| Objective:to probe into the efficacy and safety of the "reinforcing kidney and strengthening spleen and soothing liver" in treating the Hashimoto’s thyroiditis concomitant hypothyroidism by contrasting with the control group that take western medicine only, with clinical efficacy and laboratory parameters serving as the evaluation criteria; and to discuss the theory concerning the"reinforcing kidney and strengthening spleen and soothing liver" in order to provide objective bases for TCM in treating the Hashimoto’s thyroiditis concomitant hypothyroidism.Methods:52diagnosed Hashimoto’s thyroiditis patients with typical clinic manifestations of goitre as referred to in TCM were randomly divided into two groups on the principle of randomized control in clinical trials. Among them14patients were diagnosed as having hypothyroidism and38as having subclinical hypothyroidism after thyroid function tests. While thyroid ultrasonography displayed diffuse heterogeneity changes, some with thyroid nodules associated.Two patients in the treatments group (32patients) and2in the control group (20patients) fell off during the treatment.The control group was treated by taking levothyroxine sodium(L-T4Na) orally before breakfast (subclinical hypothyroidism patients were given12.5μg per day. and the dosages given to hypothyroidism patients were adjusted according to their thyroid hormone levels); the treatment group was treated by taking reinforcing kidney and strengthening spleen and soothing liver prescription orally one dose per day as supplement to the levothyroxine sodium(L-T4Na) taken orally before breakfast (dosages same as in control group).Three courses of treatment each lasting one month were given to both groups.All patients were conducted titrations on thyroid hormone level, thyroid autoantibodies TPOAb and TGAb as well as TCM syndrome score assessments before and after the treatment.All data were analyzed by the SPSS13.0statistics software.Results:Before the treatment, the two groups’general data, such as genders, sexes, courses of disease did not show statistically significant differences and thus were comparable between the groups (P>0.05); according to statistical analyses, the baseline data such as the patients’thyroid hormone levels, thyroid autoantibody TPOAb and TGAb as well as TCM syndrome scores did not show significant differences and thus comparable between the groups.After three courses of treatment:1)FT3levels have risen, showing differences that are not statistically significant when compared within each group (P>0.05). but did not show statistically significant differences when compared between the groups (P>0.05).2) FT4levels have risen, showing statistically significant differences when compared within each group (P<0.05). but did not show such differences when compared betweenthe groups (P>0.05).3)TS11levelsdropped significantly, showing differences that are statistically significant when compared within each group (P<0.05), when compared between the groups, the drop was more significant in the treatment group, showing differences that are statistically significant(P<0.05).4)TPOAblevelsdroppedsignificantlyandshowed statistically significant differences when compared within each group (P<0.01); when compared between the groups, the drop was more significant in the treatment group,showing differencesthatarestatisticallysignificant(P<0.05).5) TgAb levels dropped significantly and showed statistically significant differences when compared within each group (P<0.01); when compared between the groups, the dropwas more significantin thetreatmentgroup,showing differencesthatare statistically significant (P<0.01).6) TCM syndrome scores dropped significantly and showed statistically significant differences when compared within each group (P<0.01); when compared between the groups, the drop was more significant in thetreatment group,showingdifferencesthatarestatistically significant(P0.01).7) TCM syndrome efficacy assessment showed that the total efficiency was93.3%in the treatment group, and77.7%in the control group.The total efficiency inthetreatment groupwashigherthanthatinthecontrolgroup,andshowed statistically significant difference after the rank sum test (P<0.05).Conclusion: reinforcing kidney and strengthening spleen and soothing liver prescription proved to have an excellent treatment effect to the Hashimoto’s thyroiditis. The patients’ clinical syndromes improved significantly after the Chinese herbal medicine treatment. The impacts of the Chinese herbal medicine on the thyroid function showed slight differences between the treatment group and the control group that simply took Euthyrox. But the of thyroid autoantibody titrations showed more significant decrease in the treatment group than in the control group. The experimentshowedthat "reinforcingkidneyandstrengtheningspleenand soothingliver" has a goodtreatment effect tothe Hashimoto’s thyroiditiswith high safety and few side effects. |
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