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The American Journal of Sports Medicine Nov 2014The role of evidence-based medicine in sports medicine and orthopaedic surgery is rapidly growing. Systematic reviews and meta-analyses are also proliferating in the... (Review)
Review
BACKGROUND
The role of evidence-based medicine in sports medicine and orthopaedic surgery is rapidly growing. Systematic reviews and meta-analyses are also proliferating in the medical literature.
PURPOSE
To provide the outline necessary for a practitioner to properly understand and/or conduct a systematic review for publication in a sports medicine journal.
STUDY DESIGN
Review.
METHODS
The steps of a successful systematic review include the following: identification of an unanswered answerable question; explicit definitions of the investigation's participant(s), intervention(s), comparison(s), and outcome(s); utilization of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines and PROSPERO registration; thorough systematic data extraction; and appropriate grading of the evidence and strength of the recommendations.
RESULTS
An outline to understand and conduct a systematic review is provided, and the difference between meta-analyses and systematic reviews is described. The steps necessary to perform a systematic review are fully explained, including the study purpose, search methodology, data extraction, reporting of results, identification of bias, and reporting of the study's main findings.
CONCLUSION
Systematic reviews or meta-analyses critically appraise and formally synthesize the best existing evidence to provide a statement of conclusion that answers specific clinical questions. Readers and reviewers, however, must recognize that the quality and strength of recommendations in a review are only as strong as the quality of studies that it analyzes. Thus, great care must be used in the interpretation of bias and extrapolation of the review's findings to translation to clinical practice. Without advanced education on the topic, the reader may follow the steps discussed herein to perform a systematic review.
Topics: Evidence-Based Medicine; Humans; Medical Writing; Meta-Analysis as Topic; Orthopedics; Publishing; Review Literature as Topic; Sports Medicine
PubMed: 23925575
DOI: 10.1177/0363546513497567 -
International Journal of Cardiology Nov 2016Acute myocardial infarction (AMI) is an important health problem. Cardiac rehabilitation (CR) programs following AMI have shown to be effective in reducing mortality. We... (Review)
Review
Acute myocardial infarction (AMI) is an important health problem. Cardiac rehabilitation (CR) programs following AMI have shown to be effective in reducing mortality. We aim to systematically review the existing literature that analyzes the factors that affect participation and adherence to cardiac rehabilitation programs. We reviewed Medline, EMBASE and Cochrane databases from 01/01/2004 to June 2016 using predefined inclusion and exclusion criteria. We classified the results into factors affecting participation and factors influencing adherence to CR programs. We included 29 studies, and there was a general agreement in those factors predicting participation and adherence to CR programs. These factors can be classified into person-related factors and aspects related to CR programs. Older participants, women, patients with comorbidities, unemployed and uncoupled persons, less educated people and those with lower income had a lower participation. A similar pattern was observed for CR adherence. Also, those potential participants who live farther from CR facilities, do not have transportation, or do not drive, attended less to CR programs. These factors were very similar when analyzing adherence to CR programs. These aspects were similar in Europe and the USA. These results clearly show that participation in CR programs follows a determined pattern that is very homogeneous in different settings. Health professionals should also be aware of patients reluctant to participate in CR programs and adapt their messages and redesign CR programs, to promote participation and adherence.
Topics: Cardiac Rehabilitation; Humans; Myocardial Infarction; Patient Compliance; Program Evaluation; Referral and Consultation
PubMed: 27557484
DOI: 10.1016/j.ijcard.2016.08.120 -
The Cochrane Database of Systematic... Feb 2022Discharge planning is a routine feature of health systems in many countries that aims to reduce delayed discharge from hospital, and improve the co-ordination of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Discharge planning is a routine feature of health systems in many countries that aims to reduce delayed discharge from hospital, and improve the co-ordination of services following discharge from hospital and reduce the risk of hospital readmission. This is the fifth update of the original review.
OBJECTIVES
To assess the effectiveness of planning the discharge of individual patients moving from hospital.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase and two trials registers on 20 April 2021. We searched two other databases up to 31 March 2020. We also conducted reference checking, citation searching and contact with study authors to identify additional studies.
SELECTION CRITERIA
Randomised trials that compared an individualised discharge plan with routine discharge that was not tailored to individual participants. Participants were hospital inpatients.
DATA COLLECTION AND ANALYSIS
Two review authors independently undertook data analysis and quality assessment using a pre-designed data extraction sheet. We grouped studies by older people with a medical condition, people recovering from surgery, and studies that recruited participants with a mix of conditions. We calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous data using fixed-effect meta-analysis. When combining outcome data it was not possible because of differences in the reporting of outcomes, we summarised the reported results for each trial in the text.
MAIN RESULTS
We included 33 trials (12,242 participants), four new trials included in this update. The majority of trials (N = 30) recruited participants with a medical diagnosis, average age range 60 to 84 years; four of these trials also recruited participants who were in hospital for a surgical procedure. Participants allocated to discharge planning and who were in hospital for a medical condition had a small reduction in the initial hospital length of stay (MD - 0.73, 95% confidence interval (CI) - 1.33 to - 0.12; 11 trials, 2113 participants; moderate-certainty evidence), and a relative reduction in readmission to hospital over an average of three months follow-up (RR 0.89, 95% CI 0.81 to 0.97; 17 trials, 5126 participants; moderate-certainty evidence). There was little or no difference in participant's health status (mortality at three- to nine-month follow-up: RR 1.05, 95% CI 0.85 to 1.29; 8 trials, 2721 participants; moderate certainty) functional status and psychological health measured by a range of measures, 12 studies, 2927 participants; low certainty evidence). There was some evidence that satisfaction might be increased for patients (7 trials), caregivers (1 trial) or healthcare professionals (2 trials) (very low certainty evidence). The cost of a structured discharge plan compared with routine discharge is uncertain (7 trials recruiting 7873 participants with a medical condition; very low certainty evidence).
AUTHORS' CONCLUSIONS
A structured discharge plan that is tailored to the individual patient probably brings about a small reduction in the initial hospital length of stay and readmissions to hospital for older people with a medical condition, may slightly increase patient satisfaction with healthcare received. The impact on patient health status and healthcare resource use or cost to the health service is uncertain.
Topics: Aged; Aged, 80 and over; Hospitals; Humans; Length of Stay; Middle Aged; Patient Discharge; Patient Readmission; Patient Satisfaction; Randomized Controlled Trials as Topic
PubMed: 35199849
DOI: 10.1002/14651858.CD000313.pub6 -
Journal of the American Geriatrics... Sep 2021To examine randomized controlled trials with active music-making interventions, in which older adults with probable mild cognitive impairment (MCI) or dementia... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To examine randomized controlled trials with active music-making interventions, in which older adults with probable mild cognitive impairment (MCI) or dementia physically participate in music, and their effects on cognitive functioning, emotional well-being, and social engagement. Participating in music-making is engaging and has shown diverse benefits. Additionally, this review categorized the music activities of each intervention.
DESIGN
Systematic review and meta-analysis.
SETTING
Long-term care facilities, day centers, specialty outpatient units, and community.
METHODS
Published randomized controlled trials of active music-making interventions to support older adults with probable MCI or dementia were identified (to March 15, 2021) using searches on Medline (Ovid), APA PsycInfo (Ovid), CINAHL (Ebsco), and Embase (Elsevier). The outcomes were cognitive functioning, emotional well-being, and social engagement, including self- and clinician-reported measures such as the Mini-Mental State Examination, Positive and Negative Affect Schedule, and the Beck Depression Inventory. Studies were critically appraised and studies with similar methodology were meta-analyzed.
PARTICIPANTS
Older adults with probable MCI and mild or moderate dementia.
RESULTS
A total of 21 studies with 1472 participants were analyzed for potential effect sizes and intervention activities. Of the 21 studies, nine studies recruiting a total of 495 participants were used to produce a random-effects meta-analytic model for cognitive functioning. Music showed a small, positive effect on cognitive functioning; the combined standard mean difference for the experimental and control group was 0.30 (95% confidence interval [CI] 0.10, 0.51). There was low study heterogeneity, with an I of 24% (p = 0.004). Individual studies for emotional well-being in terms of quality of life and mood showed positive effect sizes, d = 1.08 and d = 1.74, respectively. [Corrections added on July 8, 2021, after first online publication: The preceding sentences were revised from: "… control group was 0.31 (95% confidence interval [CI] 0.10,0.52). There was low study heterogeneity, with an I2 of 25% (p = 0.004)."] CONCLUSION: This review shows that music-making has a small but statistically significant effect on cognitive functioning for older adults with probable MCI or dementia. Future music interventions can benefit from rigorous intervention protocols that isolate specific activities.
Topics: Aged; Cognitive Dysfunction; Dementia; Humans; Music Therapy
PubMed: 34008208
DOI: 10.1111/jgs.17208 -
The Cochrane Database of Systematic... May 2022Comprehensive Geriatric Assessment (CGA) is a multidimensional interdisciplinary diagnostic process focused on determining an older person's medical, psychological and... (Review)
Review
BACKGROUND
Comprehensive Geriatric Assessment (CGA) is a multidimensional interdisciplinary diagnostic process focused on determining an older person's medical, psychological and functional capability in order to develop a co-ordinated and integrated care plan. CGA is not limited simply to assessment, but also directs a holistic management plan for older people, which leads to tangible interventions. While there is established evidence that CGA reduces the likelihood of death and disability in acutely unwell older people, the effectiveness of CGA for community-dwelling, frail, older people at risk of poor health outcomes is less clear.
OBJECTIVES
To determine the effectiveness of CGA for community-dwelling, frail, older adults at risk of poor health outcomes in terms of mortality, nursing home admission, hospital admission, emergency department visits, serious adverse events, functional status, quality of life and resource use, when compared to usual care.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, CINAHL, three trials registers (WHO ICTRP, ClinicalTrials.gov and McMaster Aging Portal) and grey literature up to April 2020; we also checked reference lists and contacted study authors.
SELECTION CRITERIA
We included randomised trials that compared CGA for community-dwelling, frail, older people at risk of poor healthcare outcomes to usual care in the community. Older people were defined as 'at risk' either by being frail or having another risk factor associated with poor health outcomes. Frailty was defined as a vulnerability to sudden health state changes triggered by relatively minor stressor events, placing the individual at risk of poor health outcomes, and was measured using objective screening tools. Primary outcomes of interest were death, nursing home admission, unplanned hospital admission, emergency department visits and serious adverse events. CGA was delivered by a team with specific gerontological training/expertise in the participant's home (domiciliary Comprehensive Geriatric Assessment (dCGA)) or other sites such as a general practice or community clinic (community Comprehensive Geriatric Assessment (cCGA)).
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted study characteristics (methods, participants, intervention, outcomes, notes) using standardised data collection forms adapted from the Cochrane Effective Practice and Organisation of Care (EPOC) data collection form. Two review authors independently assessed the risk of bias for each included study and used the GRADE approach to assess the certainty of evidence for outcomes of interest.
MAIN RESULTS
We included 21 studies involving 7893 participants across 10 countries and four continents. Regarding selection bias, 12/21 studies used random sequence generation, while 9/21 used allocation concealment. In terms of performance bias, none of the studies were able to blind participants and personnel due to the nature of the intervention, while 14/21 had a blinded outcome assessment. Eighteen studies were at low risk of attrition bias, and risk of reporting bias was low in 7/21 studies. Fourteen studies were at low risk of bias in terms of differences of baseline characteristics. Three studies were at low risk of bias across all domains (accepting that it was not possible to blind participants and personnel to the intervention). CGA probably leads to little or no difference in mortality during a median follow-up of 12 months (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.76 to 1.02; 18 studies, 7151 participants (adjusted for clustering); moderate-certainty evidence). CGA results in little or no difference in nursing home admissions during a median follow-up of 12 months (RR 0.93, 95% CI 0.76 to 1.14; 13 studies, 4206 participants (adjusted for clustering); high-certainty evidence). CGA may decrease the risk of unplanned hospital admissions during a median follow-up of 14 months (RR 0.83, 95% CI 0.70 to 0.99; 6 studies, 1716 participants (adjusted for clustering); low-certainty evidence). The effect of CGA on emergency department visits is uncertain and evidence was very low certainty (RR 0.65, 95% CI 0.26 to 1.59; 3 studies, 873 participants (adjusted for clustering)). Only two studies (1380 participants; adjusted for clustering) reported serious adverse events (falls) with no impact on the risk; however, evidence was very low certainty (RR 0.82, 95% CI 0.58 to 1.17).
AUTHORS' CONCLUSIONS
CGA had no impact on death or nursing home admission. There is low-certainty evidence that community-dwelling, frail, older people who undergo CGA may have a reduced risk of unplanned hospital admission. Further studies examining the effect of CGA on emergency department visits and change in function and quality of life using standardised assessments are required.
Topics: Aged; Frail Elderly; Geriatric Assessment; Hospitalization; Humans; Independent Living; Quality of Life
PubMed: 35521829
DOI: 10.1002/14651858.CD012705.pub2 -
The Cochrane Database of Systematic... Dec 2019This review is one in a series of Cochrane Reviews of interventions for shoulder disorders. (Meta-Analysis)
Meta-Analysis
BACKGROUND
This review is one in a series of Cochrane Reviews of interventions for shoulder disorders.
OBJECTIVES
To synthesise the available evidence regarding the benefits and harms of rotator cuff repair with or without subacromial decompression in the treatment of rotator cuff tears of the shoulder.
SEARCH METHODS
We searched the CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICRTP registry unrestricted by date or language until 8 January 2019.
SELECTION CRITERIA
Randomised controlled trials (RCTs) including adults with full-thickness rotator cuff tears and assessing the effect of rotator cuff repair compared to placebo, no treatment, or any other treatment were included. As there were no trials comparing surgery with placebo, the primary comparison was rotator cuff repair with or without subacromial decompression versus non-operative treatment (exercises with or without glucocorticoid injection). Other comparisons were rotator cuff repair and acromioplasty versus rotator cuff repair alone, and rotator cuff repair and subacromial decompression versus subacromial decompression alone. Major outcomes were mean pain, shoulder function, quality of life, participant-rated global assessment of treatment success, adverse events and serious adverse events. The primary endpoint for this review was one year.
DATA COLLECTION AND ANALYSIS
We used standard methodologic procedures expected by Cochrane.
MAIN RESULTS
We included nine trials with 1007 participants. Three trials compared rotator cuff repair with subacromial decompression followed by exercises with exercise alone. These trials included 339 participants with full-thickness rotator cuff tears diagnosed with magnetic resonance imaging (MRI) or ultrasound examination. One of the three trials also provided up to three glucocorticoid injections in the exercise group. All surgery groups received tendon repair with subacromial decompression and the postoperative exercises were similar to the exercises provided for the non-operative groups. Five trials (526 participants) compared repair with acromioplasty versus repair alone; and one trial (142 participants) compared repair with subacromial decompression versus subacromial decompression alone. The mean age of trial participants ranged between 56 and 68 years, and females comprised 29% to 56% of the participants. Symptom duration varied from a mean of 10 months up to 28 months. Two trials excluded tears with traumatic onset of symptoms. One trial defined a minimum duration of symptoms of six months and required a trial of conservative therapy before inclusion. The trials included mainly repairable full-thickness supraspinatus tears, six trials specifically excluded tears involving the subscapularis tendon. All trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding, but also for other reasons such as unclearly reported methods of random sequence generation or allocation concealment (six trials), incomplete outcome data (three trials), selective reporting (six trials), and other biases (six trials). Our main comparison was subacromial decompression versus non-operative treatment and results are reported for the 12 month follow up. At one year, moderate-certainty evidence (downgraded for bias) from 3 trials with 258 participants indicates that surgery probably provides little or no improvement in pain; mean pain (range 0 to 10, higher scores indicate more pain) was 1.6 points with non-operative treatment and 0.87 points better (0.43 better to 1.30 better) with surgery.. Mean function (zero to 100, higher score indicating better outcome) was 72 points with non-operative treatment and 6 points better (2.43 better to 9.54 better) with surgery (3 trials; 269 participants), low-certainty evidence (downgraded for bias and imprecision). Participant-rated global success rate was 873/1000 after non-operative treatment and 943/1000 after surgery corresponding to (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.96 to 1.22; low-certainty evidence (downgraded for bias and imprecision). Health-related quality of life was 57.5 points (SF-36 mental component score, 0 to 100, higher score indicating better quality of life) with non-operative treatment and 1.3 points worse (4.5 worse to 1.9 better) with surgery (1 trial; 103 participants), low-certainty evidence (downgraded for bias and imprecision). We were unable to estimate the risk of adverse events and serious adverse events as only one event was reported across the trials (very low-certainty evidence; downgraded once due to bias and twice due to very serious imprecision).
AUTHORS' CONCLUSIONS
At the moment, we are uncertain whether rotator cuff repair surgery provides clinically meaningful benefits to people with symptomatic tears; it may provide little or no clinically important benefits with respect to pain, function, overall quality of life or participant-rated global assessment of treatment success when compared with non-operative treatment. Surgery may not improve shoulder pain or function compared with exercises, with or without glucocorticoid injections. The trials included have methodology concerns and none included a placebo control. They included participants with mostly small degenerative tears involving the supraspinatus tendon and the conclusions of this review may not be applicable to traumatic tears, large tears involving the subscapularis tendon or young people. Furthermore, the trials did not assess if surgery could prevent arthritic changes in long-term follow-up. Further well-designed trials in this area that include a placebo-surgery control group and long follow-up are needed to further increase certainty about the effects of surgery for rotator cuff tears.
Topics: Aged; Arthroscopy; Decompression, Surgical; Exercise Therapy; Female; Glucocorticoids; Humans; Male; Middle Aged; Quality of Life; Randomized Controlled Trials as Topic; Rotator Cuff; Rotator Cuff Injuries; Shoulder Impingement Syndrome; Shoulder Pain; Treatment Outcome
PubMed: 31813166
DOI: 10.1002/14651858.CD013502 -
Systematic Reviews Jun 2023Sport is a subset of physical activity that can be particularly beneficial for short-and-long-term physical and mental health, and social outcomes in adults. This study... (Review)
Review
BACKGROUND
Sport is a subset of physical activity that can be particularly beneficial for short-and-long-term physical and mental health, and social outcomes in adults. This study presents the results of an updated systematic review of the mental health and social outcomes of community and elite-level sport participation for adults. The findings have informed the development of the 'Mental Health through Sport' conceptual model for adults.
METHODS
Nine electronic databases were searched, with studies published between 2012 and March 2020 screened for inclusion. Eligible qualitative and quantitative studies reported on the relationship between sport participation and mental health and/or social outcomes in adult populations. Risk of bias (ROB) was determined using the Quality Assessment Tool (quantitative studies) or Critical Appraisal Skills Programme (qualitative studies).
RESULTS
The search strategy located 8528 articles, of which, 29 involving adults 18-84 years were included for analysis. Data was extracted for demographics, methodology, and study outcomes, and results presented according to study design. The evidence indicates that participation in sport (community and elite) is related to better mental health, including improved psychological well-being (for example, higher self-esteem and life satisfaction) and lower psychological ill-being (for example, reduced levels of depression, anxiety, and stress), and improved social outcomes (for example, improved self-control, pro-social behavior, interpersonal communication, and fostering a sense of belonging). Overall, adults participating in team sport had more favorable health outcomes than those participating in individual sport, and those participating in sports more often generally report the greatest benefits; however, some evidence suggests that adults in elite sport may experience higher levels of psychological distress. Low ROB was observed for qualitative studies, but quantitative studies demonstrated inconsistencies in methodological quality.
CONCLUSIONS
The findings of this review confirm that participation in sport of any form (team or individual) is beneficial for improving mental health and social outcomes amongst adults. Team sports, however, may provide more potent and additional benefits for mental and social outcomes across adulthood. This review also provides preliminary evidence for the Mental Health through Sport model, though further experimental and longitudinal evidence is needed to establish the mechanisms responsible for sports effect on mental health and moderators of intervention effects. Additional qualitative work is also required to gain a better understanding of the relationship between specific elements of the sporting environment and mental health and social outcomes in adult participants.
Topics: Adult; Humans; Mental Health; Sports; Exercise; Anxiety
PubMed: 37344901
DOI: 10.1186/s13643-023-02264-8 -
International Journal of Environmental... Feb 2021Physical inactivity is a major concern and poor adherence to exercise programs is often reported. The aim of this paper was to systematically review published reviews on...
Physical inactivity is a major concern and poor adherence to exercise programs is often reported. The aim of this paper was to systematically review published reviews on the study of adherence to physical exercise in chronic patients and older adults and to identify those adherence-related key factors more frequently suggested by reviews for that population. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Results were classified considering the target population and participants' characteristics to identify the most repeated factors obtained for each condition. Fifty-five articles were finally included. Fourteen key factors were identified as relevant to increase adherence to physical exercise by at least ten reviews: (a) characteristics of the exercise program, (b) involvement of professionals from different disciplines, (c) supervision, (d) technology, (e) initial exploration of participant's characteristics, barriers, and facilitators, (f) participants education, adequate expectations and knowledge about risks and benefits, (g) enjoyment and absence of unpleasant experiences, (h) integration in daily living, (i) social support and relatedness, (j) communication and feedback, (k) available progress information and monitoring, (l) self-efficacy and competence, (m) participant's active role and (n) goal setting. Therefore, adherence to physical exercise is affected by several variables that can be controlled and modified by researchers and professionals.
Topics: Aged; Chronic Disease; Exercise; Exercise Therapy; Humans; Patient Compliance; Review Literature as Topic; Sedentary Behavior
PubMed: 33669679
DOI: 10.3390/ijerph18042023 -
International Journal of Nursing Studies Nov 2020Resuming participation in society is an important goal of post-stroke rehabilitation. Exercise-based interventions have been shown to be effective non-pharmacological... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Resuming participation in society is an important goal of post-stroke rehabilitation. Exercise-based interventions have been shown to be effective non-pharmacological methods for improving social participation in post-stroke survivors, however it is unclear what the most effective types of exercise interventions are.
OBJECTIVE
To assess the comparative effects and ranks of all exercise-based interventions in improving social participations in patients after a stroke.
METHODS
A random-effects network meta-analysis was performed to identify evidence from relevant randomized control trials. We searched MEDLINE, CINAHL, EMBASE, PsycINFO, CINHAL, Cochrane Library, AMED, SPORTDiscus, Web of Science and Clinical Trials.gov from their earliest records to January 2020. Included trials must include at least one types of exercise for patients with stroke. The primary e was social participation. Bias will be assessed according to the revised Cochrane risk of bias tool. Data were analysed using Stata v14.0. Registration number of this study is CRD42020152523.
RESULTS
A total of 16 randomized control trials involving 1704 patients and 12 intervention arms were included in our study. We performed three subgroup analyses divided based on follow up time (1 to <6 months post-treatment, and ≥6 months post-treatment), and intervention adherence. Based on the ranking probabilities, motor relearning programme was ranked as the most effective among all exercise interventions (surface under cumulative ranking curve values [SUCRCV]: 95.6%, standardized mean difference [SMD]: 2.72, 95% confidence interval [CI]: 1.76 to 3.69) in overall and short-term treatment efficacy. In the long-term subgroup, home-based combined exercise ranked the best for the efficacy of social participation improvements among stroke survivors (SUCRCV: 71.8%, SMD: -0.23, 95% CI: -0.61 to 0.15). In the analysis of all interventions with adherence of >90%, cognitive-based exercise ranked the best (SUCRCV: 100%, SMD: 2.64, 95% CI: 1.62 to 3.66).
CONCLUSIONS
Interventions that emerged with the highest ranks in our analysis might be considered in practice when resources allow. More large, well-designed multicentre trials are needed to support the conclusion of this study.
Topics: Exercise; Humans; Network Meta-Analysis; Randomized Controlled Trials as Topic; Stroke; Stroke Rehabilitation; Survivors
PubMed: 32858433
DOI: 10.1016/j.ijnurstu.2020.103738 -
The Cochrane Database of Systematic... Jul 2021Botulinum toxin type A (BontA) is the most frequent treatment for facial wrinkles, but its effectiveness and safety have not previously been assessed in a Cochrane... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Botulinum toxin type A (BontA) is the most frequent treatment for facial wrinkles, but its effectiveness and safety have not previously been assessed in a Cochrane Review.
OBJECTIVES
To assess the effects of all commercially available botulinum toxin type A products for the treatment of any type of facial wrinkles.
SEARCH METHODS
We searched the following databases up to May 2020: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).
SELECTION CRITERIA
We included RCTs with over 50 participants, comparing BontA versus placebo, other types of BontA, or fillers (hyaluronic acid), for treating facial wrinkles in adults.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Primary outcomes were participant assessment of success and major adverse events (AEs) (eyelid ptosis, eyelid sensory disorder, strabismus). Secondary outcomes included physician assessment of success; proportion of participants with at least one AE and duration of treatment effect. We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
We included 65 RCTs, involving 14,919 randomised participants. Most participants were female, aged 18 to 65 years. All participants were outpatients (private office or day clinic). Study duration was between one week and one year. No studies were assessed as low risk of bias in all domains; the overall risk of bias was unclear for most studies. The most common comparator was placebo (36 studies). An active control was used in 19 studies. There were eight dose-ranging studies of onabotulinumtoxinA, and a small number of studies compared against fillers. Treatment was given in one cycle (54 studies), two cycles (three studies), or three or more cycles (eight studies). The treated regions were glabella (43 studies), crow's feet (seven studies), forehead (two studies), perioral (two studies), full face (one study), or more than two regions (nine studies). Most studies analysed moderate to severe wrinkles; mean duration of treatment was 20 weeks. The following results summarise the main comparisons, based on studies of one treatment cycle for the glabella. AEs were collected over the duration of these studies (over four to 24 weeks). Compared to placebo, onabotulinumtoxinA-20 U probably has a higher success rate when assessed by participants (risk ratio (RR) 19.45, 95% confidence interval (CI) 8.60 to 43.99; 575 participants; 4 studies; moderate-certainty evidence) or physicians (RR 17.10, 95% CI 10.07 to 29.05; 1339 participants; 7 studies; moderate-certainty evidence) at week four. Major AEs are probably higher with onabotulinumtoxinA-20 U (Peto OR 3.62, 95% CI 1.50 to 8.74; 1390 participants; 8 studies; moderate-certainty evidence), but there may be no difference in any AEs (RR 1.14, 95% CI 0.89 to 1.45; 1388 participants; 8 studies; low-certainty evidence). Compared to placebo, abobotulinumtoxinA-50 U has a higher participant-assessed success rate at week four (RR 21.22, 95% CI 7.40 to 60.56; 915 participants; 6 studies; high-certainty evidence); and probably has a higher physician-assessed success rate (RR 14.93, 95% CI 8.09 to 27.55; 1059 participants; 7 studies; moderate-certainty evidence). There are probably more major AEs with abobotulinumtoxinA-50 U (Peto OR 3.36, 95% CI 0.88 to 12.87; 1294 participants; 7 studies; moderate-certainty evidence). Any AE may be more common with abobotulinumtoxinA-50 U (RR 1.25, 95% CI 1.05 to 1.49; 1471 participants; 8 studies; low-certainty evidence). Compared to placebo, incobotulinumtoxinA-20 U probably has a higher participant-assessed success rate at week four (RR 66.57, 95% CI 13.50 to 328.28; 547 participants; 2 studies; moderate-certainty evidence), and physician-assessed success rate (RR 134.62, 95% CI 19.05 to 951.45; 547 participants; 2 studies; moderate-certainty evidence). Major AEs were not observed (547 participants; 2 studies; moderate-certainty evidence). There may be no difference between groups in any AEs (RR 1.17, 95% CI 0.90 to 1.53; 547 participants; 2 studies; low-certainty evidence). AbobotulinumtoxinA-50 U is no different to onabotulinumtoxinA-20 U in participant-assessed success rate (RR 1.00, 95% CI 0.92 to 1.08, 388 participants, 1 study, high-certainty evidence) and physician-assessed success rate (RR 1.01, 95% CI 0.95 to 1.06; 388 participants; 1 study; high-certainty evidence) at week four. Major AEs are probably more likely in the abobotulinumtoxinA-50 U group than the onabotulinumtoxinA-20 U group (Peto OR 2.65, 95% CI 0.77 to 9.09; 433 participants; 1 study; moderate-certainty evidence). There is probably no difference in any AE (RR 1.02, 95% CI 0.67 to 1.54; 492 participants; 2 studies; moderate-certainty evidence). IncobotulinumtoxinA-24 U may be no different to onabotulinumtoxinA-24 U in physician-assessed success rate at week four (RR 1.01, 95% CI 0.96 to 1.05; 381 participants; 1 study; low-certainty evidence) (participant assessment was not measured). One participant reported ptosis with onabotulinumtoxinA, but we are uncertain of the risk of AEs (Peto OR 0.02, 95% CI 0.00 to 1.77; 381 participants; 1 study; very low-certainty evidence). Compared to placebo, daxibotulinumtoxinA-40 U probably has a higher participant-assessed success rate (RR 21.10, 95% CI 11.31 to 39.34; 683 participants; 2 studies; moderate-certainty evidence) and physician-assessed success rate (RR 23.40, 95% CI 12.56 to 43.61; 683 participants; 2 studies; moderate-certainty evidence) at week four. Major AEs were not observed (716 participants; 2 studies; moderate-certainty evidence). There may be an increase in any AE with daxibotulinumtoxinA compared to placebo (RR 2.23, 95% CI 1.46 to 3.40; 716 participants; 2 studies; moderate-certainty evidence). Major AEs reported were mainly ptosis; BontA is also known to carry a risk of strabismus or eyelid sensory disorders.
AUTHORS' CONCLUSIONS
BontA treatment reduces wrinkles within four weeks of treatment, but probably increases risk of ptosis. We found several heterogeneous studies (different types or doses of BontA, number of cycles, and different facial regions) hindering meta-analyses. The certainty of the evidence for effectiveness outcomes was high, low or moderate; for AEs, very low to moderate. Future RCTs should compare the most common BontA (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, daxibotulinumtoxinA, prabotulinumtoxinA) and evaluate long-term outcomes. There is a lack of evidence about the effects of multiple cycles of BontA, frequency of major AEs, duration of effect, efficacy of recently-approved BontA and comparisons with other treatments.
Topics: Adult; Aged; Bias; Botulinum Toxins, Type A; Dermal Fillers; Face; Female; Humans; Male; Middle Aged; Placebos; Randomized Controlled Trials as Topic; Skin Aging
PubMed: 34224576
DOI: 10.1002/14651858.CD011301.pub2