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Anthony G Marson - One of the best experts on this subject based on the ideXlab platform.

  • clobazam add on therapy for drug resistant epilepsy
    Cochrane Database of Systematic Reviews, 2019
    Co-Authors: Rebecca Bresnahan, Anthony G Marson, Kirsty J Martinmcgill, John Williamson, Benedict D Michael
    Abstract:

    Background Epilepsy affects approximately 1% of the population, with up to 30% of patients continuing to have seizures, despite antiepileptic drug treatment. Clobazam is a 1,5-benzodiazepine and is commonly used as an add-on treatment for drug-resistant epilepsy. This review is an updated version of the original Cochrane Review, first published in 2008, and examines the most current literature regarding clobazam as an add-on for drug-resistant epilepsy. Objectives To assess the efficacy, effectiveness and tolerability of clobazam as an add-on therapy for drug-resistant generalised-onset and focal-onset seizures, with or without secondary generalisation, in adults and children. Search methods For the latest update, we searched the following databases on 9 October 2018: Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL), Medline (Ovid) 1946 to 8 October, 2018, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP). For some previous updates we also searched SCOPUS, DARE, and BIOSIS Previews, but these are no longer needed. (SCOPUS was searched as a substitute for EMBASE, but randomised and quasi-randomised controlled trials in EMBASE are now included in CENTRAL; DARE ceased operation at the end of March 2015; BIOSIS Previews yielded no relevant items that were not found in the other databases). Selection criteria Randomised trials of add-on clobazam, with adequate methods of allocation concealment, recruiting patients with drug-resistant focal or generalised-onset seizures, with a minimum treatment period of eight weeks. Data collection and analysis Two review authors independently selected trials for inclusion and extracted relevant data. The following outcomes were assessed: 50% or greater reduction in seizures, seizure freedom, treatment withdrawal and adverse events. Main results Four double-blind, placebo-controlled, Cross-over Studies, representing 197 participants, were included in the review. All four Studies were assessed as having unclear risk of bias due to the unavailability of methodological details. The Studies demonstrated significant methodological heterogeneity and differences in outcome measures were noted. Consequently, it was not possible to summarise the data in a meta-analysis. Instead, findings were summarised in a narrative data synthesis, Only two of the Studies reported 50% or greater seizure reduction. They respectively reported that 57.7% and 52.4% of participants receiving add-on clobazam experienced a 50% or greater reduction in seizure frequency, although publication bias needs to be considered (2 RCTs, n = 47, very low-quality evidence). Seizure freedom was reported by three of the included Studies. Collectively, 27 out of 175 patients were seizure-free during treatment with clobazam (3 RCTs, n = 175, very low-quality evidence). Two Studies specifically stated that seizure freedom was not observed in any of the participants receiving add-on placebo. Treatment withdrawal was reported by all four Studies. There was a slightly higher incidence of treatment withdrawal associated with receiving clobazam, although the overall incidence was still fairly low (4 RCTs, n = 197, very low-quality evidence). Adverse events were only described in two of the Studies, reportedly 36% and 85% of participants experienced one or more adverse events whilst receiving clobazam. The most commonly reported adverse event was drowsiness. Authors' conclusions Clobazam as an add-on treatment may reduce seizure frequency and may be most effective in focal-onset seizures. It is important to recognise that this finding has been derived from very low-quality evidence and from Studies judged to have an unclear risk of bias. It remains unclear which population demographic will best benefit from clobazam and over what time-frame. A large-scale, randomised controlled trial, conducted over a greater period of time, incorporating subgroups with differing seizure types, is required to effectively inform clinical practice.

  • lamotrigine add on for drug resistant partial epilepsy
    Cochrane Database of Systematic Reviews, 2016
    Co-Authors: Sridharan Ramaratnam, Mariangela Panebianco, Anthony G Marson
    Abstract:

    Background This is an updated version of the Cochrane review published in The Cochrane Library 2010, Issue 1. Epilepsy is a common neurological disorder, affecting almost 0.5% to 1% of the population. For nearly 30% of these people, their epilepsy is refractory to currently available drugs. Pharmacological treatment remains the first choice to control epilepsy. Lamotrigine is one of the newer antiepileptic drugs and is the topic of this review. Lamotrigine in combination with other antiepileptic drugs (add-on) can reduce seizures, but with some adverse effects. The aim of this systematic review was to overview the current evidence for the efficacy and tolerability of lamotrigine when used as an adjunctive treatment for people with refractory partial epilepsy. Objectives To determine the effects of lamotrigine on (1) seizures, (2) adverse effect profile, and (3) cognition and quality of life, compared to placebo controls, when used as an add-on treatment for people with refractory partial epilepsy. Search methods For the previous version of the review, the authors searched the Cochrane Epilepsy Group Specialized Register (January 2010), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2010, Issue 1), MEDLINE (1950 to January 2010), and reference lists of articles. For this update, we searched the Cochrane Epilepsy Group Specialized Register (28 May 2015), CENTRAL (The Cochrane Library 2015, Issue 4), MEDLINE (Ovid, 1946 to May 2015), and reference lists of articles. We also contacted the manufacturers of lamotrigine (GlaxoSmithKline). No language restrictions were imposed. Selection criteria Randomised placebo-controlled trials of people with drug-resistant partial epilepsy of any age, in which an adequate method of concealment of randomisation was used. The Studies were double-, single- or unblinded. For Cross-over Studies, the first treatment period was treated as a parallel trial. Eligible participants were adults or children with drug-resistant partial epilepsy. Data collection and analysis For this update, two review authors independently assessed the trials for inclusion, and extracted data. Outcomes included 50% or greater reduction in seizure frequency, treatment withdrawal (any reason), adverse effects, effects on cognition and quality of life. Primary analyses were by intention-to-treat. Sensitivity best and worse case analyses were undertaken to account for missing outcome data. Pooled Risk Ratios (RR) with 95% confidence intervals (95% Cl) were estimated for the primary outcomes of seizure frequency and treatment withdrawal. For adverse effects, pooled RRs and 99% Cls were calculated. Main results We did not identify any new Studies for this update, therefore, the results are unchanged. For the previous version of the review, the authors found five parallel add-on Studies and eight Cross-over Studies in adults or children with refractory focal epilepsy, and one parallel add-on study with a responder-enriched design in infants. In total, these 14 Studies included 1958 participants (38 infants, 199 children, and 1721 adults). Baseline phases ranged from 4 to 12 weeks; treatment phases from 8 to 36 weeks. Overall, eleven Studies (n = 1243 participants) were rated as having a low risk of bias, and three (n = 715 participants) had un unclear risk of bias due to lack of reported information around study design. Effective blinding of Studies was reported in three Studies (n = 504 participants). The overall risk ratio (RR) for 50% or greater reduction in seizure frequency was 1.80 (95% CI 1.45 to 2.23; 12 RCTs) for twelve Studies (n = 1322 participants, adults and children) indicating that lamotrigine was significantly more effective than placebo in reducing seizure frequency. The overall RR for treatment withdrawal (for any reason) was 1.11 (95% CI 0.90 to 1.36; 14 RCTs) for fourteen Studies (n = 1958 participants). The adverse events significantly associated with lamotrigine were: ataxia, dizziness, diplopia, and nausea. The RR of these adverse effects were as follows: ataxia 3.34 (99% Cl 2.01 to 5.55; 12 RCTs; n = 1524); dizziness 2.00 (99% Cl 1.51 to 2.64;13 RCTs; n = 1767); diplopia 3.79 (99% Cl 2.15 to 6.68; 3 RCTs; n = 943); nausea 1.81 (99% Cl 1.22 to 2.68; 12 RCTs; n = 1486). The limited data available precluded any conclusions about effects on cognition and quality of life. No important heterogeneity between Studies was found for any of the outcomes. Overall, we assessed the evidence as high to moderate quality, due to incomplete data for some outcomes. Authors' conclusions Lamotrigine as an add-on treatment for partial seizures appears to be effective in reducing seizure frequency, and seems to be fairly well tolerated. However, the trials were of relatively short duration and provided no evidence for the long-term. Further trials are needed to assess the long-term effects of lamotrigine, and to compare it with other add-on drugs. Since we did not find any new Studies, our conclusions remain unchanged.

  • clobazam as an add on in the management of refractory epilepsy
    Cochrane Database of Systematic Reviews, 2008
    Co-Authors: Benedict D Michael, Anthony G Marson
    Abstract:

    Background Epilepsy effects approximately 1% of the population, with up to 30% of patients continuing to have seizures despite antiepileptic drug treatment. Objectives To assess the efficacy and tolerability of clobazam when used as an add-on therapy for patients with refractory partial onset or generalised onset seizures. Search methods We searched the following databases: (a) The Cochrane Epilepsy Group Specialised Register (February 2011); (b) The Cochrane Central Register of Controlled Trials (CENTRAL Issue 1, The Cochrane Library 2011); (c) MEDLINE (1948 to January 2011); (d) Database of Abstracts of Reviews of Effectiveness (DARE Issue 1, The Cochrane Library 2011); (e) BIOSIS Previews (February 2011). Selection criteria Randomised trials of add-on clobazam, with adequate methods of allocation concealment, recruiting patients with drug refractory partial or generalised onset seizures, with a minimum treatment period of eight weeks. Data collection and analysis Two review authors independently selected trials for inclusion and extracted relevant data. The following outcomes were assessed: 50% or greater reduction in seizures; seizure freedom; treatment withdrawal and adverse effects. Main results Four Cross-over Studies, representing 196 participants, were included. However, due to significant methodological heterogeneity and differences in outcome measures it was not possible to summarise data in a meta-analysis. Only two of the Studies reported a 50% or greater seizure reduction compared to placebo; 57.7% and 52.4%. Side effects were only described in two of the Studies, reportedly present in 36% and 85% of patients. Authors' conclusions Clobazam as an add-on treatment may reduce seizure frequency and may be most effective in partial onset seizures. However, it is not clear who will best benefit and over what time-frame. A large scale, randomised controlled trial conducted over a greater period of time, incorporating subgroups with differing seizure types, is required to inform clinical practice.

Alison Church - One of the best experts on this subject based on the ideXlab platform.

  • magnitude of umeclidinium vilanterol lung function effect depends on monotherapy responses results from two randomised controlled trials
    Respiratory Medicine, 2016
    Co-Authors: James F. Donohue, Sally Kilbride, Dave Singh, Clara Munzu, Alison Church
    Abstract:

    Abstract Purpose Dual therapy with bronchodilators of different pharmacological classes may produce greater lung function improvements than either drug alone. However, the relationship between a patient's response to monotherapy and response to dual bronchodilator therapy is currently unknown. We aimed to investigate whether dual therapy with umeclidinium/vilanterol provides additional benefit over umeclidinium or vilanterol monotherapy in patients with chronic obstructive pulmonary disease (COPD) identified as responsive (increase from baseline in forced expiratory volume in 1s [FEV 1 ] of ≥12% and ≥200 mL, Day 1) or non-responsive to monotherapy. Methods In two randomised, double-blind, three-way complete-block, Cross-over Studies (DB2116132 n = 207; DB2116133 n = 182; intent-to-treat), all patients (moderate-to-very severe COPD) were randomised to 1 of 6 sequences and received once-daily umeclidinium 62.5mcg, vilanterol 25mcg, and umeclidinium/vilanterol 62.5/25mcg (one treatment/14-day period; 10–14-day washout). Key endpoints were 0–6 h weighted mean FEV 1 (Day 14) and trough FEV 1 (Day 15). Adverse events, vital signs and COPD exacerbations were assessed. Pooled data are presented. Results Umeclidinium/vilanterol significantly (p ≤ 0.001, unless stated otherwise) increased 0–6 h weighted mean FEV 1 versus umeclidinium in umeclidinium-responders (+114 mL), versus vilanterol in vilanterol-responders (+92 mL) and versus umeclidinium (+70 mL) and vilanterol (+62 mL) in non-responders. Improvements in trough FEV 1 occurred with umeclidinium/vilanterol versus umeclidinium in umeclidinium-responders (+77 mL), versus vilanterol in vilanterol-responders (+86 mL), and versus umeclidinium (+42 mL [p = 0.020]) and vilanterol (+58 mL) in non-responders. All treatments were well tolerated. Conclusions Once-daily umeclidinium/vilanterol significantly improved lung function in patients with COPD, with quantitatively greater improvements in patients identified as responders to umeclidinium and vilanterol monotherapy than non-responders.

  • evaluating lung function response to umeclidinium vilanterol umec vi 62 5 25mcg umec 62 5mcg and vi 25mcg in copd patients
    European Respiratory Journal, 2014
    Co-Authors: James F. Donohue, Sally Kilbride, Clara Munzu, D Singh, Alison Church
    Abstract:

    Background: UMEC (a LAMA) is in development as monotherapy and in combination with VI (a LABA) for COPD. Data from two similar Studies are presented. Objective: To determine if UMEC/VI provides additional benefit in COPD patients (pts) responsive (≥12% and ≥200mL increase in FEV1 from baseline) to UMEC or VI alone. Methods: In both 12 week randomised, double-blind, 3-way complete block, Cross-over Studies, COPD pts with FEV1 ≤70% pred. received UMEC 62.5mcg, VI 25mcg and UMEC/VI 62.5/25mcg once daily via ELLIPTA™ DPI during three 14-day treatment periods (with 10–14 day washout). Primary endpoint: weighted mean FEV1 over 0–6h post-dose on Day 14 of each treatment period. Safety assessments included AEs, vital signs and COPD exacerbations. Results: ITT: N=207; N=182. Primary endpoint: see table. ![Figure][1] Incidence of on-treatment AEs was similar across treatments in Studies '132 (12–18%) and '133 (16–18%). There were no unexpected effects on vital signs. Exacerbations (on/post-treatment): 3 in study '132 (1 per treatment group); 6 in study '133 (3 UMEC, 2 VI, 1 UMEC/VI). Deaths: 1 in '133 (UMEC group; not drug related). Conclusions: UMEC/VI 62.5/25mcg statistically significantly improved lung function in COPD pts identified as responders or non-responders to UMEC 62.5mcg and/or VI 25mcg monotherapy. No new safety concerns were identified. Funding: GSK (DB2116132 [[NCT02014480][2]];DB2116133 [[NCT01716520][3]]). [1]: pending:yes [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02014480&atom=%2Ferj%2F44%2FSuppl_58%2FP291.atom [3]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01716520&atom=%2Ferj%2F44%2FSuppl_58%2FP291.atom

James F. Donohue - One of the best experts on this subject based on the ideXlab platform.

  • magnitude of umeclidinium vilanterol lung function effect depends on monotherapy responses results from two randomised controlled trials
    Respiratory Medicine, 2016
    Co-Authors: James F. Donohue, Sally Kilbride, Dave Singh, Clara Munzu, Alison Church
    Abstract:

    Abstract Purpose Dual therapy with bronchodilators of different pharmacological classes may produce greater lung function improvements than either drug alone. However, the relationship between a patient's response to monotherapy and response to dual bronchodilator therapy is currently unknown. We aimed to investigate whether dual therapy with umeclidinium/vilanterol provides additional benefit over umeclidinium or vilanterol monotherapy in patients with chronic obstructive pulmonary disease (COPD) identified as responsive (increase from baseline in forced expiratory volume in 1s [FEV 1 ] of ≥12% and ≥200 mL, Day 1) or non-responsive to monotherapy. Methods In two randomised, double-blind, three-way complete-block, Cross-over Studies (DB2116132 n = 207; DB2116133 n = 182; intent-to-treat), all patients (moderate-to-very severe COPD) were randomised to 1 of 6 sequences and received once-daily umeclidinium 62.5mcg, vilanterol 25mcg, and umeclidinium/vilanterol 62.5/25mcg (one treatment/14-day period; 10–14-day washout). Key endpoints were 0–6 h weighted mean FEV 1 (Day 14) and trough FEV 1 (Day 15). Adverse events, vital signs and COPD exacerbations were assessed. Pooled data are presented. Results Umeclidinium/vilanterol significantly (p ≤ 0.001, unless stated otherwise) increased 0–6 h weighted mean FEV 1 versus umeclidinium in umeclidinium-responders (+114 mL), versus vilanterol in vilanterol-responders (+92 mL) and versus umeclidinium (+70 mL) and vilanterol (+62 mL) in non-responders. Improvements in trough FEV 1 occurred with umeclidinium/vilanterol versus umeclidinium in umeclidinium-responders (+77 mL), versus vilanterol in vilanterol-responders (+86 mL), and versus umeclidinium (+42 mL [p = 0.020]) and vilanterol (+58 mL) in non-responders. All treatments were well tolerated. Conclusions Once-daily umeclidinium/vilanterol significantly improved lung function in patients with COPD, with quantitatively greater improvements in patients identified as responders to umeclidinium and vilanterol monotherapy than non-responders.

  • evaluating lung function response to umeclidinium vilanterol umec vi 62 5 25mcg umec 62 5mcg and vi 25mcg in copd patients
    European Respiratory Journal, 2014
    Co-Authors: James F. Donohue, Sally Kilbride, Clara Munzu, D Singh, Alison Church
    Abstract:

    Background: UMEC (a LAMA) is in development as monotherapy and in combination with VI (a LABA) for COPD. Data from two similar Studies are presented. Objective: To determine if UMEC/VI provides additional benefit in COPD patients (pts) responsive (≥12% and ≥200mL increase in FEV1 from baseline) to UMEC or VI alone. Methods: In both 12 week randomised, double-blind, 3-way complete block, Cross-over Studies, COPD pts with FEV1 ≤70% pred. received UMEC 62.5mcg, VI 25mcg and UMEC/VI 62.5/25mcg once daily via ELLIPTA™ DPI during three 14-day treatment periods (with 10–14 day washout). Primary endpoint: weighted mean FEV1 over 0–6h post-dose on Day 14 of each treatment period. Safety assessments included AEs, vital signs and COPD exacerbations. Results: ITT: N=207; N=182. Primary endpoint: see table. ![Figure][1] Incidence of on-treatment AEs was similar across treatments in Studies '132 (12–18%) and '133 (16–18%). There were no unexpected effects on vital signs. Exacerbations (on/post-treatment): 3 in study '132 (1 per treatment group); 6 in study '133 (3 UMEC, 2 VI, 1 UMEC/VI). Deaths: 1 in '133 (UMEC group; not drug related). Conclusions: UMEC/VI 62.5/25mcg statistically significantly improved lung function in COPD pts identified as responders or non-responders to UMEC 62.5mcg and/or VI 25mcg monotherapy. No new safety concerns were identified. Funding: GSK (DB2116132 [[NCT02014480][2]];DB2116133 [[NCT01716520][3]]). [1]: pending:yes [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02014480&atom=%2Ferj%2F44%2FSuppl_58%2FP291.atom [3]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01716520&atom=%2Ferj%2F44%2FSuppl_58%2FP291.atom

Nicole Boluyt - One of the best experts on this subject based on the ideXlab platform.

  • ciclesonide versus other inhaled corticosteroids for chronic asthma in children
    Cochrane Database of Systematic Reviews, 2013
    Co-Authors: Sharon Kramer, Bart L Rottier, Rob J P M Scholten, Nicole Boluyt
    Abstract:

    Background Inhaled corticosteroids (ICS) are the cornerstone of asthma maintenance treatment in children. Particularly among parents, there is concern about the safety of ICS as Studies in children have shown reduced growth. Small-particle-size ICS targeting the smaller airways have improved lung deposition and effective asthma control might be achieved at lower daily doses. Ciclesonide is a relatively new ICS. This small-particle ICS is a pro-drug that is converted in the airways to an active metabolite and therefore with potentially less local (throat infection) and systemic (reduced growth) side effects. It can be inhaled once daily, thereby possibly improving adherence. Objectives To assess the efficacy and adverse effects of ciclesonide compared to other ICS in the management of chronic asthma in children. Search methods We searched the Cochrane Airways Group Register of trials with pre-defined terms. Additional searches of MEDLINE (via PubMed), EMBASE and Clinicalstudyresults.org were undertaken. Searches are up to date to 7 November 2012. Selection criteria Randomised controlled parallel or Cross-over Studies were eligible for the review. We included Studies comparing ciclesonide with other corticosteroids both at nominally equivalent doses or lower doses of ciclesonide. Data collection and analysis Two review authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials. Main results Six Studies were included in this review (3256 children, 4 to 17 years of age). Two Studies were published as conference abstracts only. Ciclesonide was compared to budesonide and fluticasone. Ciclesonide compared to budesonide (dose ratio 1:2): asthma symptoms and adverse effect were similar in both groups. Pooled results showed no significant difference in children who experience an exacerbation (risk ratio (RR) 2.20, 95% confidence interval (CI) 0.75 to 6.43). Both Studies reported that 24-hour urine cortisol levels showed a statistically significant decrease in the budesonide group compared to the ciclesonide group. Ciclesonide compared to fluticasone (dose ratio 1:1): no significant differences were found for the outcome asthma symptoms. Pooled results showed no significant differences in number of patients with exacerbations (RR 1.37, 95% CI 0.58 to 3.21) and data from a study that could not be pooled in the meta-analysis reported similar numbers of patients with exacerbations in both groups. None of the Studies found a difference in adverse effects. No significant difference was found for 24-hour urine cortisol levels between the groups (mean difference 0.54 nmol/mmol, 95% CI -5.92 to 7.00). Ciclesonide versus fluticasone (dose ratio 1:2) was assessed in one study and showed similar results between the two corticosteroids for asthma symptoms. The number of children with exacerbations was significantly higher in the ciclesonide group (RR 3.57, 95% CI 1.35 to 9.47). No significant differences were found in adverse effects (RR 0.98, 95% CI 0.81 to 1.14) and 24-hour urine cortisol levels (mean difference 1.15 nmol/mmol, 95% CI 0.07 to 2.23). The quality of evidence was judged 'low' for the outcomes asthma symptoms and adverse events and 'very low' for the outcome exacerbations for ciclesonide versus budesonide (dose ratio 1:1). The quality of evidence was graded 'moderate' for the outcome asthma symptoms, 'very low' for the outcome exacerbations and 'low' for the outcome adverse events for ciclesonide versus fluticasone (dose ratio 1:1). For ciclesonide versus fluticasone (dose ratio 1:2) the quality was rated 'low' for the outcome asthma symptoms and 'very low' for exacerbations and adverse events (dose ratio 1:2). Authors' conclusions An improvement in asthma symptoms, exacerbations and side effects of ciclesonide versus budesonide and fluticasone could be neither demonstrated nor refuted and the trade-off between benefits and harms of using ciclesonide instead of budesonide or fluticasone is unclear. The resource use or costs of different ICS should therefore also be considered in final decision making.   Longer-term superiority trials are needed to identify the usefulness and safety of ciclesonide compared to other ICS. Additionally these Studies should be powered for patient relevant outcomes (exacerbations, asthma symptoms, quality of life and side effects). There is a need for Studies comparing ciclesonide once daily with other ICS twice daily to assess the advantages of ciclesonide being a pro-drug that can be administered once daily with possibly increased adherence leading to increased control of asthma and fewer side effects.

Jonathan C. Craig - One of the best experts on this subject based on the ideXlab platform.

  • cranberries for preventing urinary tract infections
    Sao Paulo Medical Journal, 2013
    Co-Authors: Ruth Jepson, Gabrielle Williams, Jonathan C. Craig
    Abstract:

    BACKGROUND: Cranberries have been used widely for several decades for the prevention and treatment of urinary tract infections (UTIs). This is the third update of our review first published in 1998 and updated in 2004 and 2008. OBJECTIVES: To assess the effectiveness of cranberry products in preventing UTIs in susceptible populations. METHODS: Search methods: We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL in The Cochrane Library) and the Internet. We contacted companies involved with the promotion and distribution of cranberry preparations and checked reference lists of review articles and relevant Studies. Date of search: July 2012. Selection criteria: All randomised controlled trials (RCTs) or quasi-RCTs of cranberry products for the prevention of UTIs. Data collection and analysis: Two authors independently assessed and extracted data. Information was collected on methods, participants, interventions and outcomes (incidence of symptomatic UTIs, positive culture results, side effects, adherence to therapy). Risk ratios (RR) were calculated where appropriate, otherwise a narrative synthesis was undertaken. Quality was assessed using the Cochrane risk of bias assessment tool. MAIN RESULTS: This updated review includes a total of 24 Studies (six Cross-over Studies, 11 parallel group Studies with two arms; five with three arms, and two Studies with a factorial design) with a total of 4473 participants. Ten Studies were included in the 2008 update, and 14 Studies have been added to this update. Thirteen Studies (2380 participants) evaluated only cranberry juice/concentrate; nine Studies (1032 participants) evaluated only cranberry tablets/capsules; one study compared cranberry juice and tablets; and one study compared cranberry capsules and tablets. The comparison/control arms were placebo, no treatment, water, methenamine hippurate, antibiotics, or lactobacillus. Eleven Studies were not included in the meta-analyses because either the design was a Cross-over study and data were not reported separately for the first phase, or there was a lack of relevant data. Data included in the meta-analyses showed that, compared with placebo, water or not treatment, cranberry products did not significantly reduce the occurrence of symptomatic UTI overall (RR 0.86, 95% CI 0.71 to 1.04) or for any the subgroups: women with recurrent UTIs (RR 0.74, 95% CI 0.42 to 1.31); older people (RR 0.75, 95% CI 0.39 to 1.44); pregnant women (RR 1.04, 95% CI 0.97 to 1.17); children with recurrent UTI (RR 0.48, 95% CI 0.19 to 1.22); cancer patients (RR 1.15 95% CI 0.75 to 1.77); or people with neuropathic bladder or spinal injury (RR 0.95, 95% CI: 0.75 to 1.20). Overall heterogeneity was moderate (I² = 55%). The effectiveness of cranberry was not significantly different to antibiotics for women (RR 1.31, 95% CI 0.85, 2.02) and children (RR 0.69 95% CI 0.32 to 1.51). There was no significant difference between gastrointestinal adverse effects from cranberry product compared to those of placebo/no treatment (RR 0.83, 95% CI 0.31 to 2.27). Many Studies reported low compliance and high withdrawal/dropout problems which they attributed to palatability/acceptability of the products, primarily the cranberry juice. Most Studies of other cranberry products (tablets and capsules) did not report how much of the 'active' ingredient the product contained, and therefore the products may not have had enough potency to be effective. AUTHORS' CONCLUSIONS: Prior to the current update it appeared there was some evidence that cranberry juice may decrease the number of symptomatic UTIs over a 12 month period, particularly for women with recurrent UTIs. The addition of 14 further Studies suggests that cranberry juice is less effective than previously indicated. Although some of small Studies demonstrated a small benefit for women with recurrent UTIs, there were no statistically significant differences when the results of a much larger study were included. Cranberry products were not significantly different to antibiotics for preventing UTIs in three small Studies. Given the large number of dropouts/withdrawals from Studies (mainly attributed to the acceptability of consuming cranberry products particularly juice, over long periods), and the evidence that the benefit for preventing UTI is small, cranberry juice cannot currently be recommended for the prevention of UTIs. Other preparations (such as powders) need to be quantified using standardised methods to ensure the potency, and contain enough of the 'active' ingredient, before being evaluated in clinical Studies or recommended for use.

  • Cranberries for preventing urinary tract infections.
    Cochrane Database of Systematic Reviews, 2012
    Co-Authors: Ruth Jepson, Gabrielle Williams, Jonathan C. Craig
    Abstract:

    Background Cranberries have been used widely for several decades for the prevention and treatment of urinary tract infections (UTIs). This is the third update of our review first published in 1998 and updated in 2004 and 2008. Objectives To assess the effectiveness of cranberry products in preventing UTIs in susceptible populations. Search methods We searched the Cochrane Renal Group's Specialised Register (4 June 2013) through contact with the Trials' Search Co-ordinator using search terms relevant to this review.We contacted companies involved with the promotion and distribution of cranberry preparations and checked reference lists of review articles and relevant Studies. Date of search: July 2012 Selection criteria All randomised controlled trials (RCTs) or quasi-RCTs of cranberry products for the prevention of UTIs. Data collection and analysis Two authors independently assessed and extracted data. Information was collected on methods, participants, interventions and outcomes (incidence of symptomatic UTIs, positive culture results, side effects, adherence to therapy). Risk ratios (RR) were calculated where appropriate, otherwise a narrative synthesis was undertaken. Quality was assessed using the Cochrane risk of bias assessment tool. Main results This updated review includes a total of 24 Studies (six Cross-over Studies, 11 parallel group Studies with two arms; five with three arms, and two Studies with a factorial design) with a total of 4473 participants. Ten Studies were included in the 2008 update, and 14 Studies have been added to this update. Thirteen Studies (2380 participants) evaluated cranberry juice/concentrate; nine Studies (1032 participants) evaluated cranberry tablets or capsules; one study compared cranberry juice and tablets; and one study compared cranberry capsules and tablets. The comparison/control arms were placebo, no treatment, water, methenamine hippurate, antibiotics, or lactobacillus. Eleven Studies were not included in the meta-analyses because either the design was a Cross-over study and data were not reported separately for the first phase, or there was a lack of relevant data. Data included in the meta-analyses showed that, compared with placebo, water or not treatment, cranberry products did not significantly reduce the occurrence of symptomatic UTI overall (RR 0.86, 95% CI 0.71 to 1.04) or for any the subgroups: women with recurrent UTIs (RR 0.74, 95% CI 0.42 to 1.31); older people (RR 0.75, 95% CI 0.39 to 1.44); pregnant women (RR 1.04, 95% CI 0.97 to 1.17); children with recurrent UTI (RR 0.48, 95% CI 0.19 to 1.22); cancer patients (RR 1.15 95% CI 0.75 to 1.77); or people with neuropathic bladder or spinal injury (RR 0.95, 95% CI: 0.75 to 1.20). Overall heterogeneity was moderate (I² = 55%). The effectiveness of cranberry was not significantly different to antibiotics for women (RR 1.31, 95% CI 0.85, 2.02) and children (RR 0.69 95% CI 0.32 to 1.51). There was no significant difference between gastrointestinal adverse effects from cranberry product compared to those of placebo/no treatment (RR 0.83, 95% CI 0.31 to 2.27). Many Studies reported low compliance and high withdrawal/dropout problems which they attributed to palatability/acceptability of the products, primarily the cranberry juice. Most Studies of other cranberry products (tablets and capsules) did not report how much of the 'active' ingredient the product contained, and therefore the products may not have had enough potency to be effective. Authors' conclusions Prior to the current update it appeared there was some evidence that cranberry juice may decrease the number of symptomatic UTIs over a 12 month period, particularly for women with recurrent UTIs. The addition of 14 further Studies suggests that cranberry juice is less effective than previously indicated. Although some of small Studies demonstrated a small benefit for women with recurrent UTIs, there were no statistically significant differences when the results of a much larger study were included. Cranberry products were not significantly different to antibiotics for preventing UTIs in three small Studies. Given the large number of dropouts/withdrawals from Studies (mainly attributed to the acceptability of consuming cranberry products particularly juice, over long periods), and the evidence that the benefit for preventing UTI is small, cranberry juice cannot currently be recommended for the prevention of UTIs. Other preparations (such as powders) need to be quantified using standardised methods to ensure the potency, and contain enough of the 'active' ingredient, before being evaluated in clinical Studies or recommended for use.