Zoladex (goserelin acetate) and the anemic patient: results of a multicenter fibroid study.
OBJECTIVE
To compare the effects of goserelin acetate treatment with or without iron with iron alone.


METHODS
Multinational, multicenter, prospective, randomized, double-blind study.


METHODS
Premenopausal women with menorrhagia or metrorrhagia and anemia associated with uterine leiomyomata awaiting hysterectomy.


METHODS
Patients were randomized to one of three 12-week treatment groups namely goserelin acetate 3.6 mg once monthly plus placebo iron; 3.6 mg goserelin acetate once monthly plus 600 mg/d iron; or sham injection once monthly plus 600 mg/d iron.


METHODS
Preoperative hemoglobin concentration; preoperative uterine and fibroid volumes and operative blood loss.


RESULTS
Considering the entry and preoperative hemoglobin concentrations, there was a difference in least square means of just over 1 g/dL between the goserelin acetate plus iron and iron only groups and 2.6 g/dL between the goserelin acetate plus iron and goserelin acetate only group. These differences were both statistically significant. Uterine and fibroid volumes were decreased in the goserelin acetate-treated patients by between 37% and 40% and 44% and 47%, respectively, compared with 7% decreases for both in the iron only group. The differences in absolute changes were statistically significant for both the goserelin acetate-treated groups versus the iron-treated group. The least square geometric mean operative blood loss was greatest in the iron only group.


CONCLUSIONS
In the patient with uterine leiomyomata and anemia, goserelin acetate in combination with iron therapy has shown significant advantages over the iron alone in restoring hematologic normality, decreasing uterine and fibroid volumes, and reducing operative blood loss.
Benagiano
G
G
University "La Sapienza," Policlinico Umberto, Rome, Italy.
Kivinen
S T
ST
Fadini
R
R
Cronjé
H
H
Klintorp
S
S
van der Spuy
Z M
ZM
D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy*; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D017273:Goserelin / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007501:Iron / Q000097:blood / Q000627:therapeutic use; D007889:Leiomyoma / Q000097:blood / Q000150:complications; D008595:Menorrhagia / Q000097:blood / Q000209:etiology; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D014594:Uterine Neoplasms / Q000097:blood / Q000150:complications
D018931:Antineoplastic Agents, Hormonal; D006454:Hemoglobins; D017273:Goserelin; D007501:Iron