title: The effectiveness of sublingual and topical compounded bioidentical hormone replacement therapy in postmenopausal women: an observational cohort study.
abstract: Prior studies demonstrated improved menopausal symptom relief following treatment with compounded bioidentical hormone replacement therapy; however, clinical effectiveness studies evaluating different routes of bioidentical hormone replacement therapy administration are lacking. The objective of this study was to determine the effectiveness of sublingual and topical compounded bioidentical hormone replacement therapy for the treatment of vasomotor, mood, and other quality-of-life symptoms in post-menopausal women. This was a prospective, observational cohort study of women > or = 18 years of age who received a compounded sublingual or topical bioidentical hormone replacement therapy preparation between January 1, 2003 and October 1, 2010 in a community pharmacy. Data collection included patient demographics, comorbidities, hormone regimens, and therapeutic outcomes. Patients rated their vasomotor, mood, and quality-of-life symptoms as absent, mild, moderate, or severe at baseline, at one to three months follow-up, and three to six months follow-up. Baseline characteristics were compared using the chi-square test for categorical variables and the Wilcoxon rank sum test for continuous variables. Symptom intensity between baseline and follow-up periods were compared using the Wilcoxon signed-rank test. A total of 200 patients met study criteria; 160 received topical bioidentical hormone replacement therapy, and 40 received sublingual bioidentical hormone replacement therapy. Most sublingually-treated patients (70%) received an estrogen combination and 100% received progesterone. Nearly half (43%) of the topically treated patients received an estrogen combination (43%) and 99% received progesterone. The percentage of sublingually treated patients reporting "moderate" or "severe" symptoms was significantly reduced at one to three months follow-up for the following target symptoms: hot flashes (31%, P = 0.04), night sweats (38%, P < 0.01), irritability (36%, P = 0.01), anxiety (42%, P < 0.01), emotional lability (38%, P < 0.01), sleep disturbances (35%, P < 0.01), memory loss (35%, P = 0.04), fatigue (33%, P = 0.04), and libido (26%, P = 0.03). Similar reductions were seen at three to six months follow-up compared to baseline. Patients who received topical therapy did not experience significant symptom reductions at one to three months follow-up; however, significant symptom reduction was seen at three to six months for the following: emotional lability (31%, P < 0.01), irritability (29%, P = 0.02), and night sweats (20%, P = 0.04). Compounded sublingual bioidentical hormone replacement therapy is effective in reducing vasomotor, mood, and quality-of-life symptoms experienced in post-menopausal women. Topical therapy does not appear to improve symptoms as extensively or rapidly as sublingual therapy.
authors.forename: Andres D
authors.initials: AD
authors.lastname: Ruiz
authors.forename: Kelly R
authors.initials: KR
authors.lastname: Daniels
mesh_terms: D000279:Administration, Cutaneous; D000286:Administration, Sublingual; D000328:Adult; D000339:Affect / Q000187:drug effects; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D004338:Drug Combinations; D004339:Drug Compounding; D015914:Estrogen Replacement Therapy; D004967:Estrogens / Q000008:administration & dosage*; D005260:Female; D020249:Hormone Replacement Therapy / Q000379:methods*; D019584:Hot Flashes / Q000188:drug therapy / Q000503:physiopathology; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011374:Progesterone / Q000008:administration & dosage*; D011446:Prospective Studies; D011788:Quality of Life; D012890:Sleep / Q000187:drug effects; D013546:Sweating / Q000187:drug effects; D013781:Texas; D013997:Time Factors; D016896:Treatment Outcome; D014666:Vasomotor System / Q000187:drug effects / Q000503:physiopathology
chemical_list: D059451:Biosimilar Pharmaceuticals; D004338:Drug Combinations; D004967:Estrogens; D011374:Progesterone