Compounding for Patients with Polycystic Ovarian Syndrome (Stein-Leventhal Syndrome).

Polycystic ovary syndrome (Stein- Leventhal syndrome) is a common endocrinopathologic condition in reproductive- age women in the U.S. Patients with that disease are not faced with treatment choices for a single medical entity; they must manage a constellation of comorbid conditions that compromise their overall health and diminish their quality of life. The combinations of those disorders are unique to each patient. As a result, the safest and most effective therapeutic approach often requires precision pharmacy: the use of compounded therapies that, unlike commercially manufactured medications, can be precisely adjusted to meet individual needs and modified as therapeutic requirements change. In this article, the manifestations of polycystic ovary syndrome are reviewed, several common concomitant conditions are discussed, therapeutic interventions are suggested, and compounded formulations are provided.

Compounding to Prevent and Treat Dysbiosis of the Human Vaginal Microbiome.

Homeostasis of the human vaginal microbiome, which consists of the bacteriome (colonizing bacteria) and the mycobiome (resident fungi), is essential to the health of the female reproductive system. Dysbiosis of either microbial community can be caused by a variety of factors ranging from behavioral issues (personal-hygiene practices, the choice of contraceptives, smoking, etc.) to biological variables (the host-microbiome composition, menstruation, the robustness of the host's immune response). Clinicians often consult compounding pharmacistsbabout the formulation and use of customized preparations to treat vaginal diseases and re-establish a healthful vaginal microenvironment when commercially manufactured products have failed or are unavailable. In this article, the function of the human vaginal bacteriome and mycobiome are examined, a common microorganism identified in each of those microenvironments is discussed, factors that cause dysbiosis are reviewed, and the role of biofilm in the vaginal microbiota is explored. A question typical of those asked by prescribers committed to improving women's health and decreasing the incidence of recurring bacterial vaginosis or fungal infections is answered. Formulations for compounds that help ensure or reestablish the homeostasis of the human vaginal bacteriome and mycobiome are also provided.

Evaluating the efficacy of vaginal dehydroepiandosterone for vaginal symptoms in postmenopausal cancer survivors: NCCTG N10C1 (Alliance).

BACKGROUND: Women with estrogen deficiencies can suffer from vaginal symptoms that negatively impact sexual health. This study evaluated vaginal dehydroepiandrosterone (DHEA) for alleviation of vaginal symptoms. METHODS: This three-arm randomized, controlled trial evaluated DHEA 3.25 mg and DHEA 6.5 mg, each compared to a plain moisturizer (PM) over 12 weeks, to improve the severity of vaginal dryness or dyspareunia, measured with an ordinal scale, and overall sexual health using the Female Sexual Function Index (FSFI). Postmenopausal women with a history of breast or gynecologic cancer who had completed primary treatment, had no evidence of disease, and reported at least moderate vaginal symptoms were eligible. The mean change from baseline to week 12 in the severity of vaginal dryness or dyspareunia for each DHEA dose was compared to PM and analyzed by two independent t tests using a Bonferroni correction. RESULTS: Four hundred sixty-four women were randomized. All arms reported improvement in either dryness or dyspareunia. Neither DHEA dose was statistically significantly different from PM at 12 weeks (6.25 mg, p = .08; 3.25 mg, p = 0.48), although a significant difference at 8 weeks for 6.5 mg DHEA was observed (p = 0.005). Women on the 6.5 mg arm of DHEA reported significantly better sexual health on the FSFI (p < 0.001). There were no significant differences in provider-graded toxicities and few significant differences in self-reported side effects. CONCLUSION: PM and DHEA improved vaginal symptoms at 12 weeks. However, vaginal DHEA, 6.5 mg, significantly improved sexual health. Vaginal DHEA warrants further investigation in women with a history of cancer.

A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a troublesome chronic symptom that has no proven pharmacologic treatment. The purpose of this double-blind randomized placebo-controlled trial was to evaluate a novel compounded topical gel for this problem. METHODS: Patients with CIPN were randomized to baclofen 10 mg, amitriptyline HCL 40 mg, and ketamine 20 mg in a pluronic lecithin organogel (BAK-PLO) versus placebo (PLO) to determine its effect on numbness, tingling, pain, and function. The primary endpoint was the baseline-adjusted sensory subscale of the EORTC QLQ-CIPN20, at 4 weeks. RESULTS: Data in 208 patients reveal a trend for improvement that is greater in the BAK-PLO arm over placebo in both the sensory (p = 0.053) and motor subscales (p = 0.021). The greatest improvements were related to the symptoms of tingling, cramping, and shooting/burning pain in the hands as well as difficulty in holding a pen. There were no undesirable toxicities associated with the BAK-PLO and no evidence of systemic toxicity. CONCLUSION: Topical treatment with BAK-PLO appears to somewhat improve symptoms of CIPN. This topical gel was well tolerated, without evident systemic toxicity. Further research is needed with increased doses to better clarify the clinical role of this treatment in CIPN.