| Objective1.Evaluating the effectiveness and safety of electroacupuncture and western medicine using systematic review and meta-analysis.2.Evaluating the effectiveness and safety of deep electroacupuncture on "lumbar five points"and western medicine.Methods1.Systematic review and meta-analy sisThis study included randomized clinical trials about electroacupuncture treating lumbar disc herniation were included.Chinese and English electronic databases were searched from their construction date to February l st.2021 for eligible trials.Patients with lumbar disc herniation and low back pain or radicular pain were included.Eligible interventions are electroacupuncture alone or electroacupuncture plus western medicine;acupoints should be classical acupoints or Ashi points.Eligible controls were western medicine,placebo acupuncture,or sham acupuncture.Trials were excluded if they met the following criteria:interventions were manual acupuncture.auricular acupuncture,warm needle,and other types of acupuncture without electro stimulation;controls were electroacupuncture plus other types of traditional Chinese medicine treatment or rehabilitation therapy;studies compared different types,different frequencies,and different intensities of acupuncture.The primary outcomes included low back pain intensity,leg pain intensity,and low back function.The secondary outcomes included quality of life,global evaluation of efficacy,and adverse events.Study screen and data extraction were conducted by two investigators independently.The GRADE was used to evaluate the level of evidence quality.Review Manager 5.4.1 was used for data synthesis.Fixed model or random model were used to pool data according to the heterogeneity.Study results were showed in forest plots.Data were represented by Mean Difference for continuous data and Relative Risk for categorical data.The Confidence Intervals were set as 95%.2.Clinical studyPatients diagnosed with lumbar disc herniation and have low back pain or radicular pain in the Department of Acupuncture and the Department of Orthopedic in the Third Affiliated Hospital of Beijing University of Chinese Medicine were included.Total 176 patients(132 patients and 44 patients for the Electroacupuncture group and the Western medicine group,respectively)were included from March 2019 to December 2020.Patients were allocated into the Electroacupuncture group and the Western medicine group in a ratio of 3:1 according to the treatment they received.There were 132 patients and 44 patients for the Electroacupuncture group and the Western medicine group,respectively.The inclusion criteria were as follows:patients who meet the diagnosis criteria;patients were between the age of 18 and 65;patients signed the informed consent.Patients who met one of the following items were excluded:patients with absolute surgical indications;patients who had a history of lumbar surgery or about to receive surgery;patients with severe spinal stenosis or spine deformities;patients who were pregnant or lactating;patients with serious diseases of the cardiovascular system,endocrine system,digestive system,immune system,or other major systems;patients with skin damage or diseases;patients with bleeding tendency blood diseases;patients with mental disorders.Patients were regarded as drop-off if they met one of the following criteria:patients refuse to continue treatments due to server adverse events;patients were lost of follow up;patients voluntarily withdrawal the study.Treatment will be discontinued if the patients could not tolerate it.Patients in the Electroacupuncture group were received deep electroacupuncture at"lumbar five points",which were Dachangshu(BL25),Guanyuanshu(BL26),L4-S1 Jiaji(EX-B2).Needles were inserted to the points vertically and obtain a deqi sensation that radiating to the lower limb.Guanyuanshu and Dachangshu were connected with the electrical stimulator with a continuous wave and a frequency of 5 Hz.The electrical intensity will be adjusted according to the patient's tolerance.Each electroacupuncture session lasts 20 minutes.Patients receive electroacupuncture once every other day for a total of 12 sessions.Patients in the Western medicine group were received nerve root dehydration therapy for acute and subacute phase patients,and Diclofenac Diethylamine Emugel for chronic phase patients.The study period was 53 weeks in total,including a 1-week baseline assessment,4-week treatment period,and 48 weeks follow-up period.The primary outcome was the change from baseline for the most server low back pain VAS after the last treatment session.The secondary outcomes were as follows:the difference of the most severe low back VAS between two groups at every evaluation point;the between-group difference in change from baseline of the most severe low back VAS;the between-group difference in JOA score at every evaluation point;the between-group difference in change from baseline in JOA score at every evaluation point;the between-group difference in JOA improvement rate;the between-group difference in SF-36 at every evaluation point;the correlation between low back pain VAS,JOA score,and SF-36 score;the comparison of treatment satisfaction between the two groups.The SPSS 20.0 was used for data analysis.The difference was considered statistically significant when P<0.05.Results1.Systematic review and meta-analysisA total of 12 randomized clinical trials with 1421 participants were included in this study.When compared electroacupuncture alone with western medicine,5 studies evaluated low back pain VAS,5 studies evaluated JOA score.2 studies evaluated ODI score.10 studies evaluated response rate.and 2 studies evaluated the adverse events.The results showed that electroacupuncture alone were better than western medicine alone in low back pain relief(MD=-1.60[95%CI:-1.74.-1.45],P<0.00001),JOA score improvement(MD=7.30[95%CI:3.22,11.39],P=0.0005),ODI score improvement(MD=-7.30[-8.58.-6.03],P<0.00001),and response rate(RR=1.18[95%CI:1.12.1.24].P<0.00001);the adverse events rate in electroacupuncture alone was lower than western medicine alone(RR=0.06[95%CI:0.02.0.16],P<0.00001).When compared electroacupuncture plus western medicine with western medicine alone.2 studies evaluated the low back pain VAS and response rate,1 study evaluated adverse events.The results showed that electroacupuncture plus western medicine were better in relieving low back pain VAS(MD=-2.53[95%CI:-4.02,-1.04],P=0.0009)and response rate(two studies with different criteria)when compared with western medicine;adverse events occurrence rate was lower in electroacupuncture plus western medicine compared with western medicine alone.When compared electroacupuncture alone with western medicine,the evidence level in low back pain VAS.JOA score,ODI score,response rate,and safety were "very low","low","moderate","moderate",and "high",respectively.When compared electroacupuncture plus western medicine and western medicine alone,the evidence level in low back pain VAS,response rate,and adverse events were"very low","low",and "moderate",respectively.2.Clinical studyA total of 1 83 participants were enrolled in the study.the patients in the Electroacupuncture group and the Western medicine group were 136 and 47 respectively.There was no statistical difference between the two groups.Results in the primary outcome:the low back pain VAS in the Electroacupuncture group(3.29±1.86)was lower than that in the Western medicine group(2.16±1.20),with a between-group difference of 1.30(95%CI:0.54,1.73).The between-group low back pain VAS has statistical significance(P=0.000)and has a moderate clinical significance as the MD was larger than 1.0 point on the 0-10 VAS scale.The JOA score in the Electroacupuncture group(5.83 ±4.86)was higher than that in the Western medicine group(3.77±3.58),with a between-group difference of 0.80(95%CI:0.47,3.63),The between-group JOA score has statistical significance(P=0.012).Results in secondary outcomes:? the low back pain VAS were decreased in both of the groups with the increasing of treatment sessions.Low back pain VAS in the Electroacupuncture group were lower than the Western medicine group at every evaluation point with statistical significance(P=0.000).The between-group difference was most significant at the sixth session[MD=-1.14(95%CI:-1.73,-0.54)]and the twelfth session[MD=-0.70(95%CI:-1.31,-0.09)],with clinical significance as the MD were higher than 0.5 in a 0-10 VAS scale.? the change from baseline in low back pain VAS in the Electroacupuncture group was lower than the Western medicine group at every evaluation point with statistical significance(P=0.000)and small clinical significance(MD>0.5).The between-group difference was most significant at the sixth session[MD=-1.43(95%CI:-2.09,-0.78)]with moderate clinically significance as the MD were higher than 1.0 in a 0-10 VAS scale.? the JOA score was increased in both of the groups with the increase of treatment sessions.JOA scores in the Electroacupuncture group were higher than the Western medicine group at every evaluation point.The between-group difference was most significant at the sixth session[MD=3.00(95%CI:1.32,4.68)]with statistical significance(P=0.001).?the change from baseline in JOA score in the Electroacupuncture group was higher than the Western medicine group at every evaluation point.The between-group difference was most significant at the sixth session[MD=1.96(95%CI:0.54,3.37)]and the twelfth session[MD=2.25(95%CI:-0.50,5.00)]with statistically significance(P=0.008 and P=0.103,respectively).?the improvement rate in JOA score in the Electroacupuncture group was higher than the Western medicine group at every evaluation point.The between-group difference was most significant at the sixth session[MD=14.67(95%CI:5.45,23.88)]with statistical significance(P=0.003).?the score of PF,RP,BP,VT,SF,RE,and MH in SF-36 scales in the two groups were all increasing at follow-up periods.The scores in the Electroacupuncture group were higher than that in the Western medicine group.?the low back pain VAS and the JOA score showed a strong negative correlation at each evaluation point.The low back pain VAS and SF-36 score showed a week correlation.There was a strong positive correlation between low back VAS reduction and JOA score increasement.The main factor affecting the low back VAS was different treatment.? there was no statistical significance between the two groups in treatment satisfaction.Conclusion1.Systematic review and meta-analysisElectroacupuncture might have better effects in treating lumbar disc herniation compare to western medicine.Electroacupuncture might strengthen the effect and relieve the side effects of western medicine.More high quality and large-sample-sized trials need to verify the results.2.Clinical studyDeep electroacupuncture at "lumbar five points" has better effects in relieving low back pain of lumbar disc herniation patients compared with western medicine.Deep electroacupuncture at "lumbar five points" has better effects in improving low back pain function of lumbar disc herniation patients compared with western medicine.Deep electroacupuncture at "umbar five points" might better than western medicine in improving the quality of life in lumbar disc herniation patients.Both deep electroacupuncture at "lumbar five points" and western medicine are safe for treating lumbar disc herniation.The decrease of low back pain was correlated with the improvement of lumbar function. |
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