Effectiveness and acceptability of vitamin E and low-dose aspirin, alone or in combination, on Norplant-induced prolonged bleeding.
A study (ISRCTN 77665712) was undertaken to test the effectiveness and the acceptability of vitamin E and low-dose aspirin, alone or in combination, as treatment for prolonged vaginal bleeding induced by Norplant. A total of 486 Norplant users who were requesting treatment for bleeding lasting longer than 7 days were enrolled in five centers: Beijing, China; Jakarta, Indonesia; Santiago, Chile; Santo Domingo, Dominican Republic; and Tunis, Tunisia. They were randomized to one of four different 10-day oral treatments: 200 mg vitamin E daily, 80 mg aspirin daily, both or a placebo. Treatment packs were designed to ensure blinding of both the subjects and the clinical staff. Neither vitamin E nor low-dose aspirin nor their combination was found to have any effect on reducing the length of the bleeding episode for which treatment was taken or on the vaginal bleeding patterns these women experienced during the year of follow-up.
d'Arcangues
Catherine
C
Special Programme of Research, World Health Organization, Development and Research Training in Human Reproduction (HRP), CH-1211-Geneva-27, Switzerland. darcanguesc@who.int
Piaggio
Gilda
G
Brache
Vivian
V
Aissa
Rim Ben
RB
Hazelden
Catherine
C
Massai
Rebeca
R
Pinol
Alain
A
Subakir
Sri Bekti
SB
Su-juan
Gu
G
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001241:Aspirin / Q000008:administration & dosage*; D002677:Chile; D002681:China; D004293:Dominican Republic; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007214:Indonesia; D016912:Levonorgestrel / Q000009:adverse effects*; D017060:Patient Satisfaction; D016896:Treatment Outcome; D014416:Tunisia; D014592:Uterine Hemorrhage / Q000139:chemically induced / Q000188:drug therapy*; D014810:Vitamin E / Q000008:administration & dosage*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D014810:Vitamin E; D016912:Levonorgestrel; D001241:Aspirin