–65 years), diagnosed with IBS-D according to the Rome IV criteria. In addition, they were required to have an irritable bowel syndrome symptom severity score (IBS-SSS) of at least 75.Interventions TXYF granules (3.7 g) twice daily (taken orally before meals) or placebo for 8 weeks.Primary and secondary outcomes The primary outcome was the response rate measured by the change in IBS-SSS compared with baseline at week 8. Secondary outcomes included stool frequency; stool consistency at weeks 4, 8 and 20; and quality of life, anxiety and depression at week 8; and safety was monitored throughout the trial.Results The TXYF and placebo groups each comprised 48 participants. The response rate was not significantly different at week 8 between the two groups (the unadjusted treatment effect estimate (intention-to-treat analysis) was 1.12 (95% CI (0.89, 1.41)), p=0.348). Both groups had a high and similar rate of symptom reduction (79.2% (38/48) vs 70.8% (34/48)). There were no statistically significant differences between the two groups on secondary outcomes, although both groups showed substantial improvements. Adverse events in the TXYF and placebo groups were one (sinus arrhythmia) and two (elevated transaminases, weakly positive faecal occult blood), respectively. No serious adverse events occurred.Conclusions Despite showing clinically meaningful improvements in IBS-D symptoms and a reasonable safety profile after 8 weeks, no significant differences were observed between the TXYF and placebo groups. This suggests that the severity of IBS-D symptoms in both treatment arms might have decreased over time, regardless of the treatment, and highlights the need to investigate the relationship between IBS-D and patient psychology. Future large-scale, rigorously designed trials with longer treatment and follow-up periods are essential to evaluate the therapeutic effects and safety of TXYF, and to explore the psychological factors.Trial registration number ISRCTN12453166.
BackgroundCurrently, quadruple therapy is unanimously recommended as the current first-line treatment option for Helicobacter pylori (H. Pylori) eradication. However, the drug composition of quadruple therapy is very complex, and the efficacy and safety between them is not clear.AimsTo compare the efficacy and safety of H. Pylori eradication regimens, which were recommended by the Fifth Consensus of China, by network meta-analysis.MethodsLiterature databases were used to retrieve clinical randomized controlled trials of H. Pylori eradication. Network meta-analysis was performed using BUGSnet and meta package of R software, using OR values as effect size, and SUCRA was used to rank the efficacy of interventions under each outcome.ResultsA total of 55 studies and 130 arms were included. The NMA analysis found that the top regimen in term of eradication rate outcome was: Rabeprazole + Bismuth + Furazolidone + Tetracycline (SUCRA, 97.5). In terms of safety outcomes: Lansoprazole + Bismuth + Amoxycillin + Clarithromycin (SUCRA, 91.97).ConclusionsThe bismuth quadruple therapies recommended by the guidelines for the treatment of H. Pylori have good performance in terms of four-week eradication rate and safety outcome indicators, and due to the different resistance of antibiotics in different regional populations, rational use of drugs should be combined with local conditions.