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The Cochrane Database of Systematic... Aug 2017Many people with cancer experience moderate to severe pain that requires treatment with strong opioids, such as oxycodone and morphine. Strong opioids are, however, not... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Many people with cancer experience moderate to severe pain that requires treatment with strong opioids, such as oxycodone and morphine. Strong opioids are, however, not effective for pain in all people, neither are they well-tolerated by all people. The aim of this review was to assess whether oxycodone is associated with better pain relief and tolerability than other analgesic options for adults with cancer pain. This is an updated version of the original Cochrane review published in 2015, Issue 2 on oxycodone for cancer-related pain.
OBJECTIVES
To assess the effectiveness and tolerability of oxycodone by any route of administration for pain in adults with cancer.
SEARCH METHODS
For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE and MEDLINE In-Process (Ovid), Embase (Ovid), Science Citation Index, Conference Proceedings Citation Index - Science (ISI Web of Science), BIOSIS (ISI), and PsycINFO (Ovid) to November 2016. We also searched four trial registries, checked the bibliographic references of relevant studies, and contacted the authors of the included studies. We applied no language, date, or publication status restrictions.
SELECTION CRITERIA
We included randomised controlled trials (parallel group or cross-over) comparing oxycodone (any formulation or route of administration) with placebo or an active drug (including oxycodone) for cancer background pain in adults by examining pain intensity/relief, adverse events, quality of life, and participant preference.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed the included studies using standard Cochrane methodology. We meta-analysed pain intensity data using the generic inverse variance method, and adverse events using the Mantel-Haenszel method, or summarised these data narratively along with the quality of life and participant preference data. We assessed the overall quality of the evidence using GRADE.
MAIN RESULTS
For this update, we identified six new studies (1258 participants) for inclusion. In total, we included 23 studies which enrolled/randomised 2648 participants, with 2144 of these analysed for efficacy and 2363 for safety. The studies examined a number of different drug comparisons.Pooled analysis of three of the four studies comparing controlled-release (CR) oxycodone to immediate-release (IR) oxycodone showed that the ability of CR and IR oxycodone to provide pain relief were similar (standardised mean difference (SMD) 0.1, 95% confidence interval (CI) -0.06 to 0.26; low quality evidence). Pooled analyses of adverse events showed no significant differences between CR and IR oxycodone for asthenia (risk ratio (RR) 0.58, 95% CI 0.2 to 1.68), confusion (RR 0.78, 95% CI 0.2 to 3.02), constipation (RR 0.71, 95% CI 0.45 to 1.13), dizziness/lightheadedness (RR 0.74, 95% CI 0.4 to 1.37), drowsiness/somnolence (RR 1.03, 95% CI 0.69 to 1.54), dry mouth (RR 1.14, 95% CI 0.48 to 2.75), insomnia (RR 1.04, 95% CI 0.31 to 3.53), nausea (RR 0.85, 95% CI 0.56 to 1.28), nervousness (RR 0.57, 95% CI 0.2 to 1.64), pruritus (RR 1.46, 95% CI 0.65 to 3.25), vomiting (RR 0.66, 95% CI 0.38 to 1.15), and discontinuation due to adverse events (RR 0.6, 95% CI 0.29 to 1.22). The quality of the evidence was very low for all these adverse events. Three of the four studies found similar results for treatment acceptability.Pooled analysis of seven of the nine studies comparing CR oxycodone to CR morphine indicated that pain relief was significantly better after treatment with CR morphine than CR oxycodone (SMD 0.14, 95% CI 0.01 to 0.27; low quality evidence). However, sensitivity analysis did not corroborate this result (SMD 0.12, 95% CI -0.02 to 0.26).Pooled analyses of adverse events showed no significant differences between CR oxycodone and CR morphine for confusion (RR 1.01 95% CI 0.78 to 1.31), constipation (RR 0.98, 95% CI 0.82 to 1.16), dizziness/lightheadedness (RR 0.76, 95% CI 0.33 to 1.76), drowsiness/somnolence (RR 0.9, 95% CI 0.75 to 1.08), dry mouth (RR 1.01, 95% CI 0.8 to 1.26), dysuria (RR 0.71, 95% CI 0.4 to 1.26), nausea (RR 1.02, 95% CI 0.82 to 1.26), pruritus (RR 0.81, 95% CI 0.51 to 1.29), vomiting (RR 0.94, 95% CI 0.68 to 1.29), and discontinuation due to adverse events (RR 1.06, 95% CI 0.43 to 2.6). However, the RR for hallucinations was significantly lower after treatment with CR oxycodone compared to CR morphine (RR 0.52, 95% CI 0.28 to 0.97). The quality of the evidence was very low for all these adverse events. There were no marked differences in treatment acceptability or quality of life ratings.The remaining studies either compared oxycodone in various formulations or compared oxycodone to different alternative opioids. None found any clear superiority or inferiority of oxycodone for cancer pain, neither as an analgesic agent nor in terms of adverse event rates and treatment acceptability.The quality of this evidence base was limited by the high or unclear risk of bias of the studies and by imprecision due to low or very low event rates or participant numbers for many outcomes.
AUTHORS' CONCLUSIONS
The conclusions have not changed since the previous version of this review. The data suggest that oxycodone offers similar levels of pain relief and overall adverse events to other strong opioids including morphine. Although we identified a clinically insignificant benefit on pain relief in favour of CR morphine over CR oxycodone, this did not persist following sensitivity analysis and so we do not consider this important. However, in this updated analysis, we found that hallucinations occurred less often with CR oxycodone than with CR morphine, but the quality of this evidence was very low so this finding should be treated with utmost caution. Our conclusions are consistent with other reviews and suggest that while the reliability of the evidence base is low, given the absence of important differences within this analysis it seems unlikely that larger head to head studies of oxycodone versus morphine are justified, although well-designed trials comparing oxycodone to other strong analgesics may well be useful. For clinical purposes, oxycodone or morphine can be used as first-line oral opioids for relief of cancer pain in adults.
Topics: Aged; Analgesics, Opioid; Cancer Pain; Constipation; Delayed-Action Preparations; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Morphine; Nausea; Neoplasms; Oxycodone; Pain Measurement; Quality of Life; Randomized Controlled Trials as Topic; Sleep Stages; Vomiting
PubMed: 28829910
DOI: 10.1002/14651858.CD003870.pub6 -
Psychiatry Research Oct 2017No systematic reviews and meta-analyses on the use of Z-drug for schizophrenia are available. Randomized, placebo-controlled, or non-pharmacological... (Meta-Analysis)
Meta-Analysis Review
No systematic reviews and meta-analyses on the use of Z-drug for schizophrenia are available. Randomized, placebo-controlled, or non-pharmacological intervention-controlled trials published before 03/20/2017 were retrieved from major healthcare databases and clinical trial registries. A meta-analysis including only randomized, placebo-controlled trials was performed. Efficacy outcomes were measured as improvement in overall schizophrenia symptoms, total sleep time, and wake after sleep onset. Safety/acceptability outcomes were discontinuation rate and individual adverse events. Four trials [1 alpidem placebo-controlled study (n=66), 2 eszopiclone placebo-controlled studies (n=60), and 1 eszopiclone, shallow needling-controlled study (n=96)] were identified. The meta-analysis showed no significant differences in any outcome between pooled Z-drug and placebo treatment groups. For individual studies, alpidem was superior to placebo in improving the overall schizophrenia symptoms. One of the eszopiclone studies showed that eszopiclone was superior to placebo in improving the Insomnia Severity Index scores. Another eszopiclone study showed that eszopiclone did not differ from shallow needling therapy in improving both schizophrenia- and insomnia-related symptoms. Although this study failed to show significant benefits for the use of Z-drug in the treatment of schizophrenia, it showed that short-term use of eszopiclone is an acceptable method for treating persistent insomnia among these patients.
Topics: Adolescent; Adult; Aged; Clinical Trials as Topic; Eszopiclone; Female; Humans; Hypnotics and Sedatives; Imidazoles; Male; Middle Aged; Pyridines; Randomized Controlled Trials as Topic; Schizophrenia; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Outcome; Young Adult
PubMed: 28686934
DOI: 10.1016/j.psychres.2017.06.063 -
Maturitas Jun 2017We assessed the effects of programmed exercise (PE) on sleep quality and insomnia in middle-aged women (MAW). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
We assessed the effects of programmed exercise (PE) on sleep quality and insomnia in middle-aged women (MAW).
METHODS
Searches were conducted in five databases from inception through December 15, 2016 for randomized controlled trials (RCTs) evaluating the effects of PE versus a non-exercising control condition on sleep quality, sleep disturbance and/or insomnia in MAW. Interventions had to last at least 8 weeks. Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI) and insomnia with the Insomnia Severity Index (ISI). Random effects models were used for meta-analyses. The effects on outcomes were expressed as mean differences (MDs) and their 95% confidence intervals (CI).
RESULTS
Five publications reported data from four RCTs on PE effects during 12-16 weeks on sleep quality (n=4 studies reporting PSQI results) and/or insomnia (n=3 studies reporting ISI results), including 660 MAW. Low-moderate levels of exercise significantly lowered the PSQI score (MD=-1.34; 95% CI -2.67, 0.00; p=0.05) compared with controls. In a subgroup analysis, moderate PE (aerobic exercise) had a positive effect on sleep quality (PSQI score MD=-1.85; 95% CI -3.62, -0.07; p=0.04), while low levels of physical activity (yoga) did not have a significant effect (MD-0.46, 95% CI -1.79, 0.88, p=0.50). In three studies (two studies of yoga, one study of aerobic exercise), there was a non-significant reduction in the severity of insomnia measured with the ISI score (MD -1.44, 95% CI -3.28, 0. 44, p=0.13) compared with controls. Heterogeneity of effects among studies was moderate to high.
CONCLUSION
In middle-aged women, programmed exercise improved sleep quality but had no significant effect on the severity of insomnia.
Topics: Exercise Therapy; Female; Humans; Middle Aged; Randomized Controlled Trials as Topic; Sleep Initiation and Maintenance Disorders
PubMed: 28539176
DOI: 10.1016/j.maturitas.2017.04.003 -
Rheumatology (Oxford, England) Apr 2017To identify whether sleep disturbances are more prevalent in primary SS (pSS) patients compared with the general population and to recognize which specific sleep... (Review)
Review
OBJECTIVES
To identify whether sleep disturbances are more prevalent in primary SS (pSS) patients compared with the general population and to recognize which specific sleep symptoms are particularly problematic in this population.
METHODS
Electronic searches of the literature were conducted in PubMed, Medline (Ovid), Embase (Ovid), PsychINFO (Ovid) and Web of Science and the search strategy registered a priori . Titles and abstracts were reviewed by two authors independently against a set of prespecified inclusion/exclusion criteria, reference lists were examined and a narrative synthesis of the included articles was conducted.
RESULTS
Eight whole-text papers containing nine separate studies met the inclusion criteria and were included in the narrative analysis. Few of these studies met all of the quality assessment criteria. The studies used a range of self-reported measures and objective measures, including polysomnography. Mixed evidence was obtained for some of the individual sleep outcomes, but overall compared with controls, pSS patients reported greater subjective sleep disturbances and daytime somnolence and demonstrated more night awakenings and pre-existing obstructive sleep apnoea.
CONCLUSIONS
A range of sleep disturbances are commonly reported in pSS patients. Further polysomnography studies are recommended to confirm the increased prevalence of night awakenings and obstructive sleep apnoea in this patient group. pSS patients with excessive daytime somnolence should be screened for co-morbid sleep disorders and treated appropriately. Interventions targeted at sleep difficulties in pSS, such as cognitive behavioural therapy for insomnia and nocturnal humidification devices, have the potential to improve quality of life in this patient group and warrant further investigation.
Topics: Cognitive Behavioral Therapy; Epidemiologic Studies; Female; Humans; Male; Middle Aged; Polysomnography; Quality of Life; Sjogren's Syndrome; Sleep Wake Disorders
PubMed: 28013207
DOI: 10.1093/rheumatology/kew443 -
Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials.Integrative Cancer Therapies Jun 2017Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug...
BACKGROUND
Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia.
METHODS
A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers.
RESULTS
Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so.
CONCLUSION
There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.
Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Acupuncture Therapy; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Sleep Initiation and Maintenance Disorders
PubMed: 27531549
DOI: 10.1177/1534735416664172 -
BMC Complementary and Alternative... Jul 2016Insomnia is the common complaint among patients with stroke. Acupuncture has increasingly been used for insomnia relief after stroke. The aim of the present study was to... (Review)
Review
BACKGROUND
Insomnia is the common complaint among patients with stroke. Acupuncture has increasingly been used for insomnia relief after stroke. The aim of the present study was to summarize and evaluate evidence on the effectiveness of acupuncture in relieving insomnia after stroke.
METHODS
Seven databases were searched from inception through October 2014 without language restrictions. Randomized controlled trials (RCTs) were included if acupuncture was compared to placebo or other conventional therapy for treatment of insomnia after stroke. Assessments were performed using the Pittsburgh sleep quality index (PSQI), the insomnia severity index (ISI), the Athens insomnia scale (AIS), and the efficacy standards of Chinese medicine.
RESULTS
A total of 165 studies were identified; 13 RCTs met our inclusion criteria. Meta-analysis showed that acupuncture appeared to be more effective than drugs for treatment of insomnia after stroke, as assessed by the PSQI (weighted mean difference, 4.31; 95 % confidence interval [CI], 1.67-6.95; P = 0.001) and by the efficacy standards of Chinese medicine (risk ratio, 1.25; 95 % CI, 1.12-1.40; P < 0.001). Intradermal acupuncture had significant effects compared with sham acupuncture, as assessed by the ISI (weighted mean difference, 4.44; 95 % CI, 2.75-6.13; P < 0.001) and the AIS (weighted mean difference, 3.64; 95 % CI, 2.28-5.00; P < 0.001).
CONCLUSIONS
Our results suggest that acupuncture could be effective for treating insomnia after stroke. However, further studies are needed to confirm the role of acupuncture in the treatment of this disorder.
Topics: Acupuncture Therapy; Aged; Female; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Sleep Initiation and Maintenance Disorders; Stroke
PubMed: 27430619
DOI: 10.1186/s12906-016-1220-z -
Effectiveness and safety of moxibustion for primary insomnia: a systematic review and meta-analysis.BMC Complementary and Alternative... Jul 2016Primary insomnia is a widespread and refractory disease. Moxibustion therapy for insomnia shows some advantages compared with conventional therapies. This systematic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Primary insomnia is a widespread and refractory disease. Moxibustion therapy for insomnia shows some advantages compared with conventional therapies. This systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate the effectiveness and safety of moxibustion therapy for insomnia.
METHODS
We conducted a comprehensive literature review of the CENTRAL, PubMed, EMBASE, Web of science, CNKI, VIP, and Wanfang Data databases from their inception to July 2015 for RCTs that compared moxibustion with western medications, oral Chinese medicine, or other methods of traditional Chinese medicine (TCM) in patients with primary insomnia. The primary outcome measure was effective rate and secondary outcome measure was adverse events. Data collection and analysis included risk of bias evaluation, meta-analysis, sensitivity analysis, publication bias and adverse events analysis according to corresponding criteria.
RESULTS
The study included 22 RCTs (1,971 patients). The quality of the studies was low. The overall meta-analysis demonstrated that moxibustion was more effective for insomnia than western medications, oral Chinese medicine and other TCM therapies (RR = 1.17, 95 % CI 1.12 to 1.23, P < 0.00001). Subgroup analyses demonstrated that moxibustion was more effective for insomnia than western medications (RR = 1.16, 95 % CI 1.09 to 1.24, P < 0.00001), oral Chinese medicine (RR = 1.11, 95 % CI 1.04 to 1.18, P = 0.002), and other TCM therapies (RR = 1.22, 95 % CI 1.15 to 1.30, P < 0.00001). There were no serious adverse effects associated with moxibustion therapy for insomnia, and the rate of adverse events was low.
CONCLUSION
It is difficult to get the conclusion regarding the effectiveness and safety of moxibustion for primary insomnia due to insufficient evidence, such as the high risk of bias in the included studies, small sample sizes, and few reports on adverse effects. Moxibustion should be considered as a novel therapeutic option for insomnia, and more rigorous clinical trials of moxibustion therapy for insomnia are needed to assess its effects.
Topics: Adult; Aged; Female; Humans; Male; Medicine, Chinese Traditional; Middle Aged; Moxibustion; Sleep Initiation and Maintenance Disorders
PubMed: 27411310
DOI: 10.1186/s12906-016-1179-9 -
The Patient Feb 2017Benzodiazepines and Z-drugs are used to treat complaints like insomnia, anxiety and pain. These drugs are recommended for short-term use only, but many studies report... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Benzodiazepines and Z-drugs are used to treat complaints like insomnia, anxiety and pain. These drugs are recommended for short-term use only, but many studies report long-term use, particularly in older people.
OBJECTIVE
The aim of this study was to identify and synthesise qualitative studies exploring patients' experiences and perceptions of receiving benzodiazepines and Z-drugs, and through this identify factors which perpetuate use of these drugs, and strategies for achieving safer prescribing.
METHODS
A systematic search of six databases for qualitative studies exploring patients' experiences and perceptions of primary care benzodiazepine and z-drug prescribing published between January 2000 and April 2014 in a European language, and conducted in Europe, the United States, Australia or New Zealand. Reference lists of included papers were also searched. Study quality was assessed using the Critical Appraisal Skills Programme qualitative checklist. Findings were synthesised using thematic synthesis.
RESULTS
Nine papers were included and seven analytical themes were identified relating to patients' experiences and perceptions and, within that, strategies for safer prescribing of benzodiazepines and Z-drugs: (1) patients' negative perceptions of insomnia and its impact, (2) failed self-care strategies, (3) triggers to medical help-seeking, (4) attitudes towards treatment options and service provision, (5) varying patterns of use, (6) withdrawal, (7) reasons for initial or ongoing use.
CONCLUSIONS
Inappropriate use and prescribing of benzodiazepines and Z-drugs is perpetuated by psychological dependence, absence of support and patients' denial/lack of knowledge of side effects. Education strategies, increased availability of alternatives, and targeted extended dialogue with patients could support safer prescribing.
Topics: Adult; Aged; Aged, 80 and over; Anxiety Disorders; Australia; Benzodiazepines; Drug-Related Side Effects and Adverse Reactions; Europe; Female; Humans; Inappropriate Prescribing; Male; Middle Aged; Pain; Qualitative Research; Self Care; Sleep Initiation and Maintenance Disorders
PubMed: 27282559
DOI: 10.1007/s40271-016-0182-z -
Complementary Therapies in Medicine Jun 2016Acupuncture is widely used in Asia and increasingly in Western countries. We performed a systematic review and meta-analysis to examine the effects of acupuncture for... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Acupuncture is widely used in Asia and increasingly in Western countries. We performed a systematic review and meta-analysis to examine the effects of acupuncture for insomnia.
METHODS
We identified randomized controlled trials from English and Chinese databases. Data were extracted using a predefined form and analysed using RevMan 5.2. We included studies that compared acupuncture to sham/placebo, standard pharmacotherapy or cognitive behavioral therapy. Risk of bias was assessed using the Cochrane risk of bias tool. The primary outcome was sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).
RESULTS
A total of 30 studies involving 2363 participants were included. Acupuncture point combinations included the use of at least one of the recommended points for insomnia, HT7, GV20, SP6. Pharmacotherapy control was used in 27 studies and sham/placebo in three studies. Cognitive behavioral therapy was not used in any of the studies. Pharmacotherapies in all studies were benzodiazepine receptor agonists, except for one that used an antidepressant. Acupuncture was superior to sham/placebo in terms of PSQI (MD -0.79, 95% CI -1.38, -0.19, I(2)=49%). Acupuncture was also more effective than pharmacotherapy (MD -2.76, 95% CI -3.67, -1.85, I(2)=94%). Most studies were at risk of bias. Some mild adverse events were reported but they were not causally related to the acupuncture treatments.
CONCLUSIONS
Acupuncture compared to sham/placebo and pharmacotherapy showed statistically significant results. However, the evidence is limited by bias in the included studies and heterogeneity. Well-designed studies are needed to confirm the results identified in this review.
Topics: Acupuncture Therapy; Adolescent; Adult; Aged; Female; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Sleep Initiation and Maintenance Disorders; Treatment Outcome; Young Adult
PubMed: 27261976
DOI: 10.1016/j.ctim.2016.02.007 -
The Cochrane Database of Systematic... Apr 2016This review is one of a suite of six Cochrane reviews looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This review is one of a suite of six Cochrane reviews looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is a common condition involving inflammation of the lining of the nose and paranasal sinuses. It is characterised by nasal blockage and nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Oral corticosteroids are used to control the inflammatory response and improve symptoms.
OBJECTIVES
To assess the effects of a short course of oral corticosteroids as an adjunct ('add-on') therapy in people with chronic rhinosinusitis who are already on standard treatments.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 7); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing a short course (up to 21 days) of oral corticosteroids to placebo or no treatment, where all patients were also receiving pharmacological treatment for chronic rhinosinusitis.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity, and the adverse event of mood or behavioural disturbances. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score, and the adverse events of insomnia, gastrointestinal disturbances and osteoporosis. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
MAIN RESULTS
Two trials with a total of 78 participants met the inclusion criteria. Both the populations and the 'standard' treatments differed in the two studies. Oral steroids as an adjunct to intranasal corticosteroids One trial in adults with nasal polyps included 30 participants. All participants used intranasal corticosteroids and were randomised to either short-course oral steroids (oral methylprednisolone, 1 mg/kg and reduced progressively over a 21-day treatment course) or no additional treatment. None of the primary outcome measures of interest in this review were reported by the study. There may have been an important reduction in the size of the polyps (measured by the nasal polyps score, a secondary outcome measure) in patients receiving oral steroids and intranasal corticosteroids, compared to intranasal corticosteroids alone (mean difference (MD) -0.46, 95% confidence interval (CI) -0.87 to -0.05; 30 participants; scale 1 to 4) at the end of treatment (21 days). This corresponds to a large effect size, but we are very uncertain about this estimate as we judged the study to be at high risk of bias. Moreover, longer-term data were not available and the other outcomes of interest were not reported. Oral steroids as an adjunct to antibiotics One trial in children (mean age of eight years) without nasal polyps included 48 participants. The trial compared oral corticosteroids (oral methylprednisolone, 1 mg/kg and reduced progressively over a 15-day treatment course) with placebo in participants who also received a 30-day course of antibiotics. This study addressed one of the primary outcome measures (disease severity) and one secondary outcome (CT score). For disease severity the four key symptoms used to define chronic rhinosinusitis in children (nasal blockage, nasal discharge, facial pressure, cough) were combined into one score. There was a greater improvement in symptom severity 30 days after the start of treatment in patients who received oral steroids and antibiotics compared with placebo and antibiotics (MD -7.10, 95% CI -9.59 to -4.61; 45 participants; scale 0 to 40). The observed mean difference corresponds to a large effect size. At the same time point there was a difference in CT scan score (MD -2.90, 95% CI -4.91 to -0.89; 45 participants; scale 0 to 24). We assessed the quality of the evidence to be low.There were no data available for the longer term (three months).
AUTHORS' CONCLUSIONS
There might be an improvement in symptom severity, polyps size and condition of the sinuses when assessed using CT scans in patients taking oral corticosteroids when these are used as an adjunct therapy to antibiotics or intranasal corticosteroids, but the quality of the evidence supporting this is low or very low (we are uncertain about the effect estimate; the true effect may be substantially different from the estimate of the effect). It is unclear whether the benefits of oral corticosteroids as an adjunct therapy are sustained beyond the short follow-up period reported (up to 30 days), as no longer-term data were available.There were no data in this review about the adverse effects associated with short courses of oral corticosteroids as an adjunct therapy.More research in this area, particularly research evaluating longer-term outcomes and adverse effects, is required.
Topics: Administration, Intranasal; Administration, Oral; Adrenal Cortex Hormones; Adult; Chemotherapy, Adjuvant; Child; Chronic Disease; Humans; Methylprednisolone; Nasal Polyps; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Steroids; Time Factors
PubMed: 27115214
DOI: 10.1002/14651858.CD011992.pub2