Combined versus sequential hormonal replacement therapy: a double-blind, placebo-controlled study on quality of life-related outcome measures.
BACKGROUND
To compare combined and sequential hormonal replacement therapies to each other as well as placebo in patients suffering from the postmenopausal syndrome. Clinical outcomes were measured concerning both the specific postmenopausal symptoms (using the Kupperman scale) and health or well-being dimensions (using subscales of the General Health Questionnaire and specific depression and anxiety scales).


METHODS
A prospective randomized double-blind study over 12 months of 105 normal early postmenopausal women in the setting of a general hospital.


RESULTS
Both hormone replacement therapies were superior to placebo on the Kupperman scale (sweating, hot flushing, myalgia and vertigo). The psychic symptoms on the Kupperman scale were psychometrically invalid. However, psychic symptoms as measured by the Beck Depression Inventory and the General Health Questionnaire were significantly improved by the hormonal replacement therapies. No differences were observed when combined therapy was compared to sequential therapy.


CONCLUSIONS
One-year treatment with hormonal replacement therapy is superior to placebo in measuring the somatic and psychic symptoms of the menopausal syndrome. No differences were found in this respect between combined and sequential replacement therapy.
Frederiksborg General Hospital, Psychiatric Institute, Hillerod, Denmark.
P
P
Bech
N
N
Munk-Jensen
E B
EB
Obel
L G
LG
Ulrich
P
P
Eiken
S P
SP
Nielsen
D000704:Analysis of Variance; D003718:Denmark; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy / Q000379:methods* / Q000592:standards; D005260:Female; D006304:Health Status; D006306:Health Surveys; D006801:Humans; D008593:Menopause / Q000187:drug effects* / Q000523:psychology; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage*; D045167:Progesterone Congeners / Q000008:administration & dosage*; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D045167:Progesterone Congeners; D004958:Estradiol; D009640:Norethindrone