Effect of Melatonin on Cognitive Function and Sleep in relation to Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

Figure 1

CONSORT 2010 flow diagram. (*) age > 70/75 years = 134, DCIS or Mb. Paget = 30, preoperative chemotherapy = 51, selective serotonin reuptake inhibitors, antithrombotic drug therapy, monoaminoxidase inhibitors, calcium channel blockers = 31, epilepsy = 1, known and treated sleep apnea = 1, diabetes mellitus treated with insulin = 4, ongoing or previous medically treated depression or bipolar disorder = 44, known autoimmune disease = 9, severe kidney disease = 1, previous or other current cancer = 75, known medically treated sleep disorder = 1, daily intake of >5 units (1 unit = 8 g pure alcohol) = 3, preoperative, continuous treatment with psychopharmacological drugs of any kind, opioids, anxiolytics, or hypnotics = 35, and predicted poor compliance = 12. (**) Logistics = 50, <3 days till the day of surgery = 82 and patient recruited for other trial = 15. (***) Taken < 75% of the trial medication at visit 2. (****) Adverse events = 2 (one patient had insomnia at night and sleepiness during the day and the other had headaches) and coping = 4.