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Aesthetic Plastic Surgery Apr 2023The present study compiled evidence on the efficacy of botulinum toxin A (BTX) for management of bruxism. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The present study compiled evidence on the efficacy of botulinum toxin A (BTX) for management of bruxism.
METHODS
A literature review that included randomized control, cohort, as well as observational studies published between January 2000 and November 2022 was conducted. All studies related to BTX injections administered into the masseters of patients with bruxism were included. Primary outcomes were measured by performing a meta-analysis of changes in maximal biting forces and pain severity and meta-regression of the effects of the BTX dose.
RESULTS
Ten studies were included for quantitative analysis. The analysis of the maximal biting force after BTX injections demonstrated a significant reduction at 1 month or less compared with both oral splints (P < 0.000001) and saline injections (P = 0.01). BTX continued to outperform oral splinting (P = 0.001) and saline placebos (P = 0.03) at 3 months. Between 3 and 6 months, a significantly higher maximal biting strength was observed in the BTX group than the oral splinting group (P < 0.00001). No significant differences in the maximal biting force were observed between the BTX and saline placebo groups (P = 0.50). A similar trend was observed in the analysis of pain reduction after botulinum treatment. Additionally, for every unit increase in the BTX dose, pain severity decreased by 0.0831 points (P = 0.0011).
CONCLUSION
BTX is effective in reducing biting strength and pain severity. BTX effects are evident at less than 4 weeks, peak between 5 and 8 weeks, and last for up to 24 weeks. Higher BTX doses result in greater improvement in pain. Although BTX benefits manifest earlier, they gradually diminish, and oral splinting exerts a more enduring effect, especially after 9-12 weeks. BTX injections into masseters are recommended as management options for bruxers, especially for those having difficulties complying with wearing oral splints or those seeking earlier symptom relief. However, future studies should determine BTX effects beyond 24 weeks and after repetitive injections and how bruxers of different ages or genders respond to treatment.
LEVEL OF EVIDENCE III
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Topics: Humans; Male; Female; Bruxism; Neuromuscular Agents; Follow-Up Studies; Randomized Controlled Trials as Topic; Botulinum Toxins, Type A; Pain; Treatment Outcome
PubMed: 36694050
DOI: 10.1007/s00266-023-03256-8 -
The Cochrane Database of Systematic... Jul 2020Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract, in which the pathogenesis is believed to be partly influenced by the gut... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract, in which the pathogenesis is believed to be partly influenced by the gut microbiome. Probiotics can be used to manipulate the microbiome and have therefore been considered as a potential therapy for CD. There is some evidence that probiotics benefit other gastrointestinal conditions, such as irritable bowel syndrome and ulcerative colitis, but their efficacy in CD is unclear. This is the first update of a Cochrane Review previously published in 2008.
OBJECTIVES
To assess the efficacy and safety of probiotics for the induction of remission in CD.
SEARCH METHODS
The following electronic databases were searched: MEDLINE (from inception to 6 July 2020), Embase (from inception to 6 July 2020), the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane IBD Review Group Specialised Trials Register, World Health Organization (WHO) International Clinical Trials Registry, and ClinicalTrials.gov.
SELECTION CRITERIA
Randomised controlled trials (RCTs) that compared probiotics with placebo or any other non-probiotic intervention for the induction of remission in CD were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed the methodological quality of included studies. The primary outcome was clinical remission. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for dichotomous outcomes.
MAIN RESULTS
There were two studies that met criteria for inclusion. One study from Germany had 11 adult participants with mild-to-moderate CD, who were treated with a one-week course of corticosteroids and antibiotics (ciprofloxacin 500 mg twice daily and metronidazole 250 mg three times a day), followed by randomised assignment to Lactobacillus rhamnosus strain GG (two billion colony-forming units per day) or corn starch placebo. The other study from the United Kingdom (UK) had 35 adult participants with active CD (CDAI score of 150 to 450) randomised to receive a synbiotic treatment (comprised of freeze-dried Bifidobacterium longum and a commercial product) or placebo. The overall risk of bias was low in one study, whereas the other study had unclear risk of bias in relation to random sequence generation, allocation concealment, and blinding. There was no evidence of a difference between the use of probiotics and placebo for the induction of remission in CD (RR 1.06; 95% CI 0.65 to 1.71; 2 studies, 46 participants) after six months. There was no difference in adverse events between probiotics and placebo (RR 2.55; 95% CI 0.11 to 58.60; 2 studies, 46 participants). The evidence for both outcomes was of very low certainty due to risk of bias and imprecision.
AUTHORS' CONCLUSIONS
The available evidence is very uncertain about the efficacy or safety of probiotics, when compared with placebo, for induction of remission in Crohn's disease. There is a lack of well-designed RCTs in this area and further research is needed.
Topics: Adult; Anti-Bacterial Agents; Bifidobacterium longum; Ciprofloxacin; Crohn Disease; Gastrointestinal Microbiome; Humans; Lacticaseibacillus rhamnosus; Metronidazole; Placebos; Probiotics; Randomized Controlled Trials as Topic; Remission Induction
PubMed: 32678465
DOI: 10.1002/14651858.CD006634.pub3 -
Supportive Care in Cancer : Official... Dec 2021Nausea and vomiting are a common clinical symptom in the advanced cancer patient. Pharmacologic management is important. Evidence for drug choices and guidelines are...
BACKGROUND
Nausea and vomiting are a common clinical symptom in the advanced cancer patient. Pharmacologic management is important. Evidence for drug choices and guidelines are needed to help clinicians manage nausea and vomiting in this population METHODS: Evidence from a systematic review published in 2010, initial MASCC guidelines developed from a systematic review of literature to 2015, and a new systematic review of randomized trials published between 2015 and February 2, 2021, was combined to establish a new guideline.
RESULTS
A search of the literature between 2015 and February 2, 2021, revealed 257 abstracts of which there was one systematic review and 4 randomized trials which were used to modify the guideline. The new guideline is as follows: First Line: Metoclopramide (II) multiple small RCTs including a placebo-controlled trial, haloperidol (II) multiple non-placebo-controlled RCTs, high consensus. Second line: Methotrimeprazine (II) 1 well-powered non-placebo-controlled RCT, olanzapine (II) 1 placebo-controlled pilot RCT, high consensus. Third line: Tropisetron (II) large unblinded lower quality non-placebo-controlled RCT, levosulpiride (II) 1 blinded non-placebo-controlled pilot RCT, high consensus.
DISCUSSION
Haloperidol, metoclopramide, methotrimeprazine, olanzapine tropisetron, and levosulpiride have been antiemetics used in randomized trials with antiemetic activity demonstrated. There are only three placebo-controlled randomized trials we could find in our literature review. Placebo responses varied significantly between two randomized trials. More randomized placebo-controlled trials with either metoclopramide or haloperidol rescue are needed to clarify antiemetic choices in advanced cancer.
CONCLUSION
First-line antiemetics for nausea and vomiting in advanced cancer are metoclopramide and haloperidol, and second-line medications are methotrimeprazine and olanzapine.
Topics: Antiemetics; Humans; Metoclopramide; Nausea; Neoplasms; Vomiting
PubMed: 34398289
DOI: 10.1007/s00520-021-06437-w -
The Cochrane Database of Systematic... Apr 2021Miscarriage, defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, is common with approximately 25% of women experiencing a miscarriage in their... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Miscarriage, defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, is common with approximately 25% of women experiencing a miscarriage in their lifetime, and 15% to 20% of pregnancies ending in a miscarriage. Progesterone has an important role in maintaining a pregnancy, and supplementation with different progestogens in early pregnancy has been attempted to rescue a pregnancy in women with early pregnancy bleeding (threatened miscarriage), and to prevent miscarriages in asymptomatic women who have a history of three or more previous miscarriages (recurrent miscarriage).
OBJECTIVES
To estimate the relative effectiveness and safety profiles for the different progestogen treatments for threatened and recurrent miscarriage, and provide rankings of the available treatments according to their effectiveness, safety, and side-effect profile.
SEARCH METHODS
We searched the following databases up to 15 December 2020: Cochrane Central Register of Controlled Trials, Ovid MEDLINE(R), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies.
SELECTION CRITERIA
We included all randomised controlled trials assessing the effectiveness or safety of progestogen treatment for the prevention of miscarriage. Cluster-randomised trials were eligible for inclusion. Randomised trials published only as abstracts were eligible if sufficient information could be retrieved. We excluded quasi- and non-randomised trials.
DATA COLLECTION AND ANALYSIS
At least two review authors independently assessed the trials for inclusion and risk of bias, extracted data and checked them for accuracy. We performed pairwise meta-analyses and indirect comparisons, where possible, to determine the relative effects of all available treatments, but due to the limited number of included studies only direct or indirect comparisons were possible. We estimated the relative effects for the primary outcome of live birth and the secondary outcomes including miscarriage (< 24 weeks of gestation), preterm birth (< 37 weeks of gestation), stillbirth, ectopic pregnancy, congenital abnormalities, and adverse drug events. Relative effects for all outcomes are reported separately by the type of miscarriage (threatened and recurrent miscarriage). We used the GRADE approach to assess the certainty of evidence.
MAIN RESULTS
Our meta-analysis included seven randomised trials involving 5,682 women, and all provided data for meta-analysis. All trials were conducted in hospital settings. Across seven trials (14 treatment arms), the following treatments were used: three arms (21%) used vaginal micronized progesterone; three arms (21%) used dydrogesterone; one arm (7%) used oral micronized progesterone; one arm (7%) used 17-α-hydroxyprogesterone, and six arms (43%) used placebo. Women with threatened miscarriage Based on the relative effects from the pairwise meta-analysis, vaginal micronized progesterone (two trials, 4090 women, risk ratio (RR) 1.03, 95% confidence interval (CI) 1.00 to 1.07, high-certainty evidence), and dydrogesterone (one trial, 406 women, RR 0.98, 95% CI 0.89 to 1.07, moderate-certainty evidence) probably make little or no difference to the live birth rate when compared with placebo for women with threatened miscarriage. No data are available to assess the effectiveness of 17-α-hydroxyprogesterone or oral micronized progesterone for the outcome of live birth in women with threatened miscarriage. The pre-specified subgroup analysis by number of previous miscarriages is only possible for vaginal micronized progesterone in women with threatened miscarriage. In women with no previous miscarriages and early pregnancy bleeding, there is probably little or no improvement in the live birth rate (RR 0.99, 95% CI 0.95 to 1.04, high-certainty evidence) when treated with vaginal micronized progesterone compared to placebo. However, for women with one or more previous miscarriages and early pregnancy bleeding, vaginal micronized progesterone increases the live birth rate compared to placebo (RR 1.08, 95% CI 1.02 to 1.15, high-certainty evidence). Women with recurrent miscarriage Based on the results from one trial (826 women) vaginal micronized progesterone (RR 1.04, 95% CI 0.95 to 1.15, high-certainty evidence) probably makes little or no difference to the live birth rate when compared with placebo for women with recurrent miscarriage. The evidence for dydrogesterone compared with placebo for women with recurrent miscarriage is of very low-certainty evidence, therefore the effects remain unclear. No data are available to assess the effectiveness of 17-α-hydroxyprogesterone or oral micronized progesterone for the outcome of live birth in women with recurrent miscarriage. Additional outcomes All progestogen treatments have a wide range of effects on the other pre-specified outcomes (miscarriage (< 24 weeks of gestation), preterm birth (< 37 weeks of gestation), stillbirth, ectopic pregnancy) in comparison to placebo for both threatened and recurrent miscarriage. Moderate- and low-certainty evidence with a wide range of effects suggests that there is probably no difference in congenital abnormalities and adverse drug events with vaginal micronized progesterone for threatened (congenital abnormalities RR 1.00, 95% CI 0.68 to 1.46, moderate-certainty evidence; adverse drug events RR 1.07 95% CI 0.81 to 1.39, moderate-certainty evidence) or recurrent miscarriage (congenital abnormalities 0.75, 95% CI 0.31 to 1.85, low-certainty evidence; adverse drug events RR 1.46, 95% CI 0.93 to 2.29, moderate-certainty evidence) compared with placebo. There are limited data and very low-certainty evidence on congenital abnormalities and adverse drug events for the other progestogens.
AUTHORS' CONCLUSIONS
The overall available evidence suggests that progestogens probably make little or no difference to live birth rate for women with threatened or recurrent miscarriage. However, vaginal micronized progesterone may increase the live birth rate for women with a history of one or more previous miscarriages and early pregnancy bleeding, with likely no difference in adverse events. There is still uncertainty over the effectiveness and safety of alternative progestogen treatments for threatened and recurrent miscarriage.
Topics: Abortion, Habitual; Abortion, Spontaneous; Bias; Birth Rate; Dydrogesterone; Female; Humans; Hydroxyprogesterones; Live Birth; Network Meta-Analysis; Placebos; Pregnancy; Progesterone; Progestins; Randomized Controlled Trials as Topic; Stillbirth
PubMed: 33872382
DOI: 10.1002/14651858.CD013792.pub2 -
The Cochrane Database of Systematic... Feb 2021Depression is one of the most common morbidities of the postnatal period. It has been associated with adverse outcomes for women, children, the wider family and society... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Depression is one of the most common morbidities of the postnatal period. It has been associated with adverse outcomes for women, children, the wider family and society as a whole. Treatment is with psychosocial interventions or antidepressant medication, or both. The aim of this review is to evaluate the effectiveness of different antidepressants and to compare their effectiveness with placebo, treatment as usual or other forms of treatment. This is an update of a review last published in 2014.
OBJECTIVES
To assess the effectiveness and safety of antidepressant drugs in comparison with any other treatment (psychological, psychosocial, or pharmacological), placebo, or treatment as usual for postnatal depression.
SEARCH METHODS
We searched Cochrane Common Mental Disorders's Specialized Register, CENTRAL, MEDLINE, Embase and PsycINFO in May 2020. We also searched international trials registries and contacted experts in the field.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of women with depression during the first 12 months postpartum that compared antidepressant treatment (alone or in combination with another treatment) with any other treatment, placebo or treatment as usual.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data from the study reports. We requested missing information from study authors wherever possible. We sought data to allow an intention-to-treat analysis. Where we identified sufficient comparable studies we pooled data and conducted random-effects meta-analyses.
MAIN RESULTS
We identified 11 RCTs (1016 women), the majority of which were from English-speaking, high-income countries; two were from middle-income countries. Women were recruited from a mix of community-based, primary care, maternity and outpatient settings. Most studies used selective serotonin reuptake inhibitors (SSRIs), with treatment duration ranging from 4 to 12 weeks. Meta-analysis showed that there may be a benefit of SSRIs over placebo in response (55% versus 43%; pooled risk ratio (RR) 1.27, 95% confidence interval (CI) 0.97 to 1.66); remission (42% versus 27%; RR 1.54, 95% CI 0.99 to 2.41); and reduced depressive symptoms (standardised mean difference (SMD) -0.30, 95% CI -0.55 to -0.05; 4 studies, 251 women), at 5 to 12 weeks' follow-up. We were unable to conduct meta-analysis for adverse events due to variation in the reporting of this between studies. There was no evidence of a difference between acceptability of SSRI and placebo (27% versus 27%; RR 1.10, 95% CI 0.74 to 1.64; 4 studies; 233 women). The certainty of all the evidence for SSRIs was low or very low due to the small number of included studies and a number of potential sources of bias, including high rates of attrition. There was insufficient evidence to assess the efficacy of SSRIs compared with other classes of antidepressants and of antidepressants compared with other pharmacological interventions, complementary medicines, psychological and psychosocial interventions or treatment as usual. A substantial proportion of women experienced adverse effects but there was no evidence of differences in the number of adverse effects between treatment groups in any of the studies. Data on effects on children, including breastfed infants, parenting, and the wider family were limited, although no adverse effects were noted.
AUTHORS' CONCLUSIONS
There remains limited evidence regarding the effectiveness and safety of antidepressants in the management of postnatal depression, particularly for those with more severe depression. We found low-certainty evidence that SSRI antidepressants may be more effective in treating postnatal depression than placebo as measured by response and remission rates. However, the low certainty of the evidence suggests that further research is very likely to have an important impact on our effect estimate. There is a continued imperative to better understand whether, and for whom, antidepressants or other treatments are more effective for postnatal depression, and whether some antidepressants are more effective or better tolerated than others. In clinical practice, the findings of this review need to be contextualised by the extensive broader literature on antidepressants in the general population and perinatal clinical guidance, to inform an individualised risk-benefit clinical decision. Future RCTs should focus on larger samples, longer follow-up, comparisons with alternative treatment modalities and inclusion of child and parenting outcomes.
Topics: Adolescent; Adult; Antidepressive Agents; Bias; Depression, Postpartum; Female; Humans; Patient Dropouts; Placebos; Randomized Controlled Trials as Topic; Selective Serotonin Reuptake Inhibitors; Treatment Outcome; Young Adult
PubMed: 33580709
DOI: 10.1002/14651858.CD013560.pub2 -
Cureus Nov 2023Nasal congestion is a common issue stemming from various factors such as allergies and anatomical variations. Allergic rhinitis frequently leads to nasal congestion. The... (Review)
Review
Nasal congestion is a common issue stemming from various factors such as allergies and anatomical variations. Allergic rhinitis frequently leads to nasal congestion. The pathophysiology involves inflammation, swelling, and mucus production in the nasal mucosa. Multiple treatments are available, including oral phenylephrine, an over-the-counter or prescription option. However, the effectiveness and safety of phenylephrine have been subjects of debate. This systematic review aims to provide an updated perspective on the efficacy of oral phenylephrine versus placebo in addressing nasal congestion in adults. We conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines, a systematic review involving searches on PubMed, Cochrane, and Scopus databases. Inclusion/exclusion criteria were defined to identify high-quality studies. The focus was on randomized controlled trials (RCTs) and case-control studies published in English between 1998 and 2023, involving adult populations. The interventions compared oral phenylephrine with placebo or standard care, with outcomes centering on changes in nasal congestion symptoms and nasal airway resistance. We identified four articles that met the criteria. These studies exhibited varied designs and populations. The findings consistently indicated that phenylephrine was not more effective than a placebo in relieving nasal congestion. This systematic review demonstrates that oral phenylephrine did not offer substantial relief from nasal congestion compared to a placebo in adults. The studies featured diverse designs, yet the prevailing conclusion was that phenylephrine's efficacy was limited. Safety assessments showed no life-threatening adverse events, with common side effects including headaches and mild discomfort. In summary, this systematic review indicates that oral phenylephrine is not significantly more effective than a placebo in alleviating nasal congestion in adults. Clinicians should explore alternative treatment options, considering the review's limitations. Additional research may be needed to clarify the role of oral phenylephrine in managing nasal congestion.
PubMed: 38125218
DOI: 10.7759/cureus.49074 -
Pharmacological Research May 2022Anxiety disorder is a common psychiatric illness. Medicinal herbs have become a field of interest in the treatment of anxiety. This study aimed to evaluate and compare... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Anxiety disorder is a common psychiatric illness. Medicinal herbs have become a field of interest in the treatment of anxiety. This study aimed to evaluate and compare the efficacy and acceptability of all possible medicinal herbs for the treatment of anxiety.
METHODS
A Bayesian network meta-analysis was conducted for adults with diagnosed or subthreshold anxiety in randomized controlled trials identified in PubMed, EMBASE, the Cochrane Library, and Web of Science, searched between Jan 1, 1987, and Dec 31, 2021. The outcomes included efficacy (measured by endpoint Hamilton Anxiety Scale [HAMA] Scores) and acceptability (discontinuation by ineffectiveness, worsening of the symptoms, or adverse events).
RESULTS
A total of 29 trials were reviewed, comparing 12 medicinal herbs. Silexan (mean difference [MD]: -3.84, 95% credible interval [CrI]: -6.31 to -1.34) displayed a significant effect on anxiety, and possibly benefitted the treatment of depression (standard mean difference [SMD]: -0.37, 95% confidence interval [CI]: -0.53 to -0.20) and insomnia (SMD: -0.48, 95% CI: -0.76 to -0.21). Kava was found to be an effective anxiolytic (MD: -2.46, 95% CrI: -4.47 to -0.32) but possibly ineffective in patients with generalized anxiety disorder (MD: -0.17, 95% CrI: -2.55 to -1.97). Ginkgo biloba (MD: -4.63, 95% CrI: -9.01 to -0.23) and Withania somnifera (MD: -4.90, 95% CrI: -9.70 to -0.17) were efficacious, as measured by HAMA scores but the trials were limited by their small sample sizes. Galphimia glauca (MD: -1.23, 95% CrI: -4.68 to 2.23) and Manasamitravn Vataka (MD: -1.35, 95% CrI: -7.39 to 4.68) exhibited the same anxiolytic effect as standard treatments, but both were absent from trials that were rated low risk, highlighting that confidence in their ability to provide an anxiolytic effect requires additional study. Conversely, although Passionflower (MD: -4.20, 95% CrI: -8.82 to 0.16) and Saffron (MD: -2.71, 95% CrI: -6.06 to 0.57) did not reduce HAMA scores significantly in the summary network, both were worthy of further study because of support from separate networks. There was insufficient evidence to confirm the effectiveness of Valerian (MD: 0.95, 95% CrI: -6.57 to 8.42) in standard-controlled estimation or the ineffectiveness of Chamomile (MD: 0.54, 95% CrI: -5.13 to 6.25) compared with a placebo for anxiety. Gamisoyo-san (MD: -0.98, 95% CrI: -6.48 to 4.54) and L-theanine (MD: -0.49, 95% CrI: -6.54 to 5.57) did not outperform a placebo for the treatment of anxiety in terms of statistical certainty. All medicinal herbs were well-tolerated and exhibited a good safety profile compared with control groups. When all herbs were compared, there was no statistical evidence to suggest any comparison significantly reduced HAMA scores except Ginkgo biloba vs Kava (MD: -4.41, 95% CrI: -8.32 to -0.35), although Ginkgo biloba was ranked as worst due to its poor tolerability.
CONCLUSION
Medicinal herbs may be promising for the treatment of anxiety. However, these results should be considered preliminary because of the unconvincing sample sizes, together with the potential effectiveness of placebos.
Topics: Adult; Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Bayes Theorem; Humans; Network Meta-Analysis; Plants, Medicinal
PubMed: 35378276
DOI: 10.1016/j.phrs.2022.106204 -
Calcified Tissue International Jun 2023To assess the effectiveness and safety of denosumab (Prolia®) compared to bisphosphonates (alendronate, ibandronate, risedronate, zoledronate), selective estrogen... (Meta-Analysis)
Meta-Analysis Review
The Clinical Effectiveness of Denosumab (Prolia®) for the Treatment of Osteoporosis in Postmenopausal Women, Compared to Bisphosphonates, Selective Estrogen Receptor Modulators (SERM), and Placebo: A Systematic Review and Network Meta-Analysis.
To assess the effectiveness and safety of denosumab (Prolia®) compared to bisphosphonates (alendronate, ibandronate, risedronate, zoledronate), selective estrogen receptor modulators (SERMs; bazedoxifene, raloxifene) or placebo, for the treatment of osteoporosis in postmenopausal women (PMW). Systematic searches were run in PubMed, Embase & Cochrane Library on 27-April-2022. Randomized controlled trials (RCTs) that included osteoporotic PMW allocated to denosumab, SERMs, bisphosphonates, or placebo were eligible for inclusion. RCTs were appraised using Cochrane Risk of Bias 2.0. Bayesian network and/or pairwise meta-analyses were conducted on predetermined outcomes (i.e. vertebral/nonvertebral fractures, bone mineral density [BMD], mortality, adverse events [AEs], serious AEs (SAEs), withdrawals due to AEs, AEs caused by denosumab discontinuation). A total of 12 RCTs (k = 22 publications; n = 25,879 participants) were included in the analyses. Denosumab, reported a statistically significant increase in lumbar spine (LS) and total hip (TH) BMD, compared to placebo. Similarly, denosumab also resulted in a statistically significant increase in TH BMD compared to the raloxifene and bazedoxifene. However, relative to denosumab, alendronate, ibandronate and risedronate resulted in significant improvements in both femoral neck (FN) and LS BMD. With regards to vertebral fractures and all safety outcomes, there were no statistically significant differences between denosumab and any of the comparator. Relative to placebo, denosumab was associated with significant benefits in both LS and TH BMD. Additionally, denosumab (compared to placebo) was not associated with reductions in vertebral and nonvertebral fractures. Finally, denosumab was not associated with improvement in safety outcomes, compared to placebo. These findings should be interpreted with caution as some analyses suffered from statistical imprecision.
Topics: Female; Humans; Diphosphonates; Selective Estrogen Receptor Modulators; Denosumab; Alendronate; Bone Density Conservation Agents; Risedronic Acid; Raloxifene Hydrochloride; Ibandronic Acid; Network Meta-Analysis; Postmenopause; Osteoporosis, Postmenopausal; Osteoporosis; Bone Density; Spinal Fractures; Treatment Outcome
PubMed: 37016189
DOI: 10.1007/s00223-023-01078-z -
The Cochrane Database of Systematic... Apr 2021Gestational diabetes mellitus (GDM) is associated with a range of adverse pregnancy outcomes for mother and infant. The prevention of GDM using lifestyle interventions... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Gestational diabetes mellitus (GDM) is associated with a range of adverse pregnancy outcomes for mother and infant. The prevention of GDM using lifestyle interventions has proven difficult. The gut microbiome (the composite of bacteria present in the intestines) influences host inflammatory pathways, glucose and lipid metabolism and, in other settings, alteration of the gut microbiome has been shown to impact on these host responses. Probiotics are one way of altering the gut microbiome but little is known about their use in influencing the metabolic environment of pregnancy. This is an update of a review last published in 2014.
OBJECTIVES
To systematically assess the effects of probiotic supplements used either alone or in combination with pharmacological and non-pharmacological interventions on the prevention of GDM.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (20 March 2020), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised and cluster-randomised trials comparing the use of probiotic supplementation with either placebo or diet for the prevention of the development of GDM. Cluster-randomised trials were eligible for inclusion but none were identified. Quasi-randomised and cross-over design studies were not eligible for inclusion in this review. Studies presented only as abstracts with no subsequent full report of study results were only included if study authors confirmed that data in the abstract came from the final analysis. Otherwise, the abstract was left awaiting classification.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility, extracted data and assessed risk of bias of included studies. Data were checked for accuracy.
MAIN RESULTS
In this update, we included seven trials with 1647 participants. Two studies were in overweight and obese women, two in obese women and three did not exclude women based on their weight. All included studies compared probiotics with placebo. The included studies were at low risk of bias overall except for one study that had an unclear risk of bias. We excluded two studies, eight studies were ongoing and three studies are awaiting classification. Six included studies with 1440 participants evaluated the risk of GDM. It is uncertain if probiotics have any effect on the risk of GDM compared to placebo (mean risk ratio (RR) 0.80, 95% confidence interval (CI) 0.54 to 1.20; 6 studies, 1440 women; low-certainty evidence). The evidence was low certainty due to substantial heterogeneity and wide CIs that included both appreciable benefit and appreciable harm. Probiotics increase the risk of pre-eclampsia compared to placebo (RR 1.85, 95% CI 1.04 to 3.29; 4 studies, 955 women; high-certainty evidence) and may increase the risk of hypertensive disorders of pregnancy (RR 1.39, 95% CI 0.96 to 2.01, 4 studies, 955 women), although the CIs for hypertensive disorders of pregnancy also indicated probiotics may have no effect. There were few differences between groups for other primary outcomes. Probiotics make little to no difference in the risk of caesarean section (RR 1.00, 95% CI 0.86 to 1.17; 6 studies, 1520 women; high-certainty evidence), and probably make little to no difference in maternal weight gain during pregnancy (MD 0.30 kg, 95% CI -0.67 to 1.26; 4 studies, 853 women; moderate-certainty evidence). Probiotics probably make little to no difference in the incidence of large-for-gestational age infants (RR 0.99, 95% CI 0.72 to 1.36; 4 studies, 919 infants; moderate-certainty evidence) and may make little to no difference in neonatal adiposity (2 studies, 320 infants; data not pooled; low-certainty evidence). One study reported adiposity as fat mass (MD -0.04 kg, 95% CI -0.12 to 0.04), and one study reported adiposity as percentage fat (MD -0.10%, 95% CI -1.19 to 0.99). We do not know the effect of probiotics on perinatal mortality (RR 0.33, 95% CI 0.01 to 8.02; 3 studies, 709 infants; low-certainty evidence), a composite measure of neonatal morbidity (RR 0.69, 95% CI 0.36 to 1.35; 2 studies, 623 infants; low-certainty evidence), or neonatal hypoglycaemia (mean RR 1.15, 95% CI 0.69 to 1.92; 2 studies, 586 infants; low-certainty evidence). No included studies reported on perineal trauma, postnatal depression, maternal and infant development of diabetes or neurosensory disability.
AUTHORS' CONCLUSIONS
Low-certainty evidence from six trials has not clearly identified the effect of probiotics on the risk of GDM. However, high-certainty evidence suggests there is an increased risk of pre-eclampsia with probiotic administration. There were no other clear differences between probiotics and placebo among the other primary outcomes. The certainty of evidence for this review's primary outcomes ranged from low to high, with downgrading due to concerns about substantial heterogeneity between studies, wide CIs and low event rates. Given the risk of harm and little observed benefit, we urge caution in using probiotics during pregnancy. The apparent effect of probiotics on pre-eclampsia warrants particular consideration. Eight studies are currently ongoing, and we suggest that these studies take particular care in follow-up and examination of the effect on pre-eclampsia and hypertensive disorders of pregnancy. In addition, the underlying potential physiology of the relationship between probiotics and pre-eclampsia risk should be considered.
Topics: Bias; Cesarean Section; Diabetes, Gestational; Female; Humans; Obesity; Overweight; Placebos; Pre-Eclampsia; Pregnancy; Probiotics; Randomized Controlled Trials as Topic
PubMed: 33870484
DOI: 10.1002/14651858.CD009951.pub3 -
Aesthetic Surgery Journal Apr 2022Botulinum toxin A (BoNT-A) injections are a popular non-surgical procedure for facial rejuvenation. Its increase in popularity and utilization is met with limited... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Botulinum toxin A (BoNT-A) injections are a popular non-surgical procedure for facial rejuvenation. Its increase in popularity and utilization is met with limited regulations, potentially posing a significant risk to patient safety and public health.
OBJECTIVES
The authors sought to assess the safety profile of cosmetic glabellar and forehead BoNT-A injections and evaluate BoNT-A type on complication rate.
METHODS
A systematic search of MEDLINE and EMBASE was performed for studies reporting complications after cosmetic BoNT-A in the glabellar or in the forehead region in the glabellar or in the forehead region. A random effects meta-analysis was carried out to assess complication rate. Where there were sufficient randomized-controlled trials, a network meta-analysis was performed.
RESULTS
Of 556 identified articles, 24 were included in the final quantitative analysis, with 4268 BoNT-A injection sessions and 1234 placebos. Frequently observed treatment-related complications in the BoNT-A intervention group included headache, local skin reactions, and facial neuromuscular symptoms. The overall BoNT-A complication rate was 16%. The odds ratio of developing complications from abobotulinum toxin injections compared with placebo was 1.62 (1.15, 2.27; P > 0.05) and that from onabotulinum toxin injections compared with placebo was 1.34 (0.52, 3.48; P > 0.05). In 30% of the studies, the injectors were doctors, whereas the training status of the practitioner was not reported in the remaining 70%.
CONCLUSIONS
Cosmetic BoNT-A injections in the glabellar and forehead region appear to be safe, and most complications are mild and transient. Nevertheless, the literature demonstrates heterogeneous reporting of complications and a lack of consistency of the definition of treatment-related complications.
Topics: Botulinum Toxins, Type A; Face; Forehead; Humans; Neuromuscular Agents; Skin Aging
PubMed: 35178552
DOI: 10.1093/asj/sjac036