Teresa A. Rummans

Venlafaxine in management of hot flashes in survivors of breast cancer: a randomised controlled trial

BACKGROUND Hot flashes can be troublesome, especially when hormonal therapy is contraindicated. Preliminary data have suggested that newer antidepressants, such as venlafaxine, can diminish hot flashes. We undertook a double-blind, placebo-controlled, randomised trial to assess the efficacy of venlafaxine in women with a history of breast cancer or reluctance to take hormonal treatment because of fear of breast cancer. METHODS Participants were assigned placebo (n=56) or venlafaxine 37.5 mg daily (n=56), 75 mg daily (n=55), or 150 mg daily (n=54). After a baseline assessment week, patients took the study medication for 4 weeks. All venlafaxine treatment started at 37.5 mg daily and gradually increased in the 75 mg and 150 mg groups. Patients completed daily hot-flash questionnaire diaries. The primary endpoint was average daily hot-flash activity (number of flashes and a score combining number and severity). Analyses were based on the women who provided data throughout the baseline and study weeks. FINDINGS 191 patients had evaluable data for the whole study period (50 placebo, 49 venlafaxine 37.5 mg, 43 venlafaxine 75 mg, 49 venlafaxine 150 mg). After week 4 of treatment, median hot flash scores were reduced from baseline by 27% (95% CI 11-34), 37% (26-54), 61% (50-68), and 61% (48-75) in the four groups. Frequencies of some side-effects (mouth dryness, decreased appetite, nausea, and constipation) were significantly higher in the venlafaxine 75 mg and 150 mg groups than in the placebo group. INTERPRETATION Venlafaxine is an effective non-hormonal treatment for hot flashes, though the efficacy must be balanced against the drugs side-effects. Confirmation of the results of this 4-week study awaits the completion of three ongoing randomised studies to assess the effects of other related antidepressants for the treatment of hot flashes.

Religious involvement, spirituality, and medicine: Implications for clinical practice

Surveys suggest that most patients have a spiritual life and regard their spiritual health and physical health as equally important. Furthermore, people may have greater spiritual needs during illness. We reviewed published studies, meta-analyses, systematic reviews, and subject reviews that examined the association between religious involvement and spirituality and physical health, mental health, health-related quality of life, and other health outcomes. We also reviewed articles that provided suggestions on how clinicians might assess and support the spiritual needs of patients. Most studies have shown that religious involvement and spirituality are associated with better health outcomes, including greater longevity, coping skills, and health-related quality of life (even during terminal illness) and less anxiety, depression, and suicide. Several studies have shown that addressing the spiritual needs of the patient may enhance recovery from illness. Discerning, acknowledging, and supporting the spiritual needs of patients can be done in a straightforward and noncontroversial manner. Furthermore, many sources of spiritual care (e.g., chaplains) are available to clinicians to address the spiritual needs of patients.

Phase III Evaluation of Fluoxetine for Treatment of Hot Flashes

PURPOSE Hot flashes can be a prominent problem in women with a history of breast cancer. Given concerns regarding the use of hormonal therapies in such patients, other nonhormonal means for treating hot flashes are required. Based on anecdotal information regarding the efficacy of fluoxetine and other newer antidepressants for treating hot flashes, the present trial was developed. PATIENTS AND METHODS This trial used a double-blinded, randomized, two-period (4 weeks per period), cross-over methodology to study the efficacy of fluoxetine (20 mg/d) for treating hot flashes in women with a history of breast cancer or a concern regarding the use of estrogen (because of breast cancer risk). Eligible patients had to have reported that they averaged at least 14 hot flashes per week; they could have received tamoxifen or raloxifene as long as they were on a stable dose. The major outcome measure was a bivariate construct representing hot flash frequency and hot flash score, analyzed by a classic sums and differences cross-over analysis. RESULTS Eighty-one randomized women began protocol therapy. By the end of the first treatment period, hot flash scores (frequency x average severity) decreased 50% in the fluoxetine arm versus 36% in the placebo arm. Cross-over analysis demonstrated a significantly greater marked hot flash score improvement with fluoxetine than placebo (P =.02). The results were not adjusted for potential confounding influences, including age and tamoxifen use. The fluoxetine was well tolerated. CONCLUSION This dose of fluoxetine resulted in a modest improvement in hot flashes.

ECT remission rates in psychotic versus nonpsychotic depressed patients: a report from CORE.

Objective To compare the relative efficacy of electroconvulsive therapy (ECT) in psychotic and nonpsychotic patients with unipolar major depression. Methods The outcome of an acute ECT course in 253 patients with nonpsychotic (n = 176) and psychotic (n = 77) unipolar major depression was assessed in the first phase of an ongoing National Institute of Mental Health-supported four-hospital collaborative study of continuation treatments after successful ECT courses. ECT was administered with bilateral electrode placement at 50% above the titrated seizure threshold. The remission criteria were rigorous: a score ≤10 on the 24-item Hamilton Rating Scale for Depression (HRSD) after 2 consecutive treatments, and a decrease of at least 60% from baseline. Results The overall remission rate was 87% for study completers. Among these, patients with psychotic depression had a remission rate of 95% and those with nonpsychotic depression, 83%. Improvement in symptomatology, measured by the HRSD, was more robust and appeared sooner in the psychotic patients compared with the nonpsychotic patients. Conclusion Bilateral ECT is effective in relieving severe major depression. Remission rates are higher and occur earlier in psychotic depressed patients than in nonpsychotic depressed patients. These data support the argument that psychotic depression is a distinguishable nosological entity that warrants separate treatment algorithms.

Pilot evaluation of venlafaxine hydrochloride for the therapy of hot flashes in cancer survivors.

PURPOSE Hot flashes can be a prominent clinical problem for breast cancer survivors and men who undergo androgen-deprivation therapy. Anecdotal information suggested a low dose of a relatively new antidepressant, venlafaxine, could abrogate this clinical problem. MATERIALS AND METHODS This study included 28 consecutive assessable patients entered onto a phase II clinical trial. Hot flash data were collected by daily diary questionnaires during a 1-week baseline period and then for 4 weeks, during which time patients received venlafaxine 12.5 mg orally twice daily. RESULTS Fifty-eight percent of patients who completed the study had a greater than 50% reduction in hot flash scores (frequency times severity) during the fourth treatment week as compared with the baseline week. Median weekly hot flash scores were reduced by 55% from baseline during the fourth week of venlafaxine therapy. Therapy was generally well tolerated and appeared to alleviate fatigue, sweating, and trouble sleeping. CONCLUSION Venlafoxine appears to represent an efficacious new method to alleviate hot flashes. Further evaluation of this compound for alleviating hot flashes is indicated.

Impacting Quality of Life for Patients With Advanced Cancer With a Structured Multidisciplinary Intervention: A Randomized Controlled Trial

PURPOSE The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer. PATIENTS AND METHODS Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27. RESULTS Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period. CONCLUSION Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.

Special Report: Suicidal Ideation Among American Surgeons

BACKGROUND Suicide is a disproportionate cause of death for US physicians. The prevalence of suicidal ideation (SI) among surgeons and their use of mental health resources are unknown. STUDY DESIGN Members of the American College of Surgeons were sent an anonymous cross-sectional survey in June 2008. The survey included questions regarding SI and use of mental health resources, a validated depression screening tool, and standardized assessments of burnout and quality of life. RESULTS Of 7905 participating surgeons (response rate, 31.7%), 501 (6.3%) reported SI during the previous 12 months. Among individuals 45 years and older, SI was 1.5 to 3.0 times more common among surgeons than the general population (P < .02). Only 130 surgeons (26.0%) with recent SI had sought psychiatric or psychologic help, while 301 (60.1%) were reluctant to seek help due to concern that it could affect their medical license. Recent SI had a large, statistically significant adverse relationship with all 3 domains of burnout (emotional exhaustion, depersonalization, and low personal accomplishment) and symptoms of depression. Burnout (odds ratio, 1.910; P < .001) and depression (odds ratio, 7.012; P < .001) were independently associated with SI after controlling for personal and professional characteristics. Other personal and professional characteristics also related to the prevalence of SI. CONCLUSIONS Although 1 of 16 surgeons reported SI in the previous year, few sought psychiatric or psychologic help. Recent SI among surgeons was strongly related to symptoms of depression and a surgeons degree of burnout. Studies are needed to determine how to reduce SI among surgeons and how to eliminate barriers to their use of mental health resources.

Career Fit and Burnout Among Academic Faculty

BACKGROUND Extensive literature documents personal distress among physicians and a decrease in their satisfaction with the practice of medicine over recent years. We hypothesized that physicians who spent more of their time in the aspect of work that they found most meaningful would have a lower risk of burnout. METHODS Faculty physicians in the Department of Internal Medicine at a large academic medical center were surveyed in the fall of 2007. The survey evaluated demographic variables, work characteristics, and career satisfaction. Burnout was measured using the Maslach Burnout Inventory. Additional questions evaluated which professional activity (eg, research, education, patient care, or administration) was most personally meaningful and the percentage of effort that was devoted to each activity. RESULTS Of 556 physicians sampled, 465 (84%) returned surveys. A majority (68%) reported that patient care was the aspect of work that they found most meaningful, with smaller percentages reporting research (19%), education (9%), or administration (3%) as being most meaningful. Overall, 34% of faculty members met the criteria for burnout. The amount of time spent working on the most meaningful activity was strongly related to the risk of burnout. Those spending less than 20% of their time (approximately 1 d/wk) on the activity that is most meaningful to them had higher rates of burnout (53.8% vs 29.9%; P<.001). Time spent on the most meaningful activity was the largest predictor of burnout on multivariate analysis (odds ratio, 2.75; P = .001). CONCLUSIONS The extent to which faculty physicians are able to focus on the aspect of work that is most meaningful to them has a strong inverse relationship to their risk of burnout. Efforts to optimize career fit may promote physician satisfaction and help to reduce attrition among academic faculty physicians.

The Influence of Age on the Response of Major Depression to Electroconvulsive Therapy A C.O.R.E. Report

As part of a C.O.R.E., multi-site longitudinal study comparing continuation electroconvulsive therapy (ECT) vs. continuation pharmacotherapy, the authors determined the response of 253 patients with major depression to acute-phase, bilateral ECT by use of the 24-item Hamilton Rating Scale for Depression. Remission rates for three age-groups, > or =65 years; 46-64 years; and < or =45 years, were 90 percent, 89.8 percent, and 70 percent, respectively. Age, as a continuous variable, positively influenced response to treatment. Bilateral, dose-titrated ECT is a highly effective acute treatment for major depression, and older age confers a greater likelihood of achieving remission.

A prospective study of quality of life in adults with newly diagnosed high-grade gliomas: the impact of the extent of resection on quality of life and survival.

OBJECTIVE: To describe the quality of life (QOL) over time for adults with newly diagnosed high-grade gliomas and to examine the relationship between QOL and outcome data collected in three prospective cooperative group clinical trials. METHODS: The QOL study was a companion protocol for three Phase II high-grade glioma protocols. Five self-administered forms were completed by patients to assess QOL at study entry, 2 months, and 4 months after enrollment. RESULTS: QOL data were available for baseline, first, and second subsequent follow-up evaluations for 89%, 71%, and 69% of patients, respectively. A significant proportion of patients (47.1%) experienced impaired QOL (QOL ≤ 50) in at least one measure at subsequent evaluations, whereas most patients (88%) with impaired QOL at baseline continued to have impaired QOL at subsequent evaluations. On multivariable analyses, baseline QOL measures were predictive of QOL at the time of follow-up. In addition, patients who underwent a gross total resection were much less likely to have impaired QOL (P = 0.006), were less likely to experience worsening depression (P = 0.0008), and were more likely to have improved QOL (P = 0.003) at their first follow-up evaluation. Changes in QOL measures over time were not found to be associated with survival in multivariable analyses that adjusted for known prognostic variables; variables that were independently associated with improved survival were better performance status (P < 0.001), younger age (P < 0.001), and greater extent of resection (P < 0.001). CONCLUSION: Baseline QOL was predictive of QOL over time. Gross total resection was associated with longer survival and improved QOL over time for patients with high-grade gliomas.