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Open Trial (open + trial)

Distribution by Scientific Domains

Medical Sciences	100%

Distribution within Medical Sciences

Psychiatry	27%
Dermatology	18%

Selected Abstracts

Open trial of nefazodone among Hispanics with major depression: Efficacy, tolerability, and adherence issues

DEPRESSION AND ANXIETY, Issue 3 2001
J. Arturo Sánchez-Lacay M.D., M.P.H.
Abstract The efficacy and tolerability of nefazodone in the treatment of major depression among Spanish-monolingual Hispanics was examined and compared to historical controls among English-speaking, predominantly non-Hispanic subjects. Fifty monolingual Hispanic outpatients with major depression and a HAM-D17 score ,18 were treated with nefazodone in a flexible-dose 8-week open-label protocol. Sixty-three percent of the intent-to-treat (ITT) sample with ,1 efficacy visit were considered responders according to CGI-I criteria, falling within the range of response rates (58,69%) reported in six prior nefazodone trials with non-Hispanic subjects. Significant improvement was found for the ITT and completer samples in HAM-D17, HAM-D28, and SCL-90 scores and in two measures of psychosocial functioning. Endpoint mean dose in the ITT sample was 379 mg/day (SD=170), also within the range of previous trials (321,472mg/day). Adverse effects were not elevated, with only dry mouth (8%) reported by >6% of subjects. However, 42% of the sample dropped out of treatment before study termination, usually because of side effects or due to family or work difficulties, a higher rate than previously reported for nefazodone (21,33%). This open trial finds nefazodone to be an efficacious treatment for major depression among monolingual Hispanics, with comparable efficacy to previous controlled trials among non-Hispanic subjects. Double-blind studies are required to confirm this comparable efficacy. Mean endpoint doses and adverse effect rates similar to previous trials do not support the need for reduced doses of nefazodone among Hispanics. However, an elevated rate of treatment discontinuation threatens treatment efficacy among this population. Causes for this elevated rate require explanation, given the apparently unremarkable pattern of adverse effect reports. Depression and Anxiety 13:118,124, 2001. © 2001 Wiley-Liss, Inc. [source]

Open trial of ciclosporin treatment for Stevens,Johnson syndrome and toxic epidermal necrolysis

BRITISH JOURNAL OF DERMATOLOGY, Issue 4 2010
L. Valeyrie-Allanore
Summary Background, Stevens,Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are acute mucocutaneous reactions associated with poor prognosis. The treatment is mainly symptomatic, based on supportive care. Until now, several curative treatments have been proposed without evidence of effectiveness. Objectives, To evaluate the effect of ciclosporin on SJS and TEN after a short series had suggested a benefit. Methods, We conducted an open, phase II trial to determine the safety and possible benefit of ciclosporin. Among the 45 consecutive patients admitted for SJS/TEN from March 2005 to September 2007, 29 fulfilled inclusion criteria. Ciclosporin was administered orally (3 mg kg,1 daily for 10 days) and tapered over a month. Clinical and biological evaluations were performed sequentially. Predicted death rate was estimated with a validated prognostic score (SCORTEN). Results, Twenty-nine patients were included at a mean ± SD of 2·8 ± 1·8 days after onset. The final diagnosis was SJS (n = 10), SJS/TEN overlap (n = 12) and TEN (n = 7). One month of treatment was completed in 26. Ciclosporin was stopped after more than 10 days in three cases for side-effects including posterior leucoencephalopathy (n = 1), neutropenia (n = 1) and nosocomial pneumopathy (n = 1). Ciclosporin dosage was tapered earlier than scheduled in two cases for alteration in renal function. The prognostic score predicted 2·75 deaths; none occurred (P = 0·1). Mean epidermal detachment remained stable in 18 of 29 cases (62%). The mean ± SD hospital stay was 16·2 ± 9·1 days. Conclusions, Both the death rate and the progression of detachment seemed lower than expected, suggesting a possible usefulness of ciclosporin in SJS and TEN that needs to be confirmed. [source]

Open trial of nefazodone among Hispanics with major depression: Efficacy, tolerability, and adherence issues

Metabolic effects of metformin in patients with impaired glucose tolerance

DIABETIC MEDICINE, Issue 7 2001
M. Lehtovirta
Abstract Aims To assess the effect of metformin on insulin sensitivity, glucose tolerance and components of the metabolic syndrome in patients with impaired glucose tolerance (IGT). Methods Forty first-degree relatives of patients with Type 2 diabetes fulfilling WHO criteria for IGT and participating in the Botnia study in Finland were randomized to treatment with either metformin 500 mg b.i.d. or placebo for 6 months. An oral glucose tolerance test (OGTT) and a euglycaemic hyperinsulinaemic clamp in combination with indirect calorimetry was performed at 0 and 6 months. The patients were followed after stopping treatment for another 6 months in an open trial and a repeat OGTT was performed at 12 months. Results Metformin treatment resulted in a 20% improvement in insulin-stimulated glucose metabolism (from 28.7 ± 13 to 34.4 ± 10.7 µmol/kg fat-free mass (FFM)/min) compared with placebo (P = 0.01), which was primarily due to an increase in glucose oxidation (from 16.6 ± 3.6 to 19.1 ± 4.4 µmol/kg FFM; P = 0.03) These changes were associated with a minimal improvement in glucose tolerance, which was maintained after 12 months. Conclusions Metformin improves insulin sensitivity in subjects with IGT primarily by reversal of the glucose fatty acid cycle. Obviously large multicentre studies are needed to establish whether these effects are sufficient to prevent progression to manifest Type 2 diabetes and associated cardiovascular morbidity and mortality. Diabet. Med. 18, 578,583 (2001) [source]

Chronic high dose transdermal nicotine in Parkinson's disease: an open trial

EUROPEAN JOURNAL OF NEUROLOGY, Issue 12 2007
G. Villafane
Whether nicotine has therapeutic effects on Parkinson's disease (PD) symptoms is controversial, but high doses and chronic treatment have never been tested. We report the results of a pilot, open-label trial to assess the safety and possible efficacy of chronic high doses of nicotine. Six patients with advanced idiopathic PD received increasing daily doses of transdermal nicotine up to 105 mg/day over 17 weeks. All patients but one accepted the target dose. Nausea and vomiting were frequent but moderate, and occurred in most of the patients (four of six) who received over 90 mg/day and 14 weeks of nicotine treatment. During the plateau phase, patients improved their motor scores and dopaminergic treatment was reduced. These results confirm the feasibility of chronic high dose nicotinic treatment in PD but warrant validation of the beneficial effects by a randomized controlled trial. [source]

Repeat intrathecal triamcinolone acetonide application is beneficial in progressive MS patients

EUROPEAN JOURNAL OF NEUROLOGY, Issue 1 2006
V. Hoffmann
Available immunomodulatory and conventional steroid treatment regimens provide a limited symptomatic benefit for patients with progressive multiple sclerosis (MS). We performed an open trial on the short-term efficacy of repeated intrathecal application of the sustained release steroid triamcinolone acetonide (TCA) in 27 progressive MS patients. Six TCA administrations, performed every third day, reduced the Expanded Disability Status Scale (EDSS) score [initial: 5.4 ± 1.3, 3,7.5 (mean ± SD, range); end: 4.9 ± 1.1; 2.5,6.5; P < 0.001] and significantly increased the walking distance and speed in particular after the fourth TCA injection. Concomitantly serially determined cerebrospinal fluid (CSF) markers of cell injury, neuron-specific enolase, total , -protein, S-100, and , -amyloid did not significantly change within the interval of TCA treatment. No serious side effects appeared. We conclude that repeat intrathecal injection of 40 mg TCA provides a substantial benefit in progressive MS patients with predominant spinal symptoms and does not alter CSF markers of neuronal cell injury. [source]

Differences in cognitive factors between "true drug" versus "placebo pattern" response to fluoxetine as defined by pattern analysis

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 4 2006
Amy H. Farabaugh
Abstract Objective Pattern analysis has identified two types of response patterns to antidepressants: "true drug" response (TDR) and "placebo pattern" response (PPR). This study examines the relationship between cognitive factors and TDR and PPR to fluoxetine. Methods We assessed 310 outpatients meeting DSM-III-R criteria for major depressive disorder (MDD) who were enrolled in an 8-week open trial of fluoxetine 20,mg/day. Response patterns were determined using the clinical global impressions-improvement (CGI-I). We administered the following self-rated scales to all patients at the baseline visit and at endpoint: perceived stress scale (PSS), cognitions questionnaire (CQ), Beck hopelessness scale (BHS) and dysfunctional attitudes scale (DAS). Results One hundred and thirty-four patients had TDR, 66 patients had PPR, and 110 patients were non-responders (NR). Demographic variables and severity of depression at baseline (HAMD-17) were not significantly different between the two response pattern groups. We compared cognitive factors before and after treatment across patients with TDR and PPR, and there were no significant differences at baseline in CQ, PSS, BHS, and DAS scores. At endpoint, outpatients with PPR had significantly lower scores on the PSS (p,<,0.001) compared to the patients with TDR, even after adjusting for multiple comparisons and severity of depression at endpoint. Conclusions Significant differences in cognitive/psychological factors, specifically lower post-treatment perceived stress, accompany "placebo" pattern of response to antidepressant treatment and differentiate it from "true drug" response pattern, as defined by pattern analysis. Copyright © 2006 John Wiley & Sons, Ltd. [source]

Subcutaneous lispro and intravenous regular insulin treatments are equally effective and safe for the treatment of mild and moderate diabetic ketoacidosis in adult patients

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 4 2006
H. Ö. Ersöz
Summary In this prospective, randomised, open trial, we wanted to evaluate the efficacy and safety of hourly subcutaneous (SC) insulin lispro administration in the treatment of diabetic ketoacidosis (DKA) in comparison with intravenous (IV) regular insulin treatment. Twenty patients were enroled in the study. The patients were randomly assigned into two groups. Following a bolus injection of 0.15 U/kg IV regular insulin, group L received half of this dose as hourly SC insulin lispro while group R was treated conventionally with IV regular insulin infusion. At the end of treatment period, time that needed for normalisation of serum glucose, ,-hydroxybutyrate, blood pH and urine ketone levels were not different in groups L and R. There was no mortality or serious side effects in both groups. In this study, we revealed that treatment of mild and moderate DKA with SC insulin lispro is equally effective and safe in comparison with IV regular insulin. [source]

Topical formic acid puncture technique for the treatment of common warts

INTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 6 2001
Ramesh M. Bhat MD
Background Warts are a common chronic skin disorder that can be cosmetically disfiguring and, depending on the location, cause inhibition of function. The presence of dozens of topical and systemic treatments for warts is a testament to the lack of a rapid, simple, uniformly effective, inexpensive, nonscarring, and painless treatment. Aim The purpose of this study was to determine the efficacy and safety of 85% formic acid application, an inexpensive therapy, for the treatment of warts. Methods A placebo-controlled, nonrandomized, open trial was performed in 100 patients with common warts attending Father Muller's Medical College Hospital, Mangalore. Fifty patients received 85% formic acid application and 50 patients received placebo (water) using a topical application/needle puncture technique every other day. Results Ninety-two per cent of patients who received formic acid application showed complete disappearance of warts after a 3,4-week treatment period, compared to 6% in the placebo group. Conclusions The results show that 85% formic acid application is a safe, economical, and effective alternative in the treatment of common warts with few side-effects and good compliance. A multicenter trial is needed to examine the efficacy and safety of this treatment. [source]

Antidepressant efficacy and cognitive effects of repetitive transcranial magnetic stimulation in vascular depression: an open trial

INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 9 2004
I. Fabre
Abstract Background Beneficial effects of repetitive transcranial magnetic stimulation (rTMS) were demonstrated by many controlled studies in major depression. Moreover, this promising and non invasive therapeutic tool seems to be better tolerated than electroconvulsive therapy. Vascular depression is a subtype of late-life depression, associated with cerebrovascular disease and means a poorer response to antidepressant treatment. We employed rTMS over the left prefrontal cortex in 11 patients with late-onset resistant vascular depression. The primary purpose of this two-week open study was to examine antidepressant efficacy of rTMS in vascular depression. The secondary aim was to evaluate cognitive effects of rTMS in our sample. Methods Clinical status, as measured with the Hamilton Depression Rating Scale (HDRS), and cognitive effects, as evaluated by neuropsychological tests, were assessed at baseline and after two weeks of rTMS. Brain measurements to obtain an index of prefrontal atrophy were performed at both the motor cortex and prefrontal cortex. Results Five out of 11 resistant patients with late-onset vascular depression were responders. They showed a clinically meaningful improvement in HDRS scores, with a decrease of 11, 4 points (p<0.01). Antidepressant response is correlated to the relative degree of prefrontal atrophy (p = 0.05). After two weeks, verbal fluency and visuospatial memory improved. No cognitive performance deteriorated except for verbal memory, as the delayed recall decreased significantly in the responders' group. Conclusions Our preliminary observations prompt to perform a subsequent controlled study to examine if rTMS may constitute an alternative to electroconvulsive therapy. Copyright © 2004 John Wiley & Sons, Ltd. [source]

Hormone Replacement Therapy Dissociates Fat Mass and Bone Mass, and Tends to Reduce Weight Gain in Early Postmenopausal Women: A Randomized Controlled 5-Year Clinical Trial of the Danish Osteoporosis Prevention Study,

JOURNAL OF BONE AND MINERAL RESEARCH, Issue 2 2003
LB Jensen MD
Abstract The aim of this study was to study the influence of hormone replacement therapy (HRT) on weight changes, body composition, and bone mass in early postmenopausal women in a partly randomized comprehensive cohort study design. A total of 2016 women ages 45,58 years from 3 months to 2 years past last menstrual bleeding were included. One thousand were randomly assigned to HRT or no HRT in an open trial, whereas the others were allocated according to their preferences. All were followed for 5 years for body weight, bone mass, and body composition measurements. Body weight increased less over the 5 years in women randomized to HRT (1.94 ± 4.86 kg) than in women randomized to no HRT (2.57 ± 4.63, p = 0.046). A similar pattern was seen in the group receiving HRT or not by their own choice. The smaller weight gain in women on HRT was almost entirely caused by a lesser gain in fat. The main determinant of the weight gain was a decline in physical fitness. Women opting for HRT had a significantly lower body weight at inclusion than the other participants, but the results in the self-selected part of the study followed the pattern found in the randomized part. The change in fat mass was the strongest predictor of bone changes in untreated women, whereas the change in lean body mass was the strongest predictor when HRT was given. Body weight increases after the menopause. The gain in weight is related to a decrease in working capacity. HRT is associated with a smaller increase in fat mass after menopause. Fat gain protects against bone loss in untreated women but not in HRT-treated women. The data suggest that women's attitudes to HRT are more positive if they have low body weight, but there is no evidence that the conclusions in this study are skewed by selection bias. [source]

Treatment of chronic liver diseases with traditional Chinese medicine

JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 2000
Bao-En Wang
Traditional Chinese medicine is still being extensively used for treatment of liver disease in China. The anti-viral herbs, Phyllanthus amarus, P. niruri and P. urninaria, and Oxymatrine extracted from Sophora flavecientis and S. subprostratae, have been shown to have a remarkable HBV suppressing effect with a serum conversion rate for HBeAg and HBV DNA around 45%, similar to that of IFN-,. The anti-inflammatory compound, Stronger NeoMinophagen C (SNMC), is a Japanese preparation of glycerrhizin, extracted from Glyceriza glabra, which has shown an effective rate of ALT and AST normalization and reduction to < 60 U/L in 65.6% and 73.5% of patients. Compound 861, made of 10 herbs with Salvia miltiorrhiza as its chief component, has been shown experimentally to be effective in suppressing fibrogenesis, enhancing collagen degradation, and inhibiting TIMP expression. Clinically, an open trial of 2000 patients showed improvement of symptoms in 83% and normalization of serum ALT in 82%. In a controlled study of 107 patients with HBV-related diseases, double liver biopsies showed that the fibrosis reversal rate after 6 months treatment with Cpd 861 was 78% in S2, 82% in S3 (precirrhotic stage) and 75% in S4 (early cirrhosis), as assessed by Scheuer's and Chevallier's criterion. In conclusion, traditional Chinese medicine has great potential in the treatment of chronic hepatitis B. [source]

Hepatitis B vaccination in haemodialysis patients: A randomized clinical trial

NEPHROLOGY, Issue 3 2009
MARILENE BOCK
SUMMARY Aim: A short vaccination protocol against hepatitis B was compared to the standard approach in patients under haemodialysis who were primarily non-responsive to the vaccine. Methods: This randomized, controlled open trial included 51 chronic haemodialysis subjects previously vaccinated against hepatitis B and with anti-HBs levels of less than 10 IU/mol/L. Twenty-six patients received 20 µg i.m. once a week for 8 weeks (short protocol) and 25 subjects three doses of 40 µg i.m. at months 0, 1 and 6 (standard protocol). Clinical and laboratory data were compared between responders and non-responders. A logistic regression model included selected parameters to assess risk factors for non-seroconversion. Results: Seroconversion rates to vaccine at 2 months were 80% and 78% in the short and standard protocol groups, respectively (P = 0.99). Median of anti-HBs levels were similar up to 6 months of follow up, but patients in the standard protocol showed a trend to higher anti-HBs in month 3 and a more steady decline in antibody titres. Non-responders were older, had longer duration of dialysis and a higher prevalence of a prior renal transplant and hepatitis C. In multivariate analysis, only advanced age and hepatitis C remained independently associated with non-responsiveness to vaccination. Conclusion: In haemodialysis patients, a short vaccination protocol against hepatitis B did not provide any benefit compared to the standard approach with respect to peak anti-HBs titres or a higher rate of seroprotection at the end of follow up. Other strategies to increase seroconversion rates should be explored, especially in the elderly and in patients with hepatitis C. [source]

Efficacy of 1.25% and 1% topical cyclosporine in the treatment of severe vernal keratoconjunctivitis in childhood

PEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 7 2006
Laura Spadavecchia
Cyclosporine eyedrops 2% have been used for treatment of corticosteroid-resistant vernal keratoconjunctivitis (VKC) cases. The purpose of our study was to verify the efficacy of 1.25% vs. 1% topical cyclosporine in improving severe form of VKC in childhood. Twenty children with severe VKC, were enrolled in a double-blind, placebo-controlled study and received cyclosporine 1.25% in one eye for 2 wk. Then an open trial was conducted during the next 3 months and 2 wk. Thirty-two more patients were recruited the next year into a new open trial and they received cyclosporine 1% for 4 months. Ocular subjective symptoms and objective signs were scored in all children at entry, 2 wk and 4 months. Skin prick tests and conjunctival scraping tests were also performed; serum immunological and biochemical markers were assessed. The mean score values for severity of subjective symptoms and objective signs were significantly decreased after 2 wk, and 4 months, compared with those at entry (p < 0.001), in both groups of children who received cyclosporine eyedrops 1.25% and 1%, respectively. Serum markers did not differ from the beginning to the end of treatment. Conjunctival eosinophils and cyclosporine serum levels were not detectable at the end of therapy, nor were endothelial corneal cells damaged. Our findings suggest that 1% cyclosporine concentration might be the minimal effective treatment regimen to control symptoms and local inflammation in severe forms of VKC. [source]

St John's Wort treating patients with autistic disorder

PHYTOTHERAPY RESEARCH, Issue 11 2009
Helmut Niederhofer
Abstract Problems of eye contact and expressive language limit the effectiveness of educational and behavioral interventions in patients suffering from pervasive developmental disorders. For that reason, additive psychopharmacological interventions are sometimes needed to improve symptomatology. In our preliminary open trial, three male patients with autistic disorder, diagnosed by ICD-10 criteria, completed an open trial of St John's Wort. Subjects were included in the study if their eye contact and expressive language was inadaequate for their developmental level and if they had not tolerated or responded to other psychopharmacologic treatments (methylphenidate, clonidine or desipramine). Parent and mentor ratings on the Aberrant Behavior Checklist, irritability, stereotypy, and inappropriate speech factors improved slightly during treatment with St John's Wort. Clinician ratings (Psychiatric Rating Scale Autism, Anger and Speech Deviance factors; Global Assessment Scale; Clinical Global Impressions efficacy) did not improve significantly. St John's Wort was only modestly effective in the short-term treatment of irritability in some patients with autistic disorder. Copyright © 2009 John Wiley & Sons, Ltd. [source]

Perospirone in the treatment of patients with delirium

PSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 1 2007
TAKASHI TAKEUCHI phd
Abstract, Perospirone is a recently developed atypical antipsychotic with potent serotonin 5-HT2 and dopamine D2 antagonist activity. Other atypical antipsychotics including risperidone, quetiapine and olanzapine have been widely used for treatment, not only for schizophrenia symptoms but also for delirium, because of their low potential to induce extrapyramidal disturbances. In the present study the effectiveness and safety of perospirone in patients with delirium are described. Thirty-eight patients with DSM-IV delirium were given open-label perospirone. To evaluate the usefulness of perospirone, scores from 13 severity items of the Delirium Rating Scale-Revised-98 were assessed. Data were gathered from October 2003 to September 2004. Perospirone was effective in 86.8% (33/38) of patients, and the effect appeared within several days (5.1 ± 4.9 days). The initial dose was 6.5 ± 3.7 mg/day and maximum dose of perospirone was 10.0 ± 5.3 mg/day. There were no serious adverse effects. However, increased fatigue (15.2%), sleepiness (6.1%), akathisia (3.0%) and a decline in blood pressure (3.0%) were observed. It is proposed that perospirone may be another safe and effective atypical antipsychotic drug for the treatment of delirium symptoms in hospitalized patients. This is a preliminary open trial, and further randomized double-blind placebo-controlled tests are needed. [source]

Open label study of the effect of amantadine on weight gain induced by olanzapine

PSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 2 2004
WON-MYONG BAHK md
Abstract, The purpose of the present paper was to investigate the effects of the dopamine agonist amantadine in those patients with weight gain induced by olanzapine. An open trial was conducted in those patients who gained >3 kg in weight induced by olanzapine use. All subjects were evaluated by weight, body mass index (BMI), the Brief Psychiatric Rating Scale (BPRS), and the Extrapyramidal Symptom Rating Scale (ESRS) before and after the use of amantadine in addition to olanzapine. Twenty-five of 30 enrolled patients completed the present study. Mean bodyweight and BMI was increased by 6.44 ± 4.42 kg and 5.04 ± 3.47 kg/m2 significantly with olanzapine alone (P < 0.001). When amantadine and olanzapine were used together, the average weight and BMI decreased by 1.07 ± 3.19 kg and 0.84 ± 2.5 kg/m2, but did not have statistical significance. The average values of BPRS showed a significant decrease (P < 0.001). No significant changes were present in ESRS. Amantadine did not have an effect on weight gain induced by olanzapine. Randomized placebo-controlled prospective studies are needed. [source]

Topical PTH (1,34) is a novel, safe and effective treatment for psoriasis: a randomized self-controlled trial and an open trial

BRITISH JOURNAL OF DERMATOLOGY, Issue 2 2003
M.F. Holick
Summary Background There continues to be a need to develop new pharmacological approaches for treating the common skin disease psoriasis. Human skin produces parathyroid hormone related peptide. This peptide is a potent inhibitor of epidermal cell growth. Objectives A programme was initiated to determine whether an agonist of this peptide's receptor, PTH (1,34), could be developed as a drug to treat psoriasis. Methods PTH (1,34) was formulated in Novasome A® cream. Fifteen adult patients with chronic plaque psoriasis who had failed to respond to at least one standard treatment were enrolled in a randomized double-blinded placebo self-controlled trial. The patients topically applied to a 25-cm2 psoriatic lesion 0·1 g of either Novasome A® cream or Novasome A® cream that contained 20 ,g of PTH (1,34) twice a day for 2 months. At the end of the double-blind study, patients were enrolled in an open large area study. Ten patients applied PTH (1,34) (50 ,g per 0·1 g) once daily to their psoriatic lesions. The patients were evaluated for their global improvement and calcium metabolism. Results Novasome A® cream enhanced the percutaneous absorption of PTH (1,34) in human skin in comparison with formulations in propylene glycol or normal saline. Psoriatic lesions treated with PTH (1,34) showed marked improvement in scaling, erythema and induration. There was a 67·3% improvement in the global severity score for the lesion treated with PTH (1,34) compared with the placebo-treated lesion, which only showed a 17·8% improvement. Ten patients topically applied PTH (1,34) on all of their lesions in a stepwise manner. A Psoriasis Area and Severity Index score analysis of all the patients revealed improvement of 42·6% (P < 0·02). None of the patients experienced hypercalcaemia or hypercalciuria or developed any side-effect to the medication. Conclusions Patients who were resistant to at least one standard therapy for psoriasis had a remarkable improvement in their psoriasis when they applied PTH (1,34) to their lesion(s). No untoward toxicity was observed in any of the subjects. This pilot study suggests that topical PTH (1,34) is a safe and effective novel therapy for psoriasis. [source]

A randomized, open trial evaluating the effect of Saccharomyces boulardii on the eradication rate of Helicobacter pylori infection in children

ACTA PAEDIATRICA, Issue 1 2009
Victoria Hurduc
Abstract Aim: The failure rate of Helicobacter pylori (H. pylori) eradication imposes the assessment of new options. Subjects and methods: A prospective open study was performed in 90 symptomatic children (range 3,18 years) with H. pylori infection, randomized in two groups: control (42 patients) and intervention group (48 patients). Both groups were treated with the standard triple eradication therapy (omeprazole/esomeprazole, amoxicillin and clarithromycin) for 7,10 days. The intervention group was also treated with Saccharomyces boulardii (S. boulardii), 250 mg b.i.d., for 4 weeks. The eradication rate of H. pylori was assessed by the same methods (urease test and histology) 4,6 weeks after treatment. Adverse events and compliance were evaluated after 7 and 28 days of treatment. The Chi-square test was used for statistical evaluation (p < 0.05). Results: H. pylori infection was identified in 90 of 145 children (62%) and it correlated positively with age (p < 0.002) and inversely with socioeconomic status (p < 0.005). All infected children had chronic gastritis, with antral nodularity in 76.7%. Overall, H. pylori eradication rate was 87.7% (control 80.9%, S. boulardii group 93.3%) (p = 0.750). The incidence of side effects was reduced in the S. boulardii group: 30.9% in the control versus 8.3% in the probiotic group (p = 0.047). Conclusion: The addition of S. boulardii to the standard eradication treatment confers a 12% nonsignificant enhanced therapeutic benefit on H. pylori eradication and reduces significantly the incidence of side effects. [source]

Management of severe adult atopic dermatitis

CLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 4 2002
Nicholas Reynolds
In common with many units, we run a specialist atopic eczema clinic that receives both secondary and tertiary referrals. Investigation into possible provoking factors includes RAST testing and patch testing where appropriate. The mainstay of treatment for moderate to severe atopic eczema remains topical steroids and emollients. Our specialist nurses play a key role in education and in particular demonstrating topical treatments , including bandaging. It is surprising that many patients have not previously been shown how to apply the treatments prescribed. Nevertheless, despite optimizing topical treatment protocols, a proportion of patients require hospital admission or second-line therapy. Our recent double-blind, randomized, controlled trial of narrow-band UVII vs. UVA (as used in PUVA) vs. placebo has confirmed that narrow-band WB phototherapy is an effective adjunctive treatment in moderate to severe atopic eczema. This trial also highlighted the value of recording disease activity (e.g. SASSAD) in individual patients following a change of therapy. UVA1 may be useful for acute severe atopic eczema but this UV source is only available in limited centres within the UK. Selected resistant patients or patients with acute flares are considered for short-term cyclosporin therapy. Azathioprine is widely used by consultant dermatologists in the UK as a second-line agent , despite the lack of evidence of efficacy. We are currently conducting a randomized placebo-controlled trial to address this issue. The importance of checking thiopurine methyl transferase (TPMT) prior to initiating azathioprine therapy has been emphasized. Our pilot data, with a dosage regime based on the TPMT result, suggest that patients may achieve a longer-term remission after a relatively short course. Mycophenolate mofetil has been reported to be effective in an open trial and methotrexate is also used but there is a lack of published evidence. The advent of topical tacrolimus and ascomycins, which have been shown to be effective in controlled trials, appear to be a promising development in the management of patients with moderate to severe atopic eczema and may lead to reduction in the use of systemic agents. [source]