| 1 BackgroundThe patient of the cervical spondylosis accouns for a large proportion in the orthopaedic-clinic,morever,the nerve root type and cervical type occupy the highest incidence rates[1].It has been reported that the cervical type cervical spondylosis(CTCS) most often occurs in the middle-young people,which has takes up the percent of 7-10 among the population.In modern society,the people have increasing time and opportunity to use computer,mobilphone and work at the desk,as a result,the ill population trends towardsyoungerinaverageage.The CTCS has became a danger to the people’s life and health of all the dangerous diseases.There have also been reports over the years that The CTCS is the initial stage of other various types of cervical spondylosis, so the early treatment can help slow down the progress of the disease.The traction treatment is one of the common methods of all the conservative treatments which according to the CTCS.With the faster life,work and study pace,it is difficult to adhere to the systematic,complete and regular traction treatment compared with the drug therapy which is a relatively easily method.Therefore the drug therapy has a better compliance than the traction treatment.The neck pain and stiffness are the major clinical manifestation,which similary to Taiyang wind-stroke syndrome that based upon the original texts of Shang Han Lun.The original records"if someone has been diagnosed with the TaiYang disease,he would feel the neck and upon back stiffness,along with sweating and afraiding of wind,we could cure it by using GuiZhi Plus GeGen Decoction."According to these words,GuiZhi Plus GeGen Decoction has been widely applied to the Cervical spondylosis,furthermore to different kinds of pain diseases in recent years.But many problems have been founded in the clinical designs after refering to 60 literatures about the news of curing the cervical spondylosis by using of GuiZhi Plus GeGen Decoction in China hownet.For instance,firstly,in terms of sample size.there are 4 reports which less than 50 cases;Secondly,only 3 literatures has been used the method of RCT and the rest of 7 used self-controlled study in the way of clinical designs;thirdly,only VAS and the range of cervical spinal extension are taken as observed index in 1 piece among the 3 RCT literatures,and yet the remainder of 9 literatures are standarded of the therapeutic effect evaluation what the patients feel;lastly,only 1 paper sets up 3 months follow-up period except the rest 9 literatures.For these reasons,it is not enough to explain the exact curative effect of GuiZhi Plus GeGen Decoction,so it needs to observe the clinical curative effect by setting up a scientific and reasonable design.2 PurposeTo observe the clinical curative effect of GuiZhi plus GeGen Decoction on the CTCS,and have a preliminary probe into the correlation among the observation indexes through randomized clinical trials.3 MethodIn a randomized controlled trial,70 cases diagnosed the CTCS in accordance with the random number envelope table were picked out and dived into the treatment group(36 cases)and the control group(34 cases).The treatment group 36 cases were treated with GuiZhi plus GeGen Decoction,and the control group 34 cases with compound chlorzoxazone tablets,both groups were treated for 2 weeks.Cervical vertebra arc chord distance,TCM symptom score,visual analog scale(VAS),neck disability index(NDI) and its classification and pressure pain threshold grading were observed in 4 period(pre-treatment,l week after treatment,2 weeks after treatment and 1 month follow-up).Besides,having a preliminary probe into the correlation among the cervical vertebra arc chord distance,VAS,NDI and pressure pain threshold in pre-treatment and 1 month follow-up.Data analysis was performed by using SPSS19.0.Count data was described by cases and applied to Chi-square test.Grading data used Wilcoxon rank sum test.Measurement data which fitted normal distribution was described by×±s and applied to intra-team paired-samples t-test,as well as inter-team independent-samples t test.Wilcoxon rank sum test was appropriate for measurement data which not fitted normal distribution.Correlation analysis used Pearson correlation coefficient test.P<0.05 was considered to be a statistical significance.4 Result4.1 The overall curative effectThe markedly effective rate, total therapeutic effective rate of treatment group and control group are 39%,97.2% and 29.41%,76.47% after 2 weeks treatment,the difference with statistical significance(P=0.00<0.01).The one-month follow up of treatment group and control group showed markedly effective rate, total therapeutic effective rate of 36.1%,91.76% and 29.41%,73.5%, the difference with statistical significance(P=0.02<0.05).4.2 The comparison between the pre-treatment and post-treatment in two groups.Compared with the pre-treatment, the cervical vertebra arc chord distance of two groups for 1 month follow up showed no statistical significance had statistical significance(p=0.00<0.01)compared with the pre-treatment.However,the TCM symptom score,VAS,NDI and pressure pain threshold after 1 week,2 weeks after treatment and 1 month follow up were statistical significance(p=0.00<0.01) as compared with that before treatment in both groups;There were no significant differences in two groups about NDI grading before and after 1 week,2 weeks treatment and no significant difference compared with the pre-treatment(all P> 0.05);There was no significant difference (P=0.09>0.05) between the pre-treatment and 2 weeks after treatment in pressure pain threshold.4.3 The comparison between the treatment group and control group after therapy.Compared between groups, cervical vertebra arc chord distance showed no significant difference at the 1 month after treatment(p=0.19>0.05);Meantime,no significant differences of TCM scores were observed between two groups after treatment(P>0.05);Nevertheless,except 1 week after treatment,the treatment group was compared with the control group at various time in the way of pressure pain threshold increased,VAS and NDI decreased,and the significant difference between the two groups (p=0.00<0.01);On the other hand,there were significant differences in two groups about NDI grading,pressure pain threshold grading at various time after treatment (p<0.01 or p<0.05).4.4 The correlation among VAS,NDI,pressure pain threshold and cervical vertebra arc chord distance.VAS and NDI presented positively linear correlation at pre-treatment and 1 month follow-up(P=0.00<0.01); It showed a negative correlation between pressure pain threshold and VAS at pre-treatment and 1 month follow-up, as well as pressure pain threshold and NDI(P=0.00<0.01);But the linear correlation which cervical vertebra arc chord distance with NDI,VAS and pressure pain threshold was not significant(all P> 0.05).4.5 Safety EvaluationThe two groups of patients during treatment shows no significant adverse reactions.5 ConclusionThe overall curative effect of the treatment group(GuiZhi Plus GeGen Decoction) was better than the control group(compound chlorzoxazone tablets),and more durable; GuiZhi Plus GeGen Decoction can effectively alleviate the symptoms of The CTCM, mainly pain and function; The linear correlation has been showed among the three observation indexs (VAS,NDI and pressure pain threshold); The X-ray imaging changes of the CTCS is given priority to with physiological curvature straighten,and the pressure pain points focused on trapezius musc-les,levator scapulaes and paraspinal muscles. |
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