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ISSN: 2574 -1241
ISSN: 2574 -1241
Received: January 19, 2018; Published: January 30, 2018
DOI: 10.26717/BJSTR.2018.02.000706
Objective: To evaluate a new treatment for dysmenorrhea by inducing menstrual fluid streaming mechanically.
Setting: A 4-month randomized double-blind, placebo-controlled, crossover study.
Participants: Study participants were women experiencing dysmenorrhea monthly (for the 6 preceding months) at a level >5 on the visual analog scale (0-10), who were otherwise healthy. The study participants also collected their menstrual fluid for 2 baseline months, while recording their pain levels (primary outcome) systematically. A correlation between menstrual fluid characteristics and menstrual pain was studied, too.
Intervention: A newly invented device was used to attenuate dysmenorrheic pain level.
Results: From September 2011 to December 2013, 28 study participants were enrolled; 3 withdrew and 3 were excluded for protocol non-adherence. Twenty-two study participants (132 menstrual cycles) who used the device reported an average reduction of 55±7.6% in pain levels vs. 22±12% reported with placebo (p = 0.008). Analysis of menstrual fluid collected from 19 study participants (38 menstrual cycles) showed high correlation between pain levels and menstrual fluid viscosity/tissue fragments, indicating that dysmenorrhea is closely related to the rheological characteristics of the menstrual fluid.
Conclusions: The new device is highly effective in relieving menstrual pain. Rheological characteristics of the menses are correlated with severity of dysmenorrhea.
Key words: Dysmenorrhea; Menses; Randomized trial; Rheology; Vaginal device; Acti Lady
Abbreviations: PD: Primary Dysmenorrhea; NSAIDs: Nonsteroidal Anti-Inflammatory Drugs; AEs: Adverse Events; OC: Oral Contraceptives; IRB: Institutional Review Board
Abstract| Introduction| Materials and Methods| Result| Discussion| Disclosure Statement| Acknowledgement| References|
International Association of Landscape Archaeology, Czech Glass Society, Czech Republic
Department of Chemistry, Semenov Institute of Chemical Physics, USSR Academy of Sciences, Moscow, Russia
Pharmaco-kinetics, dynamics and Drug Metabolism, Touro College of Pharmacy, USA
Professor of Nuclear Medicine, Faculty of Medicine and Surgery, University of Milan, Milan, Italy
Associate Professor at Department of Breast and Thyorid Surgey, Chongqing General Hospital, China
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