Abstract
Objective: To assess the effect of acupuncture on foot and ankle pain intensity, functional status, quality of life, and incidence of adverse events in adults.
Methods: Randomized controlled trials (RCTs) were obtained from a systematic search of 6 major English databases, and a manual search of relevant systematic reviews using Google Scholar. RCTs that compared acupuncture with various forms of sham acupuncture, nonactive and waitlist controls for pain intensity, functional status, and general quality of life were included. Study screening, data extraction, risk of bias assessment, and quality assessment were all performed independently. A narrative synthesis was performed when quantitative pooling was inappropriate.
Results: Four RCTs were included, encompassing a total of 211 participants. Due to clinical heterogeneity for all outcomes, quantitative analysis was not appropriate. Our Grades of Recommendation, Assessment, Development and Evaluation rated all outcomes to have either low or very low quality of evidence. With low-quality evidence, acupuncture was shown to be efficacious for participants with plantar fasciitis for pain relief and functional status improvement at short- and intermediate-term follow-ups. Acupuncture was also shown to be efficacious for participants with Achilles tendinopathy for pain relief at short- and intermediate-term follow-ups. No adverse events were reported.
Conclusion: There is some evidence to suggest acupuncture to be a safe and efficacious treatment for relieving pain and improving functional status for the foot and ankle. The results of this systematic review should be interpreted with caution due to the limited evidence. Future research should take into consideration the findings of this systematic review.
Keywords: acupuncture, ankle disorder, foot disorder, pain, function, systematic review
INTRODUCTION
Foot and ankle conditions can be painful and are often accompanied by impairments to function and negative impacts on quality of life. The source of the resulting pain and discomfort can be a repetitive use disorder, such as Achilles tendinopathy1 and plantar fasciitis,2 or an injury, such as a sprain3 or a fracture.4 The magnitude, localization, and duration of pain with these complications can vary by cause.5 Despite the wide range of foot and ankle conditions, the common experience of pain is prevalent to such a degree that this may be a burden to the general population. A systematic review found the prevalence of frequent foot and ankle pain to be 24% and 15%, respectively, in middle and old age demographics.6 This is especially relevant for older populations as foot pain acts as an independent risk factor for physical independence in daily activities, and other various injuries and movement impairments related to aging.6
Overall, the population of people who require pain treatments for foot and ankle complications can be estimated to be higher with the inclusion of short-term injuries.
There are several existing approaches for treating foot and ankle conditions for pain relief, functional status improvements, and for general quality of life, such as pain medications (e.g., antispastic medications),7 bracing,4 orthotics,8 and corticosteroid injections.9 However, the research in this area is conflicting and limited, such as in the case of night splints, insoles, and orthotics.10 It is, therefore, evident that a population of those who experience foot and ankle pain will not find current conventional remedies to be sufficient. When conventional therapies are insufficient or ineffective in pain alleviation, alternative and complementary therapies have been considered.
For acupuncture therapies, needles are inserted at precise points and are then stimulated to encourage a variety of potential health benefits.11 Despite originating as a Traditional Chinese Medical practice, it is now generally an emerging evidence-based practice with the continuous addition of anatomy, physiology, and pathology research.11 There is evidence to support the effectiveness of acupuncture as an analgesic tool for many different musculoskeletal conditions, such as headache,12 neck,13 elbow,14 and wrist,15 through the release of endorphins16 and serotonin.17
Currently, to our knowledge, there is a lack of systematic review with regard to the effect of acupuncture on all possible painful foot and ankle conditions. To address the prevalence of foot and ankle conditions, along with the expanding research in the modernized practice of acupuncture, we conducted this systematic review. We analyzed the efficacy of acupuncture on foot and ankle disorders for pain intensity, functional status, and general quality of life in adults. In addition, the incidence of adverse events was also examined. We aim to further the field of foot and ankle research and guide practitioners toward current or alternative therapies with this review.
METHODS
We followed the Cochrane Handbook for Systematic Reviews of Interventions18 to conduct this systematic review.
Search Strategy
Randomized controlled trials (RCTs) were obtained from a manual search of Google Scholar and systematic searches of Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane library, Excerpta Medica dataBASE (EMBASE), Medical Literature Analysis and Retrieval System Online (MEDLINE), and Physiotherapy Evidence Database (PEDro), all from inception to October 19, 2020, with no limits.
Types of Studies
Published RCTs written in English or Chinese were included. To synthesize the highest level of evidence, quasi-RCTs were excluded to help to avoid potential selection biases.
Eligibility Criteria
Participants
Participants had to be 18 years of age or older and diagnosed with any foot or ankle disorder. Studies that could not be reasonably judged to include only adult participants (i.e., reported a mean age that was close to 18 years, no range of age, or did not specify adults as the population) were excluded.
Types of interventions
Techniques that involved the insertion of needles were included. Manual, electrical, heat, or other forms of stimulation may have been involved or added to the needling.
Types of controls
Sham acupuncture controls such as nonpenetrating sham acupuncture, off-point sham acupuncture, and on-point sham acupuncture were included if the acupuncture effect could be isolated between the groups. In addition, waitlist controls, and nonactive treatment controls, such as sham transcutaneous electrical nerve stimulators, were included.
Outcomes and Measures
Primary outcomes included pain intensity (e.g., visual analogue score [VAS], numerical rating scale), functional status (e.g., Foot Functional Index [FFI]), and quality of life (e.g., Short Form -36). Secondary outcomes included the incidence of adverse events.
Outcome Follow-Up Period Definitions
Guidelines from the Cochrane Handbook for Systematic Reviews of Interventions18 for follow-up periods were followed. Post-treatment was defined as up to 1 day after the last session. Short term was defined as >1 day to <3 months after the last session. Intermediate term was defined as 3 months to <1 year after the last session. Long term was defined as 1 year and longer after the last session. If multiple outcomes from the same study fell within a defined time period, the latest outcome was used to incorporate time-based effects.18
Study Selection
Two authors (N.B. and F.Z.) independently performed title and abstract screening using Covidence.19 Two authors (F.Z. and D.L.) independently performed full-text screening using an Excel spreadsheet that checked for the presence of randomization, participants' age being 18 years or older (≥18), the presence of needle insertion, any type of eligible control, and at least 1 relevant outcome. Conflicts regarding study eligibility were resolved through a third author (K.T.). For full texts that were not accessible, an attempt to contact the corresponding author and request for full text was made. The study selection process was reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework.20
Data Extraction
Two authors (N.B. and A.K.) independently extracted study characteristics and outcome data from included studies using predesigned forms in Microsoft Word.
Risk of Bias Assessment
Risk of bias (RoB) of each included study was independently assessed by 2 authors (D.L. and A.K.) using prepiloted forms based on the Cochrane Back Review Group (CBRG) RoB assessment tool (12 criteria).21 This tool includes 12 domains:
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1.
Random sequence generation.
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2.
Allocation concealment.
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3.
Blinding of patients.
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4.
Blinding of care providers.
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5.
Blinding of outcome assessors.
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6.
Dropout rate.
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7.
Patients analyzed in the group to which they were allocated to.
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8.
Selective reporting.
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9.
Similarity of baseline characteristics.
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10.
Cointerventions.
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11.
Compliance.
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12.
Timing of outcome assessment.
Each domain was rated to have either “low,” “unclear,” or “high” RoB based on the judgment of the authors. The overall RoB was rated to have either “low” or “high” RoB. Conflicts regarding study's RoB were resolved through a third author (N.B.). No predefined cutoff score was used for the RoB assessment.
Publication Bias Assessment
We planned to investigate potential biases of publication using the funnel plot and Egger's test,22 but we were unable to, due to a small number of included studies.18
Data Analysis
Measures of treatment effect
In accordance with the Cochrane Handbook for Systematic Reviews of Interventions,18 statistical analysis was performed using the Review Manager software. For primary outcomes, we planned to use standardized mean differences (SMDs) with 95% confidence intervals (95% CIs) for continuous relevant outcomes. SMD was chosen as we expected a variety of different scales to be used to measure the same outcomes. For the secondary outcome incidence of adverse effects, we planned on using risk ratios (RRs) and 95% CIs. An RR value <1 would indicate safer treatments.
Data synthesis
Calculation of the pooled effect measure was performed only when the following appropriate criteria were met:
More than 2 studies reported the same condition, studies compared acupuncture with a control group, and follow-up periods were clearly reported.
The authors judged the methodological structure of the studies in the pooled result to be clinically homogeneous.
The I2 statistic ≤60% when assessing statistical heterogeneity.18
For the primary outcomes, we planned to use the inverse variance statistical analysis and random-effects model. The random-effects model was chosen as we did not expect the true effects to be the same for all included studies. For the secondary outcome, we planned to use the Mantel–Haenszel method with the random-effects model. However, a meta-analysis for both primary and secondary outcomes was deemed inappropriate due to the clinical and statistical heterogeneity present within the included trials.
The assessment of statistical heterogeneity was performed using the I2 statistic, and a value >60% would indicate significant statistical heterogeneity.18 As the criteria for quantitative analysis were not met for all outcomes (I2 > 60%, or less than 2 studies or clinical heterogeneity), a narrative synthesis was performed.
Quality of evidence assessment
The overall quality of evidence was assessed using the Cochrane Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach, as recommended by the Cochrane Handbook for Systematic Reviews of Interventions.23 All included trials started with high quality of evidence when being assessed, however, were downgraded to moderate, low, or very low based on limitations of RoB, imprecision, inconsistency, indirectness, and publication bias. Quality of evidence would be rated higher only due to a large magnitude of effect, or a dose–response gradient. Residual confounding would decrease the magnitude of effect.18
RESULTS
Study Selection
The systematic search of databases identified 998 potential articles (Supplementary Tables S1–S7 and Fig. 1). From the systematic database search, we identified 3 relevant systematic reviews,24–26 and extracted 19 potential studies for screening. In addition, a manual search on Google Scholar was conducted, finding 1 potential article. After the removal of duplicates, 677 articles were left for screening. After full text and abstract screening, 44 articles remained and were assessed for full text screening. A total of 40 articles were excluded. Twenty-six articles were excluded for having the wrong comparator, and 14 were excluded for an ineligible population.
FIG. 1.
PRISMA flow diagram. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
Included Studies
See the characteristics of included studies in the Supplementary Material (Supplementary Table S8).
General characteristics
All 4 trials were parallel RCTs with 1 treatment group, and 1 control group.27–30 Two trials28,29 included a nonpenetrating sham acupuncture control. One trial30 included a waitlist control, and 1 trial27 included an off-point sham acupuncture control. All trials were single centered. Trials were conducted in Hong Kong,30 Australia,29 Germany,27 and the United Kingdom.28
Study participants
From the 4 trials, there were a total of 211 participants. Two trials included 164 participants with plantar fasciitis,29,30 1 trial included 22 participants with Achilles tendinopathy,28 and 1 trial included 25 participants with poststroke leg spasticity.27
Acupuncture interventions
Two trials used verum acupuncture as the intervention group,27,28 1 trial used dry needling,29 and 1 trial used electroacupuncture + warm verum needling.30
Reported outcomes
One trial28 reported on pain intensity alone at short-term and intermediate-term follow-ups. One trial reported on pain intensity, functional status change, and quality of life change at short-term and intermediate-term follow-ups.29 One trial reported on pain intensity, functional status change, and incidence of adverse effects at short-term follow-up.30 One trial reported on functional status changes at post-treatment and short-term follow-ups.27
RoB of Included Studies
The majority of trials were rated to have a low RoB for random sequence generation (3/4), patient blinding (3/4), selective reporting (3/4) and cointervention (3/4) (Figs. 2 and 3). All trials were rated to have a low risk for dropout rate, patient analyzed in groups that they were allocated, similarity of baseline characteristics, and similar timing of outcome assessment. All trials were rated to have an unclear risk for compliance and a high risk for care provider blinding. The majority of trials were rated to have a high risk for outcome assessor blinding (3/4). Half of the trials were low risk for allocation concealment (2/4).
FIG. 2.
RoB traffic light plot. (D1) Random sequence generation, (D2) allocation concealment, (D3) blinding of all patients?, (D4) blinding of all care providers?, (D5) blinding of all outcome assessors?, (D6) incomplete outcome data, was the dropout rate acceptable?, (D7) incomplete outcome data, all analyzed in the group to which they were allocated?, (D8) selective reporting?, (D9) similarity of baseline characteristics, (D10) cointerventions avoided of similar?, (D11) compliance acceptable?, and (D12) similar timing of outcome assessment?. RoB, risk of bias.
FIG. 3.
RoB summary plot.
Two trials were rated to have a low RoB.28,29 Two trials were rated to have an overall high RoB.27,30 Of the 2 trials with a high RoB, Fink et al.27 did not adequately describe the process of randomization, allocation concealment, and compliance, resulting in unclear risk in those categories. In addition, the study was rated to have a high RoB for care provider blinding and selective reporting. Ho et al.30 did not adequately describe compliance, resulting in unclear risk. Furthermore, the study was rated to high RoB for patient blinding, care provider blinding, and outcome assessor blinding.
Publication Bias of Included Studies
The criteria to assess publication bias through a funnel plot were not met, as <10 trials were included.
Participants with Achilles Tendinopathy
One trial reported on pain intensity28 (Table 1).
Table 1.
Acupuncture for Participants with Achilles Tendinopathy
| Study | Measure | Follow-up | Acupuncture group, mean (SD) | Control group, mean (SD) | P < 0.05 |
|---|---|---|---|---|---|
| Kishmishian et al.28 | NPRS | Short term | 2.64 (1.96) | 3.36 (1.63) | Yes |
| Intermediate term | 3.00 (2.19) | 4.27 (2.19) | Yes |
NPRS (0 = no pain, 10 = maximum pain).
NPRS, Numerical Pain Rating Scale; SD, standard deviation.
Verum acupuncture versus nonpenetrating sham acupuncture
Pain intensity (short term and intermediate term)
The study by Kishmishian et al.28 (n = 22/22 *n = analyzed/randomized) reported statistically significant between-group difference results that favored verum acupuncture over waitlist at both short-term and intermediate-term follow-ups. Due to the imprecision and inconsistency of the study's results on the basis of the GRADE scale, we downgraded the quality of evidence to low (Supplementary Table S9).
Participants with plantar fasciitis
Two trials reported on pain intensity22,25 and 1 reported on the function and quality of life22 (Table 2).
Table 2.
Acupuncture for Participants with Plantar Fasciitis
| Study | Measure | Follow-up | Acupuncture group, mean (SD) | Control group, mean (SD) | P < 0.05 |
|---|---|---|---|---|---|
| Cotchett et al.29 | Pain (VAS) 0–100 mm |
Short term | 28.6 (19.0) | 38.3 (25.0) | Yes |
| Intermediate term | 20.9 (19.4) | 29.9 (23.3) | Yes | ||
| Pain (FHSQ) | Short term | 63.0 (20.5) | 55.7 (23.4) | Yes | |
| Intermediate term | 72.2 (18.9) | 65.7 (20.5) | Yes | ||
| Function (FHSQ) | Short term | 65.6 (24.8) | 69.3 (25.7) | No | |
| Intermediate term | 77.2 (21.7) | 79.5 (18.1) | No | ||
| Quality of life (SF-36, physical component) | Short term | 45.9 (8.3) | 46.4 (9.0) | No | |
| Intermediate term | 46.3 (8.8) | 48.3 (7.3) | No | ||
| Quality of life (SF-36, mental component) | Short term | 52.5 (8.1) | 51.8 (11.0) | No | |
| Intermediate term | 52.1 (8.0) | 54.6 (7.9) | No | ||
| Ho et al.30 | Pain (VAS) | Short term | 40.43 (20.67) | 67.01 (16.48) | Yes |
| Pain (FFI) | Short term | 37.14 (20.77) | 65.79 (19.51) | Yes | |
| Function (FFI) | Short term | 36.93 (22.13) | 63.58 (19.98) | Yes |
FFI (Foot Health Status Questionnaire [higher score indicating greater impairment]); FHSQ (0 = worst foot health, 100 = best foot health); SF-36, (0 = worst quality of life, 100 = best quality of life); VAS, (0 = no pain, 100 = maximum pain).
FFI, Foot Function Index; FHSQ, Foot Health Status Questionnaire; SF-36, 36-item Short-form Health Survey; VAS, visual analog score.
Dry needling versus nonpenetrating sham acupuncture
Pain intensity (short-term and intermediate-term)
The study by Cotchett et al.29 (n = 84/84) reported short-term pain intensity using the VAS and FHSQ measurement scales. The between-group difference results favored dry needling over nonpenetrating sham acupuncture for both scales, and were statistically significant. Due to the imprecision and inconsistency of the study's results, on the basis of the GRADE scale, we downgraded the quality of evidence to low.
Function (short term and intermediate term)
The study by Cotchett et al.29 (n = 84/84) reported the between-group difference result for short term and intermediate term and did not reach statistical significance. Due to the imprecision and inconsistency of the study's results, on the basis of the GRADE scale, we downgraded the quality of evidence to low.
Quality of life (short term and intermediate term)
The study by Cotchett et al.29 (n = 84/84) reported the between-group difference result for short term and intermediate term, which did not reach statistical significance. Due to the imprecision and inconsistency of the study's results, on the basis of the GRADE scale, we downgraded the quality of evidence to low.
Electroacupuncture and warm verum needling versus waitlist control
Pain Intensity (short term)
The study by Ho et al.30 (n = 80/80) reported short-term pain intensity using the VAS and FFI measurement scales. For both scales, the between-group difference result favored the electroacupuncture and verum warm needling group over waitlist control, and were statistically significant. Due to the high RoB, imprecision, and inconsistency of the study's results, on the basis of the GRADE scale, we downgraded the quality of evidence to very low.
Function (short term)
Ho et al.30 (n = 80/80) reported that the between-group difference result favored the electroacupuncture and warm verum needling group over waitlist, and this was statistically significant.30 Due to the high RoB, imprecision, and inconsistency of the study's results, on the basis of the GRADE scale, we downgraded the quality of evidence to very low.
Incidence of adverse effects
Ho et al.30 (n = 80/80) reported no incidence of adverse events.
Participants with Poststroke Leg Spasticity
One trial reported on function27 (Table 3).
Table 3.
Acupuncture for Participants with Poststroke Leg Spasticity
| Study | Measure | Follow up | Acupuncture group, mean (SD) | Control group, mean (SD) | P < 0.05 |
|---|---|---|---|---|---|
| Fink et al.27 | MAS | Post-treatment | 2.9 (1.3) | 3.3 (0.8) | No |
| Short term | 3.3 (1.1) | 3.3 (0.9) | No |
MAS (0 = no increase in muscle tone, 4 = affected part rigid in flexion or extension).
MAS, Modified Ashworth Scale.
Verum acupuncture versus off-point sham acupuncture
Function (post-treatment and short term)
The study by Fink et al.27 (n = 25/25) reported the between-group difference result for post-treatment and short term, which did not reach statistical significance. Due to the high RoB, and inconsistency of the study's results, on the basis of the GRADE scale, we downgraded the quality of evidence to low.
DISCUSSION
Despite having a limited amount of evidence, our systematic review has found acupuncture to be potentially efficacious for plantar fasciitis and Achilles tendinopathy. With an overall low quality of evidence, dry needling has shown to be efficacious when compared with nonpenetrating sham acupuncture at short- and intermediate-term follow-ups.29 In addition, with very low quality evidence, electroacupuncture and warm needling have shown to be efficacious for relieving pain intensity and improving functional status at short-term follow-up.30 For patients with Achilles tendinopathy, with low quality of evidence, verum acupuncture has shown to be potentially efficacious for relieving pain at short- and intermediate-term follow-ups.28 The findings of our study were consistent with the previous systematic reviews conducted by Cox et al.24 and Clark and Tighe,25 in that acupuncture was favored over the controls for patients with Achilles tendinopathy and plantar fasciitis. Based on the findings from Ho et al.,30 it appears that acupuncture treatments are generally safe. However, as only 1 study reported the incidence of adverse effects, this finding may not be generalizable and should be interpreted with caution. Future RCTs that aim to examine the efficacy of acupuncture on foot/ankle disorders should also address the safety of the treatment.
There were consistent reported methodological issues with half of the included studies. With the 4 studies included, 2 were rated to have an overall high RoB (Fig. 2). The first trial27 was assessed to have unclear random sequence generation, unclear allocation concealment, and high risk for selective reporting, as many of the outcomes that were mentioned to be conducted were not reported. Therefore, the authors have assessed the overall RoB to be high due to the potential selection and performance bias.18 The second trial30 lacked blinding for both participants and outcome assessors. As a result, due to the potential performance bias, the overall RoB was rated to be high.18
Our GRADE assessment rated the majority of outcomes to have an overall low quality of evidence (Supplementary Table S8). This is mainly due to the lack of published studies, and the clinical heterogeneity between the included studies. All outcomes were downgraded for inconsistency by 1 level, as there was no instance of pooling being appropriate. In addition, the majority of outcomes were downgraded by 1 level for imprecision due to the large width of distributions. Although 2 trials examined acupuncture for plantar fasciitis for pain intensity, pooling was not appropriate for all outcomes due to the clinical and statistical heterogeneity, as both studies used different forms of both acupuncture and control groups.
This review had several limitations. The eligibility criteria for this review were restricted to various types of sham acupuncture, inactive treatment controls, and waitlist controls. This would allow the effects of acupuncture to be isolated between groups and provide clearer evidence for the acupuncture treatment effect when synthesized. However, after full-text screening, a majority of studies were excluded as many compared acupuncture with an active control group such as physiotherapy or exercise (Fig. 1). Although we hypothesized that a limited inclusion criteria would allow for a more appropriate synthesis of evidence, we were not expecting few or limited amount of evidence to this degree, as the previous systematic reviews published on similar topics included many trials.24–26 Due to the limited number of included trials and the presence of clinical heterogeneity, we were unable to appropriately pool any outcomes, and, as a result, we were left with the majority of outcomes being assessed to have low quality of evidence. Another limitation was that 2 trials27,28 had small sample sizes (n = 25 and n = 22, respectively), which often leads to insignificant conclusions. In addition to the small sample size in Fink et al.,27 the authors did not conduct a sample normal distribution test and preceded to report mean and standard deviation for the outcomes. Typically, with small samples, the data often do not follow a normal distribution. To avoid misleading results, median and interquartile ranges are often reported instead.31 Due to the aforementioned limitations, our findings should be interpreted with caution.
As a recommendation, future RCTs should implement controls with sham acupuncture, inactive and no treatment controls to delineate the effect of acupuncture. In addition, to avoid potential selection bias and performance bias, authors should adequately describe the random sequence generation and allocation concealment, and implement blinding for the participants and outcome assessors.18 Lastly, larger sample sizes should be included to have adequate statistical power.
CONCLUSION
With limited evidence, acupuncture may potentially be an efficacious treatment for plantar fasciitis and Achilles tendinopathy. With the GRADE approach assessments, there was overall low quality evidence, which favored acupuncture for pain relief and improvement in functional status for patients with plantar fasciitis and Achilles tendinopathy at short- and intermediate-term follow-ups. There were no reported adverse effects from the included studies. Our findings should be critically considered for future conductions of RCTs.
Supplementary Material
ACKNOWLEDGMENTS
We thank Rachel Couban for designing the search strategy and conducting the systematic database searches. We also thank Kleiton Strobl for helping draft the introduction and reviewing the article for spelling, grammar, and referencing mistakes.
AUTHORS' CONTRIBUTIONS
K.T. supervised the project, conceived and designed the methodology of the study, performed abstract screening arbitration, full text screening arbitration, and critically edited the article. N.B. designed the methodology of the study, hand searched relevant reviews, data extraction, performed RoB assessment arbitration, GRADE assessment and data analysis, and drafted the article. F.Z. designed the methodology of the study, performed title and abstract screening, full text retrieval, full text screening, data extraction, GRADE assessment and data analysis, and drafted the article. A.K. performed data extraction, RoB assessment, data analysis, and drafted the article. D.L. performed title and abstract screening, full text retrieval, full text screening, RoB assessment, and critically edited the article. E.Y. performed data analysis and drafted the article. All authors have reviewed and approved the final version of the article and agree to be held accountable for all aspects of the study.
AUTHOR DISCLOSURE STATEMENT
No competing financial interests exist.
FUNDING INFORMATION
This study was funded by Dr. Kien Trinh.
Supplementary Material
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