Well-being at onset of hormone replacement therapy: comparison between two continuous combined regimens.
OBJECTIVE
To compare the effect on well-being of two continuous combined hormone replacement therapies (HRTs) in women starting treatment ('starters') and women switching from mainly sequential HRT ('switchers').


METHODS
This was a randomized, double-blind, 1-month trial, in which 249 postmenopausal women were treated with either conjugated estrogen plus medroxyprogesterone acetate (CE/MPA 0.625 mg/5 mg) or 17beta-estradiol plus norethisterone acetate (E2/NETA 2 mg/1 mg) continuously. Twelve items for measuring climacteric symptoms and well-being were reported daily on a validated symptom scale.


RESULTS
Women taking CE/MPA reported lower scores for breast tenderness (p = 0.005), depression (p = 0.019), irritability (p = 0.004) and tension (p = 0.048), compared with women taking E2/NETA. Compared with pretreatment, both groups developed side-effects during the first week: breast tenderness, swelling and depression (p < 0.05). Starters, but also switchers, improved in sweats (p < 0.001 and p = 0.030). Compared with pretreatment ratings, switchers reported higher scores for breast tenderness (p < 0.001), depression (p = 0.050) and negative effects on daily life (p < 0.001), whereas starters reported only physical side-effects (p < 0.05). A history of premenstrual syndrome (PMS) predicted high scores for swelling (p = 0.023), depression (p = 0.024), tension (p = 0.009), irritability (p = 0.027), headache (p < 0.001) and negative effects on daily life (p < 0.001).


CONCLUSIONS
CE/MPA 0.625 mg/5 mg is better tolerated than E2/NETA 2 mg/1 mg, and starters react differently from switchers. Side-effects occur more quickly than benefits with HRT, and are more frequent in women with previous PMS.
Odmark
I S
IS
Department of Clinical Sciences, Obstetrics and Gynecology, Umeå University, Umeå, Sweden.
Bäckström
T
T
Jonsson
B
B
Bixo
M
M
D001940:Breast / Q000503:physiopathology; D003271:Contraceptive Agents, Female / Q000627:therapeutic use; D003863:Depression / Q000188:drug therapy / Q000523:psychology; D004311:Double-Blind Method; D004487:Edema / Q000503:physiopathology; D015914:Estrogen Replacement Therapy / Q000379:methods*; D004967:Estrogens / Q000627:therapeutic use; D004966:Estrogens, Conjugated (USP) / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007508:Irritable Mood; D017258:Medroxyprogesterone Acetate / Q000627:therapeutic use; D008875:Middle Aged; D009640:Norethindrone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077563:Norethindrone Acetate; D010146:Pain / Q000503:physiopathology; D017698:Postmenopause / Q000502:physiology / Q000523:psychology*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011788:Quality of Life; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy / Q000523:psychology; D013546:Sweating / Q000187:drug effects / Q000502:physiology
D003271:Contraceptive Agents, Female; D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D000077563:Norethindrone Acetate; D017258:Medroxyprogesterone Acetate; D009640:Norethindrone