Efficacy of Cannabidiol Versus Ibuprofen in the Relief of Menstrual Pain in Females Living with Primary Dysmenorrhea A Phase II, Non-Inferiority Trial

Introduction: Pain is the cardinal symptom in women living with primary dysmenorrhea (PDM), resulting in a relentless negative effect on their quality of life. Women with PDM have higher levels of prostaglandin in their endometrial fluid, which correlates with the degree of pain. The standard of care treatment for pain associated with PDM starts with nonsteroidal anti-inflammatory drugs (NSAIDs) that block prostaglandin-triggering enzymes. Although NSAIDs are a feasible option, they are also associated with a significant risk of side effects. Around 20 to 25% of patients will experience pain refractory to NSAIDs and seek alternative therapies. Cannabidiol (CBD) is a well-tolerated potential therapy for several chronic diseases, including pain, and acts by blocking prostaglandin-triggering enzymes, similar to NSAIDs. The safety of CBD is well established, with the advantage of acting via central and peripheral mechanisms. To date, no previous trials assessing CBD alone for dysmenorrhea have been conducted. Objective: To evaluate the effect of CBD alone in reducing acute menstrual pain compared to ibuprofen, as assessed by the total pain relief (TOTPAR) scale. Design: Randomized (with random block sizes), triple-blinded, multicenter, parallel-group, non-inferiority clinical trial. Participants: PDM patients aged 18 to 40 years, with regular menstrual cycles (ranging from 21 to 35 days) and a visual analog scale (VAS) score of ≥ 5. Academic Editor: Felipe Fregni Peer-reviewers: Natalia Suarez; Giovani Farina; Magali Andrea Pestana; Luis Morales Ojeda. Copyright: © 2022 by the authors. Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).