| 1 ObjectiveTo evaluate the clinical efficacy, the psychological state and the change of the psychological state of patients of severe KOA after treatment by Orally Chinese herbs Bushenjianpi prescription.2 Research contents and methodsBy using the method of randomized controlled trials,we collected 60 cases with severe KOA according to the inclusion and exclusion criteria from April 2014 to May 2015 in the 2nd Department of Orthopaedics, Wangjing Hospital of China Academy of Chinese Medical Sciences,32 cases of which in the treatment group,28 cases of which in the control group. The control group used health education, functional exercise, and psychological guidance, Loxoprofen Sodium Tablets (60mg* 20 tablets, 1 tablets each time,3 times a day) and Glucosamine Hydrochloride Capsules (0.24g* 48 capsules,2 capsules each time,3 times a day) orally, and the treatment group combined with Chinese herbs Bushenjianpi prescription orally.The treatment lasted 2 weeks, every 2 weeks for a course. In the end, we evaluate the curative effect by Nimodipine method.and analysis the scores of TCM symptoms scale, WOMAC scale and ISOA scale.3 Results3.1 Statistical descriptionA total of 60 patients with severe KOA were actually included, treatment group 32 cases(5 male cases,27 female cases), whose mean age was 64.09±7.43 years and average duration was 85.81±89.78 months; there were 28 cases in the control group, 4 male cases,24 female cases, whose mean age was 63.25±7.50 years and average duration was 79.93±64.98 months. The two groups had no statistical significance in age, duration, body weight, body mass index, TCM symptoms score, ISOA score, WOMAC score (P>0.05), and they were on similar baseline levels.These 60 patients,9 men cases accounted for 15%,and 51 women cases accounted for 85%;BMI in the normal range in 21 cases, accounted for 35%, higher than the normal in 37 cases, accounting for 62%, lower than normal in 2 cases, accounting for 3%. And there were 25 cases who completed SCL-90 scale, their ratings are within the scope of 130.02±33.6260, from literature data, the symptoms were moderate, no obvious mental health problems.3.2 Effect evaluationAccording to the WOMAC scale, after 2 weeks of treatment, it resulted that 7 cases had no effect (21.875%),25 cases were effective (78.125%),0 case was cured and significantly effective in treatment group;In control group,13 cases had no effect (46.43%),15 cases were effective (53.57%),0 case was cured and significantly effective. The total effective rate of two groups were78.125%,53.57%. Through chi-square test, there was statistical significance (P=0.01<0.05), showed that the clinical curative effect in the treatment group was superior to the control group. According to the ISOA scale, after 2 weeks of treatment, in treatment group, it resulted that 6 cases had no effect (18.75%),26 cases were effective (81.25%),0 cases were cured and significantly effective;in control group,6 cases had no effect (21.43%),22 cases were effective(78.57%),0 cases were cured and significantly effective. The total effective rate of two groups were 81.25%,78.57%. Through chi-square test, no statistical significance (P=0.07>0.05), results showed that the clinical curative effect of the treatment group is not better than the control group.After evaluating the curative effect by using the data of all 60 cases,we found that, according to the WOMAC scale data,20 cases were ineffective (33.33%),40 cases were effective(66.67%),0 cases were cured and markedly effective, the total effective rate was 66.67%; according to the ISOA scale data,12 cases were ineffective (20%), 48 cases were effective (80%),0 cases were cured and markedly effective. Through chi-square test, no statistical significance between the two groups (p=0.099>0.05), it showed that whether using WOMAC or ISOA scale to evaluate the curative effect got no obvious difference.3.3 Comparison of the scale scores before and after treatment of two groupsFor the TCM symptoms scale, the total score and the score of signs before and after treatment showed there were statistically significant difference (P=0.00<0.01), tongue and pulse points were not statistically significant (P>0.05); There was statistically significant difference in total score and signs scores between the two groups (P<0.05),but no significant difference in the symptoms, tongue and pulse score between the groups (P>0.05). After analysis of itemized statistics, the two groups all had statistically significant in knee pain, swelling, the range of motion of the score before and after treatment (P<0.05), no statistically significant in fatigued of psyche and chill of knee (P>0.05). For the score of soreness of loins and knees, there was statistically significant in treatment group between before and after treatment (P<0.05), no statistically significance in fatigued of psyche and chill of knee (P>0.05). The scores of knee pain, soreness of loins and knees, fatigued of psyche, chill of knees, tenderness and the range of motion after treatment between the two groups were not statistically significant (P>0.05), the baseline of swelling was irregularity.Referring to the WOMAC Scale total score, pain, rigidity, the difficulty of daily activities of single item scores and ISOA Scale total score, symptoms and signs of volume, maximum walking distance and the daily life single item scores after treatment compared with that before treatment had significant statistical difference (P-0.00<0.01), and they had significantly decreased. For single item score, only ISOA scale maximum walking distance scores between the two groups was statistically significant (P<0.05), other projects and WOMAC scale of single item scores between the two groups were not statistically significant (P>0.05).After a comparative analysis of the score differences of before and after treatment of TCM symptoms scale single item score, WOMAC and ISOA scale form class project score between two groups, soreness of loins and knees, fatigued of psyche and the range of motion was statistically significant between two groups (P<0.05), single item score knee pain, chill of knee, tenderness, swelling and WOMAC and ISOA scale form class project score were not statistically significant (P>0.05)On the statistical analysis of pain projects in scales after the treatment between two groups, there was statistically significant difference in the WOMAC scale up and down stairs pain scores (P<0.05), the frequency of knee pain, WOMAC scale road walking pain, disturbed sleep pain, sitting and lying quiet pain, standing pain and ISOA scale nightly bed rest pain scores had no statistical significance (P>0.05).For the SCL-90 mental state score, somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, horror, paranoid ideation, psychotic diseases and other all single factor score before treatment compared with after treatment had no significant difference (P>0.05), and there was no obvious decrease or increase. Meanwhile there was no significant difference in all factors (except somatization factor) between two groups (P>0.05).4 Conclusions4.1 Systematic conservative treatment can effectively improve the severe KOA disease.4.2 Severe KOA treatment with Chinese herbs Bushenjianpi prescription orally can improve the living ability of the patients better than without the use of traditional Chinese medicine, without obvious adverse reactions and side effects.4.3 The mental health status of the patients with severe KOA at medium level, and Severe KOA treatment with Chinese herbs Bushenjianpi prescription orally will not cause significant psychological impact on patients. |
PDF Full Text Request