CONSORT flow chart.
dyspareunia, pain, dysuria, insomnia, dyschezia
DYSPAREUNIA, DYSMENORRHEA
We used mixed models analysis to study if there were any differences between the groups over all time points for each of the five continuous outcomes recorded daily (EAPP, amount of ingested analgesic, dysuria, dyschezia and dyspareunia) [Covariance structure AR(1) with random intercept, without random slope proved to be the best fit for all outcomes. We used a model with time and treatment as fixed factors. To study if the effect between the treatments differed over time, we added an interaction between time and treatment. In addition, to study if weight and hormonal therapy would adjust the treatment effect these factors were added one at a time to the model with treatment and time and thereafter interactions between weight and treatment as well as for hormonal therapy and treatment were tested one at a time. We averaged the daily recorded values to generate one value per week, keeping the menstrual cycle as an independent variable. The first day was excluded from inference since the study drug was ingested at bedtime.Data was analysed according to the randomized treatment assignments, for patients who fulfilled the inclusion and exclusion criteria (intention-to-treat), as well as according to the per-protocol. Because the results were similar, we only present the ITT analysis.Independent t-tests were used to compare continuous data in baseline characteristics, mean days of dysmenorrhea, days of using analgesics, EHP-30, pain catastrophizing scale and insomnia sleep index. Categorical data was assessed with chi square or Fisher’s exact test. Acceptability was compared with Fisher’s exact test. A two-tailed p-value of less than 0.05 was considered to indicate statistical significance. SPSS version 26 (SPSS, Chicago, IL) was used for data analyses.