ABSTRACT
STUDY OBJECTIVE: To evaluate the efficacy and tolerability of a progestin-only pill containing 4 mg drospirenone (DRSP) as a hormonal therapy for the management of endometriosis-associated symptoms in adolescents and young adults. DESIGN: Retrospective cohort study. METHODS: A retrospective chart review was performed of all adolescents who were prescribed DRSP continuously (without placebo) for treatment of endometriosis at a single pediatric tertiary care center between 2019 and 2022. Electronic medical records were reviewed to obtain demographics and clinical characteristics of the patients. Measured outcomes included symptom resolution and medication discontinuation. The study was deemed IRB exempt. RESULTS: A total of 61 patients with endometriosis were prescribed DRSP during the study period, with a median age of 18.9 years (SD 2.3). The majority (97%) were laparoscopically confirmed to have endometriosis, and 85% had stage I disease. Before DRSP use, the most common medications trialed were norethindrone (57%) and norethindrone acetate (68%), and 56% had at least one medical contraindication to receiving estrogen-containing therapy. Of those with follow-up, 52% established an absence of bleeding/spotting, and 67% reported less pain at follow-up. One in 4 patients discontinued DRSP during the study period, most commonly due to breakthrough bleeding. CONCLUSION: DRSP is a well-tolerated and effective option for the treatment of endometriosis-associated symptoms in adolescents and young adults.
ABSTRACT
BACKGROUND: Fatigue is one of the most common symptoms treated in primary care and can lead to deficits in mental health and functioning. Light therapy can be an effective treatment for symptoms of fatigue; however, the feasibility, scalability, and individual-level heterogeneity of light therapy for fatigue are unknown. OBJECTIVE: This study aimed to evaluate the feasibility, acceptability, and effectiveness of a series of personalized (N-of-1) interventions for the virtual delivery of bright light (BL) therapy and dim light (DL) therapy versus usual care (UC) treatment for fatigue in 60 participants. METHODS: Participants completed satisfaction surveys comprising the System Usability Scale (SUS) and items assessing satisfaction with the components of the personalized trial. Symptoms of fatigue were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) daily, PROMIS weekly, and ecological momentary assessment (EMA) questionnaires delivered 3 times daily. Comparisons of fatigue between the BL, DL, and UC treatment periods were conducted using generalized linear mixed model analyses between participants and generalized least squares analyses within individual participants. RESULTS: Participants rated the usability of the personalized trial as acceptable (average SUS score=78.9, SD 15.6), and 92% (49/53) of those who completed satisfaction surveys stated that they would recommend the trial to others. The levels of fatigue symptoms measured using the PROMIS daily fatigue measure were lower or improved in the BL (B=-1.63, 95% CI -2.63 to -0.63) and DL (B=-1.44, 95% CI -2.50 to -0.38) periods relative to UC. The treatment effects of BL and DL on the PROMIS daily measure varied among participants. Similar findings were demonstrated for the PROMIS weekly and EMA measures of fatigue symptoms. CONCLUSIONS: The participant scores on the SUS and satisfaction surveys suggest that personalized N-of-1 trials of light therapy for fatigue symptoms are both feasible and acceptable. Both interventions produced significant (P<.05) reductions in participant-reported PROMIS and EMA fatigue symptoms relative to UC. However, the heterogeneity of these treatment effects across participants indicated that the effect of light therapy was not uniform. This heterogeneity along with high ratings of usability and satisfaction support the use of personalized N-of-1 research designs in evaluating the effect of light therapy on fatigue for each patient. Furthermore, the results of this trial provide additional support for the use of a series of personalized N-of-1 research trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT04707846; https://clinicaltrials.gov/ct2/show/NCT04707846.
