Acupuncture and/or moxibustion for the treatment of lumbar disc herniation: quality assessment of systematic reviews

Zi-Han Yin, Chao-Xi Zhu, Gui-Xing Xu, Cheng Ying, Ai-Ling Huang, Ya-Nan Fu, Jiao Chen, Ling Zhao, Fan-Rong Liang*

Acupuncture and/or moxibustion for the treatment of lumbar disc herniation: quality assessment of systematic reviews

Zi-Han Yin1#, Chao-Xi Zhu1#, Gui-Xing Xu1, Cheng Ying1, Ai-Ling Huang1, Ya-Nan Fu1, Jiao Chen1, Ling Zhao1, Fan-Rong Liang1*

1Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China.

In the current systematic review on acupuncture and/or moxibustion for lumbar disc herniation (LDH), we evaluated the methodology and quality of evidence and reports to provide necessary information for accurate clinical decision-making regarding acupuncture and/or moxibustion for LDH. Methods:From databases such as CBM (Chinese biomedical literature database), VIP (China science and technology journal database), CNKI (China national knowledge infrastructure), WF (Wanfang database), Web of Science, Embase, Medline, and Cochrane Library, systematic reviews on acupuncture and/or moxibustion for LDH were retrieved, and the methodological quality of the literature was evaluated according to the assessment of multiple systematic reviews (AMSTAR) list. Furthermore, the grading of recommendations assessment, development and evaluation (GRADE) system was used to grade the quality of evidence and the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement to evaluate the quality of the report. Results: A total of 18 systematic reviews were included, and the conclusion is that acupuncture and/or moxibustion have some advantages in terms of efficacy and safety with regard to LDH treatment. According to the AMSTAR score, there were 4 high-quality studies, 13 moderate-quality studies, and 1 low-quality study. GRADE showed that quality of evidence such as total effective rate of LDH and VAS was low and that of other forms of evidence was lower. The PRISMA statement showed that 8 articles were in line with 20 or more of the 27 items, and 10 articles were in line with 10-19 of the 27 items.Conclusion:At present, acupuncture and/or moxibustion for LDH has a good curative effect. More importantly, its methodological quality was of moderate level and the report quality was generally good and relatively complete. However, the poor quality of the original research results was reflected in the quality of evidence. More studies are needed to make sure whether acupuncture is more effective than other treatment methods.

Lumbar disc herniation, Acupuncture therapy, Overview of systematic reviews, AMSTAR, GRADE, PRISMA.

In the current systematic review on acupuncture and/or moxibustion for lumbar disc herniation (LDH), the methodology and quality of evidence and reports were evaluated via AMSTAR list, GRADE system and PRISMA statement and conclusion is that acupuncture and/or moxibustion have some advantages in terms of efficacy and safety with regard to LDH treatment.

LDH belongs to the category of low back pain (LBP) in Chinese medicine theory. LBP was recorded in the earliest Chinese medical classicpublished in Qinhan period of China (the time of writing is unknown). Subsequently, evidence on the use acupuncture for the treatment of LBP by a large number of scholars of Ming dynasty of China was recorded in,and other ancient books on acupuncture. With the development of modern medicine, National Institute for Health and Clinical Excellence guidelines published in 2012 highlighted the need for a treatment course of acupuncture of up to 10 sessions over 12 weeks for patients with LBP.

Background

Lumbar disc herniation (LDH) is a characteristic feature of lumbar disc disease (LDD). LDD is one of the most common musculoskeletal diseases [1]. A country report has shown that LDH is one of the main causes of lumbar and lower limb movement disorders, which is as source of heavy burden to individuals, families, and the society [2]. In China, a study including 3859 adults showed that the prevalence of lumbar osteoarthritis increased with an increase in age [3]. Forty percent of the individuals under 30 years of age have lumbar intervertebral disc degeneration, and the prevalence of LDD is increasing progressively to over 90% by 50-55 years of age [4]. LDH is usually associated with low back pain (LBP). In the United States of America (USA), LBP is one of the most common reasons behind visits to a physician [5]. Although this disease is not a threat to life, it has a huge impact on the quality of life and it may lead to many adverse effects, such as development of negative emotions, on patients' psychology. If the disease does not heal for a long time, the negative effects on patients are undeniable. Furthermore, according to a survey in 2001, family and twin studies have suggested that sciatica, disc herniation, and disc degeneration may be influenced to a large degree by genetic factors [1].

Currently known treatments for LDD are mainly divided into surgical treatment and conservative treatment. In some patients, lumbar spine surgery does not improve the condition, and such patients are considered to have failed back surgery syndrome (FBSS).” Most patients with FBSS seek further treatments for their ongoing pain and impairment [6]. Furthermore, the recurrence of LDH is one of the most feared complications following surgery [7]. Early surgery helps achieved a more rapid relief than that achieved by conservative care in patients with sciatica; however, outcomes of both the treatments were similar by the end of the first year and these did not change at 2-year or 8-year follow-up [8-9]. Recent clinical evidence suggests a health benefit of undergoing surgery; the cost effectiveness of operative intervention compared to nonoperative care remains poorly characterized [10]. Conservative treatment is mainly suitable for patients with no serious neurological symptoms or for those with ineffective surgical outcome. Nonsurgical treatment of adult patients with a history of < 12 weeks of LBP is recommended by the Danish Health Authority [11]. Some patients who do not respond to nonsteroidal anti-inflammatory drugs may benefit from the use of tramadol, opioids, and other adjunctive medications. Acupuncture, exercise therapy, multidisciplinary rehabilitation programs, massage, behavioral therapy, and spinal manipulation are effective in certain clinical situations [12-13]. In the USA, more than 1 million patients received an epidural steroid injection as part of conservative treatment for LDH; this excluded those seeking other conservative treatment methods within and outside the USA [14]. Furthermore, 42 thousand opioid overdose deaths were recorded in 2016. Overall prescription opioid deaths increased by 18% between 2009 and 2016 [15].

Acupuncture is a simple, convenient, inexpensive, widely used, and safe treatment method for LDH. LDH belongs to the category of LBP in Chinese medicine theory. LBP is recorded in the earliest Chinese medical classicpublished in Qinhan period of China (the time of writing is unknown). Subsequently, evidence on the use acupuncture for the treatment of LBP by a large number of scholars of Ming dynasty of China is recorded in some ancient books on acupuncture including(published in 1624 C.E.) and(published in 1601 C.E.). With the development of modern medicine, National Institute for Health and Clinical Excellence guidelines published in 2012 highlighted the need for a treatment course of acupuncture of up to 10 sessions over 12 weeks for patients with LBP [16]. A study found that the mechanism of action of acupuncture and electrical acupuncture stimulation could influence the pain inhibitory system by causing a transient change in blood flow to sciatic nerve and other regions, including the cauda equine and nerve root [17].Besides, acupuncture is an ideal choice for patients who need long-term treatment, especially when the curative effect of Western medicine is not obvious. Acupuncture has a good application prospect and promotion value. In this systematic review (SR) on LDH treatment by acupuncture, the assessment of multiple systematic reviews (AMSTAR) list [18], the grading of recommendations assessment, development and evaluation (GRADE) scale [19]and the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement [20]were used to conduct methodological quality review, evidence level review, and report quality study. This method is expected to play a guiding and normative role in clinical research and writing on acupuncture for LDH.

Methods

This SR has been registered on PROSPERO (CRD42019123293).

Eligibility criteria

Type of study. We included the SRs and meta-analyses that included only randomized controlled trials (RCTs) on the treatment of lumbar intervertebral disc herniation using acupuncture, with no limitation on language.

Types of participants. Patients who were diagnosed with LDH, regardless of gender, age, race, region, etc.

Types of interventions. Experimental group: acupuncture or moxibustion alone or in combination with other treatment. Control group: drugs, placebo, sham acupuncture, etc.

Types of outcome measures. Total effective rate, VAS, Japanese orthopaedic association scores (JOA), and Oswestry disability index (DOI).

Literature search

The search terms included LDH, acupuncture, acupuncture therapy, moxibustion, acupuncture point, acupuncture ear, auriculotherapy, electroacupuncture, electric stimulation therapy, acupressure, systematic review, meta-analysis. Subject terms were used for a separate retrieval. "Or" and "and" were used to connect the name of terms. The details were adjusted according to the database; CBM (Chinese biomedical literature database), CNKI (China national knowledge infrastructure), WF (Wanfang database), VIP (China science and technology journal database), Web of Science, Embase, Medline, and Cochrane Library were selected for retrieval, and retrieval was performed up to January 1, 2019. Methods used for the retrieval of Chinese and English literature were similar; retrieval from Medline is shown as an example in Supplementary annex 1.

Exclusion criteria

Articles that was duplicated; not found; not related to acupuncture, moxibustion, or LDH, and not SRs or meta-analyses and articles that were SRs but did not include RCTs.

Screening and data extraction

Two researchers independently conducted literature retrieval, screening, and data extraction. In case of disagreement, a third party was consulted to assist arrival at a judgment; missing information was obtained by contacting the author of the specific article. In the literature selection process, the title and abstract of the literature were first read using NoteExpress. After excluding obviously overlapping articles, the full text of each article was read to determine its inclusion status. According to the title and abstract, the articles that obviously did not meet the inclusion criteria were screened out and the articles that might meet the requirements were downloaded and read completely to determine whether they meet the inclusion criteria. Excel2016 was used to establish a table, and the extracted data included the title, author, year of publication, number of papers, number of cases, interventional measures, outcome indicators, AMSTAR, GRADE, and PRISMA.

Data analysis

Methodological quality of the SRs. The included SRs on RCTs used the Jadad scale or Cochrane Handbook. We chose AMSTAR to evaluate the SRs' methodological quality. According to the 11 items listed in AMSTAR, methodological quality of SRs on acupuncture treatment for LDH was evaluated. Each item was described with “yes”, “no”, or “not clear”. “Yes” is equivalent to 2 points, “no” is equivalent to 0 points, and unclear is equivalent to 1 point. Finally, we calculated the total score of each SR according to AMSTAR to determine their quality: 17-22 points, high-quality research; 9-16 points, moderate-quality research; and 0-8 points, low-quality research.

Quality of the report. The PRISMA statement's 27 items were used to evaluate the report quality specifications of each SR. We used “sufficient” and “insufficient” to indicate the sufficiency of data extraction and used statistical analysis to measure and integrate the included SRs and to prepare a chart.

Quality of the evidence. We summarized the quality of the evidence in relation to the most important outcomes by using the GRADE system. The GRADE system was used to grade five aspects of the obtained outcome indicators: research limitations, inconsistency, indirectness, inaccuracy, and publication bias. In the case of the RCTs, the GRADE classified the evidence of the outcome indicators evaluated by the system, and all the outcome indicators were graded by quality through the GRADE rating standards. Evidence quality was rated as “high”, “moderate”, “low”, or “very low” according to the GRADE rating standards. High-quality evidence indicates that future research is unlikely to change the existing evidence; moderate-quality evidence indicates that future research may have an important impact on the existing evidence and that it may change the evaluation results; low-quality evidence indicates that future research is likely to have a significant impact on the existing evidence and that it may change the evaluation results; and very low-quality evidence indicates that all existing evidence is highly uncertain.

Results

Search results

In the initial examination, 108 articles in Chinese and 10 articles in English are identified, and after the preliminary screening, 56 articles are excluded. Subsequently, 18 articles that exclude acupuncture as the main treatment method, 5 articles that exclude LDH, 11 articles that exclude SR or meta-analysis, and 10 articles that are SRs but do not include RCT are excluded. Finally, 18 articles [21-38]are included in this SR of acupuncture and moxibustion for the treatment of LDH. The literature screening process is shown in Figure 1.

Study description

Among the 18 articles [21-38] included, 16 [21, 23-34, 36-38] are Chinese articles and 2 [22, 35] are English articles. Seventeen articles are journal articles, and 1is a degree article. All these papers were published from 2008 to 2018. The first article was published in 2008, 4, 5, and 2 articleswere published in 2016, 2017, and 2018, respectively. As described above, recently, the use of acupuncture and/or moxibustion for the treatment of LDH have increased, and acupuncture has a good curative effect on LDH. In the treatment group, the intervention measures are acupuncture, moxibustion, acupuncture combined therapy, electro-acupuncture, etc., and in the control group, the intervention measures are placebo, sham acupuncture, drugs, traction, waiting for treatment, etc. The main conclusion is that acupuncture and moxibustion are effective in the treatment of LDH, but all the studies show large heterogeneity, which questions the credibility of the conclusion (Table 1).

Methodological quality

AMSTAR scale, which includes 11 items, was used for the assessment of methodological quality of SRs; the quality of 4 articles [22-24, 32] is high, 13 articles is moderate, and 1 articleis low. The score is 19 points for 2 articles [23-24], 18 points for 1 article[22], and 17 points for 1 article [32]. Scores of all moderate quality articles are in the range of 9-16 points. Among the 18 included SRs, only 2 articles [23-24] have priori design (1 item).The gray search (4 items) is generally lacking; with regard to conflicts of interest (11 items), 66.6% of the articles mentions the funding sources and only one articlementions the funding sources of the included references (Table 2).

Figure 1 Flowchart showing the article selection process

CBM, Chinese biomedical literature database; CNKI, China national knowledge infrastructure; WF, Wanfang database; VIP, China science and technology journal database; WOS, Web of science; LDH, Lumbar disc herniation; SR, Systematic review; RCT, Randomized controlled trial.

Table 1 Main characteristics of included systemic reviews

Table 1 Main characteristics of included systemic reviews (Continued)

LDH, Lumbar disc herniation; RCT, Randomized controlled trial; /, Not mentioned.

Figure 2 Number of reviews that appropriately address each PRISMA element

Table 2 Methodological quality score

Q1, A priori design; Q2, Duplicate selection and data extraction; Q3, Comprehensive search; Q4, Gray literature search; Q5, List of included and excluded studies; Q6, Characteristics of studies; Q7, Scientific quality assessed; Q8, Scientific quality in conclusions; Q9, Methods used to combine studies; Q10, Publication bias assessment; Q11, Conflict of interest; AMSTAR, Assessment of multiple systematic reviews.

Table 3 Grading of recommendation assessment, development, and review (GRADE) evidence in the meta-analysis

Table 3 Grading of recommendation assessment, development, and review (GRADE) evidence in the meta-analysis (Continued)

Note:① Most information is from the medium risk studies, and there are major limitations; ② The size and direction of the effect size and the overlap of the confidence interval are small, thevalue of the heterogeneity test is small, and the combined results of I2value is large; ③ The sample is insufficient; ④ The funnel plot is asymmetric or missing; JOA, Japanese orthopaedic association scores; ODI, Oswestry disability index; EMG, Electromyography.

Figure 3 Number of PRISMA elements that are appropriately addressed in each systemic review

Quality of evidence

The main outcome indicators were graded according to the GRADE evidence rating system, and all the SRs' evidences were further excavated. A total of 36 main outcome indicators applied in the SRs were selected for meta-analysis. Main outcome indicators included total effective rate, VAS, JOA, and ODI. Among them, the total effective rate was the most frequently used outcome, but many studies did not have the same efficacy standard; JOA, VAS, and ODI scores were also applied very frequently. All outcome indicators were graded according the GRADE evidence rating system. Quality grading of all outcome measures was performed by the GRADE. The evidence quality of total effective rate and VAS score is low and that of the other evidences is very low (Table 3).

Reporting quality of included reviews

The 18 included SRs were analyzed according to the PRISMA statement's 27 items, and the results show that title, structured summary, rationale, objectives, eligibility criteria, information sources, summary measures, results of individual studies, and conclusions have enough description; however, protocol and registration are described in only 2 articles [23-24], summary evidence is provided in 3 articles [22, 27, 34], data items are presented in only 5 papers [23-25, 30, 33], and clear search method is described in 5 articles [21, 22, 25, 30, 33, 38] while the remaining articles specify only the search term (Figure 2). Among all the studies, 8 articles [21-25, 30, 32, 34] have 20 or more of the 27 items, 10 articles [26-29, 31, 33, 35-38]have 10-19 of the 27 items, and none of the articles has less than 10 of the 27 items (Figure 3).

Discussion

Pursuit of high-quality evidence is always the goal of evidence-based medicine, and SR plays a significant role in evidence integration. However, the quality of SRs was currently uneven, which may be related to the quality of the original study and the difference in researchers' reviews, resulting in medical workers' doubts about the clinical decision. Overview came into being. It is a research method to comprehensively collect SRs on the treatment, etiology, diagnosis, and other aspects of the same health problem and summarize them [39]. The overview of SR is a way to measure the quality of SRs [40-42].

We found 16 articles[21, 23-34, 36-38] in Chinese and 2 articles[22, 35] in English to be relevant to our study.All papers were published from 2008 to 2018 and the first paper was publishedin 2008. Among the methodological quality assessment tools, the Jadad scale was used to assess 5 articles and the Cochrane Review Handbook was used to assess 12articles; 1 article was not assessed using any bias risk assessment tool. The main conclusion is that acupuncture is associated with a certain level of efficacy and safety with regard to LDH treatment.In conclusion, as described above, acupuncture has good curative effect on LDH. The report is complete and methodological quality is moderate, but evidence quality is poor. With a constant self-improvement and development in the field of evidence-based medicine, more credible review conclusions, stronger objectivity, lower bias, and greater clinical significance can be achieved.

AMSTAR scale facilitates an objective review of methodological quality of meta-analyses and SRs. AMSTAR scale was used to evaluate the methodological quality of the included SRs, and the results showed that the quality of only 4 articles was high, that of 13 articles was moderate, and that of 1article was low. There were the following methodological problems in the articles included in this study: (1) many articles did not use priori design (1 item), and only one researcher registered and filled in the research plan; (2) the inclusion criteria were not fully considered, especially in gray literature (4 item) and only 5 papersinvolved language problems; (3) when we were screening articles, we included only the articles the provided a list of articles reviewed, and 9 articlesmentioned the excluded research articles (5 item); (4) the assessment of publication bias (10 item) was generally mentioned, but there were 8 articles that didnot mention this aspect, which would lead to suspicion over authenticity of the results. Only 17 articlesmentioned the funding sources (11 item), and 1 article mentioned the funding sources of included literature. In other words, the SRs have improved in recent years, but there are still some deficiencies. Therefore, I suggest that researchers refer to AMSTAR scale to control methodological quality when they perform SRs.

The GRADE system classifies the evidence on the outcome indicators evaluated by the system, and all the outcome indicators are graded by quality using the GRADE evidence rating system. The results showed that the total effective rate of the relevant literature on LDH and the quality of the VAS outcome index were increasing progressively with time and that the total effective quality of acupuncture treatment of LDH was relatively high. The main reasons for the downgrade were associated with inconsistencies, possible publication bias, and more specifically, limitations. At the same time, the evaluation criteria for acupuncture treatment of LDH was different, which had a certain level of influence on the objective judgment of acupuncture efficacy.

The PRISMA statement is an internationally recognized tool that regulates the writing of SRs. However, in the current study, we observed that the PRISMA statement was not widely used in SRs. The quality of the research report had not been significantly improved, which also reflects that the normative PRISMA statement has not been paid attention to by most scientific researchers. Overall, all the studies had a high degree of report integrity. Eight articles had 20 or more of the 27 items, 10 articleshad 10-19 of the 27 items, and none of the articles had less than 10 of the 27 items. Little attention was paid to protocol and registration (5 item), summary evidence (24 item), data items (11 item), and search method (8 item). Title (1 item), structured summary (2 item), rationale (3 item), objectives (4 item), eligibility criteria (6 item), information sources (7 item), summary measures (13 item), results of individual studies (20 item), and conclusions (26 item) were fully described.

Although the language of the included articles was not limited, the databases in Asia and other countries such as Japan and South Korea were not searched, and manual retrieval process was not used. Therefore, there might be selection bias.

Therefore, this study involves a certain level of basis towards the clinical treatment of LDH by acupuncture and moxibustion. According to the current clinical literature, acupuncture has achieved certain results in the treatment of LDH, but the quality of evidence was still very low; verification by high-quality RCTs was required to achieve the clinical guidance. Therefore, the use of high-quality clinical trial methods and AMSTAR list or OQAQ (The Overview Quality Assessment Questionnaire) list is recommended to control the methodological quality of clinical studies regarding the treatment of LDH with acupuncture and to provide more convincing data on and to promote the use of acupuncture for LDH; (2) We hope that researchers can GRADE the outcome indicators of their studies, to provide accurate clinical decisions; (3) I hope researchers can strictly follow the PRISMA statement, to reach more standardized process of SR writing. (4) Researchers should strictly standardize the quality of methodological application, to curb the generation of bias and to improve the quality of literature and evidence.

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The study was financially supported by the Major Program of the National Natural Science Foundation of China (No. 81590951).

:

LDH, Lumbar disc herniation; LDD, Lumbar disc disease; LBP, Low back pain; FBSS, Failed back surgery syndrome; SR, Systematic review; RCTs, Randomized controlled trials; JOA, Japanese orthopaedic association scores; ODI, Oswestry disability index; AMSTAR, Assessment of multiple systematic reviews; GRADE, Grading of recommendations assessment, development and evaluation; PRISMA, Preferred reporting items for systematic reviews and meta-analyses; USA, the United States of America.

:

The authors declare that they have no conflict of interest.

:

Zi-Han Yin, Chao-Xi Zhu, Gui-Xing Xu, et al. Acupuncture and/or moxibustion for the treatment of lumbar disc herniation: quality assessment of systematic reviews. Traditional Medicine Research 2019, 5 (4): 282–294.

:Hao-Ran Zhang, Mathew Goss.

:10 July 2019,

14 September 2019,

:30 September 2019.

#Zi-Han Yin and Chao-Xi Zhu are the co-first authors of this paper.

Fan-Rong Liang, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, China. E-mail: acuresearch@126.com.

10.12032/TMR20190930137