| Objective: To evaluate the efficacy and safety of Peony-Glycyrrhiza Decoction(PGD)in the treatment of antipsychotic-induced hyperprolactinemia,and its efficacy in sexual dysfunction.Methods: Sixty-two patients with schizophrenia were recruited among inpatients and outpatients in the hospital according to the enrollment criteria.They were randomly divided into two groups: the experimental group(treated with PGD)and the control group,and underwent an 8-week randomized controlled trial.Hormone tests were performed on both groups at baseline and at 4 and 8 weeks after treatment.The Arizona Sexual Experience Scale(ASEX)was used to evaluate changes in the patients’ sexual function at baseline and at the end of the8-week study period.The Positive and Negative Syndrome Scale(PANSS)and Treatment Emergent Symptom Scale(TESS)were used to evaluate the patients’ psychiatric symptoms and adverse reactions.Results:1.32 patients were enrolled in the experimental group,and 27 patients completed the 8-week visit.30 patients were enrolled in the control group,and 28 patients completed the 8-week visit.There were no significant differences in age,course of disease,gender,and years of education between the two groups at baseline(P>0.05).2.At baseline,there were no significant differences in the antipsychotic treatment regimens between the two groups(P>0.05).The treatment regimens for the two groups were as follows(number of patients in the experimental group/control group): olanzapine combined with risperidone(6/4),risperidone(3/5),olanzapine combined with amisulpride(6/4),fluphenazine combined with quetiapine(2/2),paliperidone injection combined with olanzapine(2/2),amisulpride(3/4),amisulpride combined with clozapine(1/1),risperidone combined with quetiapine(1/1),olanzapine(6/4),and fluphenazine combined with olanzapine(2/3).The patients’ antipsychotic regimens remained unchanged throughout the study.Benzhexol and benzodiazepine drugs were used to treat extrapyramidal symptoms and insomnia.3.Sex hormone levels at different times between the two groups.There was no significant difference in prolactin levels between the two groups at baseline(P>0.05).However,at the end of week 4 and week 8,the mean serum prolactin levels in the control group were significantly higher than those in the experimental group(P<0.05).Within the experimental group,there was no significant difference in serum prolactin levels at week 4 and week 8 compared to baseline levels(P>0.05).In the control group,the mean serum prolactin levels at week 4 and week 8were significantly higher than those at baseline levels,indicating that prolactin levels in the control group increased over time(P<0.05).There was no significant difference in serum levels of estradiol,testosterone,progesterone,follicle-stimulating hormone,and luteinizing hormone between the two groups at baseline,week 4,and week 8(P>0.05).4.The difference in ASEX scores between the two groups.There was no significant difference in ASEX total score between the two groups at baseline(P>0.05).At week 8,the ASEX total score of the experimental group was significantly lower than that of the control group,and the difference between the two groups was statistically significant(P<0.05).Furthermore,compared with baseline,the ASEX total score of the experimental group showed a significant downward trend at week 8(P<0.05),indicating that Peony-Glycyrrhiza Decoctionimproved the sexual function of the patients.When each item was analyzed separately,at week 8,the scores of the experimental group in terms of sexual drive,arousal,and vaginal lubrication(for females)/penile erection(for males)were significantly lower than those of the control group,and the difference was statistically significant(P<0.05).There was no significant difference in scores between the two groups in terms of orgasmic ability and sexual satisfaction(P>0.05).The improvement in sexual function of the experimental group was mainly reflected in the aspects of sexual drive,arousal,and vaginal lubrication(for females)/penile erection(for males).5.There was no significant difference in the Treatment Emergent Symptom Scale(TESS)scores between the two groups at baseline and week 8(P>0.05).Adverse reactions during the treatment process included insomnia,abnormal liver function,dry mouth,increased saliva,nausea and vomiting,headache,constipation,and abnormal electrocardiogram(without clinical significance).All symptoms were treated symptomatically or continued to be clinically observed.6.There was no significant difference in the PANSS scores between the two groups at baseline,week 4,and week 8(P> 0.05).Conclusion:1.PGD not significantly reduce prolactin levels in hyperprolactinemia,but it can prevent further elevation of PRL levels.2.PGD improve sexual dysfunction in patients with schizophrenia caused by antipsychotic drugs. |
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