Development and validation of the Axillary Sweating Daily Diary: a patient-reported outcome measure to assess axillary sweating severity.

BACKGROUND: Hyperhidrosis is estimated to affect ~ 4.8% of the US population, and most patients experience a negative psychological impact. Here, we describe development and psychometric evaluation of a patient-reported outcome (PRO) measure to assess severity of axillary hyperhidrosis in clinical trials that meets current U.S. regulatory standards to support product approvals. METHODS: Three rounds of hybrid concept-elicitation/cognitive-debriefing qualitative interviews were conducted in adults with clinician-diagnosed primary axillary hyperhidrosis, followed by similar interviews in children/adolescents. The draft measure included diary items for presence, severity, impact and bothersomeness (basis of the Axillary Sweating Daily Diary [ASDD]), exploratory weekly impact items, and a single-item Patient Global Impression of Change (PGIC). Phase 2 (adults only) and phase 3 (adults and children ≥9 years) clinical trial data were utilized to evaluate measurement properties of the resulting draft measure: floor/ceiling effects, nonresponse bias, test-retest reliability, construct validity, and responsiveness were assessed. The primary concept of interest was axillary sweating severity (ASDD Item 2); however, additional supportive concepts were explored to allow for development of a comprehensive hyperhidrosis measure. RESULTS: Twenty-nine patient interviews were conducted (N = 21 adult and N = 8 children/adolescents), resulting in the ASDD (4 items, patients ≥16y) and child-specific ASDD-C (2 items ≥9y to <16y), as well as 6 Weekly Impact items and the PGIC (patients ≥16y). No floor/ceiling effects or response biases were identified. Consistency between hypothesized and observed correlation patterns between ASDD/ASDD-C items and other efficacy measures supported construct validity. Intraclass correlation coefficients supported test-retest reliability (0.91-0.93; Item 2). Large effect sizes (- 2.2 to - 2.4) demonstrated that the ASDD/ASDD-C Item 2 could detect changes in hyperhidrosis severity, supporting the measure's responsiveness. Patients perceiving a moderate improvement in symptoms on the PGIC experienced an average 3.8-point improvement on ASDD axillary sweating severity (Item 2); thus, a 4-point responder threshold was defined as a clinically meaningful change. CONCLUSIONS: Qualitative and quantitative evidence support the reliability and validity of the ASDD/ASDD-C and its use in the clinical evaluation of axillary hyperhidrosis treatments. Further evaluation of this measure in future research studies is warranted to demonstrate consistent performance across different axillary hyperhidrosis populations and in different study contexts.

Hammondia sp. oocysts shed by a Brazilian fox (Lycalopex vetulus) differ from Hammondia heydorni and Hammondia triffittae.

A Brazilian fox (Lycalopex vetulus) was rescued from a highway, and 16 days after maintained in captivity, the fox shed oocysts with sizes compatible with Hammondia sp. and Neospora caninum. DNA extracted from oocysts were initially tested in two PCRs targeting the internal transcribed spacer 1 (ITS-1) of the rDNA of Hammondia heydorni and the Nc-5 gene of N. caninum. A 270-bp product was visualized in the PCR for H. heydorni. No amplification was observed for N. caninum PCR. Since ITS-1-based PCR is not sufficient to differentiate Hammondia species derived from canids, oocyst DNA was examined using multilocus sequence analysis of five genetic fragments [intron 1 of the alpha tubulin gene (intron 1), internal transcribed spaces 1 and 2 (ITS-1 and ITS-2) of the rDNA, 28S rRNA gene (D2/D3 domain), and heat shock protein 70 (Hsp70)]. The Hammondia sp. oocyst from the Brazilian fox, referred here as H-FOXBR isolate, is closely related to H. heydorni and Hammondia triffittae, but differs from these parasites in three genetic markers (alpha tubulin gene, ITS-2, and 28S rRNA). As reported by other research groups, Hammondia spp. excreted by canids are genetically diverse and may encompass additional species besides H. heydorni and H. triffittae. In this study, we confirmed that H-FOXBR has significant genetic differences in comparison to H. heydorni and H. triffittae and may represent a separate species. Further studies are needed to identify the life cycle of this parasite and to characterize the parasite stages in the intermediate and definitive hosts.

Obstetric interventions and maternal morbidity among women who experience severe postpartum hemorrhage during cesarean delivery.

BACKGROUND: Compared to vaginal delivery, women undergoing cesarean delivery are at increased risk of postpartum hemorrhage. Management approaches may differ between those undergoing prelabor cesarean delivery compared to intrapartum cesarean delivery. We examined surgical interventions, blood component use, and maternal outcomes among those experiencing severe postpartum hemorrhage within the two distinct cesarean delivery cohorts. METHODS: We performed secondary analyses of data from two cohorts who underwent prelabor cesarean delivery or intrapartum cesarean delivery at a tertiary obstetric center in the United States between 2002 and 2012. Severe postpartum hemorrhage was classified as an estimated blood loss ≥1500mL or receipt of a red blood cell transfusion up to 48h post-cesarean delivery. We examined blood component use, medical and surgical interventions and maternal outcomes. RESULTS: The prelabor cohort comprised 269 women and the intrapartum cohort comprised 278 women. In the prelabor cohort, one third of women received red blood cells intraoperatively or postoperatively, respectively. In the intrapartum cohort, 18% women received red blood cells intraoperatively vs. 44% postoperatively (P<0.001). In the prelabor and intrapartum cohorts, methylergonovine was the most common second-line uterotonic (33% and 43%, respectively). Women undergoing prelabor cesarean delivery had the highest rates of morbidity, with 18% requiring hysterectomy and 16% requiring intensive care admission. CONCLUSION: Our findings provide a snapshot of contemporary transfusion and surgical practices for severe postpartum hemorrhage management during cesarean delivery. To determine optimal transfusion and management practices in this setting, large pragmatic studies are needed.

Celulite em codornas japonesas alimentadas com extrato de orégano nas dietas e inoculadas com Escherichia coli / Cellulitis in Japanese quails fed oregano extract in the diet and inoculated with Escherichia coli

Com o objetivo de avaliar a utilização do extrato de orégano nas dietas de codornas japonesas (Coturnix coturnix japonica) e desafiadas com cepas de Escherichia coli, sobre as características de desempenho, a incidência de celulite aviária e titulação de anticorpos específicos contra antígenos de E. coli, foram utilizadas 360 codornas japonesas, com 90 dias de idade, distribuídas em gaiolas de arame galvanizado em galpão convencional. O delineamento experimental foi inteiramente casualizado, em esquema fatorial 5x2 (extrato de orégano x desafiado ou não com E. oli), totalizando dez tratamentos com seis repetições de seis aves por gaiola. Os níveis do extrato de orégano (EO) avaliados foram: 0,00; 0,025; 0,050; 0,100 e 0,150%. Foram avaliadas características de desempenho produtivo, lesões macroscópicas da celulite após períodos pós-inoculação das cepas e amostras de soro foram colhidas para verificar a titulação de anticorpos nas aves. Os dados obtidos foram submetidos à análise de variância e as médias comparadas pelo Teste T. Foi observado efeito de E. coli sobre todas as características produtivas, independentemente dos níveis de EO avaliados, onde grupos desafiados apresentaram piores resultados de desempenho. As lesões macroscópicas, características da celulite, observadas somente nas aves desafiadas com E. coli foram classificadas como grau leve e sem presença de hemorragias. Para a titulação de anticorpos específicos, houve maior quantificação para aves desafiadas com as cepas de E. coli em relação às não desafiadas. Pode-se concluir que o extrato de orégano suplementado nas rações não se mostrou eficaz frente ao desafio com E. coli em codornas na fase de postura e as aves desafiadas com E. coli apresentaram maiores respostas imunes humoral e celular, em relação às não desafiadas, caracterizadas pelo aumento na titulação de anticorpos e pela lesão macroscópica peitoral, independentemente dos níveis de extrato de orégano avaliados.(AU)

The aim was to evaluate the use of oregano extract in Japanese quail (Coturnix coturnix japonica) diet, challenged with Escherichia coli strains, on performance, incidence of avian cellulitis and of antibody specific antigens against E. coli. Three hundred sixty Japanese quails with 90 days of age were distributed into galvanized wire cages in a conventional shed. The experimental design was completely randomized in factorial 5x2 design (oregano extract x challenged or not with E. coli), totaling ten treatments with six replicates of six birds per cage. Oregano extract levels were 0.00, 0.025, 0.050, 0.100 and 0.150%. Performance productive characteristics were evaluated, macroscopic lesions of cellulitis were measured after post-inoculation of the strains, and serum samples were collected for antibodies during experiment. The data were subjected to analysis of variance and averages compared by T test. Effect of E. coli was observed on all productive characteristics, regardless of the EO level evaluated, where challenged groups showed worse performance results. The macroscopic lesions, characteristic of cellulitis, observed only in birds of groups challenged with E. coli, were classified as mild and without bleeding. For specific antibodies, there was a higher number of birds challenged with E. coli strains in relation to unchallenged birds. It can be concluded that oregano extract supplemented in the diet was not effective against the challenge with E. coli in laying quails, and challenged birds with E. coli showed higher humoral and cellular immune response, compared with unchallenged birds, characterized by increased antibody titer and pectoral macroscopic lesion, regardless of the oregano extract levels evaluated.(AU)

A clinical research integration special program (CRISP) for young women with primary ovarian insufficiency.

Large-scale medical sequencing provides a focal point around which to reorganize health care and health care research. Mobile health (mHealth) is also currently undergoing explosive growth and could be another innovation that will change the face of future health care. We are employing primary ovarian insufficiency (POI) as a model rare condition to explore the intersection of these potentials. As both sequencing capabilities and our ability to intepret this information improve, sequencing for medical purposes will play an increasing role in health care beyond basic research: it will help guide the delivery of care to patients. POI is a serious chronic disorder and syndrome characterized by hypergonadotrophic hypogonadism before the age of 40 years and most commonly presents with amenorrhea. It may have adverse health effects that become fully evident years after the initial diagnosis. The condition is most commonly viewed as one of infertility, however, it may also be associated with adverse long-term outcomes related to inadequate bone mineral density, increased risk of cardiovascular disease, adrenal insufficiency, hypothyroidism and, if pregnancy ensues, having a child with Fragile X Syndrome. There may also be adverse outcomes related to increased rates of anxiety and depression. POI is also a rare disease, and accordingly, presents special challenges. Too often advances in research are not effectively integrated into community care at the point of service for those with rare diseases. There is a need to connect community health providers in real time with investigators who have the requisite knowledge and expertise to help manage the rare disease and to conduct ongoing research. Here we review the pathophysiology and management of POI and propose the development of an international Clinical Research Integration Special Program (CRISP) for the condition.

Psychometric validation of symptom severity measures in irritable bowel syndrome with constipation.

BACKGROUND: Historically, measures of symptom severity of irritable bowel syndrome with constipation (IBS-C) in clinical trials have not met the evidence requirements described in the FDA guidance on patient-reported outcomes (PROs), which describes the evidentiary requirements and review criteria for patient-reported outcome measures intended to support product approval or labelling claims. AIM: Data from two phase 3 trials (N = 1608) of linaclotide for the treatment of IBS-C were analysed to evaluate the psychometric properties of patient-reported outcome measures assessing changes in the severity of abdominal and bowel symptoms. METHODS: A set of patient-reported outcome assessments addressing abdominal and bowel symptoms, the IBS-C Symptom Severity Measures, were administered daily using interactive voice response system technology. Intraclass correlation coefficients (ICCs), Pearson correlations, factor analyses, F-tests and effect sizes were computed to evaluate the reliability, construct validity, discriminating ability and responsiveness of the IBS-C Symptom Severity Measures in a clinical trial context. RESULTS: The IBS-C Symptom Severity Measures showed highly satisfactory test-retest reliability (ICCs ranging from 0.79 to 0.95) and construct validity. Factor analyses indicated one factor for abdominal symptoms and another for bowel symptoms. Known-groups F-tests comparing subgroups based on various responder definitions were statistically significant and in the expected direction, substantiating the discriminating ability of the IBS-C Symptom Severity Measures. Responsiveness statistics (ranging from 0.6 to 2.1) demonstrated these measures are also capable of detecting change. CONCLUSIONS: The psychometric analysis results strongly support the reliability, construct validity, discriminating ability and responsiveness of the IBS-C Symptom Severity Measures and substantiate the conclusion of linaclotide treatment benefit.

An evaluation of the FDA responder endpoint for IBS-C clinical trials: analysis of data from linaclotide Phase 3 clinical trials.

BACKGROUND: Our objective was to evaluate the performance of the Food and Drug Administration (FDA) Responder Endpoint for clinical trials in IBS-C, using data from two large Phase 3 clinical trials of linaclotide. The FDA interim endpoint requires that, for 50% of trial weeks, patients report ≥30% decrease in Abdominal Pain at its worst and (in the same week) an increase in Complete Spontaneous Bowel Movements (CSBMs) of ≥1 from baseline. METHODS: Anchor-based methodology was used to estimate thresholds of clinically meaningful change using symptom-specific patient rating of change questions (PRCQs) and symptom severity questions. The diagnostic accuracy of the FDA Responder Endpoint was assessed using sensitivity/specificity-based methods. KEY RESULTS: Using anchor-based methods, the estimates of the clinically meaningful improvement thresholds for Abdominal Pain ranged from 25.9% to 32.4% and thresholds for increase in weekly CSBM rate ranged from 1.4 to 1.6 CSBMs per week. Compared with the symptom-specific PRCQs for patient rating of relief, the FDA Responder Endpoint has a sensitivity of 60.7%, a specificity of 93.5%, and an accuracy of 82.0%. Changing the number of weeks required to be a responder or the percentage improvement in the Abdominal Pain criteria did not result in notable improvement in the accuracy of the FDA Responder Endpoint. CONCLUSIONS & INFERENCES: The FDA Responder Endpoint for IBS-C clinical trials represents clinically meaningful improvements in IBS-C symptoms for patients with excellent specificity and reasonable sensitivity.

Production of potential vaccine against Dermatobia hominis for cattle.

The present study aimed to detect and characterize antigenic proteins and to assess their activity as preventive vaccines against dermatobiosis. Polyclonal antibodies were produced against three larval instars (L(1), L(2), L(3)), and their antigenic proteins were assessed for reactivity. Polyclonal antibodies produced in animals immunized with extracts were analyzed, and L(3)-derived antibodies showed proteins with better antigenic responses. The study of reactivity using immunodetection showed that the 50-kDa protein had the highest antigenicity. This protein was purified and subjected to mass spectrometry, and the sequences obtained were compared with those in the databases available. No similarities were found with existing sequences. Subsequently, large quantities of purified protein were used to immunize cattle. Vaccine effectiveness was evaluated by comparing the number of cutaneous nodules formed in the control group and immunized animals. The antigen produced proved a promising candidate for vaccine production, with 90.67 % efficacy. Immunohistochemistry of antigen-antibody reaction in larval sections showed epitopes all over larval tissues.

Association of DRD2 and DRD3 polymorphisms with Parkinson's disease in a multiethnic consortium.

OBJECTIVE: To examine genetic associations of polymorphisms in the dopamine receptor D2 (DRD2) and D3 (DRD3) genes with risk of Parkinson's disease (PD). METHODS: The study included 1325 newly diagnosed patients with PD and 1735 controls from a consortium of five North American case-control studies. We collected risk factor information by in-person or telephone interview. Six DRD2 and two DRD3 polymorphisms were genotyped using a common laboratory. Odds ratios were estimated using logistic regression. RESULTS: Among non-Hispanic whites, homozygous carriers of Taq1A DRD2 (rs1800497) polymorphism had an increased risk of PD compared to homozygous wildtype carriers (OR=1.5, 95% CI 1.0-2.3). In contrast, the direction of association for Taq1A polymorphism was opposite for African-Americans, showing an inverse association with PD risk (OR=0.10, 95% CI 0.2-0.7). Among white Hispanics who carried two alleles, the Ser9Gly DRD3 (rs6280) polymorphism was associated with a decreased risk of PD (OR=0.4, 95% CI 0.2-0.8). The inverse association of smoking with PD risk was not modified by any of the DRD2 or DRD3 polymorphisms. CONCLUSIONS: DRD2 polymorphisms are unlikely to be true disease-causing variants; however, three DRD2 polymorphisms (including Taq1A) may be in linkage disequilibrium with possible disease associated variants in the DRD2-ANKK1-NCAM1-TTC12 gene cluster.

Coffee, ADORA2A, and CYP1A2: the caffeine connection in Parkinson's disease.

BACKGROUND AND PURPOSE: In 1-methyl-4-phenyl 1,2,3,6-tetrahydropyridine animal models of Parkinson's disease (PD), caffeine protects neurons by blocking the adenosine receptor A2A (ADORA2A). Caffeine is primarily metabolized by cytochrome P450 1A2 (CYP1A2). Our objective was to examine whether ADORA2A and CYP1A2 polymorphisms are associated with PD risk or modify the caffeine-PD association. METHODS: Parkinson's Epidemiology and Genetic Associations Studies in the United States (PEGASUS) included five population-based case-control studies. One laboratory genotyped four ADORA2A and three CYP1A2 polymorphisms in 1325 PD cases and 1735 age- and sex-matched controls. Information regarding caffeine (coffee) consumption and other lifestyle factors came from structured in-person or telephone interviews. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using logistic regression. RESULTS: Two ADORA2A polymorphisms were inversely associated with PD risk - rs71651683, a 5' variant (adjusted allelic OR = 0.51, 95% CI 0.33-0.80, permutation-adjusted P = 0.015) and rs5996696, a promoter region variant (adjusted OR for AC and CC genotypes compared with the AA wild-type genotype were 0.76 (95% CI 0.57-1.02) and 0.37 (95% CI 0.13-1.01), respectively (permutation-adjusted P for trend = 0.04). CYP1A2 polymorphisms were not associated with PD risk; however, the coffee-PD association was strongest among subjects homozygous for either variant allele rs762551 (P(interaction) = 0.05) or rs2470890 (P(interaction) = 0.04). CONCLUSION: In this consortium study, two ADORA2A polymorphisms were inversely associated with PD risk, but there was weak evidence of interaction with coffee consumption. In contrast, the coffee-PD association was strongest among slow metabolizers of caffeine who were homozygous carriers of the CYP1A2 polymorphisms.

Autoimmune diseases prior to the diagnosis of multiple sclerosis: a population-based case-control study.

The objective of this study was to determine whether patients with multiple sclerosis (MS) are more likely to have other autoimmune disorders particularly prior to the diagnosis of MS. We conducted a population-based case-control study of patients enrolled in the Northern California Kaiser Permanente Medical Care Program. Electronic clinical records through 2005 were used to ascertain incident and prevalent MS cases and identify the presence and timing of 44 other diagnoses. Controls were matched 5:1 for gender, age, and Kaiser membership characteristics. We identified 5296 MS cases (including 924 diagnosed between 2001 and 2004) and 26,478 matched controls. Prior to MS diagnosis, cases were more likely than controls to have uveitis (OR = 3.2, 95%; CI 1.7-5.7), inflammatory bowel disease (IBD, OR = 1.7; 95%CI 1.2-2.5), and Bell's palsy (OR = 3.2; 95%CI 1.2-8.3). Cases were also more likely to develop Guillain- Barré syndrome (GBS, OR = 5.0; 95%CI 1.6-15.4) and bullous pemphigoid (OR = 6.7; 95%CI 1.5-29.9). Cases were not more likely than controls to have or to develop rheumatoid arthritis, lupus or thyroiditis. MS may share environmental triggers, genetic susceptibilities and/or alterations in immune homeostasis with IBD and uveitis, but not with other autoimmune disorders.

Minimum incidence of primary cervical dystonia in a multiethnic health care population.

BACKGROUND: The two existing estimates of the incidence of primary cervical dystonia were based on observations in relatively ethnically homogeneous populations of European descent. OBJECTIVE: To estimate the minimum incidence of primary cervical dystonia in the multiethnic membership of a health maintenance organization in Northern California. METHODS: Using a combination of electronic medical records followed by medical chart reviews, we identified incident cases of cervical dystonia first diagnosed between 1997 and 1999. RESULTS: We identified 66 incident cases of cervical dystonia from 8.2 million person-years of observation. The minimum estimate of the incidence of cervical dystonia in this population is 0.80 per 100,000 person-years. Ethnicity-specific incidence rates were calculated for individuals over age 30. Incidence was higher in white individuals (1.23 per 100,000 person-years) than in persons of other races (0.15 per 100,000 person-years, p < 0.0001). The minimum estimated incidence was 2.5 times higher in women than in men (1.14 vs 0.45 per 100,000 person-years, p = 0.0005). The average age at diagnosis was higher in women (56 years) than in men (45 years, p = 0.0004). There was no significant difference in reported symptom duration prior to diagnosis between women and men (3.9 vs 5.3 years). CONCLUSION: The estimated incidence of diagnosed cervical dystonia among white individuals in this Northern Californian population is similar to previous estimates in more ethnically homogeneous populations of largely European descent. The incidence in other races, including Hispanic, Asian, and black appears to be significantly lower. The incidence is also higher in women than in men.

Effect of reproductive factors and postmenopausal hormone use on the risk of Parkinson disease.

OBJECTIVE: Parkinson disease (PD) is less common in women possibly because of hormonal or reproductive influences. The objective of this study was to evaluate the associations of reproductive factors and postmenopausal hormone use with the risk of PD among postmenopausal women. METHODS: Incident cases (n = 178) and randomly selected age-matched controls (n = 189) who were members of the Kaiser Permanente Medical Care Program (KPMCP) of Northern California participated in the study conducted during the years 1994 to 1995. Statistical analyses were carried out using logistic regression. RESULTS: The association of postmenopausal hormone use with PD risk depended on the type of menopause. Among women with history of a hysterectomy with or without an oophorectomy, estrogen use alone was associated with a 2.6-fold increased risk (adjusted odds ratio (OR) 2.6, 95% CI: 1.1 to 6.1) and significant trends in the risk of PD were observed with increasing duration of estrogen use, but disease risk was not influenced by recency of use. In contrast, among women with natural menopause, no increased risk of PD was observed with hormone use (estrogen alone or a combined estrogen-progestin regimen). Early age at final menstrual period (44 years or younger) was associated with reduction in risk (adjusted OR 0.5, 95% CI: 0.3 to 1.0). Age at menarche and parity were not associated with the risk of PD. CONCLUSION: Postmenopausal use of estrogen alone may increase the risk of Parkinson disease (PD) among women with a hysterectomy. Among women with natural menopause for whom the usual treatment is combined estrogen-progestin therapy, no increased risk of PD was observed.

Adrenal antibodies detect asymptomatic auto-immune adrenal insufficiency in young women with spontaneous premature ovarian failure.

BACKGROUND: Auto-immune adrenal insufficiency is a potentially fatal disorder. Young women with spontaneous premature ovarian failure (POF) are at increased risk of developing this condition. METHODS: We further characterized auto-immune adrenal insufficiency in this population by conducting an in-depth cross-sectional evaluation of adrenal function in a series of 123 women. RESULTS: We uncovered a new diagnosis of adrenal insufficiency in four women [3.2%, 95% confidence interval (CI) 0.2-6.4%]. All four tested positive for adrenal antibodies as detected by a clinically available indirect immunofluorescence assay. A positive adrenal antibody test was highly associated with adrenal insufficiency while a negative test was associated with normal adrenal function in all cases (P < 0.001). Adrenal antibodies increased the pretest probability of adrenal insufficiency from 3.2 to 67%. As a screening method the cortisol response during a standard adrenocorticotrophic hormone (ACTH) stimulation test gave two false positive results (1.7%, upper 95% confidence limit 5.0%). CONCLUSIONS: Our findings suggest that measuring adrenal antibodies would be an effective screening method by which to detect auto-immune adrenal insufficiency in young women with spontaneous POF. The standard ACTH stimulation test should be reserved to confirm adrenal insufficiency in women with adrenal antibodies, or those with signs and symptoms of adrenal insufficiency.

Temperature-controlled radiofrequency tonsil reduction: extended follow-up.

OBJECTIVE: Initial evaluation has shown that temperature-controlled radiofrequency submucosal tonsil reduction (Tonsil Somnoplasty) effectively treats obstructive symptoms of tonsillar hypertrophy with minimal associated discomfort and rapid return to normal activity and diet. This study assesses the effects of treatment over an extended follow-up period of up to a year. STUDY DESIGN: Twelve adults with symptomatic chronic tonsil enlargement underwent an average of 1.5 treatments. Evaluation included periodic oropharyngeal airway measurements, and questionnaires on treatment morbidity and symptom improvement. RESULTS: Data on 12 patients at 3 months and 6 months, and 5 patients at 1 year show sustained increases in oropharyngeal airway size (1.7 cm/3 mo, 1.8 cm/6 mo, 2.4 cm/12 mo) and reduction in obstructive symptoms (Epworth Score decrease of 70%/3 mo, 58%/6 mo, 67%/12 mo; snoring reduction of 81%/3 mo, 79%/6 mo, 78%/12 mo) without significant differences after 3 months. A second treatment reduced tonsil size but gave variable further symptom improvement. CONCLUSION: The effects of Tonsil Somnoplasty are maintained on follow-up to 1 year.

Evaluation of bacteria isolated from rice for plant growth promotion and biological control of seedling disease of rice.

Of 102 rhizoplane and endophytic bacteria isolated from rice roots and stems in California, 37% significantly (P < or = 0.05) inhibited the growth in vitro of two pathogens, Achlya klebsiana and Pythium spinosum, causing seedling disease of rice. Four endophytic strains were highly effective against seedling disease in growth pouch assays, and these were identified as Pseudomonas fluorescens (S3), Pseudomonas tolaasii (S20), Pseudomonas veronii (S21), and Sphingomonas trueperi (S12) by sequencing of amplified 16S rRNA genes. Strains S12, S20, and S21 contained the nitrogen fixation gene, nifD, but only S12 was able to reduce acetylene in pure culture. The four strains significantly enhanced plant growth in the absence of pathogens, as evidenced by increases in plant height and dry weight of inoculated rice seedlings relative to noninoculated rice. Three bacterial strains (S3, S20, and S21) were evaluated in pot bioassays and reduced disease incidence by 50%-73%. Strain S3 was as effective at suppressing disease at the lowest inoculum density (106 CFU/mL) as at higher density (10(8) CFU/mL or undiluted suspension). This study indicates that selected endophytic bacterial strains have potential for control of seedling disease of rice and for plant growth promotion.

Combined temperature-controlled radiofrequency tongue reduction and UPPP in apnea surgery.

The objective of this study was to investigate the effects on outcomes and morbidity of combining temperature-controlled radiofrequency (TCRF) tongue reduction with uvulopalatopharyngoplasty (UPPP) as an initial site-directed approach to the surgical treatment of obstructive sleep apnea syndrome (OSAS). This investigation was a prospective, nonrandomized, open-enrollment study of 20 consecutive eligible patients with OSAS. Seven patients had a single-level velopharyngeal obstruction (Fujita type I or IIa), and they were assigned to undergo UPPP only (group 1). Thirteen patients had a multilevel velopharyngeal and retroglossal obstruction (Fujita type IIb), and they were assigned to undergo TCRF tongue reduction in addition to UPPP (group 2). Patients who had only a retroglossal obstruction (Fujita type III) were not included in this study. Following their initial operation, nine patients in group 2 underwent two subsequent in-office TCRF tongue treatments under local anesthesia. Three patients in group 2 were lost to followup, and one patient underwent only one TCRF procedure at the initial operation; data on the latter patient are included in some of the outcomes measures reported here where indicated, but no data are reported on the three who were lost to followup. The primary post-treatment outcomes measures were the results of comparative polysomnography and clinician and patient evaluations regarding morbidity and symptom improvement. Analysis of these data showed that there was no difference between the two groups in terms of postoperative pain or dysphagia following the initial operative session. The degree of symptom improvement in the two groups was similar. Overall success rates--as measured by the apnea/hypopnea index (group 1: 57.1% success; group 2: 50.0%) and by the apnea index (group 1: 71.4% success; group 2: 70.0%)--were statistically comparable, given the small size of the sample (figures are based on 10 patients in group 2). The author concludes that combining TCRF tongue reduction with UPPP in patients with multilevel obstruction improves response rates to a degree that is comparable to that seen with UPPP alone in patients with single-level velopharyngeal obstruction. Moreover, the combination treatment does not increase the risk of additional pain, morbidity, and complications compared with UPPP alone.