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Indian Journal of Pharmacology 2021Registration of study protocols brings about transparency and traceability and the amount of publication bias can be estimated. In this study, we have collected and... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Registration of study protocols brings about transparency and traceability and the amount of publication bias can be estimated. In this study, we have collected and presented data regarding clinical study registries, preclinical, in vitro and in silico study registries across the globe.
MATERIALS AND METHODS
We searched via Google Search Engine with appropriate keywords e.g. name of country (n = 198), name of continent (n = 7), registry, study registry, animal, in silico, virtual, simulation, preclinical, animal, clinical trial. The overall pooled prevalence of clinical study registries and WHO primary registries in per continent was calculated using Medcalc software.
RESULTS
The overall pooled prevalence of clinical study registries were 13% in each continent. The prevalence of WHO primary study registries were 8.9% of the countries per continent. Overall, there are 17 primary registries associated with WHO ICTRP as primary registries, 2 partner registries and 6 registries are affiliated to ICMJE. However, the amount of preclinical animal study registry was quite less (n = 4). Regarding in vitro studies, only country specific in vitro fertilization registries were available, however, in other research domains, registries were absent. Only one simulation study registry was available.
CONCLUSION
At priori study registration is essential to deal with selective reporting. Comparison between study protocol and final report allows us to know the protocol deviations and allows us to evaluate risk of bias and internal validity of the research findings. Although trialists are responsible for the completeness of records, yet the registries must have some measures for their periodic update and quality control of the data.
Topics: Animals; Clinical Protocols; Clinical Trials as Topic; Drug Evaluation, Preclinical; Humans; Registries; World Health Organization
PubMed: 34100401
DOI: 10.4103/ijp.ijp_1090_20 -
Nutrients Aug 2021is a microalga that presents various important pro-health properties, for instance lowering blood pressure in the research. The study aims to appraise the efficacy of... (Meta-Analysis)
Meta-Analysis
is a microalga that presents various important pro-health properties, for instance lowering blood pressure in the research. The study aims to appraise the efficacy of administration on systolic (SBP) and diastolic blood pressure (DBP). Randomized controlled trials (RCTs) were retrieved by a systematic search of PubMed, Web of Science, and the Cochrane Library databases from inception to June 2021 according to a standardized protocol. The effect size of each study was counted from mean and standard deviation before and after the intervention and shown as Un-standardized mean difference and 95% confidence interval. Sensitivity analyses were performed. Meta-analysis on 5 RCTs with 230 subjects was eligible. The amount of ranged from 1 to 8 g per day, and intervention durations ranged from 2 to 12 weeks. Data analysis indicated that supplementation led to a significant lowering of SBP (Mean Difference (MD): -4.59 mmHg, 95% Confidence Interval (CI): -8.20 to -0.99, I square statistic (I) = 65%) and significant lowering of DBP (MD: -7.02 mmHg, CI: -8.86 to -5.18, I = 11%), particularly in a subgroup of hypertensive patients. administration might have a supportive effect on the prevention and treatment of hypertension. More exact randomized controlled trials are needed to clarify the effect of supplementation on blood pressure.
Topics: Blood Pressure; Dietary Supplements; Humans; Hypertension; Phytotherapy; Spirulina
PubMed: 34578932
DOI: 10.3390/nu13093054 -
Ultrasound in Medicine & Biology Aug 2021The goal of this review was to systematize the evidence on pulmonary ultrasound (PU) use in diagnosis, monitorization or hospital discharge criteria for patients with...
The goal of this review was to systematize the evidence on pulmonary ultrasound (PU) use in diagnosis, monitorization or hospital discharge criteria for patients with coronavirus disease 2019 (COVID-19). Evidence on the use of PU for diagnosis and monitorization of or as hospital discharge criteria for COVID-19 patients confirmed to have COVID-19 by reverse transcription polymerase chain reaction (RT-PCR) between December 1, 2019 and July 5, 2020 was compared with evidence obtained with thoracic radiography (TR), chest computed tomography (CT) and RT-PCR. The type of study, motives for use of PU, population, type of transducer and protocol, results of PU and quantitative or qualitative correlation with TR and/or chest CT and/or RT-PCR were evaluated. A total of 28 articles comprising 418 patients were involved. The average age was 50 y (standard deviation: 25.1 y), and there were 395 adults and 23 children. One hundred forty-three were women, 13 of whom were pregnant. The most frequent result was diffuse, coalescent and confluent B-lines. The plural line was irregular, interrupted or thickened. The presence of subpleural consolidation was noduliform, lobar or multilobar. There was good qualitative correlation between TR and chest CT and a quantitative correlation with chest CT of r = 0.65 (p < 0.001). Forty-four patients were evaluated only with PU. PU is a useful tool for diagnosis and monitorization and as criteria for hospital discharge for patients with COVID-19.
Topics: COVID-19; COVID-19 Testing; Humans; Lung; SARS-CoV-2; Ultrasonography
PubMed: 34024680
DOI: 10.1016/j.ultrasmedbio.2021.04.011 -
The Cochrane Database of Systematic... Dec 2014Intermittent urethral self-dilatation is sometimes recommended to reduce the risk of recurrent urethral stricture. There is no consensus as to whether it is a clinically... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Intermittent urethral self-dilatation is sometimes recommended to reduce the risk of recurrent urethral stricture. There is no consensus as to whether it is a clinically effective or cost-effective intervention in the management of this disease.
OBJECTIVES
The purpose of this review is to evaluate the clinical effectiveness and cost-effectiveness of intermittent self-dilatation after urethral stricture surgery in males compared to no intervention. We also compared different programmes of, and devices for, intermittent self-dilatation. .
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Register (searched 7 May 2014), CENTRAL (2014, Issue 4), MEDLINE (1 January 1946 to Week 3 April 2014), PREMEDLINE (covering 29 April 2014), EMBASE (1 January 1947 to Week 17 2014), CINAHL (31 December 1981 to 30 April 2014) OpenGrey (searched 6 May 2014), ClinicalTrials.gov (6 May 2014), WHO International Clinical Trials Registry Platform (6 May 2014), Current Controlled Trials (6 May 2014) and the reference lists of relevant articles.
SELECTION CRITERIA
Randomised and quasi-randomised trials where one arm was a programme of intermittent self-dilatation for urethral stricture were identified. Studies were excluded if they were not randomised or quasi-randomised trials, or if they pertained to clean intermittent self-catheterisation for bladder emptying.
DATA COLLECTION AND ANALYSIS
Two authors screened the records for relevance and methodological quality. Data extraction was performed according to predetermined criteria using data extraction forms. Analyses were carried out in Cochrane Review Manager (RevMan 5). The primary outcomes were patient-reported symptoms and health-related quality of life, and risk of recurrence; secondary outcomes were adverse events, acceptability of the intervention to patients and cost-effectiveness. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
MAIN RESULTS
Eleven trials were selected for inclusion in the review, including a total of 776 men. They were generally small; all were of poor quality and all were deemed to have high risk of bias. Performing intermittent self-dilatation versus not performing intermittent self-dilatation The data from six trials were heterogeneous, imprecise and had a high risk of bias, but indicated that recurrent urethral stricture was less likely in men who performed intermittent self-dilatation than men who did not perform intermittent self-dilatation (RR 0.70, 95% CI 0.48 to 1.00; very low quality evidence). Adverse events were generally poorly reported: two trials did not report adverse events and two trials reported adverse events only for the intervention group. Meta-analysis of the remaining two trials found no evidence of a difference between performing intermittent self-dilatation and not performing it (RR 0.60, 95% CI 0.11 to 3.26). No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness. One programme of intermittent self-dilatation versus another We identified two trials that compared different durations of intermittent self-dilatation, but data were not combined. One study could not draw robust conclusions owing to cross-over, protocol deviation, administrative error, post-hoc analysis and incomplete outcome reporting. The other study found no evidence of a difference between intermittent self-dilatation for six months versus for 12 months after optical urethrotomy (RR 0.67, 95% CI 0.12 to 3.64), although again the evidence is limited by the small sample size and risk of bias in the included study. Adverse events were reported narratively and were not stratified by group. No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness. One device for performing intermittent self-dilatation versus another Three trials compared one device for performing intermittent self-dilatation with another. Results from one trial at a high risk of bias were too uncertain to determine the effects of a low friction hydrophilic catheter and a standard polyvinyl chloride catheter on the risk of recurrent urethral stricture (RR 0.32, 95% CI 0.07 to 1.40). Similarly one study did not find evidence of a difference between one percent triamcinolone gel for lubricating the intermittent self-dilatation catheter versus water-based gel on risk of recurrent urethral stricture (RR 0.68, 95% CI 0.35 to 1.32). Two trials reported adverse events, but one did not provide sufficient detail for analysis. The other small study reported fewer instances of prostatitis, urethral bleeding or bacteriuria with a low friction hydrophilic catheter compared with a standard polyvinyl chloride catheter (RR 0.13, 95% CI 0.02 to 0.98). 'Happiness with the intervention' was assessed using a non-validated scale in one study, but no trials formally assessed patient-reported health-related quality of life or acceptability. No trials reported on patient-reported lower urinary tract symptoms or cost-effectiveness. GRADE quality assessment The evidence that intermittent self-dilatation reduces the risk of recurrent urethral stricture after surgical intervention was downgraded to 'very low' on the basis that the studies comprising the meta-analysis were deemed to have high risk of bias, and the data was imprecise and inconsistent. Insufficient evidence No trials provided cost-effectiveness data or used a validated patient-reported outcome measure, and adverse events were not reported rigorously. Acceptability of the intervention to patients has not been assessed quantitatively or qualitatively.
AUTHORS' CONCLUSIONS
Performing intermittent self-dilatation may confer a reduced risk of recurrent urethral stricture after endoscopic treatment. We have very little confidence in the estimate of the effect owing to the very low quality of the evidence. Evidence for other comparisons and outcomes is limited. Further research is required to determine whether the apparent benefit is sufficient to make the intervention worthwhile, and in whom.
Topics: Dilatation; Humans; Male; Patient Satisfaction; Postoperative Complications; Randomized Controlled Trials as Topic; Recurrence; Self Care; Urethral Stricture
PubMed: 25523166
DOI: 10.1002/14651858.CD010258.pub2 -
The Cochrane Database of Systematic... Sep 2016Breastfeeding is important, however not all infants can feed at the breast and methods of expressing milk need evaluation. (Review)
Review
BACKGROUND
Breastfeeding is important, however not all infants can feed at the breast and methods of expressing milk need evaluation.
OBJECTIVES
To assess acceptability, effectiveness, safety, effect on milk composition, contamination and costs of methods of milk expression.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (21 March 2016), handsearched relevant journals and conference proceedings, and contacted experts in the field to seek additional published or unpublished studies. We also examined reference lists of all relevant retrieved papers.
SELECTION CRITERIA
Randomised and quasi-randomised trials comparing methods at any time after birth.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.
MAIN RESULTS
This updated review includes 41 trials involving 2293 participants, with 22 trials involving 1339 participants contributing data for analysis. Twenty-six of the trials referred to mothers of infants in neonatal units (n = 1547) and 14 to mothers of healthy infants at home (n = 730), with one trial containing mothers of both neonatal and healthy older infants (n = 16). Eleven trials compared one or more types of pump versus hand expression and 14 studies compared one type of pump versus another type of pump, with three of these studies comparing both hand expression and pump types. Twenty studies compared a specific protocol or adjunct behaviour including sequential versus simultaneous pumping protocols, pumping frequency, provision of an education and support intervention, relaxation, breast massage, combining hand expression with pumping and a breast cleansing protocol.Due to heterogeneity in participants, interventions, and outcomes measured or reported, we were unable to pool findings for most of the specified outcomes. It was not possible therefore to produce a 'Summary of findings' table in this update. Most of the included results were derived from single studies. Trials took place in 14 countries under a variety of circumstances and were published from 1982 to 2015. Sixteen of the 30 trials that evaluated pumps or products had support from the manufacturers. The risk of bias of the included studies was variable. Primary outcomesOnly one of the 17 studies examining maternal satisfaction/acceptability with the method or adjunct behaviour provided data suitable for analysis. In this study, self-efficacy was assessed by asking mothers if they agreed or disagreed with the following statement: 'I don't want anyone to see me (hand expressing/pumping)'. The study found that mothers who were using the electric pump were more likely to agree with the statement compared to mothers hand expressing, (mean difference (MD) 0.70, 95% confidence interval (CI) 0.15 to 1.25; P = 0.01, participants = 68). Mothers who were hand expressing reported that the instructions for expression were clearer compared to the electric pump, (MD -0.40, 95% CI -0.75 to -0.05; P = 0.02, participants = 68). Descriptive reporting of satisfaction in the other studies varied in the measures used, did not indicate a clear preference for one pump type, although there was satisfaction with some relaxation and support interventions.We found no clinically significant differences between methods related to contamination of the milk that compared any type of pump to hand expression (risk ratio (RR) 1.13, 95% CI 0.79 to 1.61; P = 0.51, participants = 28), manual pump compared to hand expression, (MD 0.20, 95% CI -0.18 to 0.58; P = 0.30, participants = 142) a large electric pump compared to hand expression (MD 0.10, 95% CI -0.29 to 0.49; P = 0.61, participants = 123), or a large electric pump compared to a manual pump (MD -0.10, 95% CI -0.46 to 0.26; P = 0.59, participants = 141).The level of maternal breast or nipple pain or damage was similar in comparisons of a large electric pump to hand expression (MD 0.02, 95% CI -0.67 to 0.71; P = 0.96, participants = 68). A study comparing a manual and large electric pump, reported sore nipples in 7% for both groups and engorgement in 4% using a manual pump versus 6% using an electric pump; and in one study no nipple damage was reported in the hand-expression group, and one case of nipple damage in each of the manual pump and the large electric pump groups.One study examined adverse effects on infants, however as the infants did not all receive their mothers' expressed milk, we have not included the results. Secondary outcomesThe quantity of expressed milk obtained was increased, in some studies by a clinically significant amount, in interventions involving relaxation, music, warmth, massage, initiation of pumping, increased frequency of pumping and suitable breast shield size. Support programmes and simultaneous compared to sequential pumping did not show a difference in milk obtained. No pump consistently increased the milk volume obtained significantly.In relation to nutrient quality, hand expression or a large electric pump were found to provide higher protein than a manual pump, and hand expression provided higher sodium and lower potassium compared to a large electric pump or a manual pump. Fat content was higher with breast massage when pumping; no evidence of difference was found for energy content between methods.No consistent effect was found related to prolactin change or effect on oxytocin release with pump type or method. Economic aspects were not reported.
AUTHORS' CONCLUSIONS
The most suitable method for milk expression may depend on the time since birth, purpose of expression and the individual mother and infant. Low-cost interventions including initiation of milk expression sooner after birth when not feeding at the breast, relaxation, massage, warming the breasts, hand expression and lower cost pumps may be as effective, or more effective, than large electric pumps for some outcomes. Variation in nutrient content across methods may be relevant to some infants. Small sample sizes, large standard deviations, and the diversity of the interventions argue caution in applying these results beyond the specific method tested in the specific settings. Independently funded research is needed for more trials on hand expression, relaxation and other techniques that do not have a commercial potential.
PubMed: 27684560
DOI: 10.1002/14651858.CD006170.pub5 -
BMC Pregnancy and Childbirth Feb 2015Fetal growth restriction is among the most common and complex problems in modern obstetrics. Symphysis-fundus (SF) height measurement is a non-invasive test that may... (Review)
Review
BACKGROUND
Fetal growth restriction is among the most common and complex problems in modern obstetrics. Symphysis-fundus (SF) height measurement is a non-invasive test that may help determine which women are at risk. This study is a systematic review of the literature on the accuracy of SF height measurement for the prediction of small-for-gestational-age (SGA) status at birth in unselected and low-risk pregnancies.
METHODS
The Medline, Embase, Cinahl, SweMed, and Cochrane Library databases were searched with no limitation on publication date (through September 2014), which returned 722 citations. Two reviewers then developed a short list of 51 publications of possible relevance and assessed them using the following inclusion criteria: cohort study of test accuracy performed in a routine prenatal care setting; SF height measurement for all participants; classification of SGA, defined as birth weight (BW) < 10th, 5th, or 3rd percentile or ≥ one or two standard deviations below the mean; study conducted in Northern, Western, or Central Europe; USA; Canada; Australia; or New Zealand; and sufficient data for 2 × 2 table construction. Quality of the included studies was assessed in duplicate using criteria suggested by the Cochrane Collaboration. Review Manager 5.3 software was used to analyze the data, including plotting of summary receiver operating curve spaces.
RESULTS
Eight studies were included in the final dataset and seven were included in summary analyses. The sensitivity of SF height measurement for SGA (BW < 10(th) percentile) prediction ranged from 0.27 to 0.76 and specificity ranged from 0.79 to 0.92. Positive and negative likelihood ratios ranged from 1.91 to 9.09 and from 0.29 to 0.83, respectively.
CONCLUSIONS
SF height can serve as a clinical indicator along with other clinical findings, information about medical conditions, and previous obstetric history. However, SF height has high false-negative rates for SGA. Clinicians must understand the limitations of this test. The protocol has been registered in the international prospective register of systematic reviews, PROSPERO (Registration No. CRD42014008928, http://www.crd.york.ac.uk/prospero/display_record.asp?ID=CRD42014008928 ).
Topics: Adult; Female; Fetal Growth Retardation; Humans; Infant, Newborn; Infant, Small for Gestational Age; Predictive Value of Tests; Pregnancy; Pubic Symphysis; Ultrasonography, Prenatal
PubMed: 25884884
DOI: 10.1186/s12884-015-0461-z -
The Cochrane Database of Systematic... Dec 2022Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs annually. Although most... (Review)
Review
BACKGROUND
Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs annually. Although most infections are self-limiting, symptoms can be distressing. Many treatments are used to control symptoms and shorten illness duration. Most treatments have minimal benefit and may lead to adverse events. Oral homeopathic medicinal products could play a role in childhood ARTI management if evidence for their effectiveness is established. This is an update of a review first published in 2018.
OBJECTIVES
To assess the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat ARTIs in children.
SEARCH METHODS
We searched CENTRAL (2022, Issue 3), including the Cochrane Acute Respiratory Infections Specialised Register, MEDLINE (1946 to 16 March 2022), Embase (2010 to 16 March 2022), CINAHL (1981 to 16 March 2022), AMED (1985 to 16 March 2022), CAMbase (searched 16 March 2022), and British Homeopathic Library (searched 26 June 2013 - no longer operating). We also searched the WHO ICTRP and ClinicalTrials.gov (16 March 2022), checked references, and contacted study authors to identify additional studies.
SELECTION CRITERIA
We included double-blind randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self-selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
In this 2022 update, we identified three new RCTs involving 251 children, for a total of 11 included RCTs with 1813 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for ARTIs. All studies focused on upper respiratory tract infections (URTIs), with only one study including some lower respiratory tract infections (LRTIs). Six treatment studies examined the effect on URTI recovery, and five studies investigated the effect on preventing URTIs after one to four months of treatment. Two treatment and three prevention studies involved homeopaths individualising treatment. The other studies used predetermined, non-individualised treatments. All studies involved highly diluted homeopathic medicinal products, with dilutions ranging from 1 x 10 to 1 x 10. We identified several limitations to the included studies, in particular methodological inconsistencies and high attrition rates, failure to conduct intention-to-treat analysis, selective reporting, and apparent protocol deviations. We assessed three studies as at high risk of bias in at least one domain, and many studies had additional domains with unclear risk of bias. Four studies received funding from homeopathy manufacturers; one study support from a non-government organisation; two studies government support; one study was co-sponsored by a university; and three studies did not report funding support. Methodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta-analysis. Only four outcomes were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained. All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products, whilst trials at unclear or high risk of bias reported beneficial effects. For the comparison of individualised homeopathy versus placebo or usual care for the prevention of ARTIs, two trials reported on disease severity; due to heterogeneity the data were not combined, but neither study demonstrated a clinically significant difference. We combined data from two trials for the outcome need for antibiotics (OR 0.79, 95% CI 0.35 to 1.76; low-certainty evidence). For the comparison of non-individualised homeopathy versus placebo or usual care for the prevention of ARTIs, only the outcome recurrence of ARTI was reported by more than one trial; data from three studies were combined for this outcome (OR 0.60, 95% CI 0.21 to 1.72; low-certainty evidence). For the comparison of both individualised and non-individualised homeopathy versus placebo or usual care for the treatment of ARTIs, two studies provided data on short-term cure (OR 1.31, 95% CI 0.09 to 19.54) and long-term cure (OR 1.01, 95% CI 0.10 to 9.96; very low-certainty evidence). The studies demonstrated an opposite direction of effect for both outcomes. Six studies reported on disease severity but were not combined as they used different scoring systems and scales. Three studies reported adverse events (OR 0.79, 95% CI 0.16 to 4.03; low-certainty evidence).
AUTHORS' CONCLUSIONS
Pooling of five prevention and six treatment studies did not show any consistent benefit of homeopathic medicinal products compared to placebo on ARTI recurrence or cure rates in children. We assessed the certainty of the evidence as low to very low for the majority of outcomes. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, and we could not draw conclusions regarding safety.
Topics: Child; Humans; Anti-Bacterial Agents; Homeopathy; Intention to Treat Analysis; Randomized Controlled Trials as Topic; Respiratory Tract Infections
PubMed: 36511520
DOI: 10.1002/14651858.CD005974.pub6 -
Scandinavian Journal of Pain Dec 2019Background and aims Previous systematic reviews have reported manifestations of pain sensitisation as a feature of painful knee disorders, in particular osteoarthritis,... (Meta-Analysis)
Meta-Analysis
Background and aims Previous systematic reviews have reported manifestations of pain sensitisation as a feature of painful knee disorders, in particular osteoarthritis, with moderate evidence for pain sensitisation in patellofemoral pain (PFP). However, despite past studies recruiting female mostly adolescent PFP patients, it is unclear if sex or age plays a role. Investigation is required to determine if altered pain processing is a key feature of PFP and if a subgroup of patients is at an increased risk to help provide targeted management. The primary aim of this systematic review was to examine evidence investigating pain processing in PFP. Secondary aims were to evaluate the relationship between pain processing and (1) sex, (2) age and (3) symptom duration. Methods The protocol was prospectively registered with PROSPERO (CRD42019129851). PubMed, CINAHL, Web of Science and EMBASE were systematically searched from inception to April 2019 for studies investigating pain processing in PFP patients compared to controls using quantitative sensory testing. Each included paper was assessed for methodological quality using a modified version of Downs and Black. Means and standard deviations were extracted to calculate standardised mean differences (SMD) and 95% confidence intervals (95% CI). Where possible meta-analysis and meta-regression were performed using a random effects model. Results Eleven studies were identified, two medium and nine high quality. Meta-analysis indicates moderate evidence for decreased pressure pain thresholds (SMD -0.68, 95% CI -0.93 to -0.43), increased tactile detection thresholds (SMD 1.35, 95% CI 0.49-2.22) and increased warmth detection thresholds (SMD 0.61, 95% CI 0.30-0.92) in PFP patients compared to controls. Secondary analysis indicates moderate evidence for decreased pressure pain thresholds in female compared to male patients (SMD -0.75, 95% CI -1.34 to -0.16). Meta-regression indicates a moderate correlation between decreasing local and distal pressure pain thresholds and decreasing patient age (local R2 = 0.556, p = 0.0211; distal R2 = 0.491, p = 0.0354) but no correlation with symptom duration (p > 0.05). Conclusions Evidence from this systematic review with meta-analysis and meta-regression appears to suggest the presence of altered pain processing and sensitisation in patients with PFP with increased sensitivity indicated in female patients and younger patients. Implications With evidence of altered pain processing and sensitisation in PFP, it may be beneficial for clinicians to consider management approaches that aim specifically at adressing neuropathic pain, for example neuroscience education, to improve patients outcomes. With female patients and younger patients indicated as experiencing greater degree of sensitivity, this may be a good demographic to start screening for sensitisation, in order to better identify and treat those most affected.
Topics: Adult; Humans; Knee Joint; Osteoarthritis; Pain; Pain Measurement; Pain Threshold; Patellofemoral Pain Syndrome
PubMed: 31560652
DOI: 10.1515/sjpain-2019-0079 -
BMC Psychiatry Mar 2020This paper is a systematic review and meta-analysis of the efficacy of available medications for the treatment of restricted/repetitive behavior (RRBs) in Autism... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
This paper is a systematic review and meta-analysis of the efficacy of available medications for the treatment of restricted/repetitive behavior (RRBs) in Autism Spectrum Disorder (ASD).
METHOD
We searched MEDLINE, Embase, PsycINFO, The Cochrane Library (Cochrane Database of Systematic Reviews (CDRS), the Cochrane Central Register of Controlled Trials (CENTRAL), database of Abstracts of Reviews of Effects (DARE)), Scopus, Epistimonikos, Clinicaltrials.gov, and included all randomized controlled trials published after 1993 that were directed at RRBs in patients with ASD of all ages. We extracted the relevant data from the published studies with a predefined data extraction form and assessed the risk of bias. The primary outcomes were change in restricted/repetitive behavior. We performed a meta-analysis using the random effect model and included studies with given mean and standard deviation. This study is registered with PROSPERO number CRD42018092660).
RESULTS
We identified 14 randomized controlled trials that met initial inclusion criteria. After closer inspection, nine trials - involving 552 patients in total - were included in the final analysis. The meta-analysis found no significant difference between medications (including fluvoxamine, risperidone, fluoxetine, citalopram, oxytocin, N-Acetylcysteine, buspirone) and placebo in the treatment of RRBs in ASD (P = 0.20). Similarly, the sub-group meta-analysis also showed no significant difference between Selective Serotonin Reuptake Inhibitor (SSRIs) and placebo in the treatment of RRBs in ASD (P = 0.68). There was no evidence of publication bias.
CONCLUSION
This meta-analysis finds little support for the routine use of medications to treat restricted/repetitive behaviors in Autism Spectrum Disorder. Further research of large, balanced trials with precise assessment tools and long-term follow-up are needed.
TRIAL REGISTRATION
The study protocol is registered in PROSPERO (Reference number: CRD42018092660).
Topics: Autism Spectrum Disorder; Behavior; Humans; Selective Serotonin Reuptake Inhibitors
PubMed: 32164636
DOI: 10.1186/s12888-020-2477-9 -
The Cochrane Database of Systematic... Apr 2018Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs each year. Although these... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs each year. Although these infections are self limiting, the symptoms can be distressing. Many treatments are used to control symptoms and shorten the duration of illness. They often have minimal benefit and may lead to adverse effects. Oral homeopathic medicinal products could play a role in the treatment of ARTIs for children if evidence for effectiveness is established.
OBJECTIVES
To assess the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat acute respiratory tract infections in children.
SEARCH METHODS
We searched CENTRAL (2017, Issue 11), which contains the Cochrane Acute Respiratory Infections Specialised Register, MEDLINE (1946 to 27 November 2017), Embase (2010 to 27 November 2017), CINAHL (1981 to 27 November 2017), AMED (1985 to December 2014), CAMbase (searched 29 March 2018), British Homeopathic Library (searched 26 June 2013 - no longer operating). We also searched the WHO ICTRP and ClinicalTrials.gov trials registers (29 March 2018), checked references, and contacted study authors to identify additional studies.
SELECTION CRITERIA
Double-blind, randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included eight RCTs of 1562 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for upper respiratory tract infections (URTIs). Four treatment studies examined the effect on recovery from URTIs, and four studies investigated the effect on preventing URTIs after one to three months of treatment and followed up for the remainder of the year. Two treatment and two prevention studies involved homeopaths individualising treatment for children. The other studies used predetermined, non-individualised treatments. All studies involved highly diluted homeopathic medicinal products.We found several key limitations to the included studies, in particular methodological inconsistencies and high attrition rates, failure to conduct intention-to-treat analysis, selective reporting, and apparent protocol deviations. We assessed three studies as at high risk of bias in at least one domain, and many had additional domains with unclear risk of bias. Three studies received funding from homeopathy manufacturers; one reported support from a non-government organisation; two received government support; one was cosponsored by a university; and one did not report funding support.Methodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta-analysis. Only four outcomes were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained. All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products; trials at uncertain and high risk of bias reported beneficial effects.We found low-quality evidence that non-individualised homeopathic medicinal products confer little preventive effect on ARTIs (OR 1.14, 95% CI 0.83 to 1.57). We found low-quality evidence from two individualised prevention studies that homeopathy has little impact on the need for antibiotic usage (N = 369) (OR 0.79, 95% CI 0.35 to 1.76). We also assessed adverse events, hospitalisation rates and length of stay, days off school (or work for parents), and quality of life, but were not able to pool data from any of these secondary outcomes.There is insufficient evidence from two pooled individualised treatment studies (N = 155) to determine the effect of homeopathy on short-term cure (OR 1.31, 95% CI 0.09 to 19.54; very low-quality evidence) and long-term cure rates (OR 1.01, 95% CI 0.10 to 9.96; very low-quality evidence). Adverse events were reported inconsistently; however, serious events were not reported. One study found an increase in the occurrence of non-severe adverse events in the treatment group.
AUTHORS' CONCLUSIONS
Pooling of two prevention and two treatment studies did not show any benefit of homeopathic medicinal products compared to placebo on recurrence of ARTI or cure rates in children. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, so conclusions about safety could not be drawn.
Topics: Acute Disease; Anti-Bacterial Agents; Child; Homeopathy; Humans; Intention to Treat Analysis; Placebos; Randomized Controlled Trials as Topic; Recurrence; Research Support as Topic; Respiratory Tract Infections
PubMed: 29630715
DOI: 10.1002/14651858.CD005974.pub4