title: Side effects unrelated to disease activity and acceptability of highly effective contraceptive methods in women with systemic lupus erythematosus: a randomized, clinical trial.
abstract: OBJECTIVE
  To assess the side effects unrelated to disease activity and the acceptability of combined oral contraceptives (COCs), progestin-only pills (POPs) and copper-releasing intrauterine devices (IUDs) in women with systemic lupus erythematosus (SLE).
  
  
  METHODS
  A randomized clinical trial including 162 women with SLE, assigned to COC (n=54), POP (n=54) or IUD (n=54). Follow-up visits were conducted after 1, 2, 3, 6, 9 and 12 months of treatment to monitor the presence of symptoms, changes in body weight and blood pressure as well as the development of health problems other than those relating to lupus. Reasons for discontinuation and satisfaction with the use of the assigned method were recorded at the end of treatment. Statistical analysis included descriptive statistics, repeated measure analyses and Kaplan-Meier curves.
  
  
  RESULTS
  Significantly different discontinuation rates due to any reason [35%, 55%, 29% (p<0.01)] or nonmedical reasons [(11%, 31%, 4% (p<0.05)] were observed among the COC, POP and IUD groups. Nausea was most frequent among COC users, dysmenorrhea among IUD users and acne and hirsutism among POP users. Mean blood pressures remained unchanged. Mild increases in body weight were observed over time in all treatment groups. Most women were satisfied with the use of the assigned contraceptive method.
  
  
  CONCLUSIONS
  Oral contraceptives and IUD are acceptable birth control methods for patients with lupus, when counseling and specialized health attention are provided; however, the acceptability of POP appears to be inferior. Side effects unrelated to lupus disease activity are not frequent reasons to discontinue the contraceptive methods.
  
  
  CONCLUSIONS
  This study delves into an area that has not been explored among patients with lupus. Our findings on the associated side effects and reasons for discontinuing COCs, POPs or copper-bearing IUDs may be useful in improving contraceptive counseling for women with lupus. Furthermore, they also heighten our knowledge on the reasons that may preclude the widespread use of effective contraceptives among lupus patients.
authors.affiliation: Department of Reproductive Biology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, City, Mexico. Electronic address: mcravioto@prodigy.net.mx.
authors.forename: María-del-Carmen
authors.initials: MD
authors.lastname: Cravioto
authors.affiliation: Department of Reproductive Biology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, City, Mexico.
authors.forename: Luisa
authors.initials: L
authors.lastname: Jiménez-Santana
authors.affiliation: Department of Reproductive Biology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, City, Mexico.
authors.forename: Julio
authors.initials: J
authors.lastname: Mayorga
authors.affiliation: Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
authors.forename: Armando H
authors.initials: AH
authors.lastname: Seuc
mesh_terms: D000152:Acne Vulgaris / Q000139:chemically induced; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D003278:Contraceptives, Oral, Hormonal / Q000009:adverse effects*; D004412:Dysmenorrhea / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006628:Hirsutism / Q000139:chemically induced; D006801:Humans; D007435:Intrauterine Devices, Copper / Q000009:adverse effects*; D053208:Kaplan-Meier Estimate; D008180:Lupus Erythematosus, Systemic / Q000503:physiopathology*; D009325:Nausea / Q000139:chemically induced; D010342:Patient Acceptance of Health Care; D010352:Patient Dropouts; D017060:Patient Satisfaction; D057285:Precision Medicine; D011372:Progestins / Q000009:adverse effects*; D012720:Severity of Illness Index; D015430:Weight Gain / Q000187:drug effects; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D003278:Contraceptives, Oral, Hormonal; D011372:Progestins
keywords: Birth control; Combined oral contraceptives; Counseling; Hormonal contraceptives; Intrauterine device; Progestin-only pill