title: Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study.
abstract: BACKGROUND
  Bioidentical Hormone Replacement Therapy (BHRT) is believed it to be a safer and equally effective alternative to Conventional Hormone Therapy for the relief of menopausal symptoms; however, data are needed to support these claims. The objective of this study is to evaluate the effectiveness of compounded BHRT provided in six community pharmacies.
  
  
  METHODS
  This was an observational cohort study of women between the ages of 18-89 who received a compounded BHRT product from January 1, 2003 to April 30, 2010 in six community pharmacies. Data included patient demographics, comorbidities, therapeutic outcomes, and hormone therapies. Women self-rated menopausal symptoms as absent, mild, moderate, or severe. Descriptive statistics were used to characterize the patient population, BHRT use, and adverse events. Patient symptom severity was compared at baseline and 3 to 6 months follow-up using the Wilcoxon signed-rank test.
  
  
  RESULTS
  Women (n = 296) receiving BHRT at Oakdell Pharmacy had a mean (standard deviation) age of 52 (9) years. The most common BHRT dosage forms utilized were topical (71%) and oral (43%). Compounded BHRT regimens were generally initiated at low doses regardless of route. Women experienced a 25% decrease in emotional lability (p < 0.01), a 25% decrease in irritability (p < 0.01), and a 22% reduction in anxiety (p = 0.01) within 3 to 6 months. These women also experienced a 14% reduction in night sweats (p = 0.09) and a 6% reduction in hot flashes (p = 0.50).
  
  
  CONCLUSIONS
  This study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.
authors.affiliation: Pharmacotherapy Education and Research Center, The University of Texas Health Science Center, San Antonio, TX, USA.
authors.forename: Andres D
authors.initials: AD
authors.lastname: Ruiz
authors.forename: Kelly R
authors.initials: KR
authors.lastname: Daniels
authors.forename: Jamie C
authors.initials: JC
authors.lastname: Barner
authors.forename: John J
authors.initials: JJ
authors.lastname: Carson
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Frei
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000188:drug therapy; D015331:Cohort Studies; D004339:Drug Compounding / Q000009:adverse effects; D004967:Estrogens / Q000627:therapeutic use*; D005260:Female; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D006945:Hyperhidrosis / Q000188:drug therapy; D007508:Irritable Mood / Q000187:drug effects; D008593:Menopause / Q000187:drug effects* / Q000502:physiology / Q000523:psychology; D008875:Middle Aged; D057285:Precision Medicine; D011374:Progesterone / Q000627:therapeutic use*; D011372:Progestins / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012890:Sleep; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004967:Estrogens; D011372:Progestins; D011374:Progesterone