OBJECTIVETo assess the clinical efficacy, safety and compliance of tianwang buxin decoction (TWBXD) combined with dormancy hygiene education (DHE) and TWBXD alone in treatment of sub-healthy insomnia patients of yin deficiency fire excess syndrome.

METHODSThe multi-centered, single blinded randomized clinical trial design was adopted. One hundred and one sub-healthy insomnia subjects of yin deficiency fire excess syndrome were randomly assigned to two groups. The 50 in the treatment group were treated by combined treatment with TWBXD and DHE, while the 51 in the control group were treated with TWBXD alone. The therapeutic efficacy, Pittsburgh sleep quality index (PSQI) score, clinical global impression-improvement (CGI) score, quality of life made by WHO (WHOQOL-BREF) score, and safety in the two groups were compared.

RESULTSThe effective rate in the treatment group was 68.08%, lower than that in the control group (75.00%), but the difference between them was statistically insignificant. The PSQI score in the treatment group were reduced from 12.00 +/- 2.25 to 7.55 +/- 2.91 (P < 0.01). It was reduced from 11.68 +/- 2.21 to 7.16 +/- 3.13 in the control group (P < 0.01). The improvement of CGI score and WHOQOL-BREF score was also shown in the two groups after treatment (P < 0.01). No significant difference was shown in each index between the two groups. There was no significant difference in CGI between two weeks after drug withdrawal and by the end of the therapeutic course in the same group (P > 0.05). There was no statistical significance in inter-group comparison (P > 0.05).

CONCLUSIONSignificant effect was achieved by TWBXD combined with DHE and by TWBXD alone. Their efficacies were equivalent, with high compliance and safety.