Abstract
Background
This study aimed to evaluate the effectiveness and safety of individually prescribed decoction herbal medicine for the treatment of dysmenorrhea. Herbal decoction was compared to other herbal formulations and combined treatment modalities, focusing on reductions in menstrual pain intensity, duration, and analgesic use. Personalized herbal treatments were hypothesized to alleviate symptoms more effectively by addressing individual constitutional imbalances.
Methods
This prospective observational study was conducted at 33 Korean medicine clinics and one Korean medicine hospital in South Korea, enrolling 135 participants. Based on the treatment they received, participants were categorized into three groups: herbal decoction only group (Decoction only Group, n = 82), herbal decoction with adjunctive therapies such as acupuncture or moxibustion (Combination Group, n = 37), and non-herbal decoction formulations (Non-decoction Group, n = 16). Treatments were administered over at least one menstrual cycle, and outcomes were assessed after each cycle. Primary outcomes included changes in pain intensity (numerical rating scale), duration of menstrual pain, and frequency of analgesic use. Safety was assessed through adverse event monitoring during clinic visits.
Results
Herbal decoction only showed significant reductions in menstrual pain intensity, pain duration, and analgesic use compared to those receiving other herbal formulations. Most adverse events were mild gastrointestinal symptoms related to oral intake, which resolved without intervention. No serious adverse events were reported.
Conclusions
Herbal decoction group significantly decreased the intensity and duration of menstrual pain and analgesic dosage. These findings suggest that herbal decoction may be a safe and effective personalized treatment option for dysmenorrhea.
Keywords: Dysmenorrhea, Menstrual pain, Herbal medicine, Primary dysmenorrhea, Secondary dysmenorrhea
1. Introduction
Dysmenorrhea, or menstrual pain, is a common gynecological condition characterized by cyclic lower abdominal pain during menstruation.1 It is categorized as primary dysmenorrhea, which is without pelvic disease and often linked to excess prostaglandins, or secondary dysmenorrhea, which is caused by conditions like endometriosis or fibroids.1,2 Approximately 50 % of premenopausal women, of premenopausal women experience dysmenorrhea, with 10 % suffering from severe symptoms that impair daily life and mental well-being.3,4 Common symptoms include nausea, diarrhea, fatigue, and headache.1 While NSAIDs are the standard treatment,5 they can cause digestive side effects6 and are ineffective in 10–20 % of cases,7 highlighting the need for alternative therapeutic options.
In Korean Medicine (KM), dysmenorrhea is managed through herbal medicine,3 acupuncture,8 and moxibustion.9,10 Herbal decoctions are most commonly used, allowing individualized prescriptions tailored to symptom patterns. Frequently used formulas like Gyejibokryeong-hwan11,12 and Hyunburikyung-tang13 aim to improve blood flow and reduce pain. Complementary treatments such as acupuncture, auricular acupressure, and Chuna therapy14 (a form of manual therapy in Korean medicine, similar to chiropractic or osteopathic manipulation) are also employed to enhance therapeutic outcomes through holistic care.
However, individualized herbal treatments have faced limited integration into conventional healthcare due to lack of standardization and insurance coverage.15 To improve access and support evidence-based practice, the Korean government launched a pilot project in 2020 to include herbal medicine for dysmenorrhea under the National Health Insurance.16 While the project aimed to balance standardization and personalization, variation in decoction preparation among clinics remained a challenge for consistent data collection and safety assessment.
This prospective observational study was conducted between August 2022 and June 2023, involving 33 KM clinics and one hospital. It aimed to assess the clinical effectiveness and safety of individualized herbal decoctions for dysmenorrhea under the national pilot program, providing real-world data to support the integration of KM into the broader healthcare system.
2. Methods
2.1. Study protocol
This multicenter, prospective observational study was conducted at a Korean medicine hospital and 33 clinics from July 2022 to June 2023, following the Institutional Review Board approval from Dongguk University. Participants seeking treatment for dysmenorrhea provided written informed consent prior to enrollment.
2.2. Study design
This study aimed to compare the effectiveness and safety of herbal medicines administered for at least 10 days, categorizing participants into three groups:
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Group 1 (Decoction only Group): Herbal decoction only
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Group 2 (Combination Group): Herbal decoction combined with other Korean medicine treatments (e.g., acupuncture, moxibustion, Chuna)
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Group 3 (Non-decoction Group): Non-decoction herbal formulations (e.g., granules, extracts, pills)
Group assignment was determined by clinicians based on patient symptoms, preferences, and clinical judgment. All participants received Korean medicine treatment; no untreated control group was included.
2.3. Intervention
This study involved a personalized herbal medicine intervention, primarily using decoction-type formulations commonly applied in Korean Medicine. These decoctions were individually prescribed based on each patient’s constitution, symptom severity, menstrual patterns, and clinical diagnosis. A standard dose consisted of one packet (80–120 mL), taken twice daily. All prescriptions reflected the personalized treatment principles of Korean Medicine, and a detailed list of herbal components is provided in Supplement 1.
2.3.1. Participants
Participants were eligible if they received herbal treatment for dysmenorrhea, provided informed consent, agreed to data use, understood the study, and completed the surveys. Exclusion criteria included serious comorbidities (e.g., cardiovascular, renal, neurological, or psychiatric disorders), pregnancy plans, or participation in other clinical trials.
Participants were recruited from both clinics participating in the national pilot project for insurance coverage of herbal decoctions and from general clinics offering non-insurance-based, out-of-pocket services. Among the 135 participants who completed the study, 63 (46.67 %) were enrolled through the pilot insurance program, while 72 (53.33 %) were general patients not covered by insurance.
2.4. Outcome measures
2.4.1. Primary outcome
The primary outcomes included the mean change in dysmenorrhea intensity (measured using a numerical rating scale (NRS)), duration of menstrual pain, and dosage of analgesics used. Outcomes were assessed at each treatment cycle, including evaluations after the first and second menstruations. Most assessments were conducted in person, although phone or online surveys were administered if the participants consented.
2.4.2. Secondary outcomes
Secondary outcomes included self-rated effectiveness, satisfaction, and adverse events. Clinical improvement was scored on a 4-point scale (1 = significant improvement, 4 = no effect), with lower scores indicating greater effectiveness. Satisfaction was measured separately for herbal medicine and overall Korean Medicine treatment, each rated on a 7-point scale. Herbal medicine satisfaction reflected preferences for formulation type, while overall satisfaction related to intervention type. Adverse events were monitored by clinicians throughout the study, with any symptoms, responses, or treatments recorded at each visit to assess herbal medicine safety.
2.5. Statistical analysis
Demographic data were analyzed using ANOVA and chi-square tests, with results presented as frequencies or means ± SD. Paired t-tests assessed within-group changes, and the Kruskal-Wallis test was used for between-group comparisons. When significant, Mann-Whitney U tests were conducted post hoc. A p-value < 0.05 was considered significant. Missing values were imputed (simple for categorical, mean for continuous). Analyses were performed using SPSS 23.0.
3. Results
3.1. Characteristics of participants
Demographic characteristics such as age, BMI, marital status, delivery history, alcohol intake, smoking, and dysmenorrhea type did not show statistically significant differences (p > 0.05, ANOVA, chi-square test).
3.2. Baseline characteristics of dysmenorrhea (NRS, duration of pain, and analgesic usage)
Before treatment, significant group differences were found in menstrual pain intensity, duration, and analgesic use (all p < 0.05). Combination group (decoction + intervention) reported the highest values (NRS 6.59 ± 1.99; duration 34.75 ± 28.38 h; analgesics 4.03 ± 4.68), while non-decoction group had the lowest (NRS 4.56 ± 2.10; duration 7.78 ± 12.52 h; analgesics 1.38 ± 1.75). Post-hoc Mann–Whitney U tests confirmed significant differences between non-decoction group and both other groups for pain intensity (p < 0.01) and duration (p < 0.05).
3.3. Analysis of interventions (herbal medicine)
Among all participants, 82 participants (60.74 %) received herbal decoction only, 37 (27.41 %) received decoction with other herbal formulations, and 16 (11.85 %) received only non-decoction forms (e.g., granules, extracts). Decoctions, as customizable formulations, played a central role in individualized treatment. The combination patterns of herbal interventions are detailed in Supplementary Table 2.
3.3.1. Analysis of herbal medicine administration among all participants
The five most frequently used formulas were Hyunburikyung-tang (43.7 %), Gyejibokryeong-hwan (17.6 %), Sobokchukeo-tang (9.2 %), Dangguijakyak-san, and Gamisoyo-san. Comparative analysis of the three most common single prescriptions (n = 63) versus others (n = 15) showed no significant differences in clinical outcomes (p > 0.05), suggesting consistent effectiveness regardless of the specific formula.
3.3.2. Analysis of other formulations (granules, extracts, tablets, and pills) administered to all participants
Twenty-four participants received non-decoction forms (granules, extracts, tablets, pills). Gyejibokryeong-hwan granules were the most commonly used (58.3 %).
3.4. Analysis of treatment duration
The average treatment duration was approximately 33 days in the decoction only group, 42 days in combination group, and 31 days in the non-decoction group. Although combination group showed a slightly longer duration, the differences were not statistically significant (p > 0.05).
3.5. Primary outcome evaluation
To evaluate the clinical effectiveness of herbal medicine for dysmenorrhea, dysmenorrhea pain intensity, pain duration, and analgesic dosage were analyzed as primary outcomes. Differences among the three groups were tested using the Kruskal-Wallis test, and where differences were found, post-hoc testing was conducted using the Mann-Whitney U test.
At baseline, significant differences were observed among the three groups for all outcomes (p < 0.05). Pain intensity was highest in combination group (6.59 ± 1.99), followed by the herbal decoction only group (6.09 ± 1.97), and lowest in non-decoction group (4.56 ± 2.10). After the first treatment cycle, these values decreased to 24.34, 12.90, and 1.81 h, respectively, maintaining the same group order. Analgesic use also varied at baseline, though post-hoc comparisons revealed no statistically significant pairwise differences. After treatment, analgesic use declined across all groups—most notably in combination group. Non-decoction group showed the smallest decrease (to 0.69 ± 1.14), likely due to milder symptoms at baseline.
3.5.1. Evaluation after one cycle treatment
Primary outcomes included menstrual pain intensity (NRS), duration, and analgesic use. At baseline, all measures differed significantly across groups (p < 0.05). Combination group showed the highest pain intensity and duration, while non-decoction group had the lowest. Post-hoc analysis confirmed significant differences between non-decoction group and both other groups for pain intensity and duration (p < 0.05), but not for analgesic use.
After one cycle treatment, all groups showed reductions in pain and analgesic use. There was no statistically significant difference (Table 1).
Table 1.
Baseline characteristics and menstrual pain patterns.
| Characteristics | Total | Decoction only Group | Combination Group | Non-decoction Group | p-value |
|---|---|---|---|---|---|
| N = 135 | N = 82 | N = 37 | N = 16 | ||
| Age, Mean ± SD | 30.16 ± 12.07 | 30.89 ± 12.41 | 26.35 ± 8.42 | 35.19 ± 15.65 | 0.088 |
| BMI (kg/m2) | 0.868 | ||||
| Mean ± SD | 21.19 ± 2.79 | 21.12 ± 2.73 | 21.07 ± 2.51 | 21.79 ± 3.78 | |
| Median (Min, Max) | 21.19 (15.6, 29.36) | 21.12 (16.18, 25.71) | 21.07 (16.16, 25.71) | 21.79 (15.60, 29.30) | |
| Marital Status | 0.101 | ||||
| Yes | 46 (34.07 %) | 30 (65.22 %) | 8 (17.39 %) | 8 (17.39 %) | |
| No | 89 (65.93 %) | 52 (58.43 %) | 29 (32.58 %) | 8 (8.99 %) | |
| Experience of delivery | 0.11 | ||||
| Yes | 43 (31.85 %) | 29 (35.37 %) | 7 (18.92 %) | 7 (43.75 %) | |
| No | 92 (68.15 %) | 53 (64.63 %) | 30 (81.08 %) | 9 (56.25 %) | |
| Primary dysmenorrhea | 118 (87.41 %) | 71 (86.59 %) | 31 (83.78 %) | 16 (100 %) | 0.247 |
| Secondary dysmenorrhea | 17 (12.59 %) | 11 (13.41 %) | 6 (16.22 %) | 0 | |
| Alcohol intake | 0.83 | ||||
| Yes | 46 (34.59 %) | 28 (34.15 %) | 12 (32.43 %) | 6 (37.5 %) | |
| No | 87 (65.41 %) | 52 (63.41 %) | 25 (67.57 %) | 10 (62.5 %) | |
| Unresponsive | 2 (1.50 %) | 2 (2.44 %) | 0 | 0 | |
| Smoking Status | 0.861 | ||||
| Non-smoker | 130 (96.30 %) | 78 (95.12 %) | 36 (97.30 %) | 16 (100 %) | |
| Current smoker | 4 (2.96 %) | 3 (3.66 %) | 1 (2.70 %) | 0 | |
| Unresponsive | 1 (0.74 %) | 1 (1.22 %) | 0 | 0 | |
| Menstrual pain intensity (NRS) | 6.04 ± 2.06 | 6.09 ± 1.97 | 6.59 ± 1.99 | 4.56 ± 2.10 | 0.006 |
| The duration of pain (hours) | 26.73 ± 28.06 | 26.90 ± 28.57 | 34.75 ± 28.38 | 7.78 ± 12.52 | <0.001 |
| Analgesic usage (n) | 2.91 ± 3.49 | 2.72 ± 2.97 | 4.03 ± 4.68 | 1.38 ± 1.75 | 0.042 |
NRS, numeric rating scale; SD, standard deviation.
*Combination Group: Herbal decoction + other interventions, Non-decoction Group: Other formulations.
3.5.2. Evaluation value after last cycle treatment
At the final treatment cycle, all groups showed improvements in menstrual pain outcomes. Pain intensity significantly decreased in both the decoction only group and combination group (p < 0.001). Pain duration also declined substantially in these (p < 0.001), while non-decoction group showed a smaller, non-significant decrease (p > 0.05). Analgesic use dropped significantly in all groups, including non-decoction group with the greatest reductions seen in the decoction only group and combination group (p < 0.001) (Table 2).
Table 2.
Treatment outcomes before and after herbal medicine intervention by group.
| Variable | Herbal decoction group | Combination group | Non-decoction group | P-value |
|---|---|---|---|---|
| Mean ± SD | ||||
| NRS (Before) | 6.09 ± 1.97 | 6.59 ± 1.99 | 4.56 ± 2.10 | 0.006 |
| NRS (After 1st Cycle) | 4.33 ± 2.43 | 3.64 ± 2.06 | 3.15 ± 1.95 | 0.091 |
| NRS (After Last Cycle) | 3.04 ± 2.26 | 2.62 ± 2.36 | 3.06 ± 2.02 | 0.469 |
| Duration of Pain (Before) | 26.90 ± 28.57 | 34.75 ± 28.38 | 7.78 ± 12.52 | 0.006 |
| Duration of Pain (After 1st Cycle) | 12.90 ± 18.78 | 24.34 ± 29.91 | 1.81 ± 1.41 | 0.027 |
| Duration of Pain (After Last Cycle) | 10.19 ± 17.13 | 15.49 ± 20.47 | 2.31 ± 1.92 | 0.359 |
| Analgesic Usage (Before) | 2.72 ± 2.97 | 4.03 ± 4.68 | 1.38 ± 1.75 | 0.042 |
| Analgesic Usage (After 1st Cycle) | 1.07 ± 1.77 | 1.76 ± 3.26 | 0.69 ± 1.25 | 0.55 |
| Analgesic Usage (After Last Cycle) | 0.72 ± 1.43 | 1.05 ± 2.45 | 0.69 ± 1.14 | 0.679 |
| Self-rated Effectiveness (After 1st Cycle) | 1.85 ± 0.98 | 2.00 ± 1.05 | 2.50 ± 0.73 | 0.027 |
| Satisfaction with KM Treatment | 5.93 ± 1.13 | 6.14 ± 1.11 | 4.06 ± 1.06 | p < 0.001 |
| Satisfaction with HM Treatment | 5.93 ± 1.28 | 5.92 ± 1.30 | 3.94 ± 0.93 | p < 0.001 |
HM, Herb Medicine; KM, Korean Medicine; NRS, numeric rating scale.
* Combination Group: Herbal decoction + other interventions, Non-decoction Group: Other formulations(non-decoction).
† Missing data were imputed using the Last Observation Carried Forward (LOCF) method prior to statistical analysis.
‡ Improvement was measured using a 4-point scale, where 1 indicates ‘very much improved’, 2 ‘moderately improved’, 3 ‘slightly improved’, and 4 ‘no improvement’.
§ Satisfaction was measured on a 7-point scale (1 = not at all satisfied, 7 = extremely satisfied).
3.5.3. Analysis of group differences based on change scores
To account for baseline variability, change scores (Δ = post-treatment – baseline) were analyzed for menstrual pain intensity, duration, and analgesic use. The Kruskal–Wallis test showed significant differences among groups for all three outcomes (NRS: p = 0.004; duration: p = 0.021; analgesic use: p = 0.033). Post-hoc analysis revealed that both the herbal decoction only and combination group had significantly greater reductions in pain intensity and analgesic consumption compared to the non-decoction group. For pain duration, the greatest improvement was observed in combination group with significantly larger reductions than non-decoction group. (p < 0.05).
3.6. Secondary outcomes evaluation
For secondary outcomes, the decoction only group reported the greatest clinical improvement, significantly better than non-decoction group. Satisfaction scores were highest in combination group followed by the decoction only group and lowest in non-decoction group (p < 0.001). Herbal medicine-specific satisfaction was similarly higher in the decoction groups (Table 2).
3.7. Adverse events
Adverse events (AEs) were reported by 16 of the 135 participants; after excluding two cases with no temporal relationship to treatment, 14 participants (10.4 %) were confirmed to have experienced 19 AEs potentially related to herbal medicine. The most common AEs were gastrointestinal symptoms (7 cases), followed by menstrual irregularities and ovulatory bleeding, mainly associated with Hyunburikyung-tang, Sobokchukeo-tang, and Ongungyangwi-tang (Supplement Table 4). Among 119 patients receiving herbal decoction, 14 (11.8 %) reported AEs, while none occurred in the 16 patients in non-decoction group. However, no statistically significant differences were found between groups (χ² = 1.0251, p = 0.3113; Fisher’s exact test p = 0.374).
4. Discussion
Dysmenorrhea,17 characterized by menstrual cramps and pelvic pain, is the most common gynecological disorder among women of reproductive age and is frequently accompanied by symptoms like nausea, fatigue, and psychological distress.10 Prevalence rates vary widely across studies18,19 (16–91 %), with 2–29 % experiencing severe symptoms. In South Korea, the prevalence is particularly high, affecting 87–90 % of women, with up to 25.6 % reporting severe cases.20
4.1. Summary of key findings
This prospective observational study demonstrated that decoction-type herbal medicine, both alone and in combination with other Korean Medicine (KM) treatments, was associated with meaningful reductions in menstrual pain intensity, duration, and analgesic use. A comparison of baseline menstrual pain characteristics among the three groups revealed statistically significant differences in pain intensity, duration, and analgesic use. Treatment selection appeared to reflect baseline symptom severity, with more complex or severe cases receiving decoction combined with adjunctive therapies. Despite differences in baseline characteristics, post-treatment outcomes, including patient-reported improvement and satisfaction, tended to favor herbal decoction only group. These results suggest that decoction-type herbal medicine may offer superior clinical benefits and patient satisfaction in managing dysmenorrhea compared to other formulations, while also supporting individualized treatment decisions in real-world Korean Medicine practice.
4.2. Comparison with previous studies
Our findings align with previous Korean case studies and international trials that have reported positive effects of individualized herbal prescriptions for dysmenorrhea. Domestic case reports highlight modifications of traditional formulas such as Gamisoyo-san,21 Sobokchukeo-tang,22,23 and Soeumin Kwakhyangjeonggi-san.24 International randomized controlled trials (RCTs) have reported on Gyejibokryeong-hwan and Kamitonggye-tang, among others.25 This study reinforces those results in a real-world context and supports the clinical utility of decoction-based, customized treatments over standardized herbal formulations.
4.3. Clinical and scientific implications
Once herbal therapy was initiated, patients tended to reduce their reliance on analgesics, regardless of baseline pain severity. This highlights the potential of herbal medicines—particularly decoction-type formulations—in effectively managing menstrual pain and minimizing the need for painkillers. Although the combination of decoction with adjunctive therapies showed a trend toward longer treatment durations, the difference was not statistically significant, likely reflecting treatment intensification for more severe cases.
The most frequently used decoctions—Hyunburikyung-tang,13 Sobokchukeo-tang,22 and Gyejibokryeong-hwan12,26 targeted qi and blood stagnation patterns and consistently showed reductions in pain intensity, duration, and analgesic use, with no significant differences in effectiveness among them. (Supplement 5).
Taken together, these findings suggest that herbal decoction offers effective symptom relief and may serve as a complementary approach in managing dysmenorrhea. Furthermore, despite differences in formulation, the therapeutic outcomes across these prescriptions did not show statistically significant differences in pain intensity reduction (p > 0.05), suggesting a comparable level of effectiveness among the three herbal decoctions. This consistency may be attributed to shared therapeutic actions such as improving blood circulation, relieving uterine muscle tension, and regulating qi flow—mechanisms commonly targeted in traditional prescriptions for dysmenorrhea.
Safety analysis showed that adverse events (AEs) were mild and transient, primarily involving gastrointestinal symptoms. AEs were mostly associated with Hyunburigyung-tang, Sobokchukeo-tang, and Ongungyangwi-tang. No severe or persistent reactions were reported, supporting the overall safety of decoction-type herbal treatments.
4.4. Strengths and limitations
The main strength of this study is its multicenter, prospective, observational design, reflecting real-world KM clinical practice. By including diverse treatment types and combining clinical and patient-reported outcomes, the study provides a comprehensive view of herbal medicine use for dysmenorrhea. However, several limitations exist. As a non-randomized study, treatment decisions were made by clinicians, potentially introducing selection bias. Regional concentration and physician-level variability may have affected generalizability.The sample was also regionally concentrated, with many participants from Seoul and Gyeonggi Province and one clinic contributing a large portion of cases. The short follow-up period and reliance on self-reported data limit the assessment of long-term effects. Additionally, the study was conducted during an early phase of a national pilot program restricting decoction prescriptions to once per cycle, which may have influenced treatment continuity.The recent expansion to allow two prescriptions per cycle (as of April 2024) may improve treatment continuity and outcomes in future research
4.5. Conclusions and future research directions
Decoction- type herbal medicine was effective in alleviating menstrual pain and reducing pain duration and analgesic use, with higher satisfaction levels compared to other herbal formulations. The favorable safety profile and symptom relief suggest that decoction-type treatments may serve as viable alternatives or adjuncts to conventional care. Further randomized controlled trials and long-term follow-up studies are recommended to validate these findings and assess sustained clinical benefits under broader health policy condition.
Author contributions
Se-In Cho: Data curation, Investigation, Writing – original draft, Writing – review and editing, Formal analysis; Hyo-Jeong Jung: Data curation, Investigation. Min-Jung Park: Investigation, Formal analysis, Validation; Dong-Il Kim: Supervision, Investigation, Methodology, Project administration, Conceptualization.
Declaration of competing interest
The authors declare that they have no conflicts of interest.
Acknowledgments
Funding
This study was supported by the Ministry of Health and Welfare of the Republic of Korea and National Institute for Korean Medicine Development. The data that support the findings of this study are available from the corresponding author upon reasonable request.
Ethics statement
This study was reviewed and approved by the Institutional Review Board of Dongguk University Ilsan Korean Medicine Hospital (DUIOH 2022-07-008-002). Informed consent was obtained from all participants.
Data availability
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Footnotes
Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.imr.2025.101209.
Supplement 1. Composition of major herbal prescriptions.
Supplement 2. Intervention combinations administered with herbal decoction.
Supplement 3. Comparison of score changes (Δ = Post – Baseline) across three treatment groups.
Supplement 4. Summary of adverse events by herbal decoction prescription.
Supplement 5. Comparative effectiveness of herbal decoction prescriptions for dysmenorrhea treatment.
Supplement 6. STROBE checklist.
Appendix. Supplementary materials
References
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Supplementary Materials
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.