Clinical response and patient's tolerance of vaginal versus oral bromocriptine in women who suffers hyperprolactinaemia

Abstract

Background: Hyperprolactinaemia is a real challenge for gynecologist and endocrinologists ,bromocriptine was used for treating hyperprolactinaemia ,bromocriptine associated with many side effect this study aimed to compare clinical response , side effects and tolerability of vaginal bromocriptine tablets and suppositories versus oral bromocriptine tablets for treatment of hyperprolactinemia Patients and methods: Non randomized controlled clinical trial at the outpatient Clinic of Obstetrics and Gynecology,Zagazig University and Zifta general hospital (ministry of health). This study included 87 patients who suffered hyperprolactinaemia .Patients divided into 3 groups:Group A included 29 patients who used bromocriptine 2.5mg tablets vaginally once daily for one month .Group B included 29 patients who administrated bromocriptine 2.5mg vaginal suppositories once daily for one month. Group C included 29 patients who received bromocriptine 2.5mg tablets orally twice daily for one month.Serum prolactin was measured before and after therapy in all cases. The work has been carried out in accordance with (The Code of Ethics of world Medical Association) for studies involving human. Results:Bromocriptine was effective in decreasing level of prolactin whether used orally or vaginally. Vaginal bromocriptine suppositories application was associated with minimal side effect both local and general .Nausea was the most frequent side effect with oral tablets ,while excessive vaginal discharge and dyspareunia was the most occurring local side effect. Most side effect in three groups occur within the first 10 day after starting therapy. Conclusions: Bromocriptine is a very effective drug in treating hyperprolactinaemia, restoration of normal ovulation ,improvement of mastalgia and galactorrhea ,there was a significant difference between the three studied group regarding degree of side effect and type of side effect occurred .Based on our results vaginal bromocriptine suppositories (bromotaemia) is associated with minimal local and systemic side effect when compared with bromocriptine tablets (lactodel) when used orally or vaginally.

Bromocriptine therapy: Review of mechanism of action, safety and tolerability

“…Two types of formulations of bromocriptine are available, a standard release formulation and a newly approved quick release (QR) preparation, which is used for the treatment of diabetes mellitus 24–26 . The main difference between such formulations is related to their pharmacokinetics.…”

“…The standard formulation has a somewhat low bioavailability (28%) with the terminal half‐life of ~12 to 14 h, as compared to that of the QR formulation, which is ~65% to 95% bioavailable and cleared within a few hours 27 . Moreover, apart from oral administration, 26,28 bromocriptine can be appropriately administered via various other routes such as transdermal route, 29 nasal route, 30 vaginal route, 26,31 rectal route, 32 intramuscular injections, 23 etc. relative to disease severity or to avoid the first part metabolic effect.…”