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Taco Gosens - One of the best experts on this subject based on the ideXlab platform.

  • ongoing positive effect of platelet rich plasma versus corticosteroid injection in lateral epicondylitis a double blind randomized controlled trial with 2 year follow up
    American Journal of Sports Medicine, 2011
    Co-Authors: Taco Gosens, Joost C Peerbooms, Wilbert Van Laar, Brenda Den L Oudsten
    Abstract:

    Background: Platelet-rich plasma (PRP) has been shown to be a general stimulation for repair and 1-year results showed promising success percentages. Purpose: This trial was undertaken to determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis with a 2-year follow-up. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The trial was conducted in 2 Dutch teaching hospitals. One hundred patients with chronic lateral epicondylitis were randomly assigned to a leukocyte-enriched PRP group (n = 51) or the corticosteroid group (n = 49). Randomization and allocation to the trial group were carried out by a Central Computer System. Patients received either a corticosteroid injection or an autologous platelet concentrate injection through a peppering needling technique. The primary analysis included visual analog scale (VAS) pain scores and Disabilities of the Arm, Shoulder and Hand (DASH) outcome scores. Results: The PRP group was more often successfully treated than the corticosteroid group (P\.0001). Success was defined as a reduction of 25% on VAS or DASH scores without a reintervention after 2 years. When baseline VAS and DASH scores were compared with the scores at 2-year follow-up, both groups significantly improved across time (intention-to-treat principle). However, the DASH scores of the corticosteroid group returned to baseline levels, while those of the PRP group significantly improved (as-treated principle). There were no complications related to the use of PRP. Conclusion: Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and increases function significantly, exceeding the effect of corticosteroid injection even after a follow-up of 2 years. Future decisions for application of PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.

  • positive effect of an autologous platelet concentrate in lateral epicondylitis in a double blind randomized controlled trial platelet rich plasma versus corticosteroid injection with a 1 year follow up
    American Journal of Sports Medicine, 2010
    Co-Authors: Joost C Peerbooms, J Sluimer, Taco Gosens
    Abstract:

    Background: Platelet-rich plasma (PRP) has shown to be a general stimulation for repair. Purpose: To determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis. Study Design: Randomized controlled trial; Level of evidence, 1. Patients: The trial was conducted in 2 teaching hospitals in the Netherlands. One hundred patients with chronic lateral epicondylitis were randomly assigned in the PRP group (n 5 51) or the corticosteroid group (n 5 49). A Central Computer System carried out randomization and allocation to the trial group. Patients were randomized to receive either a corticosteroid injection or an autologous platelet concentrate injection through a peppering technique. The primary analysis included visual analog scores and DASH Outcome Measure scores (DASH: Disabilities of the Arm, Shoulder, and Hand). Results: Successful treatment was defined as more than a 25% reduction in visual analog score or DASH score without a reintervention after 1 year. The results showed that, according to the visual analog scores, 24 of the 49 patients (49%) in the corticosteroid group and 37 of the 51 patients (73%) in the PRP group were successful, which was significantly different (P \ .001). Furthermore, according to the DASH scores, 25 of the 49 patients (51%) in the corticosteroid group and 37 of the 51 patients (73%) in the PRP group were successful, which was also significantly different (P 5 .005). The corticosteroid group was better initially and then declined, whereas the PRP group progressively improved. Conclusion: Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and significantly increases function, exceeding the effect of corticosteroid injection. Future decisions for application of the PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.

Salsbury Jackie - One of the best experts on this subject based on the ideXlab platform.

  • Effect of amiloride, or amiloride plus hydrochlorothiazide, versus hydrochlorothiazide on glucose tolerance and blood pressure (PATHWAY-3): a parallel-group, double-blind randomised phase 4 trial
    Elsevier, 2016
    Co-Authors: Brown, Morris J., Williams Bryan, Morant Steve, Webb, David J., Caulfield, Mark J., Cruickshank J. Kennedy, Ford Ian, Mcinnes Gordon, Sever Peter, Salsbury Jackie
    Abstract:

    Background Potassium depletion by thiazide diuretics is associated with a rise in blood glucose. We assessed whether addition or substitution of a potassium-sparing diuretic, amiloride, to treatment with a thiazide can prevent glucose intolerance and improve blood pressure control. Methods We did a parallel-group, randomised, double-blind trial in 11 secondary and two primary care sites in the UK. Eligible patients were aged 18–80 years; had clinic systolic blood pressure of 140 mm Hg or higher and home systolic blood pressure of 130 mmHg or higher on permitted background drugs of angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, β blockers, calcium-channel blockers, or direct renin inhibitors (previously untreated patients were also eligible in specific circumstances); and had at least one component of the metabolic syndrome in addition to hypertension. Patients with known diabetes were excluded. Patients were randomly assigned (1:1:1) to 24 weeks of daily oral treatment with starting doses of 10 mg amiloride, 25 mg hydrochlorothiazide, or 5 mg amiloride plus 12·5 mg hydrochlorothiazide; all doses were doubled after 12 weeks. Random assignment was done via a Central Computer System. Both participants and investigators were masked to assignment. Our hierarchical primary endpoints, assessed on a modified intention-to-treat basis at 12 and 24 weeks, were the differences from baseline in blood glucose measured 2 h after a 75 g oral glucose tolerance test (OGTT), compared first between the hydrochlorothiazide and amiloride groups, and then between the hydrochlorothiazide and combination groups. A key secondary endpoint was change in home systolic blood pressure at 12 and 24 weeks. This trial is registered with ClinicalTrials.gov, number NCT00797862, and the MHRA, Eudract number 2009-010068-41, and is now complete. Findings Between Nov 18, 2009, and Dec 15, 2014, 145 patients were randomly assigned to amiloride, 146 to hydrochlorothiazide, and 150 to the combination group. 132 participants in the amiloride group, 134 in the hydrochlorothiazide group, and 133 in the combination group were included in the modified intention-to-treat analysis. 2 h glucose concentrations after OGTT, averaged at 12 and 24 weeks, were significantly lower in the amiloride group than in the hydrochlorothiazide group (mean difference −0·55 mmol/L [95% CI −0·96 to −0·14]; p=0·0093) and in the combination group than in the hydrochlorothiazide group (−0·42 mmol/L [–0·84 to −0·004]; p=0·048). The mean reduction in home systolic blood pressure during 24 weeks did not differ significantly between the amiloride and hydrochlorothiazide groups, but the fall in blood pressure in the combination group was significantly greater than that in the hydrochlorothiazide group (p=0·0068). Hyperkalaemia was reported in seven (4·8%) patients in the amiloride group and three (2·3%) patients in the combination group; the highest recorded potassium concentration was 5·8 mmol/L in a patient in the amiloride group. 13 serious adverse events occurred but the frequency did not differ significantly between groups. Interpretation The combination of amiloride with hydrochlorothiazide, at doses equipotent on blood pressure, prevents glucose intolerance and improves control of blood pressure compared with montherapy with either drug. These findings, together with previous data about morbidity and mortality for the combination, support first-line use of amiloride plus hydrochlorothiazide in hypertensive patients who need treatment with a diureti

  • Amiloride-hydrochlorothiazide versus individual diuretic effects on glucose tolerance and blood pressure (PATHWAY-3): a double-blind randomised trial
    The Lancet Diabetes & Endocrinology, 2015
    Co-Authors: Brown, Morris J., Williams Bryan, Morant Steve, Webb, David J., Cruickshank J. Kennedy, Ford Ian, Mcinnes Gordon, Sever Peter, Caulfield Mark, Salsbury Jackie
    Abstract:

    This is the final version of the article. It first appeared from Elsevier via http://dx.doi.org/10.1016/S2213-8587(15)00377-0Background Potassium depletion by thiazide diuretics is associated with a rise in blood glucose. We assessed whether addition or substitution of a potassium-sparing diuretic, amiloride, can prevent glucose intolerance and improve blood pressure control. Methods We undertook a parallel-group, randomised, double-blind trial in 11 secondary and 2 primary care sites in the UK, with enrolment from 18th November 2009 to 15th December 2014. Patients eligible for enrolment were aged 18-80, had systolic BP on permitted background treatment ≥ 140 mmHg and home systolic BP ≥ 130mmHg, and they had at least one component of the metabolic syndrome additional to hypertension. Patients were randomly assigned (1:1:1) to 24 weeks treatment with amiloride 10 mg, hydrochlorothiazide (HCTZ) 25 mg, or the combination of both diuretics at half these doses (5/12.5 mg). Random assignment was through a Central Computer System. There was forced dose-doubling after 12 weeks. Our hierarchical primary endpoints, assessed on an intention-to-treat basis at 12 and 24 weeks, were the differences from baseline in blood glucose measured two hours after a 75 g oral glucose tolerance test (OGTT), compared first between HCTZ and amiloride and then between HCTZ and combination. Secondary endpoints included differences in home systolic BP, plasma electrolytes and renin. This trial is registered with ClinicalTrials.gov, number NCT00797862, and the MHRA, Eudract number 2009‐010068‐41. Findings 145 patients were randomly assigned to amiloride, 146 to HCTZ, and 150 to HCTZ plus amiloride. 132, 134 and 133, respectively from these groups were available for analysis. Two-hour glucose on OGTT rose in patients receiving HCTZ but fell in patients receiving amiloride. The average difference, at 12 and 24 weeks, between HCTZ and amiloride was 0·55 mmol/L (95% CI 0·14,0·96) (p=0·0093); between HCTZ and low-dose combination, the difference was 0·42 mmol/L (0·004,0·84) (p=0·048). The reduction in home systolic BP, averaged over 24 weeks, was similar on amiloride (-14·7 mmHg (-16·7,-12·6)) and HCTZ (-14·0 mmHg (-15·9,-12·0)), but the reduction on the half-dose combination (-17·5 mmHg (-19·6,-15·5) was 3·4 (0·9, 5·8) mmHg greater than on HCTZ (p=0·0068). Hyperkalaemia was reported in 0, 3 (2%) and 7 (4·8%) of the HCTZ, combination and amiloride groups, respectively; the highest recorded K+ was 5·8 mmol/L. Serious adverse events occurred in 7 (4.8%), 2 (1.4%) and 4 (2.7%) (p=0.21). Interpretation Combination of amiloride with hydrochlorothiazide, at doses equipotent on BP, prevents glucose intolerance and improves BP control. These findings, and previous morbidity-mortality data for the combination, support its first-line use in patients requiring diuretic therapy for hypertension.The study was funded by a special project grant from the British Heart Foundation (number SP/08/002), and support from National Institute of Health Research Comprehensive Local Research Networks

Jackie Salsbury - One of the best experts on this subject based on the ideXlab platform.

  • Effect of amiloride, or amiloride plus hydrochlorothiazide, versus hydrochlorothiazide on glucose tolerance and blood pressure (PATHWAY-3): a parallel-group, double-blind randomised phase 4 trial
    The Lancet Diabetes & Endocrinology, 2016
    Co-Authors: Morris J. Brown, Bryan Williams, Steve Morant, David J. Webb, Mark J. Caulfield, J. Kennedy Cruickshank, Ian Ford, Gordon T. Mcinnes, Peter S. Sever, Jackie Salsbury
    Abstract:

    Summary Background Potassium depletion by thiazide diuretics is associated with a rise in blood glucose. We assessed whether addition or substitution of a potassium-sparing diuretic, amiloride, to treatment with a thiazide can prevent glucose intolerance and improve blood pressure control. Methods We did a parallel-group, randomised, double-blind trial in 11 secondary and two primary care sites in the UK. Eligible patients were aged 18–80 years; had clinic systolic blood pressure of 140 mm Hg or higher and home systolic blood pressure of 130 mmHg or higher on permitted background drugs of angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, β blockers, calcium-channel blockers, or direct renin inhibitors (previously untreated patients were also eligible in specific circumstances); and had at least one component of the metabolic syndrome in addition to hypertension. Patients with known diabetes were excluded. Patients were randomly assigned (1:1:1) to 24 weeks of daily oral treatment with starting doses of 10 mg amiloride, 25 mg hydrochlorothiazide, or 5 mg amiloride plus 12·5 mg hydrochlorothiazide; all doses were doubled after 12 weeks. Random assignment was done via a Central Computer System. Both participants and investigators were masked to assignment. Our hierarchical primary endpoints, assessed on a modified intention-to-treat basis at 12 and 24 weeks, were the differences from baseline in blood glucose measured 2 h after a 75 g oral glucose tolerance test (OGTT), compared first between the hydrochlorothiazide and amiloride groups, and then between the hydrochlorothiazide and combination groups. A key secondary endpoint was change in home systolic blood pressure at 12 and 24 weeks. This trial is registered with ClinicalTrials.gov, number NCT00797862, and the MHRA, Eudract number 2009-010068-41, and is now complete. Findings Between Nov 18, 2009, and Dec 15, 2014, 145 patients were randomly assigned to amiloride, 146 to hydrochlorothiazide, and 150 to the combination group. 132 participants in the amiloride group, 134 in the hydrochlorothiazide group, and 133 in the combination group were included in the modified intention-to-treat analysis. 2 h glucose concentrations after OGTT, averaged at 12 and 24 weeks, were significantly lower in the amiloride group than in the hydrochlorothiazide group (mean difference −0·55 mmol/L [95% CI −0·96 to −0·14]; p=0·0093) and in the combination group than in the hydrochlorothiazide group (−0·42 mmol/L [–0·84 to −0·004]; p=0·048). The mean reduction in home systolic blood pressure during 24 weeks did not differ significantly between the amiloride and hydrochlorothiazide groups, but the fall in blood pressure in the combination group was significantly greater than that in the hydrochlorothiazide group (p=0·0068). Hyperkalaemia was reported in seven (4·8%) patients in the amiloride group and three (2·3%) patients in the combination group; the highest recorded potassium concentration was 5·8 mmol/L in a patient in the amiloride group. 13 serious adverse events occurred but the frequency did not differ significantly between groups. Interpretation The combination of amiloride with hydrochlorothiazide, at doses equipotent on blood pressure, prevents glucose intolerance and improves control of blood pressure compared with montherapy with either drug. These findings, together with previous data about morbidity and mortality for the combination, support first-line use of amiloride plus hydrochlorothiazide in hypertensive patients who need treatment with a diuretic. Funding British Heart Foundation and National Institute for Health Research.

  • spironolactone versus placebo bisoprolol and doxazosin to determine the optimal treatment for drug resistant hypertension pathway 2 a randomised double blind crossover trial
    The Lancet, 2015
    Co-Authors: Bryan Williams, Steve Morant, David J. Webb, Mark J. Caulfield, Ian Ford, Gordon T. Mcinnes, Peter S. Sever, Thomas M Macdonald, Kennedy J Cruickshank, Jackie Salsbury
    Abstract:

    Summary Background Optimal drug treatment for patients with resistant hypertension is undefined. We aimed to test the hypotheses that resistant hypertension is most often caused by excessive sodium retention, and that spironolactone would therefore be superior to non-diuretic add-on drugs at lowering blood pressure. Methods In this double-blind, placebo-controlled, crossover trial, we enrolled patients aged 18–79 years with seated clinic systolic blood pressure 140 mm Hg or greater (or ≥135 mm Hg for patients with diabetes) and home systolic blood pressure (18 readings over 4 days) 130 mm Hg or greater, despite treatment for at least 3 months with maximally tolerated doses of three drugs, from 12 secondary and two primary care sites in the UK. Patients rotated, in a preassigned, randomised order, through 12 weeks of once daily treatment with each of spironolactone (25–50 mg), bisoprolol (5–10 mg), doxazosin modified release (4–8 mg), and placebo, in addition to their baseline blood pressure drugs. Random assignment was done via a Central Computer System. Investigators and patients were masked to the identity of drugs, and to their sequence allocation. The dose was doubled after 6 weeks of each cycle. The hierarchical primary endpoints were the difference in averaged home systolic blood pressure between spironolactone and placebo, followed (if significant) by the difference in home systolic blood pressure between spironolactone and the average of the other two active drugs, followed by the difference in home systolic blood pressure between spironolactone and each of the other two drugs. Analysis was by intention to treat. The trial is registered with EudraCT number 2008-007149-30, and ClinicalTrials.gov number, NCT02369081. Findings Between May 15, 2009, and July 8, 2014, we screened 436 patients, of whom 335 were randomly assigned. After 21 were excluded, 285 patients received spironolactone, 282 doxazosin, 285 bisoprolol, and 274 placebo; 230 patients completed all treatment cycles. The average reduction in home systolic blood pressure by spironolactone was superior to placebo (–8·70 mm Hg [95% CI −9·72 to −7·69]; p Interpretation Spironolactone was the most effective add-on drug for the treatment of resistant hypertension. The superiority of spironolactone supports a primary role of sodium retention in this condition. Funding The British Heart Foundation and National Institute for Health Research.

Joost C Peerbooms - One of the best experts on this subject based on the ideXlab platform.

  • ongoing positive effect of platelet rich plasma versus corticosteroid injection in lateral epicondylitis a double blind randomized controlled trial with 2 year follow up
    American Journal of Sports Medicine, 2011
    Co-Authors: Taco Gosens, Joost C Peerbooms, Wilbert Van Laar, Brenda Den L Oudsten
    Abstract:

    Background: Platelet-rich plasma (PRP) has been shown to be a general stimulation for repair and 1-year results showed promising success percentages. Purpose: This trial was undertaken to determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis with a 2-year follow-up. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The trial was conducted in 2 Dutch teaching hospitals. One hundred patients with chronic lateral epicondylitis were randomly assigned to a leukocyte-enriched PRP group (n = 51) or the corticosteroid group (n = 49). Randomization and allocation to the trial group were carried out by a Central Computer System. Patients received either a corticosteroid injection or an autologous platelet concentrate injection through a peppering needling technique. The primary analysis included visual analog scale (VAS) pain scores and Disabilities of the Arm, Shoulder and Hand (DASH) outcome scores. Results: The PRP group was more often successfully treated than the corticosteroid group (P\.0001). Success was defined as a reduction of 25% on VAS or DASH scores without a reintervention after 2 years. When baseline VAS and DASH scores were compared with the scores at 2-year follow-up, both groups significantly improved across time (intention-to-treat principle). However, the DASH scores of the corticosteroid group returned to baseline levels, while those of the PRP group significantly improved (as-treated principle). There were no complications related to the use of PRP. Conclusion: Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and increases function significantly, exceeding the effect of corticosteroid injection even after a follow-up of 2 years. Future decisions for application of PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.

  • positive effect of an autologous platelet concentrate in lateral epicondylitis in a double blind randomized controlled trial platelet rich plasma versus corticosteroid injection with a 1 year follow up
    American Journal of Sports Medicine, 2010
    Co-Authors: Joost C Peerbooms, J Sluimer, Taco Gosens
    Abstract:

    Background: Platelet-rich plasma (PRP) has shown to be a general stimulation for repair. Purpose: To determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis. Study Design: Randomized controlled trial; Level of evidence, 1. Patients: The trial was conducted in 2 teaching hospitals in the Netherlands. One hundred patients with chronic lateral epicondylitis were randomly assigned in the PRP group (n 5 51) or the corticosteroid group (n 5 49). A Central Computer System carried out randomization and allocation to the trial group. Patients were randomized to receive either a corticosteroid injection or an autologous platelet concentrate injection through a peppering technique. The primary analysis included visual analog scores and DASH Outcome Measure scores (DASH: Disabilities of the Arm, Shoulder, and Hand). Results: Successful treatment was defined as more than a 25% reduction in visual analog score or DASH score without a reintervention after 1 year. The results showed that, according to the visual analog scores, 24 of the 49 patients (49%) in the corticosteroid group and 37 of the 51 patients (73%) in the PRP group were successful, which was significantly different (P \ .001). Furthermore, according to the DASH scores, 25 of the 49 patients (51%) in the corticosteroid group and 37 of the 51 patients (73%) in the PRP group were successful, which was also significantly different (P 5 .005). The corticosteroid group was better initially and then declined, whereas the PRP group progressively improved. Conclusion: Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and significantly increases function, exceeding the effect of corticosteroid injection. Future decisions for application of the PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.

Brenda Den L Oudsten - One of the best experts on this subject based on the ideXlab platform.

  • ongoing positive effect of platelet rich plasma versus corticosteroid injection in lateral epicondylitis a double blind randomized controlled trial with 2 year follow up
    American Journal of Sports Medicine, 2011
    Co-Authors: Taco Gosens, Joost C Peerbooms, Wilbert Van Laar, Brenda Den L Oudsten
    Abstract:

    Background: Platelet-rich plasma (PRP) has been shown to be a general stimulation for repair and 1-year results showed promising success percentages. Purpose: This trial was undertaken to determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis with a 2-year follow-up. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The trial was conducted in 2 Dutch teaching hospitals. One hundred patients with chronic lateral epicondylitis were randomly assigned to a leukocyte-enriched PRP group (n = 51) or the corticosteroid group (n = 49). Randomization and allocation to the trial group were carried out by a Central Computer System. Patients received either a corticosteroid injection or an autologous platelet concentrate injection through a peppering needling technique. The primary analysis included visual analog scale (VAS) pain scores and Disabilities of the Arm, Shoulder and Hand (DASH) outcome scores. Results: The PRP group was more often successfully treated than the corticosteroid group (P\.0001). Success was defined as a reduction of 25% on VAS or DASH scores without a reintervention after 2 years. When baseline VAS and DASH scores were compared with the scores at 2-year follow-up, both groups significantly improved across time (intention-to-treat principle). However, the DASH scores of the corticosteroid group returned to baseline levels, while those of the PRP group significantly improved (as-treated principle). There were no complications related to the use of PRP. Conclusion: Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and increases function significantly, exceeding the effect of corticosteroid injection even after a follow-up of 2 years. Future decisions for application of PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.