Clinical evidence on integrated Chinese-Western medicine for primary dysmenorrhea

Abstract

Background

Primary dysmenorrhea (PD), a common gynecological disorder, adversely affects the quality of life, mental health, and overall well-being of many young women. Given concerns about adverse effects of some Western medications, Chinese medicine (CM) and integrated Chinese–Western medicine (ICWM) approaches have gained attention. This study aims to systematically identify PD-related clinical evidence on CM and ICWM treatments, appraise and categorize the evidence by study design, and provide evidence summaries based on pre-defined clinical questions to inform evidence-based practice.

Methods

As part of the AI-empowered Clinical Evidence for Integrated Chinese-Western Medicine (ACE-iMed) series, this study followed the ACE-iMed framework to systematically screen and identify PD-related evidence addressing 14 pre-defined clinical questions. We focused on clinical practice guidelines/consensus statements, systematic reviews, and randomized controlled trials, and searched databases and relevant websites from inception through September 6, 2025. The overarching methods are detailed in the series’ methodological paper; the key and PD-specific methods are described in this article.

Results

Of 5062 records identified, 219 met inclusion criteria: 4 clinical practice guidelines, 37 systematic reviews, and 178 randomized controlled trials. Almost eighty percent were published in Chinese. Mean quality assessment scores exceeded 50% of the maximum scale. The most frequently evaluated comparisons were oral Chinese herbal medicine versus Western medications and acupuncture versus conventional Western therapy.

Conclusion

CM and ICWM interventions for PD are actively studied. Interest-holders, including clinicians, patients, the public, policymakers, and researchers, can access curated PD evidence (http://www.aceimed.org) to identify relevant studies and further support evidence-based research and practice.

1. Introduction

Primary dysmenorrhea (PD) is defined as painful menstruation in the absence of any pelvic pathology.¹ As one of the most common gynecological disorders, PD affects the majority of women, particularly adolescents and young women, by impacting their quality of life, mental health, and overall well-being.2, 3, 4, 5, 6, 7 Although its high prevalence, PD is often overlooked, underestimated, or commonly undertreated.^8,9 Western clinical practice guidelines (CPGs) recommend treating PD with pharmacologic therapy, adjunctive physical therapies, routine supportive care, and surgical approaches when clinically appropriate.⁸

Compared with Western medicine, Chinese medicine (CM), such as Chinese herbal medicine (CHM), acupuncture, moxibustion, massage, acupoint patches, and physical instrument therapy, offers extensive and unique experiences, and has demonstrated relatively favorable therapeutic effects in the treatment of PD.¹⁰ In CM, PD is classified as “menstrual abdominal pain.”¹¹ Although Western medical treatments, including non-steroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives, are effective, they may be accompanied by specific adverse effects.¹² NSAIDs are associated with gastrointestinal and neurological symptoms, such as nausea, indigestion, headache, dizziness, and drowsiness¹², whereas oral contraceptives may increase irregular bleeding, headache, and nausea.¹³ Given the recurrent nature of PD, clinicians and patients are concerned not only with immediate symptom relief but also with sustained benefits after treatment discontinuation. In this context, traditional, complementary, and integrative therapies, including CM and integrated Chinese-Western medicine (ICWM), are increasingly gaining attention for their potential advantages, such as durable symptom relief across subsequent menstrual cycles.^14,15

Therefore, following the AI-empowered Clinical Evidence for Integrated Chinese–Western Medicine (ACE-iMed) framework¹⁶, this study aims to systematically identify and appraise evidence on CM and ICWM for PD treatment, categorize the evidence by study type, and provide evidence summaries based on pre-defined clinical questions.

2. Methods

As part of the ACE-iMed series, comprehensive methodological details were provided in the methodological paper;¹⁶ the key and PD-specific methods were summarized below.

We first developed the disease literature database for PD and defined interventions, clinical questions, and outcomes. Literature searching and screening, data extraction, and risk of bias/methodological quality assessment were also conducted within the ACE-iMed framework. Five databases (China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, MEDLINE (via PubMed), the Cochrane Library, and the Cochrane Central Register of Controlled Trials) and supplementary sources (e.g., relevant standards-related websites) were searched from their inception to September 6, 2025, with detailed search strategies provided in Supplement 1. Data analysis and figure generation were performed using Microsoft Excel 2019 and R (version 4.5.1), respectively.

2.1. Eligibility criteria

We included clinical practice guidelines/consensus statements (CPGs/CSs), systematic reviews (SRs), and randomized controlled trials (RCTs) for PD, without restriction of the age and severity of PD, and the presence of other comorbidities.

• •For CPGs/CSs, 1) the title contained terms such as recommendation, consensus, guideline, or guidance; 2) the CPGs met the Institute of Medicine definition,^17,18 and the CSs met the International Organization for Standardization definition;¹⁹ and 3) the full text of CPGs/CSs addressed any of the pre-defined questions.
• •For SRs and RCTs, 1) the following two comparisons were our interest: CM interventions versus conventional Western therapy (CWT), and CM interventions combined with CWT versus CWT. Specific CM interventions were set according to pre-defined questions. Consistent with other studies in the ACE-iMed series, CWT generally includes medications (e.g., NSAIDs, short-acting oral contraceptives), routine care (basic treatment), physical therapy, and functional training; and 2) at least one outcome of interest to this study (outcomes see Supplement 2). To further assess comparative efficacy and safety across medications, we included Western Medications (WM) as the sole comparator for clinical question 1 and clinical question 2.

We excluded studies in which the interventions involving multiple CM intervention combinations; publications in languages other than Chinese or English; dissertations, conference abstracts, or records for which the full text could not be obtained; and studies with obvious data errors.

2.2. Assessment of risk of bias and methodological quality

Methodological appraisal was conducted with the Appraisal of Guidelines for Research and Evaluation II (AGREE II)²⁰ for CPGs/CSs, A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2)²¹ for SRs, and the Risk Of Bias instrument for Use in SysTematic reviews for Randomized Controlled Trials (ROBUST-RCT)²² for RCTs. Detialed appraisal methods were provided in the methodological paper.¹⁶

3. Results

3.1. Study selection and characteristics

A total of 7 interventions, 14 clinical questions, as well as 36 outcomes were identified (Table 1 for clinical questions, Supplement 2 for outcomes). After systematic searches in five databases and official websites related to standards publications, a total of 5062 records were retrieved. Following the removal of duplicate records, 4586 records remained. Based on this pool, a PD database was constructed to facilitate targeted retrieval and screening according to the interventions associated with each clinical question. Ultimately, 263 records were identified for inclusion. After further deduplication among the clinical questions, a total of 219 records were included: 4 CPGs, 37 SRs, and 178 RCTs. The included literature is presented in Fig. 1, and its basic characteristics are summarized in Table 2.

Table 1.

Literature searching and screening for each clinical question.

No.	Clinical questions for people with PD	No. of records initially retrieved in PD database	No. of records screened by titles and abstracts	No. of records included
CQ 1	How do the efficacy and safety of integrated oral CHM and WM compare with WM alone?	4053	673	31
CQ 2	How do the efficacy and safety of oral CHM compare with WM alone?	4053	694	69
CQ 3	How do the efficacy and safety of integrated acupuncture and CWT compare with CWT alone?	1221	342	5
CQ 4	How do the efficacy and safety of acupuncture compare with CWT alone?	1221	375	54
CQ 5	How do the efficacy and safety of integrated moxibustion and CWT compare with CWT alone?	820	219	4
CQ 6	How do the efficacy and safety of moxibustion compare with CWT alone?	820	224	37
CQ 7	How do the efficacy and safety of integrated tuina/massage and CWT compare with CWT alone?	223	71	1
CQ 8	How do the efficacy and safety of tuina/massage compare with CWT alone?	223	77	23
CQ 9	How do the efficacy and safety of integrated cupping and CWT compare with CWT alone?	67	20	1
CQ 10	How do the efficacy and safety of cupping compare with CWT alone?	67	14	3
CQ 11	How do the efficacy and safety of integrated external therapy of CHM (e.g., plaster/patch, bath, fumigation, wet compress) and CWT compare with CWT alone?	784	135	6
CQ 12	How do the efficacy and safety of external therapy of CHM (e.g., plaster/patch, bath, fumigation, wet compress) compare with CWT alone?	784	157	27
CQ 13	How do the efficacy and safety of integrated Chinese movement exercise (e.g., Tai chi, Baduanjin, Qigong) and CWT compare with CWT alone?	219	29	0
CQ 14	How do the efficacy and safety of Chinese movement exercise (e.g., Tai chi, Baduanjin, Qigong) compare with CWT alone?	219	32	2

CHM: Chinese herbal medicine; CM: Chinese medicine; CQ: clinical question; CWT: conventional Western therapy; PD: primary dysmenorrhea; WM: Western medication

Fig. 1.

Number of included literature and types of each PD clinical question. *: Bubble sizes are proportional to the number of included records. CPGs: clinical practice guidelines; CQs: clinical questions; RCTs: randomized controlled trials; SRs: systematic reviews.

Table 2.

Basic characteristics of the included literature.

Item	Total (n=219)	CPGs (n=4)	SRs (n=37)	RCTs (n=178)
Year of Publication
∼2000	3 (1.4%)	0	0	3 (1.7%)
2001∼2005	13 (5.9%)	0	0	13 (7.3%)
2006∼2010	34 (15.5%)	0	5 (13.5%)	29 (16.3%)
2011∼2015	56 (25.6%)	1 (25.0%)	4 (10.8%)	51 (28.7%)
2016∼2020	68 (31.1%)	1 (25.0%)	17 (46.0%)	50 (28.1%)
2021∼2025	45 (20.5%)	2 (50.0%)	11 (29.7%)	32 (18.0%)
Language
Chinese	175 (79.9%)	3 (1.7%)	11 (6.3%)	161 (92.0%)
English	44 (20.1%)	1 (2.3%)	26 (59.1%)	17 (38.6%)
Top six journals by number of publications
Hebei Journal of Traditional Chinese Medicine	10 (4.6%)	-	-	-
New Chinese Medicine	9 (4.1%)	-	-	-
Journal of Emergency in Traditional Chinese Medicine	9 (4.1%)	-	-	-
Shaanxi Journal of Traditional Chinese Medicine	8 (3.7%)	-	-	-
Chinese Journal of Traditional Medical Science and Technology	7 (3.2%)	-	-	-
Shanghai Journal of Acupuncture and Moxibustion	7 (3.2%)	-	-	-

CPGs: clinical practice guidelines; RCTs: randomized controlled trials; SRs: systematic reviews.

3.2. Quality assessment

After methodological assessment of the four included CPGs using the AGREE II instrument, the scores were 79.9%,²³ 74.9%,²⁴ 67.4%,²⁵ and 54.5%²⁶ respectively. The 37 included SRs were evaluated using AMSTAR 2 with an average score of 11.6 and a median score of 11.5 (maximum 15, minimum 8). The ROBUST-RCT tool was used to assess the 178 included RCTs, resulting in an average score of 3.0 and a median score of 3.0 (maximum 5.5, minimum 1). Fig. 2 shows the detailed assessment results for the 4 CPGs, 37 SRs, and 178 RCTs.

Fig. 2.

Quality assessment scores for included literature. AGREE II: appraisal of guidelines for research and evaluation II; AMSTAR 2: a measurement tool to assess systematic reviews 2; CPGs: clinical practice guidelines; RCTs: randomized controlled trials; ROBUST-RCT: risk of bias instrument for use in systematic reviews-for randomized controlled trials; SRs: systematic reviews.

3.3. Clinical questions and evidence

A comprehensive summary of the evidence for each clinical question can be found at http://www.aceimed.org. In here, we focus on two clinical questions with the largest number of evidence on PD, specifically clinical questions 2 (oral CHM vs WM) and 4 (Acupuncture vs CWT).

Clinical question 2: For people with PD, how do the efficacy and safety of oral CHM compare with WM alone?

Two CPGs (published in 2021 and 2024), 14 SRs (published between 2008 and 2021), and 53 RCTs (published between 1995 and 2024) provided relevant evidence for this clinical question.

The CPG published in 2021 recommends that,²⁵ for people with PD, CHMs may be used as monotherapy, with selection guided by CM pattern differentiations: Dan’e Fukang Soft Extract, Dingkun Dan, Sanjie Analgesic Capsules, or Tongjingbao Granules to improve clinical symptoms; Tiaojing Huoxue Capsules to reduce Visual Analogue Scale (VAS) scores; Guizhi Fuling Capsules to reduce VAS scores and mitigate pain intensity; or use Shaofu Zhuyu Capsules.

Another CPG published in 2024 recommends 19 CHMs, including their indications/symptom patterns and safety considerations;²³ see Supplement 3 for detailed recommendations. However, this CPG does not clarify whether oral CHMs should be combined with WM or used alone.

Across the included systematic reviews, 26 PICO questions were identified; 23 indicated that oral CHM, including Siwu Decoction, Danggui Shaoyao San, Xuefu Zhuyu Decoction, Danggui Sini Decoction, and Shaofu Zhuyu Decoction, produced statistically significant effects in increase efficacy rate, pain relief, and reduced analgesic use. Three PICO questions showed no statistically significant differences between oral CHM and WM, mainly involving comparisons of single-herb interventions (e.g., ginger powder and fennel) versus NSAIDs on VAS, as well as comparisons of Shaofu Zhuyu Decoction versus indomethacin in efficacy.27, 28, 29

64.2% (34/53) RCTs concluded that oral CHM was superior to WM for the following outcomes: VAS, Cox Menstrual Symptom Scale (CMSS), efficacy rate, treatment satisfaction, 36-Item Short Form Health Survey (SF-36), Self-Rating Depression Scale (SDS), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), Adverse Events (AEs), peripheral blood prostaglandin F2α (PGF2α), serum progesterone (P), blood viscosity, resistance index (RI), and pulsatility index (PI). One RCT found oral CHM (Dingkundan) inferior to Marvelon for VAS and CMSS, and with no significant difference in PGF2α and PGE2.³⁰ Moreover, three RCTs reported no significant differences between oral CHM (ginger capsules, Dan’e Fukang formulation, Shujing decoction, and Tongjingbao Granules) and WM (Mefenamic acid capsules, Marvelon, and Diclofenac sodium) in VAS, efficacy rate, or use of analgesics.31, 32, 33

Clinical question 4: For people with PD, how do the efficacy and safety of acupuncture compare with CWT alone?

Two CPGs (published in 2014 and 2024), 13 SRs (published between 2008 and 2024), and 39 RCTs (published between 2003 and 2024) provided relevant evidence for this clinical question.

The CPG published in 2014 recommends²⁴ filiform needle acupuncture for the treatment of PD. During acute pain episodes, particularly when pain is severe, Shiqizhui (EX-B8), Diji (SP8), Sanyinjiao (SP6), and/or Ciliao (BL32) may be needled individually or in combination to achieve rapid analgesia, addressing the symptomatic manifestation. During inter-episode periods, or when pain during attacks is mild to moderate, acupoint selection should be guided by the principles of disease differentiation and pattern identification to target the underlying root cause. Auricular acupuncture is also suitable for the management of PD and may also be used prophylactically.

The 2024 CPG publication recommends²³ acupuncture to treat PD with different patterns. The main points are Sanyinjiao (SP6), Ciliao (BL32), Diji (SP8), and Zhongji (CV3). Other points can be added according to the patterns; for example, Taichong (LV3), Qihai (CV6), and Xuehai (SP10) can be supplemented for Qi stagnation and blood stasis pattern. In addition, fire needling in Zusanli (ST36), Sanyinjiao (SP6), Ciliao (BL32), Diji (SP8), and Shiqizhui (EX-B8) are also recommended for the treatment of PD with cold induced blood stasis pattern.

Across the included SRs, 65 PICO questions were identified. Of these, 32 PICOs found acupuncture superior to WM for clinical efficacy rate, pain relief rate, VAS, CMSS, adverse events, and use of analgesics; 25 PICOs reported no statistically significant differences between acupuncture and WM for SF-36, CMSS, VAS, NRS, clinical efficacy rate, or work/school absenteeism; and 8 PICOs, mostly from network meta-analyses, indicated acupuncture was inferior to WM on clinical efficacy rate, NRS, VAS, and CMSS.

74.4% (29/39) of RCTs reported that acupuncture was superior to CWT across several outcomes, including clinical efficacy rate, VAS, CMSS, pain-relief rate, treatment satisfaction, incidence of adverse events, PGF2α, PGE2, blood viscosity, pulsatility index (PI), and resistance index (RI). Additionally, one RCT³⁴ reported that He’s Santong needling method was superior to ibuprofen in follow-up VAS, CMSS, and PGF2α, and another RCT³⁵ showed that sequential-acupuncture and routine acupuncture were superior to ibuprofen for multiple follow-up or post-treatment. Regarding inferior outcomes, two RCTs^36,37 suggested that acupuncture was inferior to CWT in the numeric pain rating scale (NPRS), the response rate in the second menstrual cycle, and VAS in the first cycle; He’s Santong needling method was inferior to the control in VAS, CMSS, and PGF2α in the first month of treatment;³⁴ and sequential acupuncture was inferior to ibuprofen in post-treatment VAS and CMSS duration.³⁵ For outcomes showing no significant differences, five RCTs38, 39, 40, 41, 42 found no significant difference compared with CWT in overall/immediate response rates, VAS at specific time points (e.g., 2 hours, 1 day, or shortly after treatment), SF-36, and CMSS at month 3; two RCTs^36,37 found no difference in VAS after the second and third cycles, response rates in the first and third cycles, analgesic use, SF-36, and adverse events; He’s Santong needling method showed no difference versus control groups in VAS, CMSS, PGF2α, and adverse events at months 2 and 3;³⁴ and routine acupuncture showed no difference compared with ibuprofen in post-treatment VAS and CMSS duration.³⁵

4. Discussion

4.1. Summary of key findings

A total of 219 relevant CPGs, SRs, and RCTs were identified for 14 clinical questions related to PD, covering 36 outcomes. Of these, 79.9% were published in Chinese. Evidence for PD interventions was concentrated in oral CHM and acupuncture, whereas evidence for cupping, tuina/massage, and Chinese movement exercise was limited. All clinical questions, interventions, outcomes, and corresponding CPGs, SRs, and RCTs pertaining to PD can be readily accessed on the ACE-iMed platform (website: http://www.aceimed.org). In this article, two clinical questions with the largest evidence (clinical questions 2 and 4) are described in detail.

4.2. Strengths and limitations

This study systematically identified the evidence for 14 clinical questions concerning the CM and ICWM in the treatment of PD, with a particular focus on high-level evidence from CPGs, SRs, and RCTs. The methodological quality of the included studies was also assessed, providing users with a valuable reference for judging the quality of the evidence prior to its application.

However, several limitations should be acknowledged. First, although a dual independent screening and data extraction process was employed, supplemented by AI cross-checking, there remains the possibility of missed studies or data bias. Second, the evidence included in this review was current up to September 6, 2025; subsequent emerging evidence has not been incorporated in this paper. Nevertheless, we will regularly update the evidence on the ACE-iMed website (http://www.aceimed.org), allowing it to serve as living evidence. Third, the clinical questions and outcomes were developed through literature review and a small-scale clinician survey, without a larger-scale investigation. Moreover, we did not standardize outcome definitions across included studies and relied on the terminology used in the original documents, potentially introducing bias into the data analysis. Fourth, although we presented evidence summaries for the clinical questions, we did not synthesize the evidence, conduct subgroup analyses, or grade evidence. Finally, due to space constraints and consistency within the ACE-iMed series, only the two clinical questions with the largest evidence base were described in detail in the main text.

4.3. Clinical and research implications

ICWM for PD is gaining recognition, and the quality of the supporting evidence is steadily improving. However, the current literature on PD is still associated with a relatively high risk of bias, highlighting the need for improved methodological rigor in future studies. Through ACE-iMed platform, users—particularly clinicians—can access up-to-date evidence regarding various interventions for PD treatment in the context of integrative medicine. These findings could further support evidence-informed clinical decision-making. Currently, some interventions are already supported by relatively robust evidence; clinicians may consider adopting these in practice based on their clinical needs and the quality of available evidence. However, for interventions with insufficient or low-quality evidence, or where evidence is lacking, clinicians should exercise caution in referencing such evidence in clinical practice. For researchers, research gaps identified through the ACE‑iMed platform, such as insufficient evidence or evidence that does not adequately reflect clinical practice, highlight opportunities to conduct more rigorous studies, thereby strengthening the evidence and advancing evidence‑based practice.

4.4. Conclusion

Evidence on CM and ICWM for PD has been steadily increasing, and their efficacy has garnered growing attention. CPGs also recommend CM or ICWM approaches for PD treatment. The available evidence, including CPGs, SRs, and RCTs, not only helps diverse interest-holders, such as clinicians, researchers, patients and the public, and policymakers, to examine evidence addressing specific clinical questions, but also supports the conduct of real-world evidence studies and the implementation of evidence-based practice.

Author contributions

Conceptualization: XY, ZXB, and YLC. Data analysis: ZJW and XY. Writing – Original Draft: XY, ZJW, and YFM. Writing – Review and Editing: XY, ZJW, YFM, SYW, KX, HL, JZ, HYZ, YLC, and ZXB. Funding acquisition: ZXB. All authors read and approved of the final manuscript.

Ethics statement

Not applicable as this is a review of previously published literature and did not involve the collection of new data from human participants or animals.

Funding

This study was supported by two independent funders: (i) the Vincent and Lily Woo Foundation; and (ii) Project “Integrative Chinese and Western Medicine Treatment Pathway for the Chronic Diseases (Project Code: TFD2024-P08)” from Hong Kong Baptist University. The funders have no role in the study design, data collection and analysis, manuscript writing, or publication process.

Declaration of generative Al and Al-assisted technologies in the writing process

Guided by the AI-empowered Clinical Evidence for Integrated Chinese–Western Medicine (ACE-iMed) framework in developing this study, the role of generative artificial intelligence is described in detail in the ACE-iMed platform design and methodology paper. In preparing this manuscript, the authors used ChatGPT-5 solely for grammar checking. All AI-assisted outputs were reviewed and edited by the authors, who take full responsibility for the final content of the published article.

Data availability

The data that supports the findings of this study are available on the ACE-iMed platform (http://www.aceimed.org). The detailed analysis data are available from the ACE-iMed working group (email: aceimed@163.com) upon reasonable request.

Declaration of competing interest

YFM, KX, and YLC are staff members and ZXB is the founding director and current co-director of the Vincent V.C. Woo Chinese Medicine Clinical Research Institute, which receives funding from the Vincent and Lily Woo Foundation. ZXB is the principal investigator of Project "Integrative Chinese and Western Medicine Treatment Pathway for the Chronic Diseases (Project Code: TFD2024-P08)." YFM, XY, YLC, and ZXB are members of the editorial board of this journal but had no role in the peer review or editorial decision for this article.

Appendix. Supplementary materials

• Supplement 1. Search strategies for databases and websites.

  Supplement 2. Outcomes of interest for people with primary dysmenorrhea.

  Supplement 3. Chinese herbal medicines recommended in the International Standard of Traditional Chinese Medicine Techniques - Clinical Guidelines for Dysmenorrhea (2022).