Clinical Research On Treating Simple Premature Thelarche By Soothing Liver And Strengthening Spleen

Background:Simple Premature Thelarche(SPT)means isolated thelarche in young girlsless than 8 years old without maturation of other secondary sexual chara-cters, which belongs to partial precocious puberty. Until now its etiologyis unclear, which is believed to be the result of various factors. Risk factorsof SPT might include unstable hypothalamic-pituitary-gonad axis, anticipationof adrenal cortical function, genetic factor, environmental hormone and nutri-tion. Years before it is thought that SPT was a kind of benign self limiteddisease without any side effect to puberty and didn't need treatment. Butin recent years, researches show it has impact on children' s mental health,lives and study, it can also effect the development of both height and boneage, part of PTcan transform into true precocious puberty. Until now, thereis no effective treatment to it with western medicine. Traditional Chinesemedicine (TCM) analyzes it from concept of wholism and determines treatmentaccording to different syndrome. It is thought from the point of TCM that normalgrowth and development and maturation of genitical gland mainly depend onsufficient kidney-qi and menstruation beginning on time. If there are imbanl-ance between kidney-yin and kidney-yang and menstruation is ahead of time,it will cause disease by bringing sexual maturity of children forward. It isalways treated by nourishing yin to lessen fire, regulating and invigoratingthe function of liver and kidney, strengthening spleen to remove phlegm, sof-tening hard lumps and dispelling nodes. We find many patients have stagnation of liver-qi with deficiency of the spleen, and because children have phys-iological features that the liver being liable to excess and asthenic susc-eptibility of spleen, we suggest to treat SPT by soothing liver and stren-gthening spleen and appraise therapeutic effect by observing hormone level(follicle stimulating hormone (FSH), luteinizing hormone (LH), estrogen (E₂))in serum and infrascan of mammary gland.Objective:We further investigate pathophysiological mechanism of SPT and its rel-ationship with hypothalamic-pituitary-gonad axis by analyzing change of clin-ical symptoms, diameter of breasts and hormone (FSH, LH, E₂)level in serum beforeand after treatment, infrascan of mammary gland, liver function and renalfunction. We try to prove if soothing liver and strengthening spleen is aneffective way in treating SPT, its features and safety, and provide a novelway in treating SPT from the point of TCM.Methods:50 girls diagnosed to be SPT in Guangzhong Hospital of Traditional ChineseMedicine (from April, 2006 to February, 2007) were randomly divided intotreatment group and control group with 25 girls in each group. Treatment groupwere treated with Xiaoyaosan, once per day; Control group were treated withRukuaixiao Capsule, 2 pills per time, 3 times per day. Treating time is 30days in both groups and without additional treatment. Clinical symptom score,breasts diameter, height, weight, infrascan of mammary gland, hormone (FSH,LH, E₂) level in serum, liver function and renal function were compared beforeand after treatment. Results were showed as (?)±s. Group comparison: inde-pendent t test was used for homogeneity of variance and rank sum test was usedfor heterogeneity of variance. Comparison before and after treatment: pairedt test was used for measurement data and x² test was used for enumeration data.SPSS10.0 was used for analysis.Results:1. Comparison of therapeutic effect: there is significant difference oftotal effective rate between two groups (92% in treatment group and 64% incontrol group; P=0.006＜0.01).2. There is significant difference of symptomatic relief time between twogroups (P＜0.01). 3. Breasts diameter: there is no significant difference between two groupsbefore treatment (28.00±13.22mm in treatment group and 25.40±11.89mm incontrol group; P＞0.05). but there is significant difference between twogroups after treatment (5.96±9.13mmin treatment group and 18.28±8.43mm incontrol group; P=0.000＜0.001).4. There is no significant difference of height and weight between twogroups before and after treatment (P＞0.05).5. There is significant difference of lump disappearance rate of mammarygland examined by infrascan between two groups (84% in treatment group and32% in control group; P=0.002＜0.01).6. FSH, LH, E₂ levelThere is no significant difference of FSH and LH level between two groupsbefore and after treatment (P＞0.05).There is no significant difference of E₂ level between two groups beforetreatment (P＞0.05); but there is significant difference of E₂ level betweentwo groups after treatment (P=0.000＜0.001).7. There is significant difference of drug's total adverse effect betweentwo groups (16% in treatment group and 56% in control group; P=0.008＜0.01).Conclusions:1. Xiaoyaosan can significantly diminish enlarged breasts, and itstherapeutic effect on SPT is better than that of Rukuaixiao Capsule.2. Xiaoyaosan is better than Rukuaixiao Capsule in treating stagnationof liver-qi with deficiency of the spleen such as painful swollen breasts,restlessness and agitation, abdominal distention and constipation.3. E₂ level increases in SPT girls and decreases after treatment, whichmeans SPT has relationship with increased E₂ level.4. Xiaoyaosan can decrease E₂ level in the body.5. There is no significant adverse effect of Xiaoyaosan, in that it isa safe method in treating SPT.6. Infrascan of mammary gland can objectively judge the development ofbreasts, which can be a referred choice for diagnosis and judging therapeuticeffect.