Hospitalized valvular heart disease in patients on renal transplant waiting list: incidence, clinical correlates and outcomes.

BACKGROUND: Patients with ESRD are at increased risk for heart valve calcification. It has not been established whether hospitalized valvular heart disease (VHD) is a substantial barrier to renal transplantation (RT) after transplant listing, or whether VHD progresses after RT. METHODS: Using data from the USRDS, we studied 35,215 patients with ESRD enrolled on the renal transplant waiting list from July 1994 to June 1997. Cox non-proportional hazards regression models were used to calculate adjusted, time-dependent hazard ratios (HR) for RT and VHD. RESULTS: In comparison to maintenance dialysis (2.2/1,000 person years), RT was independently associated with a lower hazard for hospitalization for VHD (0.7/1,000 person years, HR 0.28, 95% confidence interval 0.17 - 0.47). Renal transplant recipients had much lower rates of VHD after transplant than before (rate ratio (RR) 0.49, 95% Cl 0.47 - 0.52). Patients with VHD were significantly less likely to receive RT (adjusted rate for RT 0.38, 95% CI 0.20 - 0.45) but patients who received valve replacement surgeries (VRS) were not affected (adjusted rate for RT 1.10, 95% CI 0.52 - 2.32, not significant). CONCLUSIONS: VHD is an uncommon but serious barrier to RT after listing, while VRS is not a significant barrier to RT. Established VHD does not appear to worsen after RT. Clinicians should consider giving increased attention to the detection and treatment of VHD during the pre-transplant evaluation.

The impact of renal transplantation on the incidence of congestive heart failure in patients with end-stage renal disease due to diabetes.

BACKGROUND: Patients with end stage renal disease (ESRD) are at increased risk for cardiovascular disease. We hypothesized that the clinical incidence of congestive heart failure (CHF) would be lessened after successful renal transplantation, as many of the metabolic and intravascular volume abnormalities associated with dialysis-dependent ESRD would resolve. METHODS: Using data from the USRDS, we studied 11,369 patients with ESRD due to diabetes enrolled on the renal and renal-pancreas transplant waiting list from 1 July 1994-30 June 1997. Cox non-proportional hazards regression models were used to calculate adjusted, time-dependent hazard ratios (HR) for time to the most recent hospitalization for CHF (including acute myocardial infarction, unstable angina, or other CHF, ICD9 Code 428.x) for a given patient in the study period, controlling for both demographics and comorbidities in the medical evidence form (HCFA 2728). RESULTS: In comparison to maintenance dialysis, renal transplantation was independently associated with a lower risk for CHF (HR 0.64, 95% confidence interval, 0.54-0.77) in a model including age, gender, race, and year of first dialysis, but not in a model including comorbidities from the medical evidence form, although the sample was much smaller. CONCLUSIONS: Patients with ESRD due to diabetes on the renal transplant waiting list were much less likely to be hospitalized for congestive heart failure after renal transplantation, despite post transplant complications due to immunosuppression.

Risk factors for hospitalizations resulting from pulmonary embolism after renal transplantation in the United States.

BACKGROUND: Risk factors for pulmonary embolism (PE) have been identified in the general population but have not been studied in a national population of renal transplant recipients. METHODS: Therefore, 33,479 renal transplant recipients in the United States Renal Data System from 1 July 1994-30 June 1997 were analyzed in a historical cohort study of hospitalized PE (ICD9 Code 415.1x). HCFA form 2728 was used for comorbidities. RESULTS: Renal transplant recipients had an incidence of PE of 2.26 hospitalizations per 1000 patient years at risk. In multivariate analysis, polycystic kidney disease (adjusted odds ratio, 4.44, 95% confidence interval, 2.31-8.53), older recipient age, higher recipient weight, cadaveric donation, history of ischemic heart disease, and decreased serum albumin were associated with increased risk of PE. Body mass index and hemoglobin were not significant. Kidney-pancreas transplantation was also not significant. In Cox Regression analysis PE was associated with increased mortality (hazard ratio 2.06, 95% CI 1.34-3.18). CONCLUSIONS: The most important risk factors for PE in this population were polycystic kidney disease, advanced age and increased weight. The reasons for the increased risk of polycystic kidney disease remain to be determined but were independent of hematocrit level at initiation of end stage renal disease, and may result from venous compression. Prospective studies of anatomical and hemostatic changes after renal transplantation in recipients with polycystic kidney disease are warranted.

Impact of managed care on obstetrician-gynecologists' practice: the providers' perspective.

The American College of Obstetricians and Gynecologists' 1998 Socioeconomic Survey of Fellows included questions, developed in collaboration with the Jacobs Institute of Women's Health, to assess the impact of managed care on respondents' practices and patients. Participation in managed care is extensive among obstetricians and gynecologists (ob/gyns), especially in commercial managed care plans. The greatest areas of dissatisfaction for physicians were administrative workload, external review of clinical decisions, and promptness of payment. More research is needed to determine the impact of administrative burdens, restrictions on access to ob/gyns, and denial of coverage on women's receipt of timely and appropriate services.

Epidemiology of acute hepatitis in the Stann Creek District of Belize, Central America.

Hepatitis is common in the Stann Creek District of southern Belize. To determine the etiologies, incidence, and potential risk factors for acute jaundice, we conducted active surveillance for cases. Cases of jaundice diagnosed by a physician within the previous 6 weeks were enrolled. Evaluation included a questionnaire and laboratory tests for hepatitis A, B, C, D, and E, a blood film for malaria, and a serologic test for syphilis. Etiologies of jaundice among 62 evaluable patients included acute hepatitis A, 6 (9.7%), acute hepatitis B, 49 (79.0%), hepatitis non-A-E, 2 (3.2%), and malaria, 5 (8.1%). There were no cases of acute hepatitis E. One patient each with antibody to hepatitis C and D were detected. The annualized incidence of hepatitis A was 0.26 per 1,000. All cases of hepatitis A were in children 4-16 years of age. The annualized incidence of hepatitis B, 2.17 per 1,000, was highest in adults aged 15-44 years (4.4 per 1,000) and was higher in men (36 cases; 3.09 per 1,000) than women (13 cases; 1.19 per 1,000). Four (31%) of the women with hepatitis B were pregnant. The annualized incidence was significantly higher in Mestizo (6.18 per 1000) and Maya (6.79 per 1,000) than Garifuna (0.38 per 1,000) or Creole (0.36 per 1,000). Persons with hepatitis B were significantly more likely to be born outside of Belize (82%), had been in Belize < 5 years (73%), and lived and worked in rural areas (96%) than was the general population. Of those > or = 14 years of age with hepatitis B, only 36% were married. Few persons admitted to transfusions, tattoos, IV drug use, multiple sexual partners, visiting prostitutes, or sexually transmitted diseases. Only 1 of 49 had a reactive test for syphilis. Six patients were hospitalized (including 3 with acute hepatitis B and one with hepatitis A), and none to our knowledge died. Acute hepatitis B is the most common cause of viral hepatitis in the Stann Creek District, but the modes of transmission remain obscure. Infants, women attending prenatal clinics, and new workers are potential targets for immunization with hepatitis B vaccine.

Hospitalizations for fungal infections after initiation of chronic dialysis in the United States.

AIMS: Hospitalized fungal infections are reported frequently in renal transplant recipients and peritoneal dialysis patients, but the frequency of hospitalized fungal infections in dialysis patients has not been studied in a national population. METHODS: 327,993 dialysis patients in the United States Renal Data System initiated from January 1, 1992 to June 30, 1997 were analyzed in a retrospective registry study of fungal infections (based on ICD9 Coding). RESULTS: Dialysis patients had an age-adjusted incidence ratio for fungal infections of 9.80 (95% confidence interval (CI) 6.34-15.25)) compared to the general population in 1996 (the National Hospital Discharge Survey). Candidiasis accounted for 79% of all fungal infections, followed by cryptococcosis (6.0%) and coccidioidomycosis (4.1%). In multivariate analysis, fungal infections were associated with earlier year of dialysis, diabetes, female gender, decreased weight and serum creatinine at initiation of dialysis, chronic obstructive lung disease and AIDS. In Cox regression analysis the hazard ratio for mortality of fungal infections was 1.35 (95% CI 1.28-1.42). CONCLUSIONS: Dialysis patients were at increased risk for fungal infections compared to the general population, which substantially decreased patient survival. Female and diabetic patients were at increased risk for fungal infections. Although candidiasis was the dominant etiology of fungal infections, the frequency of cryptococcosis and coccidioidomycosis were higher than previously reported.

Psychosocial-immune relationships in HIV disease.

Human immunodeficiency virus (HIV) is now commonly viewed as a chronic disease, which often consists of a wide array of recurrent and sometimes severe psychosocial stressors. An individual's response to these multiple challenges over time may impact their health. In this article, we review research examining the relationship of psychologic factors (eg, depression, stressful life events, coping, social support) with immune system function and disease course. We also explore some of the potential physiologic pathways that may underlie these types of psychosocial-immune relationships, as well as the effects of psychologic interventions, particularly cognitive-behavioral stress management (CBSM), on the psychosocial, neuroendocrine, and immune functioning of people living with HIV. We conclude by suggesting some areas for future research, particularly the study of HIV-positive women.

Training of providers in embryo transfer: what is the minimum number of transfers required for proficiency?

BACKGROUND: Embryo transfer represents one of the most critical procedures in the practice of assisted reproduction. The objective of this study was to identify retrospectively the minimum number of embryo transfers required to train providers properly in this skill. METHODS AND RESULTS: The study group consisted of 204 patients who received embryo transfers between January 1996 and March 2000 in a university-based programme of assisted reproduction. The main outcome measure was clinical pregnancies per embryo transfer. Five Fellow trainees performed a total of 204 embryo transfers for an overall pregnancy rate of 45.5% per embryo transfer (93/204). In comparison, the programme pregnancy rate per transfer for experienced providers was 47.3% (560/1179). A chronological graph of each individual trainee's experience for the first 50 embryo transfers performed suggested a lower initial pregnancy rate for three of the five trainees. To determine whether a learning curve might exist, results of the first 25 transfers were compared as a subgroup with the second 25 transfers. Pregnancy rates were lower for the 1-25 transfer subgroup than in the 26-50 subgroup for three of the five Fellow trainees, although the difference was not statistically significant. CONCLUSION: Clinical pregnancy rates of Fellows-in-training were indistinguishable statistically from those of experienced staff by 50 transfers.

Prevalence and incidence of hepatitis C virus infection in the US military: a seroepidemiologic survey of 21,000 troops.

Because of a high prevalence of hepatitis C virus (HCV) infection (10-20%) among veterans seeking care in Department of Veterans Affairs (VA) hospitals, current US military forces were evaluated for HCV infection. Banked serum samples were randomly selected from military personnel serving in 1997 and were tested for antibody to HCV (anti-HCV). Overall prevalence of anti-HCV among 10,000 active-duty personnel was 0.48% (5/1,000 troops); prevalence increased with age from 0.1% among military recruits and active-duty personnel aged <30 years to 3.0% among troops aged >/=40 years. Prevalence among 2,000 Reservists and active-duty troops was similar. Based on sequential serum samples from 7,368 active-duty personnel (34,020 person-years of observation), annual incidence of infection was 2/10,000. Of 81 HCV RNA-positive troops for whom genotype was determined, genotypes 1a (63%) and 1b (22%) predominated, as in the civilian population. These data indicate that HCV infection risk among current military forces is lower than in VA studies and the general civilian population aged <40 years. The low level of HCV infection may be attributed to infrequent injection drug use in the military due to mandatory testing for illicit drugs prior to induction and throughout military service.

Hospitalizations for fungal infections after renal transplantation in the United States.

Fungal infections in renal transplant recipients have not been studied in a national population. Therefore, 33,420 renal transplant recipients in the United States Renal Data System from 1 July 1994 to 30 June 1997 were analyzed in a retrospective registry study of hospitalized fungal infections (FI). FI were most commonly associated with secondary diagnoses of esophagitis (68, 23.9%), pneumonia (57, 19.8%), meningitis (23, 7.6%), and urinary tract infection (29, 10.3%). Opportunistic organisms accounted for 95.4% of infections, led by candidiasis, aspergillosis, cryptococcosis, and zygomycosis. Most fungal infections (66%) had occurred by six months post-transplant, but only 22% by two months. In logistic regression analysis, end-stage renal disease due to diabetes, duration of pre-transplant dialysis, maintenance tacrolimus and allograft rejection were associated with FI. In Cox regression analysis, recipients with FI had a relative risk of mortality of 2.88 (95% CI=2.22-3.74) compared to all other recipients. Among FI, zygomycosis and aspergillosis were independently associated with both increased patient mortality and length of hospital stay. Most fungal infections in renal transplant recipients were opportunistic, occurred later than previously reported, and were associated with greatly decreased patient survival. Recipients with diabetes, prolonged pre-transplant dialysis, rejection, and tacrolimus immunosuppression should be considered high risk for FI.

Randomized, cross-over, controlled comparison of two inactivated hepatitis A vaccines.

The immunogenicity, tolerability and interchangeability of two hepatitis A vaccines, Vaqta (Merck and Co.) and Havrix (SmithKline) were studied in a randomized, crossover, controlled clinical trial. Vaccine was administered to 201 volunteers at 0 and 26 weeks in one of four vaccine regimens: Havrix-Havrix; Havrix-Vaqta; Vaqta-Havrix or Vaqta-Vaqta. Seroconversion rates (>/=10 mIU/ml) for those whose first dose was Vaqta or Havrix, respectively, were: 41/96 (43%) versus 30/95 (32%) (P=0.15) at 2 weeks and 91/98 (93%) versus 84/97 (87%) (P=0.43) at 4 weeks, and 100% at 26 weeks. Geometric mean concentrations (GMC) of total antibody to hepatitis A virus (anti-HAV) for Vaqta and Havrix were 189 and 114 mIU/ml (P=0.011) at 4 weeks and 234 and 136 mIU/ml (P<0.001) at 26 weeks. At 30 weeks, the GMC after two doses of Havrix was 2612 mIU/ml compared with 5497 after two doses of Vaqta (P<0.001). The GMC in the Havrix-Vaqta group was 5672 mIU/ml compared with 3077 mIU/ml in the Vaqta-Havrix group (P<0.001). Less than half of vaccine recipients reported tenderness or pain. In this study, seroconversion rates of the two vaccines were similar. Vaqta produces significantly higher anti-HAV antibody than Havrix. Crossover immunization is well tolerated and results in high antibody concentrations, especially when Vaqta is the booster dose. The significance of higher anti-HAV antibody concentrations in terms of long-term protection is unknown.

Cognitive-behavioral stress management reduces distress and 24-hour urinary free cortisol output among symptomatic HIV-infected gay men.

BACKGROUND: Stress management interventions can reduce symptoms of distress as well as modulate certain immune system components in persons infected with human immunodeficiency virus (HIV). These effects may occur in parallel with reductions in hypothalamic-pituitary-adrenal (HPA) axis hormones such as cortisol, which has been related in other work to a down-regulation of immune system components relevant to HIV infection. The present study tested the effects of a multimodal cognitive-behavioral stress management (CBSM) intervention on 24-hour urinary free cortisol levels and distressed mood in symptomatic HIV+ gay men. METHODS: Symptomatic HIV-infected gay men who were randomized to either a 10-week group-based CBSM intervention or a 10-week wait-list period provided psychological responses and urine samples pre-post intervention. RESULTS: Of the 59 participants providing matched questionnaire data, men assigned to CBSM (n = 40) showed significantly lower posttreatment levels of self-reported depressed affect, anxiety, anger, and confusion than those in the wait-list control group (n = 19). Among the 47 men providing urine samples (34 CBSM, 13 controls), those assigned to CBSM revealed significantly less cortisol output as compared to controls. At the individual level, depressed mood decreases paralleled cortisol reductions over this period across the entire sample. CONCLUSION: A time-limited CBSM intervention reduced distress symptoms and urinary free cortisol output in symptomatic HIV+ gay men and greater reductions in some aspects of distress, especially depressed mood, paralleled greater decreases in cortisol over the intervention period. If persisting stressors and depressed mood contribute to chronic HPA axis activation in HIV-infected persons, then interventions such as CBSM, which teaches them to relax, alter cognitive appraisals, use new coping strategies, and access social support resources, may decrease distress and depressed mood and normalize HPA axis functioning.

Cognitive-behavioral stress management reduces serum cortisol by enhancing benefit finding among women being treated for early stage breast cancer.

OBJECTIVE: This study examined the effects of a cognitive-behavioral stress management (CBSM) group intervention on serum cortisol levels in women being treated for stage I or II breast cancer. METHODS: Participants were randomly assigned to undergo a 10-week intervention (N = 24) within 8 weeks after surgery or were placed on a waiting list (N = 10). Cortisol was assessed by means of a radioimmunoassay of blood samples collected at the same time of day just before the start of the intervention and immediately after its completion. The women also reported the degree to which breast cancer had made positive contributions to their lives. RESULTS: Intervention participants showed increased benefit finding and reduced serum cortisol levels, whereas control subjects experienced neither change. Path analysis suggested that the effect of CBSM on cortisol was mediated by increases in benefit finding. CONCLUSIONS: These findings suggest that positive growth enhanced during a time-limited intervention can influence physiological parameters such as cortisol among women with early stage breast cancer.

Reductions in salivary cortisol are associated with mood improvement during relaxation training among HIV-seropositive men.

This study examined salivary cortisol and mood during relaxation training in 30 symptomatic, HIV+ gay men participating in a 10-week, group-based cognitive-behavioral stress management intervention. Cortisol levels and mood were assessed within these sessions just before and after 45-min relaxation exercises given as part of each session. Participants also recorded their stress level and compliance with daily home relaxation practice. Presession cortisol levels decreased across the 10-week period and were related to decreases in global measures of total mood disturbance and anxious mood. Reductions in presession cortisol levels were also associated with decreases in self-reported stress level during home practice. Greater reductions in cortisol during the first three sessions were associated with more frequent relaxation practice at home. These findings suggest that salivary cortisol represents an objective neuroendocrine marker for changes in anxiety and distress observed during relaxation training in symptomatic, HIV-seropositive men.

Cognitive-behavioral stress management intervention effects on anxiety, 24-hr urinary norepinephrine output, and T-cytotoxic/suppressor cells over time among symptomatic HIV-infected gay men.

The present study tested the effects of a multimodal cognitive-behavioral stress management (CBSM) intervention on anxious mood, perceived stress, 24-hr urinary catecholamine levels, and changes in T-lymphocyte subpopulations over time in symptomatic HIV+ gay men. Seventy-three men were randomized to either a group-based CBSM intervention (n = 47) or a wait-list control (WLC) condition (n = 26). Men assigned to CBSM showed significantly lower posttreatment levels of self-reported anxiety, anger, total mood disturbance, and perceived stress and less norepinephrine (NE) output as compared with men in the WLC group. At the individual level, anxiety decreases paralleled NE reductions. Significantly greater numbers of T-cytotoxic/suppressor (CD3+CD8+) lymphocytes were found 6 to 12 months later in those assigned to CBSM. Moreover, greater decreases in NE output and a greater frequency of relaxation home practice during the 10-week CBSM intervention period predicted higher CD3+CD8+ cell counts at follow-up.

Cognitive-behavioral stress management increases free testosterone and decreases psychological distress in HIV-seropositive men.

The effects of a 10-week group-based cognitive-behavioral stress management (CBSM) intervention on psychological distress and plasma free testosterone in symptomatic, HIV-seropositive men were examined. Participants were randomized to either CBSM (n = 42) or a wait-list control group (n = 23). Men in the CBSM intervention showed significant increases in testosterone, whereas control participants showed significant decreases. Those participating in CBSM had significant distress reductions, whereas controls showed no such change. Alterations in free testosterone were inversely related to changes in distress states over time, independent of any changes in cortisol. These findings demonstrate that a short-term CBSM intervention increases free testosterone levels among symptomatic, HIV-seropositive men, and alterations in free testosterone are associated with changes in psychological distress observed during CBSM.

Multicenter patient self-reporting questionnaire on impotence, incontinence and stricture after radical prostatectomy.

PURPOSE: We determined the incidence of patient self-reported post-prostatectomy incontinence, impotence, bladder neck contracture and/or urethral stricture, sexual function satisfaction, quality of life and willingness to undergo treatment again in a large multicenter group of men who underwent radical prostatectomy. We also determined whether the morbidities of sexual function satisfaction, quality of life and bladder neck contracture and/or urethral stricture are predictable from demographic and postoperative prostate cancer factors. MATERIALS AND METHODS: A self-reporting questionnaire was completed and returned by 1,069 of 1,396 eligible patients (77%) who underwent radical prostatectomy between 1962 and 1997. Of the respondents 868 (85.7%) underwent surgery after 1990 and in all prostatectomy had been done a minimum of 6 months previously. Questionnaire results were independently analyzed by a third party for morbidity tabulation and the association of patient reported satisfaction. RESULTS: The patient self-reported incidence of any degree of post-prostatectomy incontinence, impotence and bladder neck contracture or urethral stricture was 65.6%, 88.4% and 20.5%, respectively. The incidence of incontinence requiring protection was 33% and only 2.8% of respondents had persistent bladder neck contracture or urethral stricture. Although incontinence and impotence significantly affected self-reported sexual function satisfaction, quality of life and willingness to undergo treatment again (p = 0.001), 77.5% of patients would elect surgery again. This finding remained true even after adjusting for demographic variables, and the time between surgery and the survey by multiple logistic regression. CONCLUSIONS: Although radical prostatectomy morbidity is common and affects self-reported overall quality of life, most patients would elect the same treatment again. Impotence and post-prostatectomy incontinence were significantly associated with sexual function satisfaction, quality of life and willingness to undergo treatment again. Bladder neck contracture and/or urethral stricture was associated with willingness to undergo treatment again after adjusting for demographic variables and time from surgery to the survey.

Effect of an evidence-based medicine seminar on participants' interpretations of clinical trials: a pilot study.

PURPOSE: To evaluate the effect of evidence-based medicine (EBM) education on physicians' short-term and long-term understanding of research methods and statistics. METHOD: Twenty-four gastroenterology (GI) fellows attended a three-day seminar about evidence-based medicine and the critical appraisal of medical literature. Attendees completed the same 14-item test on this material at the start of the seminar, at the conclusion of the seminar, and six months after the seminar. A student's t-test and chi-square analysis were performed to determine the differences between test scores by testing date and performance on test items. RESULTS: Seminar attendees improved their test scores between pre-seminar and post-seminar tests (mean test score: 57% +/- 16% versus 82 +/- 14%, respectively; p <.001) and between pre-seminar and six-month post-seminar tests (mean test score: 57% +/- 16% versus 78% +/- 13%, respectively; p <.001). Seminar attendees showed significant improvement in frequency of correct answers with individual questions on concealment of allocation, relative risk reduction, and meta-analysis trial methods. CONCLUSIONS: In this pilot study, the critical appraisal skills necessary to practice EBM were taught to GI fellows in a seminar format that led to significant improvement in their understanding of research methods and statistics. Data from this pilot study justify a definitive trial examining the educational value of EBM seminars for physicians.

Reductions in herpes simplex virus type 2 antibody titers after cognitive behavioral stress management and relationships with neuroendocrine function, relaxation skills, and social support in HIV-positive men.

OBJECTIVE: Coinfection with herpes simplex virus type 2 (HSV-2) is common in individuals infected with human immunodeficiency virus (HIV) and may have health implications. This study examined the effect of a 10-week cognitive behavioral stress management (CBSM) intervention on immunoglobulin G (IgG) antibody titers to HSV-2 in a group of mildly symptomatic HIV-infected gay men and the degree to which these effects were mediated by psychosocial and endocrine changes during the 10-week period. METHODS: Sixty-two HIV+ gay men were randomly assigned to either a 10-week CBSM intervention (N = 41) or a wait-list control condition (N = 21). Anxious mood, social support, cortisol/dehydroepiandrosterone sulfate (DHEA-S) ratio levels, and HSV-2 IgG antibody titers were assessed at baseline and after the 10-week period. CBSM participants also recorded their stress levels before and after at-home relaxation practice. RESULTS: HSV-2 IgG titers were significantly reduced in the CBSM participants but remained unchanged in the control group after the 10-week intervention period. Increases in one type of social support, perceived receipt of guidance, during the 10 weeks was associated with and partially mediated the effect of the intervention on HSV-2 IgG. Similarly, decreases in cortisol/DHEA-S ratio levels were associated with decreases in HSV-2 IgG, and lower mean stress levels achieved after home relaxation practice were associated with greater decreases in HSV-2 IgG among CBSM participants. CONCLUSIONS: These findings suggest that behavioral and psychosocial changes occurring during CBSM interventions, including relaxation, enhanced social support, and adrenal hormone reductions, may help to explain the effects of this form of stress management on immune indices such as HSV-2 antibody titers.

Music therapy increases serum melatonin levels in patients with Alzheimer's disease.

CONTEXT: Music therapy is known to have healing and relaxing effects. Although these effects appear to be mediated by release of neurotransmitters and neurohormones, the specific neurohormonal systems involved have not been fully investigated. OBJECTIVE: To assess the effects of a music therapy intervention on concentrations of melatonin, norepinephrine, epinephrine, serotonin, and prolactin in the blood of a group of patients with Alzheimer's disease. DESIGN: Blood samples were obtained before initiating the therapy, immediately at the end of 4 weeks of music therapy sessions, and at 6 weeks follow-up after cessation of the sessions. SETTING: Miami Veterans Administration Medical Center, Miami, Fla. PATIENTS: 20 male inpatients with Alzheimer's disease. INTERVENTION: 30- to 40-minute morning sessions of music therapy 5 times per week for 4 weeks. MAIN OUTCOME MEASURES: Changes in melatonin, norepinephrine, epinephrine, serotonin, and prolactin following music therapy. RESULTS: Melatonin concentration in serum increased significantly after music therapy and was found to increase further at 6 weeks follow-up. A significant increase was found between baseline values and data recorded after the music therapy sessions as well as at 6 weeks follow-up. Norepinephrine and epinephrine levels increased significantly after 4 weeks of music therapy, but returned to pretherapy levels at 6 weeks follow-up. Serum concentration of prolactin and platelet serotonin levels remained unchanged after 4 weeks of music therapy and at 6 weeks follow-up. CONCLUSION: Increased levels of melatonin following music therapy may have contributed to patients' relaxed and calm mood.