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The Cochrane Database of Systematic... May 2021Neonatal abstinence syndrome (NAS) due to opioid withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Neonatal abstinence syndrome (NAS) due to opioid withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss, seizures and neurodevelopmental problems.
OBJECTIVES
To assess the effectiveness and safety of using a sedative versus control (placebo, usual treatment or non-pharmacological treatment) for NAS due to withdrawal from opioids and determine which type of sedative is most effective and safe for NAS due to withdrawal from opioids.
SEARCH METHODS
We ran an updated search on 17 September 2020 in CENTRAL via CRS Web and MEDLINE via Ovid. We searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.
SELECTION CRITERIA
We included trials enrolling infants with NAS born to mothers with an opioid dependence with more than 80% follow-up and using randomised, quasi-randomised and cluster-randomised allocation to sedative or control.
DATA COLLECTION AND ANALYSIS
Three review authors assessed trial eligibility and risk of bias, and independently extracted data. We used the GRADE approach to assess the certainty of the evidence.
MAIN RESULTS
We included 10 trials (581 infants) with NAS secondary to maternal opioid use in pregnancy. There were multiple comparisons of different sedatives and regimens. There were limited data available for use in sensitivity analysis of studies at low risk of bias. Phenobarbital versus supportive care: one study reported there may be little or no difference in treatment failure with phenobarbital and supportive care versus supportive care alone (risk ratio (RR) 2.73, 95% confidence interval (CI) 0.94 to 7.94; 62 participants; very low-certainty evidence). No infant had a clinical seizure. The study did not report mortality, neurodevelopmental disability and adverse events. There may be an increase in days' hospitalisation and treatment from use of phenobarbital (hospitalisation: mean difference (MD) 20.80, 95% CI 13.64 to 27.96; treatment: MD 17.90, 95% CI 11.98 to 23.82; both 62 participants; very low-certainty evidence). Phenobarbital versus diazepam: there may be a reduction in treatment failure with phenobarbital versus diazepam (RR 0.39, 95% CI 0.24 to 0.62; 139 participants; 2 studies; low-certainty evidence). The studies did not report mortality, neurodevelopmental disability and adverse events. One study reported there may be little or no difference in days' hospitalisation and treatment (hospitalisation: MD 3.89, 95% CI -1.20 to 8.98; 32 participants; treatment: MD 4.30, 95% CI -0.73 to 9.33; 31 participants; both low-certainty evidence). Phenobarbital versus chlorpromazine: there may be a reduction in treatment failure with phenobarbital versus chlorpromazine (RR 0.55, 95% CI 0.33 to 0.92; 138 participants; 2 studies; very low-certainty evidence), and no infant had a seizure. The studies did not report mortality and neurodevelopmental disability. One study reported there may be little or no difference in days' hospitalisation (MD 7.00, 95% CI -3.51 to 17.51; 87 participants; low-certainty evidence) and 0/100 infants had an adverse event. Phenobarbital and opioid versus opioid alone: one study reported no infants with treatment failure and no clinical seizures in either group (low-certainty evidence). The study did not report mortality, neurodevelopmental disability and adverse events. One study reported there may be a reduction in days' hospitalisation for infants treated with phenobarbital and opioid (MD -43.50, 95% CI -59.18 to -27.82; 20 participants; low-certainty evidence). Clonidine and opioid versus opioid alone: one study reported there may be little or no difference in treatment failure with clonidine and dilute tincture of opium (DTO) versus DTO alone (RR 0.09, 95% CI 0.01 to 1.59; 80 participants; very low-certainty evidence). All five infants with treatment failure were in the DTO group. There may be little or no difference in seizures (RR 0.14, 95% CI 0.01 to 2.68; 80 participants; very low-certainty evidence). All three infants with seizures were in the DTO group. There may be little or no difference in mortality after discharge (RR 7.00, 95% CI 0.37 to 131.28; 80 participants; very low-certainty evidence). All three deaths were in the clonidine and DTO group. The study did not report neurodevelopmental disability. There may be little or no difference in days' treatment (MD -4.00, 95% CI -8.33 to 0.33; 80 participants; very low-certainty evidence). One adverse event occurred in the clonidine and DTO group. There may be little or no difference in rebound NAS after stopping treatment, although all seven cases were in the clonidine and DTO group. Clonidine and opioid versus phenobarbital and opioid: there may be little or no difference in treatment failure (RR 2.27, 95% CI 0.98 to 5.25; 2 studies, 93 participants; very low-certainty evidence). One study reported one infant in the clonidine and morphine group had a seizure, and there were no infant mortalities. The studies did not report neurodevelopmental disability. There may be an increase in days' hospitalisation and days' treatment with clonidine and opioid versus phenobarbital and opioid(hospitalisation: MD 7.13, 95% CI 6.38 to 7.88; treatment: MD 7.57, 95% CI 3.97 to 11.17; both 2 studies, 91 participants; low-certainty evidence). There may be little or no difference in adverse events (RR 1.55, 95% CI 0.44 to 5.40; 2 studies, 93 participants; very low-certainty evidence). However, there was oversedation only in the phenobarbital and morphine group; and hypotension, rebound hypertension and rebound NAS only in the clonidine and morphine group.
AUTHORS' CONCLUSIONS
There is very low-certainty evidence that phenobarbital increases duration of hospitalisation and treatment, but reduces days to regain birthweight and duration of supportive care each day compared to supportive care alone. There is low-certainty evidence that phenobarbital reduces treatment failure compared to diazepam and very low-certainty evidence that phenobarbital reduces treatment failure compared to chlorpromazine. There is low-certainty evidence of an increase in days' hospitalisation and days' treatment with clonidine and opioid compared to phenobarbital and opioid. There are insufficient data to determine the safety and incidence of adverse events for infants treated with combinations of opioids and sedatives including phenobarbital and clonidine.
Topics: Bias; Chlorpromazine; Clonidine; Diazepam; Humans; Hypnotics and Sedatives; Infant, Newborn; Narcotics; Neonatal Abstinence Syndrome; Opioid-Related Disorders; Phenobarbital; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 34002380
DOI: 10.1002/14651858.CD002053.pub4 -
The Cochrane Database of Systematic... Nov 2017Paediatric neurodiagnostic investigations, including brain neuroimaging and electroencephalography (EEG), play an important role in the assessment of neurodevelopmental... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Paediatric neurodiagnostic investigations, including brain neuroimaging and electroencephalography (EEG), play an important role in the assessment of neurodevelopmental disorders. The use of an appropriate sedative agent is important to ensure the successful completion of the neurodiagnostic procedures, particularly in children, who are usually unable to remain still throughout the procedure.
OBJECTIVES
To assess the effectiveness and adverse effects of chloral hydrate as a sedative agent for non-invasive neurodiagnostic procedures in children.
SEARCH METHODS
We used the standard search strategy of the Cochrane Epilepsy Group. We searched MEDLINE (OVID SP) (1950 to July 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, Issue 7, 2017), Embase (1980 to July 2017), and the Cochrane Epilepsy Group Specialized Register (via CENTRAL) using a combination of keywords and MeSH headings.
SELECTION CRITERIA
We included randomised controlled trials that assessed chloral hydrate agent against other sedative agent(s), non-drug agent(s), or placebo for children undergoing non-invasive neurodiagnostic procedures.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the studies for their eligibility, extracted data, and assessed risk of bias. Results were expressed in terms of risk ratio (RR) for dichotomous data, mean difference (MD) for continuous data, with 95% confidence intervals (CIs).
MAIN RESULTS
We included 13 studies with a total of 2390 children. The studies were all conducted in hospitals that provided neurodiagnostic services. Most studies assessed the proportion of sedation failure during the neurodiagnostic procedure, time for adequate sedation, and potential adverse effects associated with the sedative agent.The methodological quality of the included studies was mixed, as reflected by a wide variation in their 'Risk of bias' profiles. Blinding of the participants and personnel was not achieved in most of the included studies, and three of the 13 studies had high risk of bias for selective reporting. Evaluation of the efficacy of the sedative agents was also underpowered, with all the comparisons performed in single small studies.Children who received oral chloral hydrate had lower sedation failure when compared with oral promethazine (RR 0.11, 95% CI 0.01 to 0.82; 1 study, moderate-quality evidence). Children who received oral chloral hydrate had a higher risk of sedation failure after one dose compared to those who received intravenous pentobarbital (RR 4.33, 95% CI 1.35 to 13.89; 1 study, low-quality evidence), but after two doses there was no evidence of a significant difference between the two groups (RR 3.00, 95% CI 0.33 to 27.46; 1 study, very low-quality evidence). Children who received oral chloral hydrate appeared to have more sedation failure when compared with music therapy, but the quality of evidence was very low for this outcome (RR 17.00, 95% CI 2.37 to 122.14; 1 study). Sedation failure rates were similar between oral chloral hydrate, oral dexmedetomidine, oral hydroxyzine hydrochloride, and oral midazolam.Children who received oral chloral hydrate had a shorter time to achieve adequate sedation when compared with those who received oral dexmedetomidine (MD -3.86, 95% CI -5.12 to -2.6; 1 study, moderate-quality evidence), oral hydroxyzine hydrochloride (MD -7.5, 95% CI -7.85 to -7.15; 1 study, moderate-quality evidence), oral promethazine (MD -12.11, 95% CI -18.48 to -5.74; 1 study, moderate-quality evidence), and rectal midazolam (MD -95.70, 95% CI -114.51 to -76.89; 1 study). However, children with oral chloral hydrate took longer to achieve adequate sedation when compared with intravenous pentobarbital (MD 19, 95% CI 16.61 to 21.39; 1 study, low-quality evidence) and intranasal midazolam (MD 12.83, 95% CI 7.22 to 18.44; 1 study, moderate-quality evidence).No data were available to assess the proportion of children with successful completion of neurodiagnostic procedure without interruption by the child awakening. Most trials did not assess adequate sedation as measured by specific validated scales, except in the comparison of chloral hydrate versus intranasal midazolam and oral promethazine.Compared to dexmedetomidine, chloral hydrate was associated with a higher risk of nausea and vomiting (RR 12.04 95% CI 1.58 to 91.96). No other adverse events were significantly associated with chloral hydrate (including behavioural change, oxygen desaturation) although there was an increased risk of adverse events overall (RR 7.66, 95% CI 1.78 to 32.91; 1 study, low-quality evidence).
AUTHORS' CONCLUSIONS
The quality of evidence for the comparisons of oral chloral hydrate against several other methods of sedation was very variable. Oral chloral hydrate appears to have a lower sedation failure rate when compared with oral promethazine for children undergoing paediatric neurodiagnostic procedures. The sedation failure was similar for other comparisons such as oral dexmedetomidine, oral hydroxyzine hydrochloride, and oral midazolam. When compared with intravenous pentobarbital and music therapy, oral chloral hydrate had a higher sedation failure rate. However, it must be noted that the evidence for the outcomes for the comparisons of oral chloral hydrate against intravenous pentobarbital and music therapy was of very low to low quality, therefore the corresponding findings should be interpreted with caution.Further research should determine the effects of oral chloral hydrate on major clinical outcomes such as successful completion of procedures, requirements for additional sedative agent, and degree of sedation measured using validated scales, which were rarely assessed in the studies included in this review. The safety profile of chloral hydrate should be studied further, especially the risk of major adverse effects such as bradycardia, hypotension, and oxygen desaturation.
Topics: Administration, Oral; Adolescent; Child; Child, Preschool; Chloral Hydrate; Dexmedetomidine; Diagnostic Techniques, Neurological; Electroencephalography; Humans; Hydroxyzine; Hypnotics and Sedatives; Infant; Melatonin; Midazolam; Music Therapy; Neuroimaging; Pentobarbital; Promethazine; Randomized Controlled Trials as Topic; Treatment Failure
PubMed: 29099542
DOI: 10.1002/14651858.CD011786.pub2 -
Oral Diseases Nov 2022The goal of this systematic review was to assess the efficacy of dexamethasone compared to other treatments in oral lichen planus (OLP). The literature search used the... (Review)
Review
The goal of this systematic review was to assess the efficacy of dexamethasone compared to other treatments in oral lichen planus (OLP). The literature search used the following inclusion criteria: randomized controlled trials (RCT) comparing dexamethasone and other treatment strategies in patients with OLP. The outcome measures included relief of symptoms, decrement of erosive area size, and changes in quality of life. A computer and manual search was performed in Pubmed, Web of Science, and Cochrane Library up to January 31, 2021. The risk of bias was measured with the Revised Cochrane risk-of-bias tool for randomized trials. Eight trials with 131 study participants and 132 controls were identified. The following interventions were compared dexamethasone mouthwash, and 5% methylene blue-mediated photodynamic therapy, low-level laser therapy, amlexanox, clobetasol mouthwash, ketoconazole with amitriptyline, and thalidomide 1% paste. The therapeutic outcomes were more advantageous for dexamethasone in comparison with photodynamic therapy (PDT) (2 RCT) and low-level laser therapy (LLLT). Comparable effects were observed for dexamethasone, amlexanox, thalidomide, and PDT (1 RCT). Clobetasol showed more effective action than dexamethasone. Given the small sample sizes, heterogeneity and the few studies included, there is limited evidence to support the selection of treatment for OLP.
Topics: Administration, Topical; Aminopyridines; Amitriptyline; Clobetasol; Dexamethasone; Humans; Ketoconazole; Lichen Planus, Oral; Methylene Blue; Mouthwashes; Thalidomide
PubMed: 34273228
DOI: 10.1111/odi.13966 -
Academic Emergency Medicine : Official... May 2023Benign paroxysmal positional vertigo (BPPV) is a common cause of acute dizziness. Medication use for its treatment remains common despite guideline recommendations... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Benign paroxysmal positional vertigo (BPPV) is a common cause of acute dizziness. Medication use for its treatment remains common despite guideline recommendations against their use.
OBJECTIVES
The objective was to evaluate the efficacy and safety of vestibular suppressants in patients with BPPV compared to placebo, no treatment, or canalith repositioning maneuvers (CRMs).
METHODS
We searched MEDLINE, Cochrane, EMBASE, and ClinicalTrials.gov from inception until March 25, 2022. for randomized controlled trials (RCTs) comparing antihistamines, phenothiazines, anticholinergics, and/or benzodiazepines to placebo, no treatment, or a CRM.
RESULTS
Five RCTs, enrolling 296 patients, were included in the quantitative analysis. We found that vestibular suppressants may have no effect on symptom resolution at the point of longest follow-up (14-31 days in four studies) when evaluated as a continuous outcome (standardized mean difference -0.03 points, 95% confidence interval [CI] -0.53 to 0.47). Conversely, CRMs may improve symptom resolution at the point of longest follow-up as a dichotomous outcome when compared to vestibular suppressants (relative risk [RR] 0.63, 95% CI 0.52 to 0.78). Vestibular suppressants had an uncertain effect on symptom resolution within 24 h (mean difference [MD] 5 points, 95% CI -16.92 to 26.94), repeat emergency department (ED)/clinic visits (RR 0.37, 95% CI 0.12 to 1.15), patient satisfaction (MD 0 points, 95% CI -1.02 to 1.02), and quality of life (MD -1.2 points, 95% CI -2.96 to 0.56). Vestibular suppressants had an uncertain effect on adverse events.
CONCLUSIONS
In patients with BPPV, vestibular suppressants may have no effect on symptom resolution at the point of longest follow-up; however, there is evidence toward the superiority of CRM over these medications. Vestibular suppressants have an uncertain effect on symptom resolution within 24 h, repeat ED/clinic visits, patient satisfaction, quality of life, and adverse events. These data suggest that a CRM, and not vestibular suppressants, should be the primary treatment for BPPV.
Topics: Humans; Benign Paroxysmal Positional Vertigo; Randomized Controlled Trials as Topic; Patient Positioning; Patient Satisfaction; Emergency Service, Hospital
PubMed: 36268806
DOI: 10.1111/acem.14608 -
European Journal of Obstetrics,... May 2018The diagnosis of peritoneal endometriosis during laparoscopy may be difficult due to the polymorphic aspects of the lesions. Enhanced imaging using contrast agents has... (Review)
Review
The diagnosis of peritoneal endometriosis during laparoscopy may be difficult due to the polymorphic aspects of the lesions. Enhanced imaging using contrast agents has potential to provide a better identification of peritoneal endometriosis. The aim of this systematic review is to provide an overview of the literature on what is known about the intraoperative laparoscopic visual enhancement of peritoneal endometriosis using contrast agents. A systematic review was done of studies about enhanced imaging during laparoscopy for endometriosis using contrast agents. Clinical studies which contained a description of imaging with a contrast agent and also reported visual findings of endometriosis during laparoscopy, were included. Nine suitable studies were identified. Intraoperative visualization of endometriosis was analyzed with or without histologic confirmation. Four studies evaluated 5-aminolevulinic acid-induced fluorescence (5-ALA), 1 study evaluated indigo carmine, 2 studies evaluated methylene blue (MB), 1 study evaluated indocyanine green (ICG) and 1 study evaluated so-called bloody peritoneal fluid painting. All studies, with a combined total of 171 included patients, showed potential of enhanced visibility of endometriosis using contrast agents. A combined total of 7 complications, all related to the use of 5-ALA, were reported. We conclude that the use of contrast-based enhanced imaging during laparoscopy is promising and that it can provide a better visualization of peritoneal endometriosis. However, based on the limited data no technique of preference can yet be identified.
Topics: Aminolevulinic Acid; Contrast Media; Endometriosis; Female; Humans; Laparoscopy; Methylene Blue; Optical Imaging; Peritoneal Diseases
PubMed: 29573627
DOI: 10.1016/j.ejogrb.2018.03.020 -
European Archives of... Sep 2021Methylene blue (MB) is frequently administered during fiberoptic endoscopic evaluation of swallowing (FEES) to enhance visualization of pharyngeal bolus transit.... (Review)
Review
OBJECTIVE
Methylene blue (MB) is frequently administered during fiberoptic endoscopic evaluation of swallowing (FEES) to enhance visualization of pharyngeal bolus transit. However, the safety of MB is being questioned since serious adverse events (AEs) such as hemodynamic instability, hemolysis, and serotonin syndrome were reported. The aim of this study is a systematic analysis of the literature to obtain an evidence-based overview of AEs due to oral administration of MB and to determine its safety as a food dye during swallowing assessment.
METHODS
A systematic literature search was carried out in PubMed, Embase, and Cochrane Library. Two reviewers independently selected articles describing oral administration of MB as a main diagnostic/therapeutic intervention, dosage, and AEs. Expert opinions, conference papers, sample size < 10, and animal studies were excluded. Level of evidence of the included studies was determined.
RESULTS
A total of 2264 unduplicated articles were obtained. Seventeen studies met the inclusion criteria with 100% agreement between the two reviewers. Among these, twelve studies were randomized controlled trials. In a pooled population of 1902 patients receiving oral MB, three serious AEs were reported related to MB. Non-serious AEs showed a dose-related trend and were usually mild and self-limiting. A meta-analysis could not be performed as studies were methodologically too heterogeneous.
CONCLUSION
Serious AEs due to oral administration of MB are rare (n = 3, 0.16%). MB-related non-serious AEs are mild, self-limiting, and show a dose-related trend. These findings indicate that it is safe to use small amounts of MB as a food dye during swallowing examinations.
Topics: Deglutition; Humans; Methylene Blue; Pharynx
PubMed: 33389001
DOI: 10.1007/s00405-020-06509-3 -
Critical Care Explorations Jul 2024Although clinicians may use methylene blue (MB) in refractory septic shock, the effect of MB on patient-important outcomes remains uncertain. We conducted a systematic... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Although clinicians may use methylene blue (MB) in refractory septic shock, the effect of MB on patient-important outcomes remains uncertain. We conducted a systematic review and meta-analysis to investigate the benefits and harms of MB administration in patients with septic shock.
DATA SOURCES
We searched six databases (including PubMed, Embase, and Medline) from inception to January 10, 2024.
STUDY SELECTION
We included randomized clinical trials (RCTs) of critically ill adults comparing MB with placebo or usual care without MB administration.
DATA EXTRACTION
Two reviewers performed screening, full-text review, and data extraction. We pooled data using a random-effects model, assessed the risk of bias using the modified Cochrane tool, and used Grading of Recommendations Assessment, Development, and Evaluation to rate certainty of effect estimates.
DATA SYNTHESIS
We included six RCTs (302 patients). Compared with placebo or no MB administration, MB may reduce short-term mortality (RR [risk ratio] 0.66 [95% CI, 0.47-0.94], low certainty) and hospital length of stay (mean difference [MD] -2.1 d [95% CI, -1.4 to -2.8], low certainty). MB may also reduce duration of vasopressors (MD -31.1 hr [95% CI, -16.5 to -45.6], low certainty), and increase mean arterial pressure at 6 hours (MD 10.2 mm Hg [95% CI, 6.1-14.2], low certainty) compared with no MB administration. The effect of MB on serum methemoglobin concentration was uncertain (MD 0.9% [95% CI, -0.2% to 2.0%], very low certainty). We did not find any differences in adverse events.
CONCLUSIONS
Among critically ill adults with septic shock, based on low-certainty evidence, MB may reduce short-term mortality, duration of vasopressors, and hospital length of stay, with no evidence of increased adverse events. Rigorous randomized trials evaluating the efficacy of MB in septic shock are needed.
REGISTRATION
Center for Open Science (https://osf.io/hpy4j).
Topics: Methylene Blue; Humans; Shock, Septic; Randomized Controlled Trials as Topic; Length of Stay; Critical Illness
PubMed: 38904978
DOI: 10.1097/CCE.0000000000001110 -
Journal of Oral Pathology & Medicine :... May 2015In recent decades, optical techniques utilising the principles of chemiluminescence and tissue autofluorescence have emerged to facilitate the early detection of any... (Review)
Review
INTRODUCTION
In recent decades, optical techniques utilising the principles of chemiluminescence and tissue autofluorescence have emerged to facilitate the early detection of any oral mucosal changes suspicious of cancer.
PURPOSE
To evaluate the effectiveness of devices that utilise the principles of chemiluminescence and tissue autofluorescence as adjuncts in the detection of oral cancer and oral potentially malignant disorders (OPMDs).
METHODS
A systematic review of the published literature to evaluate the effectiveness of the ViziLite(®) and ViziLite(®) Plus with toluidine blue, MicroLux™/DL and the VELscope™ as aids in the detection of oral cancer and OPMDs.
RESULTS
Twenty-five primary studies published between 2004 and 2013 satisfied our criteria for selection - 13 utilised chemiluminescence and 12 tissue autofluorescence. Some had utilised both study methods on the same population. Chemiluminescence shows good sensitivity at detecting any OPMDs and oral cancer. However, it preferentially detects leukoplakia and may fail to spot red patches. The additive use of toluidine blue may improve specificity. Tissue autofluorescence is sensitive at detecting white, red and white and red patches, and the area of fluorescence visualisation loss (FVL) often extends beyond the clinically visible lesion. However, in addition to OPMDs, VELScope may detect erythematous lesions of benign inflammation resulting in false-positive test results.
CONCLUSION
There is limited evidence for their use in primary care, and these tools are better suited to specialist clinics in which there is a higher prevalence of disease and where experienced clinicians may better discriminate between benign and malignant lesions.
Topics: Biopsy; Early Detection of Cancer; Humans; Luminescence; Luminescent Measurements; Mouth Diseases; Mouth Mucosa; Mouth Neoplasms; Optical Imaging; Optics and Photonics; Precancerous Conditions; Predictive Value of Tests; Tolonium Chloride
PubMed: 25183259
DOI: 10.1111/jop.12218 -
Lasers in Medical Science Oct 2022Antimicrobial photodynamic therapy (aPDT) has been proposed as an adjunctive treatment strategy for peri-implant diseases. This systematic review aimed to determine... (Meta-Analysis)
Meta-Analysis Review
Antimicrobial photodynamic therapy (aPDT) has been proposed as an adjunctive treatment strategy for peri-implant diseases. This systematic review aimed to determine whether aPDT as an adjunct to mechanical debridement has an additional benefit for smokers with peri-implant diseases. Randomized controlled trials (RCTs), which evaluated the clinical outcomes of mechanical debridement alone versus mechanical debridement + aPDT among smokers, were considered eligible to be included. The primary outcome was bleeding on probing (BOP) and secondary outcomes included probing depth (PD), plaque index (PI), and crestal bone loss (CBL). Meta-analyses using a random-effects model were conducted to calculate the mean difference (MD) with a 95% confidence interval (CI). The quality of evidence was assessed according to Grading of Recommendations Assessment, Development and Evaluation (GRADE). A total of four RCTs (188 participants) were included. The aPDT group showed significantly improved PD (MD = - 1.26, 95% CI = - 2.19 to - 0.32, p = 0.008) and PI (MD = - 10.6%, 95% CI = - 14.46 to - 6.74%, p = 0.0001) compared with mechanical debridement group at 3-month follow-up. No significant difference in bleeding on probing (BOP) was observed at 3-month follow-up (MD = - 0.60%, 95% CI = - 2.36 to 1.16%, p = 0.50). The subgroup analyses on photosensitizers demonstrated significant differences between the two groups on PD (MD = - 1.23, 95% CI = - 2.41 to - 0.05, p = 0.04) and PI (MD = - 12.33, 95% CI = - 14.74 to - 9.92, p < 0.00001) by the use of methylene blue (MB). Within the limitation of this study, compared with mechanical debridement alone, combined use of aPDT was more effective in reducing PD and PI in smokers at 3-month follow-up. MB was a predictable photosensitizer for aPDT. However, the findings should be interpreted with caution due to the limited number of included studies, methodological deficiencies, and heterogeneity between studies.
Topics: Anti-Bacterial Agents; Anti-Infective Agents; Combined Modality Therapy; Debridement; Humans; Methylene Blue; Peri-Implantitis; Photochemotherapy; Photosensitizing Agents; Smokers
PubMed: 35896900
DOI: 10.1007/s10103-022-03592-2 -
The Cochrane Database of Systematic... Aug 2014Antipsychotic drugs are the core treatment for schizophrenia. Treatment guidelines state that there is no difference in efficacy between any other antipsychotic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Antipsychotic drugs are the core treatment for schizophrenia. Treatment guidelines state that there is no difference in efficacy between any other antipsychotic compounds, however, low-potency antipsychotic drugs are often perceived as less efficacious than high-potency compounds by clinicians, and they also seem to differ in their side effects. This review examined the effects of the high-potency antipsychotic fluphenazine compared to those of low-potency antipsychotics.
OBJECTIVES
To review the effects of fluphenazine and low-potency antipsychotics for people with schizophrenia.
SEARCH METHODS
We searched the Cochrane Schizophrenia Group Trials Register (November 2010).
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) comparing fluphenazine with first-generation low-potency antipsychotic drugs for people with schizophrenia or schizophrenia-like psychosis.
DATA COLLECTION AND ANALYSIS
We extracted data independently. For dichotomous data we calculated risk ratios (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a random-effects model.
MAIN RESULTS
The review currently includes seven randomised trials and 1567 participants that compared fluphenazine with low-potency antipsychotic drugs. The size of the included studies was between 40 and 438 participants. Overall, sequence generation, allocation procedures and blinding were poorly reported. Fluphenazine was not significantly different from low-potency antipsychotic drugs in terms of response to treatment (fluphenazine 55%, low-potency drug 55%, 2 RCTs, n = 105, RR 1.06 CI 0.75 to 1.50, moderate quality evidence). There was also no significant difference in acceptability of treatment with equivocal numbers of participants leaving the studies early due to any reason (fluphenazine 36%, low-potency antipsychotics 36%, 6 RCTs, n = 1532, RR 1.00 CI 0.88 to 1.14, moderate quality evidence). There was no significant difference between fluphenazine and low-potency antipsychotics for numbers experiencing at least one adverse effect (fluphenazine 70%, low-potency antipsychotics 88%, 1 RCT, n = 65, RR 0.79 CI 0.58 to 1.07, moderate quality evidence). However, at least one movement disorder occurred significantly more frequently in the fluphenazine group (fluphenazine 15%, low-potency antipsychotics 10%, 3 RCTs, n = 971, RR 2.11 CI 1.41 to 3.15, low quality of evidence). In contrast, low-potency antipsychotics produced significantly more sedation (fluphenazine 20%, low-potency antipsychotics 64%, 1 RCT, n = 65, RR 0.31 CI 0.13 to 0.77, high quality evidence). No data were available for the outcomes of death and quality of life. The results of the primary outcome were robust in a number of subgroup and sensitivity analyses.Adverse effects such as akathisia (fluphenazine 15%, low-potency antipsychotics 6%, 5 RCTs, n = 1209, RR 2.28 CI 1.58 to 3.28); dystonia (fluphenazine 5%, low-potency antipsychotics 2%, 4 RCTs, n = 1309, RR 2.66 CI 1.25 to 5.64); loss of associated movement (fluphenazine 20%, low-potency antipsychotics 2%, 1 RCT, n = 338, RR 11.15 CI 3.95 to 31.47); rigor (fluphenazine 27%, low-potency antipsychotics 12%, 2 RCTs, n = 403, RR 2.18 CI 1.20 to 3.97); and tremor (fluphenazine 15%, low-potency antipsychotics 6%, 2 RCTs, n = 403, RR 2.53 CI 1.37 to 4.68) occurred significantly more frequently in the fluphenazine group.For other adverse effects such as dizziness (fluphenazine 8%, low-potency antipsychotics 17%, 4 RCTs, n = 1051, RR 0.49 CI 0.32 to 0.73); drowsiness (fluphenazine 18%, low-potency antipsychotics 25%, 3 RCTs, n = 986, RR 0.67 CI 0.53 to 0.86); dry mouth (fluphenazine 11%, low-potency antipsychotics 18%, 4 RCTs, n = 1051, RR 0.63 CI 0.45 to 0.89); nausea (fluphenazine 4%, low-potency antipsychotics 15%, 3 RCTs, n = 986, RR 0.25 CI 0.14 to 0.45); and vomiting (fluphenazine 3%, low-potency antipsychotics 8%, 3 RCTs, n = 986, RR 0.36 CI 0.18 to 0.72) results favoured fluphenazine with significantly more events occurring in the low-potency antipsychotic group for these outcomes.
AUTHORS' CONCLUSIONS
The results do not show a clear difference in efficacy between fluphenazine and low-potency antipsychotics. The number of included studies was low and their quality moderate. Therefore, further studies would be needed to draw firm conclusions about the relative effects of fluphenazine and low-potency antipsychotics.
Topics: Akathisia, Drug-Induced; Antipsychotic Agents; Dyskinesia, Drug-Induced; Fluphenazine; Humans; Randomized Controlled Trials as Topic; Schizophrenia
PubMed: 25087165
DOI: 10.1002/14651858.CD009230.pub2