Open Access Protocol

BMJ Open: first published as 10.1136/bmjopen-2014-007498 on 28 April 2015. Downloaded from [Link] on December 7, 2024 by guest. Protected by copyright.
Acupuncture for treating sciatica:
a systematic review protocol
Zongshi Qin,1,2 Xiaoxu Liu,1,2 Qin Yao,1,2 Yanbing Zhai,1,2 Zhishun Liu1

To cite: Qin Z, Liu X, Yao Q, ABSTRACT

et al. Acupuncture for treating Strengths and limitations of this study
Introduction: This systematic review aims to assess
sciatica: a systematic review
the effectiveness and safety of acupuncture for treating ▪ The effectiveness of conservative therapy for sci-
protocol. BMJ Open 2015;5:
e007498. doi:10.1136/
sciatica. atica is uncertain, and acupuncture may provide
bmjopen-2014-007498 Methods: The following nine databases will be an effective alternative treatment method. To the
searched from their inception to 30 October 2014: best of the authors’ knowledge, there is currently
MEDLINE, EMBASE, the Cochrane Central Register of no systematic review published in English related
▸ Prepublication history for
this paper is available online.
Controlled Trials (CENTRAL), the Chinese Biomedical to acupuncture for sciatica. The results of this
To view these files please Literature Database (CBM), the Chinese Medical systematic review will help clinicians make deci-
visit the journal online Current Content (CMCC), the Chinese Scientific Journal sions on treating sciatica, and also help patients
([Link] Database (VIP database), the Wan-Fang Database, the seeking further treatment options.
bmjopen-2014-007498). China National Knowledge Infrastructure (CNKI) and ▪ One limitation of this systematic review is that,
Citation Information by National Institute of Informatics owing to the language barrier, trials in only three
Received 19 December 2014 (CiNii). Randomised controlled trials (RCTs) of languages can be included. Hence, relevant
Revised 5 March 2015 acupuncture for sciatica in English, Chinese or studies published in other languages might be
Accepted 20 March 2015
Japanese without restriction of publication status will missed.
be included. Two researchers will independently ▪ Another limitation is that the different forms of
undertake study selection, extraction of data and acupuncture therapy and quality of methodolo-
assessment of study quality. Meta-analysis will be gies in the included studies may cause signifi-
conducted after screening of studies. Data will be cant heterogeneity.
analysed using risk ratio for dichotomous data, and
standardised mean difference or weighted mean
difference for continuous data. according to a report from Younes,6 sciatica
Dissemination: This systematic review will be in Tunisia has become a major cause of work
disseminated electronically through a peer-reviewed absenteeism and a financial burden to
publication or conference presentations.
society. Previous research has indicated that
Trial registration number: PROSPERO
60% of patients with sciatica suffer from a
CRD42014015001.
mild disability. On the basis of questionnaires
(given at the 3rd through 12th months of
symptom exhibition), it is believed that 30%
of patients live with sciatica for more than
INTRODUCTION 1 year, which results in an obvious decrease
Sciatica is a common neuralgia characterised in the quality of life.7 The current manage-
by pain radiating into the leg; it is usually ment of sciatica can be classified into
caused by nerve root compression and irrita- pharmacological and non-pharmacological
tion or inflammation of the sciatic nerve, treatment. One article supports the effective-
and is often accompanied by lower back pain ness of non-opioid medication, epidural
and neurological deficits in the lower limb.1 injections and disc surgery. It also suggests
The pain is often associated with tingling, that spinal manipulation, acupuncture and
numbness and weakness of the leg; it may be experimental treatments, such as anti-
1
sudden in onset and then persist for days or inflammatory biological agents, may be con-
Department of Acupuncture, sidered. 8 The use of pharmacological pro-
Guang’anmen Hospital, China
weeks.2 Frymoyer3 reported that sciatica is
Academy of Chinese Medical very common, with a lifetime incidence ducts such as anaesthetics or corticosteroids
Sciences, Beijing, China varying from 13% to 40% and a correspond- has associated adverse effects including sed-
2
Beijing University of Chinese ing annual incidence of sciatica episodes of ation, dizziness, ataxia and nausea, and their
Medicine, Beijing, China 1–5%.4 effectiveness decreases with long-term use.9
Sciatica commonly affects people between Although according to the prior systematic
Correspondence to
Professor Zhishun Liu; the ages of 30 and 50 years, with the pain of review epidural injections are more effective
liuzhishun@[Link] sciatica significantly damaging health.5 Thus, for pain reduction than non-opioids,8 related

Qin Z, et al. BMJ Open 2015;5:e007498. doi:10.1136/bmjopen-2014-007498 1

Open Access

BMJ Open: first published as 10.1136/bmjopen-2014-007498 on 28 April 2015. Downloaded from [Link] on December 7, 2024 by guest. Protected by copyright.
adverse effects to epidural injections have been ▸ Acupuncture plus another Western medicine treat-
reported.10–12 To date, there is no strong evidence-based ment versus the same Western medicine treatment
medicine proving that non-pharmacological conservative alone will be included.
treatment of Western medicine is effective13 14; also, sur- ▸ RCTs comparing two different types of acupuncture
gical procedures are invasive, expensive and may cause will be excluded.
neurological complications.15 ▸ Acupuncture treatment without needle insertion (eg,
In China, sciatica is a primary cause for hospitalisation acupressure, laser acupuncture and electrical stimula-
and it is commonly used for managing neuralgia pain.16 tion) will be excluded.
Acupuncture is reported to be effective in treating many ▸ Acupuncture combined with Chinese medicine, acu-
types of musculoskeletal pain including lower back point injection and/or needle knife will be excluded.
pain,17 fibromyalgia,18 osteoarthritis19 and sciatica.20–24
However, the ability of acupuncture to successfully Types of outcome assessments
manage sciatica, either as a monotherapy or as an Primary outcomes
adjunct to Western medical care, remains unclear. ▸ Pain intensity. Any validated measurement scales will
This systematic review aims to assess the effectiveness be included (eg, visual analogue scale, numeric
and safety of acupuncture for treating sciatica. To this rating scale, short-form McGill Pain Questionnaire
end, we will pose the following question: What is the (SF-MPQ)).
comparative effectiveness and safety of acupuncture ▸ Global assessment (the proportion of patients
compared with sham acupuncture, usual care or no improved or cured).
treatment to reduce pain intensity in patients diagnosed Secondary outcomes
with sciatica? Is there a definitive advantage of acupunc- ▸ Quality of life, for example, as assessed using the
ture compared with Western medication? With the Medical Outcomes Study 36-item Short Form health
resulting evaluation aiming to help clinicians make deci- survey (SF-36).
sions on treating sciatica, and to help patients seeking ▸ Physical examinations.
further treatment options. ▸ Patient satisfaction.
▸ Adverse effects.

METHODS AND ANALYSIS Search methods for identification of studies

Criteria for inclusion of studies in this review: A search strategy will be used and conducted according
to the Cochrane handbook guidelines.25 The following
Types of studies nine databases will be searched from their inception to
Only RCTs will be included; quasi-RCTs and randomised 30 October 2014: MEDLINE, EMBASE, the Cochrane
cross-over studies will be excluded. Blinding will not be Central Register of Controlled Trials (CENTRAL), the
considered because of the characteristics of acupuncture Chinese Biomedical Literature Database (CBM), the
treatment. Chinese Medical Current Content (CMCC), the Chinese
Scientific Journal Database (VIP database), the Wan-Fang
Database, the China National Knowledge Infrastructure
Types of participants (CNKI) and Citation Information by National Institute of
Patients with sciatica will be included, including those Informatics (CiNii). The search strategy is based on the
diagnosed with sciatica synonyms such as radiculopathy, guidance of the Cochrane handbook. The key words
nerve root compromise, nerve root compression, nerve include ‘sciatica’, ‘sciatic neuralgia’, ‘discogenic sciatica’,
root pain and pain radiating below the knee. There will ‘disc herniation-induced sciatica’, ‘bilateral sciatica’, ‘acu-
be no restriction on sex, age or the intensity or duration puncture’, ‘electro-acupuncture’, ‘elongated needle’,
of symptoms. ‘three-edged needle’, ‘fire needling’, ‘auricular acupunc-
Patients with acute infection, caudal equina syndrome, ture’, ‘abdominal acupuncture’ and ‘pyonex’.
primary spinal stenosis and lower back pain without sci- The strategy for searching the PUBMED database is
atica will be excluded. shown in table 1. This search strategy will also be
applied to the other electronic databases.
Types of interventions
▸ Any type of invasive acupuncture will be included, Data collection and analysis
such as acupuncture, electro-acupuncture, elongated Selection of studies
needle acupuncture, three-edged needle acupunc- Two authors (XL and YZ) will screen the title and
ture, fire needling, auricular acupuncture, abdominal abstracts of all the articles to confirm that they contain
acupuncture, warm acupuncture and pyonex. Control eligible trials, with the full text to be reviewed if neces-
interventions may include general care, sham acu- sary. Any disagreement during the selection of studies
puncture/placebo and waiting list care. will be discussed and decided by a third author (ZL).
▸ Acupuncture versus other Western medicine treat- Details of the selection process are shown in the
ment will be included. PRISMA flow chart (figure 1).

2 Qin Z, et al. BMJ Open 2015;5:e007498. doi:10.1136/bmjopen-2014-007498

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(QY and YZ) will independently evaluate methodological
Table 1 Search strategy used in the PubMed database
quality using the following seven domains: random
Number Search items sequence generation, allocation concealment, blinding
1 randomized controlled [Link] of participants and personnel, blinding of outcome
2 controlled clinical [Link] assessment, incomplete outcome data, selective report-
3 [Link],ab ing and other bias. Other sources of bias may be caused
4 [Link],ab by the different types of needles used, the duration of
5 [Link],ab sciatica, the length of therapy and the age of patients.
6 [Link],ab
Taking these domains into account, each trial will be
7 or 1-6
8 [Link],ab
categorised into low risk, high risk and unclear risk. Any
9 [Link],ab disagreements will be discussed and resolved by a third
10 elongated [Link],ab author (ZL).
11 three edged [Link],ab
12 (fire needle or warming needle).ti,ab Confidence in cumulative estimate
13 auricular [Link],ab Details of acupuncture and control interventions were
14 abdominal [Link],ab extracted on the basis of the revised Standard for
15 warm [Link],ab Reporting Interventions in Clinical Trials of
16 [Link],ab Acupuncture (STRICTA),27 a checklist that was intended
17 or 8-16 for use in conjunction with CONSORT and can estimate
18 [Link],ab
RCTs of acupuncture, include acupuncture rationale,
19 sciatic [Link],ab
20 discogenic [Link],ab
needling details, treatment regimen, co-intervention,
21 bilateral [Link],ab control interventions and treating background.
22 disc herniation-induced [Link],ab
23 or 18–22 Measurement of treatment effect
24 7 and 17 and 23 Analysis will be based on available data of included
This search strategy will be modified as required for other studies. For dichotomous data, the risk ratio (RR) will be
electronic databases. calculated with 95% CIs. For continuous variables,
means and SDs will be used to calculate a mean differ-
Data extraction and management ence with a 95% CI.
A data extraction form will be used to collect data. A
small scope trial will be done before the systematic review Dealing with missing data
is conducted to confirm that there is no obvious diver- The listed corresponding author will be contacted to try
gence between those collecting data. Two authors (XL and obtain any missing information from their trial. If it
and YZ) will independently extract the data and take the is impossible to obtain the data, the study will be
following aspects into consideration: general information excluded from the data synthesis.
(name and year of publication, date of extraction, title of
study and author’s publication details), study character- Assessment of heterogeneity
istics, eligibility criteria, interventions, outcome measure- Before combining the statistics, tests for heterogeneity
ments, duration, adverse events, results and the type of will be used to judge the homogeneity of the studies. If
needle used. All searched studies will be inputted to the resulting p value exceeds 0.1, indicating significant
EndNote software that can assist reviews to manage data heterogeneity among trials, the reasons leading to het-
and pick up duplicate publications; when two or more erogeneity will be analysed and subgroup analysis will be
publications described a single trial, we included only conducted.
one report. These data will then be entered into RevMan
V.5.3.3 software for analysis. Any disagreement will be dis- Assessment of reporting biases
cussed and finally decided on by a third author (ZL). A funnel plot will be used to assess the reporting biases
if 10 or more trials are included in a meta-analysis.
Data items
We will extract the information of each study, including Data synthesis
the type of control used, frequency and duration of If meta-analysis can be conducted, RevMan V.5.3.3 soft-
treatment, patient characteristics (age, gender, duration ware will be used to combine the RR with 95% CIs for
of symptoms, type of sciatica), trial design, trial size, dur- dichotomous outcomes and the weighted mean differ-
ation of follow-up, type and source of financial support, ence or standardised mean difference with 95% CIs for
if appropriate. continuous data. If the result of the test for heterogen-
eity results in p>0.1, the fixed-effect model will be used
Assessment of risk of bias in included studies to combine the data; if p<0.1, the random-effect model
The risk of bias assessment will be based on the will be used. If the data will not be suitable for combin-
Cochrane Collaboration Risk of Bias Tool.26 Two authors ing quantitatively, in the condition, a systematic narrative

Qin Z, et al. BMJ Open 2015;5:e007498. doi:10.1136/bmjopen-2014-007498 3

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Figure 1 Study flow diagram.

synthesis will be provided with the information that pre- systematic review will be disseminated only in a peer-
sented in the text to summarise and explain the reviewed publication.
characteristics and findings of the included studies.

Subgroup analysis DISCUSSION

The following subgroup analyses will be conducted to Sciatica causes significant suffering for the individual,
assess the heterogeneity of the studies: yet most of the currently available treatment options are
Clinical considerations not adequate to control pain. Pharmacological methods
▸ Acupuncture versus sham acupuncture, have associated adverse effects, while surgery is expen-
▸ Types of sciatica (non-discogenic sciatica vs disco- sive and is not appropriate for every patient.
genic sciatica). Acupuncture has been used for 3000 years in China and
Methodological considerations is generally regarded as a safe and effective measure to
▸ Trials with unclear or high risk of bias. alleviate pain. However, when the effectiveness of acu-
puncture for a condition remains unclear, it is difficult
Sensitivity analysis for clinicians to make appropriate recommendations.
If the test for heterogeneity p value is less than 0.1 after The mechanism of acupuncture analgesia is gradually
the data extraction has been checked and subgroup ana- becoming known. Han28 found that acupuncture can
lyses conducted, the low-quality studies will be excluded promote release of neurotransmitter such as 5-
and the meta-analysis will be conducted again. hydroxytryptamine and in addition it generates neuro-
peptide through electrical stimulation of different fre-
Ethics and dissemination quencies that has significantly effect to pain reduction.
This systematic review will not use data from individual This is a protocol for a systematic review that aims to
patients to protect privacy, and the results of this assess the safety and effectiveness of acupuncture for

4 Qin Z, et al. BMJ Open 2015;5:e007498. doi:10.1136/bmjopen-2014-007498

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BMJ Open: first published as 10.1136/bmjopen-2014-007498 on 28 April 2015. Downloaded from [Link] on December 7, 2024 by guest. Protected by copyright.
sciatica. As there has been no prior systematic review 8. Lewis RA, Willams NH, Sutton AJ, et al. Comparative clinical
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manuscript protocol was drafted by ZQ and revised by QY. The search review. Eur Spine J 2006;15:S82–92.
strategy was developed by all the authors and will be performed by YZ and 16. Wang SZ, Wu GY, Huang Y, et al. Integrated traditional Chinese and
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Competing interests None declared. acupuncture. Clin Exp Rheumatol 2012;30:112–16.
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the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,
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which permits others to distribute, remix, adapt, build upon this work non- 1983;59:3109–14.
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