Effectiveness of Balance Acupuncture for the Pain in. Neck-Shoulder-Low back-legs: A Meta-Analysis

Hou-Lian WANG et al./journal of Acupuncture and Herbs 1 (201)9-1 9 Effectiveness of Balance Acupuncture for the Pain in Neck-Shoulder-Low back-legs: A Meta-Analysis Hou-Lian WANG a, An-Lin GUO a, Jun-Yun GE b, Mai-Lan LIU b, Xiao-Rong CHANG b* a. Graduate School, Hunan University of Traditional Chinese Medicine, Changsha, 410208, China b. School of Acupuncture-Moxibustion and Tuina Massage, Hunan University of Traditional Chinese Medicine, Changsha, 410208, China Received: July 12, 201 Accepted: July1, 201 DOI: 10.11/tcm-201-0002 Abstract Objective: To systematically review the effectiveness of Balance Acupuncture for the Pain in Neck, Shoulder, Low-back and Legs (PNSLL). Methods: Web-based search on databases such as PubMed(2008.1.~2014.11) Web of Science(2008.1.~ 2014.11) Wan Fang Data(2008.1.~2014.11) CNKI(2008.1.~2014.11)to collect literature of randomized controlled trials (RCT) on Balance Acupuncture for PNSLL. Literature selection, data extraction and methodological quality assessment of the included studies were conducted by two reviewers independently. The meta-analysis was performed by using Rev Man.2 software. Results: A total of 6 studies involving 816 participants were included. Meta-analysis showed that Balance Acupuncture treatment of the PNSLL is superior to traditional Acupuncture, with significant differences (OR=0.12, 9%CI=[0.08,0.1], Z=.83, P<0.00001). Conclusion: Balance Acupuncture is an effective and safe way for treating PNSLL, though it may need further demonstration by more large-scale and well-designed RCT due to the limited quantity and quality of the included studies. Keywords: Balance Acupuncture; PNSLL; Meta-analysis; Systematic Review Pain in neck, shoulder, low-back and legs (PNSLL) is a very common symptom groups clinically. It includes cervical spondylosis, cervical herniated disc, frozen shoulder, lumbar disc herniation, lumbar muscle strain, lumbar degenerative disc disease, the third lumbar transverse process syndrome, piriformis syndrome and osteoarthritis in the elderly, and so on. Major symptom is pain in local area, accompanying with joint activity restriction. The symptom can be refractory and recurrent. Epidemiologic studies have *Corresponding author. Professor. Dean of the State Key Lab. for Acupoint-organ Relationships. Research fields: relationships between meridians and organs; clinical and experimental studies on the substance of moxibustion. E-mail address:xrchang196@163.com shown that PNSLL has the highest incidence rate among occupational diseases worldwide. It severely impact people s daily work and life quality. There are many therapeutic methods for PNSLL, however, the effects of conventional operation or medications may face the difficulty of stable and lasting in a long-term view 1. The major principle of balance acupuncture is, signal from acupuncturist delivered by the fastest speed to the central nervous system based on a neural stem stimulation 2, so the receiver can produce a benign signal inside to adjust the body. Also this benign signal can motivate the central neurotransmitters so to release large amounts of chemical substances, thus a quick analgesic effect can be achieved. In recent years, the balance acupuncture has been broadly used clinically 3. PNSLL: Pain in Neck, Shoulder, Low-back and Legs; RCT: randomized controlled trial; CCT: controlled clinical trial

10 Hou-Lian WANG et al./journal of Acupuncture and Herbs 1 (201)9-1 However, its effectiveness and safety need further review. Mata-analysis is one of the most reliable ways to demonstrate the clinical technic based on literature review, thus we employed this way to evaluate the effectiveness and safety of balance acupuncture for PNSLL, so that to provide evidence for future application. 1 Objects and methods 1.1 Research objects Clinical trials published regarding balance acupuncture for PNSLL. 1.2 Search method Web search in English and Chinese databases such as PubMed ( 2008.1. ~ 2014.11 ) Web of Science ( 2008.1. ~2014.11) WanFang Data( 2008.1. ~ 2014.11) CNKI(2008.1.~2014.11), as well as manually search related journals, to sort out articles on balance acupuncture for PNSLL. The search key words in English include Acupuncture, The pain in the neck, shoulder, lower back and legs. 1.3 Literature filtration 1.3.1 Research type The original article must be randomized controlled trial (RCT) or controlled clinical trial (CCT). Whether or not the blinding and allocation concealment adopted was not in the consideration. 1.3.2 Research subjects 1.3.2.1Inclusion criteria 1 In the acute onset, the local muscles have cords or junction nodes, with obvious tenderness; 2long-term working or injury history. The symptoms get worse while getting up in the morning, or being in a cold weather. Warmth can relieve the symptoms. 3No skin feeling disorders or nerve compression symptoms; 4 routine laboratory tests and X-ray examination usually have normal results 4. 1.3.2.2 Exclusion criteria 1 concomitant diseases with other related symptoms, such as frozen shoulder; 2 the affected area has been treated by steroids such as corticosteroids before acupuncture treatment; 3 the local skin for acupuncture has infection; 4 lumbar disc herniation and post-operation cervical disease; accompanying with severe cardiovascular/urinary diseases or any other serious diseases in an acute phase; 6 pregnant or lactating women involved in the study. 1.3.3 Intervention strategy Patients in the experimental group were treated with balance acupuncture. The principle of point selection was crossing points plus local tender points, being reached by one-step method. Patients in the control group were treated with traditional acupuncture. There was no difference for manipulation and treatment course in two groups. 1.3.4 Outcomes 1 cured: the pain disappeared completely after treatment. Joint function returned to normal and was freedom of movement. The daily life was as normal person. 2 markedly effective: the pain virtually disappeared after the treatment. Joint function almost returned to normal and was freedom to do basic movements. The patient can engage in not so heavy work in certain extent; 3 effective: pain eased after treatment. Joint function approximately returned to normal but was slight obstacle for basic movements; 4 ineffective: no changes in pain symptoms and joint function 6. The patient can not engage in normal work. The overall effective rate was equal to cure rate + markedly effective rate+ effective rate. 1.4 Document screening, data extraction and quality assessment Two researchers independently read the acquired literature, including title and abstract, and judged if it was qualified for the research based on double crossing check by the inclusion and exclusion criteria. Any discrepancy should be settled by re-discussion or consulted with the third party. The extracted contents include: 1 General information: author, title, published date and literature source; 2 general features of the study design, such as: inclusion criteria, exclusion criteria, interventions, etc; 3 outcome measurement: cured, markedly effective, effective, ineffective, the total effective rate. And then the two reviewers made evaluation of methodological quality of included studies by using the risk of bias assessment tools in the Cochrane review's Manual

Hou-Lian WANG et al./journalofacupunctureandherbs1 (201)9-1 11.1.0 7. 1. Quality evaluation The methodological quality of the included studies was evaluated by a modified Jadad rating scale 8, which includes four parts: (1) random sequence generation. appropriate (I): random numbers were generated by computer, or similar methods (2 points) ; not clear(ii): a the randomized assignment was not in the literature (1 point); inappropriate (III): some alternate distribution methods were used, such as odd and even numbers (0 points). (2) allocation concealment. Appropriate (I): the allocation strategy was controlled by the control center or pharmacy, concealed in containers with consistent sequence number, or computer program, or lightproof envelopes or other ways that clinicians and subjects could not identify(2 points). Unclear(II): the authors only that the use of a random number table or other random allocation scheme but no description of allocation concealment (1 point). Inappropriate(III): alternate assignment, allocated by case number, or date, or open random number table, or series coding envelopes or any other ways that could not prevent the predictability of grouping (0 points). No allocation concealment (IV, 0 points) (3) Blinding. Appropriate (I): complete identical placebo or similar were used (2 points). Unclear(II): just stated that the trial was blinded, but no concrete description of blinding (1 point). Inappropriate(III): No double-blind or blind approach was not appropriate, such as blinding tablets with injections (0 points ). (4) withdrawal or dropout. Have the number and reason of withdrawal or dropout(1 point). Have not the number and reason of withdrawal or dropout (0 points). The total score between 1-3 points was considered as low quality research, 4-7 points as high quality ones. 1.6 Statistics The meta-analysis was performed by RevMan.2 software provided by Cochrane Collaboration Network. Measurement data were expressed by standardized mean difference (SMD) and 9% confidence interval(ci). Count data were expressed by relative risk (RR) and 9%CI. The heterogeneity was tested by chi-squared (χ 2 ) test. If P 0.1 and I2 0%, it shows heterogeneity existing among the study results included, so we will analyze the source and reason of heterogeneity. If no clinical significance, we make a combined analysis based on random effects model. If P> 0.1 and I2 <0%, it shows no or very small heterogeneity among the results of the included studies, so the fixed effects model will be employed. Subgroup analysis was made according to the type of acupuncture treatments. If the heterogeneity was apparently induced by the methodeological quality of the included studies, sensitivity analysis will be used for evaluating the stability of research results, and inverted funnel plot is used for analysis of the potential publication bias. 2 Results 2.1 Search results and basic characteristics of included studies First a total of 72 articles were sorted out, after screening, finally 6 RCTs 9-14 were included, which includes 816 subjects. The research time and areas were very different. The publication years were from 2008 through 2014. Subject ages were between 21 and 76. The baselines between trial groups and control groups were comparable. The literature screening process and results were shown in Fig.1. Basic characteristics of included studies were shown in Table 1. 2.2 Methodological quality of included studies See table 2.

12 Hou-Lian WANG et al./journal of Acupuncture and Herbs 1 (201)9-1 Table 1 Basic characteristics of included studies Researcher n(t/c) Sex Intervention Treatment Age (male/female) T C Course Outcome Yong-Fu LI 9 110/110 137/83 47~76 BA TA 20days 1234 Hong-Wei CUI 10 90/90 94/86 22~68 BA TA 6months 234 Bi-Fang QI 11 46/46 49/43 24~64 BA TM 2weeks 1234 Jun-Dong LU 12 0/0 60/40 2~6 BA TA 3weeks 1234 Yi-Feng LI 13 0/0 63/37 21~63 BA TA 3weeks 1234 Tong-Ye CHEN 14 62/62 83/41 40~4 BA TA 20days 1234 e: BA=balance acupuncture, TA=traditional acupuncture, TM=traditional moxibustion, Acquiring literature by database search(n=112): CNKI(n=11) WanfangData(n=78) PubMed(n=0)Web of Science(n=23) Acquiring literature through other sources(n=0) Literature after excluding repeat(n=72) First screening by reading titles and abstracts(n=72) Excluding systemic review, comments, non-balance acupuncture research, non-pnsll, study on medications, study non focusing on therapeutic effects and irrelevant literature(n=16) Second screening by reading the full text(n=14) Excluding literature not fulfill the inclusion criteria(n=8) Qualitative Synthesis Documents (n=6) Quantitative Synthesis Documents(n=6) Fig.1 Literature screening and results

Hou-Lian WANG et al./journalofacupunctureandherbs1 (201)9-1 13 Table 2 Included studies and Jadad Scale Included study Randomized method Allocation concealment Patient and doctor Blinding Outcome Surveyor Outcome data integrity Withdrawal /dropout Jadad scale Yong-Fu LI 9 RCT Unclear N/A Single-blind Yes 3 Hong-Wei CUI 10 CCT Medical record number N/A Single-blind Yes 1 Bi-Fang QI 11 RCT RCT N/A Single-blind Yes Jun-Dong LU 12 RCT Unclear N/A Single-blind Yes 3 Yi-Feng LI 13 RCT RCT N/A Single-blind Yes Tong-Ye CHEN 14 RCT RCT N/A Single-blind Yes Table 3 Basic data of included studies(trail group/control group) Publishing year The first author Trail group Control group Effective Total Effective Total 2014 Yong-Fu LI 9 106 110 93 110 2013 Hong-Wei CUI 10 87 90 76 90 2012 Bi-Fang QI 11 42 46 36 46 2013 Jun-Dong LU 12 49 0 44 0 2014 Yi-Feng LI 13 49 0 44 0 2013 Tong-Ye CHEN 14 61 62 4 62 2.3 Results analysis 2.3.1Overall effective rate The overall effective rate was regarded the outcome index for the included studies. By analyzing the 6 studies, we got test results of heterogeneity thatχ 2 =0.26,P=1.00,I 2 = 0%<0%, which shows that the statistics of multiple studies having good homogeneity, therefore the fixed effect model was employed for further analysis. As shown in Fig.1, the pooled odds ratio (OR)=0.12, with 9%CI[0.08,0.1]. Z-value=,83, P< 0.00001. This result showed that compared with control group, the trial group was more effective (with statistical significance). The effect of balance acupuncture is better than traditional acupuncture on treating PNSLL.

14 Hou-Lian WANG et al./journal of Acupuncture and Herbs 1 (201)9-1 Fig.2 Meta analysis forest plot of balance acupuncture for PNSLL 2.3.2 Evaluation on publication bias As shown in Fig.3, the funnel plot has a good symmetry, so in general the publication bias in the study is small, but some potential publication bias is unavoidable. Fig.3 Funnel plot for the included studies 3 Discussion To the theory of traditional Chinese medicine, obstruction or malnutrition can lead to pain. PNSLL is usually induced by stagnation of Qi or blood, or obstruction of meridians. Balance acupuncture can activate the blood flow, harmonize Qi and blood and dredge meridians, so it has good effects for pain diseases. Modern research showed that balance acupuncture can deliver a benign signal to the body, by stimulating the nerves and exciting the cerebral cortex, the energy can be re-allocated and pain

Hou-Lian WANG et al./journalofacupunctureandherbs1 (201)9-1 1 threshold can be regulated to a new level. The body can achieve analgesic effect by itself. Our clinical experience has demonstrated that balance acupuncture has even better effects than traditional acupuncture on PNSLL, as shown in the meta-analysis results, so it is worthwhile for further promotion and popularization 1. In a word, balance acupuncture has big potential for PNSLL as a recommended treatment, but due to the quality and quantity of studies included, we may need more big-sample, high-quality clinical trial to further test this inference. Competing interests The authors declare that they have no competing interests. Acknowledgements This research was supported by the Hunan provincial level funding project- key subject development of Acupuncture and Moxibustion. References 7 Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions. version.1.0. The Cochrane Collaboration. 2011. available at http://www.cochrane-handbook.org. 8 JadadAR,MooreRA,CarrollD,et al.assessing the quality of reports of randomized clinical trials:is blinding necessary. Control Clinical Trials 1996,17(1):1-12. 9 Yong-Fu LI. Clinical analysis on the effects of balance acupuncture for pain in neck, shouder, low-back and legs in middle aged people or elderlies. Health for publics 2014,8(6):44. 10 Hong-Wei CUI. Therapeutic effects of balance acupuncture for pain in neck, shoulder, low-back and legs. Guide of China Medicine 2013,11(32):13-14. 11 Bi-Fang QI. Analysis on therapeutic effects of balance acupuncture for pain in neck, shoulder, low-back and legs. Asia-Pacific Traditional Medicine 2012,8(3):8-86. 12 Jun-Dong LU. Clinical observation of balance acupuncture for pain in neck, shoulder, low-back and legs. Clinical Journal of Chinese Medicine.2013,(6):41-42. 13 Yi-Feng LI. Clinical observation of balance acupuncture for pain in neck, shoulder, low-back and legs. Clinical Journal of Chinese Medicine 2014,6(11):3-4. 1 Dong CHEN, Jian ZHONG, Da-Dian CHEN, et al. Clinical utilization of CHEN S Tiao Zhen treatment and its mechanism. World Journal of Traditional Chinese Medicine 2012;7(2):142. 2 Yu-Hua SONG, Ai-Yun SONG. Clinical investigation on balance acupuncture for pain diseases. Journal of Clinical Acupuncture and Moxibustion 200,21:27. 3 Wen-Yuan WANG, Xiao-Jun MAO, Li-Fang ZHANG, et al. 14 Tong-Ye CHEN. Clinical observation of balance acupuncture for pain in neck, shoulder, low-back and legs. Health Required 2013,12(9):9. 1 Dan-Ni XU, Hong YUAN, Xiao-Xuan REN, et al. Clinical research progress of balance acupuncture for pain in neck, shoulder, low-back and legs. Annual meeting of Chinese Acupuncture Association 2011-2011:1. Clinical observation of balance acupuncture for pain in neck, shoulder, low-back and legs. Chinese Archives of Traditional Chinese Medicine 2009; 06:1202-1204. 4 Ya-Hui HOU. Clinical utilization of warmth acupuncture on tender points. Clinical Journal of Acupuncture 2007,23(8):3-4. Yong-Xin LIU, Zhuo-Min LIU, Huan WEI, et al. Clinical utilization of modified warmth acupuncture treatment. Modern Journal of Integrated Traditional Chinese and Western Medicine 2013,22(7):68. 6 Jun-Dong LU. Clinical observation of balance acupuncture for pain in neck, shoulder, low-back and legs. Clinical Journal of Chinese Medicine 2013,(6):42.