Clinical effectiveness and economic evaluation of acupoint injection for the treatment of primary insomnia: a systematic review and network meta-analysis.

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Learn more: PMC Disclaimer | PMC Copyright Notice Cost Eff Resour Alloc . 2026 May 9;24:70. doi: 10.1186/s12962-026-00758-5 Clinical effectiveness and economic evaluation of acupoint injection for the treatment of primary insomnia: a systematic review and network meta-analysis HuiYan Zhao 1, 2, # , Mi Hong Yim 3, # , Ho-Yeon Go 4 , Jung-Hee Jang 1, 2, ✉ Author information Article notes Copyright and License information 1 KM Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-gu, Daejeon, 34054 Republic of Korea 2 Korea Convergence Medical Science, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea 3 Digital Health Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-gu, Daejeon, 34054 Republic of Korea 4 Department of Preventive Medicine, Korean Medicine College, Semyung University, Jecheon, Republic of Korea ✉ Corresponding author. # Contributed equally. Received 2026 Jan 5; Accepted 2026 Apr 30; Collection date 2026. © The Author(s) 2026 Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/ . PMC Copyright notice PMCID: PMC13220490  PMID: 42106785 Abstract Background Primary insomnia is a highly prevalent sleep disorder that significantly affects quality of life. Acupoint injection (AJ), a traditional therapy that combines pharmacological and acupuncture effects, has been increasingly applied in clinical practice. However, evidence of its efficacy and economic value is lacking. This study determined the clinical effectiveness of AJ and established the relative ranks of AJ-related therapies for the treatment of primary insomnia. Methods The clinical effectiveness and cost-effectiveness of AJ-related therapies for primary insomnia were evaluated through a systematic review and network meta-analysis (NMA) of randomized controlled trials (RCTs). We searched 11 electronic databases for relevant studies published up to June 10, 2025. The Pittsburgh Sleep Quality Index (PSQI) and effective rate were used as outcome measures. The quality of included studies was assessed using the Risk of Bias 2.0 tool. Pairwise meta-analysis and NMA were performed using RevMan 5.4 and R, respectively. The cost-effectiveness of the interventions was subsequently determined based on regional intervention costs. Results Twenty-four randomized controlled trials involving 1,851 participants were included in the meta-analysis. AJ combined with manual acupuncture (MA) significantly reduced PSQI scores based on the results of the pairwise meta-analysis and was among the most effective interventions based on the results of the network meta-analysis. The cost-effectiveness analysis revealed that AJ combined with MA was associated with better outcomes at modest additional costs, as indicated by the favorable incremental cost-effectiveness ratio (ICER) values for PSQI improvement and additional responders. Conclusions This study is the first to comprehensively synthesize evidence on the clinical effectiveness and cost-effectiveness of acupoint injection for primary insomnia. AJ combined with MA significantly improves sleep quality and may be a cost-effective and safe adjunctive therapy within the context of traditional medicine practice. It may be a feasible treatment option for primary insomnia. However, this conclusion should be validated through future studies due to the limitations of the quality of the literature. Further high-quality RCTs with standardized economic evaluations are warranted to confirm these findings. Supplementary Information The online version contains supplementary material available at 10.1186/s12962-026-00758-5. Keywords: Primary insomnia, Network meta-analysis, Acupoint injection Background Insomnia is the most common sleep disorder. It affects more than 850 million adults older than 20 years globally, of which 415 million experience severe insomnia [ 1 ]. Primary insomnia is defined as difficulty falling asleep, staying asleep, or experiencing non-restorative sleep that is not caused by another disease, substance use, or environmental factors [ 2 ]. It is estimated that approximately 25% of cases of insomnia population are primary [ 3 ]. Sedative hypnotics or antidepressant drugs are the most common treatments of primary insomnia [ 2 , 4 , 5 ]. However, pharmacological interventions often have various side effects. For instance, benzodiazepines, which are sedative hypnotics, can cause memory impairment, respiratory arrest, vehicle accidents, and falls [ 6 ]. Similarly, antidepressant drugs may induce cardiovascular side-effects, dry month, gastrointestinal side effects, hepatotoxicity, seizure, or suicidality [ 7 ]. These safety and tolerability concerns for primary insomnia have led to an increasing demand for safer, more sustainable, and cost-effective therapeutic alternatives. In the field of traditional medicine, acupoint injection (AJ) is a therapeutic method that involves injecting a small amount of medication, vitamin, saline, or plant extract to enhance and prolong the effect of stimulation by an acupoint [ 8 ]. It has been widely used globally, including in countries such as Korea [ 9 ], China [ 10 ], the US [ 11 ], Italy [ 12 ], and Australia [ 8 ]. Moreover, AJ differs from traditional acupuncture; it combines both the pharmacological action of the injected substance and the stimulatory effect of the acupoint and produces neuroprotective and antioxidant effects [ 13 , 14 ]. It is currently used to treat various diseases, including primary insomnia. A traditional Korean medicine clinical practice guideline for insomnia disorders in 2021 recommended it as a treatment option to improve sleep quality and overall functional benefits [ 15 ]. Several clinical studies have reported that AJ can alleviate sleep disturbances and improve psychological health in patients with primary insomnia [ 16 , 17 ]. However, most of these studies are limited by small sample sizes and methodological heterogeneity, and a comprehensive systematic review evaluating the effectiveness of AJ for this condition is lacking. Beyond clinical effectiveness, it is also crucial to determine whether AJ is economically viable relative to conventional or adjunctive therapies. Modern healthcare systems require interventions that are both clinically effective and cost-effective due to limited medical resources and increasing healthcare expenditures. Demonstrating the economic value of AJ could support evidence-based decision-making, enhance its integration into clinical practice, and guide reimbursement or policy adoption in public health systems [ 18 ]. However, no previous study has comprehensively assessed the cost-effectiveness of AJ for primary insomnia [ 19 ]. The aim of this study was to systematically review randomized controlled trials (RCTs) on the effectiveness of AJ-related therapies for primary insomnia to ascertain their relative efficacies rank them through a network meta-analysis. The study was also aimed at evaluating the cost-effectiveness of AJ as an adjunct to manual acupuncture. The dual approach was expected to provide robust evidence for clinical application and optimal resource allocation for sleep disorder management. Methods This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for network meta-analysis guidelines [ 20 ]. The protocol of this study was previously registered with PROSPERO under the number: CRD420251234214. Search strategy We searched the following 11 electronic bibliographic databases: core databases (PubMed, Embase, and Cochrane Register of Controlled Trials [CENTRAL], Web of Science), Chinese databases (Chinese National Knowledge Infrastructure Database, Chinese Science and Technique Journals Database [VIP], Chinese Biomedical Literature Database [CBM], and Wanfang Database), and Korean databases (Korean Studies Information Service System, Oriental Medicine Advanced Searching Integrated System, and Korea Citation Index). The databases were searched for relevant articles published from their inception to June 10, 2025. The search strategy was as follows: (“Insomnia” or “sleep disorder”) AND (“pharmacupuncture” or “acupoint injection”) AND (“Randomized” or “Randomized Controlled Trail”). We also extended the search index based on the databases. The full search strategy is provided in Additional Table 1 . Inclusion and exclusion criteria Types of studies We included only RCTs on AJ for insomnia. We excluded case report/series, reviews, and case-control, observational, experimental, and animal studies. Participants We included participants diagnosed with primary insomnia based on guidelines such as the Chinese Classification of Mental Disorders [ 21 ], Guidelines for the Diagnosis and Treatment of Adult Insomnia in China [ 22 ], Guiding Principles for Clinical Research of New Traditional Chinese Medicines [ 23 ], Traditional Chinese Medicine [ 24 ], and Insomnia [ 25 ]. Intervention All types of AJ treatments were included. Combinations of manual acupuncture (MA), auricular acupuncture (AA), herbal plaster therapy, herbal medicine (HM), and Western medicine (WM), Chuna therapy, and moxibustion were also included. There were no restrictions on the acupoints, insertion depth, injection volume, or injection needle type. Comparisons MA, acupoint injection, WM, HM, AA, moxibustion, and herbal plaster therapy were combined. Outcomes The primary outcome was Pittsburgh Sleep Quality Index (PSQI) [ 26 ]. For the PSQI, higher scores denote poorer sleep quality; therefore, a negative mean difference (MD) indicates a greater reduction in the PSQI scores, representing a superior improvement in sleep quality compared to that in the control group. The secondary outcome was total effective rate (based on the Guidelines for the diagnosis and treatment of adult insomnia in China [ 23 ], International standard unified sleep efficiency value formula [ 17 ], sleep time [ 27 ], insomnia [ 25 ], PSQI scale [ 28 ]). Study selection and data extraction Two reviewers (HYZ and MHY) independently searched the databases and assessed the studies based on the inclusion and exclusion criteria. We excluded duplicates after screening the titles and abstracts. We reviewed the full-texts of the remaining studies to identify those that were potentially eligible. A third reviewer (HJJ) resolved any disagreements. The data for the final selected studies were extracted by the two reviewers (HYZ and MHY) using a standard data extraction form in Excel. The extracted data included the following: first author’s name, country, region of inclusion, participants, publication year, intervention and control methods, type of insomnia, patients’ age, treatment duration, outcome measurement, and adverse events. Assessment of risk of bias The risk of bias for the final included studies was independently assessed by two reviewers (HYZ and MHY) using the Cochrane Collaboration’s Risk of Bias Assessment tool 2.0 [ 29 ]. The following four domains were assessed: deviation from intended interventions, missing outcome data, outcome measurements, and selection of reports. Each domain was rated as low, high, or some concerns. Discrepancies were resolved through discussions with a third party. The ROB figures were created using Excel implementing ROB2 (Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License). Data analysis Pairwise meta-analysis The data were analyzed using Review Manager (RevMan) version 5.4. MDs with 95% confidence intervals (CIs) were used to summarize the results of the comparison of the continuous data. Risk ratios with 95% CIs were used to represent the effective rates based on the different questionnaires for the dichotomous data. A random-effects model was applied when I 2 was > 50%; otherwise, a fixed-effects model was applied. Network meta-analysis (NMA) Bayesian network meta-analysis was performed using the Bugsnet (version 1.1.3) and netmeta (version 3.2-0) packages of the R software (version 4.5.1; R Software for Statistical Computing, Vienna, Austria). The random-effects model was used to perform the NMA with MDs in the netmeta package to account for the different types of AJ. The global and local consistencies were tested using the decomp.design and netsplit functions, respectively, based on the direct and indirect evidence. The intervention rankings were determined based on the surface under the cumulative ranking curve. MA was the reference group for the network meta-analysis. Sensitivity analysis Sensitivity analysis was performed by excluding each study, one at a time to assess the trend and robustness of the overall result. The forest plot shows changes observed during the sensitivity analyses. Publication bias We used Egger’s test and funnel plots to assess publication bias when more than 10 studies were included. Health economic analysis We examined the interventions for clinical heterogeneity and consistency of intervention characteristics after pairwise meta-analysis and NMA and included only studies with comparable clinical designs in the cost-effectiveness analysis. The health-economic evaluation was conducted from the healthcare system perspective to assess the economic value of AJ combined with MA relative to MA alone for the treatment of primary insomnia. All costs were converted from Chinese yuan to international US dollars ($) [ 29 ] using the International Monetary Fund currency conversion website. Discounting was not applied because all the studies were conducted in China, and only short-term outcomes were reported. The analysis was performed using R version 4.4.1 (R Foundation for Statistical Computing, Vienna, Austria). Cost estimation was performed by considering direct medical, direct non-medical, and indirect costs associated with the treatment. The direct medical costs included the treatment and medication costs. The medical costs of AJ and MA were obtained from the price list of basic medical services in public medical institutions on the official websites of local healthcare security administrations in the three provinces (Guangzhou, Guangxi, and Henan) where the included RCTs were conducted. The data sources were as follows: the Guangzhou Medical Insurance Service Management Bureau ( https://www.gz.gov.cn/gzybj/gkmlpt/content/10/10441/post_10441602.html#14609 ), the Gvanggjih Bouxcuengh Swcigih Yihliuz Baujcang Giz ( http://ybj.gxzf.gov.cn/hdjl/yjzj/opinionDetail.shtml?opinionid=5456 ), and the Henan Provincial Medical Insurance Bureau ( https://ylbz.henan.gov.cn/2025/04-07/3145074.html ). The price of the medicine used for AJ was searched on the TuLing Website ( https://www.315jiage.cn/ ). The unit costs of AJ and MA were extracted from these official lists and applied to the analysis. The direct non-medical costs included transportation expenses (1.13 USD per hospital visit) based on previously published studies [ 30 ]. Indirect costs referred to productivity losses due to missed workdays and were estimated using the average daily wage reported in national labor statistics. We considered that each patient required 30 min for treatment and 30 min for transportation. The total time was 1 h. The transportation cost was calculated based on the average annual wage of employed persons in each city, as reported by the Bureau of Statistics (Guangzhou: Guangzhou Municipal Bureau of Statistics [ https://www.gz.gov.cn/zwfw/zxfw/jyfw/content/post_10339305.html ]; Guangxi: Guangxi Zhuang Autonomous Region Bureau of Statistics [ http://tjj.gxzf.gov.cn/tjsj/xwfb/tjxx_sjfb/t22621460.shtml ]; Heilongjiang: People Government of Heilongjiang Province [ https://www.hlj.gov.cn/hlj/c108511/list_left_tt.shtml ]; Henan: Henan Provincial Bureau of Statistics [ https://www.henan.gov.cn/2025/07-05/3177677.html ]). The fees are provided in Additional Table 2 . The costs were calculated using the following equations: The mean total cost per study was used for this economic evaluation based on a systematic review. The costs of transportation and one lost workday were assumed to be identical for the AJ and MA groups. The cost boundaries were equivalent under the healthcare system and societal perspectives. The effectiveness of the interventions was evaluated using the following indicators: (a) mean improvement in the PSQI score and (b) responder rate, which was defined as the proportion of participants with a PSQI score improvement of ≥ 4 points. The pre- and post-intervention changes in PSQI scores were determined for both groups, and the differences between the AJ + MA and MA groups were estimated for each study. A default value of r = 0.5 was used to estimate the standard deviation of the change scores because the pre- and post-intervention correlation coefficients were not reported in the individual studies [ 31 ]. The differences were synthesized using a random-effects model based on restricted maximum likelihood estimation with Hartung–Knapp–Sidik–Jonkman adjustment to account for inter-study heterogeneity and small-sample uncertainty. The probabilities of achieving the PSQI improvement threshold (K = 4), which represents the clinical responder rate, were estimated based on the assumption of a normal distribution of change scores. The threshold of 4 points was selected based on previously reported minimal clinically important differences (MCIDs; also referred to as minimal important changes) of approximately 3–4.5 points [ 32 , 33 ]. The responder rates and treatment costs for the intervention and control groups were aggregated across studies using sample-size weighting to apply a simplified probabilistic analytic approach. The incremental cost-effectiveness ratios (ICERs) were calculated based on the incremental cost per 1-point improvement in PSQI score and per additional responder. The treatment costs for both analyses were aggregated across the studies using sample-size weighting. The cost differences between the groups were determined for each study and synthesized. The costs for the intervention and control groups were determined for each study and then aggregated for the simplified probabilistic analytic approach. Deterministic sensitivity analyses were conducted by varying the assumed correlation coefficient ( r = 0.3–0.7) and the PSQI response threshold (K = 3–5). Probabilistic sensitivity analysis was performed using bootstrap resampling ( n = 4,000). Cost-effectiveness planes and cost-effectiveness acceptability curves (CEACs) were generated to illustrate the probabilities of the intervention being cost-effective at different willingness-to-pay (WTP) thresholds. Results Literature search The database search yielded 666 studies. We screened the titles and abstracts of 439 studies after removing duplicates. We excluded 376 studies because they were not RCTs, did not involve primary insomnia, did not involve acupoint injection, or were protocols. We reviewed the full-texts of the remaining studies. Thirty-nine RCTs were excluded based on our predefined inclusion and exclusion criteria. Ultimately, 24 studies (including two three-arm studies) were included in this review (Fig. 1 ). Fig. 1. Open in a new tab PRISMA flow chart. Abbreviations: CNKI, China National Knowledge Infrastructure; VIP, China Science and Technology Journal Database; OASIS, Oriental Medicine Advanced Searching Integrated System; KISS, Korean Studies Information Service System; RCT, randomized controlled trial Study characteristics The characteristics of the included studies are provided in Additional Table 3 . All the studies were conducted in China and involved 1851 participants. The sample sizes ranged from 39 to 126, and the treatment durations ranged from 5 days to 8 weeks. The included studies were categorized into 15 groups based on the interventions and comparisons: (a) AJ + MA vs. MA ( n = 8) [ 28 , 34 – 40 ]; (b) AJ + HM vs. WM ( n = 1) [ 41 ]; (c) AJ vs. MA ( n = 2) [ 39 , 42 ]; (d) AJ + AA vs. WM ( n = 2) [ 43 , 44 ]; (e) AJ vs. HM ( n = 3) [ 45 – 47 ]; (f) AJ vs. WM ( n = 3) [ 17 , 48 , 49 ]; (g) AJ + HM vs. HM ( n = 1) [ 50 ]; (h) AJ + MA+AA vs. AJ+herbal plaster therapy ( n = 1) [ 51 ]; (i) AJ+Chuna therapy vs. WM ( n = 1) [ 52 ]; (j) AJ + MA vs. AJ ( n = 1) [ 39 ]; (k) AJ+Chuna therapy vs. MA ( n = 1) [ 52 ]; (l) MA vs. WM ( n = 1) [ 52 ]; (m) AJ + HM vs. WM + HM ( n = 1) [ 27 ]; (n) AJ+Chuna therapy vs. MA + AA+moxibustion ( n = 1) [ 53 ]; and (o) AJ + MA+WM vs. WM ( n = 1) [ 16 ]. Characteristics of AJ The numbers of the 16 acupoint types used for the AJs were as follows: SP6 (10), M-HN-54 (10), ST36 (7), PC6 (4), GB20 (4), BL15 (4), BL23 (4), BL20 (4), BL18 (4), M-HN-1 (3), HT7 (3), M-HN-9 (2), BL19 (2), BL17 (2), KI3 (1), and GV16 (1). The most frequent types of AJ were vitamin B12, Radix Salviae Miltiorrhizae , and Rhizoma Gastrodiae extract. The most frequent treatment period was once daily (9 studies) and 3 times a week (7 studies) (Additional Table 4 ). Quality of the included studies All the studies used the random number table method, which was associated with a low risk of bias. However, blinding the participants and practitioners was impossible due to the characteristics of acupoint injection, and this may have introduced bias. The overall assessment should be interpreted with caution. The summaries of the risk of bias assessment are provided in Fig. 2 . Fig. 2. Open in a new tab Risk for bias in the included studies Pairwise meta-analysis Primary outcomes We assessed the effects of 11 different types of AJ, alone or in combination with other therapies, on the PSQI scores of patients with primary insomnia. The AJ and MA groups had significantly different PSQI scores (Additional Fig. 1 ). Secondary outcome The total effective rate reported in the studies included in this review was based on various guidelines. Fifteen studies [ 16 , 28 , 34 – 36 , 38 – 41 , 43 , 45 , 47 , 50 , 51 , 53 ] used the Guidelines for the Diagnosis and Treatment of Adult Insomnia in China. Three studies [ 17 , 46 , 48 ] used the international standard unified sleep efficiency value formula, two studies [ 27 , 42 ] used sleep time, and three studies [ 37 , 49 , 52 ] used the change in PSQI score. Significant differences were observed in five comparisons: AJ + HM vs. HM + WM, AJ + WM vs. WM, AJ + HM vs. HM, AJ + MA+AA vs. AJ+herbal plaster therapy, and AJ vs. HM (Additional Fig. 2 ). NMA Network evidence map Fifteen studies, including eight intervention studies involving 1165 patients, reported PSQI scores. Two of the studies were three-arm trials. The relationships of the PSQI are shown in Fig. 3 a. Two three-chain closed loops (MA-AJ + MA-AJ and AJ+Chuna therapy-MA-WM) were formed around MA. The consistency model was accepted ( P = 0.1147 > 0.05). The net-split graphs, which include the direct, indirect, and network estimates for the consistency assessment, are provided in Additional Fig. 3 . The results demonstrated that the direct and indirect estimates are consistent, with largely overlapping 95% CIs across all comparisons. This coherence indicates that the indirect evidence does not conflict with the direct evidence, thereby validating the synthesis of data within our network meta-analysis. Consequently, the network estimates provide a more comprehensive synthesis of the evidence than the pairwise meta-analysis alone, without compromising the integrity of the individual treatment comparisons. Fig. 3. Open in a new tab Network plot and treatment-level network meta-analysis forest plot for the PSQI. Abbreviations: AJ, acupoint injection; AA, auricular acupuncture; HM, herbal medicine; MA, manual acupuncture; WM, western medicine; PSQI, Pittsburgh Sleep Quality Index Comparative effectiveness of the PSQI The P-scores for the included interventions were as follows: AJ + AA (92.87), AJ + HM (89.73), AJ + MA (63.67), AJ (49.42), HM (40.74), AJ+Chuna therapy (38.74), MA (18.43), and WM (6.39). The AJ + AA combination therapy was the most effective for reducing sleep symptoms based on the PSQI (Fig. 3 b; Table 1 ). The mixed effect estimates (combining direct and indirect estimates) for the interventions compared with MA (in favor of the bold liners) were as follows: AJ + AA (MD, -4.03; 95% CI, -6.26 to -1.80), AJ + HM (MD, -3.76; 95% CI, -6.28 to -1.24), and AJ + MA (MD, -1.92; 95% CI, -2.75 to -1.09). The AJ + AA, AJ + HM, and AJ + MA groups had lower PSQI scores than the MA group. However, the differences for the AJ, AJ+Chuna therapy, HM, and WM groups were not statistically significant. Table 1. League table on PSQI AJ + AA . . . . . . -4.63 [-6.22; -3.05] -0.27 [-2.81; 2.26] AJ + HM . . -2.79 [-4.82; -0.76] . . -4.36 [-6.34; -2.38] -2.11 [-4.45; 0.23] -1.84 [-4.46; 0.78] AJ + MA -2.71 [-5.23; -0.19] . . -1.76 [-2.60; -0.93] . -2.72 [-4.87; -0.58] -2.45 [-4.90; 0.00] -0.61 [-2.16; 0.94] AJ . . -1.27 [-3.05; 0.51] -2.31 [-4.02; -0.59] -3.06 [-6.31; 0.18] -2.79 [-4.82; -0.76] -0.95 [-4.26; 2.36] -0.34 [-3.52; 2.84] HM . . . -3.19 [-5.72; -0.67] -2.92 [-5.71; -0.13] -1.08 [-3.19; 1.03] -0.47 [-2.63; 1.69] -0.13 [-3.57; 3.31] AJ+chuna_therapy -1.13 [-3.21; 0.95] -1.15 [-3.23; 0.93] -4.03 [-6.26; -1.80] -3.76 [-6.28; -1.24] -1.92 [-2.75; -1.09] -1.31 [-2.73; 0.11] -0.97 [-4.21; 2.27] -0.84 [-2.81; 1.13] MA -0.02 [-2.10; 2.06] -4.63 [-6.22; -3.05] -4.36 [-6.34; -2.38] -2.52 [-4.25; -0.80] -1.91 [-3.35; -0.47] -1.57 [-4.40; 1.26] -1.44 [-3.41; 0.53] -0.60 [-2.17; 0.97] WM Open in a new tab Abbreviation: AJ: acupoint injection; HM: herbal medicine, MA: manual acupuncture, WM: western medicine; PSQI: Pittsburgh Sleep Quality Index Sensitivity analysis AJ + AA was the most effective intervention for 15 analyses after excluding one study based on the sensitivity analysis. However, the rankings of AJ + AA and AJ + HM changed after excluding the data from [ 43 ] with AJ + HM being more effective (Additional Fig. 4 ). Publication bias The network funnel plot for the PSQI was generated. Egger’s test revealed no significant evidence of publication bias ( P = 0.9837) (Additional Fig. 5 ). Adverse events Only three studies [ 38 , 41 , 50 ] reported adverse events. Two studies reported no adverse events [ 38 , 50 ]. The adverse events reported for the AJ + HM and WM groups in the remaining study were 5/30 and 10/30, respectively [ 41 ]. They included nausea and vomiting, headache, and drug rash (Additional Table 4 ). GRADE evaluation The certainty and importance of the included trials with respect to the individual outcomes are provided in Additional Table 5 . The GRADE level of the PSQI was mostly moderate or low. The primary reasons for downgrading were the risk of bias and heterogeneity. Health economic analysis Study inclusion and analysis overview Based on the pairwise meta-analysis of PSQI, Only the AJ + MA vs. MA comparison ( n = 8) demonstrated significant effectiveness without heterogeneity (Additional Fig. 1 a). However, one study [ 34 ] was excluded from the subsequent economic analysis because the standard deviation of baseline PSQI values was not reported. Therefore, seven trials were included in the cost-effectiveness evaluation. The ranks of AJ and MA were unchanged in the sensitivity analysis. We performed the AJ + MA vs. MA cost-effectiveness analysis. Cost estimation Direct medical, non-medical, and indirect costs were derived from the official provincial fee schedules of Guangzhou, Guangxi, and Henan (Additional Table 2 ). The direct medical costs included those for injection materials and acupuncture procedures. The injection material costs were $1.41 for the Shenmai and Rhizoma Gastrodiae (Tianma) injections, $1.81 for the Radix Salviae Miltiorrhizae (Danshen) injection, $29.7 for the vitamin B12 injections, and $31.51 for the combined vitamin B12 and Danshen injection. The acupoint injection procedure costs were $2.83 per acupoint for Guangzhou and Henan and $7.07 per session for Guangxi. The manual acupuncture costs also varied by region: $22.63, $19.8, and $9.9 per session for Guangzhou, Henan, and Guangxi, respectively. The non-medical costs, primarily transportation expenses, were consistent across the provinces and were estimated at $1.13 per hospital visit. The indirect costs, which represented productivity losses due to missed work, were estimated using regional average wages. They were $7.95, $5.16, and $4.97 per day for Guangzhou, Guangxi, and Henan, respectively. The costs were calculated per session and multiplied by the total number of treatment sessions reported in each study. The total medical costs for the provinces where the injection fee was charged per acupoint (e.g., Guangzhou and Henan) were calculated based on the number of acupoints treated. Effectiveness and cost-effectiveness The cost-effectiveness evaluation was based on the mean improvement in PSQI score and the responder rate. The responder rate was defined as the proportion of participants who achieved a reduction of at least 4 points in their PSQI score. The pooled estimates derived from the included studies showed that AJ combined with MA resulted in greater improvements in the mean PSQI score and responder rate than MA alone (Fig. 4 a and b). The mean improvement approach revealed that AJ + MA resulted in an additional improvement of 2.024 points in the PSQI score and an additional cost of $434 relative to MA alone. The ICER was $214 per 1-point improvement in the PSQI score. The AJ + MA group incurred an additional cost of $434 and had an incremental gain of 0.198 compared with the MA group. The corresponding ICER was $2,198 per additional responder (Table 2 ). Fig. 4. Open in a new tab Pairwise meta-analysis of the pooled mean differences in PSQI scores. ( A ) and decision tree analysis of responder rates ( B ) comparing acupoint injection combined with manual acupuncture (AJ + MA) versus manual acupuncture alone (MA) Table 2. Base case results of the cost-effectiveness analysis Outcome indicator Incremental cost (USD) Incremental outcome ICER (USD per unit) Improvement in sleep quality (PSQI score) 434 2.024 214 Clinical responder rate (PSQI improvement ≥ 4 points) 434 0.198 2198 Open in a new tab Abbreviations: PSQI, Pittsburgh Sleep Quality Index; ICER, incremental cost-effectiveness ratio Sensitivity analysis Probabilistic and deterministic sensitivity analyses were conducted to assess the robustness of the base-case findings. The probabilistic sensitivity analysis involved 4,000 Monte Carlo iterations. The cost-effectiveness planes for the PSQI improvement and response-based approaches showed that almost all the simulated incremental cost-effect pairs were located in the northeast quadrant. The CEACs showed that the probabilities of AJ + MA being cost-effective were approximately 95% and 95% at WTP thresholds of approximately $400 per 1-point improvement in PSQI and $5,000 per additional responder, respectively (Fig. 5 ). Fig. 5. Open in a new tab Cost-effectiveness planes and cost-effectiveness acceptability curves for acupoint injection therapy for primary insomnia. Values were calculated using bootstrapping (4,000 resamples) to estimate the incremental cost-effectiveness ratio (ICER) comparing AJ + MA with MA alone Deterministic one-way sensitivity analyses were also performed to identify the key parameters influencing the ICER. The variations in the assumed correlation coefficient between the pre-treatment and post-treatment PSQI scores (r, range: 0.3–0.7) had only a minimal effect on the ICER, which remained consistently at approximately $214 per 1-point improvement in PSQI (Additional Fig. 6 a). The PSQI improvement threshold for defining responders (K, range: 3–5 points) and the correlation coefficient (r, range: 0.3–0.7) were varied in the response-based approach (Additional Fig. 6 b). The ICER values were influenced by the threshold parameter, ranging from approximately $1,900 to $2,800 per additional responder. However, variations in the correlation coefficient resulted in relatively minor changes, with ICERs ranging from $2,000 to $2,400. The results of the probabilistic and deterministic sensitivity analyses indicated that the overall findings were largely stable, and the cost-effectiveness of AJ + MA relative to MA alone was preserved across most plausible parameter ranges. Discussion This discussion has been reorganized to provide a structured and in-depth interpretation of the findings, including overall outcomes, comparative advantages, mechanisms and economic value, clinical implications, and study limitations. Overview of main findings Insomnia is a major public health concern and one of the most common sleep disorders, with a prevalence of approximately 12.4% [ 54 ]. Pharmacological treatments are widely used in clinical practice, but they carry risks such as dependence and withdrawal symptoms [ 55 ]. AJ has been shown to alleviate sleep disturbances and improve psychological well-being in patients with primary insomnia [ 16 , 17 ]. However, evidence on the effectiveness and cost-effectiveness of AJ is limited. This study aimed to comprehensively assess the therapeutic outcomes and economic value of AJ through a meta-analysis and cost-effectiveness evaluation. Understanding the economic value of emerging therapies is crucial for guiding the efficient allocation of healthcare resources. To the best of our knowledge, this study is the first to systematically review the efficacy and economic value of AJ as a complementary alternative therapy for primary insomnia. The meta-analysis of 24 RCTs involving 1,851 patients with primary insomnia revealed significant differences between AJ + MA and MA based on the pairwise comparisons. AJ + MA was also ranked higher based on the NMA. The AJ + MA vs. MA comparison was selected as the most appropriate model for the cost-effectiveness evaluation because it had the lowest heterogeneity. The AJ + MA group showed an average improvement of 2.024 points in PSQI at an additional cost of $434, yielding an ICER of approximately $214 per 1-point improvement in PSQI. The increase in the proportion of responders (≥ 4-point improvement in PSQI) was 22.8%, which corresponded to an ICER of approximately $1,907 per additional responder. In both the PSQI improvement-based and responder-based analyses, the cost-effectiveness planes indicated that nearly all simulated incremental cost–effect pairs were located in the northeast quadrant, demonstrating that AJ + MA consistently produced greater effectiveness at higher costs than MA alone (Fig. 4 a and b). The CEACs further showed that the probability of AJ + MA being cost-effective reached approximately 95% at a WTP threshold of around $400 per 1-point improvement in the PSQI (Fig. 3 c). These findings should be interpreted as indicative rather than definitive, as no established willingness-to-pay threshold exists for PSQI-based outcomes. Although the ICER suggests a potentially favorable economic profile, this interpretation remains uncertain. Sensitivity analyses demonstrated minimal variation in cost-effectiveness estimates, supporting the robustness of the results. The results suggest that AJ may provide greater therapeutic benefits when combined with other treatment modalities. Advantages and significance compared to previous studies The findings of this study were derived from a systematic and comprehensive review of multiple primary RCTs. Pooled estimates were calculated using inverse variance weighting, which provided more reliable and precise effect estimates. These synthesized results were used as key input parameters in the cost-utility model. The present study integrated the results of meta-analyses, which enhanced the robustness and validity of the findings. This contrasts with previous economic models that simply aggregated the outcomes of individual RCTs. In addition, unlike previous studies that focused solely on the clinical outcomes, this study explicitly incorporates cost-effectiveness analysis within a network meta-analysis framework. This integrated approach enhances its relevance for healthcare decision-making and resource allocation, particularly in settings with constrained healthcare budgets. The medical costs, including the unit costs of AJ and MA, were calculated using data from the local Medical Security Administration of the region where the clinical studies were conducted and extrapolated for use in the analysis. The economic evaluation was performed from the healthcare system perspective and included both direct and indirect costs. Research on the effectiveness and cost-effectiveness of complementary and alternative medicine has increased worldwide [ 56 ]. However, studies on AJ for insomnia remain extremely limited. The results of this study provide important foundational evidence for the potential inclusion of AJ as a cost-effective therapeutic option within national healthcare systems. Future studies incorporating long-term follow-up and cost surveys are needed to evaluate cost-effectiveness by assessing whether the ICER falls below the WTP threshold. Mechanism and economic value of AJ therapy AJ combines the pharmacological effects of injected substances with the stimulatory effects of acupoints to produce neuroprotective and antioxidant actions. It is currently used to treat various diseases, including primary insomnia [ 13 , 14 ]. Frequently used acupoints (e.g., SP6 [ 57 , 58 ] and M-HN-54 [ 59 ]) and injection substances (e.g., vitamin B12, Danshen, and Tianma) [ 60 – 62 ] have been associated with improvements in sleep-related outcomes through modulation of neurotransmitter activity and cerebral circulation. However, the interaction between acupoints and injected substances remains unclear and requires further investigation. From a health economics perspective, these findings suggest that AJ + MA may represent an efficient allocation of healthcare resources, as it achieves improved clinical outcomes with acceptable incremental costs. This is particularly relevant in the context of increasing demand for cost-effective, non-pharmacological interventions for chronic conditions such as insomnia. Clinical implications AJ may serve as a complementary or alternative therapeutic option, particularly for patients who experience adverse effects from pharmacological treatments. The combination of AJ with manual acupuncture demonstrated improved clinical outcomes with acceptable additional costs, supporting its potential integration into clinical practice. These findings may inform healthcare providers and policymakers regarding the incorporation of AJ into treatment strategies and reimbursement systems. Moreover, the incorporation of AJ into clinical pathways may contribute to reducing long-term healthcare utilization associated with chronic insomnia; however, this requires further validation. Limitations and future directions This study had some limitations. First, all the included studies were conducted in China, which may have introduced publication bias. The type of AJ used was based on the policy of the country. Second, blinding was impossible due to the characteristics of acupoint injection, which led to the inclusion of low-quality studies. Third, the small sample sizes, short treatment durations, and limited follow-up data reduced the reliability of the results. Fourth, different AJ injection materials were used in the RCTs. Future economic evaluations should focus on the most representative AJ injection material to ensure consistency and generalizability of the findings. The costs were extrapolated, and the analysis was conducted from a limited societal perspective rather than a full societal perspective. This study provides fundamental evidence of the therapeutic effects of AJ in patients with insomnia. It is expected to serve as a basis for exploring AJ as a potential alternative therapy to overcome the limitations and side effects of current pharmacological treatments for insomnia. Future research should focus on large-scale, multicenter randomized controlled trials with standardized AJ protocols and rigorous economic evaluations to strengthen the evidence base. Conclusions Our results indicated that AJ combined with MA may represent a promising approach for improving sleep quality. The economic analysis suggested a potentially favorable profile under specific assumptions at modest additional costs, as reflected by the favorable ICER values for PSQI improvement and additional responders. These results provide a relative indicator of economic value and suggest that AJ, especially in combination therapy, may offer clinical benefits, while the economic implications require further validation for managing insomnia. Further large-sample, multi-center, and high-quality RCTs and real-world economic studies are warranted to establish stronger evidence for the clinical management of primary insomnia. Supplementary Information Below is the link to the electronic supplementary material. Supplementary Material 1 (89KB, docx) Supplementary Material 2 (106.2KB, docx) Supplementary Material 3 (66.2KB, docx) Supplementary Material 4 (159.5KB, docx) Supplementary Material 5 (42.5KB, docx) Supplementary Material 6 (278.5KB, docx) Supplementary Material 7 (26.1KB, docx) Supplementary Material 8 (23.7KB, docx) Supplementary Material 9 (39.1KB, docx) Supplementary Material 10 (25.2KB, docx) Supplementary Material 11 (23.4KB, docx) Acknowledgements Not applicable. Abbreviations AJ Acupoint injection NMA Network meta-analysis RCTs Randomized controlled trials PSQI Pittsburgh Sleep Quality Index MA Manual acupuncture ICER Incremental cost-effectiveness ratios AA Auricular acupuncture HM Herbal medicine WM Western medicine MDs Mean differences CI Confidence intervals NMA Network meta-analysis CEACs Cost-effectiveness acceptability curves WTP Willingness-to-pay Author contributions HYZ: conceptualization, methodology, and writing–original draft; MHY: methodology, formal analysis, and writing–original draft; HYG: writing–review and editing; JHJ: supervision, writing–review and editing, and funding acquisition. Funding This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health and Welfare, Republic of Korea (RS-2025-02221995). Data availability No datasets were generated or analysed during the current study. 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Zhejiang J Traditional Chin Med. 2008:184–5. Associated Data This section collects any data citations, data availability statements, or supplementary materials included in this article. Supplementary Materials Supplementary Material 1 (89KB, docx) Supplementary Material 2 (106.2KB, docx) Supplementary Material 3 (66.2KB, docx) Supplementary Material 4 (159.5KB, docx) Supplementary Material 5 (42.5KB, docx) Supplementary Material 6 (278.5KB, docx) Supplementary Material 7 (26.1KB, docx) Supplementary Material 8 (23.7KB, docx) Supplementary Material 9 (39.1KB, docx) Supplementary Material 10 (25.2KB, docx) Supplementary Material 11 (23.4KB, docx) Data Availability Statement No datasets were generated or analysed during the current study. 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