Noninfectious inflammatory diseases (NIDs), including neurological, cardiovascular, autoimmune and metabolic diseases, impose a heavy burden on the global medical system. Currently, the main drugs used in the treatment of NIDs are nonsteroidal anti-inflammatory drugs and glucocorticoids, which can alleviate the symptoms but are often accompanied by serious adverse effects. In contrast, active components of herbal medicine provide a new option for the treatment of NIDs because of their multi-targeting properties and low toxicity. With the complexity of inflammatory responses, the cholinergic anti-inflammatory pathway (CAP) can be a potential therapeutic pathway for NIDs. This review aims to elucidate the mechanisms by which the active components, extracts and formulas of Chinese herbal medicines modulate CAP for the treatment of NIDs. These therapeutic effects can be achieved by regulating key targets in the CAP, including the α7 nicotinic acetylcholine receptor, choline acetyltransferase, acetylcholinesterase and downstream signaling. These findings provide valuable hints for the development of new potential drugs targeting NIDs.Please cite this article as: Ming ST, Guo PY, Chen F, Zhang WD, Liu X. Chinese herbal medicines in the treatment of noninfectious inflammatory diseases: Cholinergic mechanisms and therapeutic potential. J Integr Med. 2026; Epub ahead of print.
We propose a conceptual and methodological approach that treats the human body as an internal geographic information system (GIS) for studying meridian-related phenomena. Instead of searching for a single anatomical substrate, we reinterpret meridians as functional networks embedded in a body-centered coordinate system, where acupoints are modeled as both discrete nodes and probabilistic three-dimensional locations. This body-based spatial platform incorporates two key constructs: reaction fields, which map stimulation-evoked responses across body space and time, and indication fields, which map the spatial distribution of clinical indications. A multilayer body GIS can integrate sensation maps, pain drawings, thermography, electrophysiology, neuroimaging and indication databases. It can then quantify clustering, anisotropy and diffusion-like propagation, and compare meridian-based partitions with dermatomes, nerve fields and indication-based zones. By integrating spatial science and network theory, this perspective shifts meridian research from ontological debates toward empirically testable questions about internal geography. It establishes a spatial foundation for interpreting traditional East Asian medical concepts, and developing shared data structures, quantitative methods and reporting standards for meridian research.Please cite this article as: Ryu Y, Chae Y. Meridian systems as spatiotemporal networks: An internal body geographic information system. J Integr Med. 2026; Epub ahead of print.
Please cite this article as: Zhu SY. Bridging the gap between syndrome differentiation advocacy and RCT practice: A reflection on the integration of Chinese and Western medicines. J Integr Med. 2026; Epub ahead of print.
OBJECTIVE:This multi-center, real-world study aimed to characterize the clinical profiles of different traditional Chinese medicine (TCM) syndromes and assess the associated treatment outcomes, including efficacy, safety, and predictive factors. METHODS:Psoriasis patients with blood-heat syndrome (BHS), blood-stasis syndrome (BSS) and non-BHS/BSS were included. Data on demographics, lifestyle, comorbidities, disease severity, and TCM constitutions were collected. Patients received syndrome-specific oral Chinese herbal medicines. Multiple linear regression identified efficacy predictors for the reduction in psoriasis area and severity index (PASI) scores at week 8. RESULTS:This study included 689 psoriasis patients with BHS, 319 with BSS, and 349 with non-BHS/BSS. BHS patients were younger and more highly educated, while BSS patients preferred spicy food, smoked more, and carried a heavier comorbidity burden. Following 8 weeks of treatment, all groups showed similar reductions in PASI scores (P = 0.07) and comparable increases in the proportion of participants with the yin-yang harmony constitution. Patients in the BSS group, however, had a superior improvement in their dermatology life quality index (DLQI) score and their visual analog scale (VAS) score for pruritus (all P < 0.05). Key predictors of PASI improvement included baseline PASI score (β = 0.59, P < 0.001), female sex (β = 0.57, P = 0.004), baseline VAS score (β = 0.11, P = 0.02) and body mass index (β = -0.08, P = 0.007), explaining 58.9% of the outcome variance (R2 = 0.589). Treatment-related adverse events occurred in only 3.54% of cases and recurrence rates at week 16 remained below 5.02%. CONCLUSION:This study has not only clarified syndrome heterogeneity and validated the treatment system but also laid the groundwork for probing into the biological underpinnings of TCM syndromes. Please cite this article as: Sun XY, Zhou YQ, Liu L, Wei L, An YP, Weng HL, Ji YR, Guo S, Zhou WL, Hu WT, Wang JF, Fang YM, Zhao YD, Li JW, Zhu KB, Hu RY, Hu SY, Hu CX, Liang N, Yang CY, Jing FY, Zhang Y, Li X, Li B. Clinical heterogeneity in psoriasis and the predictive efficacy of traditional Chinese medicine: A multi-center real-world study. J Integr Med. 2026; Epub ahead of print.
Artificial intelligence (AI) is having a profound impact on the production of medical knowledge, research paradigms, healthcare services and the health industry. Traditional Chinese medicine (TCM), a valuable part of human heritage and an important global health resource, is entering a period of historic innovation through its integration with AI. This convergence offers significant opportunities for the collation of classical literature, the inheritance of clinical experience, diagnosis and treatment, drug discovery, talent cultivation, industrial upgrading and health management. However, AI-enabled TCM is still in its infancy and faces challenges relating to theoretical compatibility, data quality, scientific evaluation, algorithmic transparency, ethical governance, standardization, interdisciplinary training and international coordination. The Hangzhou Declaration on the Global Development of Artificial Intelligence in Traditional Chinese Medicine sets out a shared position and a consensus based on principles for trustworthy innovation in this emerging field. It emphasizes preserving the essence of TCM while pursuing innovation, prioritizing clinical value and patient safety, strengthening ethical governance, improving data standards and scientific evaluation, fostering interdisciplinary collaboration, advancing international standards, bridging the digital divide, and cultivating globally competent talent. The Declaration aims to guide the responsible, open, inclusive and sustainable development of AI-enabled TCM, contributing to the health and well-being of humanity. Please cite this article as: Fan XH, Li Y, Lai XB, Zhang JH, Li HY, Hu KF, Li J, Chen JX, Pan HD, Wen CB, Ye Q, Kan HX, Li XX, Li PF, Hu Y, Chen KX, Zhang BL. Hangzhou declaration on the global development of artificial intelligence in traditional Chinese medicine. J Integr Med. 2026; Epub ahead of print.
OBJECTIVE:Periplocin, a bioactive component derived from the traditional Chinese medicinal herb Cortex periplocae, has recently emerged as a promising agent for cancer treatment. However, its mode of action, particularly in the context of multiple myeloma (MM), remains poorly characterized. This study investigates the antitumor efficacy of periplocin against MM and elucidates its underlying molecular mechanisms. METHODS:Cell viability was assessed using the cell counting kit-8 assay, while flow cytometry was used to analyze cell cycle distribution and apoptosis rates. The in vivo antitumor effect of periplocin was validated in a murine MM xenograft model. RNA sequencing (RNA-seq) analyses, network pharmacology, molecular docking and cellular thermal shift assay (CETSA) were used to identify potential targets and signaling pathways of periplocin in treating MM. The Gene Expression Profiling database was used to evaluate the correlation between candidate gene expression and survival outcomes in MM patients. A dual-luciferase reporter assay was used to evaluate transcriptional activity, and CUT&Tag polymerase chain reaction (PCR) was used to detect the effect of periplocin on the binding of signal transducer and activator of transcription 3 (STAT3) protein to the Myc proto-oncogene protein (MYC) promoter region. The protein expressions were explored via Western blotting analysis. RESULTS:Periplocin exhibited encouraging anti-MM activity in both cellular and animal models. Periplocin induced MM cell apoptosis and cell cycle blockade. Periplocin prevented the JAK2/STAT3/AKT/mTOR signaling cascade from being activated, impeding MM cell proliferation. Molecular docking and CETSA showed the interaction between periplocin and STAT3. RNA-seq analysis showed that periplocin regulated STAT3-mediated expression of MYC, whose high expression was closely related to poor prognosis in MM. Moreover, the dual-luciferase reporter assay showed that periplocin significantly suppressed STAT3 transcriptional activity. The CUT&Tag PCR results revealed that periplocin effectively inhibited the binding of STAT3 to the MYC promoter DNA region. Periplocin downregulated MYC expression. CONCLUSION:Periplocin targets STAT3, suppressing MYC expression and leading to the inhibition of MM cell proliferation; this highlights its promise as a novel treatment option for MM. Please cite this article as: Wei RF, Chen JX, Lai SP, Chen ZA, Zhou YY, Liao YP, Chen Y. Periplocin targets STAT3 to suppress MYC expression and inhibit multiple myeloma cell proliferation. J Integr Med. 2026; Epub ahead of print.
Autism spectrum disorder (ASD) is a broad neurodevelopmental disorder characterized by impairments in social communication and limited, repetitive patterns of behavior and interests. It is frequently associated with comorbidities, including gastrointestinal dysfunction, and immune and oxidative disturbances. Recent discoveries have revealed that nutritional therapies designed to target certain pathophysiological processes may serve as adjunctive treatments. Berberine is a natural isoquinoline alkaloid isolated from various medicinal herbs. It possesses anti-inflammatory and antioxidant activities and has demonstrated neuroprotective effects in preclinical models. Recent preclinical studies have shown that berberine may help modulate key pathways implicated in ASD, such as gut microbiota-brain axis, neuroinflammatory cascades, mitochondrial dysfunction and oxidative stress responses. Berberine can restore intestinal barrier integrity, suppress microglial activation, balance neurotransmitter systems, and regulate key signaling pathways including nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) and nuclear factor erythroid 2-related factor 2 (Nrf2), which is considered a plausible basis for investigating it as an adjunctive strategy for ASD-associated biological pathways. Moreover, the impact of berberine on the composition of gut microbiota may be associated with behavioral modulation and immune homeostasis. This review explores the mechanistic basis of berberine activity in ASD. Existing preclinical evidence and indirect clinical data suggest that berberine can be regarded as an adjunct intervention and a biological therapeutic approach targeting ASD-related biological pathways. However, current evidence remains preliminary and needs to be further validated in subsequent clinical studies. Please cite this article as: Rodríguez-Vera D, Soriano-Ursúa MA, Pinto-Almazán R, Arciniega-Martínez IM, Reséndiz-Albor AA, Vergara-Castañeda A, Valadez-Vega C, Morales-González Á, Madrigal-Santillán EO, García-Machorro J, Ibañez-Cervantes G, Morales-González JA. Berberine as a modulator in autism: Insights into mechanisms of action and therapeutic potential. J Integr Med. 2026; Epub ahead of print.
BACKGROUND:Yoga has gained widespread acceptance as a complementary health practice. However, adverse events related to yoga have not been systematically evaluated for the purpose of developing evidence-based safety guidelines. OBJECTIVE:This study systematically reviews published case reports and case series of yoga-associated adverse events (YAEs), categorizing their clinical features, associated yoga practices, and treatment outcomes to inform safer yoga practice. SEARCH STRATEGY:A comprehensive search was conducted in MEDLINE/PubMed, Scopus, and Web of Science from database inception through April 2025, supplemented by Google Scholar and hand-searching of reference lists. INCLUSION CRITERIA:We included peer-reviewed case reports and case series in any language with English abstracts that described one or more adverse events temporally or causally linked to yoga practice. DATA EXTRACTION AND ANALYSIS:Two authors independently screened records and extracted study identifiers, patient demographics, yoga style and technique, affected systems, management, and outcomes; a third author validated all entries, and two additional authors assessed methodological quality using the Joanna Briggs Institute checklists. RESULTS:Eighty-four adverse events from 70 studies were identified, affecting 7 physiological systems: musculo-skeletal (34 cases, 40%), ophthalmological (16, 19%), neurological (10, 12%), cardio-respiratory (12, 14%), psychiatric (6, 7%), nasopharyngeal/gastrointestinal (4, 6%) and dermatological (2, 2%). The most frequently implicated practices were headstand (sirsasana; 15 cases, 18%) and forceful pranayama (8, 10%). Bikram, Ashtanga and Hatha yoga were the styles most often reported in association with adverse events. Patients' ages ranged from 15 to 90 years, and 60% were female. Fifty-four percent had pre-existing vulnerabilities. Complete recovery occurred in 40% of cases, partial recovery in 27%, and one individual had no recovery. CONCLUSION:Although YAEs are uncommon, they can result in significant morbidity, particularly in individuals with underlying risk factors. Systematic pre-practice screening, tailored instruction, and targeted instructor training are essential to mitigate risk and promote safe yoga practice. Please cite this article as: Sharma S, Bhandari SS, Malhotra V, Kuppusamy M, Kumar S, Dhakal M. Yoga and its risks: A systematic review of adverse events reported in case reports and case series. J Integr Med. 2026; Epub ahead of print.
Essential oils have long been used in complementary medicine, and recent research has demonstrated their potential to modulate epigenetic mechanisms such as DNA methylation, histone modification and microRNA regulation. These epigenetic effects suggest that essential oils may offer novel therapeutic benefits in palliative care, which primarily focus on symptom management, improvement of quality of life, and support for emotional well-being in patients with life-limiting conditions. This review examined the epigenetic mechanisms by which key compounds in essential oils, such as curcumin, eugenol, limonene and thymoquinone, modulate gene expression and cellular pathways associated with pain, inflammation, neurodegeneration and cancer progression. Preclinical studies indicate that these compounds demonstrate the ability to modulate inflammation, reduce oxidative stress, promote neuroprotection and support immune function, making them promising adjuncts in the management of pain, cognitive decline and psychological distress. Despite these promising preclinical findings, challenges remain regarding bioavailability, optimal dosing and clinical safety. Further human studies are necessary to establish standardised protocols for using essential oils in palliative care. As research progresses, the integration of epigenetically active essential oils may provide a personalised and non-invasive approach to symptom management, thereby improving the quality of life and overall well-being of palliative care patients. Despite the promising preclinical findings, it is essential to note that clinical studies evaluating the epigenetic effects of essential oils in palliative care patients are currently lacking, underscoring the need for future research. Please cite this article as: Gonçalves SD, Diogo RG. Epigenetic modulation by essential oils: Potential applications and challenges in palliative care. J Integr Med. 2026; Epub ahead of print.
OBJECTIVE:To achieve better therapeutic effects of combining traditional Chinese medicine (TCM) with Western medicine through exploring the attitude, perception and practice of Chinese ophthalmic patients towards TCM. METHODS:A cross-sectional study was conducted through a questionnaire between July 1 and July 15, 2025, at the Department of Ophthalmology in a hospital in Shanghai. The 1000 included participants were divided into two groups based on whether they had received any TCM therapies before. Then, a 5-point Likert scale and logistic regressions were utilized to further analyze their attitude, perception and practice. RESULTS:Ophthalmic patients more than 80 years old (compared with patients aged 18-39 years; P = 0.017, odds ratio [OR] = 2.318, 95% confidence interval [CI] [1.161, 4.631]), and qualified with senior high school (compared with primary school, P = 0.017, OR = 1.711, 95% CI [1.101, 2.657]), undergraduate (compared with primary school, P < 0.001, OR = 2.124, 95% CI [1.349, 3.344]) or postgraduate (compared with primary school, P = 0.031, OR = 2.224, 95% CI [1.074, 4.608]) degrees, who would receive eye surgery (P = 0.005, OR = 1.687, 95% CI [1.176, 2.420]), and diagnosed with dry eye disease (P < 0.001, OR = 1.719, 95% CI [1.276, 2.315]) were more likely to have an experience of TCM therapies. The patient-evaluated effects of TCM therapies between groups were different (P < 0.001). Chinese ophthalmic patients are not very optimistic about TCM, but there is still great room for progress and improvement. CONCLUSION:Both TCM doctors and ophthalmologists should work on how to enhance popularization of TCM culture and promote TCM health literacy of the ophthalmic patients. In the future, the application of TCM therapies in the department of ophthalmology should be vigorously strengthened. Please cite this article as: Li S, Wang Y, Zhong M, Sun WF, Zhang R, Gao GP, Cui X, Su QY, Zou FY, Zhang M, Li N, Meng X, Wu GQ, Chu TT, Liu XN, Zhao CY. Attitude, perception and practice towards traditional Chinese medicine among Chinese ophthalmic patients: A cross-sectional study. J Integr Med. 2026; Epub ahead of print.
Artificial intelligence (AI) technology is advancing rapidly with algorithms and models for diverse applications, such as virtual disease biologist agents, target and drug discovery, and multimodal diagnosis and treatment, emerging at an increasingly rapid pace. The development and application of AI can effectively address long-standing challenges in the research and application of traditional Chinese medicine (TCM), including the difficulty of mining classic texts, insufficient standardization of diagnosis and treatment, and lengthy drug development cycles. This creates new opportunities for the development of TCM and further propels its transition from empirical medicine to precision medicine. To seize the opportunities presented by AI development, it is necessary to build a tripartite innovation system centered on "data-algorithms-computing power," to establish a research paradigm suited to the characteristics of TCM, and to achieve a deep integration of traditional wisdom with modern technology, thereby driving high-quality development of the TCM industry. Please cite this article as: Chen KX. Artificial intelligence empowers the innovation of traditional Chinese medicine. J Integr Med. 2026; 24(4):467-470.
OBJECTIVE:Post-influenza bacterial infection is associated with higher severity and mortality rates. Qingfei Paidu decoction (QFPDD) has demonstrated efficacy as an anti-inflammatory therapeutic agent specifically for influenza. However, its role in bacterial secondary infection remains unclear. This study aimed to investigate the protective effects and underlying mechanisms of QFPDD in a mouse model of post-influenza bacterial infection. METHODS:A mouse model of post-influenza bacterial infection was established to evaluate the therapeutic effects of QFPDD. QFPDD was administered prior to the full establishment of secondary bacterial infection. Body weight, body temperature, lung indexes and pulmonary bacterial load were evaluated by lung weighing and colony counting of lung tissue homogenates. Single-cell ribonucleic acid sequencing (scRNA-seq) was performed to characterize immune cell populations and cytokine expression levels in lung tissues. Neutrophil activation, neutrophil extracellular trap (NET) formation and coagulation-related markers were examined using molecular and biochemical approaches. In vitro, pam3cys-ser-lys4 (Pam3CSK4)-stimulated macrophages were used to assess cytokine production, while the expression of phagocytic receptors was evaluated in macrophages and neutrophils following Pam3CSK4 or heat-killed Staphylococcus aureus stimulation. In addition, phorbol 12-myristate 13-acetate (PMA)-stimulated neutrophils were utilized to assess the production of reactive oxygen species (ROS) and the activation of signaling pathways. RESULTS:QFPDD prevented body weight loss, reduced lung indexes, decreased lung bacterial load and alleviated hypothermia in secondary infected mice. ScRNA-seq analysis revealed decreased cytokine scores in the lungs following QFPDD treatment, with neutrophils exhibiting the highest cytokine scores among the 18 identified cell populations. QFPDD downregulated inflammatory mediators in neutrophils. Furthermore, QFPDD reduced the expression of xanthine oxidase, myeloperoxidase, citrullinated histone H3, and peptidyl arginine deiminase 4, accompanied by decreased S100 calcium-binding protein A8 and S100 calcium-binding protein A9 levels, suggesting that QFPDD can be associated with the reduced formation of NETs. QFPDD also decreased platelet activation and hypercoagulation markers. In vitro, QFPDD inhibited cytokine and chemokine production in macrophages and suppressed ROS generation and extracellular signal-regulated protein kinase phosphorylation in neutrophils. In addition, QFPDD significantly enhanced the expression of phagocytic receptors in macrophages and neutrophils. CONCLUSION:QFPDD confers protection against post-influenza bacterial infection by inhibiting the formation of NETs and cytokine storm, highlighting its potential as a candidate for further investigation in the prevention and treatment of this condition. Please cite this article as: Mu JW, Cheng T, Hu L, Lei B, Ma YH, Cui Y, Peng YC, Huang WB, Ge YW, Ho LP, Zheng YJ. Qingfei Paidu decoction, a compound Chinese herbal medicine, protects against post-influenza bacterial infection by inhibiting the formation of neutrophil extracellular traps and cytokine storm. J Integr Med. 2026; Epub ahead of print.
OBJECTIVE:Formononetin and salvianolic acid B (FcS) are the primary bioactive components of the Astragalus mongholicus-Salvia miltiorrhiza herbal pair, a classic combination for treating pancreatic cancer associated with qi deficiency and blood stasis. This study elucidates the therapeutic potential and mechanisms of FcS in the treatment of pancreatic cancer. METHODS:A zebrafish xenograft model was used to screen bioactive combinations derived from A. mongholicus and S. miltiorrhiza, identifying FcS as a candidate with antitumor activity. Its efficacy was evaluated in vivo using the zebrafish model, orthotopic LSL-KrasG12D/+, LSL-Trp53R172H/+ and Pdx-1-Cre (KPC) mice, and subcutaneous xenograft models. Cell viability and proliferation were assessed using cell counting kit-8, 5-ethynyl-2'-deoxyuridine and colony formation assays, and migration and invasion were evaluated by wound healing and transwell assays. Membrane-bound O-acyltransferase 2 (MBOAT2) was identified as a potential target through a molecular docking study and the Cancer Genome Atlas (TCGA) analysis. MBOAT2 knockdown cells were used to explore its roles and the Janus kinase/signal transducer and activator of transcription (JAK/STAT) signaling pathway in FcS-mediated inhibition. RESULTS:In the zebrafish model, FcS strongly inhibited pancreatic tumor growth. FcS reduced tumor volume, the expression of proliferation marker Ki-67, and proliferating cell nuclear antigen in KPC mice. In vitro, FcS inhibited pancreatic cancer cell viability, proliferation, migration and invasion, which was accompanied by downregulation of MBOAT2 expression. TCGA analysis linked high MBOAT2 expression to aggressive phenotypes. MBOAT2 knockdown reduced the survival, proliferation and invasion of BxPC-3 cells. Rescue experiments revealed that MBOAT2 knockdown attenuated the antitumor effects of FcS, possibly through modulation of the JAK/STAT signaling pathway. FcS also inhibited tumor proliferation in xenograft models, and MBOAT2 expression was elevated in tumor tissues from pancreatic cancer patients. CONCLUSION:FcS suppresses pancreatic cancer progression via MBOAT2 downregulation and JAK/STAT pathway inhibition, which highlights MBOAT2 as a potential therapeutic target. Please cite this article as: Xu Y, Xu CS, Jin HB, Gu WG, Shen HZ, Lu L, Chen Y, Xu DC, Zhang XF, Yang JF, Wang Y. Targeting pancreatic cancer progression: The formononetin and salvianolic acid B combination suppresses JAK/STAT signaling via MBOAT2 downregulation. J Integr Med. 2026; Epub ahead of print.
OBJECTIVE:To investigate brain activation and functional connectivity in the prefrontal and motor regions during observation, imagery and execution tasks of Tai Chi Yunshou in healthy adults using functional near-infrared spectroscopy (fNIRS). METHODS:This cross-sectional study enrolled 100 healthy adults (48 males and 52 females; aged 26.23 ± 6.84 years) without a history of neurological, psychiatric or chronic diseases. All participants completed observation, imagery and execution tasks of Tai Chi Yunshou: (1) in the observation task, participants watched videos of the Tai Chi Yunshou movement; (2) in the imagery task, participants repeatedly imagined performing the Tai Chi Yunshou movement following verbal instructions; and (3) in the execution task, participants physically performed the Tai Chi Yunshou movement. The forty-channel wearable fNIRS system was utilized to evaluate the real-time cortical responses during the tasks. Cortical activation was analyzed using a general linear model, functional connectivity was assessed by Pearson correlation, and directional interactions between brain regions were examined using Granger causality analysis (GCA). RESULTS:During the observation task, right dorsolateral prefrontal cortex (DLPFC) and frontopolar area (FPA) were deactivated (P < 0.05). During the imagery task, right DLPFC, primary motor cortex (PMC) and premotor and supplementary motor cortex (PSMC) areas were activated. The bilateral Broca's areas, bilateral DLPFC, bilateral orbitofrontal areas, right FPA, right PMC, right PSMC and right primary somatosensory cortex were activated during the execution task. Execution of Tai Chi Yunshou showed strong functional connectivity within prefrontal cortex (PFC), within sensorimotor area as well as between PFC and sensorimotor area. The results of GCA suggested that Tai Chi Yunshou execution engaged more robust and widespread causal interactions among cortical areas compared to observation and imagery tasks. CONCLUSION:Different activation patterns were found among observation, imagery and execution of Tai Chi Yunshou. Compared with observation and imagery of Tai Chi Yunshou, execution of Tai Chi Yunshou activated and coordinated more brain regions in the PFC and sensorimotor areas, offering evidence that the practice of Tai Chi has the effect of harmonizing both the body and the mind. Please cite this article as: Fu H, Fan J, Liu XB, Li YX, Zhang JM, Xue C, Zhang J, Xie C, Zheng Z, Jiang LB, Li J, Zhong DL, Jin RJ. Brain cortical activation and functional connection of Tai Chi Yunshou during different tasks: An fNIRS study. J Integr Med. 2026; Epub ahead of print.
Objective Sham acupuncture control is essential for evaluating the specific efficacy of acupuncture. However, the complex nature of acupuncture components presents challenges in designing an inert sham acupuncture control while maintaining blinding. Currently, no standardized guidance exists for the design of sham acupuncture controls. This study aimed to propose guidelines for optimizing the design of sham acupuncture in randomized controlled trials. Methods The initial draft of the guidelines was developed through a literature review and expert interviews. The items in the guidelines were revised and finalized through consensus meetings. Results The resulting Recommendations for the DesIgn of sham acupuncture in RandomizEd Controlled Trials (the DIRECT guidelines) include issues to consider prior to adopting a sham acupuncture control, a five-stage framework for designing sham acupuncture, which addresses feasibility, risks, and recommendations for the implementation of sham acupuncture in clinical trials. Conclusion These guidelines offer practical recommendations for establishing appropriate sham acupuncture controls and optimizing their implementation in randomized controlled trials of acupuncture.Please cite this article as: Chen Y, Liu XY, Liu ZS, Guo Y, Zhou KH, Bian ZX, Wu M, Tian RH, Yang F, Zhang LY, Lu Y, Lao LX, He LY, Liu CZ, Liu BY, Yan SY. Recommendations for the DesIgn of sham acupuncture in RandomizEd Controlled Trials (the DIRECT guidelines). J Integr Med. 2026; Epub ahead of print.
