| 1. Literature search:Using quantitative and evaluation methods, toevaluate the effect and safety of bee acupuncture comparing with western medicine, Chinese medicine or other treatment modalities in patients with rheumatoid arthritis (RA). And to guide the research and clinical study.2. Clinical research:This study aimed to assess the immediate effect,the short and the long term effects of bee acupuncture on rheumatoid arthritis (RA), and to observe the effect with different amounts of bee acupuncture. On this basis, to investigate clinical efficacy and safety of bee acupuncture in patients with rheumatoid arthritis (RA) Methods:1. Literature research:Electronic retrieval CMB disc (1978-2014), CNKI(1979-2014), VIP (1989-2014), Wanfang database (1998-2014), PubMed (1966-2014), EMbase (1980-2014) and Coehrane library (ISSue4,2013) and supplemente by manual searching Archive database of Guangzhou Traditional Chinese Medicine University library. Collect relevant randomized and quasi-randomized controlled trials by two reviewers independently extracting data and assessing quality according Cochrnae Review Handbook5.0statistical analysis using RevMan5.2.0software. According to inclusion and exclusion criteria to select appropriate literature for system evaluation.2. Clinical research:2.1Grouping method:using the SPSS19.0random sequence generationmodule, the subjects were divided into three groups:(1) High-dose bee acupuncture group (bee acupuncture1group),61cases;(2) Low-dose bee acupuncture group (bee acupuncture group2),61cases;(3) Western medicine comparison group (control group),61cases. 2.2Treatment programs:High-dose bee acupuncture group and low-dose group use live domesticated Chinese bees stinging Meridian points which are Ashi points mainly with dialectical acupoints. And venom allergy tests need to be done before treatment. The method of operation is to grip the under section of live bee wasp waist using gossamer tweezers, and directly stinging on points with live bees, retaining the needle for15minutes. During the first10times desensitization, each person of high-dose bee acupuncture use2bees every time. After the10times, an increase of2bees a time, gradually increase the amount to each person using more than15bees and less than30, to maintain this dose, three times a week. During the first10times desensitization, each person of low-dose bee acupuncture use1bees every time. After the10times, an increase of1bees a time, gradually increase the amount to each’person using less than10bees, to maintain this dose, three times a week. The western medicine comparison group using methotrexate p. o10mg qw, celecoxib (Celebrex) p.o0.2g qd. If the condition is serious, celecoxib tablets add to0.2g bid. If the condition relieves, celecoxib can be reduced gradually until not taking. Each group treats8weeks. And each group were collected information on efficacy and adverse reactions at.different observation time, which are before treatment, after treating4and8weeks, after1month follow-up and after3months follow-up followed up, a total of five observation time for the collection the number of tender joints. The observation indicators are the number of swollen joints, average grip strength of both hands, duration of morning stiffness, total score of TCM syndromes, overall self-assessment, pain self-assessment, physician’s global assessment, HAQ score, RF (rheumatoid factor), ESR (Erythrocyte Sedimentation Rate, ESR), CRP (C-react ive protein), DAS28(disease activity score in28joints) score and other indicators of the efficacy evaluation. Then to evaluate the recent therapeutic effect of three groups. Evaluate the long-term effect of three groups using the number of tender joints, the number of swollen joints, average grip strength both two hands, duration of morning stiffness, total score of TCM syndromes, RF, ESR, CRP and other effect indicators. The data of blood, urine and stool routine test, liver and kidney function, ECG and other safety indicators are statistically analyzed to evaluate the safety of bee acupuncture. 2.3Data management and statistical analysis:Using excel2010to establish a database with collected data, and using SPSS19.0statistical software for analysis and processing. All statistical tests adopt two-sided test, P<0.05is considered to be statistically significance. If the data are normally distributed, using one-way ANOVA; before and after treatment within the same group is compared using paired t test;Data were compared using repeated measures analysis of variance for repeated measures design data; If the data is non-normal distribution, using the nonparametric rank sum test; count data of each group using the chi-square test.Results:1. Literature research:The evaluation included a total of11RCTs,694subjects. Using the Jadad scoring method, the researchs are all two points or less, only6researchs mentioned "random" words,4using a simple random number table, others did not mention. All the studies mentioned random words, just only three studies reference to the random method. And all of them did not mention the implementation of randomization and blinding hidden, therefore may result in selection bias. Only five trials referred to "fall off or out" cases. Combined research data of11studies do Meta-analysis, including two studies comparing bee acupuncture+methotrexate+sulfasalazine tablets+meloxicam tablets sulfasalazine with methotrexate+piece+meloxicam tablets, one study comparing bee acupuncture+methotrexate+Fenbid+herbal fumigation with methotrexate+Fenbid, one study comparing bee acupuncture with methotrexate or Reid auranof in+non-steroidal analgesics, one study comparing bee acupuncture with methotrexate, one study comparing bee acupuncture with TCM differential treatment, one study comparing bee acupuncture+penicillin+diclofenac sustained release tablets with external application of chinese medicine+penicillin+diclofenac sustained release tablets, one study comparing bee acupuncture+nourishing tongbi decoction with non-steroidal anti-inflammatory drugs+hormones, one study comparing bee acupuncture with ibuprofen+chinese medicine, one study comparing bee acupuncture with mineral bath. The results of combined analysis showed that:compared with methotrexate and other conventional western medicine, bee acupuncture in reducing the number of swollen joints of patients with RA, shortening duration of morning stiffness, reducing RF titers are significantly superior to methotrexate aspects, but in reducing the number of tender joint, compared with methotrexate to reduce sedimentation areas there was no significant difference.2. clinical research:2.1The study include183cases of patients with rheumatoid arthritis, which shed9cases (The high-dose bee acupuncture group sheds4cases, the low-dose bee acupuncture group sheds3cases, and the western medicine group sheds2cases.),3cases are excluded because of violating the treatment programs, which taking other drugs affecting the efficacy of treatment.(The low-dose bee acupuncture group sheds1cases, and the western medicine group sheds2cases.).171cases are effective which completed the trial. The falling rate of patients is4.92%, the excluding rate of patients is1.64%. And the dropout rate is6.56%, which less than20%.2.2The inter-group comparison for the same observation time of the clinical symptoms and signs, such as the duration of morning stiffness, the number of tender joint, the number of swollen joint, the average grip strength of both hands, the overall and pain of self-assessment, physician’s global assessment of three groups:These indicators except the number of swollen joint of high-dose bee acupuncture group are better than the other two groups after treating4weeks, and the differences are statistically significant (P<0.05). These indicators are compared between every two groups respectively after treating8weeks, after1month follow-up and3months follow-up, and the results show high-dose bee acupunture group is significantly better than the other two groups. And the difference is statistically significant (P<0.05),but the comparison of low-dose bee acupuncture group and western medicine control group showed no significant difference (P>0.05)2.3In terms of laboratory indexes, ESR, CRP and RF of patients of three groups are significantly improved comparing with before treatment, and the difference is statistically significant (P<0.05). Inter-group comparison for the same observation time of the three groups:the results of RF are better than the other two groups; and the laboratory indexes are compared between every two groups respectively after8weeks treatment, after1month follow-up and3months follow-up, and the results show high-dose bee acupunture group is significantly better than the other two groups. And the difference is statistically significant (P<0.05), but the comparison of low-dose bee acupuncture group and western medicine control group showed no significant difference (P>0.05).2.4In terms of total score of TCM syndromes, the results of high-dose bee acupuncture group is superior to the other two groups after4and8weeks treatment, after1month follow-up and3months follow-up, and the difference is statistically significant (P<0.05). But the comparison of the low-dose bee acupuncture group and the western group, and the difference was not statistically significant (P>0.05)2.5In terms of efficacy of DAS28score, the total effective rate of high-dose bee acupuncture group is80.70%, the total effective of low-dose group bee acupuncture is75.44%, and the total effective rate of western medicine group is78.95%. After statistical analysis, the comparison of the total effective rate among the three groups, the differences are statistically significant (P<0.05).And high-dose bee acupuncture group was significantly better than the other two groups.2.6In terms of efficacy of TCM syndromes, the total effective rate of high-dose bee acupuncture group is94.74%, the total effective of low-dose group bee acupuncture is89.47%, and the total effective rate of western medicine group is73.68%. After statistical analysis, the comparison of the total effective rate among the three groups, the differences are statistically significant (P<0.05).And high-dose bee acupuncture group was significantly better than the other two groups.2.7In terms of safety evaluation, the routine blood test, routine urine test, routine stool test, electrocardiogram, and liver and kidney functions of patients of three groups are within normal range. During the treatment period, both high-dose bee acupuncture group and the low-dose bee acupuncture group have occurred itchy skin, pigmentation, acupuncture site swelling, fever, swollen lymph nodes, hives and other adverse reactions, which do not have any treatment. And they relieve itself after a few days. Western medicine group also have some adverse reactions such as skin pigmentation, fever and leukopenia, which have not any treatment. they relieve itself after a few days too. Thus, the bee acupuncture are safe treatment.Conclusion:1. Literature search:Existing studies have shown that bee acupuncture treatment for rheumatoid arthritis are better than the control group, and are security. Because the test measures of bee acupuncture for rheumatoid arthritis are mostly inconsistent, little literature literature can be combined to do the Meta-analysis. And this study limited by the quality and quantity of the literature, so above the conclusions still need a large sample, long-term follow-up of high-quality randomized controlled trials to be confirmed. The analysis show the efficacy of bee acupuncture for rheumatoid arthritis are more advantages compared with western medicine, but the result requires more high quality randomized controlled trials to be confirmed.2. The efficacy evaluation:The different doses of bee acupuncture groups can significantly improve the clinical and laboratory indicators of RA patients, such as the number of tender joint and swollen joints, the average grip strength of both hands, duration of morning stiffness, and the overall and pain of self-assessment, physician’s global assessment, CRP, ESR, RF, DAS28score, Chinese taditional medicine symptom score and HQA score. And the study suggest that in addition to except the numbers of swollen joints, the bee pin high-dose group improved on these indicators begining four weeks of treatment, and significantly better than the other two groups. While the low-dose group of bee acupuncture compare with the western medicine group, the difference was not significant.3. Safety evaluation:The routine blood test, routine urine test, routine stool test, electrocardiogram, and liver and kidney functions of patients of three groups are normal, suggesting that bee acupuncture treatment for rheumatoid arthritis is safe in addition to the initial clinical application with some allergic reactions. |
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