An Evidence-Based Study Of Non-Operative Treatment For Lumbar Disc Herniation

Background Lumbar disc herniation(LDH)is one of the most important causes of disability,and affects patient’s quality of life.Non-operative therapy is the first-line treatment for LDH,it can relieve symptoms in 90% to 95% of patients.Therefore,through understanding the current status of non-operative treatment for LDH related studies published in Chinese and English languages,and exploring the research hotspots,and analyzing the effectiveness and safety of different non-operative therapies,these analyses were used to provide evidence for clinical practice,and help clinicians to make decision to improve the patients’ quality of life.Objectives(1)To analyze the current status of non-operative treatment for LDH related studies published in Chinese and English languages;(2)Including the randomized controlled trial(RCT)about the effectiveness and safety of non-operative treatment for LDH,then evaluating the effectiveness and safety of non-operative treatment;(3)Developing evidence-based practice guideline about non-operative treatment for LDH according to Reporting Items for Practice Guidelines in Healthcare(RIGHT),then promoting the standardization and normalization of treatment for LDH.Methods(1)Bibliometric analysis: We searched China National Knowledge Infrastructure(CNKI)and Web of Science Core Collection(WOSCC)to retrieve Chinese-and English-language RCTs about non-operative treatment for LDH.Using VOS viewer(1.6.18)and Excel 2019 to analyze the distribution of journal,country,organization,author,keywords and et.al.(2)Meta-analysis: CBM,CNKI,Wanfang,Pubmed,WOS,Embase and Cochrane Library databases were systematically searched to include RCTs related to NSAIDs,physiotherapy,steroids,ionic channel regulator,neurotrophic agent and dehydrant for LDH.Using Revman 5.4 software and randomeffect model to conduct meta-analysis,the risk ratio(RR)and mean difference(MD)were used to pool the effect sizes of binary outcomes and continuous outcomes respectively.The quality of evidence was evaluated by Grading of Recommendations Assessment,Development and Evaluation(GRADE).(3)Evidence-based practice guideline: following the standardized process: form guideline working group,manage conflicts of interest,investigation,selection and determination of clinical questions,search,evaluate and grade the evidence,formulate recommendations,recommendation consensus and confirmation,writing and publishing guideline.The guideline should also follow《Guidelines for the Formulation/Revision of Clinical Treatment Guidelines in China(2022 edition)》,《WHO handbook for guideline development(2014 edition)》,RIGHT,and AGREE Ⅱ to report and assess the guideline.Results(1)Bibliometric analysis:(1)A total of 20,027 Chinese-and 4,908 English-language literatures related to non-operative treatment for LDH were included,the number of publications showed a wavy growth trend,the annual number of articles published in Chinese and English peaked in 2018(992)and 2021(390)respectively,then showed a downward trend.(2)The most productive journals published in Chinese and English studies were Clinical Journal of Acupuncture and Moxibustion(343)and Spine(212)respectively.The countries,institutions and authors with the largest number of English-language studies are the United States(1,397),Harvard University(135)and Professor Manchikanti Laxmaiah from the Paducah Pain Management Center(106),their research areas focused on clinical neurology,anesthesiology,plastic surgery,and general internal medicine.In terms of Chinese-language studies,Gansu Provincial Hospital of Traditional Chinese Medicine(106)and Professor Wu Yaochi from the Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University(41)were the most productive institutions and authors,and focused on the area of traditional Chinese medicine and surgery.(3)Current research hotspots mainly focus on diagnosis and treatment of LDH.Non-operative treatments of English-language studies including epidural injections(241),steroids(120)and other therapies,Chinese-language studies mainly about Chinese medicine therapy,including tuina(2,564),acupuncture(1,565),Chinese herb(791)and et.al.(2)Meta-analysis: We retrieved 40,022 studies,then screened 29,541 studies after removing duplicated literatures.Among 58 included studies,twenty eight percent reported the follow up duration,and seventeen percent reported the blinding.The metaanalysis showed:(1)NSAIDs were not as effective as traditional Chinese medicine(VAS: MD 1.33,95% CI 0.81 to 1.84)and physiotherapy(VAS: MD 1.25,95% CI 0.72 to 1.78)in improving symptoms of LDH;the incidence of gastrointestinal adverse event was 11%(95% CI 3% to 18%),the rash was 5%(95% CI 1% to 10%).(2)Physiotherapy improved symptoms of LDH better than placebo(VAS:MD-1.07,95% CI-2.13 to -0.01;RMDQ: MD-1.80,95% CI-2.98 to-0.62;SF-36: no statistical difference),but not as effective as electroacupuncture(VAS: MD 1.60,95% CI 0.67 to 2.53;ODI: MD9.08,95% CI 3.78 to 14.38),traction(VAS: MD 0.91,95% CI 0.2 1to 1.61;ODI: MD1.80,95% CI 0.05 to 3.55)and Reiki therapy(VAS: MD 2.25,95% CI 1.62 to 2.88;IADL: no statistical difference),there was no significant difference with exercise therapy.(3)Epidural injection diprospan/prednisone was more effective than high intensity laser(VAS: MD-0.69,95% CI-1.21 to-0.17)/lumbar oblique manipulation(VAS: MD-0.83,95% CI-1.23 to-0.43),there was no significant difference between epidural injection dexamethasone/methylprednisolone and acupotomy/ketoprofen;Epidural steroid injection combine with routine treatment was more effective than routine treatment(VAS: MD-2.74,95% CI-3.92 to -1.57).(4)Pregabalin combined with NSAIDs improved symptoms of LDH more significantly than NSAIDs alone(VAS: MD-0.31,95% CI-0.42 to -0.19;VAS sleep quality:MD-10.80,95% CI-19.16 to-2.44;VAS lower limb numbness:MD-2.60,95% CI-2.75 to-2.45),the RR of hypersomnia was 9.02(95% CI 1.70 to 47.82).(5)The effect of mecobalamin in improving the symptoms of LDH was inferior to sticking of needle(VAS: MD 0.60,95% CI 0.08 to 1.12)and Bushen Huoxue Decoction(VAS: MD 0.96,95% CI 0.59 to1.33;JOA: MD-1.29,95% CI-1.83 to-0.75;ODI: MD 3.15,95% CI 2.04 to 4.26).(6)The effect of sodium aescinate on improving LDH symptoms was more obvious than ibuprofen(VAS: MD-1.80,95% CI-2.51 to-1.09;JOA: MD 6.54,95% CI 6.22 to 6.86),intravenous mannitol and dexamethasone provided better immediate pain relief than diosmin tablets(VAS: MD-0.48,95% CI-0.62 to-0.34).(3)Evidence-based practice guideline: Based on 41 systematic reviews and above meta-analysis,a total of 19 recommendations were made based on 14 clinical problem.The Delphi method was adopted to conduct consensus among 17 experts,and 17 valid questionnaires were collected,65% of the consensus experts judged recommendations based on clinical experience and evidence,59% of experts were familiar with the GRADE system,the agreement rates of recommendations ranged from 71% to 100%,and the median rate was 88%.We modified the recommendations according to the comments of experts,and formed the 19 recommendations of “Evidence-based practice guidelines of non-operative treatment for lumbar disc herniation”.Conclusions(1)The trend of Chinese-and English-language researches on nonoperative treatment for LDH has decreased in recent two years.Traditional Chinese medicine,which has attracted much attention in Chinese-language studies,appeared less frequently in English-language studies.In addition,studies should be further clarified the mechanism of non-operative treatment for LDH in the future.(2)Low to medium quality of evidence showed that NSAIDs,physiotherapy,steroids,ionic channel regulator,neurotrophic agent and dehydrant were effective in the treatment of LDH.The limitations of current studies were low quality and short follow-up duration,and more high-quality RCTs were needed in the future to investigate the effectiveness and safety of non-operative treatment for LDH.(3)This study formed the recommendations of “Evidence-based practice guidelines of non-operative treatment for lumbar disc herniation” through the normative process of guideline formulation.However,most recommendations were based on low-quality evidence,we suggested researchers carry out high-quality RCT,and verify the effectiveness and safety of psychological intervention therapy,muscle relaxants and opioids in the treatment of LDH.