| Objective: Through the study and research on this clinical trial, judgements reveal the clinical efficiency and safety of the assistant treatment by Shen-An-Jiao-Tai capsules on benzodiazepines drugs-dependent insomnia of disharmony of heart and kidney.Method: Adopted randomization, single blinding, positive medicine control of equal rank, placebo parallel comparative clinical trial method, in this trial calculated to select 72 suitable cases that were parted two groups at random, the ratio of treat group to control group was 1:1. The treat group adopted programme of gradual reduction of BZD dosage-fthe Shen-An-Jiao-Tai capsules (3~# tid), the control group adopted programme of gradual reduction of BZD dosage+the placebo capsules(3~# tid). The period of treatment lasted for four weeks. Before and at the end of this period, every patient of the two groups would get evaluated according to measurement of the revised Pittsburgh sleep quality index (PSQI) and the disharmony of heart and kidney symptom scale. The dosage of BZD and adverse effect would also be observed and recorded. Statistical analysis was performed by using Statistical Package for Social Science.Results:Curative effect evaluation: After the trial there were 68 cases in full analysis set (FAS), 61 cases in per-protocol set (PPS). Curative effect valued by the PPS. In the treat group, the rate of complete reductiondosage was 61.29%, the total efficiency rate of complete reductiondosage came to 90.32%. Compared with the control group (33.33%, 63.33%), there were difference in both reductiondosages between two groups (P<0.05). It showed that the treat group had better effect than the control group.The revised PSQI was significant difference in both groups between before and after the treatment (P<0.01), and the scores of two groups after the treatment were lower than the scores before the therapy. After the treatment, the revised PSQI on the two groups was similar (P>0.05).However, factors of sleeping quality, soporific and daily function showed statistics difference between two groups (P<0.05), score in the treat group was lower than that in the control group. The total revised PSQI efficiency rate of the treat group was 80.65%, which was compared with the control group (83.33%) and showed no statistics difference (P>0.05).The disharmony of heart and kidney symptom scores were significant difference in bom groups between before and after the treatment (P<0.01), score after the therapy was lower than that before it. There was significant difference in symptom scores of disharmony of heart and kidney between two groups after the treatment (P<0.05), and the score of treat group was lower than the control group. The total disharmony of heart and kidney efficiency rate of the treat group was 80.65%, which was compared with the control group (53.33%), and showed statistics difference (P<0.05), the treat group had better effect than the control group.Safety analysis: There were no untoward reactions in both treat group and control group in the clinical trial.Conclusion: The assistant treatment on disharmony of heart and kidney by Shen-An-Jiao-Tai capsules can have good effect on BZD-dependent insomnia. It will make effect on BZD reduction and enhance its success rate. It also helps patients get rid of dependence on BZD, as well as bring down the impact of TCM syndromes and improve sleeping quality and daily activities. Safety examination finds no abnormality. During the testing period, no harmful reaction appears which point out that this medicine is relatively safe. |
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