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KSR Number: KSRA82781

Does methylprednisolone improve postoperative outcomes after mandibular third molar surgery? A systematic review and meta-analysis

Risk of Bias Assessment

Overall summary: High risk of bias in the review

Bottom Line

The current evidence suggests that oral methylprednisolone (MP) might significantly improve both early and late postoperative pain, as well as early oedema and trismus compared to placebo in patients following mandibular third molar surgery. Moreover, intramuscular MP seems to improve early oedema; submucosal MP improves early postoperative pain and intra-masseteric MP improves late trismus compared to placebo. However, no significant difference was observed between intravenous MP and placebo for early or late trismus. The review had significant methodological weaknesses, so the findings should be interpreted with caution. Further research including high-quality randomised clinical trials on the use of MP in third molar surgery is required to support the current findings.

Risk of Bias Assessment

Overall summary High risk of bias in the review

High

Only studies published in full-text were included. Only PubMed, Scopus, Cochrane CENTRAL and Google Scholar were searched for relevant studies. Searches were restricted to the English language. No information was provided regarding the number of authors involved in the data extraction and risk of bias assessment. Appropriate attempts were not made to explore the possible sources of heterogeneity. Robustness of the findings was not demonstrated.

A. Did the interpretation of findings address all of the concerns identified in Domains 1 to 4? Probably no
B. Was the relevance of identified studies to the review's research question appropriately considered? Probably yes
C. Did the reviewers avoid emphasizing results on the basis of their statistical significance? Probably yes
Risk of bias in the review High

Details of Review

Number of studies 28
Number of participants 2,080
Last search date January 2018
Review type Intervention
Objective To investigate whether methylprednisolone administered via any route improves postoperative outcomes following mandibular third molar surgery.
Population Patients requiring mandibular third molar surgery.
Interventions Preoperative, intraoperative, or postoperative methylprednisolone/prednisolone via any route.
Comparator Placebo.
Outcome Pain, trismus and oedema.
Study design Randomised clinical trials and controlled clinical trials.

Retrospective cohort studies, clinical series, case reports, review papers or uncontrolled studies were excluded.

Results

The pooled analysis of five trials (n=562) demonstrated that the use of oral MP had a significantly reduced pain effect in the early (standardised mean difference [SMD] -0.45, 95% confidence interval [CI] -0.78 to -0.13) and late (SMD -0.49, 95% CI -0.78 to -0.20) postoperative period compared to placebo in patients following mandibular third molar surgery. Similarly, three trials (n=206) reported that oral MP had a significantly reduced early oedema compared to placebo (SMD -0.56, 95% CI -0.84 to -0.28), while no significant difference was observed between the two groups for late oedema (SMD -0.27, 95% CI -0.54 to 0.01). Moreover, six trials (n=520) reported that oral MP had significantly better early trismus compared to placebo (mean difference [MD] 6.11, 95% CI 1.19 to 11.03), while no significant difference was observed between the two groups for late trismus (MD 2.63, 95% CI -3.29 to 8.55).

Four trials (n=159) demonstrated no significant differences between intravenous MP and placebo for trismus in the early (MD 3.15, 95% CI -2.14 to 8.44) and late (MD 2.22, 95% CI -0.95 to 5.39) postoperative period. Three trials (n=152) reported that intramuscular MP had significantly reduced early oedema compared to placebo (MD -3.38, 95% CI -5.12 to -1.64), while no significant differences between the intramuscular MP and placebo for early trismus (MD 0.40, 95% CI -3.21 to 4.02) were found.

The narrative analysis found that submucosal MP had a significant reduction in early postoperative pain compared to placebo (3 trials), while five trials observed that intra-masseteric MP had a significantly improved late trismus compared to placebo.

Full Risk of Bias Assessment

The research objective was clearly stated. Eligibility criteria were well described and appeared appropriate to address the present review question. No restriction was reported based on study characteristics. Only studies published in full-text were included.

1.1 Did the review adhere to pre-defined objectives and eligibility criteria? Probably yes
1.2 Were the eligibility criteria appropriate for the review question? Probably yes
1.3 Were eligibility criteria unambiguous? Probably yes
1.4 Were all restrictions in eligibility criteria based on study characteristics appropriate (e.g. date, sample size, study quality, outcomes measured)? Probably yes
1.5 Were any restrictions in eligibility criteria based on sources of information appropriate (e.g. publication status or format, language, availability of data)? Probably no
Concerns regarding specification of study eligibility criteria High

PubMed, Scopus, Cochrane CENTRAL and Google Scholar were searched for relevant studies. Identified articles were scanned for additional studies and clinical trials registry platforms were searched for ongoing trials. Searches were restricted to identify English language publications. Only MeSH terms were provided for the search strategy and it was not explained how the concepts were combined or how filters were applied so it is not possible to comment on the adequacy of the search strategy. Two review authors were independently involved in study selection and disagreements were resolved by consulting the third review author.

2.1 Did the search include an appropriate range of databases/electronic sources for published and unpublished reports? Probably yes
2.2 Were methods additional to database searching used to identify relevant reports? Probably yes
2.3 Were the terms and structure of the search strategy likely to retrieve as many eligible studies as possible? No information
2.4 Were restrictions based on date, publication format, or language appropriate? Probably no
2.5 Were efforts made to minimise error in selection of studies? Yes
Concerns regarding methods used to identify and/or select studies High

No information was provided regarding the number of authors involved in the data extraction and risk of bias assessment. Sufficient study characteristics appear to have been extracted to allow interpretation of the results. Relevant study results appear to have been extracted. The quality of included studies was assessed using the Cochrane Collaboration risk assessment tool for randomised clinical trials.

3.1 Were efforts made to minimise error in data collection? No information
3.2 Were sufficient study characteristics considered for both review authors and readers to be able to interpret the results? Probably yes
3.3 Were all relevant study results collected for use in the synthesis? Probably yes
3.4 Was risk of bias (or methodological quality) formally assessed using appropriate criteria? Probably yes
3.5 Were efforts made to minimise error in risk of bias assessment? No information
Concerns regarding methods used to collect data and appraise studies Unclear

The synthesis included all relevant studies. The method of analysis was explained and appeared appropriate. There was significant evidence of heterogeneity. Appropriate attempts were not made to explore the possible sources of heterogeneity. A narrative synthesis was performed wherever meta-analysis was not possible. Robustness of the findings was not demonstrated. The quality of individual studies was considered in the synthesis.

4.1 Did the synthesis include all studies that it should? Probably yes
4.2 Were all pre-defined analyses reported or departures explained? Probably yes
4.3 Was the synthesis appropriate given the degree of similarity in the research questions, study designs and outcomes across included studies? Probably yes
4.4 Was between-study variation minimal or addressed in the synthesis? Probably no
4.5 Were the findings robust, e.g. as demonstrated through funnel plot or sensitivity analyses? Probably no
4.6 Were biases in primary studies minimal or addressed in the synthesis? Probably yes
Concerns regarding synthesis and findings High

Keywords