INTRODUCTION
Anxiety disorders are common mental health disorders characterised primarily by persistent and excessive fear, tension, and worry and often accompanied by symptoms of autonomic nervous system hyperactivity, such as palpitations, sweating, and tremors. Anxiety disorders have been categorised by the World Health Organization as the ninth leading cause of disability associated with health conditions, accounting for 3.3% of the global disease burden [1]. In China, too, there is an increasing trend in the prevalence of anxiety disorders as they become a critical issue affecting public mental health [2]. Anxiety disorders not only severely impact patients’ quality of life and social functioning but are also frequently comorbid with other conditions, such as depression, insomnia and chronic pain, substantially increasing the national disease burden [3].
Currently, first-line treatments for anxiety disorders primarily include psychotherapy (e.g., cognitive behavioural therapy) and pharmacotherapy (e.g., selective serotonin reuptake inhibitors) [4]. Although these treatments can alleviate symptoms to an extent, their application still faces numerous limitations. For instance, pharmacotherapy is often associated with a range of adverse effects, including weight gain, sexual dysfunction, and withdrawal reactions, that lead to reduced patient adherence [5,6]. Psychotherapy is limited by factors such as long treatment durations, a shortage of specialised professionals and an uneven distribution of medical resources [7]. Therefore, finding safe, effective, and easily promotable alternative or adjunctive therapies has become an important research direction in the field of mental health.
Among various non-pharmacological interventions, acupuncture holds distinct advantages that justify a focused investigation. Although other complementary approaches—such as exercise, yoga and mindfulness-based interventions—are beneficial, they often require active patient participation, sustained motivation and physical effort, which can be challenging for individuals suffering from severe anxiety or fatigue. By contrast, acupuncture is a passive therapy that does not demand cognitive exertion or skill acquisition from the patient during a session. Furthermore, unlike herbal medicine, which may carry risks of toxicity or interact with concurrent psychotropic medications, acupuncture offers a non-chemical therapeutic option with a favourable safety profile. Consequently, acupuncture serves as a unique bridge between physiological intervention and psychological relief.
As an important component of traditional Chinese medicine (TCM), acupuncture has a history of thousands of years of clinical application. Its theoretical basis lies in stimulating specific acupoints to regulate the body’s qi dynamics and visceral functions, thereby balancing yin and yang and unblocking meridians. From the perspective of modern medicine, the mechanisms of action of acupuncture are gradually being elucidated. Studies suggest that acupuncture can exert anxiolytic effects through multiple pathways, modulating neurotransmitters (e.g., serotonin and gamma-aminobutyric acid), influencing limbic system function and regulating the hypothalamic-pituitary-adrenal (HPA) axis [8-10]. In recent years, the application of acupuncture in the treatment of mental health disorders has gained increasing international attention. Numerous randomised controlled trials (RCTs) have investigated the efficacy and safety of acupuncture for various anxiety disorders, including generalised anxiety, panic and social anxiety disorders.
However, the results of existing clinical studies on acupuncture for anxiety disorders are inconsistent. Some studies have shown that acupuncture is significantly superior to sham acupuncture or standard care in improving anxiety symptoms in patients [11,12], whereas others have found no significant betweengroup differences [13]. This inconsistency may stem from a heterogeneity in study designs, sample sizes, intervention measures, and control settings. Furthermore, although several systematic reviews have summarised the efficacy of acupuncture in treating anxiety disorders, most of these reviews included a limited number of studies or did not perform subgroup analyses based on different assessment tools, thereby limiting the comprehensiveness and reliability of their conclusions [4,14].
A continuous publication of new, high-quality RCTs in recent years has made it possible to update the existing evidence. Therefore, this study aims to conduct an updated, comprehensive systematic review and meta-analysis of RCTs on acupuncture for the treatment of anxiety disorders to more accurately evaluate its efficacy and safety, explore factors that may influence its treatment effect (e.g., the assessment instruments used) and provide more targeted references for clinical practice and future research.
METHODS
Search strategy
A systematic search adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 statement [15] was conducted across four electronic databases: PubMed, Web of Science, the Cochrane Library, and Embase. The search period spanned from the inception of each database until 1 November 2025. The search strategy included the keywords “anxiety disorders,” “acupuncture,” and “randomised controlled trial.” The detailed literature search strategy is provided in the Supplementary Material. To further broaden the scope of inclusion, the reference lists of the included studies were scrutinised to identify potentially eligible articles.
Inclusion and exclusion criteria
The inclusion criteria were as follows: 1) RCTs published in peer-reviewed journals in either Chinese or English; 2) studies in which the participants were adult patients (aged ≥18 years) who had been clinically diagnosed with various anxiety disorders (e.g., generalised anxiety, panic or social anxiety disorders) using standardised diagnostic criteria (e.g., Diagnostic and Statistical Manual of Mental Disorders, Fourth/Fifth Edition and International Classification of Diseases, Tenth Revision) or assessment tools (e.g., the Hamilton Anxiety Rating Scale [HAMA]); 3) studies in which the intervention in the experimental group was any form of acupuncture involving needling as the primary therapy, including, but not limited to, body acupuncture, electroacupuncture, warm needle moxibustion, auricular acupuncture and scalp acupuncture, with no restrictions on needle manipulation techniques, treatment frequency or course duration; 4) studies in which control group measures included, but were not limited to, sham acupuncture, standard care, pharmacotherapy and psychotherapy; 5) studies for which the primary outcome was the improvement of anxiety symptoms, assessed using change scores on validated scales (e.g., the HAMA or the Self-Rating Anxiety Scale); and 6) studies with the most comprehensive data and highest reporting quality when there were duplicate publications.
The exclusion criteria were as follows: 1) non-RCTs, reviews, case reports, conference abstracts and basic experimental studies; 2) studies in which the primary population had other mental disorders (e.g., depression or schizophrenia) or the participants were minors or animals; 3) studies in which the experimental group intervention was a complex regimen combining acupuncture with other therapies (e.g., Chinese herbal medicine or psychotherapy), thus rendering the isolated effect of acupuncture indeterminable; 4) studies in which the control group intervention was another form of acupuncture (i.e., studies designed to compare the superiority of different acupuncture protocols); and 5) studies that did not report extractable quantitative data related to anxiety, in which data were incomplete or for which the full text was unavailable.
Literature screening and data extraction
The processes of literature screening and data extraction were independently performed by two researchers. Initially, both researchers screened the titles and abstracts of the retrieved records against the pre-defined inclusion and exclusion criteria to exclude obviously irrelevant literature. Subsequently, the full texts of potentially eligible articles were obtained and thoroughly reviewed to determine final inclusion. During the screening process, any disagreements between the two researchers were resolved through discussion. If a consensus could not be reached, a third researcher was consulted for arbitration. After completing the literature screening, the same two researchers independently extracted data from the included studies using a pre-designed, standardised data extraction form. After extraction, the data were cross-checked to ensure their accuracy and completeness. The data extraction form primarily included basic study information, participant characteristics, intervention and control measures, outcome indicators and data and information relevant to a methodological quality assessment.
Quality assessment
The methodological quality of the included RCTs was assessed using the Cochrane risk-of-bias tool recommended by the Cochrane Collaboration [16]. This assessment was conducted independently by two researchers and specifically evaluated the following key domains: random sequence generation, allocation concealment, the blinding of participants and personnel, outcome assessment blinding, incomplete outcome data, selective reporting, and other potential sources of bias. The assessors judged each domain as “low risk,” “high risk,” or “unclear risk” based on the specific details described in the studies. After an independent evaluation, the two researchers cross-checked their assessments. Disagreements were resolved through discussion or by arbitration with a third researcher to reach a consensus. A standard risk-of-bias graph was ultimately used to visually represent the overall assessment results.
Statistical analysis methods
Statistical analyses were performed using Stata software version 18.0 (Stata Corp.). For continuous outcomes, the effect size was expressed as the standardised mean difference (SMD). For dichotomous outcomes, the effect size was expressed as the relative risk (RR). Both were reported with 95% confidence intervals (CIs). Heterogeneity was assessed using the I² statistic and Cochran’s Q test. If I² was <50% or the p-value of the Q test was >0.1, the included studies were considered homogeneous, and a fixed-effect model was used for analysis. If I² was ≥50% or the p-value of the Q test was ≤0.1, significant heterogeneity was considered present among the included studies, and a random effects model was applied. Subgroup analysis was performed according to the different anxiety assessment scales used. Sensitivity analysis was conducted using the leave-one-out method. Unless otherwise specified, the significance level (α) was set at 0.05.
RESULTS
Basic characteristics of included studies
Based on the systematic search process, 1,392 potentially relevant records were initially identified from the electronic databases. After removing 411 duplicate records using End-Note and manual checking, 981 unique records remained. A preliminary screening based on titles and abstracts led to the exclusion of 874 records that were clearly irrelevant. The full texts of 107 articles were retrieved and assessed in detail, resulting in the final inclusion of 12 RCTs that met the pre-defined criteria [11-13,17-25]. A detailed flowchart of the study selection process and reasons for exclusion is shown in Figure 1.
The 12 included RCTs were published between 2007 and 2025. Six studies were conducted in China, with the remaining studies originating from Germany (n=1), India (n=1), Iran (n=1), Portugal (n=1), the United Kingdom (n=1) and the United States (n=1). These 12 studies involved a total of 1,240 patients with anxiety disorders, with 621 participants in the acupuncture groups and 619 in the control groups. One study enrolled only female participants. More detailed characteristics of the included studies are presented in Table 1.
Quality assessment
The methodological quality of the 12 included RCTs was assessed using the Cochrane risk-of-bias tool, with specific results shown in Figures 2 and 3. Overall, the included studies demonstrated good control of bias in two key domains: random sequence generation and allocation concealment, with over 75% of the studies rated as low risk, indicating a satisfactory control over selection bias. Most studies also showed low risk where incomplete outcome data and selective reporting were concerned. However, there was a potential risk of bias with respect to the blinding of participants and personnel, primarily due to the inherent challenges in achieving a complete blinding of both practitioners and participants in acupuncture interventions. Notably, regarding outcome assessment blinding, low-risk studies predominated, indicating that most studies effectively ensured the objectivity of subjective outcome measurements by blinding assessors.
Effect of acupuncture on anxiety disorders
A random effects model was used to evaluate the effect of acupuncture on anxiety symptoms based on both post-treatment scores and change scores from baseline. Meta-analysis results show that acupuncture demonstrated significant superiority in reducing anxiety symptom scores compared with the control group, with consistent conclusions across different statistical approaches.
The analysis of post-treatment scores included 12 RCTs (Figure 4). The pooled analysis shows that post-treatment anxiety scores were significantly lower in the acupuncture group than in the control group (SMD=-0.80, 95% CI: -1.11 to -0.48, p<0.001), indicating the clear anxiolytic effect of acupuncture. However, heterogeneity was observed among the studies (I²=82.2%, p<0.001), suggesting that the treatment effect might be influenced by factors such as study design, intervention protocol and population characteristics.
To further control for baseline differences, a pooled analysis was conducted on 11 studies that reported change scores (calculated as post-treatment score minus baseline score) (Figure 5). The results show that the acupuncture group underwent a significantly greater improvement in anxiety symptoms than the control group (SMD=-1.11, 95% CI: -1.56 to -0.65, p<0.001). This finding further supports the efficacy of acupuncture as a treatment and suggests that accounting for baseline differences might provide a more accurate assessment of its actual effect. Significant heterogeneity was also present in this analysis (I²=90.8%, p<0.001), with the effect size from the study by Dhanushya Devi et al. [25] (SMD=-6.92) markedly deviating from that of other studies and potentially being a major contributor.
Subgroup analysis based on different anxiety assessment scales
To explore the potential influence of each assessment tool on effect size, subgroup analyses were performed according to the different anxiety scales used. The results show that the overall direction favouring acupuncture for treating anxiety disorders was consistent across different scales, although the magnitude of the effect varied.
In the analysis of post-treatment scores, acupuncture showed superior effects in all scale subgroups compared with the control group (Figure 6). The Generalized Anxiety Disorder-7 (GAD-7) scale subgroup showed the largest pooled effect size (SMD=-1.21, 95% CI: -2.06 to -0.35), followed by the HAMA subgroup (SMD=-0.90, 95% CI: -1.31 to -0.48). The pooled result for the State-Trait Anxiety Inventory (STAI) subgroup did not reach statistical significance (SMD=-0.47, 95% CI: -1.83 to 0.88). A test for subgroup differences indicated no significant differences in effect size between the different scale subgroups (p=0.119).
Similarly, in the analysis of change scores, all scale subgroups demonstrated consistent treatment effects (Figure 7). The HAMA subgroup exhibited the largest effect size (SMD=-1.98, 95% CI: -3.11 to -0.85). It is noteworthy that the study by Dhanushya Devi et al. [25] showed an extreme effect value (SMD=-6.92) in this subgroup, which might account for the high heterogeneity observed. The GAD-7 scale subgroup showed a moderate effect (SMD=-0.79, 95% CI: -1.27 to -0.32), and the STAI subgroup had the smallest effect size, which was not statistically significant (SMD=-0.35, 95% CI: -1.28 to 0.57). The test for subgroup differences confirmed there were no significant differences between the subgroups (p=0.265).
The results of subgroup analysis show that, although the use of different assessment tools may lead to some variation in the estimated effect size, there is a consistent trend in the effectiveness of acupuncture for anxiety disorders across different evaluation scales, suggesting that the study conclusions are relatively stable.
Adverse events and effects of acupuncture on pain, sleep, and quality of life
This study further evaluated the safety of acupuncture and its effects on pain levels, sleep quality, and quality of life in patients with anxiety disorders. A meta-analysis of Visual Analogue Scale scores showed a trend towards reduced pain scores in the acupuncture group compared with the control group, but the pooled effect size did not reach statistical significance (SMD=-0.49, 95% CI: -2.09 to 1.11) (Supplementary Figure 1). With respect to sleep quality, analysis based on the Pittsburgh Sleep Quality Index (PSQI) showed that the overall effect of acupuncture on improving sleep quality was not statistically significant (SMD=-0.62, 95% CI: -1.53 to 0.29) (Supplementary Figure 2). Two studies reported quality-of-life scores-with opposing results: Liu et al. [18] (2020) reported no significant effect, whereas Liang et al. [23] (2024) documented a significant improvement. The pooled effect size was not statistically significant (SMD=-0.64, 95% CI: -2.27 to 0.99) (Supplementary Figure 3).
Three studies reported the incidence of adverse events. Meta-analysis showed no significant difference in the incidence of adverse events between the acupuncture group and the control group (RR=1.97, 95% CI: 0.50 to 7.74), with no heterogeneity among the studies (I²=0.0%) (Figure 8). This indicates that the safety profile of acupuncture for anxiety disorders is manageable and comparable to that of the control group.
Sensitivity analysis
To assess the robustness of the meta-analysis results, a quantitative sensitivity analysis was performed using the leave-one-out method. The results show that, after sequentially removing any single study, the pooled effect estimates for both the analysis based on post-treatment scores (Supplementary Figure 4) and the analysis based on change scores (Supplementary Figure 5) did not change direction and remained statistically significant. Specifically, for the analysis of post-treatment scores, the pooled effect size (SMD=-0.80, 95% CI: -1.11 to -0.48) showed limited fluctuation in its point estimate after the removal of any single study, and all recalculated 95% CIs had a lower limit <0 and an upper limit not exceeding -0.42, indicating a robust positive result. Similarly, the pooled effect size for the change score analysis (SMD=-1.11, 95% CI: -1.56 to -0.65) also demonstrated good stability in the sensitivity analysis. Although heterogeneity decreased significantly, and the effect size moved closer to the average after excluding the study by Dhanushya Devi et al. [25], all recalculated CIs did not cross the line of null effect. In summary, sensitivity analysis confirmed the high reliability of this study’s main findings-that the improvement in anxiety symptoms in the acupuncture group was significantly greater than that in the control group-and demonstrated that the results were not unduly influenced by any single study.
DISCUSSION
This systematic review and meta-analysis synthesised the latest evidence from 12 RCTs to evaluate the efficacy and safety of acupuncture for treating anxiety disorders. The core analyses demonstrated the significant and robust therapeutic effect of this intervention in improving anxiety symptoms. Whether based on post-treatment endpoint scores or change scores from baseline accounting for baseline differences, the anxiety reduction was significantly greater in the acupuncture group than in the control group, with effect sizes ranging from moderate to large. To translate this statistical finding into clinical practice, it is important to consider the minimal clinically important difference (MCID). For commonly used anxiety scales, such as the HAMA, the MCID is often estimated to be an approximately 3- to 5-point reduction in total score. Converting our SMDs back to the original scale using the pooled standard deviation from included studies suggests that the mean improvement in the acupuncture group exceeded this threshold, indicating a change that is not only statistically significant but also likely to be perceptible and meaningful to patients. This supports the proposition that acupuncture can provide a clinically relevant anxiolytic effect within a comprehensive management strategy. Despite heterogeneity among the studies, sensitivity analysis confirmed the reliability of this conclusion. Subgroup analyses further revealed that, although the use of different standardised anxiety assessment tools led to some variation in estimated effect sizes, the overall trend favouring acupuncture’s effectiveness remained consistent across different scales, enhancing the stability of our findings. Furthermore, this study found no significant difference in the incidence of adverse events between the acupuncture group and the control group, suggesting an acceptable safety profile for acupuncture as an intervention. However, regarding improvements in common accompanying pain, sleep disturbances, and quality of life in patients with anxiety disorders, the evidence from this study is insufficient to draw definitive conclusions.
Our findings are consistent with previous findings indicating that acupuncture is superior to non-specific interventions or standard care in alleviating anxiety symptoms [26,27]. However, the contribution of this study lies in its providing more timely evidence by including the latest trials and revealing the possible range of effect sizes (SMD: -0.80 to -1.11). Acupuncture is not merely a placebo alternative but likely an active therapy with independent physiological effects. Existing neurobiological research provides a plausible explanation for our findings. The pathophysiology of anxiety disorders is closely related to limbic system hyperactivity (especially the amygdala), a diminished regulatory function of the prefrontal cortex and a dysregulation of the HPA axis [28,29]. Functional magnetic resonance imaging studies have repeatedly confirmed that needling specific acupoints (e.g., Baihui [GV20], Yintang [EX-HN3], and Shenmen [HT7]) can modulate neural activity in these key brain regions, enhancing the “top-down” inhibitory control of the prefrontal cortex over the amygdala and thereby alleviating excessive fear and anxiety responses [30,31]. At the molecular level, acupuncture is believed to modulate multiple neurotransmitter systems, promoting the release of gamma-aminobutyric acid (a major inhibitory neurotransmitter of the central nervous system) and regulating serotonin and norepinephrine levels-effects that overlap with the mechanisms of action of many anxiolytic drugs [32]. Additionally, acupuncture may promote the homeostatic recovery of the nervous system at a broader level by modulating neurotrophic factors, including brain-derived neurotrophic factor, and inhibiting neuroinflammation.
The subgroup analysis conducted in this study, based on different anxiety assessment scales, provides a crucial perspective for interpreting heterogeneity. The results show that, although all scales pointed in the same direction (towards acupuncture’s effectiveness), the magnitude of their effect sizes varied. The GAD-7 scale and HAMA showed larger effects, whereas that of the STAI did not reach statistical significance. This discrepancy may stem from the structure and focus of the different scales. The HAMA contains numerous somatic anxiety items (e.g., muscular tension and palpitations) [33], whereas the GAD-7 scale focuses more on psychic anxiety and apprehensive worry [34]. As an intervention emphasising holistic regulation, acupuncture’s modulatory effect on autonomic nervous system function may be particularly beneficial for improving the somatic symptoms assessed by the HAMA. The STAI, however, focuses more on assessing relatively stable personality trait anxiety, which might be less sensitive to short-term therapeutic interventions than state anxiety [35]. Therefore, the results of subgroup analysis suggest that the efficacy of acupuncture might be more fully reflected on scales that focus on assessing acute, comprehensive anxiety symptoms. Future clinical trials should carefully consider the characteristics of different assessment tools when selecting primary outcome measures.
Additionally, this study found that acupuncture did not demonstrate consistent statistically significant improvements in co-morbid pain, sleep quality or quality of life in patients with anxiety. This negative result requires cautious interpretation. It might indeed indicate a limited specific effect of acupuncture on these domains, but it is more likely a result of the scarce number of studies reporting these outcomes—combined with their small sample sizes—leading to insufficient statistical power to detect real, small-to-moderate effects. For instance, quality of life was reported by only two studies, which contained conflicting results, preventing any meaningful data synthesis. Nevertheless, some primary studies still reported positive trends for acupuncture in improving sleep quality (e.g., via the PSQI), aligning with the known efficacy of acupuncture in treating insomnia [36]. Therefore, this should not be taken as a complete negation of the potential comprehensive benefits of acupuncture; rather, it underscores the need for more future studies that prospectively and systematically evaluate these patient-reported outcomes.
By contrast, the safety analysis provided a clear and reassuring conclusion. The incidence of adverse events did not differ significantly between the acupuncture and control groups, and the reported events were all mild and transient (e.g., local bleeding). This finding is highly consistent with the safety profile of acupuncture in other disease areas [8], greatly enhancing our confidence in its potential integration into long-term management strategies for anxiety disorders, especially for patients concerned about the side effects of pharmacological treatments.
This study has several limitations. First, although the number of included studies covers over 1,200 patients, it remains insufficient for certain subgroups and secondary outcome analyses, limiting the precision and generalisability of the results. Although explored through subgroup analyses, the heterogeneity observed among these studies remains a limitation tempering the strength and generalisability of the pooled conclusion. Second, the inherent limitations in the implementation of blinding in acupuncture RCTs represent a methodological challenge. Although most studies blinded their outcome assessors to ensure measurement objectivity, the complete blinding of both practitioners and patients is extremely difficult to accomplish. Performance bias could therefore have potentially influenced these results, although we observed that even sham-acupuncture-controlled studies with blinded patients often showed the superior efficacy of acupuncture. Third, the included literature was limited to studies in Chinese and English, potentially missing relevant studies published in other languages and introducing a possible language bias. Fourth, due to missing data in the original reports, we were unable to perform more in-depth subgroup analyses based on specific anxiety disorder subtypes (e.g., generalised anxiety disorder vs panic disorder) or acupuncture treatment protocols (e.g., electroacupuncture vs manual acupuncture), which could be important sources of heterogeneity. Our inability to analyse the differential effects of specific acupuncture modalities is a particularly notable limitation that should be addressed in future trials to inform more precise clinical treatment plans.
Based on the limitations and findings of this study, future research should strive to advance from the efficacy verification stage to the deepening stages of mechanism exploration and the precise clinical application of acupuncture for treating anxiety disorders. The research focus should shift towards identifying the optimal patient population responsive to acupuncture, which will require the integration of objective indicators, such as neuroimaging and biomarkers, with the syndrome differentiation system of TCM to establish individualised efficacy prediction models. Methodologically, more reliable sham acupuncture control techniques will need to be further developed and validated as superior designs for acupuncture in combination with standard treatment are actively adopted to overcome blinding difficulties and clarify the clinical incremental value of acupuncture. Furthermore, the research perspective should expand from core symptom improvement to comprehensive health benefits, systematically evaluating the holistic regulatory effects of acupuncture along multiple dimensions, including sleep disturbances, cognitive function and quality of life. Ultimately, through large-scale pragmatic trials and long-term follow-up, the sustained efficacy and cost-effectiveness of acupuncture should be validated in real-world clinical settings that provide high-level evidence for the development of evidence-based guidelines and healthcare resource allocation, thereby comprehensively enhancing the application value and scientific status of acupuncture in the field of mental health.
Conclusion
In summary, this systematic review and meta-analysis provide strong evidence supporting the efficacy and safety of acupuncture in the treatment of anxiety disorders. The study not only confirms the core anxiolytic effect of acupuncture but also explores the potential reasons for efficacy heterogeneity and clarifies acupuncture’s favourable risk-benefit ratio. Despite methodological challenges, these findings lay a solid foundation for integrating acupuncture as a valuable option into multimodal treatment strategies for anxiety disorders. Future research should dedicate itself to elucidating the biological basis of acupuncture’s mechanism of action and promoting the development of its clinical application in individualised and precision-oriented directions.
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