N.D.: A. Ahmed and D. Vold; Iowa Heart Center, Des Moines: W. Wickmeyer and N. Coffman; MetroHealth Medical Center, Cleveland: R. Finkelhor and M. Dettmer; Scarborough Cardiology Research, Scarborough, Ont., Canada: A. Ricci, and B. Bozek; Moses Cone Hospital, Greensboro, N.C.: T. Stuckey and S. Milks; Lake Forest Hospital, Bannockburn, Ill.: J. Alexander and K. Anderson; Centre Hospitalier Universitaire, Fleurimont, Que., Canada: S. LePage and L. Larrivee; Butterworth Hospital, Grand Rapids, Mich.: R. McNamara and B. Van Over; Centre Hospitalier Regional de Lanaudire, Quebec, Canada: S. Kouz and M. Roy; Craigavaon Area Hospital, Portadown, County Armagh, United Kingdom: A. Moriarty and D. McEneaney.
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Pelvic organs. When the sympathetic response lessens, the blood vessels dilate and supply more blood to the organs, delivering more hormonal stimulation to the ovaries, and improving the uterine blood flow. Sherry was also extremely anxious. Her palms were sweaty, she was despondent and scared about her poor response to the IVF cycles. Although she did not describe herself as irritable or depressed, stress had become a large part of her poor response. I taught her some qi gong breathing and meditative visualization techniques, and taught her husband the femoral massage technique to perform three times per day on Sherry. During each acupuncture visit, I performed the back acupuncture treatment on her, followed by the "de-stressing" treatment, applying stimulation to the point between the eyebrows, the point on the top of the feet one inch up from the web between the first and second toes, and the point on the hands, in the muscular tissue one inch up from the web between the thumb and first finger. I also applied stimulation to the uterus and ovarian points on the lower abdomen. When she began injecting the drugs, Sherry and her husband reported that her mental response to the hormonal stimulation was much improved and she felt calmer, almost peaceful. She was accepting of the outcome this time, no matter what the results. The response was dramatic. Her reproductive endocrinologist reported that the doppler studies revealed a great improvement in ovarian blood flow. Nine eggs were retrieved, six fertilized, and two implanted. Both were carried to almost ; term, and they are the proud parents of twins, one boy and one girl and
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Blocking drug, Rimonabant, achieves a mean weight loss of 4.7 kg along with improvements in insulin resistance and inflammation. This is achieved through the activation of cannabinoid-1 CB1 ; receptors which alters appetite and glucose and lipid metabolism.48 Rkmonabant treatment for up to 2 years is well tolerated, with adverse events reported in clinical trials being mostly mild to moderate and transient e.g mild nausea, diarrhoea, dizziness and mood disorders ; . AOD-9604 is a novel anti-obesity drug which is currently being trialled that is thought to stimulate fat metabolism by selectively mimicking the activity of growth hormone on adipose tissue. In preclinical trials weight gain was inhibited in obese rodents, an effect thought to be associated with an increase in fat breakdown and decrease in fat storage. A Phase IIb clinical trial conducted in five centres across Australia demonstrated significantly greater weight loss with AOD-9604 130 mg ; than with placebo.25 Unfortunately, weight loss medications only work while being taken and their long term safety and efficacy are yet to be established. Ideally, weight loss medications should be combined with lifestyle changes for maximum results. This has been elegantly demonstrated recently, with sibutramine alone, lifestyle modification and the combination of the two, producing 5.0 kg, 6.7 kg and 12.1 kg of weight loss at 1-year respectively.36 Two factors need to be emphasised. The first is the role of pharmacotherapy in weight loss maintenance, a concept rather like the long-term control of hypertension. Secondly, the absolute necessity for diet, activity and behaviour change a "lifestyle programme" ; to underpin abdominal fat loss, weight loss and maintenance.48 Behavioural therpay, Group therpay, Patient contact The addition of more formal behavioural therapy BT ; or cognitive behavioral therapy CBT ; can facilitate weight loss when combined with diet, exercise and pharmacotherapy. Strategies seek to aid stimulus control, reinforce principles, aid self-monitoring and problem solving, and help with goal setting. The Cochrane review found BT and CBT useful when combined. BT and CBT provided an additional 2.3 95% CI, 1.4-3.3 ; kg and 4.9 95% CI, 2.4-7.3 ; kg weight loss when combined with lifestyle modification40 and pharmacotherapy.41 Behavioural treatment has been shown to be effective in inducing a loss of 7%-10% of initial weight and that losses of this size are associated with significant improvements in health, as shown by the Diabetes Prevention Program.42 A well-controlled study found that group treatment induced a larger initial weight loss approximately 2 kg ; than did individual treatment.43 This held true even for patients who indicated that they preferred individual treatment but were randomly assigned to receive group care. These individuals lost more weight than people who preferred individual treatment and received it. Group treatment also is more cost-effective than usual care. Studies between 1996 and 2002 show that patients treated with a comprehensive group behavioural approach lose approximately 10.7kg about 10% of initial weight ; in 30 weeks of treatment. In addition, about 80% of patients who begin treatment complete it.36 Numerous studies have shown the benefits of patients.
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Multidrug resistance MDR ; is a ubiquitous biological phenomenon that occurs in living organisms to evade chemotherapy or to resist naturally occurring toxic chemical compounds for reviews, see references 10, 23, 29, and 50 ; . One common type of MDR is caused by an increased activity of specific transporters on the plasma membrane that carry chemotherapeutic drugs out of cells and subsequently lower intracellular drug concentration. These drug pumps belong to a superfamily of evolutionarily conserved proteins known as ATP-binding cassette ABC ; transporters and are characterized by a similar molecular architecture involving one or two ATP-binding sites and 6 to 17 predicted transmembrane domains for recent reviews, see references 3, 5, and 35 ; . Drugs are actively extruded across the plasma membrane at the expense of ATP hydrolysis reviewed in reference 47 ; . Among the well-studied drug transporters are the human P glycoprotein and the MDRassociated proteins MRPs ; that render tumor cells highly resistant to anticancer drugs 10, 23, 29, ; . In recent years, attention has also been turned to the ABC transporters that confer drug resistance in pathogenic microorganisms such as Candida albicans 42, 45, 59 ; , Plasmodium falciparum 43 ; , and infectious bacteria 41 ; . The ABC transporter-mediated drug efflux appears to be an evolutionarily conserved mechanism, as exemplified by the Lactococcus lactis drug pump, LmrA, which is able to confer MDR on human cells 55 ; . The unicellular eukaryote Saccharomyces cerevisiae has been extensively studied in recent years as a model system for understanding the molecular mechanisms underlying the devel.
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Other Causes of Persistent Fatigue. A number of conditions can cause persistent fatigue and should be ruled out. Obstructive sleep apnea. This is a major sleep disorder that causes fatigue and afternoon sleepiness and must be ruled out before a diagnosis of narcolepsy can be established. A person may also suffer sleep apnea and narcolepsy at the same time. ; Chronic fatigue syndrome. Head trauma. Infectious mononucleosis. Guillain-Barre syndrome. Hepatitis. Atypical pneumonia, particularly those involving echoviruses. Note, both head trauma and syndrome Guillain-Barre syndrome can also produce test results showing low levels of hypocretin in spinal fluid, just as narcolepsy can. ; Other Causes of Sleep Paralysis. Sleep paralysis may be triggered by certain conditions, such as the following: Irregular sleep habits. Sleep deprivation. Shift work. Jet lag. Psychologic stress. These conditions may also exacerbate sleep paralysis in narcolepsy, although in the sleep disorder, narcolepsy sleep paralysis usually occurs at the onset of sleep and is chronic and
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Selective CB1 receptor antagonism for the management of cardiometabolic risk factors. P. A. TATARANNI, Sanofi-Aventis, Bridgewater, NJ, USA. The endocannabinoid EC ; system is involved in regulating energy homeostasis and glucose and lipid metabolism through the action of endogenous ligands on CB1, a transmembrane G -protein coupled receptor expressed in the brain, adipose tissue, skeletal muscle, and liver. Preclinical findings show that overactivation of the EC system leads to excessive food and fat intake, exacerbation of both glucose intolerance and the atherogenic lipid profile, and excessive accumulation of intra-abdominal fat. The RIO Rinonabant In Overweight Obesity ; program with four double-blind, placebo-controlled, Phase III clinical trials evaluated the efficacy and safety of Rimonabant, the first in a new class of selective CB1 blockers, in 6, 600 patients, of whom about 1000 were type 2 diabetics. Treatment with Riminabant 20 mg ; was well tolerated and markedly improved multiple cardiometabolic risk factors including abdominal obesity, lipid and glucose metabolism, and insulin resistance, and in type 2 diabetics, HbA1c as well. Selective CB1 blockade shows promise for treating cardiometabolic risk factors associated with abdominal obesity. The effects of oral ingestion of soy protein on the somatotropic axis. J.A.H. VAN VUGHT1, 2 , A.G. NIEUWENHUIZEN1, 2 , R.J. BRUMMER2 , M.S. WESTERTERP-PLANTENGA 1, 2 . Dept. of Human Biology, P.O. Box 616, 6200 MD, Maastricht, The Netherlands, Top Institute Food and Nutrition, P.O. Box 557, 6700 AN, Wageningen, The Netherlands. Growth hormone GH ; is an important regulator of growth and body composition. Low levels of GH are likely to be involved in the pathogenesis of obesity, metabolic syndrome, sarcopenia and growth retardation. It has been shown that GH release can be promoted by administration of various amino acids, especially arginine and lysine, that are ample present in soy protein. The aim of the study was to compare the effects of hydrolysed soy protein and complete soy protein on GH-secretion. In this study, eight healthy women BMI 19-26 kg m; 19-36 years ; received a drink solution containing either placebo, hydrolysed soy protein or complete soy protein 0.6g protein per kg bodyweight ; , in a randomized, single blind crossover design. Plasma GH, insulin and somatostatin were determined every 20 minutes for 5 hours. GH-responses, as determined by area under the curve AUC ; , were significantly higher after hydrolysed and complete soy protein compared with placebo p 0.05 ; . Peak values of GH were significantly higher after complete soy protein compared with hydrolysed soy protein p 0.05 ; . Insulin responses AUC ; were significantly higher after complete and hydrolysed soy protein, compared with placebo p 0.05 ; . No significant difference was seen in plasma somatostatin concentrations. In conclusion, soy hydrolysate and soy protein stimulate GH release. Dietary protein therefore may affect physiological regulation of GH secretion. Effects of amylin and salmon calcitonin on energy expenditure and body temperature. P.Y. WIELINGA, B. ALDER, T.A. LUTZ. Institute of Veterinary Physiology and Zurich Center for Integrative Human Physiology, Vetsuisse Faculty University of Zrich, Winterthurerstrasse 260, 8057 Zrich Switzerland. The pancreatic B-cell hormone amylin is known to be involved in the regulation of meal ending satiation and it also shares typical features of adiposity signals. Chronic amylin administration has recently been shown to increase energy expenditure under certain conditions. Here we investigate the acute effect of peripheral administration of amylin or its agonist salmon calcitonin sCT ; on energy expenditure and RQ. First, rats were injected with amylin 5 g kg saline just before dark onset. Despite significantly decreased food intake in amylin-treated rats compared to controls until 2 h post-injection p 0.05 ; , amylin did not influence energy expenditure or RQ. Reduced food intake, which reduces energy expenditure, may have confounded a stimulatory effect of amylin on energy expenditure. Therefore, in the second experiment, amylin 1, 5 and 10 g kg saline was injected in the middle of the light phase t 0h ; without access to food during 3 h postinjection. Amylin had no significant effects on energy expenditure or RQ. In a similar paradigm, the effect of sCT 0.1, 1.0 and 5.0 g kg IP ; was tested. During food restriction, 1.0 and 5.0 g kg sCT significantly stimulated energy expenditure compared to control p 0.05 ; . Subsequent to refeeding at t 3h, energy expenditure was decreased compared to control from t 6h until t 12h after 5.0 g kg sCT, probably due to sCT's strong anorectic action. Amylin may prevent the compensatory decrease in energy expenditure normally seen in animals that eat less. The longer acting sCT stimulated energy expenditure in animals without access to food. Ongoing studies focus on the effect of chronic infusion of amylin and sCT on energy expenditure.
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II.2.iii.F. Study population Adults with episodic or chronic cluster headache. II.2.iii.G. Specific inclusion criteria a. Patients with episodic or chronic cluster headache conforming to IHS diagnostic criteria 3.1 or 3.2; patients with episodic cluster headache should be in at least their second cluster period. b. Acute attacks occurring between once every 2 days and 5 times per day. c. Attack duration of 30-180 minutes. d. Males and females. e. Unless otherwise justified, patients should be over 18 years of age. At the time of treatment: a. An acute attack, usually with onset within the previous 15 minutes at least 15 minutes before expected spontaneous resolution ; . b. At least 1 hour since resolution of the previous attack and 24 hours or 5 half-lives if longer ; since the latest previous use of study drug. c. Headache of moderate or greater intensity. d. So far untreated. II.2.iii.H. Specific exclusion criteria a. Other headaches not well distinguished from cluster headache. b. Other illnesses likely to interfere with assessments. c. Concurrent use of prophylactic drugs for cluster headache. d. Use of or requirement for other unacceptable concomitant therapy. e. History of drug or alcohol overuse. II.2.iii.I. Tools for assessing endpoints Paper or electronic diaries, with prompts at various time points. II.2.iii.J. Data analysis method In early efficacy studies, explanatory per protocol ; analysis may be appropriate. It is unhelpful at this stage to include patients with major protocol violations. Subgroup analyses for episodic and chronic subtypes and for gender differences ; are recommended and should be specified a priori. Standard statistical methods are appropriate. Adverse events are usually analysed descriptively. II.3. Long term studies II.3.i. Migraine prophylaxis II.3.i.A. Objectives To evaluate efficacy in migraine-attack prevention. II.3.i.B. Primary end-points a. Frequency of attacks per specified unit time usually 4 weeks ; measured during treatment after a specified period usually 8 weeks ; . b. Response rate: percentage of patients with frequency reduction of 50% or more after a specified treatment period. The number of attacks should be recorded irrespective of their duration, and the following rules distinguish an attack of long duration from two attacks and between attacks and relapses.
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GABA ANTAGONISM OF THE CENTRAL NUCLEUS OF THE AMYGDALA CNA ; ATTENUATES REDUCTIONS IN RAPID EYE MOVEMENT SLEEP REM ; AFTER FOOTSHOCK STRESS Liu X, Yang L, Sanford LD Pathology and Anatomy, Eastern Virginia Medical School, Norfolk, VA, USA Introduction : Footshock stress can produce a relatively selective decrease in REM. CNA has a central role in stress and is a strong modulator of REM. Microinjections into CNA of the GABA agonist muscimol MUS ; selectively decrease REM, whereas microinjections of the GABA antagonist bicuculine BIC ; selectively increase REM. We evaluated the effects of MUS and BIC in CNA on footshock-induced reductions in REM. Fos was used to determine the potential involvement of the locus coeruleus LC ; , a REM regulatory region that is activated by footshock and receives input from CNA. Methods : Male Wistar rats were implanted with transmitters for recording sleep and with cannulae aimed into CNA. After recovery, the rats were placed in one of four microinjection and footshock groups: SC saline [0.2 l] with no footshock, n 5 SS saline [0.2 l] plus footshock, n 4 MS MUS [1.0 uM 0.2 l] plus footshock, n 5 BS BIC [333 pM 0.2 l] plus footshock, n 5 ; . Sleep was recorded for two h after footshock 0.2 mA, 15 trials, 1.0 min interstimulus interval ; . Afterwards, the animals were sacrificed for Fos immunohistochemistry. Results : In the hour before sacrifice, REM in SS 1.02 0.28 ; and MS 0.58 0.41 ; rats was significantly less than in SC 5.05 0.68; p 0.01 ; and BS 5.18 0.9; p 0.01 ; . There was no significant difference in REM between SC and BS. Fos expression in LC was greater in SS 40.25 1.84 ; and MS 48.20 2.35 ; compared to SC 7.20 1.32; p 0.001 ; and BS 19.00 1.81; p 0.001 ; . Fos expression in LC was greater in BS than in SC p 0.01 ; . NREM sleep did not differ among groups. Conclusion : Footshock alone and MUS plus footshock selectively reduced REM and enhanced Fos activation in LC. By comparison, BIC attenuated the reduction in REM and attenuated Fos activation by footshock. The results suggest that the effects of footshock stress on REM may involve local GABA in CNA and activation of LC. Support optional ; : NIH research grant MH64827.
Peripheral and central volume of distribution of rimonabant was dependent on body weight, with more obese patients having higher volume of distribution: the predicted SS Cmax and Cmin would be 249 and 135 ng mL in and 190 and 142 ng mL in 200 Kg 46year old non-black patients. AUC would be 3839 ng.h mL in both cases. Central volume of distribution of rimonabant was influenced by age, with older patients having higher volume of distribution: the predicted SS Cmax and Cmin would be 221 and 137 ng mL in 46-year old and 238 and 137 ng mL in 75-year old 100 Kg non-black patients. AUC would be 3839 ng.h mL in both cases.
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Safety and efficacy trials for the neuraminidase inhibitor peramivir are starting this spring, BioCryst Pharmaceuticals director of peramivir development Shane Arnold, told the Bird Flu Summit held in Washington, DC, this week. The antiviral has been shown to be effective in animals in inhibiting both influenza A and B neuraminidases. Dr Arnold said the drug is easier and quicker to manufacture than oseltamivir Tamiflu ; , is potent against resistant strains and has been shown to have effects even if administered as much as 72 hours after infection. Although developed in the late 1990s, progress on peramivir was halted based on lacklustre sales of other flu-related drugs.The spectre of a flu pandemic has revived the company's interest in the antiviral. Tests are being conducted using peramivir in injectable and intravenous form since it did not perform as well in tests when administered orally.
Indicated that 76% of healthy adults were concerned that their physicians would have no treatment for sexual problems; 71% thought that physicians would dismiss concerns about their sexuality; and 68% indicated that they would feel uncomfortable discussing sexual problems with their physicians.5 These findings underscore the need for physicians to proactively begin frank discussions of sexual function with their patients. Initial evaluation of the patient with suspected ED should also include physical examination focused on the genitourinary, endocrine, and vascular systems. The laboratory evaluation, as recommended by a 2003 consensus panel on the management of ED, can include fasting plasma glucose and glycosylated hemoglobin, lipid profile, thyroid stim.
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