| Objective : The purpose of this study was to provide a safe and effective method for the insomnia by observing the clinical efficacy of rehmanniae decoction of six Ingredients and er-xian decoction based on seeking yin in yang method in the treatment of insomnia of yin-deficiency and fire-exuberance type and evaluating objectively its effectiveness and safety.Methods : 70 patients with insomnia of yin-deficiency and fire-exuberance type were selected from Wang Shuling Traditional Chinese Medicine Studio of Shijiazhuang Hospital of Traditional Chinese Medicine from December 2018 to December 2019.The patients were randomly divided into the treatment group and the control group,with 35 cases in each group.The treatment group was treated with oral Decoction-free granules,which consist of rehmanniae decoction of six Ingredients and er-xian decoction based on seeking yin in yang method and the control group was treated with Bai Lemian capsule.Both groups were treated for 4weeks.The two groups were treated with Pittsburgh Sleep Quality Index scale and Traditional Chinese Medicine syndrome score scale before and after treatment.Record adverse events.And evaluate the clinical efficacy of two groups with statistical software SPSS 19.0.Results:The clinical observation of 68 cases were actually completed in this study,with 1 shedding cases in the treatment group and 1 shedding cases in the control group.Before treatment,there was no significant difference in gender,age,course of disease,PSQI scale and TCMsyndrome score scale between the two groups(P>0.05),which was comparable.After treatment,PSQI scale in the two groups were compared.There was no significant difference in sleep time,sleep efficiency and sleep disorders between the two groups(P>0.05).There was significant difference in sleep quality,fall asleep time,daytime dysfunction and total scores of PSQI scale between the two groups(P<0.01).After treatment,TCM syndrome score scale in the two groups were compared.There was no significant difference in easy to wake up,dry throat,palpitations and sweating between the two groups(P>0.05).There was statisticial difference in dreaming,dizziness and tinnitus,amnesia and hectic fever between the two groups(P<0.05).There was significant difference in upset and insomnia,hot flashes,lumbar and knee soreness and total scores of TCM syndrome score scale between the two groups(P<0.01).Then the total scores of PSQI scale and the total scores of TCM syndrome score scale in the two group were compared.The total scores of PSQI scale and the total scores of TCM syndrome score scale in the two group all Showed a significantly downward trend after treatment compared with those before treatment(P<0.01).The clinical efficacy was judged based on the PSQI score reduction rate: 34 cases in the treatment group,11 cases were cured,17 cases were markedly effective,4 cases were effective and 2 cases were ineffective.The total improvement rate was 94.12%.34 cases in the control group,5 cases were cured,9 cases were markedly effective,13 cases were effective and 7 cases were ineffective.The total improvement rate was79.41%.There was significant difference between the two groups(P< 0.01).The evaluation of the effectiveness of TCM was based on the score reduction of traditional Chinese medicine syndrome points: 34 cases in the treatment group,8 cases were cured,22 cases were markedly effective,2cases were effective and 2 cases were ineffective.The total improvement rate was 94.12%.34 cases in the control group,1 cases were cured,15 cases were markedly effective,14 cases were effective and 4 cases wereineffective.The total improvement rate was 88.24%.There was significant difference between the two groups(P<0.01).There was no significant abnormalities in the safety indicators of the two groups.Conclusion:(1)Rehmanniae decoction of six Ingredients and er-xian decoction based on seeking yin in yang method and the Bai Lemian capsule can treat insomnia of yin-deficiency and fire-exuberance type,but the curative effect of rehmanniae decoction of six Ingredients and er-xian decoction based on seeking yin in yang method is better than the Bai Lemian capsule.(2)Rehmanniae decoction of six Ingredients and er-xian decoction based on seeking yin in yang method is better than the Bai Lemian capsule in improving TCM syndromes of insomnia of yin-deficiency and fire-exuberance type.(3)Rehmanniae decoction of six Ingredients and er-xian decoction based on seeking yin in yang method shows no obvious untoward effective,and has good safety. |
