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Biomedical subjects

Peter C O'Brien

Publications and source records attributed to Peter C O'Brien.

At least 37 records · Page 2Linked to original sources
PubMed2003

Familial clustering of stroke according to proband age at onset of presenting ischemic stroke.

BACKGROUND AND PURPOSE: The magnitude of inherited risk of stroke may lessen with age, and this would have implications for optimizing genomic approaches to identifying genetic risk factors for stroke. We investigated the relationship between age and inherited risk of stroke. METHODS: Family histories of stroke were obtained in systematic interviews with 310 adult men and women with recent CT- or MR-confirmed ischemic stroke. Probability of stroke in first-degree relatives was analyzed by logistic regression, adjusting for sibship size. RESULTS: The probability of having a sibling with stroke increased as proband age at stroke presentation increased. Per decade increase in proband age, the odds ratio was 1.65 (95% confidence interval [CI], 1.20 to 2.28; P=0.002) for a concordant sibling and 1.69 (95% CI, 1.15 to 2.49; P=0.008) for >or=2 first-degree relatives with a history of stroke. CONCLUSIONS: Clustering of stroke was not greater in families with probands manifesting symptoms of stroke in earlier than later adulthood. The relationship between proband age and positive family history of stroke does not suggest an upper age-limit cutoff for genomewide linkage studies.

Adult↗
PubMed2003

A safe and effective method for converting patients from transdermal to intravenous fentanyl for the treatment of acute cancer-related pain.

BACKGROUND: The delayed effects (12-16 hours) of transdermal fentanyl make dose titration difficult during acute exacerbations of cancer pain. Patients at the authors' institution routinely are switched from transdermal to intravenous (IV) fentanyl using a 1:1 (transdermal:IV) conversion during severe episodes of pain. METHODS: The authors evaluated nine consecutive hospitalized patients with cancer who had severe pain for up to 6 days following the conversion from transdermal to IV fentanyl. Pain intensity was rated using an 11-point (0-10) verbal numeric rating scale (NRS). All 9 patients initially reported their pain intensity with movement as >or= 8 during treatment with transdermal fentanyl. Eight patients initially reported their pain at rest as >or= 8. In each patient, all transdermal patches were removed, and a continuous infusion (CI) delivering IV fentanyl at the same hourly rate was initiated simultaneously. Demand boluses of IV fentanyl equivalent in dosage to 50-100% of the CI rate remained available by patient-controlled analgesia (PCA). Pain intensity (0-10), sedation (0-3), and hourly fentanyl requirements (micrograms per hour) were assessed and recorded immediately prior to patch removal and at least once daily after the initiation of IV fentanyl. The CI and demand boluses were titrated whenever necessary on the basis of pain intensity and supplemental PCA use. RESULTS: All 9 patients reported mild levels (<or= 4) of pain at rest within 5 days. The median time to achieve mild levels of pain at rest was 1.5 days. Six patients achieved mild levels of pain with movement within 3 days. Three patients never achieved mild levels of pain with movement while receiving IV fentanyl. No serious side effects were reported. CONCLUSIONS: The conversion from transdermal to IV fentanyl can be accomplished safely and effectively using a 1:1 (transdermal:IV) conversion during acute exacerbations of cancer pain.

Administration, Cutaneous↗
PubMed2003

Trends in the mortality burden associated with diabetes mellitus: a population-based study in Rochester, Minn, 1970-1994.

BACKGROUND: The prevalence of diabetes mellitus (DM) has increased markedly in recent decades, but trends in the mortality burden associated with DM are unclear. Therefore, we analyzed population-based longitudinal data to address this issue. METHODS: The community-based medical records of all Rochester residents 45 years and older who died between January 1, 1970, and December 31, 1994, were reviewed to identify those who met the standardized criteria for DM before death. Trends over successive quinquenniums were assessed for the proportion of all deaths in the community of persons with prevalent DM, for mortality rates for persons with and without DM, and for the distribution of causes of death among decedents with and without DM. RESULTS: Of 10 152 total deaths in 1970-1994, 1384 (13.6%) met the criteria for prevalent DM. Between 1970-1974 and 1990-1994, the proportion of decedents with DM increased by 48.2%. Mortality rates for persons with and without DM declined by 13.8% and 21.4%, respectively. This disparity in mortality trends was most apparent for older women and younger men. There were temporal declines in the proportion of all persons dying of cardiovascular disease, but temporal declines in persons dying of cerebrovascular disease were found only in decedents without DM. CONCLUSIONS: The mortality burden associated with DM increased significantly between 1970 and 1994, probably due to increases in DM incidence and smaller declines in mortality for persons with DM relative to those without DM. In the absence of improved DM prevention and treatment, the steady declines in mortality observed for the general population since the 1960s will likely begin to slow or even reverse.

Aged↗
PubMed2003

Individual attributes versus composite scores of nerve conduction abnormality: sensitivity, reproducibility, and concordance with impairment.

Composite scores may be more sensitive and reproducible than single attributes of nerve conduction for detection of peripheral neuropathy, but this requires validation in large patient cohorts. Also, the concordance of individual attributes versus composite scores with clinical measures of severity has not been tested. Here, we study these issues in prospectively studied cohorts: diabetic patients from Rochester, Minnesota (RDNS; n = 396); chronic inflammatory demyelinating polyneuropathy (CIDP) patients (n = 55); and multifocal motor neuropathy (MMN) patients (n = 18). With specificity fixed at the 97.5 percentile, we found that, in generalized polyneuropathies (diabetic and CIDP), composite scores (especially ones including conduction velocity, distal latencies, and F-waves) of individual or multiple nerves tended to be more sensitive than individual attributes. By contrast, for multiple mononeuropathies, some individual attributes or composite scores of individual nerves were more sensitive than composite scores. In diabetic polyneuropathy, composite scores tended to be more reproducible than individual attributes of nerve conduction. Highly significant correlations were found between individual attributes or composite scores and neurologic impairment in diabetic polyneuropathy and in CIDP; in general, correlation coefficients were higher for composite scores. These correlations were higher for amplitudes than for conduction velocities or distal latencies. We conclude that, with the availability of microprocessors and normative databases, electromyographers may increasingly seek to express nerve conduction abnormality also as composite scores of individual or several nerves.

Diabetic Neuropathies↗
PubMed2003

Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05).

BACKGROUND AND PURPOSE: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). MATERIALS AND METHODS: Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. RESULTS: Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than +/-10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P=0.44). CONCLUSIONS: QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation.

Bone Neoplasms↗
PubMed2003

Prognostic implications of seizure recurrence in the first year after anterior temporal lobectomy.

PURPOSE: Seizure recurrence after anterior temporal lobectomy (ATL) incites concerns of whether seizures will eventually be successfully controlled. Our study evaluated the prognostic significance of seizure recurrence in the first year after ATL. METHODS: The postoperative courses of 175 consecutive patients who had undergone ATL and had > or =2 years of follow-up were studied. Recurrence was considered early if the first seizure occurred within 7 days after ATL and late if it occurred >7 days after ATL. Recurrent seizures were considered provoked when precipitating factors were present, such as interruption of antiepileptic drug (AED) intake. Subsequent outcome was determined at terminal follow-up. RESULTS: Percentage of excellent outcome was comparable between patients whose initial recurrent seizures were auras or simple partial seizures and patients without seizure recurrence in the first year (86.7 vs. 93.1%; p > or = 0.05). However, percentage of excellent outcome was less when the initial recurrent seizure was complex partial, either with or without secondary generalization (44.8%; p < or = 0.01). Outcome was not different between early and late seizure recurrence (excellent in 41.7 vs. 55.7%; p > or = 0.05). Nonetheless, patients with either early or late seizure recurrence were less likely to have excellent outcome than were patients with no seizure recurrence in the first year (p < or = 0.001). Percentage of excellent outcome was best when patients were seizure free in the first year (93.1%), intermediate when initial recurrent seizure was provoked (72.0%), and worst when unprovoked (27.8%) (p < or = 0.001). CONCLUSIONS: In the first postoperative year, the type of initial recurrent seizure, whether aura or complex partial and whether provoked or unprovoked, is associated with long-term prognosis in seizure control after ATL. The timing of the initial seizure recurrence is not as important.

Adolescent↗
PubMed2003

Evaluation of reconstruction windows for multislice computed tomography in quantification of coronary calcium.

RATIONALE AND OBJECTIVES: To search for an optimum reconstruction window in retrospectively gated multislice computed tomography (MSCT) for quantification of coronary calcium. MATERIALS AND METHODS: Coronary calcium quantified was examined as Agatston and volume scores by two experienced observers at 10 time points across the R-R interval of the electrocardiogram in 42 patients. A combination of statistical approaches was used to evaluate the distributions of minimum and maximum scores and of interobserver variability for both scoring methods across the cardiac cycle. RESULTS: Based on the combination of evaluation approaches, 60% to 70% of the R-R interval appeared to be the optimum time point for obtaining maximum calcium scores with minimum interobserver variability. The optimum time point was more clearly defined for the Agatston score than for the volume score. CONCLUSION: A reconstruction window beginning at 60% to 70% of the R-R interval seems to be most advantageous for retrospective gating of MSCT studies performed to quantify coronary calcium.

Adult↗
PubMed2003

Energy expenditure, sex, and endogenous fuel availability in humans.

Adipose tissue lipolysis supplies circulating FFAs, which largely meet lipid fuel needs; however, excess FFAs, can contribute to the adverse health consequences of obesity. Because "normal" FFA release has not been well defined, average (mean of 4 days) basal FFA release and its potential regulation factors were measured in 50 lean and obese adults (25 women). Resting energy expenditure (REE), but not body composition, predicted most of the interindividual variation in FFA release. There was a significant, positive linear relationship between palmitate release and REE; however, women released approximately 40% more FFA than men relative to REE. Neither plasma palmitate concentrations nor respiratory quotient by indirect calorimetry differed between men and women. Glucose release rates were not different in men and women whether related to REE or fat free mass. These findings indicate that nonoxidative FFA clearance is greater in women than in men. This could be an advantage at times of increased fuel needs. We conclude that "normal" adipose tissue lipolysis is different in men and women and that the fuel export role of adipose tissue in obesity will need to be reassessed.

Adipose Tissue↗
PubMed2003

The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid: the SYDNEY trial.

OBJECTIVE: Because alpha-lipoic acid (ALA), a potent antioxidant, prevents or improves nerve conduction attributes, endoneurial blood flow, and nerve (Na(+) K(+) ATPase activity in experimental diabetes and in humans and may improve positive neuropathic sensory symptoms, in this report we further assess the safety and efficacy of ALA on the Total Symptom Score (TSS), a measure of positive neuropathic sensory symptoms. RESEARCH DESIGN AND METHODS: Metabolically stable diabetic patients with symptomatic (stage 2) diabetic sensorimotor polyneuropathy (DSPN) were randomized to a parallel, double-blind study of ALA (600 mg) (n = 60) or placebo (n = 60) infused daily intravenously for 5 days/week for 14 treatments. The primary end point was change of the sum score of daily assessments of severity and duration of TSS. Secondary end points were sum scores of neuropathy signs (NIS), symptoms (NSC), attributes of nerve conduction, quantitative sensation tests (QSTs), and an autonomic test. RESULTS: At randomization, the groups were not significantly different by the criteria of metabolic control or neuropathic end points. After 14 treatments, the TSS of the ALA group had improved from baseline by an average of 5.7 points and the placebo group by an average of 1.8 points (P < 0.001). Statistically significant improvement from baseline of the ALA, as compared with the placebo group, was also found for each item of the TSS (lancinating and burning pain, asleep numbness and prickling), NIS, one attribute of nerve conduction, and global assessment of efficacy. CONCLUSIONS: Intravenous racemic ALA, a potent antioxidant, rapidly and to a significant and meaningful degree, improved such positive neuropathic sensory symptoms as pain and several other neuropathic end points. This improvement of symptoms was attributed to improved nerve pathophysiology, not to increased nerve fiber degeneration. Because of its safety profile and its effect on positive neuropathic sensory symptoms and other neuropathic end points, this drug appears to be a useful ancillary treatment for the symptoms of diabetic polyneuropathy.

Aged↗
PubMed2003

Apolipoprotein epsilon4 allele frequency in young Africans of Ugandan descent versus African Americans.

Through its role in lipid metabolism, Apolipoprotein epsilon4 (ApoE4) may affect "brain repair" in stroke, brain hemorrhage, Alzheimer's disease, and other brain injury syndromes for which African Americans may have greater morbidity and mortality. Cross-cultural evaluations of these and other genetic factors may provide insight on possible ethnic differences in risk of morbidity to acute central nervous system (CNS) injury and chronic neurodegenerative processes. As an initial step toward expanding knowledge of ApoE allele frequencies for persons of African descent, we compared ApoE genotype of a group of 70 young Ugandans to 59 (subset of a larger group of 342 African Americans of all ages) age-matched African Americans and to published frequencies for Caucasians and Asians. We found that the ApoE4 and epsilon2 alleles are more frequent in Ugandans (U) than Caucasians (C) or Asians (A) with corresponding alleles showing significant elevations of epsilon2 (U 15.71%, C 8.40%, A 4.20%) and 14 (U 25%, C 13.70%, A 8.90%) (p < .001). Comparing the differences between Ugandans and age-appropriate African Americans (AA) was not statically significant, but this outcome may be due to small sample size. These results provide the only published ApoE frequencies for Ugandans and the complete set of data provides the largest published community group of ApoE frequencies for African Americans.

Adult↗
PubMed2002

Acute symptoms, not rectally administered sucralfate, predict for late radiation proctitis: longer term follow-up of a phase III trial--Trans-Tasman Radiation Oncology Group.

PURPOSE: To assess the potential for sucralfate administered rectally to reduce the risk of late rectal morbidity in patients undergoing nonconformal radiotherapy (RT) for carcinoma of the prostate and to study the variables potentially contributing to late rectal morbidity and particularly to explore the relationship between acute and late toxicity. METHODS AND MATERIALS: Eighty-six patients with localized prostate carcinoma were randomized in a double-blind, placebo-controlled study to a daily enema of 3 g of sucralfate in a 15-mL suspension or the same suspension without sucralfate. The enema began the first day of RT and was continued for 2 weeks after treatment completion. The primary end point of the study was acute Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) toxicity; however, the patients were followed for an additional 5 years on a 6-month basis. The evaluation included late RTOG/EORTC toxicity and a patient self-assessment questionnaire. RESULTS: With a median follow-up of 5 years, the Kaplan-Meier probability of late Grade 2 RTOG/EORTC toxicity was 12% (95% confidence interval [CI] 2-22%) for placebo and 5% (95% CI 0-12%) for sucralfate (p = 0.26). The probability of late rectal bleeding was 59% (95% CI 45-73%) for placebo and 54% (95% CI 40-68%) for sucralfate. No statistically significant difference was found between the treatment arms for the peak incidence of any of the other patient self-assessment variables. Cox proportional hazards modeling indicated acute RTOG/EORTC toxicity of Grade 2 or greater was associated with a hazard ratio of 2.74 (95% CI 1.31-5.73) for the development of late toxicity of Grade 1 or greater. Substituting the patient self-assessment variables for acute RTOG/EORTC toxicity revealed that rectal pain of a moderate or severe grade during RT was the best predictor of the subsequent development of late toxicity, with a hazard ratio of 3.44 (95% CI 1.68-7). CONCLUSION: The results of this study do not support the use of sucralfate administered rectally as a method for reducing the late toxicity of nonconformal RT for prostate cancer. There appears to be an association between the development of acute and subsequent late toxicity, although the nature of this association remains to be determined.

Anti-Ulcer Agents↗
PubMed2002

A randomized, prospective, double-blinded evaluation of selective bowel decontamination in liver transplantation.

BACKGROUND: Bacterial infection is a frequent, morbid, and mortal complication of liver transplantation. Selective bowel decontamination (SBD) has been reported to reduce the rate of bacterial infection after liver transplantation in uncontrolled trials, but benefits of this intervention have been less clear in controlled studies. METHODS: Eighty candidates for liver transplantation were randomly assigned in a double-blinded fashion to an SBD regimen consisting of gentamicin 80 mg+polymyxin E 100 mg+nystatin 2 million units (37 patients) or to nystatin alone (43 patients). Both treatments were administered orally in 10 ml (increasing to 20 ml, according to predefined criteria), four times daily, through day 21 after transplantation. Anal fecal swab cultures were performed on days 0, 4, 7, and 21. Rates of infection, death, and charges for medical care were assessed from day 0 through day 60. RESULTS: More than 85% of patients in both treatment groups began study treatment more than 3 days before transplantation. Rates of infection (32.4 vs. 27.9%), death (5.4 vs. 4.7%), or charges for medical care (median $194,000 vs. $163,000) were not reduced in patients assigned to SBD. On days 0, 4, 7, and 21, growth of aerobic gram-negative flora in fecal cultures of patients assigned to SBD was significantly less than that of patients taking nystatin alone; growth of aerobic gram-positive flora, anaerobes, and yeast was not significantly different. CONCLUSION: Routine use of SBD in patients undergoing liver transplantation is not associated with significant benefit.

Colistin↗
PubMed2002

Electronic case-report forms of symptoms and impairments of peripheral neuropathy.

BACKGROUND AND OBJECTIVE: For the conduct of controlled clinical trials, epidemiologic surveys or even of medical practice of varieties of peripheral neuropathy, the usefulness, error rate and cost-effectiveness of scannable case-report forms has not been studied. MATERIALS AND METHODS: The overall performance, the frequency of the problems identified and corrected, and the time saved from use of a standard paper case report form was evaluated in multicenter treatment trials, single center epidemiologic surveys and in our neurologic practice. The paper case report form (Clinical Neuropathy Assessment [CNA]) for pen entry at study medical centers for patient, disease and demographic information (Lower Limb Function [LLF] and Neuropathy Impairment Score [NIS]) can be faxed to a core Reading and Quality Assurance Center where the form and data is electronically and interactively evaluated and corrected, if needed, by participating medical centers before electronic entry into database. OBSERVATIONS AND CONCLUSIONS: 1) The approach provides a standard, scannable paper case report form for pen entry of neuropathy symptoms, impairments and disability at the bedside or in the office which is retained as a source document at the participating medical center but a facsimile can be transferred instantaneously, its data can be programmed, interactively evaluated, modified and stored while maintaining an audit trail; 2) it allowed efficient and accurate reading, transfer, analysis, and storage of data of more than 15,000 forms used in multicenter trials; 3) in 500 consecutive CNA evaluations, software programs identified and facilitated interactive corrections of omissions, discrepancies, and disease and study inconsistencies, introducing only a few readily identified and corrected entry errors; and 4) use of programmed, as compared to non-programmed assessment, was more accurate than double keyboard entry of data and was approximately five times faster.

Canada↗
PubMed2002

Clinical versus quantitative vibration assessment: improving clinical performance.

In 3 large cohorts (total of 787 patients), clinical vibration impairment (CVI) of the great toe using a tuning fork was compared with quantitative vibration threshold (QVT). Using a stepwise multivariate analysis, we assessed demographic and anthropomorphic patient characteristics associated with the difference between CVI and QVT for the various cohorts and the chosen QVT ranges of percentile abnormality. We also compared CVI or QVT abnormality with a composite score of nerve conduction abnormality to confirm that QVT is a valid measure of severity of neuropathy. Highly significant associations between CVI and QVT were found in all 3 cohorts studied, regardless of the chosen QVT percentile level of abnormality. However, in the 2 cohorts evaluated by many different physicians, CVI overestimated QVT much more often than underestimated it. The discordance between CVI and QVT in all QVT abnormality percentile levels was associated with age, height and body surface area (BSA) in 1 cohort, with age and BSA in another cohort, and with age in the third cohort. In the third cohort, the correlation between QVT and the composite score of nerve conduction abnormality was significantly higher than the correlation between CVI and the composite score. Using a tuning fork, neuromuscular physicians overestimate vibration sensation loss more often than when QVT testing is done, which employs quantitative stimuli, a broad range of stimulus magnitudes, null stimuli, validated algorithms of testing and validated reference values. To improve assessment of vibration sensation, physicians should take into account age, height and weight (or body surface area) when judging vibration abnormalities. Applying some useful approaches to quantitative sensory testing might improve the accuracy of clinical sensory testing.

Adult↗
PubMed2002

Nutritional problems in end-stage liver disease: contribution of impaired gastric emptying and ascites.

GOALS: To evaluate gastric emptying before and after paracentesis in patients with cirrhosis. BACKGROUND: Patients with ascites often report early satiety. The effect of paracentesis on gastric emptying has not been studied previously. STUDY: Twelve patients who required therapeutic paracentesis were studied (mean age, 57 years; range, 47-69 years). Gastric emptying was performed with radionuclide scintigraphy. Satiety was evaluated with a visual analogue scale. Wilcoxon signed-rank tests were used for comparison between pre-and poststudies. RESULTS: The causes of cirrhosis included alcohol (seven patients), a combination of alcohol and hepatitis C (two), chronic hepatitis C only (one), primary biliary cirrhosis (one), and cryptogenic (one). The median volume of ascitic fluid removed at paracentesis was 5,450 mL (range, 2,500-7,200 mL). Median 2-hour gastric emptying was 65.5% before paracentesis and 61.5% after ( p > 0.05). Median 4-hour gastric emptying was 92.5% before paracentesis and 96.5% after ( p > 0.05). Both satiety score and caloric intake were significantly improved after paracentesis ( p < 0.05). CONCLUSIONS: Although satiety and calorie intake improve after large-volume paracentesis in patients with cirrhosis, these changes do not seem to correspond with improved gastric emptying. Therefore, other mechanisms most likely contribute to satiety.

Aged↗
PubMed2002

Comparative diagnostic utility of different MR modalities in mild cognitive impairment and Alzheimer's disease.

This study compares the diagnostic accuracy of magnetic resonance (MR)-based hippocampal volumetry, single voxel (1)H MR spectroscopy ((1)H MRS) and MR diffusion-weighted imaging (DWI) measurements in discriminating patients with amnestic mild cognitive impairment (MCI), Alzheimer's disease (AD) and normally aging elderly. Sixty-one normally aging elderly, 24 MCI and 22 AD patients underwent MR-based hippocampal volumetry, (1)H MRS and DWI. (1)H MRS voxels were placed over both of the posterior cingulate gyri, and N-acetyl aspartate (NAA)/creatine (Cr), myoinositol (MI)/Cr and NAA/MI ratios were obtained. Apparent diffusion coefficient (ADC) maps were derived from DWI, and hippocampal borders were traced to measure hippocampal ADC. At 80% specificity, the most sensitive single measurement to discriminate MCI (79%) and AD (86%) from controls was hippocampal volumes. The most sensitive single measurement to discriminate AD from MCI was posterior cingulate gyrus NAA/Cr (67%). At high specificity (>85-90%), combinations of MR measures had superior diagnostic sensitivity compared with any single MR measurement for the AD vs. control and control vs. MCI comparisons. The MR measures that best discriminate more from less affected individuals along the cognitive continuum from normal to AD vary with disease severity. Selection of imaging measures used for clinical assessment or monitoring efficiency of therapeutic intervention should be tailored to the clinical stage of the disease.

Aged↗
PubMed2002

Effect of "ionized" wrist bracelets on musculoskeletal pain: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To assess objectively the perceived benefits of wearing an "ionized" wrist bracelet to treat muscle or joint pain. SUBJECTS AND METHODS: This study was performed at the Mayo Clinic in Jacksonville, Fla, in 2000 and 2001. In a randomized, double-blind design, 305 participants wore an ionized bracelet and 305 wore a placebo bracelet for 4 weeks. For each location where pain was present at baseline, participants rated the intensity of pain. Follow-up ratings were made after 1, 3, 7, 14, 21, and 28 days of wearing the bracelet. Two primary end points were defined for evaluating efficacy. The first was the change at 4-week follow-up (day 28) in the pain score at the location with the highest baseline value (maximum pain score). The second was the change at 4-week follow-up in the sum of the pain scores for all locations. RESULTS: Analysis of the data showed significant improvement in pain scores in both groups, but no differences were observed between the group wearing the placebo bracelet and the group wearing the ionized bracelet. CONCLUSION: The finding that subjective improvement in pain scores was equivalent with ionized and placebo bracelet use questions the benefit of using an ionized bracelet. New treatments in alternative medical therapy must be shown to be effective through vigorous, unbiased, objective testing before physicians acknowledge potential benefits or recommend these treatments to patients.

Adolescent↗