A Randomized Trial of Chinese Medicine Lirukang Granule (利乳康颗粒) Combined with Psychological Intervention for Cyclomastopathy and Menoxenia

Objective:To observe the influence of therapy with Chinese medicine Lirukang Granule（利乳康颗粒）,LRKG) combined with psychological intervention on anxiety states and sex hormones in patients with cyclomastopathy and menoxenia.Methods:A total of 470 subjects were randomly assigned to three groups by the net-central randomization system,the treatment group（161 patients,treated with LRKG and psychological intervention）,the Chinese medicine group（157 patients,treated with LRKG）,and the psychological intervention group（152 patients,treated with psychological intervention）.The dose of LRKG was 12 g three times per day; psychological intervention included establishing relations,cognitive intervention and psychological persuasion, 30-40 min per session,once a week.The therapy duration for all groups was three months.The efficacy was compared and anxiety state/State-Trait Anxiety Invertory（STAI） scoring was measured before and after treatment.The serum estradiol（E₂）,progesterone（P）,prolactin（PRL） and follicle stimulating hormone（FSH） levels of 60 patients selected randomly from each group during the luteal phase were measured before and after treatment,and a group of 20 healthy women were evaluated for comparison.A follow-up was arranged for one year after treatment.Results:Thirty subjects were lost to follow-up.（1） Comparison of efficacy:the markedly effective rate and the total effective rate of the treatment group were 86.67%（131/150） and 98.00%（147/150）, respectively;of the Chinese medicine group,64.58%（93/144） and 90.27%（130/144）,respectively;and of the psychological intervention group,0%（0/146） and 3.42%（5/146）,respectively.The markedly effective rate and the total effective rate in the treatment group were significantly higher than those in the Chinese medicine and psychological intervention groups（P<0.05）.（2） Comparison of STAI scoring:STAI scoring was decreased dramatically in the treatment group after treatment compared with that of the Chinese medicine group（P<0.01）, but there was no significant difference compared with the psychological intervention group.（3） Comparison of levels of sex hormones:E₂,P,PRL and FSH of the three patient groups were disordered before treatment,and significantly different from healthy women（P<0.01）.After treatment,the levels of P and FSH of the treatment group were significantly increased（P<0.01）,E₂ and PRL were significantly reduced,which were also significantly decreased compared with the psychological intervention groups（P<0.01）.（4） Follow-up:the markedly effective rate and the total effective rate of the treatment group remained higher than those of the other two groups after one year of treatment（P<0.05）.（5） Adverse reactions:no obvious adverse reactions were found among the three groups.Conclusions:Therapy with Chinese medicine combined with psychological intervention was effective for short-term and long-term treatment of cyclomastopathy and menoxenia.The mechanism might be related to the regulation of sex hormones.