Dose-effect analysis of treatment by modified Zhibaidihuang decoction on polycystic ovary syndrome hyperandrogenism

Abstract OBJECTIVE To observe the efficacy and safety of different dosages of modified Zhibaidihuang decoction (MZBDD) on polycystic ovary syndrome (PCOS) hyperandrogenism (HA) patients. METHODS Ninety PCOS HA patients and 30 infertile patients due to tubal factor were selected. Ninety PCOS HA patients were randomly divided into three groups: low dosage group (LDG), medium dosage group (MDG) and high dosage group (HDG) and infertile patients were selected as normal control group (NCG). PCOS HA patients were treated with different dosage of MZBDD for 4 weeks. For HA patients, serum total testosterone (T), estrodial (E 2 ), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolatin (PRL), alanine aminotransferase (AST), aspartate amino transferase (AST) were determined before and after treatment, while acne scores (Rosenfield) were signed. Basal body temperatures (BBT) were asked to be measured every day. And for the else, T, E 2 , FSH, LH, PRL, AST, and AST were determined before treatment. RESULTS Totally 111 patients completed the clinical research. There were no differences among the four groups on serum T before treatment ( P = 0.221). Serum T concentration of both MDG and HDG after treatment significantly were lower than that of before treatment ( P = 0.039, P = 0.000), while there was no obvious difference in LDG ( P = 0.829). Serum T concentration of both MDG and HDG were significantly lower than that of LDG after treatment ( P = 0.048, P = 0.006). To compared with before treatment, there were no differences in Serum FSH, LH, E 2 , P and PRL among the three groups (LDG, MDG, HDG) (as for FSH, P = 0.136, P = 0.503, P = 0.062; as for LH, P = 0.473, P = 0.513, P = 0.096; as for E 2 , P = 0.206, P = 0.927, P = 0.076; as for PRL, P = 0.120, P = 0.903, P = 0.407, as for P, P = 0.308, P = 0.866, P = 0480). Acne scores of all the three groups were obviously lower than that of before treatment ( P = 0.031; P = 0.033; P = 0.002). 39.5% of the patients had biphasic BBT, but there were no differences among the three groups ( P = 0.510). There were no differences with ALT and AST between after and before treatment among the three groups (LDG, MDG, HDG) (as for ALT, P = 0.742, P = 0.383, P = 0.053; as for AST, P = 0.732, P = 0.519, P = 0.120). CONCLUSION Different dosage of MZBDD has dose-effect relationship in treating PCOS HA.