Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression ass...Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression associated with the condition. Methods: 618 patients with moderate to severe psoriasis received double-blind treatment with placebo or 50 mg twice-weekly etanercept. The primary efficacy endpoint was a 75% or greater improvement from baseline in psoriasis area and severity index score (PASI 75) at week 12. Secondary and other endpoints included the functional assessment of chronic illness therapy fatigue (FACIT-F) scale, the Hamilton rating scale for depression (Ham-D), the Beck depression inventory (BDI), and adverse events. Efficacy analyses were based on the allocated treatment. Analyses and summaries of safety data were based on the actual treatment received. This study is registered with ClinicalTrials.gov with the identifier NCT00111449. Findings: 47% (147 of 311) of patients achieved PASI 75 at week 12, compared with 5% (15 of 306) of those receiving placebo (p< 0.0001; difference 42% , 95% CI 36- 48). Greater proportions of patients receiving etanercept had at least a 50% improvement in Ham-D or BDI at week 12 compared with the placebo group; patients treated with etanercept also had significant and clinically meaningful improvements in fatigue (mean FACIT-F improvement 5.0 vs 1.9; p< 0.0001, difference 3.0, 95% CI 1.6- 4.5). Improvements in fatigue were correlated with decreasing joint pain, whereas improvements in symptoms of depression were less correlated with objective measures of skin clearance or joint pain. Interpretation: Etanercept treatment might relieve fatigue and symptoms of depression associated with this chronic disease.展开更多
Background: We conducted a double-blind, placebo-controlled, randomized trial to evaluate the preliminary efficacy and safety of imiquimod 5% cream treatment for cutaneous squamous cell carcinoma (SCC) in situ. Method...Background: We conducted a double-blind, placebo-controlled, randomized trial to evaluate the preliminary efficacy and safety of imiquimod 5% cream treatment for cutaneous squamous cell carcinoma (SCC) in situ. Methods: In all, 31 patients with biopsy-proven cutaneous SCC in situ were randomly assigned to placebo (vehicle) (n = 16) or imiquimod 5% cream (n = 15) daily for 16 weeks. Patients were assessed at week 28 for the primary end point, resolution of cutaneous SCC in situ. Results: Of the 31 patients enrolled, 3 dropped out. Intention-to-treat analysis revealed 11 of the 15 patients (73% ) in the imiquimod group achieved resolution of cutaneous SCC in situ, with no relapse during the 9-month follow-up period; none in the placebo group achieved resolution (P < .001). Imiquimod 5% cream was generally well tolerated and there were no serious adverse events. Limitations: Topical imiquimod 5% cream has proven to be an effective treatment for cutaneous SCC in situ. However, studies to define the ideal dosing regimen and cost-effectiveness are required before it can be accepted as a recognized therapy. Conclusions: In this controlled trial, patients with cutaneous SCC in situ receiving topical imiquimod 5% cream as monotherapy experienced a high degree of clinical benefit compared with placebo.展开更多
Background: A multicenter, double-blind, placebo-controlled study was conducted to assess the efficacy and safety of fasudil, a Rhokinase inhibitor (RKI), in the treatment of acute ischemic stroke. Methods: A total of...Background: A multicenter, double-blind, placebo-controlled study was conducted to assess the efficacy and safety of fasudil, a Rhokinase inhibitor (RKI), in the treatment of acute ischemic stroke. Methods: A total of 160 patients, who were able to receive drug treatment within 48 h of acute ischemic stroke onset were enrolled. Patients received either 60 mg fasudil or a placebo (saline) by intravenous injection over 60 min, twice daily for 14 days. The primary end points were neurological status at 2 weeks after the start of treatment, and clinical outcome at 1 month after the onset of symptoms. Results: Fasudil treatment resulted in significantly greater improvements in both neurological functions (p = 0.0013), and clinical outcome (p = 0.0015). There were no serious adverse events reported in the fasudil group. The average trough value (12 h values)of active metabolite hydroxyfasudil, another RKI, in healthy elderl y volunteers receiving 60 mg of fasudil was 0.077 μM a concentration well above that needed to inhibit Rho-kinase (0.025-0.05 μM). Conclusion: Treatment wit h fasudil within 48 h of acute ischemic stroke onset significantly improved the patient’s clinical outcome. This study found fasudil to be a useful and safe dr ug for patients with acute ischemic stroke. Further evaluations, for example, 3 -month functional outcomes in a larger clinical trial, may help to define the e fficacy of fasudil in acute ischemic stroke.展开更多
Objective. Irritable bowel syndrome (IBS) is a common functional disorder for which there is no reliable medical treatment. The aim of this study was to determine the efficacy of two herbal remedies used in the treatm...Objective. Irritable bowel syndrome (IBS) is a common functional disorder for which there is no reliable medical treatment. The aim of this study was to determine the efficacy of two herbal remedies used in the treatment of IBS. Material and methods. In a randomized, double- blind, placebo- controlled trial, IBS patients were randomly assigned to one of three treatment groups: 1) Curcuma xanthorriza 60 mg daily (curcuma group) (n= 24), 2) Fumaria officinalis 1500 mg daily (fumitory group) (n= 24) and 3) placebo (n= 58). The study treatment was applied three times a day for 18 weeks. The main outcome parameters were changes in global patient ratings of IBS- related pain and distension on a visual analogue scale (0- 50 mm) between baseline and at the end of treatment. Additional outcome parameters included global assessments of changes in IBS symptoms and psychosocial stress caused by IBS. Results. A total of 106 patients (mean age 48 ± 12 years, 63% F) were included in the intention- to- treat group. IBS- related pain decreased by - 0.9 ± 11.5 (mm ± SD) in the fumitory group, - 0.3 ± 9.9 in the placebo group and increased by 2.0 ± 9.5 in the curcuma group (p = 0.81). IBS- related distension decreased by - 1.4 ± 12.5 in the curcuma group, - 2.1 ± 9.2 in the placebo group and increased by 0.3 ± 9.3 in the fumitory group (p = 0.48). Additionally, the global assessment of changes in IBS symptoms and psychological stress due to IBS did not differ significantly among the three treatment groups. Conclusions. Neither fumitory nor curcuma showed any therapeutic benefit over placebo in patients with IBS. Therefore, the use of these herbs for the treatment of IBS cannot be recommended.展开更多
Objective: Fatigue is a major complaint in patients with immune mediated polyneuropathies. Despite apparently good physical recovery after Guillain-Barré syndrome (GBS), many patients remain restricted in daily a...Objective: Fatigue is a major complaint in patients with immune mediated polyneuropathies. Despite apparently good physical recovery after Guillain-Barré syndrome (GBS), many patients remain restricted in daily and social activities, and have a decreased quality of life. In this trial, the effect of amantadine on severe fatigue related to GBS was studied. Methods: During the pre-treatment phase, all patients were monitored for 2 weeks. Only patients with severe fatigue, defined as a mean fatigue score of ≥ 5.0 on the Fatigue Severity Scale (FSS), were randomised for this double blind, placebo controlled, crossover study. Primary outcome measure was improvement of at least 1 point on the FSS. Secondary outcome measures were impact of fatigue, anxiety and depression, handicap, and quality of life. Results: In total, 80 patients with GBS were randomised, of whom 74 were included for analysis. Fatigue appeared to be reduced already during the pre-treatment phase (p = 0.05), probably due to increased attention provided to the patients. No significant differences in any of the primary and secondary outcome measures were found. Conclusions: Amantadine was not superior to placebo. Because fatigue remains a serious complaint, other studies evaluating new treatment options are strongly recommended.展开更多
文摘Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression associated with the condition. Methods: 618 patients with moderate to severe psoriasis received double-blind treatment with placebo or 50 mg twice-weekly etanercept. The primary efficacy endpoint was a 75% or greater improvement from baseline in psoriasis area and severity index score (PASI 75) at week 12. Secondary and other endpoints included the functional assessment of chronic illness therapy fatigue (FACIT-F) scale, the Hamilton rating scale for depression (Ham-D), the Beck depression inventory (BDI), and adverse events. Efficacy analyses were based on the allocated treatment. Analyses and summaries of safety data were based on the actual treatment received. This study is registered with ClinicalTrials.gov with the identifier NCT00111449. Findings: 47% (147 of 311) of patients achieved PASI 75 at week 12, compared with 5% (15 of 306) of those receiving placebo (p< 0.0001; difference 42% , 95% CI 36- 48). Greater proportions of patients receiving etanercept had at least a 50% improvement in Ham-D or BDI at week 12 compared with the placebo group; patients treated with etanercept also had significant and clinically meaningful improvements in fatigue (mean FACIT-F improvement 5.0 vs 1.9; p< 0.0001, difference 3.0, 95% CI 1.6- 4.5). Improvements in fatigue were correlated with decreasing joint pain, whereas improvements in symptoms of depression were less correlated with objective measures of skin clearance or joint pain. Interpretation: Etanercept treatment might relieve fatigue and symptoms of depression associated with this chronic disease.
文摘Background: We conducted a double-blind, placebo-controlled, randomized trial to evaluate the preliminary efficacy and safety of imiquimod 5% cream treatment for cutaneous squamous cell carcinoma (SCC) in situ. Methods: In all, 31 patients with biopsy-proven cutaneous SCC in situ were randomly assigned to placebo (vehicle) (n = 16) or imiquimod 5% cream (n = 15) daily for 16 weeks. Patients were assessed at week 28 for the primary end point, resolution of cutaneous SCC in situ. Results: Of the 31 patients enrolled, 3 dropped out. Intention-to-treat analysis revealed 11 of the 15 patients (73% ) in the imiquimod group achieved resolution of cutaneous SCC in situ, with no relapse during the 9-month follow-up period; none in the placebo group achieved resolution (P < .001). Imiquimod 5% cream was generally well tolerated and there were no serious adverse events. Limitations: Topical imiquimod 5% cream has proven to be an effective treatment for cutaneous SCC in situ. However, studies to define the ideal dosing regimen and cost-effectiveness are required before it can be accepted as a recognized therapy. Conclusions: In this controlled trial, patients with cutaneous SCC in situ receiving topical imiquimod 5% cream as monotherapy experienced a high degree of clinical benefit compared with placebo.
文摘Background: A multicenter, double-blind, placebo-controlled study was conducted to assess the efficacy and safety of fasudil, a Rhokinase inhibitor (RKI), in the treatment of acute ischemic stroke. Methods: A total of 160 patients, who were able to receive drug treatment within 48 h of acute ischemic stroke onset were enrolled. Patients received either 60 mg fasudil or a placebo (saline) by intravenous injection over 60 min, twice daily for 14 days. The primary end points were neurological status at 2 weeks after the start of treatment, and clinical outcome at 1 month after the onset of symptoms. Results: Fasudil treatment resulted in significantly greater improvements in both neurological functions (p = 0.0013), and clinical outcome (p = 0.0015). There were no serious adverse events reported in the fasudil group. The average trough value (12 h values)of active metabolite hydroxyfasudil, another RKI, in healthy elderl y volunteers receiving 60 mg of fasudil was 0.077 μM a concentration well above that needed to inhibit Rho-kinase (0.025-0.05 μM). Conclusion: Treatment wit h fasudil within 48 h of acute ischemic stroke onset significantly improved the patient’s clinical outcome. This study found fasudil to be a useful and safe dr ug for patients with acute ischemic stroke. Further evaluations, for example, 3 -month functional outcomes in a larger clinical trial, may help to define the e fficacy of fasudil in acute ischemic stroke.
文摘Objective. Irritable bowel syndrome (IBS) is a common functional disorder for which there is no reliable medical treatment. The aim of this study was to determine the efficacy of two herbal remedies used in the treatment of IBS. Material and methods. In a randomized, double- blind, placebo- controlled trial, IBS patients were randomly assigned to one of three treatment groups: 1) Curcuma xanthorriza 60 mg daily (curcuma group) (n= 24), 2) Fumaria officinalis 1500 mg daily (fumitory group) (n= 24) and 3) placebo (n= 58). The study treatment was applied three times a day for 18 weeks. The main outcome parameters were changes in global patient ratings of IBS- related pain and distension on a visual analogue scale (0- 50 mm) between baseline and at the end of treatment. Additional outcome parameters included global assessments of changes in IBS symptoms and psychosocial stress caused by IBS. Results. A total of 106 patients (mean age 48 ± 12 years, 63% F) were included in the intention- to- treat group. IBS- related pain decreased by - 0.9 ± 11.5 (mm ± SD) in the fumitory group, - 0.3 ± 9.9 in the placebo group and increased by 2.0 ± 9.5 in the curcuma group (p = 0.81). IBS- related distension decreased by - 1.4 ± 12.5 in the curcuma group, - 2.1 ± 9.2 in the placebo group and increased by 0.3 ± 9.3 in the fumitory group (p = 0.48). Additionally, the global assessment of changes in IBS symptoms and psychological stress due to IBS did not differ significantly among the three treatment groups. Conclusions. Neither fumitory nor curcuma showed any therapeutic benefit over placebo in patients with IBS. Therefore, the use of these herbs for the treatment of IBS cannot be recommended.
文摘Objective: Fatigue is a major complaint in patients with immune mediated polyneuropathies. Despite apparently good physical recovery after Guillain-Barré syndrome (GBS), many patients remain restricted in daily and social activities, and have a decreased quality of life. In this trial, the effect of amantadine on severe fatigue related to GBS was studied. Methods: During the pre-treatment phase, all patients were monitored for 2 weeks. Only patients with severe fatigue, defined as a mean fatigue score of ≥ 5.0 on the Fatigue Severity Scale (FSS), were randomised for this double blind, placebo controlled, crossover study. Primary outcome measure was improvement of at least 1 point on the FSS. Secondary outcome measures were impact of fatigue, anxiety and depression, handicap, and quality of life. Results: In total, 80 patients with GBS were randomised, of whom 74 were included for analysis. Fatigue appeared to be reduced already during the pre-treatment phase (p = 0.05), probably due to increased attention provided to the patients. No significant differences in any of the primary and secondary outcome measures were found. Conclusions: Amantadine was not superior to placebo. Because fatigue remains a serious complaint, other studies evaluating new treatment options are strongly recommended.
