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. 2026 Jun 10;13:1818960. doi: 10.3389/fmed.2026.1818960

Autohemotherapy combined with other external treatments of Traditional Chinese Medicine for chronic urticaria: a systematic review and meta-analysis

Jinchu Zhou 1, Boya Zhang 1, Haiying Liang 2, Xin Huang 1, Xingwei Liu 1, Yi Tong 1, Zhixuan Ai 1, Xinsheng Chen 2,*
PMCID: PMC13290604  PMID: 42359079

Abstract

Background

Chronic urticaria (CU) is a refractory, recurrent skin disease that adversely affects patients’ quality of life, mental health. Autohemotherapy (AHT) and various external treatments of Traditional Chinese Medicine (TCM) are reported to be effective in improving CU with few side effects. This study aims to evaluate the efficacy and safety of AHT combined with various TCM external treatments for CU.

Methods

This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. 11 Chinese and English databases were searched from database inception to August 10, 2025, for randomized controlled trials (RCTs) on AHT combined with other TCM external treatments for CU. Two researchers independently completed literature screening and data extraction. Study quality was evaluated using the Cochrane Risk of Bias Tool 2.0 (RoB 2.0). Meta-analysis was performed using STATA 18.0.

Results

A total of 20 studies involving 1,461 participants were included. The intervention group received AHT combined with other TCM external treatments, and the control group received Western medicine. The overall response rate was significantly better in the intervention group (RR: 1.17; 95% Confidence Interval, CI: 1.10–1.24; p < 0.001). Compared to the control group, the intervention group also showed significant improvements in recurrence rate (RR: 0.31; 95% CI: 0.23–0.42; p < 0.001), serum IgE level (SMD: −1.33; 95% CI: −1.76 to −0.91; p < 0.001), pruritus severity (SMD: −1.36; 95% CI: −2.17 to −0.54; p < 0.001), and wheal duration (SMD: −3.05; 95% CI: −6.05 to −0.06; p < 0.005). However, the results for pruritus severity and wheal duration were not robust and showed significant publication bias; therefore, their reliability is questionable.

Conclusion

Autohemotherapy combined with some other TCM external treatments can improve clinical efficacy and reduce recurrence rates. However, due to concerns regarding unclear randomization and blinding, diverse outcome measures, methodological limitations, and high clinical heterogeneity among the included studies, more rigorous prospective studies are needed to conclusively evaluate its efficacy and safety.

Systematic review registration

https://www.crd.york.ac.uk/PROSPERO/, CRD420261281760.

Keywords: chronic urticaria, external therapy of TCM, meta-analysis, randomized controlled trial, systematic review

1. Introduction

Urticaria is a localized edema reaction caused by the widening of small blood vessels and increased permeability of the skin and mucosal blood vessels. It is marked by the appearance of wheals and associated pruritus. Chronic Urticaria (CU) is defined as wheals that last for more than 6 weeks, occurring intermittently or even daily. This condition seriously affects patients’ daily activities, work, quality of life, and mental health, imposing a substantial social burden (1–3). The incidence of CU in Asia is about 1.4%, which is higher than the rates reported in Europe (0.5%) and North America (0.1%) (4). The etiology of CU is complex. Modern medicine primarily uses second-generation H1-antihistamines as first-line treatment, which have a well-established safety profile with minimal adverse effects. However, more than one-third of patients fail to achieve adequate control with standard or increased doses (5), highlighting a clear unmet need for patients with recurrent attacks. Therefore, finding additional effective treatment options for patients who do not respond well to conventional therapy is both important and challenging.

Traditional Chinese Medicine (TCM) external treatments have a long history in managing CU. Modalities such as autohemotherapy (AHT), acupuncture, moxibustion, bloodletting, cupping therapy, acupoint thread-embedding, acupoint application, acupoint injection, auricular point therapy, and scraping therapy (Gua Sha) have demonstrated favorable therapeutic effects. In clinical practice, these external treatment methods are rarely used alone; they are most frequently applied in combination to enhance clinical efficacy.

AHT was developed by Professor Rui Jin (1932–2010) from Guangzhou University of Chinese Medicine. It involves extracting a small amount of the patient’s own venous blood and reinjecting it into specific acupoints or muscle tissue for the prevention and treatment of diseases. The autologous blood injection provides continuous, benign stimulation to the local area, which may produce an effect similar to specific immunotherapy (6), and its clinical efficacy is notable. A systematic review by Li Caicai and Wang Shaojun also supports the efficacy and safety of acupoint autologous blood acupoint injection for CU (7). In clinical practice, AHT is often combined with other TCM external treatments to manage CU. Numerous studies suggest that this combined approach may offer more advantages in promoting recovery, reducing adverse reactions, and lowering recurrence rates compared to traditional Western medicine alone. However, a comprehensive evidence-based medical evaluation is lacking. To more thoroughly assess the efficacy and safety of this combined therapy, this study conducted a meta-analysis of relevant domestic and international literature, aiming to provide an evidence-based reference for clinical practice.

2. Materials and methods

2.1. Study protocol

The study protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO, registration number: CRD420261281760). This study was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines (8).

2.2. Search strategy

Literature searches were performed using a combination of database-specific subject headings (e.g., MeSH) and free-text keywords. The following electronic databases were searched from their inception to August 10, 2,025: PubMed, Embase, The Cochrane Library, Web of Science, EBSCO, Chinese Biomedical Database (CBM), China National Knowledge Infrastructure (CNKI), Wan Fang Database, Chinese Scientific Journals Database (VIP), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP). No language restrictions were applied. Chinese search terms included variations of: “自血疗法”“自体血液输注疗法”“自体血液注射疗法”“自血疗法肌内注射”“穴位自血注射”“自血穴位注射”“自体血穴位注射疗法”“经络注血疗法”“针刺”“揿针”“粗针”“腹针”“梅花针”“挑刺”“灸”“穴位埋线”“穴位贴敷”“穴位注射”“拔罐”“走罐”“线罐”“放血”“刮痧”“耳穴” and “慢性荨麻疹.” As the initial search employing “Chronic Urticaria” (and its free-text terms), “autohemotherapy,” and “autologous blood injection” in English databases did not warrant expansion, and to ensure a comprehensive search (i.e., to maximize recall), a comprehensive secondary search involving all TCM external therapy terms was not conducted. The detailed search strategy for PubMed is presented in Table 1. Authors of potentially relevant studies were contacted for missing information when necessary. Additionally, the reference lists of included articles were manually screened, and unpublished dissertations were sought. All retrieved records were imported into NoteExpress software to create a primary database, and duplicates were removed.

Table 1.

Details of search strategy in PubMed.

Steps Query
#1 (chronic urticaria[Mesh]) OR (chronic urticarias[Title/Abstract]) OR (urticaria, chronic[Title/Abstract]) OR (chronic spontaneous urticaria[Title/Abstract]) OR (chronic spontaneous urticarias[Title/Abstract]) OR (spontaneous urticaria, chronic[Title/Abstract]) OR (urticaria, chronic Spontaneous[Title/Abstract]) OR (idiopathic chronic urticaria[Title/Abstract]) OR (chronic urticaria, idiopathic[Title/Abstract]) OR (idiopathic chronic urticarias[Title/Abstract]) OR (urticaria, idiopathic chronic[Title/Abstract]) OR (chronic idiopathic urticaria[Title/Abstract]) OR (chronic idiopathic urticarias[Title/Abstract]) OR (idiopathic urticaria, chronic[Title/Abstract]) OR (urticaria, chronic idiopathic[Title/Abstract]) OR (chronic autoimmune urticaria[Title/Abstract]) OR (autoimmune urticaria, chronic[Title/Abstract]) OR (chronic autoimmune urticarias[Title/Abstract]) OR (urticaria, chronic autoimmune[Title/Abstract]) OR (autoimmune urticaria[Title/Abstract]) OR (autoimmune urticarias[Title/Abstract]) OR (urticaria, autoimmune[Title/Abstract])
#2 (autologous blood injection[Title/Abstract]) OR (autohemotherapy[Title/Abstract])
#3 #1 AND #2
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2.3. Study selection

2.3.1. Inclusion criteria

  • (1) Study Types: Randomized controlled trials (RCTs)

  • (2) Study Participants: Patients meeting the diagnostic criteria for CU (using specific or internationally recognized standards). Baseline characteristics (sex, age, disease duration) were required to be clearly reported and comparable between groups (p > 0.05). No restrictions were applied regarding age or sex.

  • (3) Intervention Measures: The intervention group received AHT combined with one or more other TCM external treatments. The control group received conventional Western medicine therapy.

  • (4) Outcome Indicators: Primary Outcome: Overall response rate, calculated as: (Total number of cases – Number of ineffective cases)/Total number of cases × 100%. Studies were required to clearly report the therapeutic outcomes (e.g., cured, markedly effective, effective, ineffective) along with the specific evaluation criteria used.

Secondary Outcomes: Serum Immunoglobulin E (IgE) level, recurrence rate, severity of pruritus, and duration of wheals.

2.3.2. Exclusion criteria

The following were excluded: studies on AHT variants (e.g., ozone autohemotherapy, light quantum autohemotherapy, ultraviolet-irradiated and oxygenated autohemotherapy); case reports, animal experiments, and pharmacological studies; duplicate publications (only the earliest published version was retained); articles with suspected plagiarism or significant errors; and studies with unpublished, unavailable, or incomplete original data.

2.4. Literature screening and data extraction

Two researchers independently screened the titles, abstracts, and full texts of retrieved articles against the inclusion and exclusion criteria. Data were subsequently extracted after careful reading of the full texts and recorded using a pre-designed Excel form. Any inconsistencies were resolved through discussion with a third researcher. Extracted information included: (1) General information (first author, publication year, Geographical region, sample size); (2) Baseline data (sex, age, disease duration); (3) Treatment details (interventions in the experimental and control groups, treatment duration, follow-up time); (4) Outcome indicators; and (5) The number of adverse reactions.

2.5. Quality assessment of included literature

Two reviewers independently evaluated the methodological quality of the included RCTs using the Cochrane Risk of Bias Tool version 2.0 (RoB 2.0). Any disagreements during the assessment were resolved by discussion with a third reviewer. The tool assessed the following domains: bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the outcome, and bias in selection of the reported result. The overall risk of bias for each study was judged as “low,” “some concerns,” or “high.”

2.6. Statistical methods

Statistical analysis was performed using STATA 18.0 software. For effect size analysis, the Risk Ratio (RR) with 95% Confidence Interval (CI) was used for dichotomous data (count data). Effect sizes were expressed as the risk ratio (RR) with 95% confidence intervals (CI) for dichotomous data, whereas the standardized mean difference (SMD) with 95% CI was used for continuous data due to variations in measurement scales or units across studies. Heterogeneity among studies was assessed using the Cochran’s Q test (with a significance level of p < 0.10) and the I2 statistic. If significant heterogeneity was present (p < 0.10 or I2 > 50%), a random-effects model was used for analysis. If heterogeneity was not statistically significant (p ≥ 0.10 and I2 ≤ 50%), a fixed-effect model was applied. In cases where the p-value from the Q-test was inconsistent with the I2 value, the I2 value was prioritized for determining the presence of heterogeneity. Subgroup analysis was conducted based on the different TCM external treatments used in the intervention groups. Sensitivity analysis was performed using the leave-one-out method. Publication bias for each outcome was analyzed using funnel plots and statistically tested with Harbord’s test (for count data) or Egger’s test (for measurement data).

2.7. Assessment of the quality of evidence

The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence for both primary and secondary outcomes (9).

3. Results

3.1. Literature search results

A total of 560 records were retrieved using the search strategy. After removing 289 duplicate records, 242 records were excluded based on title and abstract screening. The remaining 29 full-text articles were assessed for eligibility, resulting in 20 studies (10–29) being included in the final meta-analysis. The study selection process is illustrated in Figure 1.

Figure 1.

PRISMA flow diagram showing the identification, screening, and inclusion of studies for a review: 560 records identified from databases, 271 after duplicates removed, 29 assessed for eligibility, and 20 included after two screening phases.

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PRISMA flow diagram.

3.2. Characteristics of included studies

A total of 1,461 participants were enrolled across the 20 included studies (9–28), with 696 in the intervention groups and 765 in the control groups. All intervention groups received AHT. The additional TCM therapies in the intervention groups were: acupuncture (5 studies) (14, 19, 20, 23, 29), moxibustion (3 studies) (12, 15, 17), acupoint catgut embedding therapy (3 studies) (21, 22, 26), acupoint-application (2 studies) (10, 11), apex auricular bloodletting (1 study) (18), and cupping therapy (5 studies) (13, 24, 25, 27, 28). One study (16) had two distinct intervention subgroups: one receiving acupoint catgut embedding combined with cupping, and the other receiving plum-blossom needle therapy combined with cupping (these were treated as separate groups in subsequent meta-analysis). All control groups were treated with conventional Western medicine. The characteristics of each included literature are shown in Table 2. Detailed descriptions of the specific operational procedures for each study are provided in Supplementary material 1.

Table 2.

Basic characteristics of each included literature.

Study ID (Publication year) Sample size (I/C, n) Geographical region Sex (male/female) Age (year) Disease course Interventions Treatment duration Follow-up duration Outcomes Adverse events (I/C)
I C
Peng et al. (14) 30/30 Nanjing, Jiangsu NA NA NA Acupuncture+Autohemotherapy Loratadine 10 mg once daily 10wk 30d ① 0/0
Zhou et al. (29) 41/41 Foshan, Guangdong I:24/17 C:23/18 I:(44.17 ± 3.15) C:(44.12 ± 2.14) NA Abdominal acupuncture+Autohemotherapy Loratadine 10 mg once daily 30d NA ① NA
Qin (20) 33/33 Guangzhou, Guangong I:15/18 C:14/19 I:(41.82 ± 12.02) C:(36.64 ± 10.78) I:(30.27 ± 17.13)mo C:(30.73 ± 18.16)mo Acupuncture+Autohemotherapy Loratadine 10 mg once daily 30d 3mo ① ② ③ ④ 1/30
Fang et al. (14) 21/20 Changsha, Hunan; Zhangjiajie, Hunan I:13/8 C:9/11 I:(31 ± 8) C:(30 ± 8) I:(7.03 ± 2.62)mo C:(7.46 ± 2.0)mo Blood-nourishing and Wind-expelling NeedIing Method+Autohemotherapy Cetirizine 10 mg once daily 1mo 2mo ① 0/0
Xu et al. (23) 30/30 Shenzhen, Guangdong I:12/18 C:10/20 I:39.5 C:41 NA Acupuncture+Autohemotherapy Pheniramine 4 mg +Calcium Gluconate 2 g three times daily 4wk NA ① NA
Guo et al. (15) 40/40 Jinan, Shandong; Taian, Shandong I:21/19 C:18/22 I:(32.4 ± 2.3) C:(31.8 ± 3.7) I:(17.3 ± 0.6)wk. C:(17.6 ± 0.6)wk Du moxibustion+Autohemotherapy Epinastine hydrochloride 10 mg once daily 60d 6mo ① ③ ⑤ NA
Kang (17) 41/41 Panzhihua, Sichuan I:23/18C:22/19 I:(35.31 ± 6.48) C:(34.45 ± 6.52) NA Medicated Blistering Moxibustion+Autohemotherapy Mizolastine 10 mg once daily 40d 6mo ① NA
Chen et al. (12) 40/40 Nanchang, Jiangxi NA NA NA Heat-sensitive Moxibustion+Autohemotherapy Desloratadine citrate disodium 8.8 mg once daily 30d 1mo ① ② ⑤ NA
Su (21) 30/30 Nanning, Guangxi I:12/18C:13/17 I:(31.07 ± 8.96)C:(27.67 ± 3.82) I:(12.23 ± 6.80)mo C:(12.17 ± 7.27)mo Catgut embedding therapy+Autohemotherapy Loratadine 10 mg once daily 56d 3mo ① ② 1/1
Xie and Que (22) 68/68 Longyan, Fujian I:21/47 C:23/45 I:(43. 8 ± 11.5) C:(44. 0 ± 12.1) I:(5.18 ± 1.27)y C:(5.21 ± 1.30)y Catgut embedding therapy+Autohemotherapy Cetirizine 10 mg+ Ebastin 10 mg once daily 30d NA ① 0/0
Zhang (26) 29/29 Xian, Shanxi I:17/12 C:19/10 NA NA Catgut embedding therapy+Autohemotherapy Desloratadine citrate disodium 8.8 mg once daily 50d 6mo ① NA
Chen and Wu (11) 35/35 Ningde, Fujian I:16/19C:17/18 I:(34.18 ± 10.43) C:(35.43 ± 9.82) I:(16.18 ± 7.82)mo C:(16.83 ± 8.34)mo Acupoint-application+Autohemo- therapy Ebastin 10 mg once daily 6wk 3mo ① ② NA
Chen (10) 30/30 Ningde, Fujian I:14/16 C:13/17 I:(35.57 ± 11.49) C:(36.17 ± 9.89) I:(16.40 ± 8.03)mo C:(17.13 ± 8.94)mo Acupoint-application+Autohemo- therapy Ebastin 10 mg once daily 6wk 1mo ① ② ③ ⑤ 1/1
Liang et al. (18) 56/56 Gaozhou, Guangdong I:29/27 C:25/31 I:(40. 81 ± 3.71) C:(40. 71 ± 3.91) I:(3.55 ± 1.42)y C:(3.16 ± 1.81)y Apex Auricular Bloodletting+Autohemotherapy Loratadine 10 mg+ Ketotifen 10 mg once daily 4wk NA ① ② NA
Zhang et al. (24) 40/40 Chongqing I:22/18 C:21/19 I:(50.50 ± 4.72) C:(52.00 ± 3.53) NA Moving cupping +Autohemotherapy Cetirizine 10 mg once daily+ Dexamethasone acetate cream twice daily 30d NA ① ③ ④ ⑤ NA
Zhao and Chen (28) 30/30 QIqihaer, Heilongjiang I:14/16 C:15/15 I:(37.9 ± 12.44) C:(37.63 ± 13.12) I:(2.09 ± 1.48)y C:(2.14 ± 1.69)y Cupping therapy+Autohemotherapy Levocetirizine 5 mg once daily 28d NA ① ③ NA
Zhang and Lang (46) 52/52 Guangzhou, Guangdong; Beijing I:24/28 C:23/29 I:(34 ± 11) C:(34 ± 11) I:(1.3 ± 0.8)y C:(1.2 ± 0.9)y Moving cupping +Autohemotherapy Cetirizine 10 mg once daily+ Compound dexamethasone acetate cream once or twice daily 30d 3mo ① ⑤ NA
Ding (13) 30/31 Guangzhou, Guangdong I:13/17C:11/20 I:(28.23 ± 6.78) C:(25.83 ± 5.21) I:(21.97 ± 13.51)mo C:(23.00 ± 13.55)mo Cupping therapy+ Autohemotherapy Loratadine 10 mg once daily 4wk 2mo ① ② ③ ④ 0/2
Zhang (27) 30/30 Haimen, Jiangsu I:12/18 C:14/16 I:(30 ± 0.6) C:(31 ± 0.5) I:(3.2 ± 0.8)mo C:(3.0 ± 0.9)mo Acupoint Bloodletting Cupping+Autohemotherapy Loratadine 10 mg once daily 60d NA ① NA
Jia et al. (16) 30/30 Lanzhou, Gansu Ic:13/17 Ip:15/15 C:14/16 Ic:(37.43 ± 5.27) Ip:(38.1 ± 4.87) C:(36.53 ± 4.34) Ic:(21.07 ± 5.83)mo Ip: (19.03 ± 4.39)mo C:(20.4 ± 5.43)mo Catgut embedding therapy and Cupping/Plum-blossom Needle Cupping Therapy+Autohemotherapy Ebastin 10 mg once daily 9wk 3mo ① ② ⑤ Ic:0 Ip:0 C:3
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I, intervention group; C, control group; Ic, The group treated with Catgut embedding therapy and Cupping + Autohemotherapy; Ip, The group treated with Plum-blossom Needle Cupping Therapy+Autohemotherapy; d, day; wk, week; mo, month; y, year; ① Overall Response. Rate. ② Recurrence Rate. ③ Pruritus Severity. ④ Wheal Duration. ⑤ Serum IgE Level (IU/mL).

3.3. Risk of bias assessment

In the assessment of Domain 1 (randomization process), 11 studies (10, 11, 13–15, 19–21, 25, 28, 29) were rated as having a low risk of bias, where randomization sequence generation and allocation concealment were adequately described or were probably concealed. Four studies (16, 17, 22, 24) were rated as high risk due to inappropriate sequence generation methods (e.g., based on hospital number parity, order of registration, or order of visit). The remaining five studies (12, 18, 23, 26, 27) did not specify the method of sequence generation and concealment and were judged as having “some concerns.” Baseline characteristics were reported as comparable in all studies except for two (23, 24), which did not mention this information.

For Domain 2 (bias due to deviations from intended interventions), a high risk of bias was assigned to all studies, given the nature of the interventions and the lack of a suitable analytical method to adjust for deviations in adherence.

In Domains 3 (missing outcome data) and 5 (selection of the reported result), all 20 studies (10–29) were assessed as having a low risk of bias.

In Domain 4 (bias in measurement of the outcome), the outcome measures were considered to have been appropriately measured. However, none of the studies reported whether the outcome assessors were aware of the intervention received by participants. The outcomes in 13 studies (10, 12, 13, 16, 18, 20, 21, 25) were based on patient-rated scales or objective laboratory indicators, where the risk of assessment bias is considered lower. The outcomes in the remaining 7 studies (14, 22, 23, 26, 27) involved partly subjective assessments by clinicians, which introduces a potential risk of bias if assessors were aware of the treatment allocation.

The results of the risk of bias analysis are summarized in Figure 2.

Figure 2.

Bar chart and summary table showing risk of bias assessments in multiple studies across six domains: overall bias, selection of the reported result, measurement of the outcome, missing outcome data, deviations from intended interventions, and randomization process. Color codes indicate low risk (green), some concerns (yellow), and high risk (red). The highest high-risk proportion is in the randomization process domain. Individual studies are listed with corresponding colored icons indicating risk levels per domain, providing a comparative overview of bias across studies.

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Risk of bias of each included study: red, high risk; green, low risk; yellow, unclear risk.

3.4. Results of meta-analysis

3.4.1. Overall response rate

All 20 studies (9–28) compared the overall response rate between the treatment and control groups. Among them, 13 studies used urticaria symptom rating scales, though the specific scales varied. The scoring criteria of four studies (12, 16–18) were based on Mona Al-Ahmad (30) and EAACI/GA2LEN/EDF/WHO (2009, 2013) urticaria guidelines (31, 32), four studies (11, 15, 21, 29) used the “Guiding Principles for Clinical Research of New Chinese Medicines” (33), one (19) referred to “TCM Dermatology Syndrome Diagnostic and Efficacy Criteria” (34), and one (28) referred to “The Diagnostic and Efficacy Standard of TCM Syndromes” (35). The remaining 7 studies (14, 17, 22–24, 26, 27) evaluated efficacy subjectively and objectively based on changes in pruritus severity and wheal characteristics without using a formal scale. Due to the presence of heterogeneity among trials (I2 = 52.7%, p = 0.003), a random-effects model was used. The pooled analysis showed a statistically significant difference in the overall response rate favoring the intervention group (p < 0.001) (Figure 3A). Subgroup analysis based on the specific TCM therapy combined with AHT (Figure 3B) showed no significant difference in response rate for the moxibustion (p = 0.112), acupoint-application (p = 0.500), cupping therapy (p = 0.200), and plum-blossom needle cupping therapy (p = 0.321) subgroups. Significant differences were observed for the acupuncture (p = 0.001), catgut embedding therapy (p = 0.001), catgut embedding plus cupping (p = 0.029), and apex auricular bloodletting (p = 0.043) subgroups, although heterogeneity remained high in the acupuncture subgroup. Univariate meta-regression on treatment duration did not explain the heterogeneity (p = 0.918). Sensitivity analysis showed stable results (Figure 4A). Harbord’s test indicated no significant publication bias (p = 0.476) (Figure 5A). But the reliability of the overall response rate results for the acupuncture subgroup is limited as the source of heterogeneity could not be identified. The results of the other subgroups were relatively robust.

Figure 3.

Forest plots comparing intervention and control groups for various studies are shown. Panel A displays individual studies with relative risk ratios, confidence intervals, and study weight, summarizing overall effect at the bottom. Panel B groups studies by treatment modalities, showing pooled estimates for each subgroup and the overall effect. Both plots indicate weights, confidence intervals, and heterogeneity statistics, with summary effect markers and reference lines at risk ratio equals one.

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Forest plot of the overall response rate: pooled analysis (A) and subgroup analysis by specific therapeutic combinations (B). CI, confidence interval.

Figure 4.

Panel A shows a forest plot with effect estimates and confidence intervals for meta-analysis sensitivity, omitting one studyat a time among twenty studies. Panel B shows a similar forest plot for twelve studies. Panel C presents effect estimates and confidence intervals for seven studies using the same sensitivity analysis approach. Panel D has a forest plot for six studies, while Panel E displays three studies, all assessing the effect of omitting individual studies on meta-analysis estimates. Each plot includes the study names, confidence intervals, and estimate points for comparative visualization.

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Sensitivity analysis results for five outcome indicators: overall response rate (A), recurrence rate (B), serum IgE level (C), pruritus severity (D), and wheal duration (E).

Figure 5.

Panel A shows a scatter plot of Z divided by sqrt(V) versus sqrt(V) with a positive regression line and confidence interval; Panel B has the same axes but with a negative regression line; Panels C, D, and E show SND of effect estimate versus precision, each with differing regression line slopes and confidence intervals. Blue points represent study data, solid lines are regression lines, and vertical bars indicate ninety-five percent confidence intervals for the intercept.

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Publication bias diagrams for five outcome indicators: overall response rate (A), recurrence rate (B), serum IgE level (C), pruritus severity (D), and wheal duration (E).

3.4.2. Recurrence rate

A total of 12 studies (10, 12, 13, 15–17, 19–21, 25, 26) reported recurrence rates. As heterogeneity among these studies was not significant (I2 = 0%, p = 0.996), a fixed-effect model was used. The results showed a statistically significant difference in the overall recurrence rate between groups, favoring the intervention (p < 0.001) (Figure 6A). Subgroup analysis based on the specific therapeutic combinations (Figure 6B) revealed that the response rate was significantly improved in the acupuncture (p = 0.001), moxibustion (p < 0.001), catgut embedding therapy (p = 0.016), acupoint-application (p = 0.001), and cupping therapy (p = 0.001) subgroups, whereas no significant improvement was found in the catgut embedding plus cupping (p = 0.144) or plum-blossom needle cupping therapy (p = 0.292) subgroups. Sensitivity analysis of the 12 included studies showed that no single study significantly altered the overall result (Figure 4B). Harbord’s test showed no significant publication bias (p = 0.504) (Figure 5B), indicating that the analysis of recurrence rate is highly reliable and stable.

Figure 6.

Forest plot figure with two panels labeled A and B displaying meta-analysis results. Panel A shows individual study risk ratios with confidence intervals and an overall pooled effect size estimate for intervention versus control. Panel B groups studies by combination therapies, also showing subgroup and overall effect sizes, with diamonds representing pooled estimates and lines indicating confidence intervals. Dashed vertical lines mark the reference value of one for risk ratio interpretation. All values and weights are listed in tables adjacent to each plot.

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Forest plot of the recurrence rate: pooled analysis (A) and subgroup analysis by specific therapeutic combinations (B). CI, confidence interval.

3.4.3. Serum IgE level

Six studies (10, 12, 15, 16, 24, 25) reported serum IgE levels. Due to significant heterogeneity (I2 = 79.7%, p < 0.001), a random-effects model was used. The pooled result showed a statistically significant difference between groups (p < 0.001) (Figure 7A). Subgroup analysis (Figure 7B) found no statistically significant difference for the acupoint-application subgroup (p = 0.025). Significant differences were observed for the moxibustion (p = 0.020), catgut embedding plus cupping (p < 0.001), and plum-blossom needle cupping therapy (p < 0.001) subgroups, though heterogeneity remained significant in the moxibustion subgroup. Subsequent sensitivity testing showed stable results (Figure 4C). Egger’s test indicated no significant publication bias (p = 0.227) (Figure 5C). Except for the moxibustion subgroup, the results of the other subgroups were relatively reliable. The observed heterogeneity may be attributed to differences in detection methods and kits across studies.

Figure 7.

Panel A displays a forest plot summarizing seven studies' standardized mean differences (SMD) and confidence intervals (CI) regarding a specific intervention, with an overall pooled SMD of −1.33 and substantial heterogeneity (I-squared = seventy-nine point seven percent, p = zero). Panel B presents a subgroup meta-analysis by treatment type, showing pooled SMDs and CIs for each subgroup and highlighting significant heterogeneity between groups, with an overall pooled SMD matching panel A.

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Forest plot of the serum IgE level: pooled analysis (A) and subgroup analysis by specific therapeutic combinations (B). CI, confidence interval.

3.4.4. Pruritus severity

Six studies (10, 13, 15, 20, 24, 28) reported pruritus severity scores. Significant heterogeneity was present (I2 = 92.6%, p < 0.001), leading to the use of a random-effects model. The results indicated a statistically significant difference between groups (p < 0.001) (Figure 8A). Subgroup analysis (Figure 8B) showed significant differences for the acupuncture (p = 0.015), moxibustion (p < 0.001), acupoint-application (p = 0.029), and cupping therapy (p = 0.041) subgroups. Heterogeneity remained high in the cupping subgroup. Sensitivity analysis showed that the results became unstable after excluding one specific study (13) (Figure 4D). Even after removing this study, heterogeneity remained very high (I2 = 96.9%, p < 0.001). Egger’s test indicated significant publication bias (p = 0.022) (Figure 5D), thus the reliability of these results is questionable.

Figure 8.

Panel A displays a forest plot summarizing six studies' standardized mean differences (SMD) and confidence intervals (CI) regarding a specific intervention, with an overall pooled SMD of −1.36 and substantial heterogeneity (I-squared = ninety-two point six percent, p = zero). Panel B presents a subgroup meta-analysis by treatment type, showing pooled SMDs and CIs for each subgroup and highlighting significant heterogeneity between groups, with an overall pooled SMD matching panel A.

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Forest plot of the pruritus severity: pooled analysis (A) and subgroup analysis by specific therapeutic combinations (B). CI, confidence interval.

3.4.5. Wheal duration

Three studies (13, 20, 24) reported the duration of wheals. Due to extreme heterogeneity (I2 = 98.4%, p < 0.001), a random-effects model was applied. The results showed a statistically significant difference between groups (p < 0.005) (Figure 9A). Subgroup analysis (Figure 9B) found no significant difference for the acupuncture (p = 0.354) or cupping therapy (p = 0.275) subgroups. Heterogeneity remained significant in the cupping subgroup. Sensitivity analysis (Figure 4E) indicated that the results were unstable, influenced heavily by two studies (20, 24). Egger’s test showed significant publication bias (p = 0.003) (Figure 5E), further questioning the reliability of these findings.

Figure 9.

Panel A displays a forest plot summarizing three studies' standardized mean differences (SMD) and confidence intervals (CI) regarding a specific intervention, with an overall pooled SMD of −3.05 and substantial heterogeneity (I-squared = ninety-eight point four percent, p = zero). Panel B presents a subgroup meta-analysis by treatment type, showing pooled SMDs and CIs for each subgroup and highlighting significant heterogeneity between groups, with an overall pooled SMD matching panel A.

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Forest plot of the wheal duration: pooled analysis (A) and subgroup analysis by specific therapeutic combinations (B). CI, confidence interval.

3.4.6. Adverse reactions

Five studies reported adverse effects. In one study (20), the control group experienced mild adverse reactions such as dry mouth, drowsiness, and fatigue, which resolved after treatment completion. One patient in the treatment group had slight dizziness that improved after a short rest. Another study (13) reported one case of mild dizziness and 1 case of dry mouth in the control group, which were self-limiting and did not interrupt treatment. A third study (16) noted two cases of mild sleepiness and 1 case of dizziness in the control group, which resolved naturally after drug cessation. Two other studies (10, 21) mentioned one adverse event occurring in each group but did not specify the symptoms.

3.4.7. Certainty of evidence assessed using the GRADE approach

The GRADE certainty of evidence for the primary and secondary outcomes is presented in Table 3. The certainty of evidence was low for the recurrence rate and very low for the overall response rate, serum IgE levels, pruritus severity, and wheal duration.

Table 3.

GRADE assessment of the included studies.

Certainty assessment No. of patients Effect Certainty Importance
No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Intervention group Control group Relative (95% CI) Absolute (95% CI)
Overall response rate
20 Randomized trials Seriousa Seriousb Not serious Seriousc None 696/765 (91.0%) 585/764 (76.6%) RR 1.17 (1.10 to 1.24) 130 more per 1,000 (from 77 more to 184 more) ⨁◯◯◯ Very lowa,b,c Critical
Recurrence rate
12 Randomized trials Seriousa Seriousb Not serious Not serious None 49/370 (13.2%) 114/306 (37.3%) RR 0.31 (0.23 to 0.42) 257 fewer per 1,000 (from 287 fewer to 216 fewer) ⨁⨁◯◯ Lowa,b Important
Serum IgE level
6 Randomized trials Seriousa Seriousb Not serious Seriousc None SMD -1.33 (−1.76 to −0.91) -- per 1,000 (from -- to --) ⨁◯◯◯ Very lowa,b,c Important
Pruritus severity
6 Randomized trials Seriousa Seriousb Not serious Not serious Publication bias strongly suspected SMD -1.36 (−2.17 to −0.54) -- per 1,000 (from -- to --) ⨁◯◯◯ Very lowa,b Important
Wheal duration
3 Randomized trials Seriousa Not serious Not serious Seriousc Publication bias strongly suspected SMD -3.05 (−6.05 to −0.06) -- per 1,000 (from -- to --) ⨁◯◯◯ Very lowa,c Important
Open in a new tab

CI, confidence interval; RR, risk ratio. aDowngrade one level: All the research on intervention measures has specificities, and there are also unreasonable aspects in the randomization process and outcome indicators of some studies. bDowngrade one level: The evaluation process of outcome indicators and the follow-up period vary for each study. cDowngrade one level: The evaluation method for outcome indicators is relatively subjective. Low: Limited confidence in effect estimation: true values are likely to be substantially different from estimated values. Very low: We have little confidence in the effect estimate: the true value is likely to be very different from the estimate.

4. Discussion

Urticaria is one of the most common allergic skin diseases, with CU representing a more complex and refractory subtype. CU is categorized into chronic spontaneous urticaria and chronic inducible urticaria (4). Mast cell and basophil degranulation are widely recognized as central to the pathogenesis of all CU types. Regarding degranulation, two main mechanisms have been proposed. The first process is not triggered by any identifiable substance and is essentially idiopathic, but involves dysregulation of intracellular signaling pathways within mast cells and basophils. The second involves activation by autoantibodies against FcεRIα or IgE on mast cells and basophils, which may be either immunoglobulin E (IgE)-mediated or non-IgE-mediated (36). Studies show that even the non-lesional skin of CU patients exhibits alterations, such as eosinophil infiltration and increased expression of adhesion molecules and certain cytokines (37, 38). An increasing number of researchers now posit that chronic spontaneous urticaria may have an autoimmune basis, related to an imbalance in the cytokine-chemokine network driven by innate immune response dysregulation (39). The pathogenic mechanism is complex, extending beyond the simple release of vasoactive mediators from mast cells and basophils (40, 41).

The often indeterminable etiology of CU leads to suboptimal treatment responses and high recurrence rates, causing significant distress to patients and severely impacting their quality of life and mental state (42). The current first-line treatment, second-generation H1-antihistamines, often requires long-term use and can cause local or systemic adverse reactions. Overtreatment may worsen the condition (42). More than one-third of patients fail to achieve adequate control with standard or increased doses of second-generation H1-antihistamines, or with combinations of first and second-generation agents (42), highlighting a clear insufficiency for patients with recurrent attacks (5). Alternative treatments such as omalizumab, cyclosporine, and Tripterygium wilfordii preparations are also available; however, some patients remain intolerant or non-responsive, and others experience adverse reactions including gastrointestinal disturbances, renal impairment, and hematopoietic suppression. Furthermore, some newer biologic agents lack high-quality evidence or strong recommendation grades, and their efficacy and safety remain uncertain (4).

Consequently, the exploration of additional treatment options constitutes a significant research direction for CU.

Based on TCM theory, Professor Jin Rui integrated the principles of autohemotherapy with acupuncture to establish AHT. This method combines the effects of bloodletting, acupuncture, and autologous blood injection. Bloodletting and acupuncture are believed to dredge meridians, remove blood stasis, and clear heat, while the injected autologous blood is thought to promote blood circulation, regenerate tissue, and support Qi (43). When administered at specific acupoints, it may further regulate Zang-fu organ function. A key advantage of AHT lies in its historical rationale and the clinical efficacy and safety supported by multiple RCTs, particularly for cases where other drug treatments fail or are not tolerated (44). The patient’s autologous blood acts as a personalized, combined antigenic stimulus. Repeated injections may lead to gradual exposure and recognition of antigenic determinants by the immune system. Furthermore, owing to the slow metabolism of autologous blood in the subcutaneous tissue, it provides a mild yet sustained stimulus. This leads to prolonged local immunomodulation at the very site of CU pathology—the subcutaneous layer (44). Various hormones, trace elements, and enzymes present in the blood may not only regulate immune function but also improve microcirculation and skin nutrition, contributing to patient recovery (44).

Acupoint bloodletting therapy may exert its effects by inhibiting the differentiation and proliferation of Th2 cells and modulating humoral immune responses (45). In line with this, a study by Wan-Rong Zhang found that moving cupping combined with autohemotherapy demonstrated superior efficacy and a lower recurrence rate compared to conventional Western medicine for CU, potentially mediated by the downregulation of serum IL-4 and IgE (46).

Electroacupuncture has also shown potential benefits for CU through multiple mechanisms. It can reduce serum IL-4 levels in patients with certain dermatoses, contributing to the alleviation of pruritus (47). Additionally, when applied at acupoints such as Quchi (LI11), Xuehai (SP10), and Zusanli (ST36), electroacupuncture may regulate mast cell degranulation in urticaria models, potentially by suppressing the expression of Lyn and Syk proteins in mast cells, thereby reducing vascular permeability and exerting anti-allergic effects (48).

AHT is frequently combined with other TCM external therapies for managing CU. This combination therapy has demonstrated definite clinical efficacy, a favorable safety profile, and low toxicity.

This study included 20 RCTs (10–29). The meta-analysis results suggest that AHT combined with a subset of other TCM external treatments is superior to Western medicine in terms of overall response rate, recurrence rate, wheal duration, pruritus severity, and serum IgE levels, with statistical significance, and no serious adverse events were reported. The overall response rate results are relatively reliable (except for the acupuncture subgroup). The result for recurrence rate is particularly robust, with low heterogeneity. However, significant heterogeneity persisted for other outcome indicators, despite our best efforts to employ active statistical methods (including subgroup analysis, univariate meta-regression, and sensitivity analysis) to reduce heterogeneity across outcomes. The results for pruritus severity and wheal duration showed significant publication bias, suggesting that the effect sizes for these outcomes may be overestimated. The clinical relevance of changes in serum IgE levels in CU remains uncertain, and this outcome should be interpreted with caution.

Regarding risk of bias, the included studies in our review have the following limitations:① Nine studies (12, 16–18, 22–24, 26, 27) had a high or unclear risk of bias in the randomization process. Although most reported no significant baseline differences between groups, the absence of rigorous randomization and allocation concealment cannot exclude potential confounding from unknown or unmeasured factors. ② Subjective outcomes such as overall response rate and pruritus severity were susceptible to evaluation criteria, assessor judgment, and patient perception. ③ Due to the distinct operational characteristics of TCM external therapies, blinding of patients and investigators was generally difficult to implement. This may introduce a high risk of bias, particularly inflating effect estimates for subjective outcomes such as overall response rate and pruritus severity. Notably, pruritus severity showed high heterogeneity and less robust sensitivity analysis results, whereas the more objective recurrence rate had low heterogeneity. This difference suggests that lack of blinding likely overestimated the effects of subjective outcomes, further reducing the reliability of the evidence.

In addition to the risk of bias, the included studies have the following limitations: ① We only searched for studies published in Chinese or English. All studies were conducted in China, across multiple provinces (e.g., Beijing, Guangdong, Sichuan). Therefore, the applicability of these findings to populations in western China and other countries requires further evaluation. Moreover, studies published in other languages or from other regions may have been missed, which could introduce language and regional publication bias. ② The baseline characteristics of patients were inconsistent, with two studies failing to fully report this information. ③ There were inherent variations in the practical application of TCM external therapies among studies, including differences in acupoint selection, tools, manipulation techniques, treatment duration, and other factors. ④ The follow-up durations, the medications used in the control groups, and the severity and duration of chronic urticaria varied among the included trials. These factors necessitate caution when interpreting the results of this review. ⑤ Outcome assessment criteria were not uniform across studies, and some outcome measures lacked authoritative validation, with varying operational definitions across studies. This inconsistency may increase clinical heterogeneity and hinder accurate interpretation of pooled effect sizes.

Currently, AHT encompasses various techniques such as subcutaneous, intramuscular, whole blood, serum, and acupoint injection. Determining the most effective, simple, and safe method requires large-scale RCTs. Some scholars suggest that circulating autoreactive factors in the blood may have more efficient transfer mechanisms at acupoints compared to non-acupoints, possibly related to the unique distribution of nerve innervation and vascular effects at these sites (47). Furthermore, there is no standardized clinical protocol for AHT combined with various TCM external treatments. Non-standardized operations by untrained personnel in different hospitals could lead to avoidable adverse events. More high-quality RCTs are needed to clarify the efficacy and safety of AHT combined with specific regimens (e.g., loratadine). We urge future investigators to improve methodological quality by applying allocation concealment and blinding where possible, using validated and standardized assessment tools [such as the Urticaria Control Test (UCT) and Urticaria Activity Score over 7 days (UAS7)], emphasizing follow-up studies, and rigorously recording adverse events.

5. Conclusion

Existing evidence suggests that AHT combined with most TCM external treatments has good efficacy and a low recurrence rate in treating CU. However, due to the risk of bias and high heterogeneity among the included trials, more rigorous and larger-scale clinical studies are required to further verify the efficacy and safety of this integrative approach.

Funding Statement

The author(s) declared that financial support was received for this work and/or its publication. This study was supported by the Research Project “Guangdong Province’s Third Batch of Famous Traditional Chinese Medicine Practitioner Inheritance Projects - Ruiqiang Fan Guangdong Famous Traditional Chinese Medicine Inheritance Studio (No.0103030905).”

Footnotes

Edited by: Krishna Mohan Poluri, Indian Institute of Technology Roorkee, India

Reviewed by: Odair Alves da Silva, Federal University of Pernambuco, Brazil

Maykon Jhuly Martins De Paiva, University of Brasilia, Brazil

Data availability statement

The original contributions presented in the study are included in the article/Supplementary material, further inquiries can be directed to the corresponding author.

Author contributions

JZ: Writing – original draft, Writing – review & editing, Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Software, Supervision. BZ: Writing – original draft, Writing – review & editing, Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Software. HL: Conceptualization, Funding acquisition, Investigation, Resources, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing. XH: Conceptualization, Data curation, Investigation, Methodology, Software, Writing – original draft, Writing – review & editing. XL: Conceptualization, Data curation, Formal analysis, Investigation, Writing – original draft, Writing – review & editing. YT: Conceptualization, Data curation, Investigation, Methodology, Writing – original draft, Writing – review & editing. ZA: Conceptualization, Data curation, Funding acquisition, Investigation, Writing – original draft, Writing – review & editing. XC: Funding acquisition, Project administration, Resources, Software, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing.

Conflict of interest

The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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The author(s) declared that Generative AI was not used in the creation of this manuscript.

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Supplementary material

The Supplementary material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fmed.2026.1818960/full#supplementary-material

Supplementary_file_1.docx (29.8KB, docx)
Table_1.docx (46.2KB, docx)

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Associated Data

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Supplementary Materials

Supplementary_file_1.docx (29.8KB, docx)
Table_1.docx (46.2KB, docx)

Data Availability Statement

The original contributions presented in the study are included in the article/Supplementary material, further inquiries can be directed to the corresponding author.

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