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Sleep Medicine Reviews Oct 2020Cannabinoids, including the two main phytocannabinoids Δ-tetrahydrocannabinol (THC) and cannabidiol (CBD), are being increasingly utilised as pharmacological...
Cannabinoids, including the two main phytocannabinoids Δ-tetrahydrocannabinol (THC) and cannabidiol (CBD), are being increasingly utilised as pharmacological interventions for sleep disorders. THC and CBD are known to interact with the endocannabinoid and other neurochemical systems to influence anxiety, mood, autonomic function, and circadian sleep/wake cycle. However, their therapeutic efficacy and safety as treatments for sleep disorders are unclear. The current systematic review assessed the available evidence base using PubMed, Scopus, Web of Science, Embase, CINAHL and PsycInfo databases. A total of 14 preclinical studies and 12 clinical studies met inclusion criteria. Results indicated that there is insufficient evidence to support routine clinical use of cannabinoid therapies for the treatment of any sleep disorder given the lack of published research and the moderate-to-high risk of bias identified within the majority of preclinical and clinical studies completed to-date. Promising preliminary evidence provides the rationale for future randomised controlled trials of cannabinoid therapies in individuals with sleep apnea, insomnia, post-traumatic stress disorder-related nightmares, restless legs syndrome, rapid eye movement sleep behaviour disorder, and narcolepsy. There is a clear need for further investigations on the safety and efficacy of cannabinoid therapies for treating sleep disorders using larger, rigorously controlled, longer-term trials.
Topics: Animals; Cannabinoids; Humans; Rats; Sleep; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
PubMed: 32603954
DOI: 10.1016/j.smrv.2020.101339 -
PloS One 2021The ageing population brings about the appearance of age-related health disorders, such as osteoporosis or osteopenia. These disorders are associated with fragility... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The ageing population brings about the appearance of age-related health disorders, such as osteoporosis or osteopenia. These disorders are associated with fragility fractures. The impact is greater among postmenopausal women due to an acceleration of bone mineral density (BMD) loss.
OBJECTIVE
To estimate the effectiveness of Pilates or Yoga on BMD in adult women.
METHODS
Five electronics databases were searched up to April 2021. Randomized controlled trials (RCTs), non-RCTs and pre-post studies were included. The main outcome was BMD. Risk of bias was evaluated using the Cochrane risk of bias tool. A random effects model was used to pool data from primary studies. Subgroup analyses based on the type of exercise were conducted.
RESULTS
Eleven studies including 591 participants aged between 45 and 78 years were included. The mean length of the interventions ranged from 12 to 32 weeks, and two studies were performed for a period of at least one year. The pooled effect size for the effect of the intervention (Pilates/Yoga) vs the control group was 0.07 (95% Confidence interval [CI]: -0.05 to 0.19; I2 = 0.0%), and 0.10 (95% CI: 0.01 to 0.18; I2 = 18.4%) for the secondary analysis of the pre-post intervention.
CONCLUSIONS
Despite of the non-significant results, the BMD maintenance in the postmenopausal population, when BMD detrimental is expected, could be understood as a positive result added to the beneficial impact of Pilates-Yoga in multiple fracture risk factors, including but not limited to, strength and balance.
Topics: Adult; Bone Density; Exercise Movement Techniques; Female; Humans; Osteoporosis, Postmenopausal; Yoga
PubMed: 33961670
DOI: 10.1371/journal.pone.0251391 -
Alimentary Pharmacology & Therapeutics Oct 2023Ulcerative proctitis (UP) is a common highly symptomatic form of ulcerative colitis that can be difficult to treat. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Ulcerative proctitis (UP) is a common highly symptomatic form of ulcerative colitis that can be difficult to treat.
AIM
To assess the efficacy of medical treatments for UP.
METHODS
We searched MEDLINE, EMBASE, and CENTRAL on 23 November 2022 for randomised controlled trials (RCTs) of medical therapy for adults with UP. Primary outcomes included induction and maintenance of clinical remission. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for each outcome.
RESULTS
We included 53 RCTs (n = 4096) including 46 induction studies (n = 3731) and seven maintenance studies (n = 365). First-line therapies included topical 5-aminosalicylic acid (5-ASA), conventional corticosteroids, budesonide, and oral 5-ASA. Therapy for refractory UP included topical tacrolimus and small molecules. Topical 5-ASA was superior to placebo for induction (RR 2.72, 95% CI 1.94-3.82) and maintenance of remission (RR 2.09, 95% CI 1.26-3.46). Topical corticosteroids were superior to placebo for induction of remission (RR 2.83, 95% CI 1.62-4.92). Topical budesonide was superior to placebo for induction of remission (RR 2.34, 95% CI 1.44-3.81). Combination therapy with topical 5-ASA and topical corticosteroids was superior to topical monotherapy with either agent. Topical tacrolimus was superior to placebo. Etrasimod was superior to placebo for induction (RR 4.71, 95% CI 1.2-18.49) and maintenance of remission (RR 2.08, 95% CI 1.31-3.32).
CONCLUSIONS
Topical 5-ASA and corticosteroids are effective for active UP. Topical 5-ASA may be effective for maintenance of remission. Tacrolimus may be effective for induction of remission. Etrasimod may be effective for induction and for maintenance of remission. Trials should include UP to expand the evidence base for this under-represented population.
Topics: Adult; Humans; Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Budesonide; Colitis, Ulcerative; Mesalamine; Proctitis; Remission Induction; Tacrolimus
PubMed: 37589498
DOI: 10.1111/apt.17666 -
Acta Oncologica (Stockholm, Sweden) Sep 2020Overall prognosis of advanced sarcoma remains poor, optimization of systemic treatment is urgently needed in this setting. We systematically reviewed fully published...
Overall prognosis of advanced sarcoma remains poor, optimization of systemic treatment is urgently needed in this setting. We systematically reviewed fully published English-speaking literature about maintenance therapy and drug holiday in sarcoma patients management. We found that switch maintenance therapy with cyclophosphamide/vinorelbine improves the outcome of localized high-risk rhabdomyosarcoma. There is no other maintenance therapy recommended in sarcoma patients. After classical chemotherapy, maintenance therapy with immune-stimulating agents for localized osteosarcoma, bevacizumab for advanced angiosarcoma or pediatric advanced sarcoma, or mTOR inhibitors for metastatic sarcoma does not improve the outcome. Drug holiday has been assessed for metastatic gastrointestinal stromal tumor treated with imatinib as the first-line therapy or for metastatic soft-tissue sarcoma treated with trabectedin. Drug holiday has been found to lead to rapid disease progression and should be avoided. Data about both maintenance and drug holiday are spare in sarcoma management.
Topics: Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Cyclophosphamide; Disease-Free Survival; Drug Administration Schedule; Drug Substitution; Hemangiosarcoma; Humans; Maintenance Chemotherapy; Osteosarcoma; Prognosis; Rhabdomyosarcoma; Survival Rate; Trabectedin; Vinorelbine
PubMed: 32400254
DOI: 10.1080/0284186X.2020.1759825 -
The Cochrane Database of Systematic... Jan 2022Multifocal motor neuropathy (MMN) is a rare, probably immune-mediated disorder characterised by slowly progressive, asymmetric, distal weakness of one or more limbs with... (Review)
Review
BACKGROUND
Multifocal motor neuropathy (MMN) is a rare, probably immune-mediated disorder characterised by slowly progressive, asymmetric, distal weakness of one or more limbs with no objective loss of sensation. It may cause prolonged periods of disability. Treatment options for MMN are few. People with MMN do not usually respond to steroids or plasma exchange. Uncontrolled studies have suggested a beneficial effect of intravenous immunoglobulin (IVIg). This is an update of a Cochrane Review first published in 2005, with an amendment in 2007. We updated the review to incorporate new evidence.
OBJECTIVES
To assess the efficacy and safety of intravenous and subcutaneous immunoglobulin in people with MMN.
SEARCH METHODS
We searched the following databases on 20 April 2021: the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and WHO ICTRP for randomised controlled trials (RCTs) and quasi-RCTs, and checked the reference lists of included studies.
SELECTION CRITERIA
We considered RCTs and quasi-RCTs examining the effects of any dose of IVIg and subcutaneous immunoglobulin (SCIg) in people with definite or probable MMN for inclusion in the review. Eligible studies had to have measured at least one of the following outcomes: disability, muscle strength, or electrophysiological conduction block. We used studies that reported the frequency of adverse effects to assess safety.
DATA COLLECTION AND ANALYSIS
Two review authors independently reviewed the literature searches to identify potentially relevant trials, assessed risk of bias of included studies, and extracted data. We followed standard Cochrane methodology.
MAIN RESULTS
Six cross-over RCTs including a total of 90 participants were suitable for inclusion in the review. Five RCTs compared IVIg to placebo, and one compared IVIg to SCIg. Four of the trials comparing IVIg versus placebo involved IVIg-naive participants (induction treatment). In the other two trials, participants were known IVIg responders receiving maintencance IVIg at baseline and were then randomised to maintenance treatment with IVIg or placebo in one trial, and IVIg or SCIg in the other. Risk of bias was variable in the included studies, with three studies at high risk of bias in at least one risk of bias domain. IVIg versus placebo (induction treatment): three RCTs including IVIg-naive participants reported a disability measure. Disability improved in seven out of 18 (39%) participants after IVIg treatment and in two out of 18 (11%) participants after placebo (risk ratio (RR) 3.00, 95% confidence interval (CI) 0.89 to 10.12; 3 RCTs, 18 participants; low-certainty evidence). The proportion of participants with an improvement in disability at 12 months was not reported. Strength improved in 21 out of 27 (78%) IVIg-naive participants treated with IVIg and one out of 27 (4%) participants who received placebo (RR 11.00, 95% CI 2.86 to 42.25; 3 RCTs, 27 participants; low-certainty evidence). IVIg treatment may increase the proportion of people with resolution of at least one conduction block; however, the results were also consistent with no effect (RR 7.00, 95% CI 0.95 to 51.70; 4 RCTs, 28 participants; low-certainty evidence). IVIg versus placebo (maintenance treatment): a trial that included participants on maintenance IVIg treatment reported an increase in disability in 17 out of 42 (40%) people switching to placebo and seven out of 42 (17%) remaining on IVIg (RR 2.43, 95% CI 1.13 to 5.24; 1 RCT, 42 participants; moderate-certainty evidence) and a decrease in grip strength in 20 out of 42 (48%) participants after a switch to placebo treatment compared to four out of 42 (10%) remaining on IVIg (RR 0.20, 95% CI 0.07 to 0.54; 1 RCT, 42 participants; moderate-certainty evidence). Adverse events, IVIg versus placebo (induction or maintenance): four trials comparing IVIg and placebo reported adverse events, of which data from two studies could be meta-analysed. Transient side effects were reported in 71% of IVIg-treated participants versus 4.8% of placebo-treated participants in these studies. The pooled RR for the development of side effects was 10.33 (95% CI 2.15 to 49.77; 2 RCTs, 21 participants; very low-certainty evidence). There was only one serious side effect (pulmonary embolism) during IVIg treatment. IVIg versus SCIg (maintenance treatment): the trial that compared continuation of IVIg maintenance versus SCIg maintenance did not measure disability. The evidence was very uncertain for muscle strength (standardised mean difference 0.08, 95% CI -0.84 to 1.00; 1 RCT, 9 participants; very low-certainty evidence). The evidence was very uncertain for the number of people with side effects attributable to treatment (RR 0.50, 95% CI 0.18 to 1.40; 1 RCT, 9 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS
Low-certainty evidence from three small RCTs shows that IVIg may improve muscle strength in people with MMN, and low-certainty evidence indicates that it may improve disability; the estimate of the magnitude of improvement of disability has wide CIs and needs further studies to secure its significance. Based on moderate-certainty evidence, it is probable that most IVIg responders deteriorate in disability and muscle strength after IVIg withdrawal. SCIg might be an alternative treatment to IVIg, but the evidence is very uncertain. More research is needed to identify people in whom IVIg withdrawal is possible and to confirm efficacy of SCIg as an alternative maintenance treatment.
Topics: Humans; Immunoglobulins, Intravenous; Plasma Exchange; Polyneuropathies; Randomized Controlled Trials as Topic
PubMed: 35015296
DOI: 10.1002/14651858.CD004429.pub3 -
Alimentary Pharmacology & Therapeutics Aug 2023We conducted a systematic review to assess medical therapy for the treatment and prevention of pouchitis. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIMS
We conducted a systematic review to assess medical therapy for the treatment and prevention of pouchitis.
METHODS
Randomised controlled trials (RCTs) of medical therapy in adults with or without pouchitis were searched to March 2022. Primary outcomes included clinical remission/response, maintenance of remission and prevention of pouchitis.
RESULTS
Twenty RCTs (N = 830) were included. Acute pouchitis: One study compared ciprofloxacin with metronidazole. At 2 weeks, 100% (7/7) of ciprofloxacin participants achieved remission, compared with 67% (6/9) of metronidazole participants (RR: 1.44, 95% CI: 0.88-2.35, very low certainty evidence). One study compared budesonide enemas with oral metronidazole. Fifty percent (6/12) of budesonide participants achieved remission compared with 43% (6/14) of metronidazole participants (RR: 1.17, 95% CI: 0.51-2.67, low certainty evidence). Chronic pouchitis: Two studies (n = 76) assessed De Simone Formulation. Eighty-five percent (34/40) of De Simone Formulation participants maintained remission at 9-12 months compared with 3% (1/36) placebo participants (RR: 18.50, 95% CI: 3.86-88.56, moderate certainty evidence). One study assessed vedolizumab. Thirty-one percent (16/51) of vedolizumab participants achieved clinical remission at 14 weeks compared with 10% (5/51) of placebo participants (RR: 3.20, 95% CI: 1.27-8.08, moderate certainty evidence).
PROPHYLAXIS
Two studies assessed De Simone Formulation. Ninety percent (18/20) of De Simone Formulation participants did not develop pouchitis compared with 60% (12/20) of placebo participants (RR: 1.50, 95% CI: 1.02-2.21, moderate certainty evidence).
CONCLUSIONS
Apart from vedolizumab and the De Simone formulation, the effects of other medical interventions for pouchitis are uncertain.
Topics: Adult; Humans; Metronidazole; Remission Induction; Pouchitis; Ciprofloxacin; Budesonide; Randomized Controlled Trials as Topic
PubMed: 37246609
DOI: 10.1111/apt.17568 -
Journal of Crohn's & Colitis May 2016Minimisation of the placebo responses in randomised controlled trials [RCTs] is essential for efficient evaluation of new interventions. Placebo rates have been high in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIMS
Minimisation of the placebo responses in randomised controlled trials [RCTs] is essential for efficient evaluation of new interventions. Placebo rates have been high in ulcerative colitis [UC] clinical trials, and factors influencing this are poorly understood. We quantify placebo response and remission rates in UC RCTs and identify trial design factors influencing them.
METHODS
MEDLINE, EMBASE, and the Cochrane Library were searched from inception through April 2014 for placebo-controlled trials in adult patients with UC of a biological agent, corticosteroid, immunosuppressant, or aminosalicylate. Data were independently doubly extracted. Quality was assessed using the Cochrane risk of bias tool.
RESULTS
In all, 51 trials [48 induction and 10 maintenance phases] were identified. Placebo response and remission rates were pooled according to random-effects models, and mixed-effects meta-regression models were used to evaluate effects of study-level characteristics on these rates. Pooled estimates of placebo remission and response rates for induction trials were 10% (95% confidence interval [CI] 7-13%) and 33% [95% CI 29-37%], respectively. Corresponding values for maintenance trials were 19% [95% CI 11-30%] and 22% [95% CI 17-28%]. Trials enrolling patients with more active disease confirmed by endoscopy [endoscopy subscore ≥ 2] were associated with lower placebo rates. Conversely, placebo rates increased with increasing trial duration and number of study visits.
CONCLUSIONS
Objective assessment of greater disease activity at trial entry by endoscopy lowered placebo rates, whereas increasing trial duration and more interactions with healthcare providers increased placebo rates. These findings have important implications for design and conduct of clinical trials.
Topics: Anti-Inflammatory Agents; Colitis, Ulcerative; Humans; Immunosuppressive Agents; Induction Chemotherapy; Maintenance Chemotherapy; Models, Statistical; Placebo Effect; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome
PubMed: 26746169
DOI: 10.1093/ecco-jcc/jjw004 -
Expert Review of Respiratory Medicine 2016Idiopathic pulmonary fibrosis (IPF) is a chronic devastating interstitial lung disease associated with exercise intolerance, dyspnea, hypoxemia, diminished quality of... (Review)
Review
Idiopathic pulmonary fibrosis (IPF) is a chronic devastating interstitial lung disease associated with exercise intolerance, dyspnea, hypoxemia, diminished quality of life and poor prognosis. A growing body of evidence with respect to short-term effects of exercise training has demonstrated clinical benefits in IPF patients. A recent systematic review showed significant improvements in 6-min walking distance, peak aerobic capacity, reduced dyspnea and improved quality of life. However, aspects of training programs, maintenance and predictors of improvement and the impact on prognosis need to be further explored. The aim of this paper was to comprehensively review the existing scientific literature regarding exercise training in patients with IPF and identify important gaps that should be studied in the future.
Topics: Chronic Disease; Dyspnea; Exercise Therapy; Exercise Tolerance; Humans; Idiopathic Pulmonary Fibrosis; Prognosis; Quality of Life
PubMed: 26567878
DOI: 10.1586/17476348.2016.1121104 -
Journal of Substance Abuse Treatment May 2015Buprenorphine maintenance therapy (BMT) is increasingly the preferred opioid maintenance agent due to its reduced toxicity and availability in an office-based setting in... (Review)
Review
Buprenorphine maintenance therapy (BMT) is increasingly the preferred opioid maintenance agent due to its reduced toxicity and availability in an office-based setting in the United States. Although BMT has been shown to be highly efficacious, it is often discontinued soon after initiation. No current systematic review has yet investigated providers' or patients' reasons for BMT discontinuation or the outcomes that follow. Hence, provider and patient perspectives associated with BMT discontinuation after a period of stable buprenorphine maintenance and the resultant outcomes were systematically reviewed with specific emphasis on pre-buprenorphine-taper parameters predictive of relapse following BMT discontinuation. Few identified studies address provider or patient perspectives associated with buprenorphine discontinuation. Within the studies reviewed providers with residency training in BMT were more likely to favor long term BMT instead of detoxification, and providers were likely to consider BMT discontinuation in the face of medication misuse. Patients often desired to remain on BMT because of fear of relapse to illicit opioid use if they were to discontinue BMT. The majority of patients who discontinued BMT did so involuntarily, often due to failure to follow strict program requirements, and 1 month following discontinuation, rates of relapse to illicit opioid use exceeded 50% in every study reviewed. Only lower buprenorphine maintenance dose, which may be a marker for attenuated addiction severity, predicted better outcomes across studies. Relaxed BMT program requirements and frequent counsel on the high probability of relapse if BMT is discontinued may improve retention in treatment and prevent the relapse to illicit opioid use that is likely to follow BMT discontinuation.
Topics: Analgesics, Opioid; Buprenorphine; Humans; Opioid-Related Disorders; Withholding Treatment
PubMed: 25601365
DOI: 10.1016/j.jsat.2014.12.011 -
Future Oncology (London, England) May 2016Endocrine treatment is the first-line therapy in hormone-sensitive metastatic breast cancer while chemotherapy is the first option in tumors refractory to endocrine... (Review)
Review
Endocrine treatment is the first-line therapy in hormone-sensitive metastatic breast cancer while chemotherapy is the first option in tumors refractory to endocrine therapy and in hormone-negative disease. Optimal duration, efficacy and safety of a maintenance endocrine therapy or chemotherapy after an induction treatment are still a matter of debate. We performed a literature review to identify studies regarding maintenance hormonal and chemotherapy treatments in metastatic breast cancer. We analyzed data relating to efficacy (improvement of progression-free survival and overall survival) and safety (symptoms relief and quality of life [QoL]). Maintenance endocrine therapy could prolong progression-free survival with a better control of symptoms and improving QoL. Maintenance chemotherapy prolong the response to a previous treatment, worsening the QoL, except for metronomic capecitabine.
Topics: Antineoplastic Agents; Antineoplastic Agents, Hormonal; Breast Neoplasms; Disease-Free Survival; Female; Humans; Maintenance Chemotherapy; Quality of Life
PubMed: 26996100
DOI: 10.2217/fon-2015-0065