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1.
Front Pharmacol ; 15: 1358879, 2024.
Article in English | MEDLINE | ID: mdl-38562459

ABSTRACT

Background: We evaluated whether EPs® 7630 prescription in patients with acute sinusitis (AS) is associated with less frequent recurrence of AS, occurrence of chronic sinusitis or nasal polyps, or fewer antibiotic prescriptions. Methods: This retrospective cohort study used electronic medical records from the IQVIA Disease Analyzer database. Associations between initial therapy [EPs® 7630, antibiotics, intranasal corticosteroid (INCS), or corticosteroid-free nasal spray within 3 days of AS diagnosis] and AS recurrence, incidence of chronic sinusitis or nasal polyps or rate of antibiotic prescription were studied using multivariable Cox or logistic regression models, adjusting for sex, age, insurance status, month of diagnosis, and comorbidity. Results: A total of 216,360 patients were analyzed. INCS prescription was associated with a higher risk of recurrent AS (HR: 1.40; 95% CI: 1.01-1.92) and a higher incidence of chronic sinusitis or nasal polyp diagnosis (HR: 1.39; 95% CI: 1.01-1.92) compared to EPs® 7630. Initial antibiotic therapy was significantly associated with higher risk of new antibiotic prescription in the period of 31-365 days after the index date compared to EPs® 7630 (OR: 2.20; 95% CI: 1.66-2.92). Conclusion: EPs® 7630 prescription is associated with long-term benefits in AS patients. EPs® 7630 can help to reduce inappropriate antibiotic use and might reduce the risk of chronic sinusitis or nasal polyps.

2.
Front Neurol ; 12: 691917, 2021.
Article in English | MEDLINE | ID: mdl-34917009

ABSTRACT

Background: Balance training with vibrotactile neurofeedback (VNF) can improve balance and subjective impairment in age-related vertigo and dizziness. Ginkgo biloba dry extract EGb 761 has been shown to improve subjective impairment in chronic vertigo and the efficacy of conventional balance training. The combination was expected to work synergistically in this difficult-to-treat population. Objectives: To demonstrate the efficacy of VNF added to EGb 761 for age-related vertigo and dizziness. Design: Multicenter, prospective, controlled, randomized, single-blind, two-arm trial (German Clinical Trials Register https://www.drks.de No. DRKS00007633). Setting: Specialist offices and tertiary care outpatient department. Participants: One hundred and twenty subjects aged 60+ years with chronic dizziness for over 3 months, a Dizziness Handicap Inventory (DHI) Sum Score >25 and fall risk in balance-related situations as measured by the geriatric Standard Balance Deficit Test Composite Score (gSBDT-CS)>40. Patients with other distinct vestibular pathology (e.g., Meniére's disease, stroke, BPPV) were excluded. Intervention: EGb 761 (80 mg twice daily for 12 weeks) plus 10 days of individually adapted balance training with VNF, randomized 1:1 to sensitive (active) or non-sensitive (sham) neurofeedback. Measurements: The change in gSBDT-CS after 6 weeks (primary), other gSBDT outcomes, DHI, cognition, hearing, and safety. Results: One hundred nine of 120 enrolled subjects received both treatments at least once. Over 12 weeks, the gSBDT-CS improved by 6.7 (active) vs. 4.5 (sham). There was a difference in favor of the active treatment of -2.4 (95% CI -5.4; 0.6) after 6 weeks. Under active treatment, more pronounced effects occurred in all secondary analyses and in nearly all secondary endpoints. The DHI sum score decreased from 44.1 to 31.1 in the total sample with a treatment group difference after 6 weeks of -3.1, 95% CI (-7.1; 0.9). No safety issues were reported. Conclusion: Over 12 weeks, the combination of balance training with VNF and Ginkgo biloba dry extract EGb 761 reached a clinically relevant improvement of age-related vertigo and dizziness with a good pharmacological safety profile.

3.
Int J Clin Pharmacol Ther ; 56(3): 130-133, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29319499

ABSTRACT

OBJECTIVE: To provide pilot data for the safety and efficacy of EGb 761 in the oldest-old patients (aged 80 or older). MATERIALS AND METHODS: In a retrospective analysis, we compared treatment outcomes with EGb 761 or donepezil over 12 months in 189 patients aged 80 years or older suffering from Alzheimer's disease (AD). RESULTS: Over 12 months, there was no significant difference in cognitive decline, measured with the mini-mental state examination (MMSE) score, between donepezil and EGb 761 (p = 0.31). We found more adverse events in the donepezil group. CONCLUSION: Results suggest similar effects on cognitive symptoms from the use of EGb 761 in the treatment of dementia in AD together with favorable safety compared to donepezil.
.


Subject(s)
Alzheimer Disease/drug therapy , Indans/therapeutic use , Nootropic Agents/therapeutic use , Piperidines/therapeutic use , Plant Extracts/therapeutic use , Aged, 80 and over , Alzheimer Disease/physiopathology , Cognition/drug effects , Donepezil , Female , Ginkgo biloba , Humans , Indans/adverse effects , Male , Mental Status and Dementia Tests , Nootropic Agents/adverse effects , Piperidines/adverse effects , Plant Extracts/adverse effects , Retrospective Studies , Treatment Outcome
4.
Br J Pharmacol ; 174(20): 3443-3453, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28055105

ABSTRACT

BACKGROUND AND PURPOSE: We have recently shown that a reduced function of endothelial nitric oxide synthase (eNOS) in the perivascular adipose tissue (PVAT) contributes crucially to obesity-induced vascular dysfunction in mice. The current study was conducted to test the hypothesis that vascular dysfunction in obesity can be reversed by in vivo improvement of PVAT eNOS activity. EXPERIMENTAL APPROACH: Male C57BL/6J mice were fed a high-fat diet (HFD) for 22 weeks to induce obesity. During the last 4 weeks of HFD feeding, the obese mice were treated p.o. with the standardized Crataegus extract WS® 1442, which has been shown previously to improve eNOS activity. KEY RESULTS: Diet-induced obesity in mice markedly reduced the vasodilator response of thoracic aorta to acetylcholine in wire myograph experiments. Strikingly, this vascular dysfunction was only evident in PVAT-containing aorta but not in PVAT-free aorta. In vivo treatment of obese mice with WS® 1442 had no effect on body weight or epididymal fat mass, but completely restored the vascular function of PVAT-containing aorta. Feeding a HFD led to a reduced phosphorylation and an enhanced acetylation of PVAT eNOS, both effects were reversed by WS® 1442 treatment. CONCLUSION AND IMPLICATIONS: PVAT plays a key role in vascular dysfunction in diet-induced obese mice. Not obesity itself, but a PVAT dysfunction is responsible for obesity-induced vascular disorders. Improving PVAT function by pharmacological means (e.g. with WS® 1442) can ameliorate vascular function even without reducing body weight or fat mass. LINKED ARTICLES: This article is part of a themed section on Molecular Mechanisms Regulating Perivascular Adipose Tissue - Potential Pharmacological Targets? To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v174.20/issuetoc.


Subject(s)
Adipose Tissue/physiology , Aorta, Thoracic/physiology , Diet, High-Fat , Obesity/physiopathology , Acetylation/drug effects , Adipose Tissue/drug effects , Adipose Tissue/metabolism , Animals , Aorta, Thoracic/drug effects , Body Weight , Endothelium, Vascular/drug effects , Endothelium, Vascular/metabolism , Endothelium, Vascular/physiology , Flavonoids/pharmacology , Lipids/blood , Male , Mice, Inbred C57BL , Nitric Oxide/metabolism , Nitric Oxide Synthase Type III/metabolism , Phosphorylation/drug effects
5.
Hum Psychopharmacol ; 31(3): 227-42, 2016 05.
Article in English | MEDLINE | ID: mdl-27147264

ABSTRACT

OBJECTIVE: Cognitive control as well as stress reactivity is assumed to depend on prefrontal dopamine and decline with age. Because Ginkgo biloba extract EGb761 increases prefrontal dopamine in animals, we assessed its effects on cognitive functions related to prefrontal dopamine. METHODS: Effects of 240-mg EGb761 daily on task-set-switching, response-inhibition, delayed response, prospective-memory, task-related fMRI-BOLD-signals and the Trier Social Stress-Test were explored in a randomized, placebo-controlled, double-blind pilot-trial in 61 elderly volunteers with subjective memory impairment. RESULTS: Baseline-FMRI-data showed BOLD-responses in regions commonly activated by the specific tasks. Task-switch-costs decreased with EGb761 compared to placebo (ANOVA-interaction: Group × Time × Switch-Costs p = 0.018, multiple tests uncorrected), indicating improved cognitive flexibility. Go-NoGo-task reaction-times corrected for error-rates indicated a trend for improved response inhibition. No treatment effects were found for the delayed response and prospective-memory tasks and fMRI-data. A non-significant trend indicated a potentially accelerated endocrine stress-recovery. EGb761 was safe and well tolerated. CONCLUSION: We observed indications for improved cognitive flexibility without changes in brain activation, suggesting increased processing efficiency with EGb761. Together with a trend for improved response inhibition results are compatible with mild enhancement of prefrontal dopamine. These conclusions on potential beneficial effect of EGb761 on prefrontal dopaminergic functions should be confirmed by direct measurements. © 2016 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons, Ltd.


Subject(s)
Cognition/drug effects , Memory Disorders/drug therapy , Plant Extracts/pharmacology , Prefrontal Cortex/drug effects , Aged , Aging , Dopamine/metabolism , Double-Blind Method , Female , Ginkgo biloba , Humans , Magnetic Resonance Imaging , Male , Middle Aged , Pilot Projects , Plant Extracts/adverse effects , Prefrontal Cortex/metabolism , Reaction Time/drug effects , Stress, Psychological/drug therapy
6.
IEEE J Biomed Health Inform ; 20(3): 865-872, 2016 05.
Article in English | MEDLINE | ID: mdl-25872219

ABSTRACT

Among elderly males, benign prostate syndrome (BPS) is the most common urinary disorder. Nocturia is one of the major symptoms of BPS and has a considerable influence on the quality of life. For assessment of BPS (including nocturia), the International Prostate Symptom Score is widely used, but questionnaires are prone to bias. To date, there is no objective measurement system available for nocturia. In this study, we present an unobtrusive and nonstigmatizing device for objective measurement of nighttime micturition. In a preliminary study of six males diagnosed with BPS and nighttime micturition ≥ 2×, we showed that the device is accurate, with an average misdetection rate of 0.32 events and a mean absolute deviation of 3.8% when comparing the average number of nighttime micturition occurrences. In this extended study, an additional nine males were recorded and data from an occupancy sensor were also included. The results of the preliminary study were confirmed with an average misdetection rate of 0.33 events and a mean absolute deviation of 9.1%. The system can, therefore, be used to objectively measure nighttime micturition and, thereby, provide the basis for treatment, e.g., medication efficacy assessment.


Subject(s)
Monitoring, Ambulatory/instrumentation , Monitoring, Ambulatory/methods , Nocturia/diagnosis , Pattern Recognition, Automated/methods , Aged , Equipment Design , Humans , Male , Middle Aged , Nocturia/etiology , Prostatic Hyperplasia/complications , Signal Processing, Computer-Assisted
7.
Brain Behav Immun ; 46: 121-31, 2015 May.
Article in English | MEDLINE | ID: mdl-25637484

ABSTRACT

Alzheimer's disease (AD) is a neurodegenerative disease characterized by extracellular deposits of amyloid ß peptide (Aß) and microglia-dominated neuroinflammation. The therapeutic options for AD are currently limited. In this study, we investigated the antiinflammatory effects and the underlying molecular mechanisms of Ginkgo biloba extract EGb 761 when administered to TgCRND8 AD mice, which overexpress human Alzheimer's amyloid precursor protein (APP) specifically in neurons. We gave APP-transgenic mice EGb 761 as a dietary supplement for 2 or 5months. Plasma concentrations of EGb 761 components in mice were in the same range as such concentrations in humans taking EGb 761 at the recommended dose (240mg daily). Treatment with EGb 761 for 5months significantly improved the cognitive function of the mice as measured by the Barnes Maze test. It also attenuated the loss of synaptic structure proteins, such as PSD-95, Munc18-1, and SNAP25. Treatment with EGb 761 for 5months inhibited microglial inflammatory activation in the brain. The effects of treatment with EGb 761 for 2months were weak and not statistically significant. Moreover, EGb 761 activated autophagy in microglia. Treatment with EGb 761 decreased Aß-induced microglial secretion of TNF-α and IL-1ß and activation of caspase-1, both of which were abolished by the inhibition of autophagy. Treatment with EGb 761 also reduced the concentrations of NLRP3 protein that colocalized with LC3-positive autophagosomes or autolysosomes in microglia. Additionally, long-term treatment with EGb 761 may reduce cerebral Aß pathology by inhibiting ß-secretase activity and Aß aggregation. Therefore, long-term treatment with G. biloba extract EGb 761, a clinically available and well-tolerated herbal medication, ameliorates AD pathology by antiinflammatory and Aß-directed mechanisms.


Subject(s)
Alzheimer Disease/drug therapy , Brain/drug effects , Ginkgo biloba , Maze Learning/drug effects , Neurons/drug effects , Plant Extracts/therapeutic use , Alzheimer Disease/metabolism , Alzheimer Disease/pathology , Amyloid beta-Peptides/metabolism , Animals , Brain/metabolism , Brain/pathology , Disks Large Homolog 4 Protein , Guanylate Kinases/metabolism , Membrane Proteins/metabolism , Mice , Mice, Transgenic , Munc18 Proteins/metabolism , Neurons/metabolism , Neurons/pathology , Neuroprotective Agents/pharmacology , Neuroprotective Agents/therapeutic use , Plant Extracts/pharmacology , Synaptosomal-Associated Protein 25/metabolism
8.
World J Urol ; 32(5): 1149-54, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24938176

ABSTRACT

PURPOSE: To determine the effects of the herbal fixed-dose combination PRO 160/120 (extracts from saw palmetto fruits and stinging nettle roots) on nocturnal voiding frequency, as measured by question 7 of the IPSS questionnaire, in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo, to the α-blocker tamsulosin, or to the 5α-reductase inhibitor finasteride. METHODS: The study is about post hoc evaluation of four published randomized, double-blind clinical trials on PRO 160/120, two compared with placebo, one with finasteride and one with tamsulosin. In addition, a pooled data analysis of the two placebo-controlled trials was conducted. RESULTS: We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1. In the pooled analysis of placebo-controlled trials, nocturnal voids improved by 0.8 (29 %) with PRO 160/120 compared to 0.6 (18 %) with placebo (p = 0.015, Wilcoxon test, one-tailed). The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response (52 %; p = 0.003, χ (2)-test, two-tailed). The majority of responders improved by 1 void/night. Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies. There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates. CONCLUSION: PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.


Subject(s)
Nocturia/drug therapy , Phytotherapy , Plant Extracts/administration & dosage , Aged , Double-Blind Method , Drug Combinations , Humans , Lower Urinary Tract Symptoms/complications , Male , Nocturia/etiology , Prostatic Hyperplasia/complications , Remission Induction
9.
Phytomedicine ; 21(8-9): 1098-103, 2014.
Article in English | MEDLINE | ID: mdl-24837472

ABSTRACT

BACKGROUND: Valerian root and lemon balm extracts have previously shown efficacy and excellent tolerability in children<12 years suffering from restlessness and insomnia. We now examined whether treatment with a fixed combination of both may also improve concentration, hyperactivity and impulsiveness. METHODS: 169 primary school children suffering from hyperactivity and concentration difficulties but not meeting ADHS criteria were treated in an observational study by 27 office based pediatricians with a recommended daily dose of 640 mg valerian root extract WS(®) 1014 and 320 mg lemon balm extract WS(®) 1303 (Sandrin(®)), and evaluated by pediatricians and parents using standardized questionnaires at baseline, weeks 2 and 7. RESULTS: The fraction of children having strong/very strong symptoms of poor ability to focus decreased from 75% to 14%, hyperactivity from 61% to 13%, and impulsiveness from 59% to 22%. Parent rated social behavior, sleep and symptom burden showed highly significant improvements. Only in two children mild transient adverse drug reactions were observed. CONCLUSION: In primary school children with restlessness, concentration difficulties and impulsiveness treatment with WS(®) 1014 and WS(®) 1303 (Sandrin(®)) provides a viable option in addition to counseling and education.


Subject(s)
Hypnotics and Sedatives/therapeutic use , Melissa/chemistry , Phytotherapy , Plant Extracts/therapeutic use , Sleep Initiation and Maintenance Disorders/drug therapy , Valerian/chemistry , Child , Female , Humans , Hypnotics and Sedatives/chemistry , Hypnotics and Sedatives/isolation & purification , Male , Parents , Physicians, Primary Care , Plant Extracts/chemistry , Plant Extracts/isolation & purification , Plant Roots/chemistry , Prospective Studies , Psychomotor Agitation/drug therapy , Surveys and Questionnaires , Treatment Outcome
10.
Article in English | MEDLINE | ID: mdl-25570022

ABSTRACT

Nocturia is a widespread condition where patients need to micturate frequently during the nighttime. In order to define treatment and measure therapeutic success in nocturia, questionnaires are traditionally used for ambulatory assessment. However, questionnaires were reported to suffer from compliance, embarrassment and subjective bias. An automatic sensor-based system for quantification of nighttime micturition for accurate nocturia assessment would not suffer from these disadvantages, and its development was therefore the purpose of this study. We defined a sensor-based system for ambulatory use, consisting of a sensor watch and a room occupancy sensor. Using this system, we so far collected data from 6 participants and 82 nights in an ongoing study. We report the details of the system, as well as the data analysis. The system is very accurate, with an average misdetection rate of 0.32 and a mean absolute deviation of 3.8 % when comparing the average number of nighttime micturitions. This novel sensor-based nighttime micturition quantification system has the potential to be used as an objective ambulatory assessment tool for nocturia diagnosis and treatment.


Subject(s)
Monitoring, Ambulatory/instrumentation , Nocturia/diagnosis , Urination , Aged , Humans , Middle Aged
11.
BMC Complement Altern Med ; 13: 278, 2013 Oct 24.
Article in English | MEDLINE | ID: mdl-24156348

ABSTRACT

BACKGROUND: Ginkgo biloba drugs (Gb) are reimbursed within the German statutory health insurance (SHI) scheme for treatment of dementia. In 2008, a novel Gb product containing 240 mg Ginkgo extract EGb761® per tablet was introduced aiming to facilitate medication use by incorporating the recommended daily dose in one single tablet. The aim of this study was to evaluate the relationship between dosage strength and persistence in a representative population of patients treated with Gb. METHODS: Retrospective cohort study in ambulatory drug claims database within the German SHI system. Persistence was defined as continuous treatment with an allowable gap of 20% between refills. Multivariate regression models were conducted to identify variables associated with persistence. RESULTS: Among 13,810 patients initiating treatment with Gb in 2008, 430 (3.1%) received a dosage strength of 240 mg, 7,070 (51.2%) a dosage strength of 120 mg and 6,310 (45.7%) dosage strengths containing less than 120 mg Gb per tablet. After 6 months, persistence was highest for patients treated with the 240 mg dosage form (22.8% of patients), although persistence was low in general (5.7% and 0% of patients treated with 120 mg and less than 120 mg, respectively). Risk for non-persistence was reduced in patients receiving 240 mg products compared to 120 mg (HR = 0.63; 95%CI 0.57 - 0.70). CONCLUSIONS: Patients initially treated with Gb 240 mg were more persistent compared to those receiving lower dosage strengths. Nevertheless, persistence with Gb therapy is generally low and should be improved in order to better realize therapeutic effects.


Subject(s)
Dementia/drug therapy , Ginkgo biloba/chemistry , Medication Adherence , Plant Extracts/administration & dosage , Aged , Aged, 80 and over , Dementia/psychology , Dose-Response Relationship, Drug , Drug Prescriptions , Female , Germany , Humans , Male , Middle Aged , Plant Extracts/analysis , Retrospective Studies , Treatment Outcome
12.
Phytomedicine ; 18(14): 1214-9, 2011 Nov 15.
Article in English | MEDLINE | ID: mdl-21784624

ABSTRACT

OBJECTIVE: The efficacy of quantified Crataegus extract in chronic heart failure (CHF) has been assessed in numerous clinical studies. The present pooled analysis evaluates the impact of baseline severity and gender on objective and patient-reported endpoints and associations between both types of outcomes in patients with early CHF. METHODS: Available data from 687 individual patients treated with quantified Crataegus extract or placebo in ten studies were pooled. Treatment effects on physiologic outcome parameters and on symptoms were analysed for their association with baseline severity and gender. Changes in symptom scores were investigated with respect to their relation to physiologic outcome parameters. Results were compared with observations in a 3-year cohort study. RESULTS: Physiologic outcome parameters maximal workload (MWL), left ventricular ejection fraction (LVEF) and pressure-heart rate product increase (PHRPI) at 50 W ergometric exercise improved more in active treatment than in placebo patients. Magnitude of improvement was independent from baseline for LVEF but increased for MWL and PHRPI with baseline severity. Improvement of typical symptoms like reduced exercise tolerance, exertional dyspnea, weakness, fatigue, and palpitations improved more with active treatment and in patients with more severe symptoms. A weak association between improvements in MWL, PRHP, and symptoms could be demonstrated. Gender differences in treatment effects could be explained by baseline differences. Results of the pooled analysis are in agreement with observations in the cohort study. CONCLUSIONS: Crataegus extract treatment effects on physiologic outcomes and typical symptoms were modulated by baseline severity. Taking baseline differences into account, benefits were comparable in male and female patients with impaired exercise-tolerance in early chronic heart-failure.


Subject(s)
Flavonoids/therapeutic use , Heart Failure/drug therapy , Plant Extracts/therapeutic use , Aged , Clinical Trials as Topic , Cohort Studies , Crataegus , Dyspnea/drug therapy , Dyspnea/physiopathology , Exercise Test , Exercise Tolerance , Fatigue/drug therapy , Fatigue/physiopathology , Female , Heart Failure/physiopathology , Heart Function Tests , Humans , Male , Middle Aged , Quality of Life , Severity of Illness Index , Sex Factors , Treatment Outcome
14.
Eur J Med Res ; 12(2): 61-7, 2007 Feb 26.
Article in English | MEDLINE | ID: mdl-17369119

ABSTRACT

OBJECTIVE: Sildenafil and apomorphine are oral agents for the improvement of erection hardness. The aim of the study was a direct comparison of the two compounds under clinical routine conditions. METHODS: 131 previously untreated men with erectile dysfunction (ED) were enrolled in a cross-over trial and randomly allocated to 50 mg sildenafil or 2 mg apomorphine. Dose-adaptation was allowed as required. RESULTS: Improvements in rigidity, the capacity to get and maintain an erection, and sexual confidence were statistically significantly larger with sildenafil (p <0.0001). 90% of the men were satisfied with sildenafil as compared to 46% with apomorphine. At study end, 95% of the patients preferred sildenafil. Both agents were well tolerated. CONCLUSIONS: In this cross-over comparison under clinical routine conditions men reported superior efficacy of sildenafil vs apomorphine together with a statistically significantly higher treatment satisfaction.


Subject(s)
Apomorphine/therapeutic use , Erectile Dysfunction/drug therapy , Piperazines/therapeutic use , Sulfones/therapeutic use , Adolescent , Adult , Aged , Apomorphine/adverse effects , Coitus , Cross-Over Studies , Erectile Dysfunction/etiology , Humans , Male , Middle Aged , Orgasm , Patient Satisfaction , Penile Erection/drug effects , Piperazines/adverse effects , Purines/adverse effects , Purines/therapeutic use , Sexual Partners/psychology , Sildenafil Citrate , Sulfones/adverse effects , Surveys and Questionnaires , Treatment Outcome
15.
Neurourol Urodyn ; 26(2): 190-5, 2007.
Article in English | MEDLINE | ID: mdl-17096320

ABSTRACT

AIMS: We have studied the association between various symptoms, bother, and patient treatment satisfaction in overactive bladder (OAB). METHODS: Episodes of urgency, incontinence, daytime frequency and nocturia and responses to the patient perception of bladder condition scale, the urgency perception scale, and visual analog scales of limitations in daily life and of treatment satisfaction were evaluated in 3,824 OAB patients at baseline and during 9 months treatment with tolterodine ER (4 mg q.d.) in an open-label, observational study. Relationships amongst number of symptoms/ 24 hr and scales were explored. Treatment satisfaction was correlated with improvements in symptoms and scales. RESULTS: At baseline, the number of episodes of the four OAB symptoms correlated only poorly with each other and with the two bother-related scales, while the two scales assessing bother correlated much stronger with each other. Factor analysis identified four components which described "bother," "incontinence," "urgency/frequency," and "nocturia" and in combination explained 81.9% of the total variance. The component "bother" had the strongest individual effect accounting for 42.1% of the total variance. While improvements of symptoms and bother were seen with tolterodine treatment, patient treatment satisfaction correlated strongest with improvements of the two bother-related scales. CONCLUSIONS: We conclude that the counting of episodes of OAB symptoms only insufficiently describes the afflicted patients. Patient bother is the strongest individual component but only poorly explained by episodes of the four symptoms defining OAB. Alterations of bother may better reflect patient-relevant outcomes in OAB treatment than alterations in the number of symptom episodes.


Subject(s)
Urinary Bladder, Overactive/drug therapy , Urinary Bladder, Overactive/physiopathology , Adult , Aged , Aged, 80 and over , Benzhydryl Compounds/administration & dosage , Benzhydryl Compounds/therapeutic use , Cluster Analysis , Cresols/administration & dosage , Cresols/therapeutic use , Delayed-Action Preparations , Factor Analysis, Statistical , Female , Humans , Male , Middle Aged , Muscarinic Antagonists/administration & dosage , Muscarinic Antagonists/therapeutic use , Nocturia/drug therapy , Nocturia/epidemiology , Patient Satisfaction , Phenylpropanolamine/administration & dosage , Phenylpropanolamine/therapeutic use , Principal Component Analysis , Statistics, Nonparametric , Tolterodine Tartrate , Treatment Outcome , Urinary Bladder, Overactive/psychology , Urinary Incontinence/drug therapy , Urinary Incontinence/epidemiology
16.
J Sex Med ; 4(1): 38-46, 2007 Jan.
Article in English | MEDLINE | ID: mdl-17087802

ABSTRACT

INTRODUCTION: Erectile dysfunctions are prevalent but underdiagnosed and undertreated health problems. Communication barriers between patients and physicians are one of the main reasons for this and responsible for a low report rate of sexual dysfunction. AIM: The main aim of the study was to investigate which phrasing and communication strategies gained the highest acceptance from physicians and their patients and were considered the most effective. MAIN OUTCOME MEASURES: A documentation form on which each consultation was rated by the participating physicians. METHODS: A large group of physicians was asked to hand out a short patient questionnaire to all male patients over 30 years. The physician was instructed to discuss the questionnaire with the patient and to ask him about sexual problems. A total of 1,191 physicians took part in the study that documented a total of 10,622 consultations with an average duration of 15 minutes. RESULTS: The main results were: (i) the patient questionnaire found a high level of acceptance and 54% of discussions of sexual health were prompted by it; (ii) the patients' reaction to physicians addressing sexual health was positive in more than two-thirds of the sample and characterized by openness, willingness to communicate, and relief that their sexual problems had been addressed; (iii) from the physicians' perspective, the most favored communication strategies were a clear signaling of a willingness to talk, and addressing treatment possibilities or signaling that help was available; and (iv) the resulting discussion led to further diagnostic measures in 25% of patients and to further therapeutic measures in 60% of patients. CONCLUSIONS: There are good grounds for concluding that: (i) addressing a patient's sexual health as part of a physician's everyday routine is feasible in terms of duration and content; and (ii) a short patient questionnaire is an excellent aid for patients and physicians for initiating communication on the topic.


Subject(s)
Erectile Dysfunction/diagnosis , Needs Assessment/organization & administration , Patient Participation/statistics & numerical data , Physicians, Family/organization & administration , Professional-Patient Relations , Adult , Aged , Aged, 80 and over , Communication Barriers , Erectile Dysfunction/epidemiology , Germany , Health Knowledge, Attitudes, Practice , Humans , Male , Medical History Taking/methods , Middle Aged , Patient Participation/psychology , Physicians, Family/statistics & numerical data , Sex Education/methods , Surveys and Questionnaires
17.
Eur Urol ; 51(6): 1654-62; discussion 1662-3, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17161521

ABSTRACT

OBJECTIVE: To estimate the annual direct costs of overactive bladder (OAB) in Germany from a societal perspective. METHODS: Direct costs were calculated based on prevalence figures and medical resource utilisation due to hospitalisation, office-based physician visits, visits to other health care professionals, medication, medical aids and devices, and nursing care. RESULTS: A total of 6.48 million adults>or=40 yr of age in Germany are affected by OAB, and 2.18 million of these individuals experience incontinence. The annual incidence of comorbidities attributable to OAB is 310,000 for skin infections, 40,000 for falls, 12,000 for fractures, and 26,000 for depression (based on 2004 census data). Direct OAB-related costs per year are euro3.98 billion, with euro1.76 billion covered by statutory health insurance, euro1.80 billion by nursing care insurance, and euro0.41 billion by the patients. Nursing care accounts for euro1.80 billion of total costs (45%), devices account for euro0.68 billion (17%), physician visits account for euro0.65 billion (16%), complications account for euro0.75 billion (19%), and medication accounts for euro0.08 billion (2%). CONCLUSION: OAB imposes a substantial economic burden on German health and nursing care, insurance, and on patients with OAB. Direct annual costs are comparable to those of other chronic diseases such as dementia or diabetes mellitus.


Subject(s)
Cost of Illness , Urinary Bladder, Overactive/economics , Comorbidity , Costs and Cost Analysis , Female , Germany/epidemiology , Health Care Costs , Humans , Male , Models, Economic , Prevalence , Urinary Bladder, Overactive/epidemiology , Urinary Bladder, Overactive/therapy
18.
Curr Drug Saf ; 2(1): 5-8, 2007 Jan.
Article in English | MEDLINE | ID: mdl-18690944

ABSTRACT

Erectile dysfunction occurs extensively among patients with arterial hypertension. We investigated the safety of sildenafil for patients with and without antihypertensive medication. Our study included data from 35 double-blind, placebo-controlled, and randomized investigations, with a total of 8115 patients. The term of therapy was between 6 weeks and 6 months, for both the sildenafil group (5-200 mg, n=4819) as well as the placebo group (n=3296). We studied the adverse events in the men who received 1 or more hypertensives (n=2388), and in those who took no antihypertensive medication (n=5727). Our findings disclosed equal frequency of adverse events in both groups, without influence by the number of different antihypertensives administered. The occurrence of AEs associated with blood pressure was slight, and was comparable between the individual groups. These results support the conclusion that sildenafil is also well tolerated by patients taking one or more antihypertensives. Patients being treated with alpha blockers should be stable on this therapy in order to minimize the possibility of orthostatic hypotension. An initial dose of 25 mg should furthermore be considered for these patients.


Subject(s)
Antihypertensive Agents/adverse effects , Erectile Dysfunction/complications , Piperazines/adverse effects , Sulfones/adverse effects , Vasodilator Agents/adverse effects , Antihypertensive Agents/therapeutic use , Drug Interactions , Erectile Dysfunction/drug therapy , Erectile Dysfunction/etiology , Humans , Hypertension/complications , Hypertension/drug therapy , Male , Piperazines/therapeutic use , Purines/adverse effects , Purines/therapeutic use , Sildenafil Citrate , Sulfones/therapeutic use , Vasodilator Agents/therapeutic use
19.
Article in English | MEDLINE | ID: mdl-12452529

ABSTRACT

It is proposed that alcoholism and panic disorder/agoraphobia demonstrate in part common genetic and environmental origins. Shared subthreshold symptom patterns in the parents' generation could confirm the proposed genetic role in alcoholism and panic disorder/agoraphobia, even if the parents do not fulfil the diagnostic criteria for a primary psychiatric diagnosis. This is the first family study of exploratively analyzing subthreshold symptoms in both disorders. The authors investigated families with panic disorder/agoraphobia and/or alcoholism with the Munich-Composite International Diagnostic Interview (M-CIDI). We documented the diagnoses according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and subdivided the answers of the probands into 16 subthreshold diagnostic groups comprising 259 single items. We found statistically significant correlations of subthreshold syndrome profiles in the parents of patients with panic disorder/agoraphobia and alcoholism. The presented method of analyzing syndrome profiles in a family study seems to be a possibility to demonstrate references to genetic links between patients and parents in anxiety- and alcohol-related disorders.


Subject(s)
Agoraphobia/psychology , Alcoholism/psychology , Panic Disorder/psychology , Adult , Aged , Family/psychology , Female , Humans , Interview, Psychological , Male , Middle Aged , Parents , Psychiatric Status Rating Scales
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