Contents lists available at ScienceDirect European Journal of Integrative Medicine journal homepage: www.elsevier.com/locate/eujim Clinical trial Balneotherapy is an alternative treatment for mastalgia; a randomized controlled trial ☆,☆☆ Aysun Genç a , Suleyman Utku Çelik b , Deniz Evcik c , Ebru Düşünceli Atman d , Atilla Halil Elhan e , Volkan Genç b, ⁎ a Ankara University Haymana Vocational School, Physiotherapy Program, Ankara, Turkey b Ankara University Faculty of Medicine, Department of General Surgery, Ankara, Turkey c Ankara Güven Hospital, Department of Physical Medicine and Rehabilitation, Ankara, Turkey d Ankara University Faculty of Medicine, Department of Radiology, Ankara, Turkey e Ankara University Faculty of Medicine, Department of Biostatistics, Ankara, Turkey ARTICLE INFO Keywords: Balneotherapy Mastalgia Breast pain Fibromyalgia Randomized controlled trial ABSTRACT Introduction: Mastalgia is the most common breast related complaint. Balneotherapy is widely used as a non- pharmacological treatment modality in many European countries. The objective of this study was to determine the efficacy of balneotherapy in patients with mastalgia. Methods: A randomized controlled clinical trial was conducted with forty women with mastalgia. Patients were randomly assigned to the control and balneotherapy groups. Conventional therapy was recommended for both groups for 6 weeks. The balneotherapy group was also given a total of ten sessions of balneotherapy during the last two weeks. Breast pain level, serum cytokine levels including interleukin-1β and tumor necrosis factor (TNF)-α and quality of life were evaluated in both groups before and 6-weeks after study. The Breast pain questionnaire was used for the assessment of mastalgia. This questionnaire includes sensorial and affective data, visual analog scale (VAS) and present pain intensity (PPI). Quality of life was measured by using Short Form (SF)-36. Results: Baseline total breast pain scores (BPS) and cytokine levels were similar between the groups. Total BPS (p = 0.001), VAS (p = 0.039) and PPI (p = 0.004) in the balneotherapy group significantly improved after therapy. TNF-α level in the balneotherapy group also significantly decreased after therapy (p = 0.003). The results of SF-36 showed that five subscales were significantly improved in the balneotherapy group however only social functioning was significantly improved in the control group after treatment. Conclusion: The results of the study revealed that balneotherapy may be an effective method in the treatment of mastalgia and it can be recommended by clinicians. 1. Introduction Mastalgia or breast pain is the most common breast related com- plaint, occurring in up to 69% of women at some time in their life [1,2]. Mastalgia can be severe enough to prevent usual daily living activities and it diminishes quality of life. Although many factors including hormonal, nutritional, and psychological factors were considered in the etiopathogenesis, literature related to this topic is not clear. Further- more, there is no breast-related disease cause to explain breast pain in many patients with mastalgia. The hypothalamic-pituitary adrenal (HPA) axis dysfunction, abnormal hormonal response to stimuli, hormonal medications, disorders of lipid metabolism, and psycholo- gical factors has been discussed in the etiopathogenesis of mastalgia [3]. The lack of clarity in etiopathogenesis is also reflected in the treatment. Current treatments are unsatisfactory for many patients and there is no single ideal treatment for mastalgia. Frequent mastalgia (weekly, daily or almost daily) is strongly as- sociated with posttraumatic stress disorder, depression and panic dis- order, or unexplained pain syndromes such as irritable bowel syn- drome, chronic pelvic pain and fibromyalgia (FM) [4]. In 2011, we also detected two distinctive entities mastalgia and FM which seem to fre- quently coexist in approximately 40% of patients [5]. The HPA axis https://doi.org/10.1016/j.eujim.2018.03.004 Received 12 December 2017; Received in revised form 12 March 2018; Accepted 13 March 2018 ☆ The study has been presented at “11th International Society of Physical and Rehabilitation Medicine World Congress” (30 April–4 May, 2017, Buenos Aires, Argentina). ☆☆ This trial was registered on Ankara University Scientific Research Projects (Project number: 15B0306001) ⁎ Corresponding author at: Ankara University School of Medicine, Department of Surgery, Ibni Sina Hastanesi Akademik Yerleske K4, 06100, Sihhiye, Ankara, Turkey. E-mail addresses: aysun@ankara.edu.tr (A. Genç), sucelik@ankara.edu.tr (S.U. Çelik), evcikd@yahoo.com (D. Evcik), eatman@ankara.edu.tr (E.D. Atman), elhan@medicine.ankara.edu.tr (A.H. Elhan), volkan@medicine.ankara.edu.tr (V. Genç). European Journal of Integrative Medicine 19 (2018) 100–104 1876-3820/ © 2018 Elsevier GmbH. All rights reserved. T