| Objective Discussing the clinical effect of Huang Qi Gui Zhi Wu Wu decoction with pramipexole dihydrochloride tablets for treatment of the restless legs syndrome,understanding whether the combination of traditional Chinese and Western medicine is better than the treatment of single Chinese medicine or western medicine,exploring the optimal solution for the treatment of restless legs syndrome are helping to provide new ideas and treatment basis for clinical treatment and promotion.Methods This clinical study will meet the inclusion criteria of90 cases of restless legs syndrome(RLS),using randomized,controlled design methods divided into TCM and western,TCM and western treatment group,30 cases in each group.TCM treatment group are treated with the Huang Qi Gui Zhi Wu Wu decoction,western group are treated with the pramipexole dihydrochloride tablets,the Huang Qi Gui Zhi Wu Wu decoction combined with the pramipexoledihydrochloride tablets are used in TCM and Western group.The patients’ sleep(International Restless Legs Syndrome Rating(IRLS),Restless Legs Syndrome Quality(RLSQoL),Pittsburgh Sleep Quality Index(PSQI)),cognitive function(Mini-mental State Examination(MMSE),Montreal Cognitive Assessment(MOCA))and emotional change(Hamilton Anxiety(HAMA))were assessed before treatment,after the 4th week of treatment and after the 12 th week of treatment.At the same time,before the treatment and after the12 th week of treatment,the Polysomnography(PSG)was improved to evaluate the sleep of the patients in the TCM and Western treatment group and the Western treatment group.Results(1)Before the treatment,there were no significant differences in IRLS,RLSQoL,PSQI,MMSE,and MOCA scores among the3 groups(P>0.05).(2)After 4 weeks of treatment,the scores of all the scales of the TCM and Western group,the TCM group and the Western group were statistically significant compared with those before treatment(P<0.05);The scores of all the scales of TCM and Western group were statistically significant difference with TCM group(P<0.05);The scores of all the scales of TCM and Western group were statistically significant difference with Western group(P<0.05);The scores of all the scales of TCM group were statistically significant difference with Western group(P<0.05).(3)After 12 weeks of treatment,the scores of all the scales of the TCM and Western group,the TCM group and the Western group were statistically significant compared with those before treatment(P<0.05);The scores of all the scales of TCM and Western group were statistically significant difference with TCM group(P<0.05);Thescores of all the scales of TCM and Western group were statistically significant difference with Western group(P<0.05);The scores of all the scales of TCM group were statistically significant difference with Western group(P<0.05).(4)Before the treatment,the rating scales of the sleep latency(SL)time,the number of awakening(NW),the total time of stagewake(SW),sleep efficiency(SE)and periodic leg movement in sleep(PLMS)between TCM and Western group and Western group were no statistically significant difference(P<0.05).(5)After 12 weeks of treatment,the rating scales of TCM and Western group and Western group such as SL,NW,SW and PLMS reduced,the sleep efficiency(SE)increased.The above indicators of the two groups of patients were statistically significant compared with those before treatment(P<0.05);the above indicatorsof TCM and Western group were statistically significant difference with Western group at the same time(P<0.05).Conclusion The curative effect of Huang Qi Gui Zhi Wu Wu decoction combined with the pramipexole dihydrochloride tablets is obviously better than TCM group and Western group.After treatment,the patient’s clinical performance,cognitive function and sleep quality were significantly improved.As a kind of sleep disorder,restless leg syndrome has a low diagnosis and treatment rate in China,which seriously affects the health and quality of life of patients.Through the combination of TCM and Western,it can effectively improve the symptoms of patients and produce good therapeutic effects.It provides a new idea for the clinical treatment of restless legs syndrome,which can be adopted and promoted by clinicians. |