OBJECTIVETo appraise the clinical efficacy, safety and compliance of the intervention of spleen-restoring decoction combined with dormancy hygiene education and the intervention of spleen-restoring decoction alone on sub-healthy insomnia of deficiency of both the heart and spleen pattern.

METHODStudy design took multi-centers, blind and randomized control trial, 107 participants with sub-healthy insomnia of deficiency of both the heart and spleen pattern were assigned to A group (52 cases) which was treated with the intervention of spleen-restoring decoction combined with dormancy hygiene education and B group (55 cases) which was treated with the intervention of spleen-restoring decoction single, compared by efficacy, PSQI score, CGI score, WHOQOL-BREF score and security.

RESULTThe efficacy of two group was 79.58%. There was no significant different between them. The PSQI scores before treatment was (11.80 +/- 2.08) and which afer treatment was (6.78 +/- 2.84) of A group. The PSQI scores before treatment was (11.61 +/- 2.00) and which afer treatment was (6.73 +/- 2.27) of B group. There was significant difference in PSQI scores both A group and B group after treatment (P < 0.01); the results of CGI score and WHOQOL-BREF score before and after measurement showed the same as PSQI. There were no significant difference between two groups in all scores after treatment and there was no interaction between time pots and treatment factors . Withdrawal reaction analysis: comparing CGI after withdraw 2 weeks and at the end of treatment course, there was no significant difference between two groups. The same result was in comparison among groups.

CONCLUSIONBoth the intervention of spleen-restoring decoction integrating with dormancy hygiene education and spleen-restoring decoction had obvious clinical efficacy on treating subhealthy insomnia of deficiency of both the heart and spleen pattern, and had high compliance and safety. The intervention of spleen-restoring decoction integrating with dormancy hygiene education showed no better clinical efficacy than spleen-restoring decoction did.

Adult ; Female ; Health Education ; Humans ; Hygiene ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Sleep Initiation and Maintenance Disorders ; drug therapy ; physiopathology ; Splenic Diseases ; drug therapy

ObjectiveTaking the oligosaccharides in Rehmanniae Radix（RR） as the research object， the content determination method based on high performance liquid chromatography-evaporative light scattering detection（HPLC-ELSD） and thin layer chromatography（TLC） identification method were established to explore the content and distribution of oligosaccharides in different RR herbs and decoction pieces. MethodA total of 10 batches of fresh and raw RR， 12 batches of RR decoction pieces and Rehmanniae Radix Praeparata（RRP） were collected. A TLC identification method for fructose， sucrose， manninotriose， raffinose and stachyose in RR was established by using silica gel G thin-layer plates with ethyl acetate-water-anhydrous formic acid-glacial acetic acid（12∶6∶5∶4） as the developing agent and 10% sulfuric acid-ethanol solution as chromogenic agent. A HPLC-ELSD was used to determine the contents of fructose， glucose， sucrose， melibiose， raffinose， manninotriose and stachyose in different RR herbs and decoction pieces. Then principal component analysis（PCA） and partial least squares-discriminant analysis（PLS-DA） were used to analyze the contents of 7 kinds of saccharides in RR herbs and decoction pieces， and the differential components were screened with the value of variable importance in the projection（VIP）>1. ResultThe results of TLC identification showed that fresh RR， raw RR and its decoction pieces showed spots of the same color on the corresponding positions with the control products of stachyose， raffinose and sucrose， while the TLC of RRP showed spots of the same color at corresponding positions to manninotriose and fructose controls. The results of methodological investigations of 7 analytes met the requirements of determination. Only glucose， sucrose， raffinose and stachyose were detected in 10 batches of fresh RR and 10 batches of raw RR herbs， the average contents of which were 0.84%， 4.62%， 2.42% and 57.90% in fresh samples， while those were 3.16%， 9.36%， 7.05% and 38.10% in raw samples， respectively. In 12 batches of RR decoction pieces， the contents of the above seven sugars（fructose， glucose， sucrose， melibiose， raffinose， manninotriose and stachyose） were 1.68%， 4.27%， 9.96%， 0.53%， 6.85%， 3.05% and 37.52%， respectively. In 12 batches of RRP， the contents of the above seven sugars were 10.62%， 11.01%， 1.25%， 3.35%， 1.12%， 28.16% and 6.39%， respectively. The results of multivariate statistical analysis showed that fresh RR， raw RR and RRP could be distinguished from each other by the contents of the 7 sugars， and the main differential components were stachyose， sucrose， raffinose and manninotriose. ConclusionIn terms of oligosaccharides， the contents and types of saccharides in different herbs and decoction pieces of RR are quite different， and the TLC identification method based on this can be used to distinguish raw RR from RRP， which can lay a foundation for improving the quality standard of RR and developing and applying oligosaccharides in different processed products of RR.