Biomedical subjects

Paul J Novotny

Publications and source records attributed to Paul J Novotny.

At least 19 recordsLinked to original sources

PubMed2006

Phase III trial of gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in women who have inadequate control with an antidepressant alone: NCCTG N03C5.

PURPOSE: Despite the utility of newer antidepressants for alleviating hot flashes, antidepressants do not work adequately enough in many patients. Gabapentin is a nonhormonal agent that also can reduce hot flashes. No data have been available to address whether the combination of both agents would more effectively alleviate hot flashes, compared with gabapentin alone, in patients with inadequate hot flash control with an antidepressant alone. PATIENTS AND METHODS: This was a randomized trial in which 118 patients with inadequate hot flash control on an antidepressant were randomly assigned to receive both an antidepressant and gabapentin versus being weaned off the antidepressant and receiving gabapentin alone. Patients were observed for 5 weeks (including a baseline week in which patients continued on their current antidepressant without gabapentin) during which time they completed validated daily hot flash diaries. RESULTS: Ninety-one patients provided complete data at the 5-week assessment. Regardless of whether or not the antidepressant was continued when gabapentin was started, there was an approximately 50% median reduction in hot flash frequencies (54%; 95% CI, 34% to 70% for combined treatment v 49%; 95% CI, 26% to 58% for gabapentin alone) and scores (56%; 95% CI, 26% to 71% for combined treatment v 60%; 95% CI, 33% to 73% for gabapentin alone). CONCLUSION: Gabapentin seems to decrease hot flashes by approximately 50% in women with inadequate hot flash control who were using an antidepressant. This study saw no significant additional hot flash reduction from continuation of the antidepressant.

Adult↗

PubMed2006

Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study.

CONTEXT: Medical errors are associated with feelings of distress in physicians, but little is known about the magnitude and direction of these associations. OBJECTIVE: To assess the frequency of self-perceived medical errors among resident physicians and to determine the association of self-perceived medical errors with resident quality of life, burnout, depression, and empathy using validated metrics. DESIGN, SETTING, AND PARTICIPANTS: Prospective longitudinal cohort study of categorical and preliminary internal medicine residents at Mayo Clinic Rochester. Data were provided by 184 (84%) of 219 eligible residents. Participants began training in the 2003-2004, 2004-2005, and 2005-2006 academic years and completed surveys quarterly through May 2006. Surveys included self-assessment of medical errors and linear analog scale assessment of quality of life every 3 months, and the Maslach Burnout Inventory (depersonalization, emotional exhaustion, and personal accomplishment), Interpersonal Reactivity Index, and a validated depression screening tool every 6 months. MAIN OUTCOME MEASURES: Frequency of self-perceived medical errors was recorded. Associations of an error with quality of life, burnout, empathy, and symptoms of depression were determined using generalized estimating equations for repeated measures. RESULTS: Thirty-four percent of participants reported making at least 1 major medical error during the study period. Making a medical error in the previous 3 months was reported by a mean of 14.7% of participants at each quarter. Self-perceived medical errors were associated with a subsequent decrease in quality of life (P = .02) and worsened measures in all domains of burnout (P = .002 for each). Self-perceived errors were associated with an odds ratio of screening positive for depression at the subsequent time point of 3.29 (95% confidence interval, 1.90-5.64). In addition, increased burnout in all domains and reduced empathy were associated with increased odds of self-perceived error in the following 3 months (P=.001, P<.001, and P=.02 for depersonalization, emotional exhaustion, and lower personal accomplishment, respectively; P=.02 and P=.01 for emotive and cognitive empathy, respectively). CONCLUSIONS: Self-perceived medical errors are common among internal medicine residents and are associated with substantial subsequent personal distress. Personal distress and decreased empathy are also associated with increased odds of future self-perceived errors, suggesting that perceived errors and distress may be related in a reciprocal cycle.

Adult↗

PubMed2006

Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1.

PURPOSE: Hot flashes can cause significant morbidity in postmenopausal women undergoing or finished with breast cancer treatment. Black cohosh has been used to treat hot flashes, but definitive clinical data about efficacy have been equivocal. METHODS: A double-blind, randomized, cross-over clinical trial with two 4-week periods, was used to study the efficacy of black cohosh (1 capsule, Cimicifuga racemosa 20 mg BID) for the treatment of hot flashes in women. Participants kept a daily hot flash diary during a baseline week and then during two 4-week crossover treatment periods. Hot flash scores were measured by assigning points (1 to 4 for mild to very severe) to each hot flash based on severity and then adding the points for a given time period. RESULTS: Between October 31, 2003, to March 4, 2004, 132 patients were randomly assigned. Toxicity was minimal and not different by treatment group. Patients receiving black cohosh reported a mean decrease in hot flash score of 20% (comparing the fourth treatment week to the baseline week) compared with a 27% decrease for patients on placebo (P = .53). Mean hot flash frequency was reduced 17% on black cohosh and 26% on placebo (P = .36). Patient treatment preferences were measured after completion of both treatment periods by ascertaining which treatment period, if any, the patient preferred. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. CONCLUSION: This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.

Adult↗

PubMed2006

Evaluation of the National Eye Institute visual function questionnaire in Graves' ophthalmopathy.

PURPOSE: To determine the potential suitability of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) for measuring health-related quality of life (HRQL) in patients with Graves' ophthalmopathy. DESIGN: Cross-sectional study. PARTICIPANTS: Thirty adult patients with mild to severe Graves' ophthalmopathy. METHODS: Participants self-administered the NEI VFQ-25 and completed a semistructured interview to provide feedback about the questionnaire. The percentage of responses at the maximum and minimum value was calculated to assess ceiling and floor effects, respectively, for the 12 subscales of the NEI VFQ-25. The NEI VFQ-25 scores were compared for Graves' ophthalmopathy patients who reported symptomatic diplopia and those who did not report diplopia using univariate and multivariate linear regression models. MAIN OUTCOME MEASURES: The NEI VFQ-25 subscale and composite scores. RESULTS: Health-related quality of life in those with Graves' ophthalmopathy was moderately impaired, with median composite score of 69. The greatest impairment was measured in the Mental Health (median, 50) and the Role Difficulties (median, 50) subscales. Significant ceiling effects were seen in 7 of the 12 subscales. More than two thirds of Graves' ophthalmopathy patients perceived that the NEI VFQ-25 lacked items relevant to their disease. The NEI VFQ-25 scores were lower for those with diplopia symptoms (composite score, 61) compared with those without diplopia (composite score, 90). Comparing these 2 groups, the largest differences were measured in the Driving and Peripheral Vision subscales. CONCLUSIONS: The NEI VFQ-25 includes many items that are applicable to Graves' ophthalmopathy patients. However, it shows significant ceiling effects in more than half of the subscales and it lacks items on issues that are important to Graves' ophthalmopathy patients, such as altered appearance and ocular discomfort. Efforts to develop an HRQL instrument that adds Graves' ophthalmopathy-specific items to relevant aspects of the NEI VFQ-25 are warranted.

Adult↗

PubMed2006

Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer.

PURPOSE: To compare maintenance epoetin alfa administered once every 3 weeks with continued weekly epoetin alfa for patients with cancer-associated anemia. PATIENTS AND METHODS: Eligible patients were randomly assigned at enrollment to receive three weekly doses of epoetin alfa 40,000 U subcutaneously (SC), followed by either standard weekly epoetin alfa (40K arm) or 120,000 U of epoetin alfa (120K arm) SC every 3 weeks for 18 additional weeks. RESULTS: Three hundred sixty-five patients were enrolled. One hundred eighty-three patients were assigned to the 40K arm, and 182 were assigned to the 120K arm. There was no difference in the proportion of patients requiring transfusions during the study (23% in 40K arm and 18% in 120K arm, P = .22) or specifically during the maintenance phase (13% in 40K arm v 15% in 120K arm, P = .58). Patients randomly assigned to the 40K arm were more likely to have a > or = 2 or > or = 3 g/dL hemoglobin (Hb) increment, were more likely to have a drug dose held because of high Hb, and had higher mean end-of-study Hb levels. Toxicities, including thromboembolism, and overall survival were similar. Patients in the 40K arm had a higher global quality of life (QOL) at baseline for unclear reasons, whereas patients in the 120K arm had a greater global QOL improvement during the study, so end-of-study QOL was equivalent. CONCLUSION: After three weekly doses of epoetin alfa 40,000 U, a dose of 120,000 U can be administered safely once every 3 weeks without increasing transfusion needs or sacrificing QOL. The Hb increment is somewhat greater with continued weekly epoetin alfa. Lack of blinding as a result of different treatment schedules may have confounded results.

Adult↗

PubMed2006

A stoma quality of life scale.

PURPOSE: Few studies have evaluated the impact of a stoma on patient quality of life because of a lack of specific validated measures. This study documents the development and initial application of a Stoma Quality of Life Scale. METHODS: Content experts generated initial questions. Patient focus groups were conducted to ensure that the questions addressed all stoma-related issues considered important by patients. Responses from pilot groups allowed refinement to produce the final measure, the Stoma Quality of Life Scale, a 21-item questionnaire. Three scales are featured: Work/Social Function (6 items), Sexuality/Body Image (5 items), and Stoma Function (6 items). In addition, one item (scored separately) measures financial impact, one measures skin irritation, and two measure overall satisfaction. This questionnaire was administered to 100 consecutive ostomy patients, and readministered three weeks later. Reliability was assessed by using coefficient alpha for internal consistency and intraclass correlation coefficient for test-retest reproducibility. To test validity in extreme groups, scores were compared for patients with improved quality of life vs. those whose stoma worsened their quality of life. To evaluate convergent validity, we analyzed correlation of instrument scales with the SF12. RESULTS: The Stoma Quality of Life scales demonstrated adequate test-retest reproducibility (intraclass correlation coefficient>0.8) and acceptable internal consistency (coefficient alpha approximately 0.8). The scales were capable of discriminating between patients with better and worse quality of life after stoma formation (P<0.02 for all scales). The Stoma Quality of Life scales significantly correlated (range, 0.12-0.75) with the Physical and Mental Health Composite Scale Scores of the SF-12. CONCLUSIONS: The Stoma Quality of Life Scale demonstrates reasonable psychometric properties for measuring quality of life in patients with stomas. Further studies are needed to refine the instrument.

Adult↗

PubMed2006

Personal life events and medical student burnout: a multicenter study.

PURPOSE: Burnout, a marker of professional distress prevalent among residents and physicians, has been speculated to originate in medical school. Little is known about burnout in medical students. The authors sought to identify the prevalence of burnout, variation of its prevalence during medical school, and the impact of personal life events on burnout and other types of student distress. METHOD: All medical students (n = 1,098) attending the three medical schools in Minnesota were surveyed in spring 2004 using validated instruments to assess burnout, quality of life, depression, and alcohol use. Students were also asked about the prevalence of positive and negative personal life events in the previous 12 months. RESULTS: A total of 545 medical students (response rate 50%) completed the survey. Burnout was present in 239 (45%) of medical students. While the frequency of a positive depression screen and at-risk alcohol use decreased among more senior students, the frequency of burnout increased (all p < .03). The number of negative personal life events in the last 12 months also correlated with the risk of burnout (p = .0160). Personal life events demonstrated a stronger relationship to burnout than did year in training on multivariate analysis. CONCLUSIONS: Burnout appears common among U.S. medical students and may increase by year of schooling. Despite the notion that burnout is primarily linked to work-related stress, personal life events also demonstrated a strong relationship to professional burnout. The authors' findings suggest both personal and curricular factors are related to burnout among medical students. Efforts to decrease burnout must address both of these elements.

Adult↗

PubMed2006

Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis.

PURPOSE: To prospectively determine the safety and effectiveness of percutaneous cryoablation for the reduction of pain, improvement in the activities of daily life, and reduction in the use of analgesic medications for patients with painful metastatic lesions involving bone. MATERIALS AND METHODS: This study was compliant with HIPAA and was approved by the institutional review board. Written informed consent was obtained. During 18 months, 14 patients (eight men, six women; age range, 21-72 years; mean age, 54 years) with one or two painful metastatic lesions involving bone, with a score of 4 or greater out of 10 for worst pain in a 24-hour period, and who did not respond to or refused conventional radiation treatment or chemotherapy were treated with percutaneous cryoablation. Patient response was measured with the Brief Pain Inventory, and analgesic use was recorded before and after the procedure at days 1 and 4, weekly for 4 weeks, and then every other week for a total of 6 months. Complications were monitored. Analysis of the primary end points was undertaken with paired comparison procedures by using paired t tests across individual time points supplemented with repeated measures analysis of variance. RESULTS: Treated lesions were 1-11 cm in diameter. Before cryoablation, the mean score for worst pain in a 24-hour period was 6.7 of 10; the score decreased to 3.8 (P = .003) 4 weeks after treatment. Mean pain interference with activities of daily living was 5.5 of 10 before treatment and decreased to 3.2 (P = .004) 4 weeks after treatment. All eight (100%) patients (exact 95% binomial confidence interval: 63%, 100%) for whom narcotics were prescribed prior to the procedure reported a reduction in these medications after cryoablation. No serious complications were observed. CONCLUSION: Percutaneous cryoablation is a safe and effective method for palliation of pain due to metastatic disease involving bone.

Activities of Daily Living↗

PubMed2006

A multicenter study of burnout, depression, and quality of life in minority and nonminority US medical students.

OBJECTIVE: To determine the well-being of minority medical students in a multicenter sample of US medical students. PARTICIPANTS AND METHODS: All 1098 medical students at 3 medical schools in Minnesota were surveyed in April 2004. Validated instruments were used to assess burnout, depression, and quality of life (QOL). Students were also asked about the prevalence of significant personal life events in the previous 12 months and strategies used to cope with stress. RESULTS: Although symptoms of depression and overall burnout were similar among minority and nonminority students, minority students were more likely to have a low sense of personal accomplishment (P=.02) and lower QOL In a number of domains (all P< or =.05). These differences persisted on multivariate analysis that controlled for demographic characteristics and recent life events. Minority students were also more likely to have a child (P=.01), originate from outside Minnesota (P<.001), and experience a major personal Illness in the last 12 months (P=.03). CONCLUSION: As a group, the minority medical students in this survey had a lower sense of personal accomplishment and QOL than nonminority students. Additional studies are needed to provide insight regarding the causes of these inequities and the unique challenges faced by minority medical students. Efforts to improve minority students' well-being, QOL, and learning experience may help prevent attrition among minority medical students and promote diversification in the physician workforce.

Adult↗

PubMed2006

Association of optimism-pessimism with quality of life in patients with head and neck and thyroid cancers.

OBJECTIVE: To examine the relationship between optimism-pessimism and quality of life (QOL) in survivors of head and neck and thyroid cancers. PATIENTS AND METHODS: Between 1963 and 2000, 190 patients completed both the Minnesota Multiphasic Personality Inventory (MMPI), used to assess explanatory style (optimism-pessimism), and either the 12-Item or 36-Item Short-Form Health Survey (SF-12 or SF-36), used to assess QOL. The MMPIs were completed an average of 13.4 years before the QOL assessment. The QOL measures were completed an average of 12.5 years after cancer diagnosis. Patients were divided into quartiles based on their MMPI Optimism-Pessimism scale score. Analysis was performed for all patients, those with head and neck cancer, and those with thyroid cancer. Adjustments were made for age, sex, and disease stage. RESULTS: For all 190 patients, optimism was associated with a higher QOL on both the mental and the physical component scales and 6 of 8 subscales of the SF-12 and SF-36. For patients with head and neck cancer, optimism was associated with higher QOL on 3 subscales but neither component scale. For patients with thyroid cancer, optimism was associated with higher QOL on both component scales and 6 subscales. After adjusting for age, sex, and disease stage, optimism was not associated with QOL in the head and neck cancer group. CONCLUSIONS: Optimism was associated with a higher QOL in survivors of thyroid cancer compared with survivors of head and neck cancer. After adjusting for age, sex, and disease stage, optimism was not associated with QOL for survivors of head and neck cancer. Optimism was more associated with the mental rather than physical QOL subscales.

Adult↗

PubMed2006

Low-molecular-weight heparin in patients with advanced cancer: a phase 3 clinical trial.

OBJECTIVE: To prospectively assess whether low-molecular-weight heparin (LMWH) provides a survival benefit in patients with advanced cancer. PATIENTS AND METHODS: Between December 1998 and June 2001, we performed a randomized controlled study of patients with advanced cancer. Initially, the study was double blinded and placebo controlled, with the patients receiving daily injections of 5000 U of LMWH or saline. However, because of low accrual midway through the study, the placebo injection arm was eliminated, and the study became open labeled, with patients receiving either LMWH injections plus standard clinical care or standard clinical care alone. The primary study end point was overall survival. RESULTS: Of 141 patients randomized to this clinical trial, 3 dropped out, leaving 138 patients. The median survival time was 10.5 months (95% confidence interval, 7.6-12.2 months) for the combined standard care and placebo groups. The median survival time for the combined LMWH arms was 7.3 months (95% confidence interval, 4.8-12.2 months). These median survival times were not significantly different (log-rank P = .46). The median survival times for the blinded and unblinded LMWH groups were 6.2 months and 9.0 months, respectively. The median survival times were 10.3 months for the blinded placebo arm and 10.5 months for the standard care arm. The rate of severe or life-threatening venous thromboembolism was 6% in the LMWH arms and 7% in the control arms. The rate of severe or life-threatening bleeding was 3% in the LMWH arms and 7% in the control arms.

Adult↗

PubMed2004

Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy.

PURPOSE: To determine whether weekly epoetin alfa could improve hemoglobin (HgB) levels, reduce RBC transfusions, and improve quality of life (QOL) in patients with advanced cancer and with anemia after receiving myelosuppressive chemotherapy. PATIENTS AND METHODS: This double-blind, placebo-controlled study randomly assigned patients to placebo or epoetin alfa (Ortho Biotech, Bridgewater, NJ) 40,000 U subcutaneous weekly for 16 weeks. QOL, HgB, and RBC transfusions were measured pretreatment and monthly. RESULTS: The study accrued 344 patients; 330 were assessable for efficacy and 305 were assessable for QOL. Placebo-treated patients had a mean increase in HgB of 0.9 g/dL (range, -3.8 to +5.3) compared with 2.8 g/dL (range, -2.2 to +7.5) for epoetin-treated patients (P < .0001). During the study, 31.7% of placebo-treated patients achieved a > or = 2 g/dL HgB increase compared with 72.7% of epoetin-treated patients (P < .0001). The incidence of RBC transfusion for placebo and epoetin treatment arms was 39.6% and 25.3% (P = .005), respectively. The placebo group received 256 units of RBCs compared with 127 units in the epoetin group (P < .0001). The incidence of toxicity in the groups was similar. Changes in the average QOL scores from baseline to the end of the study were similar in the two groups (P = not significant). The HgB responders (irrespective of treatment arm) had a mean change in Functional Assessment of Cancer Therapy (FACT) fatigue score from a baseline of +5.1 compared with -2.1 for the nonresponders (P = .006). CONCLUSION: Epoetin alfa significantly improved HgB and reduced transfusions in this patient population. These results support the use of weekly epoetin alfa as an ameliorative agent for cancer-related anemia.

Adult↗

PubMed2004

An eicosapentaenoic acid supplement versus megestrol acetate versus both for patients with cancer-associated wasting: a North Central Cancer Treatment Group and National Cancer Institute of Canada collaborative effort.

PURPOSE: Studies suggest eicosapentaenoic acid (EPA), an omega-3 fatty acid, augments weight, appetite, and survival in cancer-associated wasting. This study determined whether an EPA supplement-administered alone or with megestrol acetate (MA)-was more effective than MA. PATIENTS AND METHODS: Four hundred twenty-one assessable patients with cancer-associated wasting were randomly assigned to an EPA supplement 1.09 g administered bid plus placebo; MA liquid suspension 600 mg/d plus an isocaloric, isonitrogenous supplement administered twice a day; or both. Eligible patients reported a 5-lb, 2-month weight loss and/or intake of less than 20 calories/kg/d. RESULTS: A smaller percentage taking the EPA supplement gained >or= 10% of baseline weight compared with those taking MA: 6% v 18%, respectively (P =.004). Combination therapy resulted in weight gain of >or= 10% in 11% of patients (P =.17 across all arms). The percentage of patients with appetite improvement (North Central Cancer Treatment Group Questionnaire) was not statistically different: 63%, 69%, and 66%, in EPA-, MA-, and combination-treated arms, respectively (P =.69). In contrast, 4-week Functional Assessment of Anorexia/Cachexia Therapy scores suggested MA-containing arms experienced superior appetite stimulation compared with the EPA arm, with scores of 40, 55, and 55 in EPA-, MA-, and combination-treated arms, respectively (P =.004). Survival was not significantly different among arms. Global quality of life was not significantly different among groups. With the exception of increased impotence in MA-treated patients, toxicity was comparable. CONCLUSION: This EPA supplement, either alone or in combination with MA, does not improve weight or appetite better than MA alone.

Aged↗

PubMed2004

Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study.

PURPOSE: Few options are available for pain relief in patients with bone metastases who fail standard treatments. We sought to determine the benefit of radiofrequency ablation (RFA) in providing pain relief for patients with refractory pain secondary to metastases involving bone. PATIENTS AND METHODS: Thirty-one US and 12 European patients with painful osteolytic metastases involving bone were treated with image-guided RFA using a multitip needle. Treated patients had > or = 4/10 pain and had either failed or were poor candidates for standard treatments such as radiation or opioid analgesics. Using the Brief Pain Inventory-Short Form, worst pain intensity was the primary end point, with a 2-unit drop considered clinically significant. RESULTS: Forty-three patients were treated (median follow-up, 16 weeks). Before RFA, the mean score for worst pain was 7.9 (range, 4/10 to 10/10). Four, 12, and 24 weeks following treatment, worst pain decreased to 4.5 (P <.0001), 3.0 (P <.0001), and 1.4 (P =.0005), respectively. Ninety-five percent (41 of 43 patients) experienced a decrease in pain that was considered clinically significant. Opioid usage significantly decreased at weeks 8 and 12. Adverse events were seen in 3 patients and included (1) a second-degree skin burn at the grounding pad site, (2) transient bowel and bladder incontinence following treatment of a metastasis involving the sacrum, and (3) a fracture of the acetabulum following RFA of an acetabular lesion. CONCLUSION: RFA of painful osteolytic metastases provides significant pain relief for cancer patients who have failed standard treatments.

Adult↗

PubMed2004

Investigating the utility of serum cytokine measurements in a multi-institutional cancer anorexia/weight loss trial.

BACKGROUND: Interleukin-1 beta (IL-1beta), tumor necrosis factor alpha (TNFalpha), and interleukin-6 (IL-6) have been implicated in the cancer anorexia/weight loss syndrome. However, previous smaller studies have yielded conflicting results as to whether circulating, serum concentrations of these cytokines are in fact elevated. As the translational component of a large multi-institutional trial, this study assessed the clinical value of serum concentrations of these cytokines in patients with this syndrome. METHODS: Patients with incurable cancer with anorexia and/or weight loss were eligible. All underwent weekly weight measurements and appetite assessment for the first month and then monthly assessments thereafter. Serum was obtained at baseline and at 1 month, and all three cytokines were measured with the Immunolite assay. RESULTS: A total of 118 patients participated. At baseline, 99%, 54%, and 47% of patients' samples had undetectable IL-1beta, TNFalpha, and IL-6, respectively. Similar results were obtained at 1 month. No correlations were observed between serum cytokine concentrations and changes in weight or appetite. Baseline serum IL-6 predicted a diminished survival but only after adjustment for age and cancer site. CONCLUSION: Serum concentrations of IL-1beta, TNFalpha, and IL-6, as measured in this study, provide data of limited clinical value for patients with the cancer anorexia/weight loss syndrome.

Aged↗

PubMed2004

Pilot evaluation of black cohosh for the treatment of hot flashes in women.

BACKGROUND: Hot flashes cause significant morbidity in postmenopausal women, including women with breast cancer. We undertook a pilot study to estimate the effectiveness of black cohosh to reduce hot flashes. METHODS: Women who reported significant hot flashes (> or = 14 per week) were enrolled. Black cohosh was given in the form of the commercial product Remifemin. The first week was a no-treatment baseline period, and therapy was given for the subsequent 4 weeks. Hot flash data were collected by daily questionnaires during baseline and treatment weeks. Adverse effects were recorded. RESULTS: Twenty-one women completed the study. Their mean age was 56 years (range, 38-80). Thirteen patients had a history of breast cancer. Six patients were taking tamoxifen or raloxifene. Patients reported an average of 8.3 hot flashes per day during the baseline week. The reduction in mean daily hot flash frequency was 50% (95% CI, 34%-65%), while weekly hot flash scores were reduced 56% (95% CI, 40%-71%) at completion of the study. Overall, patients reported less trouble with sleeping, less fatigue, and less abnormal sweating. No patients stopped therapy because of adverse effects. CONCLUSIONS: Black cohosh appeared to reduce hot flashes and had a low toxicity. The efficacy found in this trial seems to be more than would be expected by a placebo effect (20%-30% hot flash reduction in previous trials). These results suggest that further evaluation of this black cohosh preparation with a phase III randomized trial is indicated.

Adolescent↗

PubMed2004

A contest to create media messages aimed at recruiting adolescents for stop smoking programs.

This project engaged adolescents in a contest to create advertising messages aimed at recruiting teens for stop smoking programs. Middle school students were invited to design a media message for television, radio, Web, or print (newspaper or billboard). Of 4,289 students in eight middle schools of Rochester, Minn., 265 (6.2%) developed 172 stop smoking messages. The quality of their work confirmed that teens can design media messages to encourage their smoking adolescent peers to enroll in a program to stop smoking.

Adolescent↗

PubMed2004

Pilot evaluation of paroxetine for treating hot flashes in men.

OBJECTIVE: To provide prospective information on the potential utility of paroxetine for treating hot flashes In men receiving androgen ablation therapy for prostate cancer. PATIENTS AND METHODS: Men with symptomatic androgen ablation therapy-related hot flashes were entered into this clinical trial between August 2001 and October 2003. After a baseline week of documentation of the frequency of hot flashes, patients were assigned to receive paroxetine; the initial dosage was 12.5 mg/d, and it was increased to 37.5 mg/d over the ensuing 4 weeks. RESULTS: Of the 24 patients in whom medication was initiated, 18 completed the 5-week study. In these patients, the median frequency of hot flashes decreased from 6.2 per day during the baseline week to 2.5 per day during the last study week. Hot flash scores (frequency x mean severity) during the same period decreased from 10.6 per day to 3.0 per day. Overall, paroxetine was well tolerated by most patients. CONCLUSION: The results from this trial suggest that paroxetine Is an effective agent for diminishing hot flashes in men receiving androgen ablation therapy.

Aged↗