Psychometric evaluation of a radio electric auricular treatment for stress related disorders: a double-blinded,placebo-controlled controlled pilot study

Background  

The aim of this double-blind randomized study is to test the efficacy of a radio electric stimulator device using an auricular reflex therapy protocol for stress-related symptoms.     

Effects of tomato extract on platelet function: a double-blinded crossover study in healthy humans

BACKGROUND: Aqueous extracts from tomatoes display a range of antiplatelet activities in vitro. We previously showed that the active components also alter ex vivo platelet function in persons with a high response to ADP agonist. OBJECTIVE: The objective was to evaluate the suitability of a tomato extract for use as a dietary supplement to prevent platelet activation. DESIGN: A randomized, double-blinded, placebo-controlled crossover study was conducted in 90 healthy human subjects selected for normal platelet function. Changes from baseline hemostatic function were measured 3 h after consumption of extract-enriched or control supplements. RESULTS: Significant reductions in ex vivo platelet aggregation induced by ADP and collagen were observed 3 h after supplementation with doses of tomato extract equivalent to 6 (6TE) and 2 (2TE) tomatoes [3 micromol ADP/L: 6TE (high dose), -21.3%; 2TE (low dose), -12.7%; P < 0.001; 7.5 micromol ADP/L: 6TE, -7.8%, 2TE, -7.6%; P < 0.001; 3 mg collagen/L: 6TE, -17.5%; 2TE, -14.6%; P = 0.007]. No significant effects were observed for control supplements. A dose response to tomato extract was found at low levels of platelet stimulation. Inhibition of platelet function was greatest in a subgroup with the highest plasma homocysteine (P < 0.05) and C-reactive protein concentrations (P < 0.001). CONCLUSION: As a functional food or dietary supplement, tomato extract may have a role in primary prevention of cardiovascular disease by reducing platelet activation, which could contribute to a reduction in thrombotic events.     

Acamprosate during and after acute alcohol withdrawal: a double-blind placebo-controlled study in Spain

To test acamprosate's role as an aid in preventing relapse after detoxification, 296 alcohol-dependent patients entered a prospective, multicentre, randomized, double-blind, parallel comparison of acamprosate treatment consisting of two 333 mg tablets given three times daily for 180 days with matching placebo treatment. Unlike previous studies, acamprosate was prescribed from the start of alcohol withdrawal, rather than after the detoxification process. During the treatment period, 110 patients dropped out. The two treatment groups were balanced with regard to baseline values and reasons for discontinuation. There was no difference between the groups in the severity of withdrawal symptoms as measured by the CIWA-Ar (Clinical Institute Withdrawal Assessment for Alcohol scale). Acamprosate given during withdrawal did not cause unwanted effects. The cumulative abstinence duration (CAD, main end-point) was 19 days longer in the acamprosate treatment group than the placebo treatment group (analysis of variance on ranks, P = 0.0006) and the stable recovery duration, defined as the number of abstinent days between the last relapse into any drinking and the end of the trial, was 16 days longer in the acamprosate treatment group (P = 0.021). Continuous abstinence, estimated by survival analysis on time to first relapse, was achieved by 35% of acamprosate-treated patients and 26% of placebo-treated patients (log rank P = 0.068). The geometric mean of the ratio final/baseline values for serum carbohydrate-deficient transferrin was 0.802 (placebo) and 0.733 (acamprosate) (P = 0.059). The geometric mean of the ratio final/baseline values for serum gamma-glutamyltransferase was 0.496 (placebo) and 0.415 (acamprosate) (P = 0.024) which corroborated the greater abstinence reported by the acamprosate group.     

Environmental organochlorines and semen quality: results of a pilot study

There have been numerous studies that suggest that sperm concentrations (sperm counts) are declining in men. However, other studies suggest that sperm counts are not declining or may be increasing in some areas. Although there is disagreement on whether there is a downward temporal trend in sperm counts, the studies provide evidence that sperm counts vary by geographic location. It has been hypothesized that the geographic variation in sperm concentrations may be due to environmental exposures, lifestyle factors, or some unknown causes. To determine whether contemporary ambient levels of polychlorinated biphenyls (PCBs) and p,p-DDE are associated with altered semen quantity and quality, we selected a study population without specific exposure to PCBs or p,p-DDE. The present study presents the results from a pilot study on the relationship between serum PCBs and p,p-DDE and semen quality in 29 subjects recruited from the Massachusetts General Hospital Andrology Laboratory. Of the 29 subjects, 3 had sperm concentrations < 20 million/mL, 7 had < 50% motile sperm, 9 had < 4% normal morphology, and 6 were below normal in more than one semen parameter. The 18 subjects with normal spermatozoa concentration, motility, and morphology were used as comparison subjects. The mean (SE) concentration of the sum of PCBs and p,p-DDE was 242 ng/g lipids (34.0) and 354 ng/g lipids (120), respectively, for men with below normal motility as compared to 202 ng/g lipids (16.6) and 240 ng/g lipids (31.1), respectively, for the comparison subjects. The data showed general trends that were suggestive of an association between PCBs and p,p-DDE and abnormal motility, as well as with sperm concentration and morphology. A full-scale study is currently in progress.     

Daily consumption of red grape cell powder in a dietary dose improves cardiovascular parameters: a double blind,placebo-controlled,randomized study

Abstract

Consumption of polyphenol-rich food and food ingredient such as grape and grape products improved various cardiovascular parameters. In this study, we investigate the effect of dietary daily consumption of red grape cell powder (RGC) on blood pressure (BP) and flow-mediated dilatation (FMD) as well as on oxidative stress in 50 subjects with prehypertension and mild hypertension. The subjects were randomized into groups that consumed 200, 400?mg RGC or placebo daily for 12 weeks. RGC consumption was associated with an improvement of FMD (p?=?0.013). There was a significant decrease in lipid peroxidation (p?=?0.013) after 12 weeks in a combined RGC-treated group. The diastolic BP decreased significantly in the 200?mg RGC group compared to the placebo group (p?=?0.032). Our results indicate that a daily supplementation, of red grape cell powder, for 12 weeks affects endothelial function, diastolic BP and oxidative stress without any adverse effects.     

Involuntary and voluntary psychiatric patients: a pilot study of resource consumption.

This pilot study compares the resources utilized caring for "voluntary" and "involuntary" patients in a community hospital inpatient psychiatric unit. "Voluntary" patients committed less episodes of violence. "Emergency involuntaries" experienced more episodes of restraint and were involved in more violent episodes than "other involuntaries". A critical predictor of behavior was whether patients were brought to the hospital by police. Implications for public policy and psychiatric DRGs (diagnosis related groups) are discussed.     

Effect of exogenous beta-galactosidase in patients with lactose malabsorption and intolerance: a crossover double-blind placebo-controlled study

OBJECTIVE: To evaluate the efficacy of the addition to milk, 5 min and 10 h before its consumption, of a lactase obtained from Kluyveromyces lactis in lactose malabsorbers with intolerance. DESIGN: Double-blind, placebo-controlled, crossover study. SETTING: University Hospital. SUBJECTS: In total, 11 male and 19 female (aged from 18 to 65 y, mean age 43.3 y) lactose malabsorbers with intolerance participated. INTERVENTIONS: Each patient underwent three H(2) breath tests, in a random order. We used 400 ml of cow's semiskimmed milk as substrate and a beta-galactosidase obtained from K. lactis. The test A was carried out adding to the milk the enzyme (3000 UI), 10 h before its consumption; the test B was performed adding the beta-galactosidase (6000 UI) 5 min before milk ingestion and the test C was made using placebo. We evaluated the maximum breath H(2) concentration, the cumulative H(2) excretion and a clinical score based on intolerance symptoms (bloating, abdominal pain, flatulence and diarrhoea). RESULTS: Our study showed a significant reduction of the mean maximum H(2) concentration after both test A (12.07 +/- 7.8 p.p.m.) and test B (13.97 +/- 7.99 p.p.m.) compared with test C (51.46 +/- 16.12 p.p.m.) (ANOVA F = 54.33, P < 0.001). Similarly, there was a significant reduction of the mean cumulative H(2) excretion after both test A (1428 +/- 1156 p.p.m.) and test B (1761 +/- 966 p.p.m.) compared with test C (5795 +/- 2707 p.p.m.) (ANOVA F = 31.46, P < 0.001). We also observed a significant reduction of the mean clinical score after both test A (0.36 +/- 0.55) and test B (0.96 +/- 0.85) compared with test C (3.7 +/- 0.79) (ANOVA F = 106.81, P < 0.001). Moreover, with regard to the mean clinical score, there was a significant reduction after test A with respect to test B (Bonferroni's P = 0.03). CONCLUSIONS: Our study shows that in lactose malabsorbers with intolerance, the lactase obtained from K. lactis can represent a valid therapeutic strategy, with objective and subjective efficacy and without side effects.     

Long-term immunogenicity after single and booster dose of a live attenuated hepatitis A vaccine: results from 8-year follow-up

Live, attenuated hepatitis A vaccines are used widely in China but there is uncertainty regarding the persistence of vaccine-induced anti-HAV antibodies after single dose and booster dose administrated at month 12. A large scale clinical trial to evaluate the live, attenuated hepatitis A vaccine was conducted in Hebei province between 1996 and 1999. Five years after the trials, children in single dose and booster dose groups were bled and followed. Seventy two percent (61/85) of children who received a single trial dose had detectable anti-HAV antibodies for 96 months (GMC at 96 months: 89.0 mIU/mL). In the booster group 98% (48/49) children remained anti-HAV positive with GMC of 262.8 mIU/mL at month 96. The reinjection with live attenuated HAV vaccine can elicit a booster effect. Results from single dose group seems not to support the need for booster doses of live attenuated hepatitis A vaccine in immunocompetent individuals regarding the persisting anti-HAV and anamnestic response of a single dose vaccine. Continued monitoring of anti-HAV antibodies is needed for a rational hepatitis A immunization strategy in China.     

Flupenthixol decanoate and relapse prevention in alcoholics: results from a placebo-controlled study

Flupenthixol, with its broad receptor profile, interacts with a variety of dopamine and serotonin binding sites which are important in the neurobiology of alcohol dependence. Its pharmacology, together with encouraging results from both animal studies and clinical trials with cocaine users, led us to postulate that flupenthixol would significantly prevent relapse in detoxified alcohol-dependent individuals. We conducted a prospective, randomized, double-blind, placebo-controlled, multi-centre trial with two parallel groups and appropriate statistical evaluation. Subjects met criteria for moderate to severe alcohol dependence (DSM-III-R), without any concomitant psychiatric disorder. After complete detoxification, 281 women and men received either 10 mg of flupenthixol decanoate or placebo as i.m. injection every second week for 6 months on an out-patient basis, followed by 6 months of follow-up. Efficacy was based on absolute abstinence, with relapse being defined as consumption of any alcohol after inclusion in the study. In contrast to the hypothesis, flupenthixol did not reduce, but was associated with more, relapses. Though well tolerated, relapse rates after 6 months of treatment were 85.2% (flupenthixol) versus 65.5% (placebo), a highly significant difference from the medication. Flupenthixol was also inferior to placebo with regard to other secondary criteria of efficacy (cumulative abstinence duration, relapse rate after 12 months). These results indicate that a 10 mg dose of flupenthixol decanoate does not have a beneficial effect on abstinence maintenance in alcohol-dependent individuals.     

Immunotoxic effects on freshwater mussels of a primary-treated wastewater before and after ozonation: a pilot plant study

The immunotoxic potential of a primary-treated municipal effluent following enhanced disinfection by ozonation was studied in the freshwater mussel Elliptio complanata. Mussels were exposed to increasing concentrations (0%, 1%, 3%, 10%, and 20% v/v) of the effluent before and after ozone treatment (approximately 10 mg/L of purged O(3)) in a continuous flow-through laboratory for 7 weeks. Immunocompetence was appraised by measuring phagocytosis, cell viability (fluorescein retention), cell adherence to polystyrene micro-wells, cyclooxygenase (COX) activity and total nitrite levels in peripheral hemocytes from the hemolymphs. The results showed that phagocytosis was significantly inhibited by the primary-treated effluent at a threshold concentration of 1.7% v/v. Cell viability was also significantly reduced three-fold compared to controls at the same effluent threshold concentration, but hemocyte adherence was unchanged. COX activity was increased 1.3-fold at a threshold concentration of 14% v/v. Total nitrite levels were significantly increased 2.2-fold at a threshold concentration of 5.5% v/v. Ozone treatment of the effluent was not successful in removing phagocytic inhibition, but did completely remove cytotoxicity from hemocytes. Ozonation also reduced cell adherence at a threshold concentration of 1.7% v/v. The inflammatory properties of the effluent appeared to be accentuated by the ozone, as evidenced by an increase in COX activity, which reached 2.6-fold activity compared to controls, as compared to the 1.3-fold increase witnessed in the primary-treated effluent. Furthermore, total nitrite levels reached a two-fold induction at a threshold concentration of 1.7% v/v in the ozone-enhanced effluent compared to 5.5% v/v in the primary-treated effluent. In conclusion, ozonation of a primary-treated effluent successfully reduced microbial loading and completely removed cytotoxicity, but increased the inflammatory properties of the effluent. Investigations aimed at examining the impacts of sustained inflammation on the host's capacity to remove potentially pathogenic bacteria are recommended.     

A thyroid testing algorithm: results of a pilot study.

We conducted a pilot study to evaluate an algorithm for thyroid function testing consisting of initial serum thyrotropin values, measured by a sensitive immunoradiometric assay (TSH-IRMA), followed by a computer-directed decision to order further studies. We divided 216 outpatients according to their serum TSH-IRMA values as follows: suppressed (less than 0.1 mU/L, group I); low (0.1 to 0.4 mU/L, group II); normal (0.5 to 5.0 mU/L, group III); and high (greater than 5.0 mU/L, group IV). Thyroxine (T4), resin uptake (RU), and free thyroxine index (FTI) tests on groups I, II, and IV revealed that T4 and RU were normal for most patients in all groups and FTI was normal in 80% of group I, 93.4% of group II, and 93.3% of group IV. All patients in group I were designated hyperthyroid from either an exogenous or endogenous source. All patients in group II were clinically euthyroid except one; 50% were taking either L-thyroxine or propylthiouracil and 50% had no identifiable thyroid disease. Patients in group IV were hypothyroid. Overall, TSH was more effective in detecting both hypothyroidism and hyperthyroidism than either serum T4, RU ratio, or both combined in FTI since results of these measures fell in the normal range for most patients in all groups.(ABSTRACT TRUNCATED AT 250 WORDS)     

Impediment profiling for smoking cessation: results of a pilot study

OBJECTIVE: To test the effectiveness of a smoking cessation program based on "impediment profiling," the elucidation of an individual participant's personal barriers, with provision of tailored interventions accordingly. METHODS: A literature search was conducted to identify established impediments to smoking cessation. A long impediment profiler (LIP) was developed from validated survey instruments and used as a screening tool to identify individuals' barriers to quitting. Once barriers were identified, participants were assigned to up to seven interventions. Self-reported smoking cessation was confirmed with measurements of carbon monoxide concentrations in expired air of < or = 10 ppm. RESULTS: Nineteen adults participated in the pilot program. At the year 1 mark, 63.2% of the study population was smoke-free. The mean number of impediments of the study population was 3.5 +/- 1.5. There was a negative association between subjects' quit status and the following impediments: stress (p = .0061), anxiety (p = .0445), and depression (p < .001). No single impediment was predictive of quit status. CONCLUSIONS: Impediment profiling as a basis for tailored smoking cessation intervention is associated with a high quit rate in this initial study, and it appears promising. Long-term follow-up is warranted, as is replication in a larger cohort with a concurrent control group.     

Problems with the graduated frequency approach to measuring alcohol consumption: results from a pilot study in Toronto, Canada

Aims: To evaluate advantages and disadvantages of the graduatedfrequency (GF) approach, which asks about the frequency of alcoholconsumption at mutually exclusive quantity levels (i.e. 12 ormore drinks, at least eight drinks but less than 12, etc.). Methods: Telephone survey of 464 adults aged 18 and older inToronto, Canada, using random digit dialling and computer-assistedtelephone interviewing. Results: Respondents reported higher frequency and volume ofdrinking on the GF compared to overall and beverage-specificquantity–frequency type measures; however, at least 16%of GF responses included double counting on their frequencyestimates using the GF. When these cases were excluded or corrected,differences between the GF and quantity–frequency measuresmostly disappeared. The GF was superior to quantity–frequencymeasures for identifying heavy episodic drinkers. However, theGF had little advantage over the weekly recall method exceptfor identifying very infrequent (i.e. less often than twicea month) heavy drinkers. Conclusions: Because the GF has a highrate of response errors in terms of measuring frequency of alcoholconsumption, other combinations of measures, including alternatemeasures of heavy episodic drinking should be considered.     

Anthocyanin-rich plum juice reduces ambulatory blood pressure but not acute cognitive function in younger and older adults: a pilot crossover dose-timing study

Consumption of anthocyanins from fruit sources may exert protection against hypertension and improve cognition. However, the effect of dose timing in studies is rarely considered. We hypothesized that timed-dose consumption of juice from an anthocyanin-rich Japanese plum variety (Queen Garnet plum, QGP) will have acute and dose-timing effects on cardiovascular responses, cognition, and urinary anthocyanin excretion profiles. Our study objective was to investigate the impact of plum juice on these health parameters. Twelve older (65+ years) and 12 younger (18-45 years) adults participated in an acute crossover study. Participants received, randomly, either 1 × 300 mL or 3 × 100 mL plum juice over 3 hours on 2 different occasions with a 2-week washout period. A battery of cognitive tasks was administered at 0 and 6 hours on each study day. Blood pressure (BP) and urinary anthocyanin/metabolite excretion profiles were measured over 24 hours. Area under the curve for BP was calculated (0-6 hours). A significant reduction in BP and cardiovascular responses was observed in both age groups which was more obvious in the older age group on the single dose for systolic BP, diastolic BP, mean arterial pressure, and heart rate (P values = .035, .028, .017, and .006, respectively). No significant difference was observed between dose-timing regimens for either age group. There was no observed effect on cognition. Native QGP anthocyanins, as well as methylated/glucuronidated metabolites, were detected in urine with no significant differences between age groups or dose timing. High-anthocyanin plum juice significantly reduced BP, but dose timing did not appear to be a significant factor in the potential acute BP-lowering effect of QGP juice.     

Augmentation of influenza surveillance with rapid antigen detection at the point-of-care: results of a pilot study in Tasmania, 2004

Tasmania contributes very few laboratory confirmed cases to Australia's national influenza surveillance statistics. In 2004, a study was conducted to pilot test sentinel syndromic surveillance for influenza-like illness supplemented by point-of-care testing using the Binax Now Flu A Test Kit and by viral culture, to assess the feasibility and acceptability of this method of surveillance. Overall, the goal of such a system would be to increase laboratory surveillance activity within Tasmania and increase the number of specimens sent for viral culture. Five sites participated in the study, including three public hospital emergency departments and two general practices. Despite being conducted during a period of low influenza activity, the pilot study demonstrated that augmentation of syndromic surveillance with point-of-care testing is both feasible and acceptable but is best conducted in the general practice setting.     

Antide bioavailability: single dose administration for suppression of testosterone and inhibin in male monkeys.

The pharmacokinetics and pharmacodynamics of a single sc injection of Antide on testosterone (T) and inhibin secretion in intact male cynomolgus monkeys were examined. Fifteen primates were randomized to three groups receiving: propylene glycol and water vehicle, 3 mg/kg Antide, and 10 mg/kg of Antide. Antide at the 10 mg/kg dose caused long-term suppression of T ranging from 24-56 days. At the 3 mg/kg dose, suppression of T was of shorter duration. Serum Antide levels were significantly greater in the 10 mg/kg group than the 3 mg/kg group (p less than 0.02), both initially and through 35 days post-treatment. The duration of testosterone inhibition and sustained Antide levels were significantly correlated (p less than 0.01). Inhibin concentrations followed the same general pattern as testosterone reaching a nadir on day 21 post-treatment before subsequent recovery. The prolonged suppressive effect of Antide on T without detectable side effects makes this compound an excellent candidate for clinical evaluation.