ABSTRACT
Objective
To evaluate the effectiveness of acupuncture for knee osteoarthritis across different comparators, including usual care, sham acupuncture, waiting‐list, pharmacological treatments, and other non‐pharmacological interventions.
Methods
An umbrella review of systematic reviews/meta‐analyses of acupuncture in adults with knee osteoarthritis was performed. MEDLINE, Embase, Cochrane Library, CNKI, WanFang, and VIP databases were searched. Comparisons were conducted among different acupuncture types. Methodological quality was assessed using Revised Assessment of Multiple Systematic Reviews (R‐AMSTAR), and the best available evidence was selected.
Results
Twenty‐three systematic reviews were included, with a mean R‐AMSTAR score of 30.87. Most acupuncture modalities showed consistent improvements in pain and physical function. Compared with sham acupuncture, usual care, and waiting‐list, acupuncture produced clinically meaningful improvements in pain and joint function. Compared with pharmacological treatments, acupuncture demonstrated effects similar to non‐steroidal anti‐inflammatory drugs, while electroacupuncture was superior in improving joint stiffness and overall response rates. Compared with Tui Na or massage, acupuncture showed a slower onset of effect and similar or slightly inferior improvements in function and stiffness. Adverse events were generally mild and local, with a lower risk of gastrointestinal complications. Treatment effects were most evident at the end of treatment and during short‐term follow‐up (<3 months), whereas long‐term evidence remained limited.
Conclusions
Acupuncture of all modalities relieves pain and improve function in knee osteoarthritis patients, thus is a key non‐pharmacological option or add‐on therapy when medications are unsuitable. For optimal and sustained effect of acupuncture treatment in knee osteoarthritis, more rigorous sham acupuncture–controlled designs and long‐term follow‐up are needed.
Keywords: acupuncture, knee osteoarthritis, non‐pharmacological therapy, systematic review, umbrella review
1. Introduction
Knee osteoarthritis (KOA) is a highly prevalent degenerative joint disorder and a leading cause of chronic pain, joint stiffness, and functional impairment, predominantly affecting middle‐aged and elderly individuals [1]. Characterized by a progressive, often recurrent clinical course, this disorder significantly impairs ambulatory capacity and quality of life [2, 3]. Pharmacological therapies, particularly non‐steroidal anti‐inflammatory drugs (NSAIDs), offer symptomatic relief but are limited by contraindications, particularly in high‐risk populations, and often related to gastrointestinal, renal, and cardiovascular adverse effects [4, 5, 6, 7]. Thus current guidelines strongly recommend two effective non‐pharmacological interventions—exercise and weight loss, which are however found hard to maintain over the long term in real‐world practice [8]. Therefore, there is an urgent need for safe, effective, and sustainable therapeutic strategies that may serve as adjuncts or alternatives to existing treatments.
Acupuncture has long been a widely used adjunctive treatment for KOA. Despite the expanding evidence base from randomized controlled trials (RCTs) and systematic reviews, there is so far no consensus regarding the clinical value of acupuncture for KOA management. Major international guidelines, including those from the American College of Rheumatology/Arthritis Foundation (ACR/AF, 2019) and the American Academy of Orthopaedic Surgeons (AAOS, 2021), provide only conditional or limited recommendations for acupuncture [5, 9]. In contrast, domestic guidelines in China, such as the 2023 guidelines issued by the Orthopedics Branch of the Chinese Medical Association, strongly recommend acupuncture, often designating it as a first‐line intervention or a highly recommended treatment option. These divergent recommendations may result from differences in standards of evidence, interpretation of clinical relevance, and contextual factors, including healthcare systems and cultural practices (Supplementary Material A) [10, 11].
Despite the large amount of RCTs on the clinical effectiveness of acupuncture on KOA, their findings remain inconsistent. Some studies have reported no clinically meaningful benefit of acupuncture compared with sham acupuncture [12, 13], whereas comparisons with waiting‐list or usual care controls have demonstrated clear improvements from administrating of acupuncture [13]. Such confounding at the evidence‐level undermines the certainty of evidence assessments during guideline development, and hinders clinicians from identifying clinically informative conclusions. This umbrella review aimed to provide practical evidence for clinical decision‐making in treating KOA with acupuncture by collating related systematic reviews and meta‐analyses. Methodological quality was assessed using the Revised Assessment of Multiple Systematic Reviews (R‐AMSTAR) tool; the best available evidence was selected from the original studies to evaluate the clinical efficacy of different types of acupuncture in various situations.
2. Methods
2.1. Study Design and Reporting
This study adopted an umbrella review approach to comprehensively compare the evidence for different types of acupuncture in the treatment of KOA [14]. The reporting followed the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) 2020 guidelines [15]. The study protocol was prospectively registered in the PROSPERO database (CRD420251240761).
2.2. Eligibility Criteria
Systematic reviews and meta‐analyses were included if they met the following criteria: (1) synthesized evidence derived exclusively from RCTs; (2) enrolled adult participants clinically diagnosed with KOA; (3) evaluated acupuncture‐based interventions, including manual acupuncture, electroacupuncture, warm needle acupuncture, laser acupuncture, acupotomy (needle knife), fire needling, or Fu's subcutaneous needling (FSN); (4) assessed acupuncture as a monotherapy, an adjunctive therapy (such as acupuncture + A vs. A alone), or in direct comparison with non‐acupuncture controls (such as sham acupuncture, waiting‐list or no‐treatment, usual care, pharmacological therapies, or other non‐pharmacological interventions); and (5) reported at least one clinically relevant outcome related to pain intensity or physical function.
To ensure interpretability of effect estimates, reviews combining different comparator types (e.g., sham acupuncture with active treatment or waiting‐list controls) within a single control group were excluded. Additional exclusions included conference abstracts, duplicate or retracted publications, reviews of multimodal interventions in which the independent effect of acupuncture could not be isolated, reviews comparing acupuncture modalities only, reviews focused on thermal‐based interventions (e.g., moxibustion), network meta‐analyses (because of methodological differences from conventional pairwise meta‐analyses, and narrative reviews without meta‐analytic pooling.
2.3. Literature Search
A comprehensive and systematic literature search was conducted across major electronic databases in English and Chinese from inception to November 15, 2025, including MEDLINE (OVID), Embase (OVID), the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data, and the Chinese VIP database. Detailed search strategies are provided in Supplementary Material B. To ensure comprehensive evidence retrieval, reference lists of all included reviews were manually screened for additional relevant literature.
2.4. Study Selection and Data Extraction
Titles, abstracts, and full texts were screened independently by two reviewers (Y.X.Y. and Y.L.L.) using prespecified eligibility criteria. Discrepancies were resolved through discussion or consultation with a third reviewer (M.C.). A standardized framework was used during data extraction to ensure consistency and completeness. Extracted data included publication year, number of RCTs included in each review, type of acupuncture interventions and comparator groups, primary and secondary outcomes, pooled effect estimates, statistical models, measures of heterogeneity (I2), risk‐of‐bias assessments of primary studies, reported Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments (if available), funding sources, and potential conflicts of interest.
2.5. Methodological Quality Assessment
The methodological quality of the included systematic reviews was independently assessed using the R‐AMSTAR tool [16], an 11‐item instrument with scores ranging from 11 to 44. Based on established thresholds, methodological quality was categorized into four levels: Grade A (high quality: 36–44 points), Grade B (moderate quality: 28–35 points), Grade C (low quality: 20–27 points), and Grade D (critically low quality: 11–19 points). GRADE‐based certainty‐of‐evidence assessments, where reported, were extracted directly from the original systematic reviews [17]. No secondary re‐evaluation of primary RCTs quality was performed. Instead, we extracted the quality assessments reported in the included reviews and interpreted the findings in light of both the methodological quality of the reviews and the reported certainty of evidence.
2.6. Selecting the Evidence
To ensure that conclusions were derived from the most reliable and clinically relevant data, a hierarchy evidence selection strategy was applied, adapted from a previous umbrella review in orthopedic research [18]. In this umbrella review, level 1 evidence was defined as evidence derived from systematic reviews or meta‐analyses of RCTs. When multiple reviews addressed the same comparison, prioritization was based on methodological quality (R‐AMSTAR), followed by recency and the use of predefined primary outcomes. Meta‐analyses primarily composed of RCTs with low risk of bias were interpreted alongside high methodological quality systematic reviews to ensure that the conclusions for each comparison reflected the most robust and clinically credible evidence available. Where discrepancies between systematic reviews and individual RCT findings were observed, greater weight was given to the results of systematic reviews. All results presented in this figure are derived from included systematic reviews and meta‐analyses; no estimates are directly calculated from individual RCTs.
3. Results
Among the total of 816 records were initially identified, 116 were retained following the screening process (Figure 1), and 23 studies ultimately included in our research. Specific reasons for exclusion during the full‐text review are listed in Supplementary Material C. Baseline characteristics of the included reviews are provided in Supplementary Material D.
FIGURE 1.
PRISMA flow diagram.
The methodological quality assessment using the R‐AMSTAR scale revealed a mean score of 30.87 (Table 1). Most studies presented notable methodological deficiencies, including inadequate grey literature searching, absence of excluded study lists, insufficient quality assessment for included studies, and lack of evaluation of publication bias and statistical testing. By contrast, data extraction and evidence synthesis were adequately conducted in most studies.
TABLE 1.
Methodological quality of eligible studies (n = 23).
| Study | R‐AMSTAR items | R‐AMSTAR score (11‐44) | Grade (A‐D) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | |||
| Wang et al. 2020 [12] | 3 | 4 | 4 | 2 | 2 | 3 | 2 | 3 | 4 | 3 | 2 | 32 | B |
| Manheimer et al. 2007 [13] | 3 | 4 | 2 | 2 | 3 | 4 | 2 | 3 | 4 | 2 | 3 | 32 | B |
| Cao et al. 2012 [19] | 3 | 4 | 3 | 2 | 2 | 3 | 2 | 2 | 4 | 1 | 1 | 27 | C |
| Manheimer et al.2010 [20] | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 2 | 4 | 3 | 4 | 41 | A |
| Liu et al.2024 [21] | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 2 | 4 | 4 | 3 | 41 | A |
| Shim et al. 2016 [22] | 4 | 4 | 4 | 2 | 2 | 4 | 2 | 2 | 4 | 2 | 2 | 32 | B |
| Zeng et al. 2025 [23] | 4 | 4 | 4 | 4 | 2 | 4 | 4 | 3 | 3 | 2 | 4 | 38 | A |
| Park et al. 2023 [24] | 4 | 4 | 3 | 4 | 2 | 4 | 3 | 2 | 4 | 2 | 3 | 35 | B |
| Kwak et al. 2023 [25] | 3 | 4 | 3 | 2 | 2 | 2 | 2 | 2 | 4 | 4 | 3 | 31 | B |
| Chen et al. 2017 [26] | 3 | 4 | 2 | 2 | 2 | 4 | 2 | 2 | 4 | 2 | 2 | 29 | B |
| Li et al. 2023 [27] | 3 | 4 | 4 | 2 | 2 | 4 | 4 | 2 | 4 | 2 | 3 | 34 | B |
| Zhao et al. 2016 [28] | 3 | 4 | 4 | 2 | 2 | 4 | 3 | 1 | 3 | 1 | 1 | 28 | B |
| Liu et al. 2025 [29] | 4 | 4 | 3 | 2 | 2 | 4 | 2 | 2 | 4 | 4 | 3 | 34 | B |
| Du et al. 2021 [30] | 3 | 4 | 2 | 2 | 2 | 4 | 2 | 2 | 4 | 3 | 1 | 29 | B |
| Zhu et al. 2023 [31] | 3 | 4 | 2 | 2 | 2 | 2 | 2 | 1 | 4 | 3 | 1 | 26 | C |
| Lu et al. 2015 [32] | 3 | 1 | 3 | 2 | 1 | 2 | 2 | 2 | 4 | 3 | 1 | 24 | C |
| Guo et al. 2018 [33] | 3 | 4 | 2 | 1 | 1 | 2 | 2 | 2 | 4 | 3 | 1 | 25 | C |
| Feng et al. 2019 [34] | 3 | 4 | 2 | 1 | 1 | 1 | 2 | 2 | 4 | 3 | 2 | 25 | C |
| Sun et al. 2020 [35] | 3 | 4 | 2 | 2 | 2 | 2 | 2 | 1 | 4 | 3 | 2 | 27 | C |
| Di et al. 2025 [36] | 4 | 4 | 3 | 2 | 2 | 4 | 2 | 3 | 4 | 4 | 3 | 35 | B |
| Sun et al. 2020 [37] | 4 | 4 | 4 | 2 | 2 | 4 | 2 | 3 | 4 | 3 | 3 | 35 | B |
| Wang et al. 2025 [38] | 4 | 4 | 2 | 2 | 2 | 2 | 2 | 2 | 4 | 3 | 3 | 30 | B |
| Yu et al. 2018 [39] | 3 | 2 | 2 | 2 | 1 | 1 | 2 | 1 | 3 | 2 | 1 | 20 | C |
| Average | 3.39 | 3.78 | 2.96 | 2.26 | 2.04 | 3.13 | 2.43 | 2.04 | 3.87 | 2.70 | 2.26 | 30.87 | B |
R‐AMSTAR items: 1—Was an “a priori” design provided?; 2—Was there duplicate study selection and data extraction?; 3—Was a comprehensive literature search performed?; 4—Was the status of publication used as an inclusion criterion?; 5—Was a list of studies provided?; 6—Were the characteristics of the included studies provided?; 7—Was the scientific quality of the included studies assessed and documented?; 8—Was the scientific quality of the the included studies used appropriately in formulating conclusions? 9—Were the methods used to combine the findings of studies appropriate? 10—Was the likelihood of publication bias assessed? 11—Was the conflict of interest included? In theory, the lowest score of R‐AMSTAR is 11, and the highest is 44. The higher the score, the higher the degree of rigor of the research method.
Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; R‐AMSTAR, Revised Assessment of Multiple Systematic Reviews.
3.1. Acupuncture Versus Sham Acupuncture
3.1.1. Acupuncture
Five systematic reviews comparing acupuncture with sham acupuncture were included [12, 13, 19, 20, 21], comprising 19 RCTs with a total of 3465 participants. These reviews (published between 2007 and 2024) were of moderate to high methodological quality (R‐AMSTAR 27–41; Table 1). Baseline characteristics are provided in Supplementary Material D. Acupuncture interventions included manual acupuncture and electroacupuncture, unless otherwise specified. All included systematic reviews indicated that acupuncture yielded statistically significant improvements in pain intensity and physical function relative to sham acupuncture, with such beneficial effects predominantly observed in the short‐term follow‐up (≤3 months). However, available evidence suggests that these benefits may not be sustained at long‐term follow‐up (≥ 6–12 months). The highest‐quality evidence [21] demonstrated significant improvements in pain (standardized mean difference (SMD) = −0.74, 95% CI −1.08 to −0.39) and function (SMD = −0.77, 95% CI −1.21 to −0.34), with effect sizes exceeding the predefined minimal clinically important difference (MCID) threshold (MCID = 0.37) (Table 2; Figure 2), although the certainty of evidence was very low. These findings were further supported by evidence from RCTs with relatively low risk of bias (Supplementary Material E) [40]. Overall, the available evidence indicated that acupuncture provided clinically meaningful short‐term benefits in patients with KOA compared with sham acupuncture.
TABLE 2.
Summary of results of the umbrella review.
| Comparator | Study | Intervention | Control | Key findings | Assessment time | MCID threshold | GRADE results |
|---|---|---|---|---|---|---|---|
| Sham acupuncture | Liu et al.2024 [21] | Acupuncture (MA, EA) | SA |
14 RCTs (N = 2488): Pain: SMD = −0.74 (95%CI −1.08 to −0.39) Function: SMD = −0.77 (95%CI −1.21 to −0.34) |
End of treatment | 0.37 | very low |
| Liu et al.2024 [21] | EA | SA |
6 RCTs (N = 857): Pain: SMD = −1.09 (95%CI −1.77 to −0.40) Function: SMD = −1.40 (95%CI −2.47 to −0.34) |
End of treatment | 0.37 | NR | |
| Zeng et al. 2025 [23] | LA | SA |
4 RCTs (N = 184): Pain (VAS 10 cm): WMD = −2.33 cm (95%CI −3.57 to −1.09) Function (WOMAC 0–240): WMD = −39.06 (95%CI −63.79 to −14.32) |
28‐63 days follow‐up | 1 cm on 10 cm VAS | Low | |
| Waiting‐list | Manheimer et al. 2010 [20] | Acupuncture (MA, EA) | Waiting list |
4 RCTs (N = 615): Pain: SMD = −0.96 (95%CI −1.21 to −0.70) Function: SMD = −0.93 (95%CI −1.16 to −0.69) |
≤3 months | Pain = 0.39, Function = 0.37 | NR |
| Usual care | Manheimer et al. 2007 [13] | Acupuncture (MA, EA) | Usual care |
2 RCTs (N = 420): Pain: SMD = 0.52 (95%CI 0.39 to 0.66) Function: SMD = 0.45 (95%CI 0.32 to 0.59). Benefits maintained at 6 months. |
≤3 months | Pain = 0.39, Function = 0.38 | NR |
| Pharmacological treatments | Liu et al.2024 [21] | Acupuncture (MA, EA) | NSAIDs |
14 RCTs (N = 1313): Pain: SMD = −1.01 (95%CI −1.47 to −0.54); Function: SMD = −0.61 (95%CI −1.01 to −0.21). Physical health: MD = 4.85 (95%CI 2.95 to 6.75) Mental health: MD = 2.90 (95%CI 0.51 to 5.29) Global health: no difference |
End of treatment | NR | very low |
| Kwak et al. 2023 [25] | Acupuncture + oral NSAIDs | Oral NSAIDs |
6 RCTs (N = 939): End of treatment: VAS: MD = 21.30 (95%CI 6.13 to 36.47) WOMAC total: MD = 12.69 (95%CI 7.61 to 17.77) Short‐term (4‐6 weeks): VAS: MD = 23.05 (95%CI 19.67 to 26.43) WOMAC total: MD = 13.67 (95%CI 10.16 to 17.18) |
4–6 week follow‐up | NR | NR | |
| Li et al., 2023 [27] | EA | NSAIDs |
20 RCTs (N = 1616): VAS: no difference (MD = 0.80, 95%CI −0.23 to 1.82) WOMAC total: MD = 8.39 (95%CI 2.77 to 14.00 Effective rate: RR 1.27 (95% CI 1.19–1.35) Stiffness: MD = 1.56 (95%CI 0.34 to 2.78) WOMAC pain: no difference (MD = 0.53, 95%CI −0.58 to 1.63) Physical function: no difference (MD = 0.18, 95%CI −1.52 to 1.88) |
NR | NR |
VAS pain: Very low WOMAC total: Low Clinical Effective rate: High |
|
| Liu et al. 2025 [29] | FSN | Medication |
4 RCTs (N = 321): VAS pain: SMD = −2.35 (95%CI −4.31 to −0.38) WOMAC function: SMD = −1.68 (95%CI −2.59 to −0.77) Total effective rate: OR = 3.09 (95%CI 1.67 to 5.73) |
<12 week | NR | NR | |
| Du et al. 2021 [30] | AA+Western medicine | Western medicine |
2 RCTs (N = 217): VAS pain: MD = −1.08 (95%CI −1.52 to −0.64) HSS function: MD = 9.63 (95%CI 6.74 to 12.52) Total effective rate: RR = 1.32 (95%CI 1.05 to 1.65) |
End of treatment | NR | NR | |
| Zhu et al. 2023 [31] | FFNA | Western medicine |
3 RCTs (N = 220): VAS pain SMD: = −0.53 (95%CI −0.79 to −0.26) WOMAC function: SMD = −0.87 (95%CI −1.51 to −0.24) Total effective rate: no difference (3 RCTs, N = 210; RR = 1.28, 95%CI 1.00 to 1.65) |
NR | NR | NR | |
| Sun et al. 2020 [35] | WNA | Nabumetone |
2 RCTs (N = 140): WOMAC pain: SMD = 1.30 (95%CI 0.93 to 1.67 |
NR | NR | NR | |
| Sun et al. 2020 [37] | AC | NSAIDs |
6 RCTs (N = 381): VAS pain: MD = −0.68 (95%CI −0.99 to −0.37) WOMAC pain: no difference (MD = −2.07, 95%CI −4.62 to 0.48) Total effectiveness rate: no difference |
3‐5 week follow‐up | NR | NR | |
| Di et al. 2025 [36] | AC | Sodium hyaluronate injection |
6 RCTs (N = 534): WOMAC pain: SMD = −1.84 (95%CI −2.15 to −1.49) WOMAC stiffness: SMD = −0.86 (95%CI −1.65 to −0.06) WOMAC total: SMD = −1.73 (95%CI −2.54 to −0.93) VAS pain: SMD = −1.90 (95%CI −2.19 to −1.61) ISOA: SMD = −1.43 (95%CI −1.73 to −1.12) Total effectiveness: SMD = −1.90 (95%CI −2.19 to −1.61) |
End of treatment | NR | NR | |
| Massage | Liu et al. 2025 [29] | FSN | Massage |
3 RCTs (N = 248): VAS pain: SMD = −2.46 (95%CI −3.91 to −1.02) WOMAC: function SMD = −2.08 (95%CI −3.31 to −0.84) |
<12 week | NR | NR |
| Wang et al. 2025 [38] | WNA+massage | Massage |
12 RCTs (N = 1136): VAS pain: SMD = −1.84 (95%CI −2.96 to −0.72) WOMAC total: SMD = −1.01 (95%CI −1.49 to −0.52) Stiffness/function: no difference |
NR | NR | NR | |
| Wang et al. 2025 [38] | AC+massage | Massage |
5 RCTs (N = 374): VAS pain: SMD = −1.57 (95%CI −2.51 to −0.64) WOMAC tota:l SMD = −0.88 (95%CI −1.36 to −0.39) |
NR | NR | NR | |
| TMT | Yu et al., 2018 [39] | Acupuncture | TMT |
6 RCTs (N = 590): WOMAC pain: no difference (SMD = 0.79, 95%CI 0.01 to 1.57, p = 0.05) WOMAC function: no difference (SMD = 0.59, 95%CI −0.09 to 1.26) WOMAC stiffness: SMD = 0.66 (95%CI 0.06 to 1.27) |
End of treatment | NR | NR |
| Exercise | Zeng et al. 2025 [23] | LA | Exercise |
1 RCT (N = 109): VAS pain: WMD = −0.84 cm (95%CI −1.12 to −0.56); Clinical relevance uncertain |
28 days follow‐up | 1 cm on 10 cm VAS | Low |
Abbreviations: CM, Chinese medicine; CNKI, China National Knowledge Infrastructure; FFNA, filiform fire needle acupuncture; FSN, Fu's subcutaneous needling; HA, hyaluronic acid; ISOA, Index of Severity for Osteoarthritis; KOA, knee osteoarthritis; LKSS, Lysholm Knee Scoring Scale; MCID, minimal clinically important difference; NSAIDs, non‐steroidal anti‐inflammatory drugs; RCTs, randomized controlled trials; SA, sham acupuncture; SRs, systematic reviews; VAS, visual analogue scale; WM, Western medicine; WNA, warm needle acupuncture; EA, electroacupuncture; MA, manual acupuncture; LA, laser acupuncture; AA, abdominal acupuncture; AC, acupotomy; TMT, traditional manual therapy; ET, exercise therapy; MD, mean difference; SMD, standardized mean difference; WMD, Weighted Mean Difference; RR, risk ratio; OR, odds ratio; CI, confidence interval; NR, not reported.
FIGURE 2.
Summary of results of the umbrella review. LKSS, Lysholm Knee Scoring Scale; HSS, hospital for special surgery knee score; ISOA, Index of Severity for Osteoarthritis; Acu, acupuncture; EA, electroacupuncture; MA, manual acupuncture; LA, laser acupuncture; AA, abdominal acupuncture; FSN, Fu's subcutaneous needling; FFNA, filiform fire needle acupuncture; WNA, warm needle acupuncture; AC, acupotomy; TMT, traditional manual therapy; ET, exercise therapy; VAS, visual analogue scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index. †Acu interventions include both MA and EA. * The control group received analgesics. ₹ The control group included Chinese patent medicines, oral Western medications, and topical agents. The comparisons were categorized as, FSN combined with oral medication versus oral medication alone (where oral medication included Chinese patent medicines or oral Western medications), and FSN versus topical flurbiprofen gel plaster. ** The control group received non‐steroidal anti‐inflammatory drugs (NSAIDs). € Comparison of Acu combined with oral medication versus oral medication alone (oral medication includes analgesics or NSAIDs). € € Comparison of AA combined with Western medicine versus Western medicine alone. £ WNA combined with massage versus massage alone. ₺ AC combined with massage versus massage alone. é Data for WOMAC pain represents the subgroup analysis results of warm needle acupuncture versus nabumetone. ֏ The control group received intra‐articular hyaluronic acid injections. § The control group received rehabilitation or massage therapy.
3.1.2. Electroacupuncture
Three systematic reviews comparing EA with sham acupuncture were included [20, 21, 22], comprising 11 RCTs with a total of 1549 participants. These reviews (published between 2010 and 2024) were of moderate to high methodological quality (R‐AMSTAR 32–41; Table 1). All included systematic reviews demonstrated that electroacupuncture significantly improved pain and physical function compared with sham acupuncture (Supplementary Material D). The highest‐quality evidence [21] reported clinically meaningful improvements in pain (SMD = −1.09, 95% CI −1.77 to −0.40) and function (SMD = −1.40, 95% CI −2.47 to −0.34), exceeding the predefined MCID threshold (MCID = 0.37; Table 2; Figure 2). These findings were supported by low‐risk‐of‐bias RCTs [40], which showed sustained improvements at the end of treatment and during follow‐up (approximately 4–5 months) (Supplementary Material E). Adverse events were predominantly mild and localized, and serious adverse events were rare. Overall, the available evidence supported a clinically meaningful benefit of EA over sham acupuncture in patients with KOA.
3.1.3. Laser Acupuncture
One systematic review comparing laser acupuncture with sham acupuncture was included, comprising five RCTs with a total of 293 participants. The review was of high methodological quality (R‐AMSTAR = 38; Table 1). The systematic review reported clinically meaningful improvements in pain (weighted mean difference WMD) = −2.33 cm, 95% CI −3.57 to −1.09 cm) and function (WMD = −39.06, 95% CI −63.79 to −14.32), exceeding the predefined MCID threshold (1 cm on a 10‐cm visual analogue scale (VAS) for pain; Table 2; Figure 2), although the certainty of evidence was low. Adverse events were infrequently reported and showed no significant differences between groups. These findings were supported by low‐risk‐of‐bias RCTs [41], which showed sustained improvements at 28 days (Supplementary Material E). Overall, the available evidence suggested a potential short‐term benefit of laser acupuncture over sham acupuncture in patients with KOA, although the certainty of evidence was limited.
3.2. Acupuncture Versus Waiting‐List Controls
Three systematic reviews comparing acupuncture with waiting‐list controls were included [13, 19, 20]. These reviews (published between 2007 and 2012) were of moderate to high methodological quality (R‐AMSTAR 27–42; Table 1). All included systematic reviews demonstrated that acupuncture made significant improvements in pain and physical function compared with waiting‐list controls at short‐term follow‐up (≤3 months) (Supplementary Material D). The highest‐quality evidence [20] demonstrated clinically meaningful improvements in pain (SMD = −0.96, 95% CI −1.21 to −0.70) and function (SMD = −0.93, 95% CI −1.16 to −0.69), exceeding the established MCID thresholds (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain = 0.39, WOMAC function = 0.37; Table 2; Figure 2). Though long‐term follow‐up data were not identified for this comparison, its findings were further supported by evidence from RCTs with relatively low risk of bias (Supplementary Material E) [42]. Overall, the available evidence indicated that acupuncture provided clinically meaningful benefits over waiting‐list controls in patients with KOA.
3.3. Acupuncture Versus Usual Care
Two systematic reviews comparing acupuncture with usual care were included [13, 19], comprising six RCTs with a total of 1406 participants. These reviews (published in 2007 and 2012) were of moderate methodological quality (R‐AMSTAR 27–32; Table 1). All included systematic reviews confirmed that acupuncture yielded significant improvements in pain and physical function compared with usual care during short‐term follow‐up (≤3 months), with effects maintained up to approximately 6 months (Supplementary Material D). The highest‐quality evidence [13] demonstrated clinically meaningful improvements in pain (SMD = 0.52, 95% CI 0.39 to 0.66) and function (SMD = 0.45, 95% CI 0.32 to 0.59), exceeding established MCID thresholds (WOMAC pain = 0.39, WOMAC function = 0.38), with benefits sustained at 6 months (Table 2; Figure 2). These findings were supported by meta‐analyses that included RCTs with relatively low risk of bias (Supplementary Material E) [43]. Overall, the available evidence supported a clinically meaningful benefit of acupuncture over usual care in patients with KOA.
3.4. Acupuncture Versus Pharmacological Treatments
3.4.1. Acupuncture
Three systematic reviews comparing acupuncture with pharmacological treatments were included [21, 24, 25], comprising 40 RCTs with a total of 3522 participants. These very recent reviews (published between 2023 and 2024) were of moderate to high methodological quality (R‐AMSTAR 31–41; Table 1). All included systematic reviews demonstrated that acupuncture was associated with improvements in pain and physical function compared with pharmacological treatments (Supplementary Material D). The highest‐quality evidence [21] reported significant improvements in pain (SMD = −1.01, 95% CI −1.47 to −0.54) and function (SMD = −0.61, 95% CI −1.01 to −0.21), although the certainty of evidence was very low (Table 2; Figure 2). Acupuncture combined with NSAIDs showed greater improvements in pain and function than NSAIDs alone, with larger reductions in VAS and WOMAC scores at both the end of treatment and short‐term follow‐up (approximately 4–6 weeks) (Table 2). These findings were further supported by evidence from RCTs with relatively low risk of bias (Supplementary Material E) [44]. Acupuncture showed effects comparable to intra‐articular injections in pain relieving and function recovery, although the certainty of evidence was very low (Supplementary Material D) [21]. Overall, the available evidence indicates that acupuncture provides beneficial effects compared with pharmacological treatments in patients with KOA.
3.4.2. Electroacupuncture
Three systematic reviews comparing EA with pharmacological treatments were included [26, 27, 28], comprising 33 RCTs (N = 2834). These reviews (published between 2016 and 2023) were of moderate methodological quality (R‐AMSTAR 28–34; Table 1). All included systematic reviews demonstrated that EA improved clinical outcomes compared with pharmacological treatments (Supplementary Material D). The highest‐quality evidence [27] showed improved overall clinical effectiveness and knee function versus NSAIDs, with significant benefits in WOMAC total scores (MD = 8.39, 95% CI 2.77 to 14.00) and stiffness (MD = 1.56, 95% CI 0.34 to 2.78), supported by high‐certainty evidence. No significant differences were observed for pain or physical function (Table 2; Figure 2). EA combined with pharmacological therapy may further improve pain compared with pharmacological treatment alone. These findings were supported by evidence from RCTs with relatively low risk of bias (Supplementary Material E) [45]. Adverse events were less frequent with EA than with pharmacological treatments. Overall, the available evidence supported a beneficial effect of EA compared with pharmacological treatments in patients with KOA.
3.4.3. FSN
One systematic review comparing FSN with pharmacological treatments was included [29], comprising four RCTs (N = 321). The review was of moderate methodological quality (R‐AMSTAR = 34; Table 1). FSN was associated with significant improvements in pain, as measured by VAS (SMD = −2.35, 95% CI −4.31 to −0.38), and in joint function, as assessed by WOMAC (SMD = −1.68, 95% CI −2.59 to −0.77), and overall clinical effectiveness (OR = 3.09, 95% CI 1.67 to 5.73) compared with pharmacological treatments at follow‐up (<12 weeks) (Table 2). These findings were supported by RCTs (Supplementary Material E) [46]. Overall, the available evidence suggested a beneficial effect of FSN compared with pharmacological treatments in patients with KOA.
3.4.4. Abdominal Acupuncture
One systematic review comparing abdominal acupuncture with pharmacological treatments was included [30], comprising two RCTs (N = 217). The review was of moderate methodological quality (R‐AMSTAR = 29; Table 1). Abdominal acupuncture combined with pharmacological therapy was associated with significant improvements in pain, as assessed by VAS (MD = −1.08, 95% CI −1.52 to −0.64), in knee function, as assessed by hospital for special surgery knee score (HSS) (MD = 9.63, 95% CI 6.74 to 12.52), and overall clinical effectiveness (RR = 1.32, 95% CI 1.05 to 1.65) compared with pharmacological treatment alone at the end of treatment (Table 2; Figure 2). These findings were supported by RCTs with relatively low risk of bias, with greater improvements for combination therapy at 1‐month follow‐up but not at 2 months (Supplementary Material E) [47]. Overall, the available evidence suggested that abdominal acupuncture as an adjunct to pharmacological therapy may improve pain and function in the short term, although these effects were not sustained at later follow‐up (up to 2 months).
3.4.5. Filiform Fire Needle Acupuncture (FFNA)
One systematic review comparing FFNA with pharmacological treatments was included [31], comprising nine RCTs (N = 648). The review was of low methodological quality (R‐AMSTAR = 26; Table 1). Across the included comparisons, FFNA was associated with improved symptom relief compared with pharmacological treatments. The magnitude of these effects is reflected in direct comparisons with Western medicine, showing significant improvements in pain, as assessed by VAS (SMD = −0.53, 95% CI −0.79 to −0.26), and in function, as assessed by WOMAC (SMD = −0.87, 95% CI −1.51 to −0.24), with no significant difference in total effective rate (RR = 1.28, 95% CI 1.00 to 1.65; Table 2). These findings were supported by evidence from RCTs with relatively low risk of bias (Supplementary Material E) [48]. Overall, the available evidence suggested a potential benefit of FFNA compared with pharmacological treatments in patients with KOA, although the evidence is limited.
3.4.6. Warm Needle Acupuncture
Four systematic reviews comparing warm needle acupuncture with pharmacological treatments were included [32, 33, 34, 35]. These reviews (published between 2015 and 2020) were of low methodological quality (R‐AMSTAR 24–27; Table 1). The highest‐quality evidence [35] showed significant improvements in WOMAC pain with warm needle acupuncture compared with nabumetone (SMD = 1.30, 95% CI 0.93 to 1.67; Table 2; Figure 2). These findings were supported by RCTs with relatively low risk of bias, showing comparable effects to NSAIDs at treatment end but greater benefits during short‐term follow‐up (<10 weeks) (Supplementary Material E) [49]. Additional evidence indicates improvements in functional outcomes (HSS) and overall response rates compared with pharmacological treatment (Supplementary Material D) [32, 33, 34]. Overall, the available evidence suggested a potential benefit of warm needle acupuncture in patients with KOA.
3.4.7. Acupotomy
Two systematic reviews comparing acupotomy with pharmacological treatments were included [36, 37], comprising 16 RCTs (N = 1372). These reviews (published in 2020 and 2025) were of moderate methodological quality (R‐AMSTAR = 35; Table 1). Across two systematic reviews, acupotomy demonstrated superior effects compared with intra‐articular sodium hyaluronate injections in improving pain and function (Supplementary Material D). The highest‐quality evidence [36] showed significant improvements in WOMAC total, pain (SMD = −1.84, 95% CI −2.15 to −1.49), stiffness (SMD = −0.86, 95% CI −1.65 to −0.06), VAS (SMD = −1.90, 95% CI −2.19 to −1.61), and ISOA scores, as well as higher overall effectiveness (Table 2; Figure 2). Compared with NSAIDs, the highest‐quality evidence [37] showed greater reductions in pain, as assessed by VAS (MD = −0.68, 95% CI −0.99 to −0.37), with no significant differences in overall effectiveness or WOMAC pain (Table 2; Figure 2). These findings were supported by RCTs (Supplementary Material E) [50]. Overall, acupotomy demonstrated superior efficacy to intra‐articular injections and comparable pain relief to NSAIDs in KOA.
3.5. Acupuncture Versus Other Non‐Pharmacological Therapies
3.5.1. FSN Versus Massage
One systematic review comparing FSN with massage therapy was included [29], comprising three RCTs (N = 248). The review was of moderate methodological quality (R‐AMSTAR = 34; Table 1). FSN combined with massage therapy significantly improved in pain, as assessed by VAS (SMD = −2.46, 95% CI −3.91 to −1.02), and in joint function, as assessed by WOMAC (SMD = −2.08, 95% CI −3.31 to −0.84) compared with massage therapy alone at short‐term follow‐up (<12 weeks; Table 2). These findings were supported by RCTs (Supplementary Material E) [51]. Overall, FSN showed a beneficial effect compared with massage therapy in patients with KOA.
3.5.2. Warm Needle Acupuncture Versus Massage
One systematic review comparing warm needle acupuncture combined with massage therapy versus massage alone was included [38], comprising 12 RCTs (N = 1136). The review was of moderate methodological quality (R‐AMSTAR = 30; Table 1). Combined therapy significantly improved in pain, as assessed by VAS (SMD = −1.84, 95% CI −2.96 to −0.72), and in overall joint function, as assessed by WOMAC (SMD = −1.01, 95% CI −1.49 to −0.52) compared with massage alone, with no significant differences in stiffness or functional subscales (Table 2; Figure 2). These findings were supported by RCTs (Supplementary Material E) [52]. Overall, combined therapy showed additional benefits over massage alone in patients with KOA.
3.5.3. Acupotomy Versus Massage
One systematic review comparing acupotomy combined with massage therapy versus massage alone was included [38], comprising five RCTs (N = 374). The review was of moderate methodological quality (R‐AMSTAR = 30; Table 1). Combined therapy significantly improved in pain, as assessed by VAS (SMD = −1.74, 95% CI −2.50 to −0.98), and in knee function, as assessed by Lysholm Knee Scoring Scale (SMD = 1.50, 95% CI 0.62 to 2.38) compared with massage therapy alone (Table 2). These findings were supported by RCTs (Supplementary Material E) [53]. Overall, the available evidence suggested that acupotomy combined with massage therapy may provide additional benefits compared with massage therapy alone.
3.5.4. Acupuncture versus Traditional Manual Therapy
One systematic review comparing acupuncture with traditional manual therapy was included [39], comprising six RCTs (N = 590). The review was of low methodological quality (R‐AMSTAR = 20; Table 1). The magnitude of these effects is reflected in the available evidence [39], which showed no significant differences between acupuncture and traditional manual therapy in pain (WOMAC pain SMD = 0.79, 95% CI 0.01 to 1.57, p = 0.05) or physical function (WOMAC function SMD = 0.59, 95% CI −0.09 to 1.26) at the end of treatment, although stiffness outcomes favored manual therapy (WOMAC stiffness SMD = 0.66, 95% CI 0.06 to 1.27) (Table 2). These findings were supported by RCTs (Supplementary Material E) [54]. Overall, acupuncture and manual therapy showed comparable effects on pain and function, with manual therapy demonstrating greater improvement in joint stiffness.
3.5.5. Laser Acupuncture Versus Exercise Therapy
One systematic review comparing laser acupuncture with exercise therapy was included [23], comprising one RCT (N = 109). The review was of high methodological quality (R‐AMSTAR = 38; Table 1). The magnitude of these effects is reflected in the available evidence [23] showed that laser acupuncture significantly reduced pain compared with exercise therapy at follow‐up (28 days) (WMD = −0.84 cm, 95% CI −1.12 to −0.56), although the improvement did not reach the MCID threshold (1 cm on 10 cm VAS for pain; Table 2; Figure 2). Overall, the available evidence suggested that laser acupuncture may provide modest short‐term pain relief compared with exercise therapy. However, this improvement did not appear to translate into a clinically meaningful advantage.
4. Discussion
This umbrella review synthesized the best available evidence from 23 systematic reviews and meta‐analyses to evaluate the effectiveness of acupuncture for KOA. Overall, acupuncture demonstrated consistent beneficial effects on pain relieving and physical function recovery. Compared with usual care, waiting‐list treatments or sham acupuncture, acupuncture demonstrated clinically meaningful improvements in both pain and physical function [20, 21, 38]. In drug‐controlled studies, acupuncture demonstrated efficacy broadly comparable to NSAIDs, while electroacupuncture showed additional benefits in improving joint stiffness, and combined therapy appeared more effective than pharmacotherapy alone [21, 24, 25, 27]. More specifically, conventional acupuncture (including MA and EA) showed similar effects in pain and functional outcomes with intra‐articular injection therapies [21]. Acupotomy, however, showed greater improvements than intra‐articular sodium hyaluronic injections [29, 36]. Compared with traditional manual therapies such as Tuina, acupuncture provided comparable analgesic effects but a slower onset in improving joint stiffness and function [21, 29, 36, 38, 39]. In terms of safety, reported acupuncture‐related adverse events were predominantly mild and localized [55, 56].
In addition to understanding the effectiveness and safety of acupuncture in treating KOA, we also analyzed the discrepancies between international and domestic clinical guidelines. International guidelines (e.g., ACR and AAOS) have generally adopted a cautious position [6, 9], largely based on earlier evidence showing that although acupuncture was statistically superior to sham acupuncture, the effect did not reach the MCID threshold [12, 20]. However, more recent high‐quality evidence indicates clinical benefits of acupuncture in pain relieving and function recovery exceeding MCID thresholds [21]. Different from the international ones, Chinese guidelines make stronger recommendations in using acupuncture for KOA treatment, mainly based on the effectiveness and safety of acupuncture in comparison with classic treatments. Though both acupuncture and sham acupuncture outperform no‐treatment control, suggesting that the latter is not physiologically inert, the physiological stimulation in sham interventions may be a disturbance factor that attenuates the real differences between effects of acupuncture and sham [57, 58]. In comparison with pharmacological treatment, acupuncture demonstrates comparable analgesic effects with NSAIDs and additional benefits in outcomes including joint stiffness and overall response rates. Moreover, the markedly lower gastrointestinal and cardiovascular adverse effects makes acupuncture a more favorable safety profile [27, 55, 59]. These findings suggest that differences between guidelines are likely attributable to variations in comparator selection and outcome interpretation rather than inconsistencies in the underlying evidence [60]. Therefore, from a clinical and policy perspective, acupuncture evidence should be interpreted within specific clinical contexts rather than a binary “recommend or not” framework.
Current evidence suggests that different acupuncture interventions are associated with superior improvements in pain and physical function in patients with KOA at treatment completion and during short‐term follow‐up (<3 months), whereas no sustained advantages have been observed at 1‐year follow‐up [60, 61]. This temporal pattern may reflect a mismatch between the mechanism of acupuncture and the pathophysiology of KOA. As we know, KOA is a progressive degenerative joint disease, and acupuncture primarily exerts symptomatic relief through neuromodulation rather than structural modification [62]. Obviously, it is unlikely to reverse the underlying structural degeneration of KOA, so the short‐term treatment effects may gradually diminish after cessation of therapy. In real world practice, clinicians should inform patients that the benefits of acupuncture are likely to be short‐term. In addition, maintenance strategies may be considered to sustain treatment effects. For example, intermittent consolidation treatment, such as booster sessions administered approximately 3 months after the initial treatment course, may help prolong clinical benefits [55, 59].
In modality‐specific comparisons, acupotomy demonstrated greater improvements than intra‐articular sodium hyaluronic injections. This difference may be explained by distinct mechanisms of action, as acupotomy involves mechanical release of periarticular soft tissue adhesion, whereas hyaluronic acid primarily provides intra‐articular lubrication [63, 64, 65]. Overall, no consistent evidence indicates any acupuncture modality as superior to others. This may partly reflect shared analgesic mechanisms across techniques, such as activation of endogenous opioid systems and modulation of spinal and supraspinal pain pathways [66]. Furthermore, the lack of direct head‐to‐head comparisons between acupuncture modalities limits the identification of their relative therapeutic differences. Accordingly, relative findings should therefore be interpreted with caution [60].
This umbrella review synthesized the best available evidence from systematic reviews and meta‐analyses to provide a comprehensive evaluation of acupuncture for KOA across multiple clinical contexts. However, several limitations should be acknowledged. First, many included systematic reviews were based on primary RCTs with methodological limitations, particularly in allocation concealment, blinding, and outcome assessment. Second, some findings, especially those related to pharmacological comparisons, were derived from subgroup analyses rather than pre‐specified primary outcomes. Third, most evidence was limited to short‐term follow‐up, with insufficient data on long‐term effectiveness. Despite these limitations, the consistency of findings across multiple systematic reviews and the inclusion of RCTs with relatively low risk of bias support the overall credibility of the evidence.
To this point, our findings may help refine the clinical application pathways of existing guidelines. In practice, acupuncture may serve as an alternative treatment option for patients with contraindications to NSAIDs or intolerance to pharmacotherapy. For patients with inadequate symptom control under medication alone, a multimodal strategy combining acupuncture with pharmacological therapy may be considered. Future research should focus on evaluating the long‐term effectiveness of acupuncture through well‐designed RCTs with extended follow‐up (≥1 year). In addition to patient‐reported outcomes, future studies should incorporate objective imaging measures, such as MRI cartilage T2 mapping or cartilage thickness, to assess structural joint changes [67, 68]. Furthermore, maintenance strategies, such as intermittent consolidation treatment, should be further investigated to determine whether booster interventions (e.g., those applied approximately 3 months after the initial treatment course) can sustain clinical benefits over time.
Funding
This work was supported by the National Natural Science Foundation of China (82574861).
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Supporting File 1: jebm70143‐sup‐0001‐SuppMat.docx.
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Supporting File 1: jebm70143‐sup‐0001‐SuppMat.docx.