Herbal medicine (Danggui-Shaoyao-San) and Ear Acupoint Pressing Beans in the treatment of dysmenorrhea caused by endometriosis and adenomyosis: a study protocol randomized controlled trial
Abstract Endometriosis and adenomyosis are two of the most common causes of secondary dysmenorrhea and often lead to a deterioration in the quality of life. Traditional Chinese medicine and acupuncture are widely used in the treatment of menstrual pain in clinical practice. Danggui Shaoyao San (DSS) and ear acupoint pressing beans may constitute an effective treatment strategy for women with dysmenorrhea due to endometriosis and/or adenomyosis, although evidence is limited. Methods/design This randomized, controlled clinical trial aims to recruit patients who suffer from menstrual pain due to endometriosis and/or adenomyosis to evaluate the efficacy and safety of DSS and auriculotherapy. Primary outcome measures are Visual Analog Scale (VAS), Short-Form McGill Pain Questionnaire (SF-MPQ), dysmenorrhea symptoms and traditional Chinese medicine correlative time points. Discussion This pivotal trial will be a standardized, scientific, clinical trial designed to evaluate the use of DSS and auriculotherapy in the treatment of dysmenorrhea due to endometriosis and/or adenomyosis. The trial will also conform to the international standards of clinical trials for the recognition of traditional Chinese medicine. Trail registration Chinese Clinical Trail Registry, ID: ChiCTR-IOR-17013829 Registered on 11th December 2017 Keywords: Danggui Shaoyao San; Ear pressing beans; Endometriosis; Adenomyosis; Dysmenorrhea; Randomized controlled trial