Risks and Effectiveness of Compounded Bioidentical Hormone Therapy: A Case Series

Davis, Ruth J.; Batur, Pelin; Thacker, Holly L.

doi:10.1089/jwh.2014.4770

Cited by 30 publications

(16 citation statements)

References 26 publications

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“…Consequently, use of unapproved, compounded HT formulations in the USA has risen [37][38][39][40] , reaching an estimated 39 million prescriptions filled annually 41 . Unfortunately, most compounded HT products have not been rigorously studied [42][43][44][45][46] , and many may not provide sufficient endometrial protection or appropriate relief of menopausal VMS, possibly due to non-standardized hormone preparations 41 . Historically, the combination of E2/ P4 in a single oral capsule has been challenging 47 .…”

Section: Discussionmentioning

confidence: 99%

Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms

et al. 2019

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Objective: This study aimed to evaluate the effects of TX-001HR (17b-estradiol [E2] and progesterone [P4] in a single oral capsule) on cardiometabolic markers and outcomes. Methods: Four E2/P4 doses (1 mg/100 mg, 0.5 mg/100 mg, 0.5 mg/50 mg, 0.25 mg/50 mg) were compared with placebo in menopausal women with vasomotor symptoms (VMS) and a uterus in the phase 3 REPLENISH (ClinicalTrials.gov, NCT01942668) trial. Changes in lipid and coagulation parameters and blood glucose from baseline at 6, 9, and 12 months as well as cardiovascular events are summarized. Results: A total of 1835 participants took 1 capsule of daily E2/P4; 1684 received E2/P4 and 151 received placebo. No clinically significant changes in lipid parameters, coagulation factors, or glucose were observed between treatment groups. Minimal increases of potential clinical importance were observed in total cholesterol, triglycerides, and glucose at month 12 with E2/P4 (1-4%, 6-11%, and 1%, respectively) and placebo (3%, 7%, and 2%, respectively). One episode of deep venous thrombosis and three cases of cardiovascular disease were observed, similar to expected rates of these events in the general population. Conclusions: In the REPLENISH trial, postmenopausal women with VMS treated with E2/P4 had no clinically meaningful effects on lipids, glucose, or coagulation parameters compared with placebo.

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Section: Discussionmentioning

confidence: 99%

Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms

et al. 2019

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“…Estrogen therapy in women shows benefits, although this issue is controversial (Ryan et al 2008); there is, however, no clear evidence of the effect of testosterone substitution in men (Pike et al 2009). Although short-term estrogen therapy could provide benefits to the brain and bones (Daniel et al 2015), breast and endometrial cancer risk after continued exposure has been reported (Davis et al 2014).…”

Section: Discussionmentioning

confidence: 99%

Reduction in Aβ‐induced cell death in the hippocampus of 17β‐estradiol‐treated female rats is associated with an increase in IGF‐I signaling and somatostatinergic tone

Perianes-Cachero

Canelles

Aguado-Llera

et al. 2015

Journal of Neurochemistry

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Several studies indicate that 17b-estradiol (E2) protects against amyloid b-peptide (Ab)-induced cell death and activates factors associated with learning and memory, a function involving the hippocampal somatostatinergic system. As alterations in somatostatin have been demonstrated in Alzheimer 0 s disease, we examined whether E2 prevents changes in the hippocampal somatostatinergic system induced by Ab25-35 and cell death, as well as the possible involvement of leptin and insulin-like growth factor (IGF)-I signaling. We also measured the levels of Ab proteases neprilysin and insulin-degrading-enzyme. Co-administration of E2 with Ab25-35 reduced both its levels and cell death, in addition to preventing the Ab-induced depletion of some somatostatinergic parameters. Activation of leptin and IGF-I pathways increased after E2 co-administration, and this correlated with changes in the somatostatinergic system. Changes in some components of this system were inversely related with Ab levels and cell death. Moreover, neprilysin levels were increased only in Ab plus E2-treated rats and E2 prevented the Ab-induced insulin-degradingenzyme reduction. Our results suggest that the E2-induced E2, 17b-estradiol; ER, estradiol receptor; GAPDH, glyceraldehyde 3-phosphate dehydrogenase; Gi proteins, guanine nucleotide-binding inhibitory proteins; GSK3b, glycogen synthase kinase-3b; HRP, horseradish peroxidase; IDE, insulin-degrading-enzyme; IGF-I, insulin-like growth factor-I; IGF-IR, IGF-I receptor; IRS1, insulin receptor substrate 1; NeuN, neuronal nuclei; Ovx, ovariectomized; SOCS3, suppressor of cytokine signaling 3; SRIF, somatostatin; sst, somatostatin receptor subtype; STAT, signal transducer and activator of transcription; TTBS, Tris-Tween buffered saline; TUNEL, terminal deoxynucleotidyltransferase-mediated dUTP nick end labeling.

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“…24,25 2011 yılında yayımlanmış gözlemsel kohort çalışmada, aynı coğrafi bölgenin 6 eczanesinde hazırlanmış biyo-özdeş hormon bileşimleriyle 2003-2010 yılları arasında 296 kadın vazomotor semptomları için tedavi edilmiş, duygu durumda belirgin bir iyileşme rapor edilmiştir. Bunun dı-şında, vazomotor semptomlar, kardiyovasküler hastalıklar ve meme kanseri konularında yorum yapılamamıştır.…”

Section: Karşit Görüşunclassified

Bio-Identical Hormones: Estrogen and Progesterone: Review

Biberoğlu¹,

Biberoğlu²

2017

Turkiye Klinikleri J Gynecol Obst

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Ö ÖZ ZE ET T "Women's Health Initiative WHI" çalışmasının 2002 yılında yayımlanmasını takiben, pek çok menopozal kadın ya hormon tedavisi almayı reddetmiş ya da almakta oldukları hormon ilaçla-rını kesmişlerdir. Bunun arkasından biyo-özdeş hormon tedavilerinde bir artış baş göstermiştir. Biyo-özdeş moleküller, bitkilerin belirli ekstrelerinden konsantre edilmektedirler. Amaç, vücudun kendi endokrin sisteminin ürettiği doğal hormonları taklit etmektir. Biyo-özdeş terim, genellikle reçete edilen formüle uygun olarak ihtiyacı olan kişiye özel üretilen kimyasal formülasyon olarak tanımlanmaktadır. En sık olarak östriol, östron, östradiol, testosteron, progesteron ve dehidroepiandrosteron formları vardır. Bununla birlikte, biyo-özdeş maddeler tam olarak doğal hormonlar olmayıp, laboratuvarda birçok şekilde değişikliğe uğramaktadır. Genellikle etkinlik ve güvenirlilikleri test edilmediği gibi, herhangi bir uluslararası ilaç kurumu tarafından da onaylanmamışlardır. Son zamanlarda bazı aktif içerikler ABD Besin ve İlaç Denetleme Kurumu ve Avrupa Tıp Ajansı tarafından onaylanmaya başlanmıştır. Temel amaç, sağlığa yararlı, minimal risk taşıyan, bireyselleştirilmiş ve yaşam kalitesini artıran tedaviler oluşturmaktır.A An na ah h t ta ar r K Ke e l li i m me e l le er r: : Östojen yerine koyma tedavisi; hormon replasman tedavisi; östrojenler; progesteron

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Risks and Effectiveness of Compounded Bioidentical Hormone Therapy: A Case Series

Cited by 30 publications

References 26 publications

Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms

Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms

Reduction in Aβ‐induced cell death in the hippocampus of 17β‐estradiol‐treated female rats is associated with an increase in IGF‐I signaling and somatostatinergic tone

Bio-Identical Hormones: Estrogen and Progesterone: Review

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