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Transdermal scopolamine patches (1.5 mg) were used to control drooling in a two-year-old boy with severe spastic quadriparetic cerebral palsy and developmental delay. He responded well to the continuous scopolamine therapy, with a decrease in drooling, and a secondary decrease in respiratory distress and frequency of suctioning. No significant side-effects were noted.
OBJECTIVE: To study the effect of total body irradiation (14.4 Gray) in childhood and adolescence on ovarian and uterine characteristics, and to investigate the response to physiological sex steroid serum concentrations. DESIGN: All long term post-pubertal female survivors of total body irradiation who had been treated in paediatric centres in Scotland were identified. Their ovarian and uterine characteristics were studied. SETTING: Recruitment was from follow up oncology clinics. SAMPLE: Nine women were identified, eight of whom were assessed and five progressed to detailed investigation. A control population of 12 women treated for acute leukaemia, but not treated with total body irradiation, and five healthy women with no history of childhood malignancy were recruited as controls. METHODS: Ovarian function was determined by measurement of serum gonadotrophins and sex steroids. Uterine response to physiological sex steroid replacement was investigated in women with ovarian failure, and to endogenous sex steroid production in women with ovarian function by ultrasound scan. The physiological sex steroid replacement was achieved with transdermal oestradiol patches and self administered vaginal progesterone pessaries. MAIN OUTCOME MEASURES: Determination of ovarian function and uterine response to physiological sex steroid serum concentrations. RESULTS: Six of eight women treated with total body irradiation had ovarian failure; preservation of function was seen in two girls treated pre-pubertally who had biochemical evidence of incipient ovarian failure. Four women with ovarian failure had reduced uterine volume, undetectable blood supply and absent endometrium at baseline assessment; after three months of physiological sex steroid replacement treatment uterine blood supply and endometrial response were not significantly different from controls; uterine volume improved but remained significantly smaller than controls and correlated with age at total body irradiation. CONCLUSIONS: Ovarian failure after total body irradiation is common and risk relates to age at treatment. Physiological sex steroid replacement improved uterine measures and these women may benefit from assisted reproductive technology.
Nicotine is widely reported to increase alertness, improve co-ordination and enhance cognitive performance; however, to our knowledge there have been no attempts to replicate these findings in relation to exercise endurance. The purpose of this study was to determine the effects nicotine might have on cycling endurance, perception of exertion and a range of physiological variables. With local ethics committee approval and having obtained informed consent, 12 healthy, non-smoking men (22 +/- 3 years; maximal O2 uptake, 56 +/- 6 ml kg(-1) min(-1), mean +/- s.d.) cycled to exhaustion at 18 degrees C and 65% of their peak aerobic power, wearing either a 7 mg transdermal nicotine patch (NIC) or a colour-matched placebo (PLA) in a randomized cross-over design; water was available ad libitum. Subjects were exercising at approximately 75% of their maximal O2 uptake with no differences in cadence between trials. Ten out of 12 subjects cycled for longer with NIC administration, and this resulted in a significant 17 +/- 7% improvement in performance (P < 0.05). No differences were observed for perceived exertion, heart rate or ventilation. There were no differences in concentrations of plasma glucose, lactate or circulating fatty acids. In the absence of any effect on peripheral markers, we conclude that nicotine prolongs endurance by a central mechanism. Possible modes of action are suggested.
AIM: To examine the role of sociodemographic factors as predictors of sustained smoking cessation for the population who volunteer to participate in intervention programmes. METHOD: Data for the 3575 smokers who participated in the CEASE (collaborative European anti-smoking evaluation) trial, a European multicentred study that used transdermal nicotine patches as an adjunct to smoking cessation in the chest clinic, were analysed. The effects of age, sex, smoking habit, socioeconomic status (housing conditions, education, and employment), disease, smoking habits of relatives, and baseline markers of tobacco use on sustained smoking cessation (self-reported abstinence and expired carbon monoxide < 10 parts per million) were assessed using logistic regression modelling (odds ratio (OR), 95% confidence interval (CI)). RESULTS: 477/3575 smokers were sustained abstainers one year after the intervention (overall success rate 13.3%). In the univariable logistic regression models an effect of active treatment on smoking cessation was observed (OR 1.50, 95% CI 1.15 to 1.96), and additional effects on outcome were found for age (OR 1.02, 95% CI 1.01 to 1.03), sex (men v women: OR 1.38, 95% CI 1.14 to 1.68), housing conditions (OR 1.43, 95% CI 1.25 to 1.65), current respiratory (OR 0.79, 95% CI 0.67 to 0.92) or cardiac disease (OR 0.46, 95% CI 0.28 to 0.75), and markers of tobacco use (cigarettes per day: OR 0.79, 95% CI 0.69 to 0.90; expired carbon monoxide: OR 0.98, 95% CI 0.97 to 0.99). Education and employment did not have a significant effect on the outcome. The effect of the variables associated with success in smoking cessation persisted after adjustment for covariates. CONCLUSION: Age, sex, and housing conditions have a major effect on smoking cessation in European smokers participating in smoking cessation programmes.
OBJECTIVE: To test the hypothesis that among adolescent smokers hospitalised for psychiatric and substance use disorders, motivational interviewing (MI) would lead to more and longer quit attempts, reduced smoking, and more abstinence from smoking over a 12 month follow up. DESIGN: Randomised control trial of MI versus brief advice (BA) for smoking cessation, with pre- and post-intervention assessment of self efficacy and intentions to change, and smoking outcome variables assessed at one, three, six, nine, and 12 month follow ups. SETTING: A private, university affiliated psychiatric hospital in Providence, Rhode Island, USA. PATIENTS OR OTHER PARTICIPANTS: Consecutive sample (n = 191) of 13-17 year olds, admitted for psychiatric hospitalisation, who smoked at least one cigarette per week for the past four weeks, had access to a telephone, and did not meet DSM-IV criteria for current psychotic disorder. INTERVENTIONS: MI versus BA. MI consisted of two, 45 minute individual sessions, while BA consisted of 5-10 minutes of advice and information on how to quit smoking. Eligible participants in both conditions were offered an eight week regimen of transdermal nicotine patch upon hospital discharge. MAIN OUTCOME MEASURES: Point prevalence abstinence, quit attempts, changes in smoking rate and longest quit attempt. Proximal outcomes included intent to change smoking behaviour (upon hospital discharge), and self efficacy for smoking cessation. RESULTS: MI did not lead to better smoking outcomes compared to BA. MI was more effective than BA for increasing self efficacy regarding ability to quit smoking. A significant interaction of treatment with baseline intention to quit smoking was also found. MI was more effective than BA for adolescents with little or no intention to change their smoking, but was actually less effective for adolescents with pre-existing intention to cut down or quit smoking. However, the effects on these variables were relatively modest and only moderately related to outcome. Adolescents with comorbid substance use disorders smoked more during follow up while those with anxiety disorders smoked less and were more likely to be abstinent. CONCLUSIONS: The positive effect of MI on self efficacy for quitting and the increase in intention to change in those with initially low levels of intentions suggest the benefits of such an intervention. However, the effects on these variables were relatively modest and only moderately related to outcome. The lack of overall effect of MI on smoking cessation outcomes suggests the need to further enhance and intensify this type of treatment approach for adolescent smokers with psychiatric comorbidity.
To evaluate the effect of menopause and estrogen replacement therapy on leptin levels, 17 white postmenopausal women were recruited for the study. After an overnight fasting, blood samples were collected for LH, FSH, estradiol, testosterone, androstenedione, DHEA sulfate, insulin and leptin assays. Body mass index (BMI) and the waist-to-hip ratio were also evaluated. Patients were reanalyzed after a 12-week administration of transdermal estrogen patches delivering 50 microg 17beta-estradiol. The results were compared to those obtained from a group of 11 female volunteers in reproductive age, in whom basal blood was sampled during the early follicular phase of their cycle. Patients were divided into lean and obese according to their BMI. Obese postmenopausal women showed lower leptin levels when compared to premenopausal counterparts (25.1 +/- 5.9 vs. 37 +/- 11.3; p < 0.05), whereas no significant differences were found between the lean groups (14.5 +/- 3.8 vs. 14.4 +/- 4.9). Estrogen administration did not significantly change serum leptin concentrations in hypoestrogenized women (obese: 25.1 +/- 5.9 vs. 28. 6 +/- 9.2; lean: 14.4 +/- 4.9 vs. 17.6 +/- 7.2). A positive linear correlation was found between leptin plasma levels and BMI only in obese patients (r = 0.58; p < 0.01) both before and after estrogen treatment. Menopause is characterized by a decreased expression of the obese gene, even if estrogens do not seem to represent a main causal factor.
BACKGROUND: Nicotine was effective in the treatment of skin disorders attributable to neutrophils such as pyoderma gangrenosum and orogenital ulcerations due to Behçet's disease. OBJECTIVE: We assessed the efficacy of nicotine for treating skin disorders with prominent eosinophilic infiltration. PATIENTS AND METHODS: A 67-year-old man with Kimura's disease was treated for 2 weeks with nicotine chewing gum (6 mg/day). A 50-year-old woman with erythema nodosum with eosinophilic infiltration was treated for 4 weeks with transdermal nicotine patches (5 mg/day). RESULTS: Both patients showed a dramatic clinical and histopathological improvement. CONCLUSION: Our results suggest that nicotine may be useful for treating skin disorders with eosinophilic infiltration as well as neutrophilic dermatoses.
Using hormone replacement therapy (HRT), absolute and relative contradictions have to be considered, which are primarily classified according to a "worst case" scenario on the assumption of group effects, in order to satisfy forensic demands. However, in patients with severe complaints it make sense to apply HRT even at increased risk. To minimize the risk, a differentiated choice of the preparation especially in terms of progestin component and application mode is feasible apart from a general dose reduction. For internal risk patients, transdermal estradiol in a patch or gel and neutral progestins like progesterone and dydrogesterone or combination patches for a completely transdermal HRT are to be preferred. In the Women's Health Initiative, a study investigating a population strongly burdened with cardiovascular risks, the most important risks were venous thromboses and strokes, in old age also myocardial infarctions. In this context, the risk groups with diabetes, hypertension and dyslipoproteinemia as well as smokers in general are of particular importance. Other common internal risk groups comprise women with thyroid and hepatobiliary diseases. Rare but prognostically important diseases such as porphyria and lupus erythematosus are considered as relative contraindications. The available data on these risk groups are described and practical recommendations are given.
OBJECTIVE: Accepted treatments for cigarette smoking rarely achieve abstinence rates of >35% at 1 year. Low rates may reflect failure to provide extended and multifocal treatment for this complex and chronic addiction. Using a chronic disease model of smoking, the authors undertook a study to determine the effects of long-term antidepressant and psychological treatment. METHOD: One hundred sixty smokers of > or =10 cigarettes/day were randomly assigned to one of four treatment conditions in a two-by-two (nortriptyline versus placebo by brief versus extended treatment) design. All subjects received 8 weeks of a transdermal nicotine patch, five group counseling sessions, and active or placebo treatment. Interventions for subjects in brief treatment ended at this point. Subjects in extended treatment continued taking drug or placebo to week 52 and received an additional 9 monthly counseling sessions, with checkup telephone calls midway through each session. Subjects were assessed at baseline and weeks 12, 24, 36, and 52. The principal outcome variables were repeated abstinence at each assessment after the first over a 1-year period and a point prevalence of 7 days of abstinence. RESULTS: At week 52, point-prevalence abstinence rates with missing subjects imputed as smokers were 30% for placebo brief treatment, 42% for placebo extended treatment, 18% for active brief treatment, and 50% for active extended treatment. With missing subjects omitted, these rates were 32%, 57%, 21%, and 56%, respectively. CONCLUSIONS: Comprehensive extended treatments that combine drug and psychological interventions can produce consistent abstinence rates that are substantially higher than those in the literature.
People with schizophrenia smoke more than the general population and more than other psychiatric diagnostic groups. The rate of smoking in the general population is 30 percent, and reported rates for people with schizophrenia range between 62 percent and 81 percent. The author briefly reviews evidence that nicotine's augmentation of dopamine release may account for the high prevalence of smoking in this group. The affective, cognitive, and social difficulties and the symptoms experienced by many patients with schizophrenia indicate that existing smoking cessation programs may not be appropriate for them. The author describes three programs developed for use with this population and reviews evidence of their effectiveness. Preliminary evidence suggests that transdermal nicotine patches are effective and that patients do not misuse them. The author concludes that stopping smoking is possible for individuals with schizophrenia, especially if the treatment is specifically designed for them.
Long-acting nitroglycerin preparations are a mainstay of therapy of angina pectoris. The trademark name of one such preparation led to the incorrect administration of a similarly named scopolamine preparation to a patient with angina. Physicians and pharmacists must be alert to the potential for medication error inherent in the brand names for these two preparations. The case also illustrates other aspects of the proper use of transdermal nitroglycerin patches.
OBJECTIVE: We assessed the effects of progestin when added to estrogen on the adaptive patterns to provoked stress in postmenopausal women. METHODS: Fourteen postmenopausal women were randomized to receive either a transdermal estrogen patch (TE2) (n = 7) for 6 weeks or TE2 with added medroxyprogesterone acetate (10 mg) (TE2/MPA) (n = 7) for the last 10 days of the 6-week regimen. Behavioral stress tests were administered to each group, with measurements of biophysical and neuroendocrine responses. In a crossover fashion, after each group received the first treatment and testing, treatment was continued for another 6 weeks with the alternate regimen, at which time another stress test was administered. Responses to stress in the two treatment groups were compared to each other and to established placebo responses. RESULTS: Biophysical responses in the TE2 group were significantly blunted compared to both TE2/MPA and placebo responses (P < .05). Without MPA treatment, there were significantly blunted speech (P < .05) and cold pressor (P < .01) blood pressure responses. With added progestin, there was a greater systolic blood pressure response (P < .01) compared with estrogen alone. Both groups (TE2 and TE2/MPA) had blunted and nonsignificant responses of ACTH and cortisol upon testing, whereas the placebo group showed a significant response (P < .01). Plasma norepinephrine responses, however, were significantly blunted after TE2, compared with the increased responses observed with both TE2/MPA and placebo (P < .01). CONCLUSION: Although estrogen significantly reduces behaviorally induced stress reactivity in postmenopausal women, certain doses of progestin administration may blunt this effect.
We examined the effects of GH and/or testosterone (T) administration on body composition, performance, mood, sexual function, bone turnover, and muscle-gene expression in healthy older men. Ten men [mean (SEM) age, 68 (2.5) yr; height, 171.5 (2.4) cm; and weight, 80 (3.0) kg] completed each of the following 1-month, double-blind interventions after a baseline (B) study in randomized order with an intervening 3-month washout: transdermal T patch (5.0 mg/daily); recombinant human GH (6.25 micro g/kg sc daily); and combined hormones (GHT). ANOVA with repeated measures was used to evaluate interventional effects. Integrated serum GH concentrations [mean (SEM)] were elevated comparably by GH and GHT: [B = 363 (55), GH = 1107 (120), T = 459 (131), and GHT = 1189 (46) micro g/liter.min; P < 0.0001]. Serum IGF-I concentrations also increased commensurately after GH and GHT: [B = 168 (14), GH = 285 (16), T = 192 (25), and GHT = 294 (25) micro g/liter; P < 0.0001]. GHT administration increased total estradiol: [B = 110 (20), GH = 106 (13), T = 129 (13), and GHT = 153 (17) pmol/liter; P < 0.02], and both T and GHT elevated free T: [B = 12 (2.1), GH = 11 (1.5), T = 22 (2.8), and GHT = 24 (2.5) pg/ml; P < 0.0001]. No significant changes occurred in strength, flexibility, percentage body fat, or sexual function and mood. However, fat-free mass increased under combined GHT exposure: [B = 55 (1.3), GH = 56 (1.1), T = 55 (1.5), GHT = 57 (1.7) kg; P < 0.03]. Balance improved in response to GH intervention (P < 0.05), as did 30-m walk time during T and GHT interventions [B = 6.6 (0.3), GH = 6.2 (0.7), T = 5.9 (0.3), GHT = 5.5 (0.3) sec; P = 0.04] and stair climb time for all three interventions [B = 32.2 (1.4), GH = 29.8 (1.2), T = 30.5 (1.4), and GHT = 29.9 (1.2) sec (P = 0.0034), wherein the effects of GH, T, and GHT were different from that of B]. Muscle IGF-I gene expression increased by 1.9-fold during GH administration and by 2.3-fold during GHT administration (P < 0.05, compared with B). Myostatin and androgen receptor gene expression were not affected. Serum osteocalcin increased in response to the GH and GHT interventions: [B = 4.8 (0.52), GH = 5.7 (0.54), T = 4.7 (0.33), and GHT = 5.5 (0.39); P <0.009]. There were no significant adverse events during 30 patient-months of intervention. We conclude that 1 month of GH and/or T administration improves certain measures of balance and physical performance in older men and increases muscle IGF-I gene expression.
In both men and women, a decrease in bone mineral density (BMD) is a major symptom of hypogonadism. Although the effects of estrogens on osteoporosis in women are well documented, comparatively little is known about the effects of long term testosterone substitution on BMD in hypogonadal men. Therefore, we studied BMD in 72 hypogonadal patients (37 men with primary and 35 men with secondary hypogonadism) under testosterone substitution therapy that continued for up to 16 yr. Thirty-two of these men were also seen before initiation of therapy. At annual intervals, trabecular BMD of the lumbar spine was measured by quantitative computed tomography, a true volumetric and reproducible method for long term serial BMD measurements. Serum levels of testosterone increased to the normal range in all androgen-treated hypogonadal men. The most significant increase in BMD was seen during the first year of testosterone treatment in previously untreated patients, when BMD increased from 95.2 +/- 5.9 to 120.0 +/- 6.1 mg/cm3 hydroxyapatite (mean +/- SE). Long term testosterone treatment maintained BMD in the age-dependent reference range in all 72 hypogonadal men, independent of the type of hypogonadism. Transdermal testosterone patches applied to the scrotum were as effective in normalizing BMD as im testosterone enanthate injections. In summary, testosterone therapy increases BMD in hypogonadal men regardless of age. The greatest increase is seen during the first year of treatment in previously untreated patients with low initial BMD. In hypogonadal men, BMD can be normalized and maintained in the normal range by continuous, long term testosterone substitution.
Ultrasound is frequently used in medicine for diagnostic purposes. Recently, there have been numerous reports on application of ultrasound energy for controlling drug release or targeting. This new concept of therapeutic ultrasound combined with drugs has induced excitement in various areas. Ultrasound energy can enhance effects of thrombolytic agents as urokinase. Ultrasound emitting catheters are currently being developed for cardiovascular diseases. Device with ultrasound transducers implanted in transdermal drug patches are also being evaluated for possible delivery of insulin through the skin. Chemical activation of drugs by ultrasound energy for treatment of cancers is another new field recently termed as "Sonodynamic Therapy". Various examples of application of ultrasound for drug delivery systems are discussed.
The management of symptomatic bradyarrhythmias can be challenging in patients in whom cardiac pacing is not indicated, such as in the terminally ill or severely demented. We applied a transdermal scopolamine patch on one such patient with resultant substantial improvement in his supraventricular bradyarrhythmia.
Transdermal nicotine patches have been successfully introduced as a safe and powerful aid to smoking cessation; this has contributed to the rising interest in additional therapeutic applications for nicotine and synthetic nicotinic agonists. Nicotine and nicotinic agonists may have a therapeutic potential for a variety of disorders, including Alzheimer's and Parkinson's diseases, depression, attention deficit disorder, Tourette's syndrome and ulcerative colitis. These interests are partially fuelled by the urgent need of the tobacco industry to find new niches for nicotine in a world bound eventually to retire from cigarette smoking. At the same time, there is an increased interest in developing drugs for fighting obesity, a growing affliction of industrialised nations. This review presents data on the potential of nicotine, and in particular synthetic nicotinic agonists, for controlling body weight. Nicotinic agonists may become relatively safe, effective and inexpensive alternatives for several optional drugs currently being developed for treating human obesity, including beta-3-adrenergic agonists, leptin and its agonists, and neuropeptide Y antagonists.
OBJECTIVES: Transdermal nicotine patches have shown considerable promise in improving smoking cessation outcomes. The present study assessed telephone support as an adjunct to a managed care-based, single-session group orientation smoking cessation program with nicotine patch therapy. METHODS: The unit of randomization was the orientation session (n = 35). Subjects (n = 509) were randomly assigned to a group session without telephone support, the session plus access to a toll-free help line, or the session with telephone help line plus active telephone outreach. RESULTS: Contrary to hypothesis, there were no differences between treatment conditions. Overall abstinence rates were 22% at 6 months and 21% at 1 year. Fewer than 1% of eligible subjects called the toll-free help line. An average of 3.8 of a possible 4 calls were completed in the telephone outreach condition. CONCLUSIONS: Abstinence results obtained in this program were comparable to those obtained with more extensive counseling. However, there was no evidence of benefit from telephone support beyond the initial physician-led group orientation session.