Document Type : Original Article
Authors
1
Department of Acupuncture, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
2
Department of Obstetrics and Gynecology, School of Medicine, Omolbanin Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
3
Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.
4
Department of Epidemiology, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.
5
Social Determinants of Health Research Center Mashhad University of Medical Sciences, Mashhad, Iran.
Abstract
Background: Endometriosis-associated dysmenorrhea and dyspareunia are common and difficult to manage with conventional pharmacotherapy; polydioxanone (PDO) thread embedding acupuncture (TEA) has been increasingly studied for its analgesic and anti-inflammatory effects in this setting.
Objectives: To compare TEA with classical medical therapy for dyspareunia and dysmenorrhea in women with endometriosis, and to evaluate effects on hormonal profile, antral follicle count, and quality of life.
Methods: This prospective, randomised, parallel-group, assessor- and analyst-blinded trial enrolled 80 women with endometriosis, allocated to embedding (n = 38) or classical therapy (low-dose combined oral contraceptives or dienogest; n = 42). Embedding involved subcutaneous implantation of 40 absorbable PDO threads at 22 standardised acupoints in two sessions six weeks apart. Dyspareunia, dysmenorrhea (VAS, 0–10), serum FSH and LH, antral follicle count, and quality of life (WHOQOL-BREF) were assessed at baseline and 1, 2, 3, and 6 months.
Results: Both interventions produced large, significant within-group reductions in dyspareunia and dysmenorrhea at every follow-up (all p < 0.001). For dyspareunia, the omnibus group×time interaction was not significant (F = 0.14, p = .968), indicating parallel improvement in both arms; a modest overall between-group difference favoured classical therapy (main effect of group, p = .036, partial η² = 0.055). None of the exploratory, non-normality-adjusted time-point comparisons remained significant after Bonferroni correction (α = .0125 across four comparisons), including the 2-month comparison (nominal p = .015). Dysmenorrhea trajectories did not differ between groups at any time point (interaction F = 0.61, p = .653). FSH and LH fell significantly in both groups (all within-group p < .001) with no between-group difference after treatment; AFC decreased and quality of life improved comparably across groups. Adverse events with TEA were mild, transient, and local; comparative safety versus classical therapy was not systematically assessed.
Conclusions: TEA achieved dyspareunia and dysmenorrhea control with no statistically significant difference in trajectory from classical therapy across six months, with adverse effects limited to mild, transient local reactions, supporting its potential role as a complementary intervention for endometriosis-associated pain.
Keywords
Acknowledgments: The authors thank the women who participated in this trial for their time and cooperation, and the clinical and administrative staff of the Acupuncture Clinic, Imam Reza Hospital, Mashhad University of Medical Sciences, for their assistance with recruitment and data collection. [Authors: please review and personalise this acknowledgment before submission.]
Ethical considerations: This study adhered to all ethical standards required for clinical research. The research was reviewed and approved by the relevant institutional Ethics Committee on 7 April 2023 (18/01/1402), under approval code IR.MUMS.REC.1402.020. Written informed consent was obtained from all participants following a comprehensive explanation of the study objectives, procedures, and potential risks. Patient data were anonymised using unique identification codes, and access was restricted exclusively to authorised project investigators.
Clinical trial registration: The study was prospectively registered with the Iranian Registry of Clinical Trials (IRCT) under registration number IRCT20121228011912N5.
Consent for publication: Not applicable.
Data availability: Data will be made available on request.
Conflicts of interest: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Financial disclosure: This work was supported by the Research Deputy of Mashhad University of Medical Sciences. The funder had no role in study design, data collection, analysis, interpretation, manuscript preparation, or the decision to submit the article for publication.
Authors' Contribution: S.S.S.: Conceptualization, Methodology, Investigation, Data curation, Writing, original draft, Writing, review & editing, Visualization. M.M.: Conceptualization, Investigation, Writing, review & editing. M.H.A.: Conceptualization, Methodology, Writing, review & editing. E.M.F.: Methodology, Formal analysis, Writing, review & editing. M.N.: Investigation, Methodology, Writing, review & editing. M.V.T.: Visualization, Data curation, Writing, review & editing. M.Z.G.: Investigation, Writing, review. H.R.B.T.: Investigation, Funding acquisition, Writing, review & editing, Supervision.
Open Access Policy: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/
