Non-pharmacological pain management approaches, including acupoint hot compress, may provide valuable support for women dealing with pain during the latent stage of labor, but the evidence supporting this effect is limited. We investigated whether acupoint hot compress reduced labor pain among primiparous parturients with planned vaginal delivery. We conducted a randomized controlled trial (RCT) at nine obstetric centers across China. Primiparous women aged 20–34 years, at 37–41 weeks’ gestation with singletons and with planned vaginal delivery, were randomly assigned (1:1) to receive standard obstetrical care with acupoint hot-compress therapy or standard obstetrical care alone. The acupoint hotcompress therapy, involving the medial malleolar, plantar, and lumbosacral regions, was provided for parturients in the latent phase of the first stage of labor at (42±2) °C for 4 h, starting 1 h after the onset of regular uterine contractions. The primary outcome measured was labor pain at 3 and 5 h after the onset of regular uterine contractions, with labor pain at 1 h used as the baseline. Pain intensity was assessed using the visual analog scale (VAS) and expressed as no pain (0), mild pain (range 1–3), moderate pain (range 4–6), or severe pain (range 7–10). The secondary outcomes were the durations of the first, second, and third stages of labor, maternal blood loss quantified at 0 and 2 h postpartum, and depression symptoms identified using the Edinburgh postnatal depression scale (EPDS) within 48 h postpartum, as well as newborn Apgar scores. All statistical analyses were based on the modified intention-to-treat (ITT) population. Between April 2024 and May 2025, 580 women were randomly assigned to the acupoint hot-compress intervention group and the standard-care control group. Of the 564 women included in the modified ITT population, baseline characteristics were comparable between the two groups, with the exception of baseline labor pain. Compared with parturients in the control group, those in the intervention group who underwent acupoint hot compress from the latent phase of the first stage had reduced labor-pain intensity (3 h: odds ratio [OR]=0.46, 95
Background:Traditional medicines can contribute to achieving universal health coverage, particularly in low- and middle-income countries where access to conventional treatments is limited. International collaboration is crucial to bridge the lag in modernised research and promote access to traditional medicines. This study focused on China's global collaborative research and development (R&D) efforts on traditional medicine, in the hope of improving global recognition for traditional medicine. Methods:We conducted a cross-sectional study to analyse collaborative R&D outputs on Chinese patent medicines from 1996 to 2022. The study cohort included the collaborative outputs of scientific research, patent applications, and clinical trials between China and other countries. We analysed the outputs using data from the Web of Science, Worldwide Patent Statistical Database, and the International Clinical Trials Registry Platform. The Zero Inflated Negative Binomial regression model was employed to investigate the association between outputs and the characteristics of participating countries. Results:The majority of collaborative outputs (n = 964, 92.4%) originated from collaborations with high-income countries, with only 7.6% involving low- and middle- income countries (LMICs). The percentage of R&D collaborations with LMICs showed an increasing trend from 0% in 1996 to 11.7% in 2022. Most collaborations focused on non-communicable diseases (n = 912, 87.4%). Low-income countries accounted for a larger share of collaborative R&D on communicable diseases (14.3%) compared with high-income countries (1.4%). The total number of outputs was positively associated with the degree of cooperative institutionalisation and the collaborator's traditional medicine development score. Conclusions:Gaps still remain in the involvement of low- and middle-income members compared with high income countries. Findings highlight the importance of encouraging greater engagement of low- and middle- income countries in global R & D collaboration on traditional medicine, particularly through South-South partnerships. Such collaborations should prioritise research agendas that address local health priorities, especially those related to communicable diseases.
Acupuncture (AT) has accumulated an extensive clinical evidence base, yet its efficacy remains controversial, partly because of sham acupuncture in randomized controlled trials testing the specific effects of acupuncture. The aim of this overview is to critically review the assumption that sham acupuncture is inert, examine the methodological implications of sham needle design, and evaluate whether the sham needling points affects clinical outcomes. We argue that sham acupuncture cannot be considered a valid placebo treatment because it activates the somatosensory system through tactile stimulation, which is a component of the mechanism of acupuncture. We also discuss evidence showing that the use of sham-devices in the sham and verum arms of acupuncture trials results in a suboptimal representation of verum acupuncture as practiced clinically. Meanwhile, the location of the points selected for sham acupuncture is highly relevant. Comparisons across multiple clinical conditions show no significant difference between ‘verum acupuncture and sham needling at real acupuncture points’ [Sham AT (verum)], however sham AT (verum) produces significantly greater pain relief than ‘sham needling at non-acupoints’ [Sham AT (sham)] in chronic low back pain. The reporting quality of sham needle characteristics has not improved over time, which presents an obstacle to the full understanding of sham interventions. We conclude that sham acupuncture is an active intervention that leads to underestimation of acupuncture efficacy. Researchers should carefully consider control design, adhere to the ACURATE reporting guideline, and interpret the results of sham-controlled trials appropriately.
Acupoint specificity is a central concept in traditional acupuncture theory but remains controversial in modern scientific studies. Methodological inconsistencies and a predominant reliance on single-dissociation approaches have contributed to this uncertainty. Therefore, we propose a double-dissociation research framework designed to rigorously test the functional specificity of two commonly used acupoints. This model applies doubledissociation methodology to provide stronger causal inferences regarding acupoint-specific effects, where dissociation refers to a pattern in which each acupoint preferentially modulates one physiological domain relative to another. The framework contrasts two theoretically distinct acupoints, PC6 and ST36, with respect to two physiological outcome domains that are hypothesized to be functionally dissociable. In particular, PC6 is predicted to selectively influence cardiovascular measures, such as blood pressure, whereas ST36 is predicted to selectively influence gastric function. Within this framework, a double dissociation would be demonstrated if PC6 produces greater changes in cardiovascular measures than in gastric indices, whereas ST36 produces greater changes in gastric indices than in cardiovascular measures. Evidence of such crossed selectivity would provide support for functional acupoint specificity. The proposed double-dissociation paradigm can be extended to other clinically relevant acupoints and acupoint combinations, and this proof-of-concept article is aimed at stimulating future empirical studies that formally test acupoint-specific effects using such designs. Demonstrating this crossed selectivity-where each acupoint predominantly affects only its predicted outcome-would provide stronger evidence for the functional specialization of acupuncture points. This methodological approach aims to align acupuncture research more closely with contemporary scientific standards.
Background This study evaluated the robustness of real-world data (RWD)–based observational studies of acupuncture to unmeasured confounding using the E-value as a quantitative index. We examined how data source, exposure specification, and methodological characteristics influence robustness across published literature. Methods A systematic MEDLINE search identified observational RWD studies of acupuncture (2000–2025) reporting effect estimates with confidence intervals. Minimum E-values were computed to quantify the strength of unmeasured confounding needed to nullify observed associations. Study-level variables—including country, data source, disease category, treatment parameters, and analytic methods—were extracted. Group comparisons used nonparametric tests, while segmented temporal regression and ordinary least squares (OLS) meta-regression identified determinants of robustness. Results Sixty-five studies met inclusion criteria, mainly using national insurance claims and medical records. Mean minimum E-values ranged from 1.2 to 2.9. Although no continuous temporal trend was observed (Spearman’s ρ = −0.07, p = 0.60), segmented regression revealed a structural break at 2021, showing gradual improvement until 2021 followed by a marked decline. In OLS models, higher minimum session counts were inversely associated with E-values (p = 0.037), suggesting potential selection bias from longer exposures. Studies using electronic medical records were more robust than claims-based studies, and specification of treatment initiation increased robustness. Propensity score methods were not significantly associated with E-values. Conclusion Robustness of acupuncture RWD studies depends more on data richness and exposure definition than analytic complexity. Post-2021 declines highlight the need for standardized exposure definitions, data integration, and design-based control strategies to strengthen causal validity in nonpharmacological RWD research.
Background Evidence regarding the effectiveness of acupuncture for cancer-related fatigue (CRF) in breast cancer survivors (BCS) remains inconsistent, warranting large pragmatic randomized controlled trials (RCTs). Methods The AcuBreast trial was a pragmatic, two-arm RCT comparing acupuncture plus usual care versus usual care alone. Inclusion criteria required CRF lasting 6 months post-treatment, written informed consent, and sufficient Norwegian proficiency. Exclusion criteria included conditions known to contribute to fatigue, ongoing acupuncture, pregnancy, and bleeding disorders. The acupuncture group received 10–12 treatments over 8–12 weeks alongside usual care. Control group received usual care only. The primary outcome was CRF measured by the Chalder Fatigue Questionnaire (CFQ14/11). Secondary outcomes included fatigue severity (FSS), adverse events, and quality-adjusted life years (QALYs). Results Of 221 randomized survivors (acupuncture n=112, control n=109; mean age 52.5 years [SD=8.9]), retention at 3 months was 106 versus 85, and at 6 months was 102 versus 83. At 3 months, CFQ14 scores were significantly lower in the acupuncture group (mean difference: −6.9, 95% CI: −8.8 to −4.9, p0.001), sustained at 6 months (−3.5, 95% CI: −5.5 to −1.6, p0.001). FSS scores were also significantly lower at 3 months (−4.2, 95% CI: −7.2 to −1.3, p=0.005) and 6 months (−4.2, 95% CI: −7.1 to −1.2, p=0.006). Adverse events were mild and self-limiting. Conclusions Acupuncture significantly reduces CRF in BCS with effect sizes exceeding minimal clinically important differences for both CFQ14/11 and FSS. Treatment is safe with only mild, transient adverse events. Trial registration ClinicalTrials.gov Identifier: NCT04418115.
OBJECTIVES:To evaluate the status and methodological quality of randomized controlled trials published in 2024 on Chinese patent medicines and Classic Traditional Chinese Medicine Prescriptions, providing evidence for clinical practice and policy. METHODS:We systematically searched multiple Chinese and English databases and trial registries for randomized controlled trials (RCTs) on Chinese patent medicines (CPMs) and Classic Traditional Chinese Medicine Prescriptions (CTCMPs) published in 2024. Two researchers independently screened studies, extracted data, and assessed methodological quality using the Cochrane RoB tool. Inter-rater reliability was evaluated using Kappa statistics and intraclass correlation coefficient. Spearman's correlation and Wilcoxon rank-sum tests were performed to analyze factors influencing methodological quality. RESULTS:In 2024, 1874 RCTs were included (1550 CPM, 324 CTCMP). Circulatory and digestive diseases predominated in CPM and CTCMP studies, respectively. Two-arm "Chinese medicine plus Western medicine" designs were mainstream. CPM RCTs favored physical/chemical outcomes, while CTCMP RCTs prioritized symptoms/signs outcomes; 169 patient-reported outcomes were identified. Most studies had small samples (100 cases) and were single-center. Methodological quality revealed adequate randomization but serious deficiencies in allocation concealment and blinding. Ethics approval (CPM≈68.5%, CTCMP≈61.1%) and trial registration (CPM≈3.8%, CTCMP≈0.9%) were suboptimal. Funding, higher journal IF, and multicenter design were positively associated with ROB scores. CONCLUSIONS:This evidence mapping reveals a significant disconnect between the quantity and quality of randomized controlled trials in Traditional Chinese Medicine. Persistent methodological weaknesses undermine evidence reliability. Future research should prioritize methodological rigor, adequate statistical power, and prospective trial registration. There is an urgent need to develop a dedicated evaluation framework that captures both methodological quality and clinical value.
BackgroundBreast cancer remains the most commonly diagnosed malignancy in women worldwide. While the use of herbal medicine as a complementary approach has expanded, the existing literature is highly heterogeneous, and a comprehensive overview mapping the research landscape is lacking.ObjectiveThis evidence map identifies the evidence and research gaps in herbal medicine for breast cancer.MethodsTen electronic databases were systematically searched from inception to 30 April 2025. Systematic reviews (SRs) and meta-analyses of randomized controlled trials (RCTs) evaluating herbal medicine for breast cancer patients were included. Two reviewers independently screened the literature, selected eligible studies, and extracted data, and the methodological quality of the included reviews was assessed using AMSTAR 2. The included SRs were stratified into two groups based on the timing of herbal medicine administration (“Undergoing treatment” and “Mixed / Both phase”) and visualized as a bubble chart using custom HTML5 and Scalable Vector Graphics (SVG) code, developed with the assistance of Claude (Claude sonnet 4.6, Anthropic). In this map, the treatment phase and clinical condition are plotted on the x-axis and 12 predefined outcome domains on the y-axis, with bubble color indicating the direction of effect, and bubble size representing the number of SRs.ResultsA total of 31 SRs were included, published between 2012 and 2025. The included reviews were more concentrated in the “Undergoing treatment” phase (n = 27) than in the “Mixed / Both phase” (n = 4). Most SRs addressed non-symptom-specific chemotherapy outcomes (n = 13), followed by menopausal-like symptoms (n = 4), with predominantly positive findings. According to AMSTAR 2, 28 SRs (90.3%) were rated as “Critically Low” quality and 3 SRs (9.7%) as “Low” quality, with critical deficits in protocol registration and risk of bias consideration.ConclusionThis evidence map provides the first comprehensive visual overview of SRs on herbal medicine for breast cancer. While clustering around treatment-related symptom management, the methodological quality is consistently low. Future research must prioritize high-quality trials in under-investigated domains and long-term, patient-centered outcomes, using standardized protocols and rigorous adherence to international reporting guidelines.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD420261330650, identifier CRD420261330650.
Abstract Background Generative artificial intelligence (GenAI) chatbots have shown utility in assisting with various research tasks. Traditional, complementary, and integrative medicine (TCIM) is a patient-centric approach that emphasizes holistic well-being. The integration of TCIM and GenAI presents numerous key opportunities. However, TCIM researchers’ attitudes toward GenAI tools remain less understood. This large-scale, international cross-sectional survey aimed to elucidate the attitudes and perceptions of TCIM researchers regarding the use of GenAI chatbots in the scientific process. Methods A search strategy in Ovid MEDLINE identified corresponding authors who were TCIM researchers. Eligible authors were invited to complete an anonymous online survey administered via SurveyMonkey. The survey included questions on socio-demographic characteristics, familiarity with GenAI chatbots, and perceived benefits and challenges of using GenAI chatbots. Results were analysed using descriptive statistics and thematic content analysis. Results The survey received 716 responses. Most respondents reported familiarity with GenAI chatbots (58.08%) and viewed them as very important to the future of scientific research (54.37%). The most acknowledged benefits included workload reduction (74.07%) and increased efficiency in data analysis/experimentation (71.14%). The most frequently reported challenges involved bias, errors, and limitations. More than half of the respondents (57.02%) expressed a need for training to use GenAI chatbots in the scientific process, alongside an interest in receiving training (72.07%). However, 43.67% indicated that their institutions did not offer these programs. Conclusion By developing a deeper understanding of TCIM researchers’ perspectives, future AI applications in this field can be more informed, and guide future policies and collaboration among researchers.
Background:Gastroesophageal reflux disease (GERD) may present as chronic cough, known as GERD-related chronic cough (GERC). Conventional treatment, including proton pump inhibitors, is often suboptimal. Acupuncture has been proposed as a complementary therapy, however, its clinical effectiveness for GERC remains unclear. This study aimed to evaluate the efficacy and safety of acupuncture-related therapies for GERC. Methods:We systematically searched 11 international and regional databases up to June 2025 for randomized controlled trials (RCTs) on acupuncture for GERC. Primary outcomes were daytime and nighttime cough symptom scores; secondary outcomes included the Leicester Cough Questionnaire (LCQ) score and total effective rate (TER). A random-effects model was used for meta-analysis. Risk of bias was assessed with RoB 2, and certainty of evidence with GRADE. Results:Five RCTs involving 390 participants were identified. Compared with Western medicine alone, acupuncture significantly reduced daytime (MD = -0.41, 95% CI [-0.75, -0.07]) and nighttime cough scores (MD = -0.38, 95% CI [-0.59, -0.17]). LCQ scores improved (MD = 2.29, 95% CI [1.99, 2.60], p < 0.00001), and TER was higher in the acupuncture group (RR = 1.13, 95% CI [1.01, 1.27]). No serious adverse events were reported. The overall risk of bias was moderate, mainly due to blinding and allocation limitations. Conclusion:Acupuncture may be a safe and effective complementary therapy for GERC, improving cough symptoms and quality of life. However, the current evidence is limited; larger, high-quality RCTs with standardized protocols are warranted. Systematic review registration:https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=627037, Identifier CRD42024627037.
Background Artificial intelligence chatbots (AICs) are increasingly being integrated into scholarly publishing, with the potential to automate routine editorial tasks and streamline workflows. In traditional, complementary, and integrative medicine (TCIM) publishing, editorial and peer review processes can be particularly complex due to diverse methodologies and culturally embedded knowledge systems, presenting unique opportunities and challenges for AIC adoption. Methods An anonymous, online cross-sectional survey was distributed to the editorial board members of 115 TCIM journals. The survey assessed familiarity and current use of AICs, perceived benefits and challenges, ethical concerns, and anticipated future roles in editorial workflows. Results Of 5119 invitations, 217 eligible participants completed the survey. While approximately 70% of respondents reported familiarity with AI tools, over 60% had never used AICs for editorial tasks. Editors expressed strongest support for text-focused applications, such as grammar and language checks (81.0%) and plagiarism/ethical screening (67.4%). Most respondents (82.8%) believed that AICs would be important or very important to the future of scholarly publishing; however, the majority (65.3%) reported that their journals lacked AI-specific policies and training programs to guide editors and peer reviewers. Conclusions Most TCIM editors believe that AICs have potential to support routine editorial functions but also have limited adoption into editorial and peer review processes due to practical, ethical, and institutional barriers. Additional training and guidance are warranted by journals to direct responsible and ethical use if AICs are to be adopted in TCIM academic publishing.
Existing reporting checklists lack the specificity and comprehensiveness required to effectively guide the documentation of acupuncture case reports. Therefore, we developed a reporting guideline tailored specifically for acupuncture case reports, building upon the CAse REport (CARE) statement. A multidisciplinary group of international experts including clinicians, researchers and methodologists was convened to draft the initial checklist in accordance with the methodology recommended by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network. Through an extensive literature review and a series of expert interviews, the final CARE for acupuncture checklist comprised of 30 items. 38 experts from diverse disciplines participated in three rounds of modified Delphi surveys to refine and clarify these items. CARE for acupuncture is a comprehensive reporting guideline focused on acupuncture case reports developed with rigorous methodology. We hope that CARE for acupuncture will further guide authors, editors, peer reviewers and readers to enhance the transparency, completeness and accuracy of reporting of case reports in acupuncture.
BACKGROUND:Alopecia areata (AA) is characterized by hair loss triggered by an autoimmune response that leads to emotional distress and a poor quality of life. However, conventional treatments may also have potential side effects. Therefore, traditional medicine methods such as acupuncture are emerging as alternative treatments for AA, with recent evidence suggesting their effectiveness and prompting further research to assess their safety and efficacy. METHODS:This systematic review aimed to evaluate the current evidence regarding AA treatment using acupuncture. We searched 13 databases until December 2024 for studies that compared the efficacy of acupuncture and Western medicine in treating AA. The present review solely targeted randomized controlled trials (RCTs). The risk of bias was assessed using the Risk of Bias tool (ROB), whereas the quality of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. RESULTS:Eleven RCTs with 1144 participants were included in this review. The included studies had an unclear risk of bias in most domains. Among these, 7 RCTs tested the total treatment effects of combining plum-blossom needling with western medicine compared with western medicine alone. The results revealed that combining plum-blossom needling with western medicine resulted in a higher rate of improved symptoms than using western medicine alone (RR 1.09, 95% CI 1.03-1.16, I2 = 50%, P = .005, 7 RCTs, 756 participants, low certainty of evidence). CONCLUSION:This review provides evidence for the benefits of acupuncture in AA treatment. However, the quality of the evidence was low, and the sample size was small. Therefore, future large-scale studies should be conducted using more rigorous methodologies.
Mixed methods research provides a valuable opportunity to deepen our understanding of phenomena. However, practical guidance on using the method to develop methodological models in clinical practice guidelines (CPGs) field is limited. This article illustrates the use of exploratory sequential mixed methods design to develop a methodological model to standardize the formation of good practice recommendation (GPR) within CPGs in the context of weak evidence or no evidence. It demonstrates how qualitative and quantitative data can be systematically integrated throughout the model construction and validation. The GPR methodological model includes three main themes: connotation , procedure and methods , and reporting guideline . It assists CPGs developers in GPR formulation, aligns researchers’ methodological understanding of GPR, and informs future GPR methodological development.
ObjectiveNumerous systematic reviews (SRs) and meta-analyses (MAs) have investigated the clinical effectiveness of acupuncture therapy (AT) for fibromyalgia syndrome (FMS); however, the quality and consistency of the evidence remain unclear. This study aimed to evaluate the methodological quality and strength of evidence in published SRs and MAs on the efficacy and safety of AT for FMS.MethodsA comprehensive literature search was conducted in 11 databases up to May 2025. Two reviewers independently selected studies, extracted data, and assessed methodological quality using A MeaSurement Tool to Assess systematic Reviews-2 (AMSTAR-2), reporting quality via Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 and certainty of evidence with Grading of Recommendations Assessment, Development, and Evaluation (GRADE).ResultsThirteen SRs and MAs were included. According to AMSTAR-2, only one SR and MA was rated high quality, three were moderate, and eight were low or critically low, respectively. Following the PRISMA guidelines, five SRs demonstrated compliance >85%. No high-quality evidence with GRADE assessment was found. The overall quality of evidence in the included SRs ranged from “very low” to “moderate.” AT was found to be superior to sham AT or standard pharmacological therapies (SPT) in treating FMS and pain. Evidence from 10 SRs (collectively reporting on 63 outcomes) indicated that AT provided superior pain relief than sham AT or SPT. AT was more effective than sham AT (Visual Analog Scale; mean difference [MD] −1.04 [−1.70, −0.38], p = 0.002) and SPT (MD −1.77 [−2.10, −1.44], p < 0.00001) in reducing pain. It also showed significantly better long-term pain relief (standard mean difference [SMD] 0.40 [−0.77, −0.03], p = 0.03), lower Fibromyalgia Impact Questionnaire scores (SMD −0.69 [−0.91, −0.47], p < 0.00001), reduced fatigue (SMD −0.03 [−0.42, 0.35], p = 0.87), reduced number of tender points (SMD −2.38 [−3.40, −1.37], p < 0.00001), and increased pain pressure threshold (SMD 0.31 [0.02, 0.61], p = 0.04). No adverse effects attributed to AT were reported.ConclusionThe current SRs and MAs provide low-quality evidence for the effectiveness of AT in treating FMS. Robust and well-designed studies using standardized methods are needed to provide more reliable and convincing evidence.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD42024536968, Identifier CRD42024536968.
[This corrects the article DOI: 10.3389/fphar.2025.1501634.].