Acupuncture Combined With Fu’s Jing-moxibustion On Knee Osteoarthritis:a Randomized Controlled Clinical Trial

Objective1. By the systematic evaluation of previous literature, this study aim to look for the evidence of evidence-based medicine of acupuncture and moxibustion on knee osteoarthritis2. This study aimed to assess the short and long term therapeutic effect of acupuncture combined with Fu’s Jing-moxibustion on knee osteoarthritis.Methods1. System evaluationCollect randomized controlled clinical research literature of acupuncture and moxibustion on osteoarthritis of the knee by means of electronic and manual search. Computer retrieval MEDLINE, EMBASE, Cochrane library、Elsevier, ClinicalKey, EBSCO, Ovid LWW, Up to date, CNKI, VIP, Wanfan, CBM, and manual retrieval guangzhou university of traditional Chinese medicine Library database in the back, ICTRP of WHO and Chinese Clinical Trial Register. Then evaluate the test bias risk and quality evaluation according to the Cochrane Handbook, and statistics analysis using RevMan5.2 software.2. Clinical researchResearch time is between January 2014 and December 2014. The patients came from Outpatient Clinics of branch courts of Guangdong Hospital of TCM and the acupuncture and rehabilitation part of Guangzhou hospital of integrated traditional and western medicine.This study was a randomized controlled clinical trial.3 groups were set, including acupuncture combined with Fu’s Jing-moxibustion treatment group(AJG), pure acupuncture treatment group(AG) and pure Fu’sJing-moxibustion treatment group(JG). PEMS 3.1 statistical software was used to estimate the sample size. There are 105 cases of patients all together need to collect in the study, and 35 cases in every group. Simple random method was used in this research. First, input the sample size into the PEMS3.1 statistical package obtaining sequence random number. Then, make random cards and enclose the cards into the envelopes. According to the order entry, every patient could get a number on the envelope, and the number inside the envelope was the evidence of randomization. Treatment protocolsAG The acupoints are bilateral Neiguan(PC6), bilateral Yanglingquan (GB34), bilateral Yinlingquan(SP9), bilateral Xiyan(EX-LE4.5),Shuifen(RN9), Qihai(RN6), Guanyuan(RN4), Daheng(SP15). Operation After sterilizing, punched the acupoints with disposable needle tube until De-qi was felt by the patients, and the depth of the needle determined by the acupoints themselves. Place the needles in the points for 30 minutes.JG The acupoints were the same to AG and the treatment were Fu’s Jing-moxibustion only. Operation Moxa cone should be made as a conical and the size about 3mm high and 2mm diameter at the bottom. Marked the points with universal oil then put the moxa cone onto the acupoints and lighted. When unbearable causalgia was felt moved the moxa cone away. Repeat 2 times for each acupoint.AJG The acupoints were the same to AG. The patients got the acupuncture operation as the AG specifications above, and then they would get the moxibustion operation. Course of Treatment All the patients in the three groups received 3 sessions for the first two weeks and 2 sessions during the following two weeks, with total 4 weeks of treatmentEvaluation Tool WOMAC Osteoarthritis Scale,. VAS score, Short Form 36-items Health Survey (SF-36), adverse reactions record.Evaluation point Three groups were evaluated at the following 5points: before treatment, after the sixth times of treatment, after whole sessions, after one month follow-up and after three months follow-up by means of WOMACOsteoarthritis Scale, VAS score, Short Form 36-items Health Survey (SF-36), combined with the record adverse reactions caused by safety assessment after the whole treatments.Therapeutic Evaluation The scores of WOMAC Osteoarthritis Scale reduced above 30%(≥30%) after treatment suggesting cured, reduced between 20% and 30%(<30% and≥20%) suggesting marked effect, reduced between 10% and 20%(<20% and≥10%) suggesting effective, reduced below 10%(<10%) suggesting ineffective.Statistic analysis The SPSS18.0 descriptive analysis software, chi-square, t-test and multivariate analysis of variance and repeated measurement data analysis of variance. Count data is treated with X2 analysis and measurement data with t-test. All the materials carried on two-sided statistical test and there was a statistical significance when P<0.05 occurred. Results1. Systematic EvaluationThere 26 trials were ultimately meet the standards and selected into the Meta-analysis. All the 23 Chinese literatures have higher risk of bias. Meta-analysis showed that the improvement of efficiency of acupuncture on knee osteoarthritis better than western medicine by means of Lequesne and WOMAC Osteoarthritis Scale, and also better than placebo-acupuncture.2 Clinical research2.1 Baseline DateThere is no difference in three groups of the baseline data, including sex, pathological sites, age composition, diseases course and TCM syndrome type (P>0.05). And also there is no statistically difference in three groups in VAS, WOMAC, SF-36 before treatment (P>0.05).2.2 WOMAC Osteoarthritis Scale2.2.1 Scores of painIntra-group Comparison The Scores of pain in all three groups were all significantly decline (P<0.05) at the four points of evaluation after the start of treatment.Comparison between Groups The scores of pain after six times treatments, are AJG 102.4±47.9, AG 126.5±45.3, JG 137.9±44.6. The scores of pain after the whole therapy, are AJG 74.8±38.3, AG 94.0±39.8, JG 105.9±45.0. The scores of three groups after one month follow-up are AJG 80.6±43.7, AG 101.6 ±41.0, JG 115.9±47.3. The scores of three groups after three month follow-up, are AJG 85.8±42.2, AG 101.6±41.8, JG 120.8±47.7. There is statistically significant difference in the AJG when compared with other two groups respectively (P<0.05). And there is no statistically significant differences between the groups of AG and JG (P>0.05).2.2.2 Scores of RigidityIntra-group Comparison The scores of rigidity in all three groups were all significantly decline (P<0.05) at the four points of evaluation.Comparison between Groups The scores of rigidity after six times treatments, are AJG 17.2±23.1, AJ 29.8±25.5, JG 26.5±24.2. The scores of pain after the whole therapy, are AJG 10.3±21.3, AG 23.9±25.7, JG 20.6±20.3. The scores of three groups after one month follow-up are AJG 11.0±21.3, AG 24.6±22.2, JG 21.4±20.6. The scores of three groups after three month follow-up, are AJG 12.4±21.3, AG 25.0±21.1, JG 22.8±20.5. There is statistically significant difference in the AJG when compared with other two groups respectively (P<0.05). And there is no statistically significant differences between the groups of AG and JG (P>0.05).2.2.3 Scores of FunctionIntra-group Comparison The Scores of function in all three groups were all significantly decline (P<0.05) at the four points of evaluation.Comparison between Groups The scores of function after six times treatments, are AJG 307.1±187.5, AG 396.7±185.0, JG 401.1±177. The scores of function after the whole therapy, are AJG 210.1±185.1,AG 306.7±193.3, JG 312.0± 188.1.The scores of three groups after one month follow-up are AJG 231.4± 183.1, AG 328.8±182.3,323.2±186.1. The scores of three groups after three month follow-up, are AJG 45.4±185.2, AG 343.2±181.9, JG 339.3±188.3. There is statistically significant difference in the AJG when compared with other two groups respectively (P<0.05). And there is no statistically significant differences between the groups of AG and JG (P>0.05).2.3 VAS ScoreIntra-group Comparison The Scores of VAS in all three groups were all significantly decline (P<0.05) at the four points of evaluation.Comparison between Groups The scores of vas after six times treatments, are AJG 3.2±1.2, AG 4.1±1.1, JG 5.8±1.2. The scores of VAS after the whole therapy, are AJG 2.8±1.3, AG 3.5±1.3, JG 4.5±1.1. The scores of three groups after one month follow-up are AJG 3.1±1.5, AG 3.8±1.3, JG 4.8±1.1. The scores of three groups after three month follow-up, are AJG 3.3±1.4, AG 4.0±1.2, JG 5.1±1.1. There is statistically significant difference in the. AJG when compared with other two groups respectively (P<0.05). And there isstatistically significant differences between the groups of AG and JG (P<0.05), and the scores of AG decline more obviously than JG (P<0.05).2.4 SF-36:2.4.1 PFIntra-group Comparison The Scores of PF in all three groups all significantly increased (P<0.05) at the four points of evaluation.Comparison between Groups The scores of PF after six times treatments, are AJG 73.5±6.4, AG 66.4±7.7, JG 67.2±6.9..The scores of PF after the whole therapy, are AJG 88.9±7.2, AG 82.8±6.9, JG 83.7±5.6..The scores of three groups after one month follow-up are AJG 86.8±5.0,AG 78.9±7.4,JG 79.5± 4.8..The scores of three groups after three month follow-up, are AJG 83.8 ±6.9, AG 72.9±6.1, JG 3.0±5.4. There is statistically significant difference in the AJG when compared with other two groups respectively (P<0.05). And there is no statistically significant differences between the groups of AG and JG(P>0.05).2.4.2 RPIntra-group Comparison The Scores of RP in all three groups all significantly increased (P<0.05) at the four points of evaluation.Comparison between Groups The scores of RP after six times treatments, are AJG 76.8±15.2, AG 68.4±14.7, JG 67.9±15.5. The scores of RP after the whole therapy, are AJG 90.8±12.7, AG 81.3±14.3, JG 80.7±11.4. The scores of three groups after one month follow-up are AJG 88.7±12.1, AG 78.2±14.9, JG 77.7 ±13.3. The scores of three groups after three month follow-up, are AJG 84.7 ±9.4.AG 75.6±10.8, JG 74.6±11.8. There is statistically significant difference in the AJG when compared.with other two groups respectively (P<0.05). And there is no statistically significant differences between the groups ofAG and JG(P>0.05).2.4.3 BPIntra-group Comparison The Scores of BP in all three groups all significantly increased (P<0.05) at the four points of evaluation.Comparison between Groups The scores of BP after six times treatments, are AJG 72.9±5.4, AG 67.5±6.4, JG 60.9 ±6.6. The scores of BP after the whole therapy, are AJG 85.9±4.0, AG 74.9±6.0, JG 66.7±6.3. The scores of three groups after one month follow-up are AJG 78.9±5.3, AG 70.2±6.2, JG 64.8 ±4.5.. The scores of three groups after three month follow-up, are AJG 75.0 ±4.9, AG 65.8±4.7, JG 62.6±6.1.. There is statistically significant difference in the AJG when compared with other two groups respectively (P<0.05). And there is statistically significant differences between the groups of AG and JG (P<0.05)2.4.4 GHIntra-group Comparison The Scores of GH in all three groups all significantly increased (P<0.05) at the four points of evaluation.Comparison between Groups The scores of GH after six times treatments, are AJG 65.0±15.3, AG 55.7±16.4, JG 56.9±16.6.. The scores of GH after the whole therapy, are AJG 73.3±14.4, AG 63.0±13.6, JG 64.2±16.9.. The scores of three groups after one month follow-up are AJG 70.3±15.8, AG 61.8±12.3, JG 60.6 ±13.6. The scores of three groups after three month follow-up, are AJG 68.7 ±14.6, AG 59.1±14.7, JG 58.4±15.0. There is statistically significant difference in the AJG when compared with other two groups respectively (P<0.05). And there is no statistically significant differences between the groups of AG and JG(P>0.05).2.4.5 VTIntra-group Comparison The Scores of VT in all three groups all significantly increased (P<0.05) at the four points of evaluation.Comparison between Groups The scores of VT after six times treatments, are AJG 69.4±9.3, AG 61.1±8.3, JG 64.3±10.4.. The scores of VT after the whole therapy, are AJG 83.7±11.5, AG 77.3±8.5, JG 76.8±9.3.. The scores of three groups after one month follow-up are AJG 81.8±10.0, AG 74.0±12.9, JG 72.5 ±11.2. The scores of three groups after three month follow-up, are AJG 76.2 ±9.8, AG 70.8±12.5, JG 69.5±10.1. There is statistically significant difference in the AJG when compared with other two groups respectively (P<0.05). And there is no statistically significant differences between the groups of AG and JG(P>0.05).2.4.6 SFIntra-group Comparison The Scores of SF in all three groups all significantly increased (P<0.05) at the four points of evaluation.Comparison between Groups The scores of SF after six times treatments, are AJG 68.3±10.7, AG 62.6±12.0, JG 62.9+11.7.. The scores of SF after the whole therapy, are AJG 76.2± 10.3, AG 70.0±9.4, JG 68.2±13.5.. The scores of three groups after one month follow-up are AJG 74.6±9.8, AG 67.0±9.8, JG 68.9 ±11.1. The scores of three groups after three month follow-up, are AJG 71.5 ±10.2, AG 64.8±12.2, JG 65.4 ± 10.6. There is statistically significant difference in the AJG when compared with other two groups respectively (P<0.05). And there is no statistically significant differences between the groups of AG and JG(P>0.05).2.4.7 REIntra-group Comparison The Scores of RE in all three groups all significantly increased (P<0.05) at the four points of evaluation.Comparison between Groups The scores of RE after six times treatments, are AJG69.7±17.7, AG 61.0±16.7, JG 60.1±17.0.. The scores of RE after the whole therapy, are AJG 88.1 ± 15.4, AG 77.4± 16.2, JG 76.7± 16.8.. The scores of three groups after one month follow-up are AJG 79.7±16.9, AG 70.6±15.9, JG 71.3 ±15.3. The scores of three groups after three month follow-up, are AJG 75.5 ±16.2, AG 66.7±15.8, JG 66.9±15.6. There is statistically significant difference in the AJG when compared with other two groups respectively (P<0.05). And there is no statistically significant differences between the groups of AG and JG(P>0.05).2.4.8 MHIntra-group Comparison The Scores of MH in all three groups all significantly increased (P<0.05) at the four points of evaluation.Comparison between Groups The scores of MH after six times treatments, are AJG 68.0±8.4, AG 63.7±7.6,JG 64.9±7.7..The scores of MH after the whole therapy, are AJG 76.9±9.8, AG 72.6±7.7, JG 72.3±7.3..The scores of three groups after one month follow-up are AJG 74.3±8.3, AG 68.3±9.6, JG 69.7 ±7.7. The scores of three groups after three month follow-up, are AJG 71.7 ±8.5, AG 65.1±10.7, JG 64.6±11.1. There is no statistically significant difference in the AJG when compared with other two groups respectively (P >0.05). And there is also no statistically significant differences between the groups of AG and JG(P>0.05).2.5 Record of Adverse ReactionThere are all together four cases of slight subcutaneous hematoma in whole study, which did not affect the compliance of the patients.2.6 Effective RateAfter treatment, the clinical effective rates of three groups are 94.29%, AG is 82.86%, JG is 82.6%. There is statistically significantly difference of them by means of rank sum test (P<0.05).Three months after the end of treatment, the clinical effective rates of AJG is 94.29%, AG is 74.2% and JG is 74.29%. There is statistically significantly difference of them by means of rank sum test (P<0.05).Conclusion1. System evaluation shows that acupuncture and moxibustion in treating knee osteoarthritis has better effect than western medicine and placebo-acupuncture. However, because of the low quality of the literatures, high-quality evidence-based evidence cannot be required2. Acupuncture combined with Fu’s Jing-moxibustion in treating knee osteoarthritis has better therapeutic effect in short term and long term, than acupuncture or moxibustion in treating neck pain due to cervical spondylosis.3. Acupuncture combined with Fu’s Jing-moxibustion cannot only relieve pain, improve function, but also can overall improve life quality of patients.