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European Journal of Neurology Jan 2022Sialorrhea often happens in patients with neurologic disorders, and botulinum toxin (BoNT), which inhibits acetylcholine activation, may be an effective treatment for... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND PURPOSE
Sialorrhea often happens in patients with neurologic disorders, and botulinum toxin (BoNT), which inhibits acetylcholine activation, may be an effective treatment for drooling. This systematic review and meta-analysis of randomized control trials aims to evaluate the efficacy and safety of BoNT in adults and children with sialorrhea due to neurological disorders.
METHODS
The PubMed, Embase, and Cochrane databases were searched for relevant studies published before August 2021. The pooled estimate of outcomes was calculated using a random effect model.
RESULTS
The review included 17 studies involving 981 patients. Compared with placebo, both BoNT type A (BoNT-A) and BoNT type B (BoNT-B) alleviated drooling frequency and severity (mean difference, 95% CI; BoNT-A: -1.20, -1.89 to -0.51; BoNT-B: -1.62, -2.07 to -1.17), reduced saliva weight (BoNT-A: -1.70, -2.30 to -1.10; BoNT-B: -1.12, -1.97 to -0.27), and improved global impression of change (BoNT-A: -1.30, -1.73 to -0.86; BoNT-B: -1.58, -1.95 to -1.21) in adults 4 weeks postinjection. BoNT-B remained effective at 12 weeks. In children, BoNT-A and BoNT-B alleviated sialorrhea symptoms (BoNT-A: -1.63, -2.42 to -0.85; BoNT-B: -5.20, -6.03 to -4.37) and BoNT-A reduced saliva weight (-0.77, -1.54 to 0.00) at 4 weeks postinjection. After 12 weeks, BoNT-B remained efficacious. Most adverse effects (AEs) were mild to moderate and self-limited.
CONCLUSIONS
There is moderate certainty of evidence (COE) that either BoNT-A or BoNT-B could relieve sialorrhea after 4 and 12 weeks of follow-up without significantly more severe AEs in adults. However, the COE is very low to low in children.
Topics: Botulinum Toxins, Type A; Child; Humans; Neuromuscular Agents; Sialorrhea; Treatment Outcome
PubMed: 34449931
DOI: 10.1111/ene.15083 -
International Wound Journal Dec 2017Enzymatic debridement with collagenase is a technique that is commonly used in clinical practice. This systematic review examines the effect of collagenase on all kinds... (Meta-Analysis)
Meta-Analysis Review
Enzymatic debridement with collagenase is a technique that is commonly used in clinical practice. This systematic review examines the effect of collagenase on all kinds of wounds, compared to an alternative therapy, on wound healing, wound bed characteristics, cost-effectiveness and the occurrence of adverse events. We conducted a systematic literature search on available literature in Cochrane databases, MEDLINE, EMBASE and CINAHL. Two investigators independently assessed the titles and abstracts of all randomised controlled trials obtained involving collagenase of all kinds of wounds based on inclusion criteria. Of the 1411 citations retrieved, 22 studies reported outcomes with the use of collagenase either for wound healing or wound debridement. Results support the use of collagenase for enzymatic debridement in pressure ulcers, diabetic foot ulcers and in conjunction with topical antibiotics for burns. However, studies presented a high risk of bias. Risk ratio of developing an adverse event related to collagenase versus the alternative treatment was statistically significant (for 10 studies, RR: 1·79, 95% CI 1·24-2·59, I =0%, P = 0·002). There is very limited data on the effect of collagenase as an enzymatic debridement technique on wounds. More independant research and adequate reporting of adverse events are warranted.
Topics: Burns; Collagenases; Debridement; Humans; Skin Ulcer; Wound Healing
PubMed: 28440050
DOI: 10.1111/iwj.12760 -
Aesthetic Surgery Journal May 2017A systematic review of the published literature (from January 2000 to January 2016) to ascertain the safety of, and patient satisfaction with, the aesthetic use of... (Review)
Review
A systematic review of the published literature (from January 2000 to January 2016) to ascertain the safety of, and patient satisfaction with, the aesthetic use of abobotulinumtoxinA was conducted. In addition to the licensed indications, other special populations were considered for discussion. The potential impact of neutralizing antibodies and systemic toxicity were also addressed. A total of 364 papers were screened and 86 were found to be relevant to the population, intervention(s), and outcomes stipulated in the protocol. The safety and patient satisfaction data from these publications are discussed in this review.
Topics: Antibodies, Neutralizing; Botulinum Toxins, Type A; Cicatrix, Hypertrophic; Clinical Trials as Topic; Cosmetic Techniques; Facial Muscles; Female; Humans; Injections, Intradermal; Injections, Intramuscular; Keloid; Neuromuscular Agents; Patient Satisfaction; Pregnancy; Skin Aging; Surveys and Questionnaires; Treatment Outcome
PubMed: 28388721
DOI: 10.1093/asj/sjx010 -
International Journal of Colorectal... Jan 2012The main purpose of this study was to investigate the efficacy and safety of botulinum toxin in the treatment of anal fissure. An answer was attempted to the following... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The main purpose of this study was to investigate the efficacy and safety of botulinum toxin in the treatment of anal fissure. An answer was attempted to the following research questions: (i) what is the efficacy of botulinum toxin in healing of anal fissure compared to placebo, (ii) what is the efficacy of botulinum toxin in healing of anal fissure compared to other means of chemical sphincterotomy, (iii) what is the efficacy of botulinum toxin in healing of anal fissure compared to surgical sphincterotomy, (iv) what is the short term safety of botulinum toxin injections and (v) what is the long term safety of botulinum toxin injections.
METHODS
Clinical trials investigating the effect of botulinum toxin in the treatment of anal fissure met inclusion criteria. Case reports and case series were also included for the estimation of safety. Meta-analysis was not performed due to clinical heterogeneity.
RESULTS
The comparator could be placebo, nitroglycerin ointment, or lateral internal sphincterotomy, with dosage ranging from 20 IU to 50 IU of botulinum toxin. Fissure healing was the most commonly reported primary endpoint but the time period from botulinum toxin injection to fissure healing ranged from 2 weeks to 4 months. Accordingly, outcome data were also heterogenous.
CONCLUSIONS
Botulinum toxin injections should be considered a minimally invasive therapeutic option for the treatment of chronic anal fissure. However, well designed randomized trials are needed for the valid estimation of the efficacy and safety of botulinum toxin in this therapeutic indication.
Topics: Botulinum Toxins; Dose-Response Relationship, Drug; Fissure in Ano; Humans; Lidocaine; Nitrates; Placebos; Randomized Controlled Trials as Topic; Treatment Outcome; Wound Healing
PubMed: 21822595
DOI: 10.1007/s00384-011-1286-5 -
International Journal of Surgery... Mar 2023
Meta-Analysis
Botulinum toxin as a promising surgical strategy for chronic anal fissure: do the dose and injection site matter? Comparison of doses and injection sites of botulinum toxin for chronic anal fissure: A systematic review and network meta-analysis of randomized controlled trials.
Topics: Humans; Fissure in Ano; Network Meta-Analysis; Randomized Controlled Trials as Topic; Botulinum Toxins, Type A; Anal Canal; Chronic Disease; Treatment Outcome
PubMed: 36906767
DOI: 10.1097/JS9.0000000000000022 -
International Urology and Nephrology Jan 2016The aim of this study was to overcome the limitation of overlooking the placebo effect in previous studies and to demonstrate the overall treatment efficacy and safety... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The aim of this study was to overcome the limitation of overlooking the placebo effect in previous studies and to demonstrate the overall treatment efficacy and safety of botulinum toxin type A (BTX-A) compared with placebo.
METHODS
We conducted a systematic review and meta-analysis of the published literature in PubMed, Cochrane Library, and Embase reporting on BTX use in lower urinary tract symptoms (LUTS)/benign prostate hyperplasia (BPH). Single-group analysis for the placebo effect and meta-regression analysis for the moderator effect were performed with high-quality RCTs compared with placebo.
RESULTS
A total of three studies were included, with a total sample size of 522 subjects (260 subjects in the experimental group and 262 subjects in the control group). Study duration ranged from 8 to 24 weeks. The pooled overall SMD in the mean change in IPSS for the BTX-A group versus the placebo group was -1.02 (95 % CI -1.97, -0.07). The other outcomes (Q max, prostate volume, and post-voided residual volume) were not statistically different between the two groups. The placebo effect in single-group analysis ranged from 0 to 27.9 % for IPSS, and from -1.1 to 28.7 % for Q max (lowest to highest, respectively).
CONCLUSIONS
This evidence-based systematic review and meta-analysis of the BTX-A injection for LUTS/BPH showed no differences in efficacy compared with placebo and also showed no difference in procedure-related adverse events occurred. Thus, the results of this study do not provide evidence of clinical benefits of using the BTX-A injection for LUTS/BPH in real clinical practice.
Topics: Botulinum Toxins, Type A; Humans; Injections; Male; Neuromuscular Agents; Prostatic Hyperplasia; Treatment Outcome
PubMed: 26560471
DOI: 10.1007/s11255-015-1153-3 -
Blood Reviews Jul 2014Von Willebrand Factor (VWF) plays an important role in hemostasis by mediating platelet adhesion and aggregation. Ultralarge VWF multimers are cleaved by ADAMTS13 in... (Meta-Analysis)
Meta-Analysis Review
Von Willebrand Factor (VWF) plays an important role in hemostasis by mediating platelet adhesion and aggregation. Ultralarge VWF multimers are cleaved by ADAMTS13 in smaller, less procoagulant forms. An association between high VWF levels and cardiovascular disease has frequently been reported, and more recently also an association has been observed between low ADAMTS13 levels and arterial thrombosis. We reviewed the current literature and performed meta-analyses on the relationship between both VWF and ADAMTS13 with arterial thrombosis. Most studies showed an association between high VWF levels and arterial thrombosis. It remains unclear whether ADAMTS13 is a causal independent risk factor because the association between low ADAMTS13 and arterial thrombosis is so far only shown in case-control studies. Prospective studies are awaited. A causal role for ADAMTS13 is supported by mice studies of cerebral infarction where the infusion of recombinant human ADAMTS13 reduced the infarct size.
Topics: ADAM Proteins; ADAMTS13 Protein; Animals; Arteries; Cardiovascular Diseases; Disease Models, Animal; Humans; Mice; Thrombosis; von Willebrand Diseases; von Willebrand Factor
PubMed: 24825749
DOI: 10.1016/j.blre.2014.04.003 -
International Journal of Dermatology Feb 2022Hyperhidrosis is excessive sweating that is uncontrollable and occurring regardless of temperature. Quality of life is significantly impaired, and psychiatric... (Review)
Review
Hyperhidrosis is excessive sweating that is uncontrollable and occurring regardless of temperature. Quality of life is significantly impaired, and psychiatric comorbidity is common. The objective of the study is to undertake a systematic review of research in the last 5 years regarding hyperhidrosis. Five databases were searched from July 2015 to July 2020 for all research on hyperhidrosis. High-quality research articles were sought for progress in diagnosis, etiology and epidemiology, and use of patient reported outcomes (PROs) as well as randomized clinical trials (RCTs) on any treatment intervention. Outcomes of interest were disease severity, sweat rate, quality of life, patient satisfaction, and adverse events. Trial quality was assessed by the Cochrane risk-of-bias tool. A narrative synthesis was presented. Twenty-nine papers were included in the review: 13 investigational articles, 10 RCTs, three cohort studies, and three reviews. The studies varied in terms of quality, population, intervention, and methods of outcome assessment. The majority were very small studies, and most RCTs were at high risk of bias. Few studies on diagnosis, epidemiology, and etiology were of sufficient quality to be presented. The interventions discussed were iontophoresis, botulinum toxin, anticholinergic medication, curettage, and energy-based technologies. Progress in the diagnostics and etiology of hyperhidrosis is limited with the same being true for treatment. In a 5-year-old systematic review, it was concluded that there was moderate-quality evidence to support the use of botulinum toxin for axillary hyperhidrosis. It was advocated to conduct a trial comparing BTX and iontophoresis for palmar hyperhidrosis. Unfortunately, this has not yet been performed. Hyperhidrosis is still as underserved and under-studied as before.
Topics: Botulinum Toxins, Type A; Child, Preschool; Humans; Hyperhidrosis; Iontophoresis; Patient Satisfaction; Treatment Outcome
PubMed: 34080686
DOI: 10.1111/ijd.15654 -
World Journal of Surgery Feb 2023Haemorrhoidectomy is often complicated by significant post-operative pain, to which spasm of the internal anal sphincter is thought to be a contributing factor. This... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Haemorrhoidectomy is often complicated by significant post-operative pain, to which spasm of the internal anal sphincter is thought to be a contributing factor. This study appraises the evidence behind interventions aimed at lowering sphincter spasm to relieve post-haemorrhoidectomy pain.
METHODS
A Preferred Reporting Items for Systematic Reviews and Meta-analyses compliant systematic review was conducted. Medline, EMBASE, and CENTRAL databases were systematically searched. All RCTs which compared interventions targeting the internal anal sphincter to relieve pain post excisional haemorrhoidectomy were included. The primary outcome measure was pain on the visual analogue scale.
RESULTS
Of the initial 10,221 search results, 39 articles were included in a qualitative synthesis, and 33 studies were included in a meta-analysis. Topical glyceryl trinitrate (GTN) reduced pain on day 7 (7 studies, 485 participants), with a mean difference and 95% confidence interval (MD, 95% CI) of -1.34 (-2.31; -0.37), I = 91%. Diltiazem reduced pain on day 3 on the VAS, and the MD was -2.75 (-398; -1.51) shown in five studies (n = 227). Botulinum toxin reduced pain on day 7, in four studies with 178 participants, MD -1.43 (-2.50; -0.35) I = 62%. The addition of Lateral Internal Sphincterotomy to haemorrhoidectomy reduced pain on day 2 in three studies with 275 participants, MD of -2.13 (-3.49; -0.77) I = 92%. The results were limited by high heterogeneity and risk of bias.
CONCLUSION
Evidence suggests that lateral sphincterotomy, administration of botulinum toxin and the application of topical diltiazem or GTN can reduce post-operative pain after haemorrhoidectomy. Lateral sphincterotomy should not be routinely used due to the risk of incontinence.
Topics: Humans; Hemorrhoidectomy; Diltiazem; Nitroglycerin; Pain, Postoperative; Spasm; Botulinum Toxins
PubMed: 36357803
DOI: 10.1007/s00268-022-06807-3 -
European Urology May 2014Botulinum toxin A (BoNTA) has received regulatory approval for use in neurogenic detrusor overactivity (NDO) and overactive bladder (OAB), but it remains unlicensed in... (Review)
Review
CONTEXT
Botulinum toxin A (BoNTA) has received regulatory approval for use in neurogenic detrusor overactivity (NDO) and overactive bladder (OAB), but it remains unlicensed in other lower urinary tract symptoms (LUTS) indications such as nonneurogenic LUTS in men with benign prostatic enlargement (LUTS/BPE), bladder pain syndrome (BPS), and detrusor sphincter dyssynergia (DSD).
OBJECTIVE
To compare statistically the outcomes of high level of evidence (LE) studies with placebo using BoNTA for LUTS indications; NDO, OAB, LUTS/BPE, BPS and DSD.
EVIDENCE ACQUISITION
We conducted a systematic review of the published literature on PubMed, Scopus, and Embase reporting on BoNTA use in LUTS dysfunction. Statistical comparison was made between high LE studies with placebo and low LE studies.
EVIDENCE SYNTHESIS
In adult NDO, there are significantly greater improvements with BoNTA in daily incontinence and catheterisation episodes (-63% and -18%, respectively; p<0.01), and the urodynamic parameters of maximum cystometric capacity (MCC), reflex volume, and maximum detrusor pressure (MDP) (68%, 61%, and -42%, respectively; all p<0.01). In OAB, BoNTA leads to significant improvements in bladder diary parameters such as daily frequency (-29%), daily urgency (-38%), and daily incontinence (-59%) (all p<0.02). The urodynamic parameters of MCC and MDP improved by 58% (p=0.04) and -29% (p=0.002), respectively. The risk of urinary tract infection was significantly increased from placebo at 21% versus 7% (p<0.001), respectively; the risk of intermittent self-catherisation increased from 0% to 12% (p<0.001). Men with LUTS/BPE showed no significant improvements in International Prostate Symptom Score, maximum flow rate, or prostate volume. There were insufficient data for statistical analysis in DSD, BPS, and paediatric studies. Low LE studies were found to overestimate the effects of BoNTA in all indications, but differences from high LE studies were significant in only a few parameters.
CONCLUSIONS
BoNTA significantly improves all symptoms and urodynamic parameters in NDO and OAB. The effect of BoNTA in treating LUTS dysfunction appears to be overestimated in lower as opposed to higher LE studies.
Topics: Ataxia; Botulinum Toxins, Type A; Humans; Male; Neuromuscular Agents; Prostatism; Urinary Bladder Diseases; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Tract Infections; Urodynamics
PubMed: 24239446
DOI: 10.1016/j.eururo.2013.10.033