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PubMed1999

Sleep and serotonin: an unfinished story.

Serotonin (5-HT) was first believed to be a true neuromodulator of sleep because the destruction of 5-HT neurons of the raphe system or the inhibition of 5-HT synthesis with p-chlorophenylalanine induced a severe insomnia which could be reversed by restoring 5-HT synthesis. However the demonstration that the electrical activity of 5-HT perikarya and the release of 5-HT are increased during waking and decreased during sleep was in direct contradiction to this hypothesis. More recent experiments suggest that the release of 5-HT during waking may initiate a cascade of genomic events in some hypnogenic neurons located in the preoptic area. Thus, when 5-HT is released during waking, it leads to an homeostatic regulation of slow-wave sleep.

Animals↗

PubMed2003

Neuropsychologic side-effects of tacrolimus in pediatric renal transplantation.

Calcineurin inhibition with tacrolimus has been used after renal transplantation (RTPL) as rescue therapy for insufficient immunological control or if cyclosporin A (CSA) toxicity occurred. Neurologic side-effects occur but are rare in children, usually presenting as tremor; however, serious complications, e.g. the posterior leukoencephalopathy syndrome are also documented. Twenty children (10 girls) were switched to tacrolimus: 11 (55%) for immunological reasons (n = 9: steroid-resistant rejection; n = 2: recurrent rejections) and nine for CSA side-effects. Tacrolimus was started at a median of 8 wk (range 10 d to 8.7 yr) after RTPL and was continued for a median of 2.5 yr (range 5 wk to 4.6 yr). Renal function significantly improved over a period of 12 months following conversion to tacrolimus (glomerular filtration rate 56 +/- 19 vs. 66 +/- 16 mL/min/1.73 m2; p < 0.03; n = 13). Fifteen of 20 (75%) patients tolerated tacrolimus well. The most frequent side-effects were neuropsychological and behavioral symptoms in three children, ranging from anorexia nervosa-like symptoms with weight loss, amenorrhea, depression and school problems to severe insomnia and to aggressive and anxious behavior in one child. Only the latter child was exposed to toxic tacrolimus blood levels. All side-effects were fully reversible after discontinuation of tacrolimus. In conclusion, tacrolimus had a beneficial effect on renal function and was well tolerated in the majority of pediatric patients. However, neuropsychologic and behavioral side-effects are important and maybe underrecognized in children.

Abdominal Pain↗

PubMed2004

Internet-based cognitive-behavioral self-help treatment of tinnitus: clinical effectiveness and predictors of outcome.

The aim of this investigation was to evaluate Internet-based cognitive-behavioral therapy for tinnitus in a nonrandomized clinical effectiveness study with a sample of consecutive patients referred for psychological treatment (N = 77). Results were calculated at a group level on an intention-to-treat basis and showed significant reductions of distress on the Tinnitus Reaction Questionnaire (P. H. Wilson, J. Henry, M. Bowen, & G. Haralambous, 1991), the Hospital Anxiety and Depression Scale (A. S. Zigmond & R. P. Snaith, 1983), and on the Insomnia Severity Index (C. H. Bastien, A. Vallières, & C. M. Morin, 2001). A 3-month follow-up showed that patients remained improved. The dropout rate was 30%. Treatment compliance, external referral to the treatment, and number of earlier treatments for tinnitus were associated with positive outcome. The number of e-mails between therapist and patient concerning treatment problems was associated with worse outcome. Internet-based cognitive-behavioral therapy holds some promise as a treatment modality for tinnitus. Future research should focus on further controlled evaluations of the treatment technique and evaluate the cost-effectiveness compared to other forms of tinnitus treatments.

Adult↗

PubMed2001

Morvan's syndrome: peripheral and central nervous system and cardiac involvement with antibodies to voltage-gated potassium channels.

Morvan's 'fibrillary chorea' or Morvan's syndrome is characterized by neuromyotonia (NMT), pain, hyperhydrosis, weight loss, severe insomnia and hallucinations. We describe a man aged 76 years with NMT, dysautonomia, cardiac arrhythmia, lack of slow-wave sleep and abnormal rapid eye movement sleep. He had raised serum antibodies to voltage-gated K(+) channels (VGKC), oligoclonal bands in his CSF, markedly increased serum norepinephrine, increased serum cortisol and reduced levels and absent circadian rhythms of prolactin and melatonin. The neurohormonal findings and many of the clinical features were very similar to those in fatal familial insomnia, a hereditary prion disease that is associated with thalamic degenerative changes. Strikingly, however, all symptoms in our MFC patient improved with plasma exchange. The patient died unexpectedly 11 months later. At autopsy, there was a pulmonary adenocarcinoma, but brain pathology showed only a microinfarct in the hippocampus and no thalamic changes. The NMT and some of the autonomic features are likely to be directly related to the VGKC antibodies acting in the periphery. The central symptoms might also be due to the direct effects of VGKC antibodies, or perhaps of other autoantibodies still to be defined, on the limbic system with secondary effects on neurohormone levels. Alternatively, changes in secretion of neurohormones in the periphery might contribute to the central disturbance. The relationship between VGKC antibodies, neurohormonal levels, autonomic, limbic and sleep disorders requires further study.

Aged↗

PubMed2003

Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue.

Cancer-related fatigue is the most reported symptom among patients with cancer. Researchers in the field of psychooncology have encouraged the development of short instruments, which allow for easier completion by clinical populations while still maintaining solid psychometric properties. The current study examined the validity and reliability of the French Canadian adaptation of the Multidimensional Fatigue Inventory (MFI) among women (n = 277) and men (n = 327) undergoing therapy for breast or prostate cancer, respectively. An exploratory factor analysis of the selected 15-item MFI yielded the following four factors: general/physical, mental, reduced motivation, and reduced activity. This was supported by a confirmatory factor analysis. The reliability, as evaluated by test-retest and Cronbach alpha internal consistency reliability coefficients of the French Canadian shortened MFI, was acceptable. In addition, the four factor-based scores correlated in a theoretically meaningful manner with existing measures of mood disturbance (Profile of Mood States and Hospital Anxiety and Depression Scale), cancer-related stressors (Inventory of Recent Life Experiences), coping with illness (Coping with Health Injuries and Problems Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire), and insomnia (Insomnia Severity Index), suggesting good construct, convergent, and concurrent criterion validity. Although further validation is recommended, the results for the French Canadian MFI in assessing cancer-related fatigue in both women and men undergoing cancer treatments showed good psychometric qualities.

Adaptation, Psychological↗

PubMedDate not supplied

Neurophysiologic studies in Morvan syndrome.

This study was conducted to clarify the clinical and neurophysiologic characteristics of patients with Morvan syndrome, and to compare and contrast this syndrome with other forms of autoimmune encephalitis. A retrospective chart review of the clinical features and neurophysiologic studies of two cases of Morvan syndrome seen at the Mayo Clinic was performed. Neurophysiologic studies included polysomnography, comprehensive autonomic testing, MRI, positron emission tomography, EEG, and single-photon emission computed tomography. In two cases of Morvan syndrome, the clinical features, electrophysiologic findings, and immunologic studies (high levels of voltage-gated potassium channel antibodies) were consistent with previously reported findings. Several novel observations were made. Autonomic testing demonstrated peripheral autonomic neuropathy in addition to autonomic hyperactivity. Polysomnography showed complete absence of sleep. Neuroimaging study findings were largely normal. Morvan syndrome is an autoimmune disorder affecting both the peripheral and central nervous system. Neurophysiologic studies demonstrate hyperexcitability of peripheral nerves, autonomic dysfunction, and severe insomnia. The absence of abnormalities on imaging studies suggests that central nervous system symptoms are related to functional rather than structural disruption of neural networks.

Adult↗

PubMed2003

Effects of sertraline on sleep architecture in patients with depression.

Previous studies indicate that selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, fluvoxamine, citalopram and paroxetine, suppress rapid eye movement sleep, and increased nocturnal arousals. There has been no published report of the impact of sertraline on the sleep of depressed patients. This study examines such effects. Forty-seven patients with major depressive disorder, randomized to double-blind treatment with sertraline or placebo, completed sleep studies before and after 12 weeks of pharmacotherapy. Groups were compared using multivariate analyses of covariance and/or analyses of covariance to examine 4 empirically defined sets of sleep measures. Compared to the placebo-treated group, patients who received sertraline experienced an increase in delta wave sleep in the first sleep cycle and prolonged rapid eye movement (REM) sleep latency. Although, sertraline therapy decreased the average number of REM periods (from 3.86 to 2.40), the activity of both REM period 1 and REM period 2 was significantly increased. Aside from an increase in sleep latency, sertraline therapy was not associated with a worsening of measures of sleep continuity. There was also no significant difference between the groups on a measure of subjective sleepiness. These findings are both similar and different from those observed in previous studies of other SSRIs. The increase in delta sleep ratio and consolidation of REM sleep may have some other clinical implications. However, the generalizability of these findings is limited because of a number of reasons. Further studies are needed to examine the effects of SSRIs in acute treatment of depressed patients with severe insomnia, and the relationship of acute changes and relapse prevention of recurrent depression.

Adult↗

PubMedDate not supplied

Depression predicts self-reported sleep quality in patients with obstructive sleep apnea.

OBJECTIVE: Depression is a common problem in patients with obstructive sleep apnea. The objective of this study was to examine whether depression is independently associated with lower self-reported sleep quality in patients with obstructive sleep apnea (OSA), after controlling for polysomnographic measures of sleep. METHODS: The sample comprised 135 patients who had been referred to a university teaching hospital's multidisciplinary sleep medicine center for polysomnographic evaluation of OSA. The median age of the subjects was 45 (mean age, 46 years) 55% were female, 69% were white, 31% were black, and their mean body mass index was 37.9 +/- 11.2 kg/m2. Self-reported sleep quality during the past 2 weeks was assessed by the insomnia severity index. Polygraphic measures of sleep quality included the respiratory disturbance index, sleep onset latency, arousals for no apparent reason, sleep efficiency, and periodic leg movements associated with arousal. Depressive symptoms were assessed by the Beck Depression Inventory. RESULTS: None of the polygraphic measures of sleep quality was related to self-reported sleep quality or depression. Oxygen desaturation was correlated with self-reported sleep quality (r = 0.21, p =.02). Depression correlated with self-reported sleep quality (r = 0.55, p <.0001). In a multiple regression analysis, depression remained a significant predictor of self-reported sleep quality after controlling for all of the polysomnographic measures of sleep quality (F = 9.65, partial r2 = 0.28 p =.0001). CONCLUSION: Depression is a better predictor of self-reported sleep quality than are polysomnographic measures of sleep in patients with OSA.

Adolescent↗

PubMed1983

Efficacy and safety of midazolam and oxazepam in insomniacs.

In a multicentre, double-blind, parallel study performed in 78 hospitalized patients who complained of mild, moderate or severe insomnia, the efficacy and safety of 15 mg midazolam were compared with those of 15 mg oxazepam, both orally administered. The results showed statistically significant better results in the onset of sleep in the patients treated with midazolam. Other sleep parameters, such as quality and duration of sleep as well as the condition of the patients on morning awakenings, were also improved in more patients treated with midazolam. Safety (clinical and biological) was very good in both groups of patients.

Anti-Anxiety Agents↗

PubMed2005

A multicenter, open-label study to evaluate satisfaction and menopausal quality of life in women using transdermal estradiol/norethindrone acetate therapy for the management of menopausal signs and symptoms.

AIM: This multicenter, open-label, single-arm study evaluated subject satisfaction and improvements in menopausal quality of life among menopausal women using the CombiPatch transdermal system consisting of 17beta-estradiol 0.05 mg plus norethindrone acetate 0.14 mg in a matrix patch formulation. METHODS: The 193 postmenopausal women between the ages of 45 and 65 years who comprised the modified intent-to-treat population (at least one patch and one efficacy assessment) were required to have reported at least five daily moderate-to-severe hot flashes and episodes of nocturnal sweating upon study entry for at least 1 month and applied one patch twice a week for 12 weeks. At weeks 0, 6, and 12, the women completed the Menopause-Specific Quality of Life (MENQOL) Questionnaire and, as a secondary study outcome, reported the scale of their application site discomfort. During weeks 1-12, they also kept diary records of number and severity of hot flashes and four other menopausal symptoms. Skin tolerance and adherence of the transdermal system were evaluated at weeks 6 and 12 by qualified evaluators. At week 6 and the end of the study, both subjects and physicians rated their satisfaction with the system. RESULTS: Among women in the modified intent-to-treat population, transdermal 17beta-estradiol plus norethindrone acetate significantly reduced the mean daily number of moderate-to-severe hot flashes experienced by women from 4.1 at week 1 to 0.6 at week 12 (p < 0.0001). The mean ratings of headache severity, insomnia, and vaginal irritation/dryness also improved significantly by week 6 and were maintained at week 12. At week 12, 92.4% of the subjects and 97.3% of the physicians reported that they were 'satisfied' or 'very satisfied' with the transdermal hormone delivery system. CONCLUSIONS: The results of this study compare favorably with previous placebo-controlled studies of transdermal hormone therapy in managing menopausal signs and symptoms. Furthermore, quality of life was significantly improved by the transdermal hormone therapy system, and both subjects and physicians reported high levels of satisfaction.

Administration, Cutaneous↗

PubMed1984

A clinical trial with DSIP.

In an open study 7 patients with severe insomnia were treated by a series of 10 injections with the delta-sleep-inducing peptide (DSIP). In all but 1 case sleep was normalized for follow-up periods of 3-7 months. The mood and performance during the daytime improved as well. A problem may be a long-standing habit of drug addiction.

Adult↗

PubMed1995

Delayed sleep phase syndrome: a review of its clinical aspects.

OBJECTIVE: Delayed sleep phase syndrome is a common but little reported cause of severe insomnia. Since it was first described, few detailed reports of delayed sleep phase syndrome have appeared, and treatment methods have not been reviewed. From the literature, the authors provide diagnostic descriptions and review treatment methods, and from their sleep disorder clinic, they describe the management and outcome of the largest series of patients with delayed sleep phase syndrome thus far reported. METHOD: The authors reviewed all articles with primary data on delayed sleep phase syndrome published through 1993 and add data from a group of 33 patients at their sleep disorder clinic. RESULTS: Delayed sleep phase syndrome involves undesirably late bedtimes and arising times, early night insomnia, and poor morning alertness but lack of insomnia on vacations. The mean bedtime and arising time for the 33 patients were 4:00 a.m. and 10:38 a.m., respectively. Twenty-five patients were, or had been, depressed. Individual responses to treatments varied widely. Seventeen patients showed little treatment response. Delayed sleep phase syndrome had a worse treatment outcome than other sleep disorders. CONCLUSIONS: Delayed sleep phase syndrome presents in a heterogeneous manner. In the sleep disorder clinic population, it was often associated with major depression and was more resistant to treatment than other sleep disorders. Multiple and varied treatments are required.

Adolescent↗

PubMed1996

Melatonin replacement corrects sleep disturbances in a child with pineal tumor.

A child with a germ cell tumor involving the pineal region had marked suppression of melatonin secretion associated with severe insomnia. Exogenous melatonin (3 mg in the evening) for 2 weeks restored sleep continuity, as demonstrated by objective monitoring of rest-activity cycles. This case report provides direct evidence of the essential role of melatonin in normal sleep.

Adolescent↗

PubMed1993

Antidepressant drugs and the emergence of suicidal tendencies.

Although antidepressant medications represent the cornerstone of treatment for patients with moderate to severe clinical depression, they also carry serious risks. There is evidence which suggests that antidepressants can, in rare instances, induce or exacerbate suicidal tendencies. Nine clinical mechanisms have been proposed through which this may occur. These are: (a) energizing depressed patients to act on pre-existing suicidal ideation; (b) paradoxically worsening depression; (c) inducing akathisia with associated self-destructive or aggressive impulses; (d) inducing panic attacks; (e) switching patients into manic or mixed states; (f) producing severe insomnia or interfering with sleep architecture; (g) inducing an organic obsessional state; (h) producing an organic personality disorder with borderline features; and (i) exacerbating or inducing electroencephalogram (EEG) or other neurological disturbances. Epidemiological and controlled studies also provide data on the association between antidepressant drugs and suicidal ideation, attempts and fatalities. These include studies which: (a) suggest that electroconvulsive therapy may be more effective than antidepressant drugs in reducing the frequency of suicide attempts; (b) indicate that antidepressants may differ in their capacity to reduce the frequency of suicide attempts; (c) find that more overdose attempts were made by patients receiving maprotiline than placebo; and (d) suggest that fluoxetine may be associated with a greater risk of inducing de novo suicidal ideation. Evidence suggests that antidepressants may vary by at least 15-fold in the number of fatal overdoses per million prescriptions. Estimated overdose proclivity rates were derived after adjusting the fatal toxicity data by the therapeutic index of the drug. These rates were very consistent between agents with the same pharmacological properties, and correlated well with known overdose risk rates for amitriptyline, mianserin and maprotiline. Estimated overdose proclivity rates suggest that the highly selective noradrenaline (norepinephrine) uptake inhibitors (desipramine, nortriptyline, maprotiline) may be associated with a greater risk for overdose than more mixed uptake inhibitors and monoamine oxidase inhibitors (MAOIs). Antidepressants are not uniformly neutral in regard to suicidal ideation and attempts. Data clearly demonstrate that antidepressants ameliorate suicidal ideation more effectively than placebo in patients with depression. Although antidepressants diminish suicidal ideation in many recipients, about as many patients experience worsening suicidal ideation on active medication as they do on placebo. Furthermore, at least as many patients attempted suicide on fluoxetine and tricyclic antidepressants as on placebo, and more patients attempted to overdose on maprotiline than placebo. These observations suggest that antidepressants may redistribute suicide risk, attenuating risk in some patients who respond well, while possible enhancing risk in others who respond more poorly.(ABSTRACT TRUNCATED AT 400 WORDS)

Antidepressive Agents↗

PubMed2026

Effectiveness of Mobile-Delivered Exercise and Yoga Programs on Depressive Symptom Reduction in Employees: Randomized Controlled Trial.

BACKGROUND: Mental health challenges such as stress and depression are prevalent among employees. Mobile health platforms that deliver exercise or yoga interventions offer a promising approach to improve mental health outcomes in this population. OBJECTIVE: This study aimed to assess the effectiveness of 12-session adaptive moderate-intensity exercise and yoga programs delivered via a motion-detecting digital platform in reducing stress and depressive symptoms among employees. METHODS: This was an unblinded, 3-arm, parallel-group, randomized controlled trial conducted at Seoul National University Bundang Hospital and Boramae Medical Center between November 2023 and January 2024. Eligible participants were full-time employees. Seventy-five participants were randomly assigned to an exercise, a yoga, or a cognitive behavioral therapy-based self-care control group using computer-generated randomization. The exercise and yoga groups engaged in motion-detecting, adaptive physical activity training, whereas the control group accessed mobile-based, self-directed stress management educational materials. The intervention was largely automated, with no individualized therapeutic guidance provided. Allocation was concealed until trial entry. All recruitment and outcome assessments were conducted in person at the hospitals. The primary outcomes were perceived stress and depressive symptoms, whereas the secondary outcomes included posttraumatic stress, insomnia severity, cognitive stress response, occupational stress, and burnout. Physiological outcomes were assessed using heart rate variability and electroencephalography. Measurements were collected at baseline, immediately after the intervention, and at 4-week follow-up. Data were analyzed using a multivariate linear model to evaluate the main effects of time, group, and time×group interactions. RESULTS: Of the 75 randomized participants (exercise: n=24, 32%; yoga: n=25, 33.3%; and control: n=26, 34.7%), 71 (94.7%) who completed at least 9 of the 12 sessions (≥40 min each) were included in the outcome analysis (exercise: n=21, 29.5%; yoga: n=24, 33.8%; and control: n=26, 36.6%). For the coprimary outcomes, the group×time interaction for depressive symptoms (Patient Health Questionnaire-9) approached but did not reach the Bonferroni-corrected threshold (F4,136=2.71; P=.03; adjusted α=.025); however, planned pairwise comparisons revealed significantly greater improvement in the yoga group compared to the control group at 4-week follow-up (β=-3.67; adjusted P<.001). For the Perceived Stress Scale, the interaction was not significant (P=.29), although a significant main effect of time (P<.001) indicated overall stress reduction across all groups. For secondary outcomes, a significant group×time interaction was found for the Cognitive Stress Responses Scale (P=.003), indicating differential trajectories of improvement. The yoga group showed a consistent linear decrease, whereas the exercise group showed immediate but less sustained gains. CONCLUSIONS: Digitally delivered adaptive yoga programs demonstrated superior and sustained improvements in depressive symptoms and Cognitive Stress Responses Scale scores compared with the active cognitive behavioral therapy-based self-care control group. However, the exercise program showed more modest and less sustained effects, warranting further investigation using larger samples.

Adult↗

PubMed2026

[Efficacy and safety of acute-phase transcutaneous auricular vagus nerve stimulation for herpes zoster-related pain in middle-aged and elderly patients with comorbid depression and anxiety].

Objective: To evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) during the acute phase in middle-aged and elderly patients with herpes zoster (HZ) comorbid depressive and anxiety states. Methods: This was a randomized controlled trial. Forty middle-aged and elderly patients with acute-phase HZ who attended the Department of Dermatology at Xuanwu Hospital, Capital Medical University, from June 2024 to June 2025 were enrolled and randomly assigned in a 1∶1 ratio using a random number table to receive either taVNS (n=20) or sham stimulation (n=20) for 5 consecutive days. Both groups received antiviral therapy and on-demand rescue analgesia. Pain, anxiety/depression, and sleep quality were evaluated using the Visual Analog Scale (VAS), the 4-item Patient Health Questionnaire (PHQ-4), and the Insomnia Severity Index (ISI), respectively. The primary outcome was the incidence of subacute pain at 30 days post-rash onset. Secondary outcomes included cumulative analgesic consumption at 1 and 2 weeks after treatment, the changes from baseline (Δ values) in PHQ-4 and ISI scores at 2 weeks, and the incidence of postherpetic neuralgia (PHN) at 90 days post-rash onset. Results: In the taVNS group, 7 patients (35%) were female, with a mean age of (64.1±9.7) years; in the sham group, 10 patients (50%) were female, with a mean age of (61.5±8.5) years. There were no statistically significant differences between the two groups in baseline VAS, PHQ-4, or ISI scores (all P>0.05). The incidence of subacute pain was significantly lower in the taVNS group than in the sham group [5% (1/20) vs 35% (7/20), RD=-30.0% (95%CI:-52.1%--4.9%); RR=0.14 (95%CI: 0.02-1.06); P=0.044]. At 2 weeks after treatment, the Δ values of PHQ-4 and ISI in the taVNS group were significantly greater than those in the sham group. The proportion of patients taking Lofentadine and the cumulative Lofentadine consumption at weeks 1 and 2 were both lower in the taVNS group than in the sham group (all P<0.05). No serious adverse events occurred in either group, and the difference in PHN incidence between groups was not statistically significant (P>0.05). Conclusions: Acute-phase taVNS appears to be feasible and safe in middle-aged and elderly patients with HZ and comorbid depressive and anxiety, effectively reducing subacute pain and improving emotional and sleep outcomes.

Humans↗

PubMedDate not supplied

Children in homeless families in Melbourne: health status and use of health services.

OBJECTIVE: To determine the prevalence of health and behaviour problems in a sample of children in homeless families and of psychological problems in their parents, and to assess the use of health services by homeless families. DESIGN: A cross-sectional, questionnaire-based prevalence survey. SETTING: Supported accommodation provided by a welfare service in Melbourne between May 1994 and June 1995. SUBJECTS: 51 children from 31 families soon after housing crises. RESULTS: More than one-third of all children had total behaviour problems scores in the "deviant" range (i.e., requiring mental health referral). Intellectual disability/developmental delay, skin problems, vision problems, recurrent headache, and asthma or other breathing problems were more prevalent in these homeless children than in a large Australian normative population. Their mothers scored higher than a large normative sample on the mental health questionnaire, most markedly for "anxiety-insomnia", "severe depression" and total score. Cost of treatment and transport difficulties were seen as barriers to using health care services. RECOMMENDATIONS: Australian health-care practitioners should be aware of the health and health service access problems of children in homeless families, and work to minimise their physical, emotional, developmental and academic disadvantages. Psychological support services should be available for homeless families, particularly for mothers.

Adult↗

PubMed1997

Once Daily Fleroxacin and Twice Daily Ciprofloxacin are Both Effective in the Treatment of Complicated Urinary Tract Infections.

In a multicenter randomized double-blind, trial, 90 patients received either fleroxacin 400mg pa once/day or ciprofloxacin 500mg po twice/day for treatment of complicated urinary tract infections (UTI). Treatment was administered orally and presumptively. Bacteriological efficacy was assessed 7 days post-treatment. In total, 78 patients were available for efficacy testing: 40 in the fleroxacin group and 38 in the ciprofloxacin group. The bacteriological cure rate was 92.5% and 94.7% in the fleroxacin and ciprofloxacin groups, respectively. The most commonly isolated pathogen (E.coli) was erradicated in 94.1% and 95.8% of the cases in fleroxacin and ciprofloxacin groups, respectively. Eight patients in the fleroxacin group had some adverse events, two of them severe (insomnia and photodermatitis). In the ciprofloxacin group, 11 patients had adverse events of mild to moderate intensity, mainly affecting the digestive system. ln conclusion, fleroxacin 400mg po once/day and ciprofloxacin 500mg po twice/day were both effective in the treatment of complicated urinary tract infections.

Journal Article↗