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Hernia : the Journal of Hernias and... Aug 2023Surgical repair of large hernia defects requires detailed pre-operative planning, particularly in cases with loss of domain. This situation often hampers mid-line... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Surgical repair of large hernia defects requires detailed pre-operative planning, particularly in cases with loss of domain. This situation often hampers mid-line reconstruction, even after component separation, when the size of the hernia is disproportional to the volume of the abdominal area. In this case, other strategies may be needed to place the viscera back into the abdominal cavity after reducing the hernia sac. The administration of botulinum toxin prior to the surgical procedure has been indicated as an adjunct for more complex cases. This results in stretching of the lateral musculature of the abdomen, allowing midline approximation. In addition, the application of botulinum toxin alone has been investigated as a means of downstaging in the management of ventral hernias, thereby precluding component separation and enabling primary closure of the midline by placement of mesh within the retromuscular space using the Rives Stoppa technique.
METHODS
Systematic review of the literature for observational studies involving patients undergoing pre-operative application of botulinum toxin for ventral hernia repair was conducted according to the PRISMA guidelines.
RESULTS
Advance of the lateral musculature of the abdomen by an average of 4.11 cm with low heterogeneity, as well as low rates of surgical site infection (SSI), surgical site occurrences (SSO) and recurrence, was shown.
CONCLUSION
Pre-operative application of botulinum toxin for ventral hernia repair promoted an increase in the length of the lateral musculature of the abdomen which can help improve the outcomes of morbidity and recurrence.
Topics: Humans; Abdominal Wall; Herniorrhaphy; Botulinum Toxins, Type A; Surgical Mesh; Hernia, Ventral; Recurrence
PubMed: 37329437
DOI: 10.1007/s10029-023-02816-w -
Toxicon : Official Journal of the... Nov 2023Dyssynergic defecation (DD) is a common cause of chronic constipation. Owing to the lack of a comprehensive synthesis of available data on the effectiveness of botulinum... (Meta-Analysis)
Meta-Analysis
Dyssynergic defecation (DD) is a common cause of chronic constipation. Owing to the lack of a comprehensive synthesis of available data on the effectiveness of botulinum neurotoxin (BoNT) for treating DD, we performed a systematic review and meta-analysis. We searched the PubMed, Embase, and Cochrane databases from inception to May 9, 2023. The outcomes comprise short-term and long-term symptom improvement, various anorectal function measurements, complications of fecal incontinence, and symptom improvement after repeated BoNT injections. A meta-analysis comparing BoNT injection with either surgery or biofeedback (BFB) therapy in treating DD was also conducted. Subgroup analysis and meta-regression were performed to identify possible moderator effects. We included five randomized controlled trials, seven prospective studies, and two retrospective observational studies. Short-term potential improvement in symptoms (event rate [ER], 66.4%; 95% CI, 0.513 to 0.783) was identified, but in the long-term (>12 months), this effect was decreased (ER, 38.2%; 95% CI, 0.267 to 0.511). Short-term improvements in objective anorectal physiologic parameters were also observed. Repeated BoNT injection was effective for patients with symptom recurrence. Subgroup analysis revealed enhanced long-term symptom improvement with high-dose BoNT, but this treatment also increased the risk of complications and recurrence compared with low doses. The effectiveness, complications, and recurrence of symptoms associated with BoNT injection and surgery did not differ significantly. BoNT injection significantly provided short-term symptom improvement but also heightened the risk of incontinence compared with BFB therapy. Our systematic review and meta-analysis indicated that BoNT could be beneficial for short-term symptom improvement in patients with DD, but this effect tended to decline 12 months after injection. Standardized BoNT intervention protocols remain warranted. Among the several treatments for DD, we concluded that BoNT injection is not inferior to other options considering its effectiveness in relieving symptoms, the associated complication development, and the risk of symptom recurrence.
Topics: Humans; Botulinum Toxins; Defecation; Retrospective Studies; Prospective Studies; Constipation
PubMed: 37816487
DOI: 10.1016/j.toxicon.2023.107311 -
Diseases of the Esophagus : Official... Oct 2023The aim of this study was to evaluate the effect of intraoperative botulinum toxin (BT) injection on delayed gastric emptying (DGE) and need for endoscopic pyloric... (Meta-Analysis)
Meta-Analysis
Effect of intraoperative botulinum toxin injection on delayed gastric emptying and need for endoscopic pyloric intervention following esophagectomy: a systematic review, meta-analysis, and meta-regression analysis.
The aim of this study was to evaluate the effect of intraoperative botulinum toxin (BT) injection on delayed gastric emptying (DGE) and need for endoscopic pyloric intervention (NEPI) following esophagectomy. In compliance with Preferred Reporting Items for Systematic reviews and Meta-Analyses statement standards, a systematic review of studies reporting the outcomes of intraoperative BT injection in patients undergoing esophagectomy for esophageal cancer was conducted. Proportion meta-analysis model was constructed to quantify the risk of the outcomes and direct comparison meta-analysis model was constructed to compare the outcomes between BT injection and no BT injection or surgical pyloroplasty. Meta-regression was modeled to evaluate the effect of variations in different covariates among the individual studies on overall summary proportions. Nine studies enrolling 1070 patients were included. Pooled analyses showed that the risks of DGE and NEPI following intraoperative BT injection were 13.3% (95% confidence interval [CI]: 7.9-18.6%) and 15.2% (95% CI: 7.9-22.5%), respectively. There was no difference between BT injection and no BT injection in terms of DGE (odds ratio [OR]: 0.57, 95% CI: 0.20-1.61, P = 0.29) and NEPI (OR: 1.73, 95% CI: 0.42-7.12, P = 0.45). Moreover, BT injection was comparable to pyloroplasty in terms of DGE (OR: 0.85, 95% CI: 0.35-2.08, P = 0.73) and NEPI (OR: 8.20, 95% CI: 0.63-105.90, P = 0.11). Meta-regression suggested that male gender was negatively associated with the risk of DGE (coefficient: -0.007, P = 0.003). In conclusion, level 2 evidence suggests that intraoperative BT injection may not improve the risk of DGE and NEPI in patients undergoing esophagectomy. The risk of DGE seems to be higher in females and in early postoperative period. High quality randomized controlled trials with robust statistical power are required for definite conclusions. The results of the current study can be used for hypothesis synthesis and power analysis in future prospective trials.
Topics: Female; Humans; Male; Gastroparesis; Esophagectomy; Pylorus; Botulinum Toxins; Regression Analysis; Gastric Emptying; Postoperative Complications
PubMed: 37539558
DOI: 10.1093/dote/doad053 -
BMC Pharmacology & Toxicology Oct 2023Botulinum toxin (BoNT) injection is an important adjunctive method to treat sialorrhea. The purpose of this systematic review was to analyze the effect and safety of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Botulinum toxin (BoNT) injection is an important adjunctive method to treat sialorrhea. The purpose of this systematic review was to analyze the effect and safety of BoNT injections in the intervention of sialorrhea with Parkinson's disease (PD).
METHODS
We searched PubMed, Web Of Science (WOS), Scopus, Cochrane CENTRAL, and Embase from inception until April 2022. Randomized controlled trials or randomized crossover trials comparing BoNT with placebo in sialorrhea with PD were eligible. PRISMA guidelines were used to carry out the meta-analysis. The Drooling Severity Frequency Scale (DSFS) score and the number of adverse events (AEs) were the primary and secondary outcomes, respectively. Standardized mean differences (SMDs) and risk differences (RDs) are used to express continuous and categorical outcomes, respectively. Heterogeneity among these studies was evaluated using I tests. We used the GRADE tool to assess the certainty of evidence (COE).
RESULTS
Eight articles involving 259 patients compared BoNT injections with a placebo for PD with sialorrhea. This meta-analysis showed a significant reduction in DSFS scores between BoNT injections and placebo (SMD=-0.98; 95% CI, -1.27 to 0.70, p<0.001; COE: high). This meta-analysis showed a significant difference in AEs between BoNT injections and placebo (RD=0.15; 95% CI, 0.05 to 0.24, p=0.002; COE: low).
CONCLUSIONS
The pooled results suggest that BoNT injections have some effect on DSFS scores with sialorrhea caused by PD. There are also mild adverse events, which generally recover within a week or so. The results indicate that BoNT injection is one of the treatments for sialorrhea caused by PD, but we need to pay attention to adverse events. In addition, the follow-up time was extended to observe oral hygiene, ulceration or dental caries, and digestive function.
TRIAL REGISTRATION
Our review protocol was registered on PROSPERO (42021288334).
Topics: Humans; Botulinum Toxins, Type A; Sialorrhea; Parkinson Disease; Dental Caries; Treatment Outcome
PubMed: 37828600
DOI: 10.1186/s40360-023-00694-7 -
Annals of Vascular Surgery Oct 2023The optimal diagnostic and treatment algorithm for patients with suspected thoracic outlet syndrome (TOS) remains challenging. Botulinum toxin (BTX) muscle injections... (Review)
Review
BACKGROUND
The optimal diagnostic and treatment algorithm for patients with suspected thoracic outlet syndrome (TOS) remains challenging. Botulinum toxin (BTX) muscle injections have been suggested to shrink muscles in the thoracic outlet reducing neurovascular compression. This systematic review evaluates the diagnostic and therapeutic value of BTX injections in TOS.
METHODS
A systematic review of studies reporting BTX as a diagnostic or therapeutic tool in TOS (or pectoralis minor syndrome as TOS subtype) was conducted in PubMed, Embase, and CENTRAL databases on May 26, 2022. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement was followed. Primary end point was symptom reduction after primary procedure. Secondary end points were symptom reduction after repeated procedures, the degree of symptom reduction, complications, and duration of clinical effect.
RESULTS
Eight studies (1 randomized controlled trial [RCT], 1 prospective cohort study, and 6 retrospective cohort studies) were included reporting 716 procedures in at least 497 patients (at minimum 350 primary and 25 repeated procedures, residual unclear) diagnosed with presumably only neurogenic TOS. Except for the RCT, the methodological quality was fair to poor. All studies were designed on an intention to treat basis, one also investigated BTX as a diagnostic tool to differentiate pectoralis minor syndrome from costoclavicular compression. Reduction of symptoms was reported in 46-63% of primary procedures; no significant difference was found in the RCT. The effect of repeated procedures could not be determined. Degree of symptom reduction was reported by up to 30-42% on the Short-form McGill Pain scale and up to 40 mm on a visual analog scale. Complication rates varied among studies, no major complications were reported. Symptom relief ranged from 1 to 6 months.
CONCLUSIONS
Based on limited quality evidence, BTX may provide short-lasting symptom relief in some neurogenic TOS patients but remains overall undecided. The role of BTX for treatment of vascular TOS and as a diagnostic tool in TOS is currently unexploited.
Topics: Humans; Treatment Outcome; Thoracic Outlet Syndrome; Algorithms; Databases, Factual; Botulinum Toxins
PubMed: 37236533
DOI: 10.1016/j.avsg.2023.05.009 -
Farmacia Hospitalaria : Organo Oficial... 2023Post-stroke spasticity is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a...
OBJECTIVE
Post-stroke spasticity is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a cost-effectiveness analysis (CEA) of the treatment of post-stroke spasticity, in adults, with abobotulinumtoxinA compared to the best supportive care, based on results from a systematic literature review. Given that abobotulinumtoxinA (aboBoNT-A) is always accompanied by the best supportive care treatment, the CEA compared aboBoNT-A plus the best supportive care with the best supportive care alone.
METHODS
A systematic literature review in EMBASE (including Medline and PubMed), Scopus, and other sources (Google Scholar) was conducted. Articles of all types, providing information on the costs and/or effectiveness measures for the current treatments of post-stroke spasticity in adults were included. The synthesis of information from the review provided the parameters for the design of a CEA of the mentioned treatment of interest. The societal perspective was compared to a perspective where only direct costs were observed.
RESULTS
In total, 532 abstracts were screened. Full information was revised from 40 papers and 13 of these were selected as core papers for full data extraction. Data from the core publications formed the basis for the development of a cost-effectiveness model. In all the included papers physiotherapy was the best supportive care treatment. The cost-effectiveness analysis showed that even in the most conservative scenario, assuming the worst case scenario, the probability of a cost per quality-adjusted life-year (QALY) gained below €40,000, for aboBoNT-A together with physiotherapy is above 0.8, and with certainty below €50,000/QALY when either a direct costs, or a societal perspective was taken. On average, the probabilistic model obtains a negative mean incremental cost-effectiveness ratio of around -15,000 €/QALY.
CONCLUSION
The cost-effectiveness analyses show that aboBoNT-A together with physiotherapy would be a cost-effective treatment compared with physiotherapy alone, independently of the perspective considered.
Topics: Adult; Humans; Cost-Effectiveness Analysis; Cost-Benefit Analysis; Botulinum Toxins, Type A; Physical Therapy Modalities; Quality-Adjusted Life Years
PubMed: 37507277
DOI: 10.1016/j.farma.2023.06.008 -
Phlebology Oct 2023Post-thrombotic syndrome (PTS) is a frequent chronic complication of deep venous thrombosis (DVT). Biomarkers are potentially valuable clinical tools for handling PTS....
Biomarkers and the post-thrombotic syndrome: A systematic review of biomarkers associated with the occurrence of the post-thrombotic syndrome after lower extremity deep venous thrombosis.
INTRODUCTION
Post-thrombotic syndrome (PTS) is a frequent chronic complication of deep venous thrombosis (DVT). Biomarkers are potentially valuable clinical tools for handling PTS. The purpose of this review was to examine which biomarkers are associated with the development of PTS in adults with lower extremity DVT.
METHODS
We performed a systematic review of all English language prospective studies of biomarkers and PTS published in PubMed and EMBASE. Studies were included if diagnosing DVT by diagnostic imaging and assessing PTS by clinical scales, for example, the Villalta scale. Biomarkers of thrombophilia and pathological clot properties were not assessed. Data was reported qualitatively.
RESULTS
15 prospective studies were included. Studies varied widely in study design and methods of data analysis. Forty-six different biomarkers were examined, with seven being measured in two or more studies. The most frequently studied biomarkers were D-dimer, CRP, and IL-6. Associations between PTS and D-dimer were predominantly significant, while results on CRP and IL-6 were inconsistent. ICAM-1 was consistently associated with PTS in all studies and at all timepoints. IL-10 was significantly related to PTS development in the largest study and at all time points. Adiponectin, tPA, HRG and TAFI, MMP-1 and -8, and TIMP-1 and -2 were significantly associated with PTS in single studies.
CONCLUSION
(1) Further research on biomarkers and PTS is clearly warranted. (2) Significant differences in study designs made it difficult to draw reliable conclusions regarding individual biomarkers. We suggest the implementation of a standardized framework for the study of biomarkers and PTS, to make comparison of future studies more feasible. (3) D-dimer, ICAM-1, IL-10, MMP-1 and 8, TIMP-1, TIMP-2, and adiponectin are clinical biomarkers of particular interest to include in future studies of PTS. Large scale systemic quantitative proteomic analyses of DVT patients could help identify novel biomarkers of interest in PTS-patients.
Topics: Adult; Humans; Adiponectin; Biomarkers; Intercellular Adhesion Molecule-1; Interleukin-10; Interleukin-6; Lower Extremity; Matrix Metalloproteinase 1; Postthrombotic Syndrome; Prospective Studies; Proteomics; Risk Factors; Tissue Inhibitor of Metalloproteinase-1; Venous Thrombosis
PubMed: 37620994
DOI: 10.1177/02683555231186681 -
PloS One 2024The current body of research on utilizing botulinum toxin (BTX) to manage temporomandibular disorders (TMDs) has not yet yielded definitive conclusions. The primary... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The current body of research on utilizing botulinum toxin (BTX) to manage temporomandibular disorders (TMDs) has not yet yielded definitive conclusions. The primary objective of this study was to determine the effectiveness of BTX in pain reduction for TMDs compared to placebo and other treatments. The secondary outcomes evaluated were adverse events, maximum mouth opening, bruxism events, and maximum occlusal force.
MATERIALS AND METHODS
A literature search was performed on PubMed, Dimension Publication, Scopus, and Google Scholar. The RoB 2 tool was used for quality assessment. The mean differences in pain scores were estimated to measure the effect of BTX on pain reduction. For adverse events, the risk ratio for the incidence of side effects was calculated.
RESULTS
Two hundred and sixty non-duplicate articles were identified; however, only 14 RCTS were included in this review. The total study population included 395 patients. The overall risk of bias showed a low to moderate quality of evidence. Results from 6 studies were reported only narratively; four studies were used for meta-analysis on pain reduction, and five were used for meta-analysis on adverse events. The control used in the meta-analysis was placebo injections. Results of the meta-analysis for pain reduction were statistically insignificant for the BTX group with mean differences at MD = -1.71 (95% CI, -2.87 to -0.5) at one month, -1.53 (95% CI, -2.80 to -0.27) at three months, and -1.33 (95% CI, -2.74 to 0.77) at six months. This showed that BTX treatment was not significantly better than placebo for a reduction in pain scores at 1, 3, and 6 months. Regarding safety, the placebo group showed a relative risk of 1.34 (95%CI, 0.48-6.78) and 1.17 (95%CI, 0.54-3.88) at 1 and 3 months respectively. However, the risks were not statistically significant. There was also no difference in the effectiveness of BTX compared to placebo and other treatments for maximum mouth opening, bruxism events, and maximum occlusal force.
CONCLUSION
BTX was not associated with better outcomes in terms of pain reduction, adverse events, maximum mouth opening, bruxism events, and maximum occlusal force. More high-quality RCTs are needed to better understand this topic.
Topics: Humans; Botulinum Toxins, Type A; Bruxism; Pain; Temporomandibular Joint Disorders; Bite Force
PubMed: 38483856
DOI: 10.1371/journal.pone.0300157 -
British Journal of Haematology Feb 2024Immune thrombotic thrombocytopenic purpura (iTTP) is a rare and life-threatening haematological condition. Initial treatment involves plasma exchange (PLEX),...
Immune thrombotic thrombocytopenic purpura (iTTP) is a rare and life-threatening haematological condition. Initial treatment involves plasma exchange (PLEX), corticosteroids, caplacizumab and rituximab. In relapsed and refractory cases despite initial treatments, further immune-modulating therapy includes the proteasome inhibitor, bortezomib. Evidence for bortezomib in this setting is limited to case reports and case series. We report our experience and perform a systematic review of the literature. We identified 21 publications with 28 unique patients in addition to our cohort of eight patients treated with bortezomib. The median age of patients was 44 years (IQR: 27-53) and 69% female. They were usually in an initial, refractory presentation of iTTP where they had received PLEX, corticosteroids, rituximab and another line of therapy. After bortezomib administration, 72% of patients had a complete response, with 85% maintaining a durable response without relapse at the last follow-up.
Topics: Humans; Female; Adult; Middle Aged; Male; Bortezomib; Rituximab; Purpura, Thrombotic Thrombocytopenic; Retrospective Studies; Purpura, Thrombocytopenic, Idiopathic; Adrenal Cortex Hormones; Plasma Exchange; ADAMTS13 Protein
PubMed: 37571963
DOI: 10.1111/bjh.19035 -
The Cochrane Database of Systematic... Jun 2024Constipation that is prolonged and does not resolve with conventional therapeutic measures is called intractable constipation. The treatment of intractable constipation... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Constipation that is prolonged and does not resolve with conventional therapeutic measures is called intractable constipation. The treatment of intractable constipation is challenging, involving pharmacological or non-pharmacological therapies, as well as surgical approaches. Unresolved constipation can negatively impact quality of life, with additional implications for health systems. Consequently, there is an urgent need to identify treatments that are efficacious and safe.
OBJECTIVES
To evaluate the efficacy and safety of treatments used for intractable constipation in children.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, and two trials registers up to 23 June 2023. We also searched reference lists of included studies for relevant studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing any pharmacological, non-pharmacological, or surgical treatment to placebo or another active comparator, in participants aged between 0 and 18 years with functional constipation who had not responded to conventional medical therapy.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were symptom resolution, frequency of defecation, treatment success, and adverse events; secondary outcomes were stool consistency, painful defecation, quality of life, faecal incontinence frequency, abdominal pain, hospital admission for disimpaction, and school absence. We used GRADE to assess the certainty of evidence for each primary outcome.
MAIN RESULTS
This review included 10 RCTs with 1278 children who had intractable constipation. We assessed one study as at low risk of bias across all domains. There were serious concerns about risk of bias in six studies. One study compared the injection of 160 units botulinum toxin A (n = 44) to unspecified oral stool softeners (n = 44). We are very uncertain whether botulinum toxin A injection improves treatment success (risk ratio (RR) 37.00, 95% confidence interval (CI) 5.31 to 257.94; very low certainty evidence, downgraded due to serious concerns with risk of bias and imprecision). Frequency of defecation was reported only for the botulinum toxin A injection group (mean interval of 2.6 days). The study reported no data for the other primary outcomes. One study compared erythromycin estolate (n = 6) to placebo (n = 8). The only primary outcome reported was adverse events, which were 0 in both groups. The evidence is of very low certainty due to concerns with risk of bias and serious imprecision. One study compared 12 or 24 μg oral lubiprostone (n = 404) twice a day to placebo (n = 202) over 12 weeks. There may be little to no difference in treatment success (RR 1.29, 95% CI 0.87 to 1.92; low certainty evidence). We also found that lubiprostone probably results in little to no difference in adverse events (RR 1.05, 95% CI 0.91 to 1.21; moderate certainty evidence). The study reported no data for the other primary outcomes. One study compared three-weekly rectal sodium dioctyl sulfosuccinate and sorbitol enemas (n = 51) to 0.5 g/kg/day polyethylene glycol laxatives (n = 51) over a 52-week period. We are very uncertain whether rectal sodium dioctyl sulfosuccinate and sorbitol enemas improve treatment success (RR 1.33, 95% CI 0.83 to 2.14; very low certainty evidence, downgraded due to serious concerns with risk of bias and imprecision). Results of defecation frequency per week was reported only as modelled means using a linear mixed model. The study reported no data for the other primary outcomes. One study compared biofeedback therapy (n = 12) to no intervention (n = 12). We are very uncertain whether biofeedback therapy improves symptom resolution (RR 2.50, 95% CI 1.08 to 5.79; very low certainty evidence, downgraded due to serious concerns with risk of bias and imprecision). The study reported no data for the other primary outcomes. One study compared 20 minutes of intrarectal electromotive botulinum toxin A using 2800 Hz frequency and botulinum toxin A dose 10 international units/kg (n = 30) to 10 international units/kg botulinum toxin A injection (n = 30). We are very uncertain whether intrarectal electromotive botulinum toxin A improves symptom resolution (RR 0.96, 95% CI 0.76 to 1.22; very low certainty evidence) or if it increases the frequency of defecation (mean difference (MD) 0.00, 95% CI -1.87 to 1.87; very low certainty evidence). We are also very uncertain whether intrarectal electromotive botulinum toxin A has an improved safety profile (RR 0.20, 95% CI 0.01 to 4.00; very low certainty evidence). The evidence for these results is of very low certainty due to serious concerns with risk of bias and imprecision. The study did not report data on treatment success. One study compared the injection of 60 units botulinum toxin A (n = 21) to myectomy of the internal anal sphincter (n = 21). We are very uncertain whether botulinum toxin A injection improves treatment success (RR 1.00, 95% CI 0.75 to 1.34; very low certainty evidence). No adverse events were recorded. The study reported no data for the other primary outcomes. One study compared 0.04 mg/kg oral prucalopride (n = 107) once daily to placebo (n = 108) over eight weeks. Oral prucalopride probably results in little or no difference in defecation frequency (MD 0.50, 95% CI -0.06 to 1.06; moderate certainty evidence); treatment success (RR 0.96, 95% CI 0.53 to 1.72; moderate certainty evidence); and adverse events (RR 1.15, 95% CI 0.94 to 1.39; moderate certainty evidence). The study did not report data on symptom resolution. One study compared transcutaneous electrical stimulation to sham stimulation, and another study compared dietitian-prescribed Mediterranean diet with written instructions versus written instructions. These studies did not report any of our predefined primary outcomes.
AUTHORS' CONCLUSIONS
We identified low to moderate certainty evidence that oral lubiprostone may result in little to no difference in treatment success and adverse events compared to placebo. Based on moderate certainty evidence, there is probably little or no difference between oral prucalopride and placebo in defecation frequency, treatment success, or adverse events. For all other comparisons, the certainty of the evidence for our predefined primary outcomes is very low due to serious concerns with study limitations and imprecision. Consequently, no robust conclusions could be drawn.
Topics: Humans; Constipation; Child; Randomized Controlled Trials as Topic; Child, Preschool; Adolescent; Defecation; Botulinum Toxins, Type A; Quality of Life; Laxatives; Infant; Bias; Lubiprostone
PubMed: 38895907
DOI: 10.1002/14651858.CD014580.pub2