Real-World Evidence Shows Gaps in Awareness, Medical Help-Seeking, and Diagnosis for Primary Dysmenorrhea but Not Premenstrual Syndrome: Cross-Sectional Observational Study.

Background: Menstrual complaints are widespread but often stigmatized. The most common is dysmenorrhea, or menstrual cramps, which manifests as mild to severe pain during menstruation and affects >40% of women throughout their reproductive lifespan. Dysmenorrhea is often endured silently or managed through self-medication. Consequently, a vast majority of patients with dysmenorrhea may not be found in medical practices, highlighting the need for direct-to-patient communication to reach a broad and diverse patient population. Objective: Primarily, this study aims to reveal the diagnosis status, pain levels, comorbidities, eligibility, and willingness to participate in clinical trials of women affected by dysmenorrhea and menstrual discomfort, based on a broad patient population not necessarily reached in medical practices. Second, this study attempts to test the effectiveness of direct-to-patient communication via online campaigns in engaging patients affected by dysmenorrhea or conditions that may benefit from direct-to-patient communication. Methods: Women experiencing menstrual pain were reached through a targeted online campaign using Google Ads (Google LLC) and Facebook (Meta Platforms, Inc) in Germany, Austria, and Poland and were surveyed from April to June 2023. This study is observational. Results: We surveyed 3546 women, 94.6% (3230/3413) of whom reported symptoms consistent with dysmenorrhea, highlighting the high specificity of the Google and Facebook campaigns. Of the affected women in Germany and Austria, 88.5% (874/988) reported pain levels of 6 or higher on a scale of 0 to 10, with even higher pain levels observed in Poland. Elevated pain levels were correlated with dysmenorrhea symptoms but not with premenstrual syndrome (PMS) symptoms. Notably, of the 3230 women reporting symptoms consistent with dysmenorrhea, only 4.6% (n=149) reported being diagnosed with the condition, regardless of elevated pain levels. This can be attributed to two factors: (1) 90.3% (3065/3395) of surveyed women did not seek medical advice, were uncertain about their diagnosis, or their menstrual-related symptoms were not recognized as pathological and (2) among the 9.7% (330/3395) diagnosed, only half of DYS-affected women (149/318, 46.9%) were diagnosed with dysmenorrhea. The other 53.1% (169/318) were diagnosed with PMS but not dysmenorrhea despite regularly experiencing dysmenorrhea symptoms. The situation was better for PMS. Among the 330 diagnosed women, 77.3% (n=255) were diagnosed with PMS, in line with the 80.1% (2729/3409) PMS prevalence in the survey population. Overall, about 8.6% (235/2729) of women with PMS symptoms reported having been diagnosed with PMS, nearly double the diagnosis rate reported for dysmenorrhea. Conclusions: The data reveal a significant diagnostic gap for dysmenorrhea, but not necessarily for PMS, even in high-income countries, as observed in Germany, Austria, and Poland. In these 3 countries, most dysmenorrhea-affected women do not seek medical advice, and up to half of dysmenorrhea diagnoses might be missed. Thus, most affected women might not be found in medical settings (doctors' offices and clinics) despite experiencing significant pain. Online campaigns are shown to effectively reach individuals with menstrual complaints, including those who are undiagnosed or not seeking medical care.