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2019年10月20日 星期日

【論文解讀】The efficacy and safety of acupuncture in women with primary dysmenorrhea:A systematic review and meta-analysis

Updated until 2025

Guideline: Acupuncture and Related Therapies for Primary Dysmenorrhea

This guideline provides healthcare providers, including Traditional Chinese Medicine (TCM) practitioners and Western medical doctors, with a concise, evidence-based summary of acupuncture and related therapies for managing primary dysmenorrhea. The recommendations are synthesized from recent systematic reviews and meta-analyses to translate complex clinical evidence into clear, actionable guidance for practice.

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1.0 Understanding Primary Dysmenorrhea and the Role of Complementary Therapies

1.1 Introduction to the Clinical Challenge

Primary dysmenorrhea is defined as cramping menstrual pain that occurs without any identifiable pelvic pathology. It is one of the most common gynecological complaints, affecting an estimated 50% to 90% of adolescent girls and women of reproductive age. The condition's high prevalence makes it a significant public health concern worldwide, as it is a leading cause of recurrent absenteeism from school and work, which seriously compromises women's quality of life. Despite its impact, primary dysmenorrhea is often underdiagnosed or inadequately treated. This clinical reality underscores the need to identify and validate effective, safe, and feasible treatment options for patients.

1.2 Limitations of Conventional First-Line Treatments

The consensus guidelines for primary dysmenorrhea recommend nonsteroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives (OCs) as first-line treatments. While these therapies can provide relief for many patients, they are associated with significant limitations that necessitate the exploration of alternative approaches.

  • Efficacy: A notable portion of patients do not experience adequate pain reduction with these conventional medications. Furthermore, the long-term efficacy of these treatments is often unsatisfactory, with some methods providing only temporary relief.

  • Side Effects (NSAIDs): Patients may experience a range of adverse reactions, including nausea, dyspepsia, headache, and drowsiness. Long-term use has also been associated with more significant concerns, such as the disruption of intestinal microbiota and gastrointestinal inflammation.

  • Side Effects & Suitability (OCs): Oral contraceptives can cause adverse effects such as nausea, vomiting, weight gain, and abnormal vaginal bleeding. Critically, OCs are not a suitable option for patients who are actively attempting to become pregnant.

Given these challenges, many patients seek complementary and alternative therapies that may offer high efficiency with fewer unpleasant side effects.

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2.0 Evidence Synthesis: Efficacy of Acupuncture and Related Modalities

This section systematically evaluates the clinical evidence for various acupuncture and related modalities, drawing upon data from meta-analyses of randomized controlled trials (RCTs). The efficacy of each modality is assessed relative to different control groups—including no treatment, placebo interventions, and conventional medications (e.g., NSAIDs)—to provide a comprehensive understanding of its therapeutic potential in managing primary dysmenorrhea.

2.1 Manual Acupuncture (MA)

A 2018 systematic review by Woo et al. provides the following evidence on Manual Acupuncture:

  • Comparison with No Treatment: Meta-analysis shows MA is significantly more effective than no treatment in reducing menstrual pain, as measured by the Visual Analog Scale (VAS), Cox Menstrual Symptom Scale (CMSS), and Retrospective Symptom Scale (RSS).

  • Comparison with NSAIDs: Meta-analysis indicates that MA is significantly more effective than NSAIDs at reducing pain intensity (VAS), improving overall menstrual symptoms (Menstrual Symptom Score - MSS), and providing a greater degree of overall pain relief (Total Effective Rate - TER).

  • Comparison with Placebo and OCs: Evidence is mixed regarding MA versus placebo acupuncture; while two reviewed studies found no significant difference in pain reduction, one reported significantly greater pain relief with MA. In a single study, Oral Contraceptives were found to be more effective than MA, though this is based on limited data.

  • Long-Term Efficacy: Some studies suggest that the pain-reducing effects of MA can be maintained during a short-term follow-up period after treatment completion.

2.2 Electroacupuncture (EA)

The meta-analysis by Woo et al. (2018) demonstrates:

  • EA is significantly more effective at reducing menstrual pain (VAS) compared to both no treatment and placebo acupuncture.

  • The evidence for improving associated symptoms (as measured by VRS and RSS) is not significant.

  • The comparison between EA and NSAIDs shows no significant difference in overall pain relief (TER).

2.3 Warm Acupuncture (WA)

The Woo et al. (2018) review found:

  • WA is significantly more effective at reducing menstrual pain (VAS) and providing overall pain relief (TER) compared to NSAIDs.

  • When used as an adjunctive therapy, WA combined with NSAIDs provides significantly more pain relief than treatment with NSAIDs alone.

2.4 Auricular Therapies

Auricular therapies stimulate acupoints located on the ear. The evidence varies depending on whether the modality is invasive (needles) or non-invasive (pressure).

  • Auricular Acupressure (AA - Non-invasive): A 2023 meta-analysis by Kong et al. found that this non-invasive technique is effective for increasing the cure rate and total effective rate, and for reducing pain (VAS) and symptom scores.

    • AA is significantly superior to analgesics and non-intervention.

    • AA is also effective when used as an adjunctive strategy to other therapies.

    • However, when used alone, AA was not found to be superior to other active TCM therapies like traditional acupuncture or Chinese herbal medicine.

  • Auricular Acupuncture (AA - with needles): The Woo et al. (2018) review included a single study on auricular acupuncture with needles, which reported no significant difference in pain reduction when compared to NSAIDs.

2.5 Catgut Embedding Therapy (CET)

The Woo et al. (2018) review reports:

  • CET is significantly more effective than NSAIDs in reducing pain (VAS), providing overall pain relief (TER), and improving associated menstrual symptoms (MSS).

  • One study indicated that its efficacy was maintained after a 3-month follow-up period.

2.6 Other TCM Modalities

In addition to acupuncture, several other TCM modalities are well-established practices for primary dysmenorrhea. As reviewed by Duan et al. (2025), these therapies have supportive evidence and established mechanisms.

  • Moxibustion: A heat therapy that involves burning moxa near the skin's surface to warm acupoints. It is proposed to work by regulating endocrine and immune functions.

  • Acupoint Application: An external therapy where herbal pastes are applied to specific acupoints.

  • Massage (Tuina): A form of therapeutic massage that targets acupoints and meridians, which may improve uterine blood flow microcirculation.

  • Cupping Therapy: Involves placing cups on the skin to create suction, which is thought to relieve pain.

These modalities, supported by clinical practice and emerging research, broaden the therapeutic armamentarium for primary dysmenorrhea.

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3.0 Clinical Recommendations for Practice

This section translates the synthesized evidence into practical recommendations for clinicians. It provides guidance on patient selection, treatment timing and frequency, and commonly used acupoints to facilitate the effective and appropriate application of acupuncture and related therapies for primary dysmenorrhea.

3.1 Patient Assessment and Selection

Acupuncture and its related therapies are suitable for female patients of reproductive age who have a confirmed diagnosis of primary dysmenorrhea, characterized by cyclic pelvic pain during menstruation without underlying gynecological pathology. These interventions should be particularly considered as an alternative or adjunctive therapy for patients who have experienced inadequate pain relief or intolerable side effects from first-line conventional treatments, such as NSAIDs and oral contraceptives.

3.2 Treatment Timing and Frequency

While there is no single standardized protocol, the clinical trials reviewed have demonstrated efficacy using several different approaches to treatment timing. Clinicians can select a protocol based on patient preference and clinical presentation.

  • Pre-menstrual Initiation: Treatment begins several days before the expected onset of menstruation, with initiation typically occurring 3 to 7 days prior to menses. This was the most common approach in the reviewed trials, with 31 studies initiating treatment before the onset of menstruation. One review highlighted that pre-menstrual moxibustion is particularly effective for analgesia.

  • Initiation at Onset of Menstruation or Pain: Treatment starts on the first day of the menstrual cycle or at the first sign of menstrual pain. This approach is often used for acute pain relief.

  • Continuous Treatment: Treatment is administered regularly throughout the menstrual cycle, with sessions typically paused during the days of menstruation.

For treatment duration, successful clinical outcomes in the reviewed trials were generally achieved over a course of one to three consecutive menstrual cycles.

3.3 Commonly Utilized Acupoints

The following acupoints were most frequently used in the clinical trials reviewed in the Woo et al. (2018) systematic review for the treatment of primary dysmenorrhea.

Acupoint Name

Meridian Point

Sanyinjiao

SP6

Guanyuan

CV4

Diji

SP8

Ciliao

BL32

Zusanli

ST36

Xuehai

SP10

Taichong

LR3

Zhongji

CV3

Shiqizhui

EX-B8

Shenshu

BL23

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4.0 Safety Profile and Adverse Events

Based on the evidence from numerous RCTs, acupuncture and its related therapies are generally considered safe when performed by qualified and trained practitioners. Most reported adverse events are mild, transient, and do not pose a serious risk to patient health.

4.1 Acupuncture-Related Adverse Events

The comprehensive systematic review by Woo et al. (2018), which included 60 RCTs of needle-based acupuncture (MA, EA, WA, CET), found that no severe adverse events were reported. The mild adverse events that were occasionally noted include:

  • Regional discomfort or pain at the needle site

  • Hematoma (bruising) or minimal bleeding

  • Dizziness

These events were typically self-limiting and resolved quickly without intervention.

4.2 Adverse Events in Other Modalities

The safety profiles for non-needle and heat-based therapies are also favorable.

  • Auricular Acupressure: The meta-analysis by Kong et al. (2023) considers this non-invasive therapy to be very safe, with the majority of included studies not mentioning any adverse events at all.

  • Moxibustion and Cupping: As noted by Duan et al. (2025), therapies involving heat or suction carry a potential risk of adverse effects such as burns, skin irritation, blisters, or skin infections. However, it is crucial to note that these risks are minimal when the therapies are applied correctly by a trained professional.

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5.0 Limitations of Current Evidence and Future Directions

While the evidence for acupuncture in treating primary dysmenorrhea is promising, it is important for clinicians to have a balanced perspective by acknowledging the limitations of the existing research. Synthesizing the critiques from multiple systematic reviews reveals several key areas for improvement. Many of the included clinical trials are of low methodological quality, with a high or unclear risk of bias, particularly concerning allocation concealment and the blinding of participants and assessors. There is also substantial heterogeneity among trials, stemming from wide variations in treatment protocols (e.g., acupoint selection, frequency, and duration) and the types of control interventions used. Furthermore, the lack of standardization in TCM treatment models presents an ongoing challenge for research synthesis.

To provide more definitive evidence, future research should focus on rigorously designed, larger-scale RCTs. Adherence to established reporting guidelines, such as STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) and CONSORT (Consolidated Standards of Reporting Trials), is essential to improve the quality and transparency of future studies.

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6.0 Conclusion

The available body of evidence strongly suggests that acupuncture and related therapies, particularly Manual Acupuncture and Warm Acupuncture, can be effective and safe treatment options for primary dysmenorrhea. These therapies offer a significant reduction in menstrual pain compared to no treatment. Furthermore, meta-analyses demonstrate that Manual and Warm Acupuncture provide significantly greater pain relief than NSAIDs. No severe adverse events have been reported, and most associated side effects are mild and transient. Therefore, acupuncture and its related modalities represent a valuable clinical option for patients, especially those for whom conventional treatments are ineffective, poorly tolerated, or contraindicated.

References

Duan W, Chen D, Li D, et al. Traditional Chinese medicine treatment strategies for primary dysmenorrhea. Front Endocrinol (Lausanne). 2025;16:1580051. Published 2025 May 2.

Hu XY, Tian ZY, Chen H, et al. Use of Evidence-Based Research Approach in RCTs of Acupuncture-Related Therapies for Primary Dysmenorrhea: A Meta-Research. Chin J Integr Med. 2024;30(6):551-558.

Kong X, Fang H, Li X, Zhang Y, Guo Y. Effects of auricular acupressure on dysmenorrhea: A systematic review and meta-analysis of randomized controlled trials. Front Endocrinol (Lausanne). 2023;13:1016222. Published 2023 Jan 5. 

Woo HL, Ji HR, Pak YK, et al. The efficacy and safety of acupuncture in women with primary dysmenorrhea: A systematic review and meta-analysis. Medicine (Baltimore). 2018;97(23):e11007.

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