Surgeon variation in patient quality of life after radical prostatectomy.

PURPOSE: We assessed variation among surgeons in patient quality of life outcomes. MATERIALS AND METHODS: A survey of standard questions used to examine current urinary and sexual function was mailed to 1,500 randomly selected patients from the Utah Cancer Registry who met certain criteria, including prostatectomy for cancer cure more than 1 year previously, current age 70 years or less and no metastatic disease or other cancer therapy. Questionnaire information was linked to cancer registry and hospital discharge abstract information. Hierarchical mixed models were used to examine whether surgeons varied with respect to risk adjusted outcomes. RESULTS: The cooperation rate was 64%. Of the 678 qualifying responders 22% reported leaking urine more than once per day, 7% used more than 1 pad per day and 40% reported no erection without medication. Surgeon variation was significant for 3 patient outcomes, including erectile strength, urine leakage and length of hospital stay (each p <0.001). Surgeon risk adjusted erectile outcomes significantly correlated with leakage outcomes (r = 0.84, p <0.0001) and length of stay (r = -0.55, p = 0.0004). Annual surgeon volume significantly correlated with less leakage and shorter length of stay (r = 0.34 and -0.36, respectively, each p = 0.05). Compared to open retropubic surgery, robotic surgery was associated with a shorter stay. The perineal approach was associated with shorter stay, less urine leakage and weaker erection. CONCLUSIONS: Patient quality of life outcomes after prostatectomy varies substantially among surgeons. Administering patient surveys through cancer registries may provide valuable data for improving prostatectomy outcomes statewide.

Association between postoperative complications and clinical cancer outcomes.

INTRODUCTION: The treatment for a majority of solid organ tumors is surgical resection; 10-20 % of patients suffer a perioperative complication. Perioperative complications may contribute to cancer recurrence. This study examined the relationship between postoperative complications and risk-adjusted patient overall survival. METHODS: Data from 2003 to 2009 were linked from our clinical cancer registry, the National Surgery Quality Improvement Project (NSQIP), and medical records. Patients who had tumor extirpation for cure were included. The NSQIP was used to identify complications. Patients with a complication were matched to patients without a complication. χ (2) tests and Cox proportional hazard regression models were used. RESULTS: A total of 415 patients were included for survival analysis. The hazard ratio (HR) for mortality associated with having a complication was 2.17. The HR for mortality after 200 days postoperatively was 2.47. Infectious complications were associated with the highest association with increased mortality (HR = 3.56). Noninfectious complications were not associated with an increased risk of mortality. CONCLUSIONS: This study investigated the relationship of surgical infectious complications in cancer patients with long-term survival for patients who had a number of different types of cancer. After taking into account the site, histology, and stage of the cancer, we found that patients with infectious complications had earlier death.

Why is greater medication adherence associated with better outcomes.

BACKGROUND: Previous studies found an association of greater adherence to placebo medication with better outcomes. The present study tested whether this association was explained by any of the following factors: 1) adherence to other medications, 2) healthcare behaviors, 3) disease risk, or 4) predicted degree of adherence. Data included information on more than 800 risk factors from 27,347 subjects in two randomized controlled trials of hormone therapy in the Women's Health Initiative. RESULTS: Greater adherence to placebo was not associated with colon cancer but was substantially and significantly associated with several diverse outcomes: death, myocardial infarction, stroke, and breast cancer. Adherence to hormone therapy was only weakly associated with outcomes. The WHI risk factors only poorly predicted degree of adherence, R2 < 4%. No underlying factors accounted for the association between placebo adherence and outcome. CONCLUSION: The results suggest that adherence to placebo is a marker for important risk factors that were not measured by WHI. Once identified these risk factors may be used to increase the validity of observational studies of medical treatment by reducing unmeasured confounding.

Risk factors for colon cancer in 150,912 postmenopausal women.

BACKGROUND: Prospective data from the Women's Health Initiative were analyzed to evaluate more than 800 possible risk factors for an association with colon cancer in postmenopausal women. METHODS: Data included 150,912 postmenopausal women between the ages of 50 and 79. The Cox proportional hazard regression analysis was used to identify risk factors independently associated with the development of colon cancer during a median follow-up time of 8 years. RESULTS: A total of 1,210 women developed colon cancer and 282 developed rectal cancer. Eleven risk factors were independently associated with an increased risk of colon cancer at the p < 0.001 level. In decreasing order of associated χ(2) values, they were age, waist girth (especially for subjects without diabetes), use of hormone therapy at baseline (protective), years smoked, arthritis (protective presumably because of medications used for treatment), relatives with colorectal cancer, lower hematocrit levels, fatigue, diabetes, less use of sleep medication, and cholecystectomy. Of the 11 factors, three were significantly associated with an increased risk of rectal cancer: age, waist, and not taking hormone therapy. CONCLUSIONS: The results provide additional support for the importance of waist girth, hormone therapy, smoking, NSAID use, diabetes, and cholecystectomy as risk factors for colon cancer. Some factors previously identified as influencing risk (exercise and black race) did not have a strong independent association with colon cancer in this analysis.

A cluster randomized trial to evaluate physician/pharmacist collaboration to improve blood pressure control.

This was a prospective, cluster randomized controlled trial in patients with uncontrolled hypertension aged 21 to 85 years (mean, 61 years). Pharmacists made recommendations to physicians for patients in the intervention clinics (n=101) but not patients in the control clinics (n=78). The mean adjusted difference in systolic blood pressure (BP) between the control and intervention groups was 8.7 mm Hg (95% confidence interval [CI], 4.4-12.9), while the difference in diastolic BP was 5.4 mm Hg (CI, 2.8-8.0) at 9 months. The 24-hour BP levels showed similar effects, with a mean systolic BP level that was 8.8 mm Hg lower (CI, 5.0-12.6) and a mean diastolic BP level that was 4.6 mm Hg (CI, 2.4-6.8) lower in the intervention group. BP was controlled in 89.1% of patients in the intervention group and 52.9% in the control group (adjusted odds ratio, 8.9; CI, 3.8-20.7; P<.001). Physician/pharmacist collaboration achieved significantly better mean BP values and overall BP control rates, primarily by intensification of medication therapy and improving patient adherence.

Community physicians' strategies for patients with medically unexplained symptoms.

BACKGROUND AND OBJECTIVES: This qualitative study examined the management strategies that community primary care physicians use for patients with medically unexplained symptoms (MUS). METHODS: Volunteer community physicians identified patients with chronic MUS. The physicians and patients were interviewed separately about management strategies used and their effectiveness. Thematic analyses were used to categorize these strategies. RESULTS: Thirty-six physicians and 49 of their patients completed interviews. Physician strategies considered effective by physicians and patients included medical treatment, exploring causes of symptoms with tests and referrals, attentive listening, validating complaints, demonstrating commitment over time (eg, assuring patients of continued care, allowing extended office visits, and returning phone calls), providing clear explanations of symptoms and management, and providing explanatory models for the linkage between psychosocial factors and physical symptoms. Strategies used that conflict with published recommendations included ordering potentially unnecessary diagnostic tests, scheduling patients on demand, and prescribing narcotics. Physicians expressed concerns about these strategies but considered the benefits for specific patients worth the costs and risks. CONCLUSIONS: Physicians used some strategies recommended in the medical literature and others not recommended. The ability to effectively implement certain strategies may depend on having a long-term relationship with a patient and a health care environment that permits extensive patient-physician interaction.

Risk factors for insomnia in a rural population.

PURPOSE: This study compared in one data set the relative importance of most previously examined risk factors for different symptoms of insomnia. METHODS: Data were obtained from personal interviews of 1,588 adults in a rural area. Statistical methods evaluated the association of 42 risk factors with any insomnia and each of four insomnia subtypes: difficulty with initiating sleep (DIS), difficulty maintaining sleep (DMS), early morning awakening (EMA), and restless sleep (RS). RESULTS: Insomnia rates were greater in this rural population than most U.S. studies and greater in the United States than other countries. The correlations between insomnia subtype and energy level was highest for RS, -0.29, and lowest for EMA, -0.11. All sleep disturbances increased monotonically with depressive symptoms, but the increase was greatest for RS (r = 0.57) and weakest for EMA (r = 0.24). Anxiety and pain also were independently associated with each insomnia subtype. Insomnia problems of spouses were uncorrelated. Other risk factors were independently associated with some insomnia subtypes but not others. For example, the association of age with difficulty maintaining sleep was independent of health measures. CONCLUSION: The results suggest that different insomnias have different rates and risk factors and therefore possibly different etiologies and management strategies.

Colorectal cancer testing among patients cared for by Iowa family physicians.

BACKGROUND: Colorectal cancer (CRC) can be largely prevented or effectively treated, yet about half of eligible Americans have not been screened. The purpose of this study was to examine patient and physician factors associated with documented CRC testing according to national guidelines. METHODS: Cross-sectional study where 511 randomly selected rural patients aged 55 to 80 years of 16 board-certified Iowa family physicians were enrolled in 2004. Patient survey and medical record information were linked with physician surveys. Predictors of CRC testing were examined using a regression procedure that accommodated random physician effects (2005-2006). RESULTS: Forty-six percent of patients were up-to-date with CRC testing in accordance with national guidelines. This percentage varied from 5% to 75% by physician (p < 0.0001). Of the patients who were up-to-date, 89% had colonoscopy, and 62% had symptoms prior to testing that could indicate CRC. The strongest univariate predictors other than symptoms were patient recollection of physician recommendation (odds ratio [OR] = 6.4, 95% confidence interval [CI] = 4.2-9.6) and physician documentation of recommendation (OR = 14.1, CI = 8.5-23.3). A multivariable regression model showed testing in accordance with guidelines significantly increased with government insurance (OR = 1.6, CI = 1.2-2.3), having a health maintenance visit in the preceding 26 months (OR = 2.4, CI = 1.4-4.1), family history of CRC (OR = 3.1, CI = 1.6-5.8), number of medical conditions (OR = 1.2 for each additional condition, CI = 1.1-1.3), high importance of screening to patient (OR = 2.6, CI = 1.5-4.5), patient satisfaction with doctor's discussions (OR = 3.3, CI = 2.2-4.8), physician trained in flexible sigmoidoscopy (OR = 2.3, CI = 1.6-3.4), and physician report of trying to follow American Cancer Society (ACS) guidelines (OR = 1.7, CI = 1.2-2.5). After excluding patients who had symptoms prior to screening, most of the ORs in the logistic regression analysis increased except that the number of medical conditions and physician trying to follow ACS guidelines became nonsignificant. CONCLUSIONS: Fewer than half of rural patients received CRC testing, and most of those tested had symptoms. Physician recommendations and the manner of presenting the recommendations greatly influenced whether patients were tested.

Do randomized controlled trials always trump case reports? A second look at propranolol and depression.

STUDY OBJECTIVE: To explore reasons for discrepancies between findings from case reports and those from a meta-analysis of randomized controlled trials regarding the association between beta-adrenergic blockers and depression. DESIGN: Systematic review. DATA SOURCE: PubMed/MEDLINE database. MEASUREMENTS AND MAIN RESULTS: We reviewed 24 published case reports showing an association between beta-blockers and depression and eight randomized controlled trials included in a meta-analysis of the adverse effects of these drugs. We abstracted the beta-blocker taken, patients' age and sex, diagnoses, history of depression, type of depressive symptoms reported, and method and timing of the assessment of depression. Naranjo criteria were used to evaluate the strength of evidence from each case report for a possible association between beta-blockers and depression. Twelve case reports had a Naranjo score of 5 or more (suggesting a likely causal relationship), nine of which involved propranolol. In all nine, depression began soon after treatment, and in four, the patient had a history of depression. Three randomized controlled trials assessed propranolol. Depression rates in the control groups of these studies differed substantially from each other (0-40%, p<0.0001). In only one randomized controlled trial did investigators assess depression systematically; they evaluated depression after 1 year of treatment and eliminated patients who had previously been prescribed an antidepressant. CONCLUSION: A criterion standard to assess the true relationship between beta-blockers and depression is lacking. Factors such as the lack of systematic assessment of depression, the timing of assessments, and the selection of patients may have reduced the ability of researchers in the randomized controlled trials to detect depression as an adverse effect. Evidence from case reports should be carefully considered when relevant randomized controlled trials have not been adequately designed to detect adverse effects.

Factors that influence improvement for patients with poorly controlled type 2 diabetes.

OBJECTIVE: Assess reasons for improved control for patients with initially poorly controlled diabetes. RESEARCH DESIGN AND METHODS: Patients in seven practices with type 2 diabetes were selected if within a 6-month period they had two glycosylated hemoglobin (HbA1c) levels of at least 8.0%. Patient factors that may influence control were compared for patients grouped according to their last two HbA1c levels. RESULTS: Review of 643 medical records of diabetic patients treated by 29 clinicians identified 69 study patients. After at least 1 year of follow-up 26 patients became well controlled, 14 had intermediate control, and 29 remained in poor control. Becoming controlled was not significantly associated with gender, age, duration of diabetes, BMI, or HbA1c levels prior to baseline. It was inversely associated with greater use of medications (P = 0.04), and positively associated with understanding of diabetes (P = 0.03), adherence to recommendations for meal plan (P = 0.001), and glucose monitoring (P = 0.02). Thirty-one percent of patients who became controlled had a change in life circumstances. Reasons for not advancing medications were probably justified for 69% of patients who remained uncontrolled. CONCLUSION: Improved control depends largely on patient self-care behaviors.

Relationship between physician knowledge of hypertension and blood pressure control.

The purpose of this study was to evaluate the cross-sectional relationship between physician knowledge of hypertension guidelines and blood pressure (BP) control. The authors evaluated a sample of primary care faculty (n=32) and a sample of their patients (n=613). When treating patients as independent observations, the authors found an inverse relationship (r=-0.524; p=0.002) where higher knowledge scores were associated with lower BP control. The authors conducted a multivariate analysis to accommodate the nonindependence due to random physician effects and found that there was no longer a significant association between knowledge and BP control, but there was still a trend (odds ratio=0.84; p=0.130). This study demonstrates that there is no evidence that high knowledge of hypertension guidelines will improve BP control rates and that higher knowledge may actually be associated with lower BP control. Strategies that are designed only to improve knowledge of hypertension guidelines are insufficient to improve BP control rates.

Empirically identified goals for the management of unexplained symptoms.

BACKGROUND AND OBJECTIVES: Effective management of patients with medically unexplained symptoms may be influenced by physicians' goals. This study's objective was to identify physicians' goals for managing primary care patients with unexplained symptoms. METHODS: This was a qualitative study of patients and clinicians from primary care clinics in Iowa and Illinois. Interviews were conducted with 47 patients who had unexplained symptoms and the 36 primary care clinicians who managed them. The interviews were transcribed and coded independently by two investigators. Categories for coding responses were derived from the data and the literature. RESULTS: Eleven goals were identified and grouped into four classes based on whether they were disease centered, patient centered, society centered, or clinician centered. The three goals most commonly held by patients were patient centered: clinician support (62%), functional improvement (45%), and patient coping (43%). The most common clinician goals were symptom alleviation (38%), patient coping (32%), and functional improvement (30%). Only one clinician (2%) cited making the patient feel supported as a goal. CONCLUSIONS: The goals of clinician support and patient coping appear to have value to patients beyond being means for achieving symptom alleviation. Although receiving physician support is an important goal for patients, it was not a commonly recognized goal by physicians. Clearly identified management goals may improve the care of patients with medically unexplained symptoms and help clinicians achieve greater satisfaction with the management of these patients.

Assessment of the quality of reporting observational studies in the pediatric dental literature.

PURPOSE: The purpose of this assessment was to evaluate reporting of observational studies in the pediatric dental literature. METHODS: This assessment included the following steps: (1) developing a model for reporting information in clinical dentistry studies; (2) identifying treatment comparisons in pediatric dentistry that were evaluated by at least 5 observational studies; (3) abstracting from these studies any data indicated by applying the reporting model; and (4) comparing available data elements to the desired data elements in the reporting model. RESULTS: The reporting model included data elements related to: (1) patients; (2) providers; (3) treatment details; and (4) study design. Two treatment comparisons in pediatric dentistry were identified with 5 or more observational studies: (1) stainless steel crowns vs amalgams (10 studies); and (2) composite restorations vs amalgam (5 studies). Results from studies comparing the same treatments varied substantially. Data elements from the reporting model that could have explained some of the variation were often reported inadequately or not at all. CONCLUSIONS: Reporting of observational studies in the pediatric dental literature may be inadequate for an informed interpretation of the results. Models similar to that used in this study could be used for developing standards for the conduct and reporting of observational studies in pediatric dentistry.

Long-term effects of stress reduction on mortality in persons > or = 55 years of age with systemic hypertension.

Psychosocial stress contributes to high blood pressure and subsequent cardiovascular morbidity and mortality. Previous controlled studies have associated decreasing stress with the Transcendental Meditation (TM) program with lower blood pressure. The objective of the present study was to evaluate, over the long term, all-cause and cause-specific mortality in older subjects who had high blood pressure and who participated in randomized controlled trials that included the TM program and other behavioral stress-decreasing interventions. Patient data were pooled from 2 published randomized controlled trials that compared TM, other behavioral interventions, and usual therapy for high blood pressure. There were 202 subjects, including 77 whites (mean age 81 years) and 125 African-American (mean age 66 years) men and women. In these studies, average baseline blood pressure was in the prehypertensive or stage I hypertension range. Follow-up of vital status and cause of death over a maximum of 18.8 years was determined from the National Death Index. Survival analysis was used to compare intervention groups on mortality rates after adjusting for study location. Mean follow-up was 7.6 +/- 3.5 years. Compared with combined controls, the TM group showed a 23% decrease in the primary outcome of all-cause mortality after maximum follow-up (relative risk 0.77, p = 0.039). Secondary analyses showed a 30% decrease in the rate of cardiovascular mortality (relative risk 0.70, p = 0.045) and a 49% decrease in the rate of mortality due to cancer (relative risk 0.49, p = 0.16) in the TM group compared with combined controls. These results suggest that a specific stress-decreasing approach used in the prevention and control of high blood pressure, such as the TM program, may contribute to decreased mortality from all causes and cardiovascular disease in older subjects who have systemic hypertension.

Prospective observational study of treatments for unexplained chronic fatigue.

BACKGROUND: Unexplained chronic fatigue is a frequent complaint in primary care. A prospective observational study design was used to evaluate whether certain commonly used therapies for unexplained chronic fatigue may be effective. METHOD: Subjects with unexplained chronic fatigue of unknown etiology for at least 6 months were recruited from the Wisconsin Chronic Fatigue Syndrome Association, primary care clinics, and community chronic fatigue syndrome presentations. The primary outcome measure was change in a 5-question fatigue score from 6 months to 2 years. Self-reported interventions tested included prescribed medications, non-prescribed supplements and herbs, lifestyle changes, alternative therapies, and psychological support. Linear regression analysis was used to test the association of each therapy with the outcome measure after adjusting for statistically significant prognostic factors. RESULTS: 155 subjects provided information on fatigue and treatments at baseline and follow-up. Of these subjects, 87% were female and 79% were middle-aged. The median duration of fatigue was 6.7 years. The percentage of users who found a treatment helpful was greatest for coenzyme Q10 (69% of 13 subjects), dehydroepiandrosterone (DHEA) (65% of 17 subjects), and ginseng (56% of 18 subjects). Treatments at 6 months that predicted subsequent fatigue improvement were vitamins (p = .08), vigorous exercise (p = .09), and yoga (p = .002). Magnesium (p = .002) and support groups (p = .06) were strongly associated with fatigue worsening from 6 months to 2 years. Yoga appeared to be most effective for subjects who did not have unclear thinking associated with the fatigue. CONCLUSION: Certain alternative therapies for unexplained chronic fatigue, especially yoga, deserve testing in randomized controlled trials.

Assessing observational studies of medical treatments.

BACKGROUND: Previous studies have assessed the validity of the observational study design by comparing results of studies using this design to results from randomized controlled trials. The present study examined design features of observational studies that could have influenced these comparisons. METHODS: To find at least 4 observational studies that evaluated the same treatment, we reviewed meta-analyses comparing observational studies and randomized controlled trials for the assessment of medical treatments. Details critical for interpretation of these studies were abstracted and analyzed qualitatively. RESULTS: Individual articles reviewed included 61 observational studies that assessed 10 treatment comparisons evaluated in two studies comparing randomized controlled trials and observational studies. The majority of studies did not report the following information: details of primary and ancillary treatments, outcome definitions, length of follow-up, inclusion/exclusion criteria, patient characteristics relevant to prognosis or treatment response, or assessment of possible confounding. When information was reported, variations in treatment specifics, outcome definition or confounding were identified as possible causes of differences between observational studies and randomized controlled trials, and of heterogeneity in observational studies. CONCLUSION: Reporting of observational studies of medical treatments was often inadequate to compare study designs or allow other meaningful interpretation of results. All observational studies should report details of treatment, outcome assessment, patient characteristics, and confounding assessment.

The limited effect of screening for depressive symptoms with the PHQ-9 in rural family practices.

CONTEXT: Previous studies have found that routine screening for depression does not improve patient outcome unless it is combined with case management. However, these studies were conducted before the widespread use of SSRIs or in settings other than traditional primary care. PURPOSE: This study investigated whether screening for depressive symptoms improves outcomes for depressed patients seen in rural fee-for-service primary care offices. METHODS: Depression screening was conducted at 2 private rural clinics in Iowa using the PHQ-9. Patients with depressive symptoms were randomized to the control group or the intervention group, where providers were given completed PHQ-9 questionnaires at the baseline visit. The outcome PHQ-9 scores were assessed by telephone at 4, 10, and 24 weeks after the index visit. FINDINGS: A total of 861 patients were screened for depressive symptoms; 51 subjects enrolled in the trial. The intervention and control groups did not significantly differ with respect to changes in PHQ-9 scores at any of the 3 follow-up times. They also did not differ with respect to the proportion of subjects who were actively managed with medication or by referral to a mental health specialist: 46% vs 33% (P = .38) for all subjects and 50% vs 50% (P = .96) for subjects with major depression at baseline. CONCLUSIONS: Screening for depressive symptoms with the PHQ-9 in 2 rural medical clinics did not significantly increase physicians' active management of depression or lead to improved patient outcomes.

Overview of the evidence for clinical interventions in pediatric dentistry.

PURPOSE: The purpose of this report was to describe the quantity of published literature and types of studies supporting the use of 4 pediatric dentistry procedures: (1) ferric sulfate pulpotomy; (2) stainless steel crowns; (3) space maintainers; and (4) atraumatic restorative technique (ART). METHODS: When available, titles and abstracts of reports written in English and published over a 36-year period (1966-2002) concerning these procedures were retrieved from MEDLINE. They were classified using a modified classification scheme that, in addition to the study designs, also considered the 4 dimensions of measuring dental outcomes. RESULTS: The quantity of available literature concerning each dental procedure varied considerably. Even though many reports were published on treatments, only a small proportion of the published literature for each procedure was found to evaluate outcomes, regardless of outcome dimension. Besides outcomes evaluations, studies on techniques, material properties, and review articles comprised a large proportion of the literature. Clinical dimension of outcomes was most commonly studied. Case series and case reports were the most frequently used study designs to report outcomes. CONCLUSIONS: The outcomes-related literature to support some of the commonly performed treatments is limited both in quantity and study types. More reports are needed to develop the evidence base to support the commonly performed procedures in pediatric dental practice. Additional analyses reporting of the literature are also needed to assess internal and external validity of the studies.

Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants.

OBJECTIVE: The available data on antidepressant levels in nursing infants were analyzed in order to calculate average infant drug levels and determine what factors influence plasma drug levels in breast-feeding infants of mothers treated with antidepressants. METHOD: Electronic searches of MEDLINE, PreMEDLINE, Current Contents, Biological Abstracts, and PsycINFO from 1966 through July 2002 followed by bibliographic searches identified 67 relevant studies (two unpublished). By consensus the authors identified 57 studies of maternal plasma, breast milk, and/or infant plasma antidepressant levels from nursing mother-infant pairs, measured by liquid chromatography. RESULTS: Infants with recent prenatal exposure and symptomatic infants included in case reports were analyzed separately. Infant plasma levels were standardized against the average maternal level for each drug. The average infant-maternal plasma ratio was calculated for each drug, and correlations of infant plasma level to maternal dose, maternal plasma level, and breast milk level were calculated. Nortriptyline, paroxetine, and sertraline usually produce undetectable infant levels. Of drugs currently used, fluoxetine produces the highest proportion (22%) of infant levels that are elevated above 10% of the average maternal level. Based on smaller numbers, the data on citalopram indicate that it produces elevated levels in 17% of infants. The milk-to-plasma ratios for 11 antidepressants had a statistically significant negative association with the percentage of the drug bound to protein. CONCLUSIONS: Nortriptyline, paroxetine, and sertraline may be preferred choices in breast-feeding women. Minimizing the maternal dose may be helpful with citalopram. Current data do not support monitoring breast milk levels in individual patients. Future researchers should report maternal, breast milk, and infant antidepressant levels along with other appropriate variables.

The effectiveness of citalopram for idiopathic chronic fatigue.

BACKGROUND: Chronic fatigue greatly affects quality of life and is a common reason for physician visits. Patients with chronic fatigue are often treated with antidepressants. METHOD: Prior to enrollment, all subjects had substantial fatigue for 6 months or more that was not explained by depression, organic illness, or lifestyle behaviors. Patients already taking an antidepressant were excluded from the study. Two designs were used. (1) Thirty-one subjects were given placebo for 1 week and then citalopram, 20 to 40 mg/day, for 2 months. Statistical testing evaluated whether fatigue (measured with the Rand Vitality Index) was reduced after citalopram was started. (2) Fatigue changes for subjects taking citalopram were compared with fatigue changes after 1 month and 2 months for 76 similar subjects taking an ineffective treatment. RESULTS: In design 1, fatigue for subjects taking citalopram was significantly and substantially reduced when subjects were switched from placebo to citalopram, p <.05. Benefits at 2 months were greatest for subjects who had fatigue less than 5 years, p <.01, and women, p <.01. In design 2, fatigue scores for subjects taking citalopram were not significantly better than the comparison group for all subjects but were significantly better at 2 months for subjects with less severe fatigue at baseline, p =.005, and for women, p =.08. Depression scores were not significantly better for citalopram subjects overall (p >.10) but were for certain subgroups. For all subjects, citalopram was associated with greater decrease in headaches and muscle aches at 1 month, p <.01. CONCLUSION: Citalopram may improve fatigue and symptoms associated with fatigue for some patients.