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1.  Non-Cancer Life Stressors Contribute to Impaired Quality of Life in Ovarian Cancer Patients 
Gynecologic oncology  2013;131(3):10.1016/j.ygyno.2013.09.025.
OBJECTIVES
Diagnosis and treatment for a life threatening illness such as cancer is known to be psychologically impactful. However, little is known about the influence that non-cancer life stressors have on the quality of life (QOL) of ovarian cancer patients. The goal of the present study was to examine associations between non-cancer life stressors and QOL in 123 women with invasive epithelial ovarian cancer who were followed prospectively and longitudinally for one year.
METHODS
Mixed models for repeated measures were used to examine the relationship between life stressors and QOL pre-surgery and one year later, while adjusting for age, cancer stage, depressive symptoms, anxiety, and chemotherapy status (at one year). Prospective associations between QOL pre-surgery and one-year QOL were also examined.
RESULTS
Number and severity of life stressors were unrelated to QOL of participants before surgery. At one year, however, participants experiencing a greater number of life stressors reported poorer concurrent physical well-being (PWB) (p = 0.015), functional well-being (FWB) (p < 0.0001), social well-being (SWB) (p = 0.0003), and total QOL (p<0.0001). Similar effects were found for life event severity. Finally, experiencing a greater number of life stressors pre-surgery predicted poorer overall QOL one year post-diagnosis (p < 0.0001).
CONCLUSIONS
Non-cancer life stressors can substantially impact long-term QOL of ovarian cancer patients, adjusting for medical variables such as chemotherapy and cancer stage, thus highlighting the importance of evaluating the stress burden of patients in ongoing cancer care.
doi:10.1016/j.ygyno.2013.09.025
PMCID: PMC3882020  PMID: 24096110
ovarian cancer; life stress; life events; quality of life; depression; anxiety
2.  LONG TERM EFFICACY OF BIOFEEDBACK THERAPY FOR DYSSYNERGIA -RANDOMIZED CONTROLLED TRIAL 
Objectives
Although biofeedback therapy is effective in the short term management of dyssynergic defecation, its long term efficacy is unknown. Our aim was to compare the one year outcome of biofeedback (manometric- assisted pelvic relaxation, and simulated defecation training), with standard therapy (diet, exercise, laxatives) in patients who completed 3 months of either therapy.
Methods
Stool diaries, visual analog scales (VAS), colonic transit, anorectal manometry, and balloon expulsion time were assessed at baseline, and at one year after each treatment. All subjects were seen at 3 month intervals and received reinforcement. Primary outcome measure (ITT analysis) was a change in the number of complete spontaneous bowel movements (CSBM) per week. Secondary outcome measures included bowel symptoms, changes in dyssynergia and anorectal function.
Results
Of 44 eligible patients with dyssynergic defecation, 26 agreed to participate in the long term study. All 13 subjects who received biofeedback, and 7 of 13 who received standard therapy completed one year; 6 failed standard therapy. The number of CSBMs/week increased significantly (p<0.001) in the biofeedback but not in the standard group. Dyssynergia pattern normalized (p<0.001), balloon expulsion time improved (p=0.0009), defecation index increased (p<0.001) and colonic transit time normalized (p=0.01) only in the biofeedback group.
Conclusions
Biofeedback therapy provided sustained improvement of bowel symptoms and anorectal function in constipated subjects with dyssynergic defecation while standard therapy was largely ineffective.
doi:10.1038/ajg.2010.53
PMCID: PMC3910270  PMID: 20179692
Biofeedback therapy; constipation; dyssynergia; anorectal function; treatment
3.  Active choice but not too active: Public perspectives on biobank consent models 
Purpose
Despite important recent work, US public attitudes toward specific biobank consent models are not well understood. Public opinion data can help shape efforts to develop ethically sound and publicly trusted mechanisms for informing and consenting prospective biobank donors. The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks.
Methods
The study used an exploratory mixed-methods design, using focus groups and telephone surveys. Eligible participants were English-speaking residents in the catchment area of a comprehensive biobank being developed at the University of Iowa.
Results
Forty-eight participants in seven focus groups and 751 survey participants were recruited. Biobanks were unfamiliar to almost all study participants but were seen as valuable resources. Most focus group (63%) and survey (67%) participants preferred a prospective opt-in over an opt-out consent approach. Broad, research-unspecific consent was preferred over categorical and study-specific consent models for purposes of approving future research use.
Conclusion
Many individuals may want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result.
doi:10.1097/GIM.0b013e31821d2f88
PMCID: PMC3658114  PMID: 21555942
biobank; consent models; public perspectives
4.  Variants of the Serotonin Transporter Gene, Selective Serotonin Reuptake Inhibitors, and Bone Mineral Density in Risperidone-Treated Boys: A Reanalysis of Data From a Cross-Sectional Study With Emphasis on Pharmacogenetics 
The Journal of clinical psychiatry  2011;72(12):1685-1690.
Objective
Selective serotonin reuptake inhibitors (SSRIs) may reduce bone mineral density (BMD). Here, we investigate whether variants of the serotonin transporter-linked polymorphic region (5-HTTLPR) of the serotonin transporter gene moderate this association in boys.
Method
Between November 2005 and August 2009, medically healthy boys, aged 7 to 17 years, were enrolled in a cross-sectional study exploring the effect of risperidone-induced hyperprolactinemia on BMD. Volumetric BMD of the ultradistal radius was measured using peripheral quantitative computed tomography, and areal BMD of the lumbar spine was estimated using dual energy x-ray absorptiometry. Multiple linear regression analysis tested whether the 5-HTTLPR genotypes interacted with SSRI treatment status to affect BMD, adjusting for relevant confounders. Participant enrollment was conducted at the University of Iowa, Iowa City.
Results
Of 108 boys (mean ± SD age = 11.7 ± 2.8 years), with DSM-IV clinical diagnoses based on chart review, 52% (n = 56) had been taking an SSRI for a median duration of 2.8 years. After adjusting for pubertal development, anthropometric measures, physical activity, calcium intake, and prolactin concentration, there was a significant 5-HTTLPR genotype × SSRI treatment interaction effect on total lumbar spine BMD z score (P < .05) in non-Hispanic whites. The interaction effect on BMD at the ultradistal radius failed to reach statistical significance. Among LS genotype carriers, those treated with SSRIs had lower lumbar BMD z score and trabecular BMD at the radius compared to those not treated (P < .02 and P < .008, respectively).
Conclusions
These findings add to the growing evidence implicating the serotonin system in bone metabolism. They suggest the potential use of 5-HTTLPR genotypes to guide the safer long-term prescribing of SSRIs in youths. However, prospective confirmation in a controlled matched population is warranted.
doi:10.4088/JCP.10m06198
PMCID: PMC3653135  PMID: 22244026
5.  Iron Status in Toddlerhood Predicts Sensitivity to Psychostimulants in Children 
Journal of attention disorders  2010;16(4):295-303.
Introduction
Iron deficiency is associated with impaired dopaminergic signaling and externalizing behavior. However, whether iron stores in toddlerhood influence later response to psychostimulants is unknown.
Methods
Youths participating in a study monitoring the long-term safety of risperidone were included in this analysis if they had received psychostimulant monotherapy for at least 3 weeks and had a complete blood count obtained prior to psychostimulant treatment. Sensitivity to psychostimulants was defined based on the weight-adjusted dose during the first year of treatment. Regression analysis examined whether the hematological tests based on the characteristics of red blood cells were associated with sensitivity to psychostimulants.
Results
Twenty nine participants (93% males, 76% Caucasians), primarily with ADHD (93%), comprised the current sample. The hematological tests were obtained, on average, 3 years before the initiation of psychostimulants monotherapy which occurred at 5.8 years of age and continued for a median of 0.85 years, at an average daily dose of 0.98 mg/kg (SD=0.38) in methylphenidate-equivalent. Compared to those that were poorly sensitive to psychostimulants, after adjusting for age, mean corpuscular volume was significantly higher in the highly and moderately sensitive groups.
Conclusions
If replicated, our findings suggest that more attention should be paid to optimizing body iron in early childhood.
doi:10.1177/1087054710385067
PMCID: PMC3556512  PMID: 20978274
6.  A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids for Inhibition of Supraventricular Arrhythmias After Cardiac Surgery: The FISH Trial 
Background
Omega-3 polyunsaturated fatty acids (n3-PUFAs) might have antiarrhythmic properties, but data conflict on whether n3-PUFAs reduce rates of atrial fibrillation (AF) after coronary artery bypass graft surgery (CABG). We hypothesized that n3-PUFAs would reduce post-CABG AF, and we tested this hypothesis in a well-powered, randomized, double-blind, placebo-controlled, multicenter clinical trial.
Methods and Results
Patients undergoing CABG were randomized to pharmaceutical-grade n3-PUFAs 2 g orally twice daily (minimum of 6 g) or a matched placebo ≥24 hours before surgery. Gas chromatography was used to assess plasma fatty acid composition of samples collected on the day of screening, day of surgery, and postoperative day 4. Treatment continued either until the primary end point, clinically significant AF requiring treatment, occurred or for a maximum of 2 weeks after surgery. Two hundred sixty patients were enrolled and randomized. Before surgery, n3-PUFA dosing increased plasma n3-PUFA levels from 2.9% to 4% and reduced the n6:n3-PUFA ratio from 9.1 to 6.4 (both P<0.001). Similar changes were noted on postoperative day 4. There were no lipid changes in the placebo group. The rate of post-CABG AF was similar in both groups (30% n3-PUFAs versus 33% placebo, P=0.67). The post-CABG AF odds ratio for n3-PUFAs relative to placebo was 0.89 (95% confidence interval 0.52–1.53). There were no differences in any secondary end points.
Conclusions
Oral n3-PUFA supplementation begun 2 days before CABG did not reduce AF or other complications after surgery.
Clinical Trial Registration
url: http://www.clinicaltrials.gov Unique identifier: NCT00446966. (J Am Heart Assoc. 2012;1:e000547 doi: 10.1161/JAHA.111.000547.)
doi:10.1161/JAHA.111.000547
PMCID: PMC3487324  PMID: 23130134
fatty acids; coronary artery bypass graft surgery; atrial fibrillation
7.  Correlates of weight gain during long-term risperidone treatment in children and adolescents 
Background
Most clinical trials of antipsychotics in children are brief, failing to address their long-term safety, particularly when taken concurrently with other psychotropics. This hypothesis-generating analysis evaluates potential correlates of weight gain in children receiving extended risperidone treatment.
Methods
Medically healthy 7–17 year-old patients treated with risperidone for six months or more were enrolled. Anthropometric measurements were conducted. Developmental and medication history was obtained from the medical record. Information related to birth weight, dietary intake, physical activity, and parental weight was collected. Mixed regression analyses explored the contribution of various demographic and clinical factors to age- and sex-adjusted weight and body mass index (BMI) z scores over the treatment period.
Results
The sample consisted of 110 patients (89% males) with a mean age of 11.8 years (sd = 2.9) upon enrollment. The majority had an externalizing disorder and received 0.03 mg/kg/day (sd = 0.02) of risperidone, for 2.5 years (sd = 1.7), to primarily target irritability and aggression (81%). Polypharmacy was common with 71% receiving psychostimulants, 50% selective serotonin reuptake inhibitors (SSRIs), and 32% α2-agonists. Weight and BMI z score were positively correlated with baseline weight at the start of risperidone, treatment duration, and the weight-adjusted dose of risperidone but inversely associated with the weight-adjusted dose of psychostimulants and the concurrent use of SSRIs and α2-agonists. The effect of risperidone dose appeared to attenuate as treatment extended while that of psychostimulants became more significant. The rate of change in weight (or BMI) z score prior to and within the first 12 weeks of risperidone treatment did not independently predict future changes neither did birth weight, postnatal growth, dietary intake, physical activity, or parental weight.
Conclusions
This comprehensive analysis exploring correlates of long-term weight (or BMI) change in risperidone-treated youths revealed that pharmacotherapy exerts significant but complex effects.
Trial Registration
Not applicable.
doi:10.1186/1753-2000-6-21
PMCID: PMC3489823  PMID: 22643087
Child; Adolescent; Weight gain; Obesity; Antipsychotics; Risperidone; Predictors
8.  Relationship between HER-2 overexpression and brain metastasis in esophageal cancer patients 
AIM: To study if HER-2 overexpression by locally advanced esophageal cancers increase the chance of brain metastasis following esophagectomy.
METHODS: We retrospectively reviewed the medical records of esophageal cancer patients who underwent esophagectomy at University of Iowa Hospitals and Clinics between 2000 and 2010. Data analyzed consisted of demographic and clinical variables. The brain metastasis tissue was assayed for HER-2 overexpression utilizing the FDA approved DAKO Hercept Test®.
RESULTS: One hundred and forty two patients were reviewed. Median age was 64 years (36-86 years). Eighty eight patients (62%) received neoadjuvant chemoradiotherapy. Pathological complete and partial responses were achieved in 17 (19%) and 71 (81%) patients. Cancer relapsed in 43/142 (30%) patients. The brain was the first site of relapse in 9/43 patients (21%, 95% CI: 10%-36%). HER-2 immunohistochemistry testing of the brain metastasis tissue showed that 5/9 (56%) cases overexpressed HER-2 (3+ staining).
CONCLUSION: HER-2 overexpression might be associated with increased risk of brain metastasis in esophageal cancer patients following esophagectomy. Further studies will be required to validate this observation.
doi:10.4251/wjgo.v4.i5.103
PMCID: PMC3360103  PMID: 22645633
Esophageal neoplasm; Esophageal cancer; HER-2; Genes, erbB-2; Brain Neoplasms; Brain metastasis
9.  Diurnal Cortisol Dysregulation, Functional Disability, and Depression in Women With Ovarian Cancer 
Cancer  2010;116(18):4410-4419.
BACKGROUND
Multiple alterations in circadian rhythms have been observed in cancer patients, including the diurnal rhythm of the adrenal hormone cortisol. Diurnal cortisol alterations have been associated with cancer-related physiological processes as well as psychological stress. Here we investigate alterations in diurnal cortisol rhythm in ovarian cancer patients, and potential links with depression, life stress, and functional disability.
METHODS
Women (n = 177) with suspected ovarian cancer completed questionnaires and collected salivary cortisol 3× daily for 3 consecutive days before surgery. One hundred women were subsequently diagnosed with ovarian cancer and 77 with benign disease. In addition, healthy women (n = 33) not scheduled for surgery collected salivary cortisol at the same time points.
RESULTS
Ovarian cancer patients demonstrated significantly elevated nocturnal cortisol (P = .022) and diminished cortisol variability (P = .023) compared with women with benign disease and with healthy women (all P values <.0001). Among ovarian cancer patients, higher levels of nocturnal cortisol and less cortisol variability were significantly associated with greater functional disability, fatigue, and vegetative depression, but not with stress, distress, or depressed affect. There were no significant associations between functional or psychological variables and diurnal cortisol in women with benign disease.
CONCLUSIONS
Nocturnal cortisol and cortisol variability show significant dysregulation in ovarian cancer patients, and this dysregulation was associated with greater functional disability, fatigue, and vegetative depression. These findings suggest potential hypothalamic-pituitary-adrenal involvement in functional disability in ovarian cancer, and may have implications for disease progression.
doi:10.1002/cncr.25299
PMCID: PMC3118555  PMID: 20564155
cortisol; ovarian cancer; diurnal rhythm; fatigue; functional disability; depression; stress
10.  A Cross-sectional Evaluation of the Effect of Risperidone and Selective Serotonin Reuptake Inhibitors on Bone Mineral Density in Boys 
Objective
The aim of the present study was to investigate the effect of risperidone-induced hyperprolactinemia on trabecular bone mineral density (BMD) in children and adolescents.
Methods
Medically healthy 7–17yo males chronically treated, in a naturalistic setting, with risperidone were recruited through child psychiatry outpatient clinics between November 2005 and June 2007. Anthropometric measurements and laboratory testing were conducted. Developmental and treatment history was obtained from the medical record. Volumetric BMD of the ultra-distal radius was measured using peripheral quantitative computerized tomography and areal BMD of the lumbar spine was estimated using dual energy X-ray absorptiometry.
Results
Hyperprolactinemia was present in 49% of 83 boys (n=41) treated with risperidone for an average of 2.9 years. Serum testosterone concentration increased with pubertal status but was not affected by hyperprolactinemia. As expected, bone mineral content and BMD increased with sexual maturity. After adjusting for the stage of sexual development, height and BMI Z-scores, serum prolactin was negatively associated with trabecular volumetric BMD at the ultra-distal radius (p<0.03). Controlling for relevant covariates, we also found treatment with selective serotonin reuptake inhibitors (SSRIs) to be associated with lower trabecular BMD at the radius (p=0.03) and BMD Z-score at the lumbar spine (p<0.05). These findings became more marked when the analysis was restricted to non-Hispanic Caucasians. Of 13 documented fractures, only two occurred after risperidone and SSRIs were started and none in patients with hyperprolactinemia.
Conclusions
This is the first study to link risperidone-induced hyperprolactinemia and SSRI treatment to lower BMD in children and adolescents. Future research should evaluate the longitudinal course of this adverse event to determine its temporal stability and whether a higher fracture rate ensues.
doi:10.4088/JCP.08m04595gre
PMCID: PMC2845988  PMID: 20331935
11.  Leptin promoter -2548G/A variants predict risperidone-associated weight gain in children and adolescents 
Psychiatric genetics  2009;19(6):320-327.
Objective
As the use of atypical antipsychotics in children and adolescents has increased, concerns have been raised about their long-term safety. We aimed to investigate the association between risperidone-induced weight gain, leptin concentration, and the leptin gene (LEP) -2548G/A variants in youths.
Methods
Medically healthy 7-17yo children and adolescents, in extended naturalistic treatment with risperidone, were recruited through pediatric psychiatry clinics. Anthropometric measures and laboratory testing were conducted. Growth and medication history was obtained from the medical record. The effect of the LEP genotypes on leptin concentration and on the slopes of the weight and body mass index (BMI) z score curves before and after the onset of risperidone treatment was investigated.
Results
In 74 subjects, chronically treated with risperidone, the A allele was associated with higher leptin concentration at low weight and BMI z scores. There was no effect of the LEP genotypes on weight or BMI z scores before risperidone was started. Afterwards, however, the A allele carriers showed a steeper rate of increase in weight and BMI z scores. As a result, the GG genotype carriers were 2.5 times less likely to be overweight/obese (i.e. having a BMI above the 85th percentile). This genetic effect on risperidone-associated weight gain did not extend to weight loss related to psychostimulants.
Conclusions
The LEP -2548G/A variants appear to moderate the weight-altering effect of risperidone but not psychostimulants. This may be related to genetic differences in tissue sensitivity to leptin, resulting in differential body composition.
PMCID: PMC2919234  PMID: 19873684
Leptin gene; Antipsychotics; Weight Gain; Children; Adolescents; Variants; Predictors
12.  Glucose as a prognostic factor in ovarian carcinoma 
Cancer  2009;115(5):1021-1027.
Background
Research suggests that glucose levels in cancer patients may be an important prognostic indicator. In ovarian tumors, increased expression of GLUT1, a transmembrane protein responsible for glucose uptake, is related to shorter survival time in ovarian cancer patients. This study tested the hypothesis that higher pre-surgical glucose levels predict shorter disease-specific survival time and time to recurrence in ovarian cancer patients.
Methods
Non-fasting plasma glucose levels were determined for 74 patients with ovarian cancer at the time of their pre-surgical consultation and for 125 ovarian cancer patients in an independent validation set. Survival time and time to recurrence (disease free interval--DFI) were ascertained from medical records. Cox proportional hazards regression models were used to estimate the hazard ratio (HR) for survival time and DFI in relation to glucose level, adjusting for body mass index, stage, grade, and cytoreduction as appropriate.
Results
Higher glucose levels were associated with shorter survival times in univariate analyses (HR, 1.88; P = 0.05). Multivariate analysis adjusting for stage showed that higher glucose levels were associated with shorter survival times (HR, 2.01; P = 0.04) and DFI (HR, 2.32; P = 0.05). In the validation set, higher glucose levels were associated with shorter survival times (HR, 2.01; P = 0.02) and DFI (HR, 2.48; P = 0.001) in univariate analysis, although glucose was not independent of the effect of cytoreduction when predicting survival time in this latter set.
Conclusion
These findings contribute to mounting evidence that glucose levels have prognostic value in ovarian carcinoma.
doi:10.1002/cncr.24126
PMCID: PMC2649990  PMID: 19156916
glucose; cancer; ovarian cancer; prognosis; recurrence; survival rate
13.  Clinical Trial: Effects of Botulinum Toxin on Levator Ani Syndrome: A Double Blind, Placebo Controlled Study 
Background
Levator ani syndrome is characterized by anorectal discomfort/pain, whose treatment is unsatisfactory. We hypothesized that Botulinum toxin relieves spasm and improves symptoms.
Aim
Randomized, placebo-controlled, crossover study to examine efficacy and safety of botulinum toxin.
Methods
Twelve patients with levator ani syndrome (≥ 1year) received anal intra sphincteric injections of 100 units botulinum toxin A and placebo at 90 day intervals using EMG guidance. Daily frequency, severity, duration, and intensity of pain (VAS) were recorded. Anorectal manometry, balloon expulsion, and pudendal nerve latency tests were performed to examine the physiological changes and adverse effects.
Results
Seven patients (male/female = 4/3) completed and three had incomplete data, but all ten were analyzed in an ITT analysis; two others dropped out. After botulinum toxin, the mean frequency, intensity, and duration of pain was unchanged (p=0.31) compared to baseline. The 90 day mean VAS pain score was 6.79 ± 0.27 versus baseline score of 7.08 ± 0.29 (p=0.25). Anal sphincter pressures, rectal sensory thresholds pudendal nerve latency and balloon expulsion times were unchanged after drug or placebo.
Conclusions
Injection of botulinum toxin into anal sphincter is safe but does not improve anorectal pain in levator ani syndrome.
doi:10.1111/j.1365-2036.2009.03964.x
PMCID: PMC2730637  PMID: 19222415
Botulinum toxin; Levator Ani Syndrome; Anorectal Pain; Anorectal Manometry
14.  Depressed and anxious mood and T-cell cytokine expressing populations in ovarian cancer patients 
Brain, behavior, and immunity  2008;22(6):890-900.
The adaptive immune response of ovarian cancer patients has been linked to survival, and is known to be impaired in the tumor microenvironment. Little is known about relationships between biobehavioral factors such as depressed mood and anxiety and the adaptive immune response in ovarian cancer. Thirty-seven patients with epithelial ovarian cancer and 14 patients with benign neoplasms completed psychosocial questionnaires pre-surgery. Lymphocytes from peripheral blood, tumor, and ascites (fluid around the tumor), were obtained on the day of surgery. Expression of the Type-1 cytokine interferon gamma (IFNγ), and the Type-2 cytokine interleukin-4 (IL-4) by T-helper (CD4+) and T-cytotoxic (CD8+) cells was measured under autologous tumor-stimulated, polyclonally-stimulated, or unstimulated conditions. Links with mood were examined. Among cancer patients, marked elevations in unstimulated and tumor-stimulated Type-2 responses were seen, particularly in ascites and tumor-infiltrating lymphocytes (P values < 0.01). With polyclonal stimulation, lymphocytes from all compartments expressed elevated Type-1 cytokines (P values <0.014). Depressed and anxious mood were both associated with significantly lower ratios of polyclonally-stimulated CD4+ cells producing IFNγ (TH1 cells) vs. IL-4 (TH2 cells) in all compartments (depressed mood: P = 0.012; anxiety: P = 0.038) and depressed mood was also related to lower ratios of polyclonally-stimulated CD8+ cells producing IFNγ (TC1) vs. IL-4 (TC2) (P =0.035). Although effects of polyclonal stimulation should be generalized with caution to the in vivo immune response, findings suggest that depressed and anxious mood are associated with greater impairment of adaptive immunity in peripheral blood and in the tumor microenvironment among ovarian cancer patients.
doi:10.1016/j.bbi.2007.12.012
PMCID: PMC2605940  PMID: 18276105
Ovarian cancer; Cytokines; Depressed mood; anxiety; Psychoneuroimmunology; T-cell response, distress, tumor microenvironment
15.  COMPARABLE EFFECTIVENESS OF CAUDAL VS. TRANS-FORAMINAL EPIDURAL STEROID INJECTIONS 
Study Design: Retrospective case-control study.
Objective: To compare the effectiveness between caudal and trans-foraminal epidural steroid injections for the treatment of primary lumbar radiculopathy.
Summary of Background Data: Spinal injections with steroids play an important role in non-operative care of lumbar radiculopathy. The trans-foraminal epidural steroid injection (TESI) theoretically has a higher success rate based on targeted delivery to the symptomatic nerve root. To our knowledge, these results have not been compared with other techniques of epidural steroid injection.
Methods: 93 patients diagnosed with primary lumbar radiculopathy of L4, L5, or SI were recruited for this study: 39 received caudal epidural steroid injections (ESI) and 54 received trans-foraminal epidural steroid injections (TESI). Outcomes scores included the SF-36, Oswestry disability index (ODI) and pain visual analogue scale (VAS), and were recorded at baseline, post-treatment (<6 months), long-term (>1 year). The average follow-up was 2 years, and 16 patients were lost to follow-up. The endpoint “surgical intervention” was a patient-driven decision, and considered failure of treatment. Intent-to-treat analysis, and comparisons included t-test, Chi-square, and Wilcoxon rank-sum test.
Results: Baseline demographics and outcomes scores were comparable for both treatment groups (ESI vs. TESI): (SF-36 PCS (32.3 ± 7.5 vs. 29.5 ± 8.9 respectively; p = 0.173), MCS (41.2 ± 12.7 vs. 41.1 ± 10.9, respectively; p = 0.971), and VAS (7.4 ±2.1 vs. 7.9 ± 1.2, respectively; p = 0.228)). Surgery was indicated for failure of treatment at a similar rate for both groups (41.0% vs. 44.4%, p=0.743). Symptom improvement was comparable between both treatment groups (ESI vs. TESI): SF-36 PCS improved to 42.0±11.8 and 37.7±12.3, respectively; p=0.49; ODI improved from 50.0±21.2 to 15.6±17.9and from 62.1±17.9 to 26.1±20.3, respectively (p=0.407).
Conclusions: The effectiveness of TESI is comparable to that of ESI (approximately 60%) for the treatment of primary lumbar radiculopathy. The increased complexity of TESI is not justified for primary cases, and may have a more specific role in recurrent disease or for diagnostic purposes.
PMCID: PMC2723700  PMID: 19742093
16.  Visual stimulus induced changes in human near-infrared fundus reflectance 
Purpose: Imaging studies from anesthetized cat, monkey and human retinas have revealed near-infrared fundus reflectance changes induced by visible light stimulation. Here, we characterize the spatial and temporal properties of similar changes in normal, awake humans.
Methods: 5 normal human subjects were studied. A modified fundus camera was used to image changes in retinal reflectance of 780nm near-infrared light imaged onto a 12 bit CCD camera in response to a green (540nm) visual stimulus. During 60s of recording (frame rate, 3Hz) 10 cycles were recorded, during each of which 3s of blank and then 3s of either vertical bar or blank stimulus was projected. The change in the average near-infrared reflectance of the stimulated retinal region relative to an equal sized non-stimulated region (ratio of reflectance between the two retinal areas=r) was analyzed with a mixed model for repeated measures.
Results: The mixed model showed a significant average decrease in r of 0.14% (95% CI, −0.25 to −0.03) over all subjects induced by bar stimulus cycles with a gradual return to baseline after stimulus offset compared to only 0.04% (95% CI, −0.11 to 0.20) decrease in r for blank non stimulated cycles,. The mixed model for individuals showed a decreasing linear trend in r over time during bar stimulation but no decrease for blank cycles in 3/5 subjects.
Conclusions: There exists a localized decrease in reflectance to 780nm near-infrared light in the retinal region exposed to a visual stimulus, which is significant in 3/5 subjects. It is presumed that the reflectance change represents the functional activity of the retina in response to a visual stimulus.
doi:10.1167/iovs.05-0008
PMCID: PMC1473026  PMID: 16431972

Results 1-16 (16)