This study aims to evaluate the efficacy and safety of acupuncture for blepharospasm using system valuation and meta-analysis. It also provides a safer and more effective treatment for patients with blepharospasm.
This protocol (registration number CRD42020222489) has been registered on the International Prospective Register of Systematic Reviews (PROSPERO). The protocol will strictly follow the guideline of Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P). The PRISMA-P checklist for our study is displayed in Additional file 1. If necessary, the authors will update the protocol during our research.
Type of study
Randomized controlled trials (RCTs) of all acupuncture treatment for blepharospasm includes:
1. Traditional acupuncture
2. Warm-needle techniques
No publication date was imposed on the initial search. Language restrictions are Chinese and English.
Types of participants
1. Blepharospasm patients (aged 18 years or older) regardless of gender and nationality.
2. Patients with Meige syndrome or blepharospasm.
3. Types of blepharospasm are not restricted.
Types of intervention
Acupuncture therapies used in the observation group include body acupuncture, ear acupuncture, scalp acupuncture, fire acupuncture, warming acupuncture and electroacupuncture. There is no limit on the length or frequency of treatment.
Control interventions include no treatment/wait list, sham control, or no active treatment (such as physical therapy, oral medications, surgery, injections, or other traditional medication). Studies that compare the effects of blepharospasm to herbal remedies will be excluded. If participants in the blepharospasm group received another aggressive treatment, only studies that included all control group participants receiving the same aggressive treatment as the combined intervention would be selected.
Types of efficacy index
1. Muscle motor function using dystonias scales (eg, BurkeFahn-Marsden dystonia rating scale(BFM), UDRS) ,and the Blepharospasm Severity Scale (BSS), the Jankovic Rating Scale (JRC), the Blepharospasm Disability Scale (BDS), and Blepharospasm Disability Index (BSDI) [12,21].
2. Change in level of consciousness.
3. Severe adverse events.
1. Comprehensive assessment of participant improvement (eg, proportion of overall improvement and subjective improvement).
2. Adverse events associated with blepharospasm or any other treatments.
1. Diagnostic criteria is unclear .
2. The data are duplicated, or the data information is incomplete.
3. The research is a type of Non-RCTs or Quasi-RCTs.
4. The studies are observational or retrospective.
5. The study subjects are non-human.
Search methods for identification of studies
Electronic data sources
We will screen eligible published studies from 9 databases up to December 2020, including 5 English databases (Cochrane Central Register of Controlled Trials, Web of Science, MEDLINE, PubMed, and Excerpta Medica Database) and 4 Chinese databases (China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database, China Wanfang Database, and VIP Database).
Searches will be also carried out on the Cochrane Central Register of Controlled Trials, the PROSPERO Register of Controlled Trials, and the Cochrane Complementary Medicine Field Specialized Register. If part of the data is incomplete, we will also obtain complete data information from the author by certain means.
Acupuncture and randomized controlled trial/RCT will be search teams. Multiple retrieval methods in Chinese and English databases will be conducted without publication restriction. The search strategy in PubMed is presented in Table1. Additionally, appropriate modifications will be conducted in accordance with requirements.
The literature collection and data analysis
Screening of literature
Two researchers(HH, QH) will screen the studies in accordance with the inclusion and exclusion standard independently. The final selection procedure will be demonstrated in Figure 1 according to the PRISMA guidelines.
Data extraction and management
The data will be extracted by QH and NG. Each study is evaluated in terms of the type of design, randomisation, inclusion or exclusion standard, the characteristics of participants, intervention measures, outcomes measures, and the quality of study. Encountering differences, they will turn to YLZ for verification.
Quality assessment of the studies included
Two researchers (HH, RXL) will evaluate the included literature quality. According to Cochrane Handbook for Systematic Reviews of Interventions, 7 aspects of bias risk will be assessed:
1. whether the sequence is randomly generated;
2. whether allocation concealment is adopted;
3. whether participants and personnel implement the blind method;
4. whether the blind method is used to evaluate the results;
5. whether the outcome data are complete;
6. whether the selective outcome has been reported;
7. other bias: follow-up, conflicts of interest, non-intention-to-treat or per-protocol analysis, etc.
The study quality will be described as “bias of low risk,” “bias of high risk,” and “uncertainty of bias risk.”
Measures of treatment effect
The odds ratio (OR) is used as the effect size if the data type is binary, while the standardized mean difference (SMD) and its 95% confidence interval (CI) is adopted as the effect size if the data type is quantitative.
Management of missing data
The missing data will be acquired through contacting first authors. The incomplete data will be deleted if they cannot be obtained. If necessary, the potential influence of missing data on the conclusions of the research would be clarified in the section of ‘Discussion’.
The Cochran Q statistic and the I2 statistic will be used to evaluate the heterogeneity across studies. If I2>50%, heterogeneity exiting, a random-effects model (REM) will be selected. If I2< 50%, indicating no significant heterogeneity, a fixed-effects model (FEM) will be adopted.
Assessment of publication biases
Egger’s and Beg’s tests will be conducted to assess publication bias in a meta-analysis through funnel plot asymmetry. P value <.05 refers to significant publication bias.
In case of sufficient studies (>10), the the heterogeneity source will be clarified by the mothod of subgroup analysis based on acupoint therapy combined with other treatments. The study with low quality will be excluded to assure the reliability of the funding.
Sensitivity analysis will be performed to assesses the reliability of the conclusions and indicate the impact of the protocol deviations on results. If the stability is poor, the analysis model, inclusion and exclusion criteria will be adjusted to increase stability.
The RevMan 5.4.1 software will be used to analyse the data. The X2 test and I2 test will indicate the application of a FEM or a REM. Substantial statistical heterogeneity not found, a systematic narrative synthesis will be performed to summarize and analyse the findings of the studies included.
Grading of quality of evidence
The evidence quality will be conducted according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system in terms of inconsistency, limitation, imprecision, indirectness, and the publication bias. The system classifies evidence into high, moderate, low, and very low.
Ethics and dissemination
We will publish this review in peer-reviewed journals, or address it in meetings. The individual participant data will be excluded, so it is not necessary to acquire the ethical approval or informed consent.