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Double Blind (double + blind)
Terms modified by Double Blind Selected AbstractsTrials update in walesCYTOPATHOLOGY, Issue 2007A. Fiander Three ongoing studies will be presented and discussed. Prevalence of Human Papillomavirus Infection in a South Wales Screening population Methods: A total of 10 000 consecutive, anonymous liquid based cytology screening samples were collected over a five month period in 2004. Age, cytology result and social deprivation score was provided for each specimen. The methodology was chosen to ensure inclusion of all women attending routine cervical screening, avoiding potential constraints associated with obtaining individual informed consent. The liquid based cytology samples were processed and reported by the receiving cytology laboratory and the residual specimens sent to the HPV Research Laboratory, Wales College of Medicine, where they were processed and stored at -80°C until analysis. High risk and low risk HPV Typing was undertaken using PCR , EIA (Jacobs et al 1997). Full high risk typing was performed on HPV positive specimens. Results: The study population had a mean age of 38 years with 92% negative, 5% borderline and 3% dyskaryotic cytology. The average social deprivation score was 17.4 (based upon the Welsh Index of multiple deprivation). The following results will be presented: HPV prevalence by age. HPV prevalence by cytology result. Type specific HPV prevalence in single and multiple infection. Conclusion: This study represents the largest type specific HPV Prevalence Study in the UK to date. As such it will form a useful base line against which to access performance of marketed HPV tests and evaluating the impact following implementation of HPV vaccination. [Funded by Welsh Office for Research and Development] CRISP , 1 Study (Cervical Randomized Intervention Study Protocol -1) Background: Indole-3-carbinol (I3C) and Diindolylmethane (DIM) are found in cruciferous vegetables and have been identified as compounds that could potentially prevent or halt carcinogenesis. I3C spontaneously forms DIM in vivo during acid digestion. I3C has been shown to prevent the development of cervical cancer in HPV 16 transgenic mice and both I3C and DIM have been shown to promote cell death in cervical cancer cell models. DIM is the major active bi-product of I3C and preliminary data indicate that DIM is active in cervical dysplasia and may be better tolerated than I3C. Aim: To investigate chemoprevention of high grade cervical neoplasia using Diindolylmethane (DIM) supplementation in women with low grade cytological abnormalities on cervical cytology. Objectives: To observe any reduction in the prevalence of histological proven high-grade cervical intraepithelial neoplasia (CIN) after 6 months of supplementation. ,,To observe any reduction in the prevalence of cytological abnormalities. ,,To observe any changes in the clinical appearance of the cervix. To assess acceptability and monitor any side effects of DIM supplementation. ,,To assess whether any benefit is seen in relation to Human Papillomavirus (HPV) status including HPV Type, Viral load and integration. Methods: This is a double blind randomized placebo-controlled trial involving 600,700 women with low grade cytological abnormalities on a cervical smear. Randomization is in the ratio of 2 : 1 in favour of active medication. Women with first mildly dyskaryotic smear or second borderline smear are eligible. They are asked to take two capsules daily for 6 months. At the end of 6 months they undergo repeat cervical cytology, HPV testing and colposcopy. Results: A progress report will be given for this ongoing study. [Funded: - Cancer Research UK] Type Specific HPV Infection in Welsh Cervical Cancers Background: Whilst there have been numerous studies of HPV infection associated with cervical cancer and on prevalence of Human Papillomavirus in diverse populations there have been no studies of these variables in the same population. Against a background of prophylactic HPV vaccination it is important to assess potential protection against cervical cancer within a given population. The most comprehensive analysis of HPV type specific cervical cancer is a meta-analysis published by the IARC in 2003. This however included only three UK based studies, totalling 118 cases, 75 of which were only investigated by HPV type PCR for four high risk types. None of this data was presented with associated population based prevalence data. Therefore, the research objectives for this study in combination with the first study above, are as follows: To determine the frequency of specific HPV types in cervical cancers in Wales. To compare the distribution of specific HPV types amongst cervical cancers with their prevalence in the general population. This will allow accurate delineation of the relationship between prevalence of specific HPV types in the general population and their association with clinically relevant disease. This information is a pre-requisite to assess the potential impact of prophylactic vaccination against HPV infection in Wales. Methods: Welsh Cervical Cancer specimens from 2000,2005 will be identified from pathology departments within Wales. The pathology of each tumour will be reviewed by a single Gynaecological Pathologist. The age of the patient and pathological features of the tumour will be noted. DNA will be extracted from the paraffin sections and HPV typed by PCR-EIA. Results: A progress report will be given for this ongoing study. [Funded by Welsh Office for Research and Development] [source] Behavioral and cardiovascular effects of 7.5% CO2 in human volunteersDEPRESSION AND ANXIETY, Issue 1 2005Jayne E. Bailey M.Sc. Abstract The study of carbon dioxide (CO2) inhalation in psychiatry has a long and varied history, with recent interest in using inhaled CO2 as an experimental tool to explore the neurobiology and treatment of panic disorder. As a consequence, many studies have examined the panic-like response to the gas either using the single or double breath 35% CO2 inhalation or 5,7% CO2 inhaled for 15,20 min, or rebreathing 5% CO2 for a shorter time. However, this lower dose regime produces little physiological or psychological effects in normal volunteers. For this reason we have studied the effects of a higher concentration of CO2, 7.5%, given over 20 min. Twenty healthy volunteers were recruited to a double blind, placebo-controlled study where air and 7.5% CO2 were inhaled for 20 min. Cardiovascular measures and subjective ratings were obtained. When compared to air, inhaling 7.5% CO2 for 20 min increases systolic blood pressure and heart rate, indicating increased autonomic arousal. It also increases ratings of anxiety and fear and other subjective symptoms associated with an anxiety state. The inhalation of 7.5% CO2 for 20 min is safe for use in healthy volunteers and produces robust subjective and objective effects. It seems promising as an anxiety provocation test that could be beneficial in the study of the effects of anxiety on sustained performance, the discovery of novel anxiolytic agents, and the study of brain circuits and mechanisms of anxiety. Depression and Anxiety 00:000,000, 2005. © 2005 Wiley-Liss, Inc. [source] Comparing botulinum toxin A with casting for treatment of dynamic equinus in children with cerebral palsyDEVELOPMENTAL MEDICINE & CHILD NEUROLOGY, Issue 9 2005Jeffrey D Ackman MD The purpose of this study was to compare the cumulative efficacy (three treatment sessions) of botulinum toxin A (BTX-A) alone, casting alone, and the combination of BTX-A and casting in the management of dynamic equinus in ambulatory children with spastic cerebral palsy (CP). Thirty-nine children with spastic CP (mean age 5y 10mo, range 3 to 9y) were enrolled in the study. A multicenter, randomized, double blind, placebo-controlled prospective study was used. Children were randomly assigned to one of three treatment groups: BTX-A only (B), placebo injection plus casting (C), or BTX-A plus casting (B+C). The dosage for the BTX-A injections was 4U/kg per extremity. Assessments were performed at baseline, 3,6,7.5, and 12 months with a total of three treatments administered after the evaluations at baseline, 3, and 6 months. Primary outcome measures were ankle kinematics, velocity, and stride length. Secondary outcome measures were ankle spasticity, strength, range of motion, and ankle kinetics. Group B made no significant change in any variable at any time. Groups C and B+C demonstrated significant improvements in ankle kinematics, spasticity, passive range of motion, and dorsiflexor strength. Results of this 1-year study indicate that BTX-A alone provided no improvement in the parameters measured in this study, while casting and BTX-A/casting were effective in the short- and long-term management of dynamic equinus in children with spastic CP. [source] Tiludronate infusion in the treatment of bone spavin: A double blind placebo-controlled trialEQUINE VETERINARY JOURNAL, Issue 5 2010M. R. GOUGH Summary Reasons for performing study: Tiludronate regulates bone remodelling through a decrease of the resorptive process and should therefore ameliorate the remodelling processes active in osteoarthritis of the distal tarsal joints (,bone spavin') and alleviate pain associated with abnormal bone lysis. Objective: To confirm the efficacy of tiludronate, administered as a single infusion at a dose of 1 mg/kg bwt, in the treatment of bone spavin in the horse. Methods: A double blind placebo controlled trial on 108 clinical cases of bone spavin was undertaken. The lameness score of the lamest limb was assessed following distal tarsal analgesia of the contralateral limb and followed-up using the same procedure throughout the study. Bone spavin in the lamest limb was confirmed by distal tarsal analgesia and radiography. Horses were treated at Day 0 and reassessed 60 days later after controlled exercise. A second nonblinded treatment was given to unresponsive horses and all horses were re-examined at Day 120. Exercise levels were recorded at each examination. Results: Eighty-seven horses completed the trial as per the protocol. The tiludronate horses were significantly less lame than the placebo horses (P = 0.0318). Horses treated at Day 60 with tiludronate showed further improvement in lameness at Day 120 (P = 0.0096 and P = 0.0034 for horses treated with tiludronate and placebo at Day 0, respectively). The only significant difference in radiographic findings between tiludronate and placebo was for presence of periarticular osteophytes (P = 0.006). Conclusions: Tiludronate treatment is proven to be effective in bone spavin in horses in association with a controlled exercise programme. Clinical relevance: Tiludronate in combination with controlled exercise offers an alternate medical treatment for bone spavin. [source] A cost-effectiveness analysis of caspofungin vs. liposomal amphotericin B for treatment of suspected fungal infections in the UKEUROPEAN JOURNAL OF HAEMATOLOGY, Issue 6 2007Karin Bruynesteyn Abstract Objective:, To evaluate the cost-effectiveness of caspofungin vs. liposomal amphotericin B in the treatment of suspected fungal infections in the UK. Methods:, The cost-effectiveness of caspofungin vs. liposomal amphotericin B was evaluated using a decision-tree model. The decision tree was populated using both data and clinical definitions from published clinical studies. Model outcomes included success in terms of resolution of fever, baseline infection, absence of breakthrough infection, survival and quality adjusted life years (QALYs) saved. Discontinuation due to nephrotoxicity or other adverse events were included in the model. Efficacy and safety data were based on additional analyses of a randomised, double blind, multinational trial of caspofungin compared with liposomal amphotericin B. Information on life expectancy, quality of life, medical resource consumption and costs were obtained from peer-reviewed published data. Results:, The caspofungin mean total treatment cost was £9762 (95% uncertainty interval 6955,12 577), which was £2033 (,2489; 6779) less than liposomal amphotericin B. Treatment with caspofungin resulted in 0.40 (,0.12; 0.94) additional QALYs saved in comparison with liposomal amphotericin B. Probabilistic sensitivity analysis found a 95% probability of the incremental cost per QALY saved being within the generally accepted threshold for cost-effectiveness (£30 000). Additional analyses with varying dose of caspofungin and liposomal amphotericin B confirmed these findings. Conclusion:, Given the underlying assumptions, caspofungin is cost-effective compared with liposomal amphotericin B in the treatment of suspected fungal infections in the UK. [source] CLINICAL STUDY: FULL ARTICLE: Immunomodulating properties of gamma-hydroxybutyrate (GHB), flunitrazepam and ethanol in ,club drugs' usersADDICTION BIOLOGY, Issue 3 2010Simona Pichini ABSTRACT Despite the increasing concern about gamma-hydroxybutyrate (GHB) toxicity in users, no studies have addressed GHB and other club drugs effects on the immune system under controlled administration. Lymphocyte subsets and functional responsiveness of lymphocytes to mitogenic stimulation were measured in 10 healthy male recreational users of GHB who participated in five experimental sessions within the framework of a clinical trial. The study was randomized, double blind, double dummy and cross-over. Drug conditions were: a single oral dose of GHB (40 mg/kg or 60 mg/kg), ethanol (0.7 g/kg), flunitrazepam (1.25 mg) and placebo. Acute GHB produced a time-dependent immune impairment in the first 4 hours after drug administration associated with an increase in cortisol secretion. Although total leukocyte count remained unchanged, there was a significant decrease in the CD4 T/CD8 T-cell ratio, as well as in the percentage of mature T lymphocytes, probably because of a decrease in both the percentage and absolute number of T helper cells. A significant decrease was also observed in natural killer cells and in functional responsiveness of lymphocytes to mitogenic stimulation. Flunitrazepam administration did not produce any change in the immune system, while ethanol intake produced a decrease in B lymphocytes and in lymphocyte proliferative response to mitogens. These results provide the first evidence that GHB intake under a controlled environmental setting impairs the immunological status and confirms the alterations in the immune function caused by ethanol. [source] Evaluation of the clinical efficacy of a mouthwash and oral gel containing the antimicrobial proteins lactoperoxidase, lysozyme and lactoferrin in elderly patients with dry mouth , a pilot studyGERODONTOLOGY, Issue 1 2008Jose Antonio Gil-Montoya Objectives:, To evaluate the clinical efficacy of a mouthwash and oral gel containing the antimicrobial proteins lactoperoxidase, lactoferrin and lysozyme, in a sample of elderly individuals with dry mouth. Material and methods:, Twenty elderly institutionalised subjects with dry mouth and with a certain degree of independence for daily life activities were included in this pilot study. A randomised, double blind and cross-over design was used. The study variables comprised subjective dry mouth sensation, the severity of discomfort assessed by means of a visual analogical scale (VAS), the Oral Health Impact Profile (OHIP), the presence of signs and symptoms of dry mouth, sialometry and Candida albicans culture. All the variables were recorded before and after each of the two periods of the study. Results:, The 20 selected subjects we made up of 16 women and four men, with a mean age of 81.3 years. Improvement was observed on analysing the data between the first and second intervention period in terms of the OHIP values, the presence of dry mouth, and the need to drink fluids to swallow. However, the improvement in certain variables before and after treatment did not take a positive course in all cases, and some subjects even improved with placebo. Conclusions:, The evaluated mouthwash and oral gel improved some subjective and clinical aspects in elderly individuals with dry mouth, though a placebo effect cannot be entirely discarded. [source] Effects of a multi-vitamin/mineral supplement on cognitive function and fatigue during extended multi-tasking,HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 6 2010Crystal F. Haskell Abstract Objectives A significant minority of the population consume multi-vitamins/minerals for their putative health benefits, including potentially beneficial effects on cognitive performance, fatigue and mood. The current study investigated the effect of supplementation with a multi-vitamin/mineral on fatigue and cognitive function in healthy females. Methods In this placebo-controlled, double blind, randomized, parallel groups trial the effect of a multi-vitamin/mineral (Supradyn®) was assessed in 216 females aged 25,50 years. Participants attended the laboratory before and 9 weeks after commencing treatment. During both visits cognitive function and the modulation of task related mood/fatigue were assessed in two discrete 20-min assessment periods during which participants completed a four-module version of the Multi-Tasking Framework. Results Those in the vitamin/mineral group exhibited an attenuation of the negative effects of extended task completion on mood/fatigue. Multi-tasking performance for this group was also improved in terms of accuracy across all tasks, and on two of the individual tasks (Mathematical Processing and Stroop) in terms of both faster and more accurate responses. Analysis of a subsection (N,=,102) demonstrated significant reductions in homocysteine levels following the vitamins/mineral supplement. Conclusions These findings suggest that healthy members of the general population may benefit from augmented levels of vitamins/minerals via direct dietary supplementation. Copyright © 2010 John Wiley & Sons, Ltd. [source] Verbal memory performance improved via an acute administration of D -amphetamineHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2007Inge Zeeuws Abstract Background An improved long-term retention of verbal memory was observed after an acute D -amphetamine administration. It was proposed that D -amphetamine modulates consolidation, but a possible drug effect on retrieval could not be rejected. Objectives We want to provide additional support for the consolidation hypothesis, and investigate whether an influence on intervening retrieval can be refuted. Methods Thirty-six male paid volunteers participated in a double blind, counterbalanced, placebo-controlled design in which the number of intermediate free recall tests was manipulated. Results A significant D -amphetamine facilitation effect on recall performance emerged 1 h and 1 day after list learning. In line with the consolidation hypothesis, no effect was found on immediate tests. Importantly, the number of intermediate retrievals did not affect the magnitude of the drug effect, suggesting that the D -amphetamine facilitation effect is independent of retrieval. Conclusion The D -amphetamine facilitation effect on verbal memory does not involve a modulation of the initial encoding or short-term memory (STM) processes. Moreover, the drug does not enhance long-term retention by acting on intervening retrieval processes. The current findings are in line with the conjecture of an involvement of the consolidation process in the D -amphetamine facilitation effect on verbal memory in healthy humans. Copyright © 2007 John Wiley & Sons, Ltd. [source] A high sugar content, low caffeine drink does not alleviate sleepiness but may worsen itHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2006C. Anderson Abstract Although the ingestion of high levels of glucose might have a short acting alerting effect, there is evidence of an ensuing enhancement of sleepiness in people already sleepy. Some ,energy drinks' contain large quantity of sugars. We compared 250 ml of a well known ,energy drink' (42 g sugars, containing a low [30 mg] level of caffeine for ,flavouring') with a nil sugar nil caffeine, similar tasting control. These were given a week apart, in a repeated measures, double blind, balanced design, to 10 participants sleep restricted to 5 h the prior night. They had a light lunch, consumed a drink at 13:50 h, and 10 min later underwent 3,×,30 min consecutive periods at a reaction time (RT) task (the Psychomotor Vigilance Test), separated by 3 min breaks when self-ratings of sleepiness were made. The energy drink did not counteract sleepiness, and led to slower RTs and more lapses during the final 30 min session, around 80 min after consumption. Copyright © 2006 John Wiley & Sons, Ltd. [source] A placebo controlled investigation into the effects of paroxetine and mirtazapine on measures related to car driving performanceHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 4 2003F. Ridout Abstract Objective To assess the effects of paroxetine and mirtazapine on psychometric performance related to car driving, including an on-the-road test of BRT. Method In a 4-way, double blind randomised crossover study, 12 healthy volunteers received paroxetine 20,mg mane, mirtazapine 15,mg/30,mg nocte (comparator), mirtazapine 15,mg mane/15,mg b.i.d.(verum) and placebo over a 5 day period with a washout period of 7 days between treatments. Psychometric assessments included ,on-the-road' BRT (BRT), CFF (CFF), CRT (CRT) and subjective measures of sedation and sleep parameters. Results Paroxetine had no significant effect on BRT compared with placebo. Although subjective ratings of sleep quality and sedation were impaired, there were significant improvements in both CFF and the recognition reaction component of CRT with paroxetine. Mirtazapine 15,mg/30,mg nocte impaired laboratory performance and some subjective tests. Mirtazapine 15 mg mane/15,mg b.i.d. improved sleep, but significantly impaired all other measures. Conclusion Paroxetine 20,mg/day has no psychomotor or behavioural toxicity and has no negative impact on BRT. Further research into the chronic and sub-chronic effects of mirtazapine is needed to establish the clinical significance of these results. Copyright © 2003 John Wiley & Sons, Ltd. [source] Saccadic peak velocity and EEG as end-points for a serotonergic challenge testHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 2 2002Harm J. Gijsman Abstract We previously reported that a single dose of the serotonin receptor agonist meta-chlorophenylpiperazine increased the peak velocity of saccadic eye movements and decreased low-frequency electroencephalographic activity. Methods We administered a single dose of the serotonin releaser dexfenfluramine in a double blind, placebo controlled randomised cross-over design and measured saccadic eye movements and EEG every hour up to 6,h. Subjects were 62 males (18,30 years) with a history of no, moderate or heavy use of ecstasy tablets. Results Dexfenfluramine increased saccadic peak velocity and decreased alpha, delta and theta electroencephalographic activity, the latter predominantly in heavy users of ecstasy. Conclusions This study supports the idea that saccadic peak velocity and EEG can be useful endpoints of a serotonergic challenge. This could be an important anatomical extension of these end-points, which until now were limited to the effect on hypothalamic serotonergic projections. Copyright © 2002 John Wiley & Sons, Ltd. [source] Vaccination trial with HPV16 L1E7 chimeric virus-like particles in women suffering from high grade cervical intraepithelial neoplasia (CIN 2/3)INTERNATIONAL JOURNAL OF CANCER, Issue 12 2007Andreas M. Kaufmann Abstract Persistent infection with human papillomaviruses (HPV) is a prerequisite for the development of cervical cancer. Vaccination with virus-like particles (VLP) has demonstrated efficacy in prophylaxis but lacks therapeutic potential. HPV16 L1E7 chimeric virus-like particles (CVLP) consist of a carboxy-terminally truncated HPV16L1 protein fused to the amino-terminal part of the HPV16 E7 protein and self-assemble by recombinant expression of the fusion protein. The CVLP are able to induce L1- and E7-specific cytotoxic T lymphocytes. We have performed a first clinical trial to gain information about the safety and to generate preliminary data on the therapeutic potential of the CVLP in humans. A randomized, double blind, placebo-controlled clinical trial has been conducted in 39 HPV16 mono-infected high grade cervical intraepithelial neoplasia (CIN) patients (CIN 2/3). Two doses (75 ,g or 250 ,g) of CVLP were applied. The duration of the study was 24 weeks with 2 optional visits after another 12 and 24 weeks. The vaccine showed a very good safety profile with only minor adverse events attributable to the immunization. Antibodies with high titers against HPV16 L1 and low titers against HPV16 E7 as well as cellular immune responses against both proteins were induced. Responses were equivalent for both vaccine concentrations. A trend for histological improvement to CIN 1 or normal was seen in 39% of the patients receiving the vaccine and only 25% of the placebo recipients. Fifty-six percent of the responders were also HPV16 DNA-negative by the end of the study. Therefore, we demonstrated evidence for safety and a nonsignificant trend for the clinical efficacy of the HPV16 L1E7 CVLP vaccine. © 2007 Wiley-Liss, Inc. [source] Lichen planopilaris [cicatricial (scarring) alopecia] in a childINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 7 2001FNASC, FRAS (Lond.), Virendra N. Sehgal MD A mother of a 12-year-old boy, 2 years ago, noticed that he showed patchy loss of hair on the vertex of the scalp. It was asymptomatic and progressive. Subsequently, similar patches appeared elsewhere on the scalp. Some of these patches joined to form a large bald patch. This was accompanied by dusky blue eruptions over the left upper lip and eyebrows. Later, there was localized loss of hair. A family history of a similar ailment was absent. Examination of the scalp revealed plaques of alopecia with mild to moderate erythema. The skin was smooth, shiny, and atrophic (Fig. 1). Atrophy was apparent by the presence of wrinkles in places, and by holding the skin between the thumb and the index finger. The periphery of the lesions was well demarcated and was occupied by erythematous, scaly, follicular papules. Lesions were also located on the patches of alopecia. In addition, flat-topped, dusky blue, papules/plaques were present over the upper lip. Figure 1. Lichen planopilaris: plaques of alopecia showing smooth, shiny, atrophic skin with erythema A study of hematoxylin and eosin-stained microsections prepared from the upper lip and vertex of the scalp was undertaken. The former revealed hyperkeratosis, hypergranulosis, sawtooth irregular acanthosis, and destruction of the basal cell layer which, in turn, was embraced by a lymphohistiocytic infiltrate disposed in a band-like fashion. A few cells were seen invading the epidermis. Pigment-laden histiocytes were found intermingled with the infiltrate. In the scalp skin, on the other hand, atrophy of the epidermis with punctuation of keratin plugs, together with fibrosis of the dermis, was prominent. The walls of the hair follicles were hyperkeratotic, while their lumina were conspicuous by their dilatation and contained keratotic plugs (Fig. 2a,b). Sebaceous and sweat glands were absent. Figure 2. Lichen planopilaris showing atrophy of the epidermis, fibrosis of the dermis, dilatation of the hair follicle lumina containing keratotic plug(s), and hyperkeratosis of the wall of the follicle (hematoxylin and eosin: a , ×,40; b , ×,100) Response to treatment, comprising ultramicronized griseofulvin (Gris O.D.) 375 mg/day (Sehgal VN, Abraham GJS, Malik GB. Griseofulvin therapy in lichen planus ,- a double blind controlled trial. Br J Dermatol 1972; 86: 383,385; Sehgal VN, Bikhchandani R, Koranne RV et al. Histopathological evaluation of griseofulvin therapy in lichen planus. A double blind controlled study. Dermatologica 1980; 161: 22,27) and prednisolone 20 mg/day for 6 months, was excellent (Fig. 3). Topical betamethasone dipropionate (Diprovate) lotion was used as a supplement. Figure 3. Perceptible decline in band-like lymphohistiocytic inflammatory infiltrate (hematoxylin and eosin, a, × 40; b, ×,100) [source] A double blind, randomized clinical trial assessing the efficacy and safety of augmenting standard antidepressant therapy with nimodipine in the treatment of ,vascular depression'INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 3 2001Fernando E. Taragano Abstract Background ,Vascular depression' may be caused by cerebrovascular disease. Calcium channel blockers, which are putative treatments for cerebrovascular disease, might be expected to improve depression reduction and to prevent recurrence of depression in this patient population. This clinical trial was designed to test these hypotheses. Design This was a controlled, double blind, randomized clinical trial in which 84 patients with vascular depression (Alexopoulos criteria) were treated with antidepressants at standard doses. Patients were also randomized to nimodipine (n,=,40) or an inactive comparator, vitamin C (n,=,44). Treatment outcomes were assessed using the Hamilton depression rating scale (HDRS) regularly up to 300 days after treatment initiation. Results As expected, depression reduction was successful in most patients. In addition, those treated with nimodipine plus an antidepressant had greater improvements in depression overall in repeated measures ANCOVA (F(1,81),=,8.64, p,=,0.004). As well a greater proportion of nimodipine-treated participants (45 versus 25%) exhibited a full remission (HDRS,,10) (,2(df, 1),=,3.71, p,=,0.054). Among those experiencing a substantial response in the first 60 days (50% reduction in HDRS), fewer patients on nimodipine (7.4%) had a recurrence of major depression when compared to those on antidepressant alone (32%) (,2(df, 1),=,3.59, p,=,0.058). Conclusions In treating vascular depression, augmentation of antidepressant therapy with a calcium-channel blocker leads to greater depression reduction and lower rates of recurrence. These findings support the argument that cerebrovascular disease is involved in the pathogenesis and recurrence of depression in these patients. Copyright © 2001 John Wiley & Sons, Ltd. [source] Blinding in clozapine trials: a problem and a potential solutionINTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue 3 2009Tamar Wohlfarth Abstract Background:,A methodological problem arises when efficacy of clozapine is compared with other antipsychotic medication in double blind randomized studies. Due to the risk of leucopenia and agranulocytosis, patients in the clozapine condition need to have regular blood testing. The problem is that in order to maintain blinding, patients in the comparison conditions need to undergo blood testing as well and this can lead to underestimation of treatment acceptability and efficacy of the comparators. Methods:,A thought experiment considering all possible solutions for the methodological problem. Results:,We propose a special study design that preserves randomization and blinding while at the same time prevents underestimation of the effect in the comparator treatments. In addition, the necessity for blood testing is limited to only a small number of patients who receive comparative treatments. The design involves initial randomization to a sub-study including clozapine and a small comparator arm or to a sub-study that includes only comparator arms. Blood testing is only necessary in the first sub-study. Discussion:,Limitations of the proposed design are discussed. It is noted that this study design may offer a solution to similar situations where blood testing or other types of monitoring (e.g. as with lithium) is required in one but not in all of the treatment arms of a double blind randomized study. Copyright © 2009 John Wiley & Sons, Ltd. [source] A double blind, randomized, placebo controlled study to evaluate the efficacy of erythromycin in patients with knee effusion due to osteoarthritisINTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, Issue 1 2009Shahram SADREDDINI Abstract Objective:, The efficacy of erythromycin in treatment of knee effusion due to osteoarthritis was evaluated. Method:, We assessed efficacy and safety of erythromycin during 16 weeks in patients enrolled in a randomized double-blind study. One hundred and eight patients with knee effusion due to osteoarthritis (OA) received 12-week courses of erythromycin or placebo allocated randomly, and were followed for 4 months. Acetaminophen 650 mg/day was used in both groups, while they received no other anti-inflammatory drugs (such as corticosteroid or nonsteroidal anti-inflammatory drugs) during the course of the study. Our patients were divided in two groups, erythromycin in doses of 200 mg four times per day was given to the first group (51 patients) over the first 3 months of the study and in the second group we used placebo with the same dosage and schedule (53 patients). Outcomes improvement for the erythromycin-treated group was assessed by a significantly higher mean score from baseline to the end of the trial, compared with placebo group. Patients were examined monthly during the treatment period. Measurement values included recording of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire subscales (pain, stiffness and function), range of motion and knee circumference. Results:, Erythromycin produced a higher response rate than placebo in treatment of knee effusion due to OA. Significant reduction in knee circumference (P < 0.0005) and pain (P < 0.001) with functional improvement (P < 0.0005) were seen. At the first month after treatment, 11.8% (6 patients) in erythromycin and 9.4% (5 patients) in placebo groups had 50% pain reduction, which was not significant (P = 0.75). At the fourth month, 50% reduction of pain was seen in 45.1% (23 patients) of the erythromycin and 11.3% (6 patients) of the placebo group. This was statistically significant (P < 0.0005). Erythromycin treatment was well tolerated and mild adverse events caused no discontinuation during the study. Conclusion:, This is a placebo-controlled study of macrolid efficacy on knee effusion due to OA in a short period. Results of this research showed the better efficacy of erythromycin in controlling effusion and pain with functional improvement in patients with knee effusion due to OA. [source] Efficacy, Safety, and Pharmacokinetics of Candesartan Cilexetil in Hypertensive Children Aged 6 to 17 YearsJOURNAL OF CLINICAL HYPERTENSION, Issue 10 2008Howard Trachtman MD This 4-week randomized, double blind, placebo-controlled study (N=240), 1-year open label trial (N=233), and single-dose pharmacokinetic study (N=22) evaluated candesartan cilexetil (3 doses) in hypertensive children aged 6 to 17 years. Seventy-one percent were 12 years of age or older, 71% were male, and 47% were black. Systolic (SBP)/diastolic (DBP) blood pressure declined 8.6/4.8,11.2/8.0 mm Hg with candesartan and 3.7/1.8 mm Hg with placebo (P<.01 compared to placebo for SBP and for the mid and high doses for DBP; placebo-corrected 4.9/3.0,7.5/6.2 mm Hg). The slopes for dose were not, however, different from zero (P>.05). The response rate (SBP and DBP <95th percentile) after 1 year was 53%. The pharmacokinetic profiles in 6- to 12- and 12- to 17-year-olds were similar and were comparable to adults. Eight candesartan patients discontinued treatment because of an adverse event. Candesartan is an effective, well-tolerated antihypertensive agent for children aged 6 to 17 years and has a pharmacokinetic profile that is similar to that in adults. [source] Effect of triclosan dentifrices on mouth volatile sulphur compounds and dental plaque trypsin-like activity during experimental gingivitis developmentJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 12 2002G. R. Nogueira-Filho Abstract Background: The objective of this study was to evaluate the effect of three commercial anti-plaque dentifrices containing 0.3% triclosan + 2% pvm/ma (Colgate Total®), 0.3% triclosan + 0.75% Zn (Signal Global®) and 0.3% triclosan + 5% PPi (Crest Complete®) in comparison with an experimental dentifrice (0.3% triclosan + 2% pvm/ma + 0.75% Zn + 4% PPi) and a control dentifrice without anti-plaque agents on trypsin-like activity in dental plaque (detected by the hydrolysis of [Na-Benzoyl-DL-Anginine p-Nitroanilide (BAPNA)] and volatile sulphur compounds (VSCs) in mouth air during experimental gingivitis development. Method: A 5-step double blind, crossover experimental gingivitis study was conducted on 19 volunteers during a 21-day period. The volunteers refrained from brushing an experimental quadrant of teeth. The dentifrices were applied to those teeth via toothshield three times per day; simultaneously they brushed the other teeth with the same dentifrice. After each period, VSCs in mouth air and BAPNA hydrolysis by dental plaque accumulated in the experimental quadrant were determined. Results: There was an increase (p < 0.05) in VSCs in mouth air when experimental gingivitis was induced in only one quadrant of teeth. None of the dentifrices was able to avoid the increase of VSCs during the experimental gingivitis development. The majority of the antiplaque dentifrices evaluated reduced the increase of VSC formation in comparison with the control (p < 0.05). There was no relationship between the ability of the dentifrices in reducing VSC formation and the inhibition of trypsin-like activity in dental plaque. Conclusions: Anti-plaque dentifrices reduce the increase of VSCs that occurs during the development of experimental gingivitis. [source] Post-operative pain relief following intrathecal injection of acetylcholine esterase inhibitor during lumbar disc surgery: a prospective double blind randomized studyJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 6 2008Z. H. Khan MD Summary Background:, As spinal cholinergic receptors participate in the control of somatic pain, this effect could be potentiated by intrathecal injection of a cholinesterase inhibitor, neostigmine. Objective:, This study was designed to evaluate the effectiveness of intrathecal administration of neostigmine on pain relief after single level lumbar disectomy. Methods:, Sixty-six patients with unilateral extruded lumbar disc were randomly allocated into two groups, neostigmine (,N'), and control (,C'); the former received 100 ,g of neostigmine methylsulphate, whereas the latter received placebo intrathecally after termination of the surgery. Visual Analogue Scale was employed to measure post-operative pain, which was a primary outcome of the study. Opiate dosage consumed was also recorded as a primary outcome during the first 24 h following surgery. Nausea and vomiting although important were considered as secondary outcomes. Results:, Mean Visual Analogue Scale scores post-operatively at 1, 4 and 8 h were 2·24, 1·82 and 1·88 in group ,N' and 5·36, 5·61 and 4·88 in group C. Mean morphine used intravenously in the first 24 h was 0·9 mg in group ,N' and 4·7 mg in group C. All results were found to be significantly different in the two groups. The frequency of nausea and vomiting was not significantly different in the two groups ,C' (24%) and ,N' (18%). Conclusion:, Injection of 100 ,g hyperbaric neostigmine intrathecally was effective for pain relief, and reduced post-operative opiate demand. [source] An evaluation of topical 3% salicylic acid and 1% hydrocortisone in the maintenance of scalp pruritusJOURNAL OF COSMETIC DERMATOLOGY, Issue 3 2005Zoe Diana Draelos Summary Background, Scalp pruritus is a common condition causing dermatologic distress. The presence of skin scale on clothing is cosmetically undesirable and scalp scratching in public is socially embarrassing. Scratching can also result in removal of the cuticle and premature hair shaft fracture. Objective, To demonstrate the efficacy of 3% salicylic acid in combination with 1% hydrocortisone in the treatment of scalp pruritus. Methods, Sixty subjects with moderate scalp scaling and scalp pruritus were enrolled in a three-arm double blind 2-week study. The 20 subjects in arm 1 applied a topical 1% hydrocortisone product twice daily. The 20 subjects in arm 2 applied a topical 3% salicylic acid product twice daily. Lastly, the 20 subjects in arm 3 applied a topical 3% salicylic acid product in the morning and a topical 1% hydrocortisone product in the evening. Evaluations were performed at baseline, after 1 week of treatment, and after 2 weeks of treatment. The study investigator evaluated the subjects for scalp scale, erythema, excoriation, and overall assessment. In addition, scalp scale scrapings were collected and analyzed to gain further insight into scalp scale morphology. Subject assessments and scalp photography was also performed. Results, The investigator assessments revealed less excoriation in the hydrocortisone twice daily arm over the salicylic acid twice daily arm (P = 0.03), which might be expected because of its anti-inflammatory effect. The morning salicylic acid application and evening hydrocortisone application arm performed better than the salicylic acid twice daily group at week 2 in terms of erythema (P = 0.02), excoriation (P = 0.03), and overall assessment (P = 0.01). Scalp scale scrapings revealed the least amount of retained skin scale in the combination salicylic acid/hydrocortisone group. Conclusion, The combination of a 3% salicylic acid keratolytic combined with a 1% hydrocortisone anti-inflammatory provides the best relief of scalp pruritus. [source] Effects of vitamin D supplementation on symptoms of depression in overweight and obese subjects: randomized double blind trialJOURNAL OF INTERNAL MEDICINE, Issue 6 2008R. Jorde Abstract. Objectives., The objective of the present study was to examine the cross-sectional relation between serum 25-hydoxyvitamin D [25-(OH) D] levels and depression in overweight and obese subjects and to assess the effect of vitamin D supplementation on depressive symptoms. Design., Cross-sectional study and randomized double blind controlled trial of 20.000 or 40.000 IU vitamin D per week versus placebo for 1 year. Setting., A total of 441 subjects (body mass index 28,47 kg m,2, 159 men and 282 women, aged 21,70 years) recruited by advertisements or from the out-patient clinic at the University Hospital of North Norway. Main outcome measures., Beck Depression Inventory (BDI) score with subscales 1,13 and 14,21. Results., Subjects with serum 25(OH)D levels <40 nmol L,1 scored significantly higher (more depressive traits) than those with serum 25(OH)D levels ,40 nmol L,1 on the BDI total [6.0 (0,23) versus 4.5 (0,28) (median and range)] and the BDI subscale 1,13 [2.0 (0,15) versus 1.0 (0,29.5)] (P < 0.05). In the two groups given vitamin D, but not in the placebo group, there was a significant improvement in BDI scores after 1 year. There was a significant decrease in serum parathyroid hormone in the two vitamin D groups without a concomitant increase in serum calcium. Conclusions., It appears to be a relation between serum levels of 25(OH)D and symptoms of depression. Supplementation with high doses of vitamin D seems to ameliorate these symptoms indicating a possible causal relationship. [source] A comparison between the effect of oxytocin only and oxtocin plus propranolol on the labor (A double blind randomized trial)JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 3 2008Maryam Kashanian Abstract Objective:, The comparison between the effect of oxytocin alone or in combination with propranolol on labor. Methods:, A double blind randomized controlled trial was performed on 150 nulliparas with a gestational age of 39,41 weeks of pregnancy and a Bishop score of ,5. In the first group (oxytocin group = 75), oxytocin alone was used for induction of labor. In the second group (propranolol group = 75 cases), before the beginning of oxytocin, 2 mg propranolol was slowly injected intravenously then the oxytocin was initiated. Results:, The number of patients who delivered in the first day showed no difference between the two groups. The mean duration for obtaining good contractions was shorter in the propranolol group in both the first and second day of induction The mean interval between the beginning of induction until the beginning of active phase at the first day of induction was shorter in the propranolol group. The mean interval between the beginning of induction until delivery at the first day of induction was shorter in the propranolol group. The amount of necessary oxytocin for the first day of induction was less in the propranolol group. Conclusion:, Propranolol may shorten the induction duration and labor and reduce the amount of necessary oxytocin. [source] Extracorporeal shock wave therapy for plantar fasciitis.JOURNAL OF ORTHOPAEDIC RESEARCH, Issue 5 2003A double blind randomised controlled trial Abstract Background: Extracorporeal shock wave therapy (ESWT) is an increasingly popular therapeutic approach in the management of a number of tendinopathies. Benefit has been shown in calcific tendinitis of the rotator cuff, but evidence for its use in non-calcific disorders is limited. Aims: To perform a double blind randomised controlled trial of moderate dose shock wave therapy in plantar fasciitis. Methods: Adults with plantar fasciitis for at least 3 months were randomised to receive either active treatment (0.12 mJ/mm) or sham therapy, monthly for 3 months. Pain in the day, nocturnal pain and morning start-up pain were assessed at baseline, before each treatment and 1 and 3 months after completion of therapy. Results: Eighty-eight subjects participated and no differences existed between the groups at baseline. At 3 months, 37% of the subjects in the ESWT group and 24% in the sham group showed a positive response (50% improvement from baseline) with respect to pain. Positive responses in night pain occurred in 41% and 31% in the ESWT and sham groups, respectively. Positive responses in start-up pain occurred in 37% and 36% in the ESWT and sham groups, respectively. Both groups showed significant improvement over the course of the study, but no statistically significant difference existed between the groups with respect to the changes were seen in any of the outcome measures over the 6-month period. Conclusions: There appears to be no treatment effect of moderate dose ESWT in subjects with plantar fasciitis. Efficacy may be highly dependent upon machine types and treatment protocols. Further research is needed to develop evidence based recommendation for the use ESWT in musculoskeletal complaints. © 2003 Orthopaedic Research Society. Published by Elsevier Science Ltd. All rights reserved. [source] Simultaneous feedforward recruitment of the vasti in untrained postural tasks can be restored by physical therapyJOURNAL OF ORTHOPAEDIC RESEARCH, Issue 3 2003Sallie M. Cowan Abstract Background and purpose: Physical therapy rehabilitation strategies are commonly directed at the alteration of muscle recruitment in functional movements. The aim of this study was to investigate whether feedforward strategies of the vasti in people with patellofemoral pain syndrome can be changed by a physical therapy treatment program in a randomised, double blind, placebo controlled trial. Subjects: Forty (25 female, 15 male) subjects aged 40 yrs or less (27.2 ± 7.8 yrs). Methods: Subjects were allocated to either a placebo treatment or a physical therapy intervention program. The postural challenge used as the outcome measure was not included in the training program. Electromyography (EMG) onsets of vastus medialis obliquus (VMO), vastus lateralis (VL), tibialis anterior and soleus were assessed before and after the six week standardised treatment programs. Results: At baseline the EMG onset of VL occurred prior to that of VMO in both subject groups. Following physical therapy intervention there was a significant change in the time of onset of EMG of VMO compared to VL with the onsets occurring simultaneously. This change was associated with a reduction in symptoms. In contrast, following placebo intervention the EMG onset of VL still occurred prior to that of VMO. Conclusion and discussion: The results indicate that the feedforward strategy used by the central nervous system to control the patella can be restored. Importantly, the data suggest that this intervention produced a change that was transferred to a task that was not specifically included in the training program. Furthermore, the change in motor control was associated with clinical improvement in symptoms. © 2002 Orthopaedic Research Society. Published by Elsevier Science Ltd. All rights reserved. [source] Extracorporeal shock wave therapy for lateral epicondylitis,a double blind randomized controlled trialJOURNAL OF ORTHOPAEDIC RESEARCH, Issue 5 2002C. A. Speed Abstract Extracorporeal shock wave therapy (ESWT) is an increasingly popular therapeutic approach to the treatment of a number of soft tissue complaints. Whilst benefit has been demonstrated in calcific tendinitis, evidence is lacking for benefit in the management of non-calcific rotator cuff disorders. Aims: To perform a double-blind placebo controlled trial of moderate dose ESWT in chronic lateral epicondylitis. Methods: Adults with lateral epicondylitis were randomised to receive either active treatment (1500 pulses ESWT at 0.12 mJ/mm2) or sham therapy, monthly for three months. All were assessed before each treatment and one month after completion of therapy. Outcome measures consisted of visual analogue scores for pain in the day and at night. Results: Seventy-five subjects participated and there were no significant differences between the two groups at baseline. The mean duration of symptoms was 15.9 and 12 months in the ESWT and sham groups, respectively. Both groups showed significant improvements from two months. No significant difference existed between the groups with respect to the degrees of change in pain scores over the study period. In the ESWT group the mean (SD, range) pain score was 73.4 (14.5, 38,99) at baseline and 47.9 (31.4, 3,100) at three months. In the sham group the mean (SD, range) pain score was 67.2 (21.7, 12,100) at baseline and 51.5 (32.5, 3,100) at three months. At three months, 50% improvement from baseline was noted in 35% of the ESWT group and 34% of the sham group with respect to pain. Conclusions: There appears to be a significant placebo effect of moderate dose ESWT in subjects with lateral epicondylitis but there is no evidence of added benefit of treatment when compared to sham therapy. © 2002 Orthopaedic Research Society. Published by Elsevier Science Ltd. All rights reserved. [source] Clinical trial: the impact of cyclooxygenase inhibitors on gastrointestinal recovery after major surgery , a randomized double blind controlled trial of celecoxib or diclofenac vs. placeboALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2009D. A. WATTCHOW Summary Background, Ileus occurs after abdominal surgery and may be severe. Inhibition of prostaglandin release reduces post-operative ileus in a rat model. Aim, To determine whether prostaglandin inhibition by cyclooxygenase inhibitors, celecoxib or diclofenac, could enhance gastrointestinal recovery and reduce post-operative ileus in humans. Methods, Two hundred and ten patients undergoing elective major abdominal surgery were randomized to receive twice daily placebo (n = 67), celecoxib (100 mg, n = 74) or diclofenac (50 mg, n = 69), preoperatively and continuing for up to 7 days. Primary outcomes were hallmarks of gut recovery. Secondary outcomes were paralytic ileus, pain and complications. Results, There was no clinically significant difference between the groups for restoration of bowel function. There was a significant reduction in paralytic ileus in the celecoxib-treated group (n = 1, 1%) compared with diclofenac (n = 7, 10%) and placebo (n = 9, 13%); P = 0.025, RR 0.20, CI 0.01,0.77. Pain scores, analgesia, transfusion requirements and adverse event rates were similar between study groups. Conclusions, Perioperative low dose celecoxib, but not diclofenac, markedly reduced the development of paralytic ileus following major abdominal surgery, but did not accelerate early recovery of bowel function. This was independent of narcotic use and had no increase in post-operative complications. [source] Diode laser hair removal does not interfere with botulinum toxin A treatment against axillary hyperhidrosisLASERS IN SURGERY AND MEDICINE, Issue 3 2010Anna Paul MD Abstract Background and Objective The possible interference of combined laser hair removal and Botulinum toxin A (BoNT/A) injections in the treatment of axillary hyperhidrosis has not previously been explored. In order to examine this potential interference, we assessed the effect of BoNT/A on axillary hyperhidrosis with and without concomitant diode laser axillary hair removal. Study Design/Materials and Methods In a prospective, double blind, randomized cross over trial, nine patients suffering from primary axillary hyperhidrosis were laser-treated on one randomly assigned axilla. One week later, both axillas were injected intradermally with BoNT/A (100,MU per axilla). During the same session, the previously untreated axilla was lasered. Axillary sweat rates (in g/5,minutes.) were determined by gravimetry and compared at rest, during mental exercise, and during physical exercise. Additionally, subjective outcome measures were assessed by a visual analogue scale, Dermatology Life Quality Index, and Global Clinical Impression score. Results No differences were found regarding the effect of BoNT/A on previously laser-treated and laser co-treated sides over time course for any of the outcome parameters. Sweat production was reduced 3 weeks after BoNT/A treatment by 93.5% at rest, 96.5% during mental exercise, and 67% during physical exercise. Conclusions Concomitant laser hair removal does not interfere with BoNT/A treatment on axillary hyperhidrosis. Lasers Surg. Med. 42:211,214, 2010. © 2010 Wiley-Liss, Inc. [source] Effect of low-dose rabeprazole and omeprazole on gastric acidity: results of a double blind, randomized, placebo-controlled, three-way crossover study in healthy subjectsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2004S. Bruley des Varannes Summary Background :,The treatment of acid-related symptoms requires rapid and consistent acid suppression, especially with on-demand regimens. Aim :,To compare the antisecretory activity of low-dose rabeprazole and omeprazole in healthy, Helicobacter pylori -negative subjects. Methods :,In this randomized, double-blind, placebo-controlled, three-way crossover study, 27 volunteers were given rabeprazole 10 mg, omeprazole 10 mg, or placebo once daily for 7 days with a 10,14-day washout between treatments. Intragastric pH was monitored for 24-h on days 1 and 7 of each treatment. Results :,Median gastric pH was significantly higher with rabeprazole than with omeprazole or placebo: day 1: 2.3, 1.4 and 1.3, respectively (P = 0.0056, rabeprazole vs. omeprazole; P < 0.0001, rabeprazole vs. placebo); day 7: 3.7, 2.2 and 1.3, respectively (P = 0.0016 rabeprazole vs. omeprazole; P < 0.0001, rabeprazole vs. placebo). Time with gastric pH above 4 was significantly higher with rabeprazole than with omeprazole: day 1, 5.8 h vs. 3.7 h, respectively (P < 0.02); day 7, 10.5 h vs. 4.6 h, respectively (P = 0.0008). Conclusions :,Rabeprazole 10 mg provides more rapid acid inhibition compared with omeprazole 10 mg. After 7 days, the time with pH above 4 is more than doubled with rabeprazole 10 mg vs. omeprazole 10 mg. [source] Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patientsALLERGY, Issue 1 2009C. Bachert Background:, Bilastine is a novel, nonsedating H1 -antihistamine developed for symptomatic treatment of Allergic Rhinitis and Chronic Idiopathic Urticaria. The objective of this study was to compare the efficacy and safety of bilastine 20 mg vs placebo and desloratadine 5 mg in subjects with seasonal allergic rhinitis (SAR). Methods:, This randomized, double blind, placebo-controlled, parallel-group multicentre study evaluated the effect of 2 weeks' treatment with bilastine 20 mg, desloratadine 5 mg or matched placebo once daily, in 12,70 years old symptomatic SAR patients. All subjects assessed the severity of nasal (obstruction, rhinorrhoea, itching, and sneezing) and nonnasal (ocular itching, tearing, ocular redness, itching of ears and/or palate) symptoms on a predetermined scale to provide a total symptom score (TSS), composed of nasal and nonnasal symptom scores (NSS and NNSS, respectively). The primary efficacy measure was the area under the curve (AUC) for the TSS over the entire treatment period. Results:, Bilastine 20 mg significantly reduced the AUC of TSS to a greater degree from baseline compared to placebo (98.4 with bilastine vs 118.4 with placebo; P < 0.001), but not compared to desloratadine 5 mg (100.5). Bilastine 20 mg was not different from desloratadine 5 mg but significantly more effective than placebo in improving the NSS, NNSS, and rhinitis-associated discomfort scores (P < 0.05), and rhinoconjunctivitis quality of life questionnaire total (P < 0.005) and four out of seven individual domain (P < 0.05) scores. The incidence of treatment emergent adverse events was similar for bilastine (20.6%), desloratadine (19.8%), and placebo (18.8%). Conclusion:, Bilastine 20 mg once daily was efficacious, safe and not different from desloratadine 5 mg once daily in the treatment of SAR symptoms. [source] | ||||||||||||||||||||||||||||||||||