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Revista Brasileira de Ginecologia E... Feb 2018Interstitial cystitis (IC), including bladder pain syndrome (BPS), is a chronic and debilitating disease that mainly affects women. It is characterized by pelvic pain...
Interstitial cystitis (IC), including bladder pain syndrome (BPS), is a chronic and debilitating disease that mainly affects women. It is characterized by pelvic pain associated with urinary urgency, frequency, nocturia and negative urine culture, with normal cytology. In 2009, the Society for Urodynamics and Female Urology (SUFU) defined the term IC/BPS as "an unpleasant sensation (pain, pressure, and discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than 6 weeks duration, in the absence of infection or other identifiable causes." This is the definition used by the American Urological Association (AUA) in the most recent guidelines on IC/BPS. Interstitial cystitis may be sufficiently severe to have a devastating effect on the quality of life, but it may also be associated with moderate symptoms whose effects are less debilitating. Although there are several clinical trials to assess oral and intravesical therapies, the treatment for IC remains far from ideal. This systematic assessment evaluates published randomized clinical trials on oral medications used to treat symptoms of BPS. This study was performed according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) method. Two independent reviewers screened the studies to determine their inclusion or exclusion and to perform the methodological analysis. The inclusion criteria included randomized studies published between April of 1988 and April of 2016 that used oral medications to treat symptoms of BPS or IC. According to the systematic review performed, we should consider pentosan polysulfate as one of the best options of oral drugs for the treatment of BPS symptoms. However, this drug is not an available option in Brazil. Orally administered amitriptyline is an efficacious medical treatment for BPS, and it should be the first treatment offered.
Topics: Administration, Oral; Brazil; Cystitis, Interstitial; Female; Humans; Practice Guidelines as Topic; Randomized Controlled Trials as Topic
PubMed: 29241263
DOI: 10.1055/s-0037-1609049 -
Experimental and Therapeutic Medicine Jul 2016Cyclosporine A (CyA) is emerging as a potential therapeutic strategy for painful bladder syndrome/interstitial cystitis (PBS/IC), which is currently an incurable...
Cyclosporine A (CyA) is emerging as a potential therapeutic strategy for painful bladder syndrome/interstitial cystitis (PBS/IC), which is currently an incurable disease. The purpose of this systematic review was to evaluate the treatment effects of CyA in PBS/IC. Electronic and manual retrieval procedures were carried out to identify eligible references for the systematic review. The entire contents of the included articles were assessed, from study design to reported results. Eight studies, comprising three randomized controlled trials (RCTs), four prospective studies and one retrospective cohort study, were included, involving a total of 298 subjects. Meta-analysis was not implemented due to heterogeneity of the manner of reporting the outcome parameters. All studies reported an improvement in symptoms following treatment with CyA. The results of the three RCTs implied that the treatment effects of CyA were better than those of pentosan polysulfate sodium. Some adverse events, for example, elevation of serum creatinine levels and an increase in blood pressure, were noted in five studies. In conclusion, the evidence from the studies implied that treatment of CyA can result in a long-term benefit in patients of PBS/IC; however, further evidence is required to verify this.
PubMed: 27347076
DOI: 10.3892/etm.2016.3301 -
The Cochrane Database of Systematic... Nov 2015Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the forearm or hand, no consensus exists on the optimal management of this condition in clinical practice.
OBJECTIVES
To summarise the evidence from randomised clinical trials (RCTs) concerning the efficacy and safety of (topical, oral or parenteral) medical therapy of superficial thrombophlebitis of the upper extremity.
SEARCH METHODS
The Cochrane Vascular Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2015) and the Cochrane Register of Studies (2015, Issue 3). Clinical trials registries were searched up to April 2015.
SELECTION CRITERIA
RCTs comparing any (topical, oral or parenteral) medical treatment to no intervention or placebo, or comparing two different medical interventions (e.g. a different variant scheme or regimen of the same intervention or a different pharmacological type of treatment).
DATA COLLECTION AND ANALYSIS
We extracted data on methodological quality, patient characteristics, interventions and outcomes, including improvement of signs and symptoms as the primary effectiveness outcome, and number of participants experiencing side effects of the study treatments as the primary safety outcome.
MAIN RESULTS
We identified 13 studies (917 participants). The evaluated treatment modalities consisted of a topical treatment (11 studies), an oral treatment (2 studies) and a parenteral treatment (2 studies). Seven studies used a placebo or no intervention control group, whereas all others also or solely compared active treatment groups. No study evaluated the effects of ice or the application of cold or hot bandages. Overall, the risk of bias in individual trials was moderate to high, although poor reporting hampered a full appreciation of the risk in most studies. The overall quality of the evidence for each of the outcomes varied from low to moderate mainly due to risk of bias and imprecision, with only single trials contributing to most comparisons. Data on primary outcomes improvement of signs and symptoms and side effects attributed to the study treatment could not be statistically pooled because of the between-study differences in comparisons, outcomes and type of instruments to measure outcomes.An array of topical treatments, such as heparinoid or diclofenac gels, improved pain compared to placebo or no intervention. Compared to placebo, oral non-steroidal anti-inflammatory drugs reduced signs and symptoms intensity. Safety issues were reported sparsely and were not available for some interventions, such as notoginseny creams, parenteral low-molecular-weight heparin or defibrotide. Although several trials reported on adverse events with topical heparinoid creams, Essaven gel or phlebolan versus control, the trials were underpowered to adequately measure any differences between treatment modalities. Where reported, adverse events with topical treatments consisted mainly of local allergic reactions. Only one study of 15 participants assessed thrombus extension and symptomatic venous thromboembolism with either oral non-steroidal anti-inflammatory drugs or low-molecular-weight heparin, and it reported no cases of either. No study reported on the development of suppurative phlebitis, catheter-related bloodstream infections or quality of life.
AUTHORS' CONCLUSIONS
The evidence about the treatment of acute infusion superficial thrombophlebitis is limited and of low quality. Data appear too preliminary to assess the effectiveness and safety of topical treatments, systemic anticoagulation or oral non-steroidal anti-inflammatory drugs.
Topics: Anti-Inflammatory Agents; Anticoagulants; Catheterization, Peripheral; Dalteparin; Diclofenac; Drug Combinations; Drugs, Chinese Herbal; Escin; Gels; Heparin; Heparinoids; Humans; Ibuprofen; Nitroglycerin; Pentosan Sulfuric Polyester; Phospholipids; Polydeoxyribonucleotides; Randomized Controlled Trials as Topic; Thrombophlebitis; Upper Extremity
PubMed: 26588711
DOI: 10.1002/14651858.CD011015.pub2 -
International Urogynecology Journal May 2016Bladder pain syndrome/interstitial cystitis (BPS/IC) has various treatments; however, no standardized treatment has been established. The aim was to analyze different... (Review)
Review
INTRODUCTION AND HYPOTHESIS
Bladder pain syndrome/interstitial cystitis (BPS/IC) has various treatments; however, no standardized treatment has been established. The aim was to analyze different types of treatment of BPS/IC and their effectiveness.
METHODS
A literature review with a search strategy for articles related to BPS/IC published between 1990 and 2014 was conducted on MEDLINE, PUBMED, and SCOPUS. Only randomized controlled trials in women were included in the meta-analysis, while other experimental studies were used as bases for a systematic review of the topic. Clinical trial quality was defined according to the Jadad scale.
RESULTS
Of 356 articles, 13 were included in the analysis. The intervention methods were as follows: instillation of hyaluronic acid, botulinum toxin A, intravesical lidocaine, hyperbaric chamber, massage, physiotherapy, phosphate-buffered saline, piroxicam in combination with doxepin, and others. We did not find any treatment with at least two randomized controlled trials for meta-analysis. Among the assessment tools for symptoms of BPS/IC, the most frequently used were the visual analogue scale, voiding record, and the O'Leary-Sant questionnaire.
CONCLUSION
Existing studies were not able to define the best approach for the treatment of BPS/IC. The lack of standardized treatment may be related to the diversity of interventions used; therefore, further studies with better methodological quality are needed.
Topics: Acetylcholine Release Inhibitors; Adjuvants, Immunologic; Administration, Intravesical; Anesthetics, Local; Anti-Inflammatory Agents, Non-Steroidal; Antidepressive Agents; Botulinum Toxins, Type A; Cystitis, Interstitial; Drug Therapy, Combination; Female; Humans; Hyaluronic Acid; Hyperbaric Oxygenation; Lidocaine; Pentosan Sulfuric Polyester; Physical Therapy Modalities; Sodium Chloride
PubMed: 26272202
DOI: 10.1007/s00192-015-2815-5 -
European Urology Jan 2012Different types of behavioural, dietary, interventional, pharmacologic, and surgical therapies have been used to treat painful bladder syndrome/interstitial cystitis... (Meta-Analysis)
Meta-Analysis Review
CONTEXT
Different types of behavioural, dietary, interventional, pharmacologic, and surgical therapies have been used to treat painful bladder syndrome/interstitial cystitis (PBS/IC). Because of the paucity of randomised placebo-controlled studies on different treatments, an evidence-based management approach has not yet been developed.
OBJECTIVE
To critically review and synthesize data from a wide range of current therapeutic approaches to PBS/IC, to quantify the effect size from randomised controlled trials (RCTs), and to reach clinical agreement on the efficacy of treatments for PBS/IC.
EVIDENCE ACQUISITION
We performed a systematic review of the literature to identify articles published between 1990 and September 2010 on the management of PBS/IC. We included articles restricted to the English language published since 1990 to date that reported on oral and intravesical treatment, multimodal or combined treatment, and surgical treatment. For all RCTs, standardised mean differences (SMDs) were extracted and combined in a meta-analysis applying a random-effect model that incorporated the heterogeneity of effects. The four outcomes assessed in all studies were a change in the Interstitial Cystitis Symptom Index (ICSI), pain, urgency, and frequency. Non-RCTs (nRCTs) were analysed with a narrative synthesis of the evidence from all research designs.
EVIDENCE SYNTHESIS
We included 7709 adult patients from 29 RCTs and 57 nRCTs. Meta-analysis of RCTs showed that only cyclosporine A provided a simultaneous great effect size of SMD on ICSI, pain, and frequency. Amitriptyline at different dosages showed a great effect size of SMD on pain and urgency or on ICSI and frequency. The remaining RCTs showed sporadic significant changes in only one of the four considered parameters. The attributed levels of evidence for treatments reported in RCTs were 1b; grades of recommendations ranged from A to C. According to the Jadad score, 11 RCTs were high-quality studies. Meta-analysis of RCTs showed a great heterogeneity in the applied methodologies, clinical outcomes assessed, and the obtained results in different studies. The results from the nRCTs showed that the most frequently adopted treatment is oral pentosan polysulfate and that the use of botulinum A toxin intradetrusorial injections in PBS/IC is increasing. A high heterogeneity in drugs and treatment modalities, clinical outcomes, and obtained results was also found for nRCTs.
CONCLUSIONS
Limited evidence exists for the few treatments for PBS/IC. The lack of definitive conclusions is due to the great heterogeneity in methodology, symptoms assessment, duration of treatment, and follow-up in both RCTs and nRCTs.
Topics: Adult; Aged; Aged, 80 and over; Cystitis, Interstitial; Evidence-Based Medicine; Female; Humans; Male; Middle Aged; Pain Measurement; Severity of Illness Index; Treatment Outcome; Young Adult
PubMed: 21920661
DOI: 10.1016/j.eururo.2011.07.069 -
BMJ Clinical Evidence Jul 2011Chronic prostatitis can cause pain and urinary symptoms, and usually occurs without positive bacterial cultures from prostatic secretions (known as chronic abacterial... (Review)
Review
INTRODUCTION
Chronic prostatitis can cause pain and urinary symptoms, and usually occurs without positive bacterial cultures from prostatic secretions (known as chronic abacterial prostatitis or chronic pelvic pain syndrome [CP/CPPS]). Bacterial infection can result from urinary tract instrumentation, but the cause and natural history of CP/CPPS are unknown.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for chronic bacterial prostatitis? What are the effects of treatments for chronic abacterial prostatitis/chronic pelvic pain syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 33 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: 5 alpha-reductase inhibitors, allopurinol, alpha-blockers, biofeedback, local injections of antimicrobial drugs, mepartricin, non-steroidal anti-inflammatory drugs (NSAIDs), oral antimicrobial drugs, pentosan polysulfate, prostatic massage, quercetin, radical prostatectomy, sitz baths, transurethral microwave thermotherapy, and transurethral resection.
Topics: 5-alpha Reductase Inhibitors; Chronic Disease; Humans; Male; Mepartricin; Pentosan Sulfuric Polyester; Prostatitis; Quercetin
PubMed: 21736764
DOI: No ID Found -
Contact Dermatitis Oct 2011Heparins are a widely used class of drugs known to cause delayed-type hypersensitivity (DTH) reactions. Recent publications indicate that the incidence of these may be... (Meta-Analysis)
Meta-Analysis Review
The risk for cross-reactions after a cutaneous delayed-type hypersensitivity reaction to heparin preparations is independent of their molecular weight: a systematic review.
BACKGROUND
Heparins are a widely used class of drugs known to cause delayed-type hypersensitivity (DTH) reactions. Recent publications indicate that the incidence of these may be higher than previously thought. To date, patient-related but no drug-related risk factors for the development of DTH reactions to heparins have been identified, although molecular weight is discussed as a potentially relevant parameter.
OBJECTIVES
To address this, a systematic review was conducted on the frequency of cross-reactions after DTH reactions to heparin preparations.
METHODS
We electronically searched MEDLINE and EMBASE, hand-searched selected journals and references, and contacted experts for unpublished data.
RESULTS
Sixty-six publications and unpublished data of 14 patients resulted in 198 patients with 1084 tests for cross-reactivity. The primary causative agents were mostly unfractionated heparin (50%) and low molecular weight heparins (49.5%). Cross-reactions were more likely after an initial DTH reaction to unfractionated heparin than after an initial DTH reaction to low molecular weight heparin. Our findings also indicate that molecular weight does not correlate with the risk for cross-reactivity, which is in line with recent observations, indicating that different heparins have to be individually considered.
CONCLUSIONS
The available data demonstrated the lowest overall risk for cross-reactions for pentosan polysulfate (36.4%) and fondaparinux (10.4%). In the clinical context, fondaparinux is recommended as the current best alternative when a DTH reaction occurs.
Topics: Anticoagulants; Cross Reactions; Dermatitis, Allergic Contact; Drug Eruptions; Female; Fondaparinux; Heparin; Humans; Incidence; Male; Pentosan Sulfuric Polyester; Polysaccharides; Risk
PubMed: 21631519
DOI: 10.1111/j.1600-0536.2011.01932.x -
Brain and Nerve = Shinkei Kenkyu No... Aug 2009Prion diseases are fatal infectious neurodegenerative disorders; examples include the Creutzfeldt-Jakob disease affecting humans and bovine spongiform encephalopathy in... (Review)
Review
Prion diseases are fatal infectious neurodegenerative disorders; examples include the Creutzfeldt-Jakob disease affecting humans and bovine spongiform encephalopathy in cattle. The causative agents of these diseases--the prions--are thought to consist of the pathogenic isoform of the prion protein PrP(Sc), which is produced by the conformational conversion of the normal isoform PrP(c). Many lines of evidence indicate that the constitutive conversion of PrP(c) to PrP(Sc), resulting in a marked accumulation of PrP(Sc) in the brain, is a central event in the pathogenesis of prion diseases. A large number of compounds have been identified as anti-prion agents and capable of reducing the PrP(Sc) levels in infected cells. Some of these compounds have been found to be partially effective in infected animals, thus resulting in the prolongation of the incubation or survival times and a few of these compounds were or are under clinical trials. However, none of these compounds have proven to be therapeutically effective against this group of diseases. This is probably because (1) these compounds fail to cross the blood-brain barrier and (2) their effectiveness is reduced because they are administered only to patients with clinically advanced disease owing to a lack of diagnostic indicators for presymptomatic individuals. In this communication, we systematically list these anti-prion compounds and summarize their effectiveness and possible mechanisms of action.
Topics: Aminopyridines; Animals; Antibodies, Monoclonal; Blood-Brain Barrier; Brain; Cattle; Clinical Trials as Topic; Drug Discovery; Gene Silencing; Humans; Pentosan Sulfuric Polyester; Polyelectrolytes; Polymers; PrPC Proteins; PrPSc Proteins; Prion Diseases; Protein Isoforms; Quinacrine; Species Specificity
PubMed: 19697882
DOI: No ID Found -
BMJ Clinical Evidence May 2008Chronic prostatitis can cause pain and urinary symptoms, and usually occurs without positive bacterial cultures from prostatic secretions (known as chronic abacterial... (Review)
Review
INTRODUCTION
Chronic prostatitis can cause pain and urinary symptoms, and usually occurs without positive bacterial cultures from prostatic secretions (known as chronic abacterial prostatitis or chronic pelvic pain syndrome, CP/CPPS). Bacterial infection can result from urinary tract instrumentation, but the cause and natural history of CP/CPPS are unknown.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for chronic bacterial prostatitis? What are the effects of treatments for chronic abacterial prostatitis/chronic pelvic pain syndrome? We searched: Medline, Embase, The Cochrane Library and other important databases up to August 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 30 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: 5 alpha-reductase inhibitors, allopurinol, alpha-blockers, biofeedback, local injections of antimicrobial drugs, mepartricin, non-steroidal anti-inflammatory drugs, oral antimicrobial drugs, pentosan polysulfate, prostatic massage, quercetin, radical prostatectomy, sitz baths, transurethral microwave thermotherapy, and transurethral resection.
Topics: Cholestenone 5 alpha-Reductase; Humans; Male; Prostatitis
PubMed: 19450305
DOI: No ID Found -
The Cochrane Database of Systematic... Oct 2007Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC) occurs predominantly in women. It is a poorly-understood condition with symptoms of bladder pain, urinary... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC) occurs predominantly in women. It is a poorly-understood condition with symptoms of bladder pain, urinary frequency, urgency and nocturia. Treatments for PBS/IC include dietary/lifestyle interventions, oral medication, intravesical instillations and, in some cases, surgery. Success rates are generally modest and there is little consensus as to the best form of treatment for this condition.
OBJECTIVES
To assess the effectiveness of intravesical treatment for PBS/IC.
SEARCH STRATEGY
We searched the Cochrane Incontinence Group specialised trials register (30 May 2006) as well as reference lists of all selected trials. Recognised researchers in the field were contacted for any additional relevant material.
SELECTION CRITERIA
Randomised or quasi-randomised controlled trials were included in the review if they had recruited participants with a clinical diagnosis of PBS/IC and if at least one arm of the trial was treatment with an intravesical preparation. Outcome measures were pre-determined, the primary ones being the effect on pain and bladder capacity. Others included symptomatic response to treatment, quality-of-life assessment, economic factors and adverse events.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed trial eligibility and quality, then extracted relevant data from the studies.
MAIN RESULTS
Nine eligible trials were identified - six parallel group, one incomplete cross-over and two cross-over trials - with a total of 616 participants. Six trials compared an 'active' instillation with placebo instillation, two compared different types of instillation, and one was a comparison of an instillation plus bladder training versus bladder training alone. Altogether, the review included trials of six different types of intravesical instillation: Resiniferatoxin, Dimethyl sulfoxide, BCG, pentosanpolysulphate, oxybutin, and alkalinisation of urine pH. Confidence intervals were generally wide. Resiniferatoxin was not associated with sustained differences in the review outcomes reported but pain during instillation and withdrawal from treatment was significantly more common. The data available about Dimethyl sulfoxide (DMSO) were very limited but with no apparent differences from placebo. Groups treated with BCG tended to report less pain and fewer general symptoms. Although adverse events were commonly reported, these were no more common after BCG than after placebo instillation. The few data about Pentosanpolysulphate tended to favour the actively treated, but with wide confidence intervals; there was little information about adverse events. Oxybutinin instillation was associated with increased bladder capacity, reduced frequency, improved quality of life scores and fewer drop-outs. Alkalinisation of urine pH did not make any clear difference, but with potentially wide confidence intervals.
AUTHORS' CONCLUSIONS
Overall, the evidence base for treating PBS/IC using intravesical preparations is limited and the potential for meta-analysis reduced by variation in the outcome measures used. The quality of trial reports was mixed and in some cases this precluded any meaningful data extraction. BCG and oxybutin are reasonably well-tolerated and evidence is most promising for these. Resiniferatoxin showed no evidence of effect for most outcomes and caused pain, which reduced treatment compliance. There is little evidence for the other treatments included in this review. Randomised controlled trials are still needed and study design should incorporate outcomes that are most relevant to these with PBS/IC and should be standardised.
Topics: Administration, Intravesical; BCG Vaccine; Cystitis, Interstitial; Dimethyl Sulfoxide; Diterpenes; Humans; Mycobacterium bovis; Pain Management; Pentosan Sulfuric Polyester; Randomized Controlled Trials as Topic
PubMed: 17943887
DOI: 10.1002/14651858.CD006113.pub2