Efects Of Lingnan Tianjiu Prescription No.3 On Lubmar Pian Lumbar Disc Herniation

ObjectiveRandomized controlled clinical trials were adopted to evaluate the efficacy and safety of treating lumbar disc herniation with Lingnan Tianjiu (crude herb moxibustion therapy) prescription No.3 through comparison with placebo and Lingnan Tianjiu prescription No.1, so as to inherit and expand the disease spectrum of Lingnan Tianjiu.MethodsRandomized controlled clinical trials were adopted to evaluate the efficacy and safety of treating lumbar disc herniation with Lingnan Tianjiu (crude herb moxibustion therapy) prescription No.3 through comparison with placebo and Lingnan Tianjiu prescription No.1, so as to inherit and expand the disease spectrum of Lingnan Tianjiu.A total of 150 lumbar disc herniation subjects conforming to the inclusion criteria were randomly divided into three groups:treatment group, control group 1 and a control group 2. Selected acupoints were ① Pi shu, Pangguang shu, Yao yangguan, Mingmen, Tianshu, Xin shu (left), Dan shu (right) and Wei zhong zuo, and ② Shen shu, Dachang shu, Wai ling, Shui fen, Qi hai, Xin shu (right), Dan shu (left) and Wei zhong you. These two groups of acupoints were used alternately. The locations of acupoints were determined in accordance with the 2006 PRC national standard (GB/T 12346-2006) Name and Location of Acupoints. The main drugs applied in the treatment group were:yellow mustard seed, prepared daughter root of common monkshood and Chinese clematis root, etc.; the main drugs applied in the control group 1 were:yellow mustard seed, asarum, euphorbia kansui and rhizoma corydalis; according to relevant study experiences, buckwheat was selected as the placebo drug in control group 2.Treatment groups:about lOg herb powder was taken and mixed with 10old ginger juice (filtrated twisted peeled ginger), and prepared into medical cake sized about 1cm×1cm×1cm and affixed to the acupoints with Tianjiu tape (circular tape with diameter about 5cm); the target acceptance of each cake fixation should be the maximum endurable heat pain of the patient and the upper limit of treatment time is 3 hours. Remove the tape and wash off the cream after reaching the target acceptance, and process as the procedures for adverse reactions once adverse reactions occur at the local area of drug fixation.Control group 1:The methods of acupoint selection and operation are identical to that of the treatment group.Control group 2:The methods of acupoint selection and operation are identical to that of the treatment group.Therapies were provided twice a week for a total of 8 times in 4 weeks and the interval of every two therapies was no less than 2 days. The target acceptance of each drug fixation was the maximum endurable heat pain of the patient and the upper limit of treatment time was 2 hours. At time points of before treatment, the end of treatment, one month after the end of treatment and three months after the end of treatment, JOA scale, VAS scale and SF-36 scale were adopted for efficacy evaluation, and safety assessment was conducted in combination with the records of adverse reactions. Descriptive analysis, chi-square test, nonparametric rank sum test, ANOVA and ANOVA on repeated measuring data were performed with SPSS 18.0 software.Results1. Intragroup comparison:the scores of three groups at each time point after treatment decreased from those before treatment and all the decreases were statistically significant (P=0.000).2. JOA ScaleCompare the JOA scores at each time point of the three groups with that of before treatment, Differences were statistically significant (P<0.05).JOA score at the end of treatment:treatment group:15.56±3.93, control group 1:14.02±3.17, control group 2:12.64±2.60. The difference between treatment group and control group 1 was statistically significant (P=0.02); the difference between treatment group and control group 2 was statistically significant (P=0.000); the difference between control group 1 and control group 2 was statistically significant (P=0.037).JOA score after one month of treatment:treatment group:14.88±3.16, control group 1:13.98±3.93, control group 2:12.52±2.47. There was no difference between treatment group and control group 1 (P=0.168); the difference between treatment group and control group 2 was statistically significant (P=0.000); the difference between control group 1 and control group 2 was statistically significant (P=0.026).JOA score after three months of treatment:treatment group:14.56±3.07, control group 1:13.78±2.6, control group 2:12.50±2.47. No difference was found between treatment group and control group 1 (P=0.159); the difference between treatment group and control group 2 was statistically significant (P=0.000); the difference between control group 1 and control group 2 was statistically significant (P=0.021).3. VAS scoresCompare the VAS scores at each time point of the treatment groups with that of before treatment, Differences were statistically significant (Pvalues was 0.000);As to the control group 1, (Pvalues was 0.000,0.001,0.001); control group 2(P values was 0.001,0.005,0.001)VAS score at the end of treatment:treatment group:3.78±1.56, control group 1:4.43±1.41, control group 2:5.00±1.49. The difference between treatment group and control group 1 was statistically significant (P=0.0313); the difference between treatment group and control group 2 was statistically significant (P=0.000); the difference between control group 1 and control group 2 was statistically significant (P=0.036).VAS score after one month of treatment:treatment group:3.97± 1.41, control group 1:4.43±1.41, control group 2:5.17±1.47. The difference between treatment group and control group 1 was statistically significant (P=0.037); the difference between treatment group and control group 2 was statistically significant (P=0.000); the difference between control group 1 and control group 2 was statistically significant (P=0.036).VAS score after one month of treatment:treatment group:4.07± 1.42, control group 1:4.64±1.51, control group 2:5.14±1.53. There was no difference between treatment group and control group (P=0.058); the difference between treatment group and control group 2 was statistically significant (P=0.000); No difference between control group 1 and control group 2 (P=0.096).4. SF-36①Domains at the end of treatmentTreatment group:physical function:79.50±15.29, role physical:66.20 ±26.92, body pian:62.10±11.29, general health:57.90±15.32, vitality:41.90 ±16.96, social functioning:80.05±16.37, role emotional:60.03±13.28, mental health:57.94±13.35;Contol group 1:physical function:71.60±17.03, role physical:52.80 ±32.09, body pian:57.20±12.08, general health:55.70±13.13, vitality:34.90 ±17.12, social functioning:70.55±18.38, role emotional:58.30± 15.02, mental health:58.30±15.02;Contol group 2:physical function:70.52±18.05, role physical:48.90 ±33.38, body pian:54.30±13.70, general health:52.10±12.53, vitality:31.30 ±13.58, social functioning:69.45±20.46, role emotional:51.47± 19.31, mental health:49.68±13.08;Comparing treatment group with contol group 1, The difference was statistically significant (P values were 0.020、0.030、0.011) at physical function, role physical, vitality and social functioning. The difference between treatment group and control group 2 was statistically significant (Pvalues were 0.009、0.006、0.002、0.036、0.001、0.005、0.009、 0.002) at every domains; The difference between control group 1 and control group 2 was statistically significant at role emotional and mental health (P values were 0.036 and 0.022)②Domains after one month of treatmentTreatment group:physical function:79.20±14.96, role physical:69.20 ±22.99, body pian:61.10±10.75, general health:55.70±13.66, vitality:0.70 ±14.74, social functioning:75.10±19.98, role emotional:60.36± 14.20, mental health:56.36±14.25;Contol group 1:physical function:69.22±20.52, role physical:51.10 ±34.63, body pian:53.80±12.63, general health:52.70±12.58, vitality:30.40 ±14.13, social functioning:67.65±21.52, role emotional:51.87± 20.21,mental health:48.48±12.45;Contol group 2:physical function:69.22±20.52,role physical:51.10 ±34.63, body pian:53.80±12.63, general health:52.70±12.58, vitality:30.40 ±14.13, social functioning:67.65 ± 21.52, role emotional:51.87± 20.21, mental health:48.48±12.45;Comparing treatment group with contol group 1,The difference was statistically significant (P values were 0.048,0.025,0.007)) at physical function, body pian, vitality and social functioning. The difference between treatment group and control group 2 was statistically significant (P values were 0.003,0.005,0.003,0.000,0.012,0.002) at six domains except general health and social functioning; The difference between control group 1 and control group 2 was statistically significant at physical function, role physical and mental health (P values were 0.005,0.049 and 0.015)③Domains after three months of treatmentTreatment group:physical function:78.50±17.29, role physical:56.10 ±36.24, body pian:61.70±10.28, general health:56.60±13.79, vitality:39.60 ±14.70, social functioning:73.20±19.02, role emotional:58.63± 12.98, mental health:56.72±14.82;Contol group 1:physical function:76.40±17.55, role physical:66.80 ±25.41, body pian:55.20±12.24, general health:55.20±13.05, vitality:33.80 ±15.27, social functioning:72.05±19.90, role emotional:56.90± 13.90, mental health:58.30±15.02;Contol group 2:physical function:69.20±18.05, role physical:50.10 ±34.38, body pian:53.70±13.84, general health:52.30±12.74, vitality:31.00 ±14.14, social functioning:66.75±21.07, role emotional:51.47± 20.24, mental health:54.56±11.45;Comparing treatment group with contol group 1, The difference was statistically significant (P=0.009)) at body pian. The difference between treatment group and control group 2 was statistically significant (P values were 0.009,0.011,0.001,0.004,0.027,0.000) at physical function, role physical, body pain, validity, role emotional and mental health. The difference between control group 1 and control group 2 was statistically significant at mental health(P=0.006)5. Effective rate Effective rate was evaluated by comparing of treatment group with that of control group 1 and control group 2 at three time points. The rate were respectively 84%,72%% and 52% at the end of treatment,82%,68% and 50% at one minth after treatment,80%,68% and 48% at 3 month after treatment, All of them had statistical differences (P<0.05).ConclusionIt was indicated by this clinical trial that:therapies for the treatment group can improve the scores of JOA scale and SF-36 QOL scale, lower the VAS score, and relieve the lumbago symptom in patients with lumbar disc herniation effectively and improve the QOL of patients; the therapeutic effect in the treatment group was superior to that in the control group.