Effects of acupuncture and Chinese herbal medicine (Zhi Mu 14) on hot flushes and quality of life in postmenopausal women: results of a four-arm randomized controlled pilot trial

OBJECTIVE: The aim of this study was to evaluate the feasibility of a clinical trial investigating the effects of acupuncture (AP) and Chinese herbal medicine (CHM) on hot flushes and quality of life in postmenopausal women. METHODS: Forty postmenopausal women reporting at least 20 hot flushes per week were enrolled in a randomized controlled trial. They were randomly allocated to receive traditional Chinese medicine (TCM) AP, sham AP, verum CHM, or placebo CHM for 12 weeks. Follow-up assessment was conducted 12 weeks after intervention. Primary outcome measures included hot flush frequency and severity. As a secondary outcome measure, the severity of menopausal symptoms was assessed using the Menopause Rating Scale (MRS) II. RESULTS: TCM AP induced a significant decline in all outcome measures from pretreatment to posttreatment compared with sham AP (hot flush frequency, P = 0.016; hot flush severity, P = 0.013; MRS, P < 0.001). In the TCM AP group, a larger decrease in MRS scores persisted from pretreatment to follow-up (P = 0.048). No significant differences were noted between the verum CHM group and the placebo CHM group. Compared with the verum CHM group, there was a significant decrease in MRS scores (P = 0.002) and a trend toward a stronger decrease in hot flush severity (P = 0.06) in the TCM AP group from pretreatment to posttreatment. CONCLUSIONS: TCM AP is superior to sham AP and verum CHM in reducing menopausal symptoms, whereas verum CHM shows no significant improvements when compared with placebo CHM.

Newborn screening for cystic fibrosis in Switzerland - Consequences after analysis of a 4 months pilot study

BACKGROUND: Switzerland introduced newborn screening (NBS) for CF in 2011, using an IRT/DNA/IRT protocol. This paper describes the results of the first year and compares two versions of the protocol with different IRT cut-offs, particularly effects on recall rate, sensitivity and specificity. METHODS: IRT cut-offs were >45ng/ml (99.0th percentile) in period 1 (months 1-4) and >50ng/ml (99.2nd percentile) in period 2 (months 5-12). In period 2 we abstained from recalls when none of the 7 most common CF mutations were detected and IRT was <60ng/ml. RESULTS: In periods 1 and 2, 26,535 and 56,663 tests were performed. Recall rates were 0.94% and 0.48%, respectively (p<0.001), PPV increased from 23% to 47% (p=0.024) and sensitivity was 90% and 100%. CONCLUSIONS: Raising initial IRT cut-off from the 99.0th to the 99.2nd percentile and abstaining from recalls for children with an IRT<60ng/ml and carrying no major CFTR mutation significantly reduced the recall rate without affecting sensitivity.

Forced-use therapy for children with cerebral palsy in the community setting: a single-blinded randomized controlled pilot trial

The aim of this study was to elucidate the feasibility, efficacy, and sustainability of a home-based, two-week, forced-use therapy (FUT) program for children with hemiplegic cerebral palsy (CP).

Mechanical and radiological assessment of the influence of rhTGFbeta-3 on bone regeneration in a segmental defect in the ovine tibia: pilot study

Limitations in the use of autologous bone graft, which is the gold standard therapy in bone defect healing, drive the search for alternative treatments. In this study the influence of rhTGFbeta-3 on mechanical and radiological parameters of a healing bone defect in the sheep tibia was assessed. In the sheep, an 18-mm long osteoperiosteal defect in the tibia was treated by rhTGFbeta-3 seeded on a poly(L/DL-lactide) carrier (n = 4). In a second group (n = 4), the defect was treated by the carrier only, in a third group (n = 4) by autologous cancellous bone graft, and in a fourth group (n = 2) the defect remained blank. The healing process of the defect was assessed by weekly in vivo stiffness measurements and radiology as well as by quantitative computed tomographic assessment of bone mineral density (BMD) every 4 weeks. The duration of the experiment was 12 weeks under loading conditions. In the bone graft group, a marginally significant higher increase in stiffness was observed than in the PLA/rhTGFbeta-3 group (p = 0.06) and a significantly higher increase than in the PLA-only group (p = 0.03). The radiographic as well as the computed tomographic evaluation yielded significant differences between the groups (p = 0.03), indicating the bone graft treatment (bone/per area, 83%; BMD, 0.57 g/cm(3)) performing better than the PLA/rhTGFbeta-3 (38%; 0.23 g/cm(3)) and the PLA-only treatment (2.5%; 0.09 g/cm(3)), respectively. Regarding the mechanical and radiological parameters assessed in this study, we conclude that rhTGFbeta-3 has a promoting effect on bone regeneration. However, under the conditions of this study, this effect does not reach the potential of autologous cancellous bone graft transplantation.

TSE surveillance in small ruminants and pigs: a pilot study

Switzerland is controlling Transmissible Spongiform Encephalopathies (TSE) in cattle (BSE) and small ruminants (scrapie). Since BSE is potentially transmissible to sheep, goats or pigs through feeding of contaminated meat and bone meal, implementation of an active surveillance programme for TSE in these species is discussed. The aim of this pilot study was to obtain preliminary data on the prevalence ofTSE and other neurological disorders in these populations. For that purpose, a total of 398 perished and 825 slaughtered adult small ruminants and pigs was examined for the presence of neuropathological changes. None of these animals revealed positive for TSE. However, the investigations demonstrated that perished sheep and goats exhibited a higher prevalence of relevant neuropathological changes when compared with slaughtered animals. From these results, it is concluded that perished small ruminants are probably a risk population for TSE and should be considered as target populations for an active surveillance programme.

Detection of regional blood perfusion changes in epileptic seizures with dynamic brain perfusion CT--a pilot study

BACKGROUND AND PURPOSE: Perfusion CT (P-CT) is used for acute stroke management, not, however, for evaluating epilepsy. To test the hypothesis that P-CT may identify patients with increased regional cerebral blood flow during subtle status epilepticus (SSE), we compared P-CT in SSE to different postictal conditions. METHODS: Fifteen patients (mean age 47 years, range 21-74) underwent P-CT immediately after evaluation in our emergency room. Asymmetry indices between affected and unaffected hemispheres were calculated for regional cerebral blood volume (rCBV), regional cerebral blood flow (rCBF), and mean transit time (MTT). Regional perfusion changes were compared to EEG findings. RESULTS: Three patients in subtle status epilepticus (group 1) had increased regional perfusion with electro-clinical correlate. Six patients showed postictal slowing on EEG corresponding to an area of regional hypoperfusion (group 2). CT and EEG were normal in six patients with a first epileptic seizure (group 3). Cluster analysis of asymmetry indices separated SSE from the other two groups in all three parameters, while rCBF helped to distinguish between chronic focal epilepsies and single events. CONCLUSION: Preliminary results indicate that P-CT may help to identify patients with SSE during emergency workup. This technique provides important information to neurologists or emergency physicians in the difficult clinical differential diagnosis of altered mental status due to subtle status epilepticus.

Pilot study on the comprehensive economic costs of major trauma: Consequential costs are well in excess of medical costs

BACKGROUND: Trauma care is expensive. However, reliable data on the exact lifelong costs incurred by a major trauma patient are lacking. Discussion usually focuses on direct medical costs--underestimating consequential costs resulting from absence from work and permanent disability. METHODS: Direct medical costs and consequential costs of 63 major trauma survivors (ISS >13) at a Swiss trauma center from 1995 to 1996 were assessed 5 years posttrauma. The following cost evaluation methods were used: correction cost method (direct cost of restoring an original state), human capital method (indirect cost of lost productivity), contingent valuation method (human cost as the lost quality of life), and macroeconomic estimates. RESULTS: Mean ISS (Injury Severity Score) was 26.8 +/- 9.5 (mean +/- SD). In all, 22 patients (35%) were disabled, causing discounted average lifelong total costs of USD 1,293,800, compared with 41 patients (65%) who recovered without any disabilities with incurred costs of USD 147,200 (average of both groups USD 547,800). Two thirds of these costs were attributable to a loss of production whereas only one third was a result of the cost of correction. Primary hospital treatment (USD 27,800 +/- 37,800) was only a minor fraction of the total cost--less than the estimated cost of police and the judiciary. Loss of quality of life led to considerable intangible human costs similar to real costs. CONCLUSIONS: Trauma costs are commonly underestimated. Direct medical costs make up only a small part of the total costs. Consequential costs, such as lost productivity, are well in excess of the usual medical costs. Mere cost averages give a false estimate of the costs incurred by patients with/without disabilities.

The effect of terazosin on functional bladder outlet obstruction in women: a pilot study

PURPOSE: We assessed the effect of terazosin (Hytrin(R)) on functional bladder outlet obstruction in women. MATERIALS AND METHODS: Functional bladder outlet obstruction was defined as a maximum flow rate of less than 12 ml per second combined with a detrusor pressure at maximum flow rate of more than 20 cm H2O in pressure flow studies in the absence of neurological disorders or mechanical causes. In a prospective pilot study 15 women with functional bladder outlet obstruction were treated with terazosin. Terazosin was initiated at 1 mg daily and gradually increased to the maintenance dose of 5 mg daily during 2 weeks. Symptoms and urodynamic parameters were assessed before and 3 to 4 weeks after the initiation of alpha-blocker therapy. RESULTS: While on terazosin, voiding symptoms subjectively improved greater than 50% in 10 of the 15 women (p = 0.002). Median maximum urethral closure pressure at rest decreased significantly from 98 to 70 cm H2O (p = 0.001), median maximum detrusor pressure decreased from 45 to 35 cm H2O (p = 0.008), median detrusor pressure at maximum flow decreased from 34 to 27 ml per second and median post-void residual urine decreased from 120 to 40 ml (p = 0.006 and 0.002, respectively). There was a significant increase in the median maximum flow rate from 9 to 20 ml per second and in median voided volume from 300 to 340 ml (p = 0.0005 and 0.021, respectively). Storage symptoms, functional urethral length and maximum cystometric capacity did not change significantly with alpha-blocker therapy (p > 0.05). Overall terazosin resulted in a significant improvement in symptoms and urodynamic parameters in 10 of the 15 women (67%). CONCLUSIONS: Terazosin had a significant symptomatic and urodynamic effect in two-thirds of our patients. These results suggest that terazosin may be an effective treatment option in women with voiding dysfunction due to functional bladder outlet obstruction.

Intradermal injection of heat-killed Mycobacterium vaccae in dogs with atopic dermatitis: a multicentre pilot study

Canine atopic dermatitis (cAD) is a common disease with a multifactorial aetiology associated with impaired immunoregulation. The immunopathogenesis has similarities to that of human atopic dermatitis. Clinical signs of allergic disease in humans and mice are reduced by administration of saprophytic mycobacteria that amplify regulatory cytokines and hence the effect of Mycobacterium vaccae on the clinical severity of cAD was investigated. Sixty-two dogs with cAD, selected according to strict criteria, were treated with a single intradermal injection and evaluated monthly for 3 months in a placebo-controlled double-blind clinical trial. Clinical severity was quantified using standardized scores and by owner assessment of pruritus. A single injection of a heat-killed suspension of M. vaccae was found to be well tolerated and effective in treating mild to moderate cases of cAD demonstrable for 3 months, but was insignificant in more severely affected dogs.

Laser Doppler flowmetry for assessment of anterior mandibular teeth in conjunction with bone harvesting in the symphysis: a clinical pilot study

PURPOSE: To evaluate the pulp sensitivity and vitality of mandibular incisors and canines before and after bone harvesting in the symphysis. MATERIALS AND METHODS: In 20 patients requiring bone grafts from the symphysis, pulp sensitivity (carbon dioxide [CO2]) and pulpal blood flow (laser Doppler flowmetry [LDF]) of mandibular incisors and canines were evaluated preoperatively, postoperatively, and 6 months after surgery. Teeth were allocated to 1 of 3 groups according to their initial and final reaction to CO2 (group A = teeth with a positive reaction throughout the study, group B = teeth that exhibited a sensitivity change from positive to negative, and group C = teeth with a negative reaction throughout the study). RESULTS: Preoperative flux measurements (LDF) did not differ between groups A, B, and C. Teeth with sensitivity changes (group B) showed the greatest decrease (a statistically significant decrease) of pulpal blood flow over time, whereas teeth in groups A and C demonstrated an insignificant reduction of flux over time. DISCUSSION AND CONCLUSIONS: LDF was purely used as an experimental tool in the present study. Pulpal blood flow measurements using LDF demonstrated a decrease of flux over time in anterior mandibular teeth following bone harvesting in the symphysis. A significant change of flux, however, was only observed for teeth that also demonstrated a loss of pulp sensitivity during the same study period. Loss of pulp sensitivity appeared to be correlated to a significant decrease of blood flow assessed by LDF.

A Nonstationary Negative Binomial Time Series with Time-Dependent Covariates: Enterococcus Counts in Boston Harbor

Boston Harbor has had a history of poor water quality, including contamination by enteric pathogens. We conduct a statistical analysis of data collected by the Massachusetts Water Resources Authority (MWRA) between 1996 and 2002 to evaluate the effects of court-mandated improvements in sewage treatment. Motivated by the ineffectiveness of standard Poisson mixture models and their zero-inflated counterparts, we propose a new negative binomial model for time series of Enterococcus counts in Boston Harbor, where nonstationarity and autocorrelation are modeled using a nonparametric smooth function of time in the predictor. Without further restrictions, this function is not identifiable in the presence of time-dependent covariates; consequently we use a basis orthogonal to the space spanned by the covariates and use penalized quasi-likelihood (PQL) for estimation. We conclude that Enterococcus counts were greatly reduced near the Nut Island Treatment Plant (NITP) outfalls following the transfer of wastewaters from NITP to the Deer Island Treatment Plant (DITP) and that the transfer of wastewaters from Boston Harbor to the offshore diffusers in Massachusetts Bay reduced the Enterococcus counts near the DITP outfalls.

Cerebral correlates of muscle tone fluctuations in restless legs syndrome: A pilot study with combined functional magnetic resonance imaging and anterior tibial muscle electromyography

BACKGROUND: The pathology of restless legs syndrome (RLS) is still not understood. To investigate the pathomechanism of the disorder further we recorded a surface electromyogram (EMG) of the anterior tibial muscle during functional magnetic resonance imaging (fMRI) in patients with idiopathic RLS. METHODS: Seven subjects with moderate to severe RLS were investigated in the present pilot study. Patients were lying supine in the scanner for over 50min and were instructed not to move voluntarily. Sensory leg discomfort (SLD) was evaluated on a 10-point Likert scale. For brain image analysis, an algorithm for the calculation of tonic EMG values was developed. RESULTS: We found a negative correlation of tonic EMG and SLD (p <0.01). This finding provides evidence for the clinical experience that RLS-related subjective leg discomfort increases during muscle relaxation at rest. In the fMRI analysis, the tonic EMG was associated with activation in motor and somatosensory pathways and also in some regions that are not primarily related to motor or somatosensory functions. CONCLUSIONS: By using a newly developed algorithm for the investigation of muscle tone-related changes in cerebral activity, we identified structures that are potentially involved in RLS pathology. Our method, with some modification, may also be suitable for the investigation of phasic muscle activity that occurs during periodic leg movements.

Real-time broad-range PCR versus blood culture. A prospective pilot study in pediatric cancer patients with fever and neutropenia

MATERIALS AND METHODS: In a pilot study, results of real-time broad-range (16S rRNA) polymerase chain reaction (PCR) performed on 45 blood samples of pediatric cancer patients with fever and neutropenia were compared with blood culture results. RESULTS: The PCR assay used, having proven a high sensitivity in artificially spiked blood samples, was positive in only three of ten blood culture-positive samples, and it was positive in 10 of 35 (29%) culture-negative samples. CONCLUSION: This broad-range PCR assay, which may identify not-grown bacteria potentially contributing to fever, needs improvement in sensitivity, and different reasons for positive PCR in negative blood culture samples need to be assessed before clinical application.