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Introduction
Primary dysmenorrhoea (PD) is the most common gynaecological condition among young women and is associated with significant socioeconomic repercussions. It is unclear which works best for pain relief when pharmacological and non-pharmacological interventions are compared. This systematic review and network meta-analysis (NMA) will aim to compare and rank the effects of pharmacological and non-pharmacological interventions in patients with PD.
Methods and analysis
Randomised controlled trials of pharmacological and non-pharmacological interventions for PD will be identified via a search of the PubMed, Cochrane Library, Web of Science, Embase, Scopus database and Google Scholar search engine until September 2025. The primary outcome will be a change in pain intensity among patients with PD, while the secondary outcomes include health-related quality of life, symptoms of depression and anxiety, and treatment-related adverse events. Two independent reviewers will perform document screening, study selection and data extraction. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias tool (V.2). The RevMan, Stata and Aggregate Data Drug Information System software will be used to perform a pairwise meta-analysis and Bayesian NMA in a random-effects model. The certainty of the evidence will be rated using the Grading of Recommendations, Assessment, Development, and Evaluation System.
Ethics and dissemination
This systematic review protocol is exempt from ethical approval as it involves analysis of previously published data. The findings of this review will be submitted to peer-reviewed journals.
Trial Registration number
CRD42024543573.
Full text
Correspondence to Prof FanRong Liang; [email protected]
STRENGTHS AND LIMITATIONS OF THIS STUDY
Randomised controlled trials published in English or Chinese will be included to comprehensively capture available evidence.
The quality of the included trials will be assessed using the Revised Cochrane Risk of Bias Tool for randomised trials.
This systematic review will rigorously follow the methodological standards outlined in the Cochrane Handbook for Systematic Reviews.
The efficacy of different regimens of the same intervention will not be investigated in this study.
Background
Primary dysmenorrhoea (PD) is one of the most frequent complaints in women of childbearing age and is characterised by cyclic pelvic pain before or during menstruation without organic diseases.1 Severe cases are often accompanied by symptoms such as nausea, back pain and fatigue.2 Epidemiological surveys report the prevalence of PD to be 45% to 95%, with 2% to 29% of menstruating women experiencing severe symptoms.3 4 Moreover, PD frequently progresses to chronic pain and significantly impacts the daily lives and psychological states of patients to varying extents,5 6 including problems with work or social activities, anxiety and depression.7 PD has been reported as the leading cause of school absenteeism in adolescent girls. A recent review estimated that, in the USA alone, PD contributes to the loss of 600 million working hours and $2 billion annually due to decreased productivity and increased healthcare costs.8 Thus, exploring effective and proper management strategies for PD will benefit individuals and society.
The exact pathogenesis of PD is not yet fully clear; however, it is widely accepted that this condition is attributed to excessive synthesis and release of prostaglandins that lead to uterine hypercontraction, ischemia and hypoxia, along with inflammation and decreased pain threshold. Treatment of PD can be classified into pharmacological and non-pharmacological approaches. For the pharmacological approach, non-steroidal anti-inflammatory drugs (NSAIDs), hormonal contraceptives and acetaminophen are highly prescribed agents in the treatment of PD.5 Among them, NSAIDs and acetaminophen act by interrupting prostaglandin production; hormonal contraceptives work by suppressing ovulation.5 Meanwhile, a range of non-drug interventions have been proven effective in treating PD, including physical activities (eg, aerobic exercise, resistance training, balance training, stretching);9 thermotherapy (heating pad, local heat compress);10 acupoint stimulation (eg, acupuncture, acupressure, auriculotherapy);11 transcutaneous electrical nerve stimulation (TENS);12 behavioural intervention (eg, biofeedback, relaxation, hypnotherapy, imagery);13 dietary supplements (eg, vitamin, fennel, zinc, ginger);14 aromatherapy;15 manual therapy (eg, massage, tuina, manipulation techniques)16 and herbal preparations.17 These interventions are associated with different characteristics, effects and patient preferences. While medications are considered highly effective for short-term pain relief, their long-term effects on PD remain underexplored,18 and prolonged use can lead to adverse effects.19 This highlights the importance of exploring safe alternative treatments. Currently, several non-drug interventions such as auricular acupressure,20 moxibustion,21 TENS,22 exercise23 and acupuncture24 have shown promising results in reducing pain intensity over various follow-up periods with few side effects, suggesting their potential for long-term pain management in PD. Many studies have also investigated the impact of these treatments on quality of life (QoL) and emotional well-being in patients with PD, though the findings remain inconsistent. For instance, Bazarganipour et al25 observed significant improvements in specific QoL domains with acupressure compared with placebo, but not in overall QoL. Bai et al26 found that no significant differences in QoL between TENS and sham TENS groups (difference (95% CI): 0.2 (0.1 to 0.3)), whereas Lauretti et al22 reported notable QoL improvements in the TENS group compared with placebo. Liu et al21 demonstrated that moxibustion significantly improved anxiety and depression scores compared with a waiting-list group (difference (95% CI): −9.88 (−12.08 to −7.67); −8.86 (−11.12 to −6.59)), while Lu et al27 found no significant difference between acupressure and placebo groups (median (IQR): 44.00 (6.25) vs 43.00 (6.00)). Despite these mixed results, no systematic review has comprehensively assessed the long-term efficacy of these interventions or their impact on QoL and psychological well-being in PD patients, highlighting a significant gap in the literature.
The current guidelines for PD from the Society of Obstetricians and Gynaecologists of Canada (SOGC)28 and the opinion of the American College of Obstetricians and Gynecologists Committee (ACOG)29 recommend NSAIDs and oral contraceptives as first-line treatment options for adults PD, with some non-pharmacological interventions also suggested. These recommendations are based on randomised controlled trials (RCTs) or systematic reviews published up to 2018. The most recent systematic reviews cited, published in 2016, focused on the efficacy of acupuncture and dietary supplements for PD.30 31 Since the publication of the SOGC and ACOG guidelines, a number of additional RCTs have been conducted to evaluate the efficacy and safety of diverse interventions for PD.32–37 The literature is extensive and can be conflicting. For example, one RCT38 reported no significant benefits of TENS in reducing pain compared with placebo, whereas another observed a significant pain reduction with TENS versus sham TENS.12 Similarly, an earlier RCT showed no difference between acupressure and ibuprofen in pain reduction,39 while a more recent study found acupressure to be significantly more effective than ibuprofen in reducing pain intensity.40 Several traditional meta-analyses have evaluated the effects of different types of interventions for PD.36 41–45 However, these analyses are limited to direct comparison of pair-wised interventions, making it difficult for patients and clinicians to identify the best intervention. Therefore, further studies are needed to determine the effective priorities of interventions in PD treatment.
Unlike traditional meta-analysis, network meta-analysis (NMA) is an analytical method that simultaneously estimates the relative efficacy of multiple treatments by gathering direct and indirect evidence, which can provide a hierarchy of the effectiveness of the treatment options.46 Although a previous NMA has compared the efficacy of non-pharmacological interventions for PD and concluded that exercise was the most effective,47 this study was limited to a select group of non-drug interventions and did not include others, such as manual therapy, behavioural interventions, nutritional supplements or pharmacological treatments. Two additional NMAs evaluated the comparative effects of pharmacological interventions for PD, but they focused exclusively on specific drugs—five over-the-counter analgesics or NSAIDs.48 49 A comprehensive comparative study that integrates both pharmacological and non-pharmacological interventions for PD is lacking. Therefore, we propose this systematic review and NMA protocol to evaluate and rank the effects of pharmacological and non-pharmacological interventions in comparison with each other, no treatment, placebo, or standard care on short- and long-term pain intensity, QoL and psychological well-being in patients with PD. The findings of this study will provide a reference to inform recommendations for decision-makers in clinical and policy settings.
Methods
Study registration
This protocol has been registered at PROSPERO (CRD42024543573) and was designed and written in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) statement.50 The NMA will be performed in compliance with the guidelines of the Cochrane Handbook,51 and findings will be reported following the guidelines of the PRISMA-NMA.52
Eligibility criteria
This review will include RCTs or randomised studies comparing pharmacological and non-pharmacological interventions for PD from January 2000 to September 2025. Details regarding the eligibility criteria, including study characteristics, participants, interventions, control groups and outcome measures, are presented in table 1.
Table 1Eligibility criteria for included studies on pharmacological and non-pharmacological interventions for primary dysmenorrhoea
| Category | Inclusion criteria | Exclusion criteria |
| Study characteristics | RCTs and randomised studies comparing pharmacological and non-pharmacological interventions, published in English or Chinese from January 2000 to September 2023. Publication types include peer-reviewed articles, conference proceedings and theses. | Reviews, comments or studies involving animal models. |
| Participants | Women with primary dysmenorrhoea and regular cycles, regardless of age, severity or disease duration. | Women with secondary dysmenorrhoea. |
| Treatment groups | Pharmacological (eg, NSAIDs, oral contraceptives, herbal preparations) and non-pharmacological (eg, acupuncture therapy, acupressure, aromatherapy, exercise, TENS, physiotherapy, psychological intervention, manual therapy, moxibustion, nutritional therapy and non-invasive brain stimulation) treatments. | Combined two or more interventions. |
| Control groups | Pharmacological or non-pharmacological interventions distinct from those in the intervention group, no treatment, placebo or standard care. | Different types of the same treatment, including comparisons of different drug doses, or different stimulus parameters of a single intervention. |
| Primary outcomes | The short-term and long-term efficacy of treatment, defined as mean score changes in pain intensity from baseline to the end of treatment and follow-up, respectively. | |
| Secondary outcomes | Changes in health-related quality of life and psychological issues, including depression and anxiety, from baseline to post-intervention, as well as treatment-related adverse events | |
NSAIDs, non-steroidal anti-inflammatory drugs; RCTs, randomised controlled trials; TENS, transcutaneous electrical nerve stimulation.
Data sources and search strategy
PubMed, Cochrane Library, Web of Science, Embase, Scopus database and Google Scholar search engine will be searched for articles published between January 2000 and September 2024. Clinical registry platforms (WHO ICTRP and ChiCTR) will also be retrieved for unpublished trials. Additionally, the reference lists of the included papers and relevant reviews will be manually searched to identify qualified studies. The search will be limited to English-language publications. The search terms will include “randomised controlled trial”, “dysmenorrhoea”, “NSAID”, “acetaminophen”, “oral contraceptive”, “herb”, “exercise”, “thermotherapy”, “acupuncture”, “acupressure”, “nerve stimulation”, “massage”, “aromatherapy”, “physiotherapy”, “biofeedback”, “relaxation”, “nutrition”, “ginger” and “pain”. The detailed search strategy for each database is presented in online supplemental appendix 1.
Selection of studies
All retrieved records will be imported into Endnote V.X9, and duplicates will be automatically removed. Two reviewers will independently screen the titles and abstracts for initial eligibility, and the final selection of eligible studies will be based on a thorough full-text review. In case where full texts are unavailable, efforts will be made to contact the corresponding author or other co-authors to request the necessary documents. Any disagreements between the reviewers will be resolved through discussion with a third reviewer. The PRISMA flowchart of the selection procedure is shown in figure 1.
Figure 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram of the study selection process. ChiCTR, Chinese Clinical Trial Register; WHO ICTRP, World Health Organization International Clinical Trials Registry Platform; WOS, Web of Science.
Data extraction and management
Two reviewers will independently extract essential information from the included studies using a pre-designed Excel spreadsheet. The extracted data will include details, such as the first author, publication year, country, age, sample size, intervention and control methods, pain intensity before treatment, treatment session and duration, follow-up period, time points, outcome measures data and adverse events. In a study measuring pain intensity in multiple regions (eg, lower abdominal pain, back pain and thigh pain), we will extract data on lower abdominal pain. Similarly, in a limited number of RCTs, both mean and peak pain intensity are reported. In such cases, we will extract data on mean pain intensity to ensure consistency in pain measurement across studies. When pain intensity is measured across multiple days within a single menstrual cycle, we will prioritise data from the initial day, as symptoms are typically most pronounced on that day.53 For missing data or unclear information that may affect the analysis, the corresponding author will be contacted to obtain as much detailed information as possible.
Risk of bias assessment
The methodological quality of all included studies will be assessed by two independent reviewers using the Cochrane Risk of Bias (RoB) V.2.0 tool.54 The overall RoB will be evaluated as low, high or with some concerns across various domains, including the randomisation process, deviations from intended interventions, missing outcome data, outcome measurement and selective reporting of results. Any disputes during the assessment will be resolved by a third reviewer.
Statistical analysis
Pairwise meta-analysis
We will perform a pairwise meta-analysis using RevMan software V.5.4 (Review Manager, The Cochrane Collaboration, 2020) to compare the interventions with direct evidence. Given that the outcomes of interest are typically reported as continuous data, the mean difference, along with 95% credible intervals (CIs), will be synthesised to represent the relative treatment effect. If the mean and SD are not directly available in the primary study, they will be calculated from reported statistics (eg, median and range, standard errors, or 95% CIs) using appropriate formula. The heterogeneity between direct comparisons will be estimated using I2 statistics and p values. I2 values of >30%, 50% and 75% represent moderate, substantial and considerable heterogeneity, respectively.55 The selection of a random-effects or fixed-effects model will be guided by the properties of the included studies and the meta-analysis,56 and possible sources of heterogeneity will be explored using prespecified subgroup analyses.
Network meta-analysis
The NMA will be implemented in a Bayesian random-effects framework using the Aggregate Data Drug Information System (ADDIS) software V.1.16.6 (Drugis, Groningen, Netherlands). The Markov chain Monte Carlo method will be used for all analyses; the parameters will include four chains with 50 000 simulation iterations, and the initial burn-in of 10 000 will be discarded. The node-splitting method will be used to examine the inconsistency between direct and indirect comparisons. The inconsistency model will be chosen when p<0.05, which represents a statistically significant difference; otherwise, the consistency model will be selected. The potential scale reduction factor (PSRF) value will be analysed to evaluate the convergence of the pooled results. A PSRF value close to 1 indicates successful convergence. Network plots will be created using the Stata software V.15.1 (Stata Corp., College Station, Texas, USA) to present the geometry of all comparisons in the included studies. The nodes in these plots signify different interventions, and the lines between every pair of nodes imply a direct comparison. Larger nodes represent a larger sample size, and thicker lines reflect a greater number of RCTs. Finally, ranking probability plots will be generated for each intervention.
Subgroup analysis and sensitivity analysis
In the event that heterogeneity is detected and necessary data are available, we intend to carry out subgroup analyses based on factors such as different intervention timing (eg, premenstrual, menstrual period), treatment courses, study locations, the overall risk of bias and any notable differences among the study populations. Sensitivity analysis will be performed to verify the stability of our results by excluding trials with a high risk of bias, a dropout rate of more than 20% and small sample sizes.
Publication bias assessment
A comparison-adjusted funnel plot57 and Egger’s test58 will be used to evaluate the presence of reporting bias. Asymmetry in the funnel plot or statistical significance (p<0.05) in Egger’s test will indicate the presence of publication bias.
Evidence quality assessment
The Grading of Recommendations, Assessment, Development, and Evaluation Profiler software will be applied to evaluate the strength of the evidence for all outcomes. The quality of evidence will be judged as ‘high’, ‘moderate’, ‘low’ or ‘very low’ quality in terms of the downgraded factors (risk of bias, inconsistency, indirectness, imprecision and publication bias) and upgraded factors (large effect, dose-response, all plausible confounding).59
Ethics and dissemination
This study does not involve primary data collection and instead relies on the analysis of published data. Thus, ethical approval is not required. The findings will be shared via publication in a peer-reviewed journal or presentation at relevant scientific conferences. Any significant protocol amendments will be documented and updated on the PROSPERO registry.
Patient and public involvement
None.
Discussion
PD is prevalent in reproductive women.60 Owing to recurrent monthly pain, patients with PD commonly experience decreased QoL and poor physical and mental health, which may, in turn, worsen the severity of pain.61 62 Currently, various pharmacological and non-pharmacological interventions can be used for the management of menstrual pain in patients with PD; however, their comparative effectiveness remains uncertain. This NMA will provide a ranking of pharmacological and non-pharmacological interventions for the treatment of PD to assist clinicians and patients in clinical decision-making.
This study has several strengths. First, it will be the first and most extensive NMA to verify the effectiveness of pharmacological and non-pharmacological interventions for PD and determine the best intervention. Second, we will investigate the comparative effects of interventions on the QoL and emotional symptoms of women with PD. Third, the comparative effect of interventions in the short- and long-term will be investigated in this study.
However, there will be certain unavoidable limitations as well. First, heterogeneity between studies may be high owing to the variability of various methods; however, we intend to explore any sources of heterogeneity through subgroup analysis. Second, including only trials published in English may result in bias.
Ethics statements
Patient consent for publication
Not applicable.
QB, JY and XD contributed equally.
Contributors QB conceptualised this study, QB and JY wrote the first draft of the current protocol, QB and XD wrote the revised manuscript, while YZ and FL critically revised the final manuscript. YL and X-YZ developed the protocol methodology. Literature searching, screening, data extraction, analyses and methodological assessment will be implemented by M-ZX, CZ, W-QZ, and K-XW. YZ will arbitrate any conflicts between reviewers and perform quality checks at all stages of review. The guarantor is FL. All authors read, provided feedback and approved the submitted version.
Funding This study was financially supported by the Central financial transfer payment to local projects in 2022 of the National Administration of Traditional Chinese Medicine.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
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