Hormonal suppression treatment or dietary therapy versus placebo in the control of painful symptoms after conservative surgery for endometriosis stage III–IV. A randomized comparative trial
published online 16 April 2007.
Objective
To evaluate the effectiveness for the outcomes of endometriosis-related pain and quality of life of conservative surgery plus placebo compared with conservative surgery plus hormonal suppression treatment or dietary therapy.
Design
Randomized comparative trial.
Setting
University hospital.
Patient(s)
Two hundred twenty-two consecutive women who underwent conservative pelvic surgery for symptomatic endometriosis stage III–IV (r-AFS).
Intervention(s)
Six months of placebo (n = 110) versus GnRH-a (tryptorelin or leuprorelin, 3.75 mg every 28 days) (n = 39) or continuous estroprogestin (ethynilestradiol, 0.03 mg plus gestoden, 0.75 mg) (n = 38) versus dietary therapy (vitamins, minerals salts, lactic ferments, fish oil) (n = 35).
Main Outcome Measure(s)
Painful symptoms (visual analogue scale score) and quality-of-life endometriosis-related symptoms (SF-36 score) at 12 months' follow-up.
Result(s)
Patients treated with postoperative hormonal suppression therapy showed less visual analogue scale scores for dysmenorrhoea than patients of the other groups. Hormonal suppression therapy and dietary supplementation were equally effective in reducing nonmenstrual pelvic pain. Surgery plus placebo showed significative decrease in dyspareunia scores. Postoperative medical and dietary therapy allowed a better quality of life than placebo.
Conclusion(s)
Postoperative hormonal suppression treatment or dietary therapy are more effective than surgery plus placebo to obtain relief of pain associated with endometriosis stage III–IV and improvement of quality of life.
aEndometriosis Center, Section of Gynecology & Obstetrics, Department of Surgery, Tor Vergata University Hospital, Rome, Italy
bSection of Clinical Nutrition, Department of Internal Medicine, Tor Vergata University Hospital, Rome, Italy
Reprint requests: Francesco Sesti, M.D., Section of Gynaecology and Obstetrics, Department of Surgery, School of Medicine, “Tor Vergata” University Hospital, Viale Oxford 81, 00133 Rome, Italy (FAX: +39.06.20.902.921).