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Jamal M.M.,Long Beach Medical Center | Jansen J.-P.,SZ Schmerzzentrum Berlin GmbH | Webster L.R.,PRA Health science
American Journal of Gastroenterology | Year: 2015

OBJECTIVES:This multicenter, phase 3 trial evaluated oral lubiprostone for constipation associated with non-methadone opioids in patients with chronic noncancer-related pain.METHODS:Adults with opioid-induced constipation (OIC; <3 spontaneous bowel movements "SBMs" per week) were randomized 1:1 to double-blind lubiprostone 24 μg or placebo twice daily for 12 weeks. The primary end point was the overall SBM response rate. Responders had at least moderate response (≥1 SBM improvement over baseline frequency) in all treatment weeks with available observed data, as well as full response (≥3 SBMs per week) for at least 9 of the 12 treatment weeks.RESULTS:In total, 431 patients were randomized; 212 each received lubiprostone and placebo, and 7 were not treated. Overall, the SBM response rate was significantly higher for patients treated with lubiprostone vs. placebo (27.1 vs. 18.9%, respectively; P=0.030). Overall mean change from baseline in SBM frequency was significantly greater with lubiprostone vs. placebo (3.2 vs. 2.4, respectively; P=0.001). The median time to first SBM was significantly shorter with lubiprostone vs. placebo (23.5 vs. 37.7 h, respectively; P=0.004). Compared with placebo, the patients treated with lubiprostone exhibited significant improvements in straining (P=0.004), stool consistency (P<0.001), and constipation severity (P=0.010). No significant differences were observed in quality-of-life measures or the use of rescue medication; however, the percentage of patients who used rescue medication was consistently lower in the lubiprostone group than in the placebo group at months 1 (34.9 vs. 37.7%), 2 (23.4 vs. 26.6%), and 3 (20.5 vs. 22.0%). Adverse events (AEs) >5% were diarrhea, nausea, vomiting, and abdominal pain (lubiprostone: 11.3, 9.9, 4.2, and 7.1%, respectively; placebo, 3.8, 4.7, 5.2, and 0%, respectively). None of the serious AEs (lubiprostone, 3.3%; placebo, 2.8%) were related to lubiprostone.CONCLUSIONS:Lubiprostone significantly improved symptoms of OIC and was well tolerated in patients with chronic noncancer pain. © 2015 by the American College of Gastroenterology.


Sanyal A.,Virginia Commonwealth University | Younossi Z.M.,Inova Fairfax Hospital | Bass N.M.,University of California at San Francisco | Mullen K.D.,Case Western Reserve University | And 8 more authors.
Alimentary Pharmacology and Therapeutics | Year: 2011

Background Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol-related liver disease, and is characterised by cognitive, psychiatric and motor impairments. Recurrent bouts of overt HE negatively impact daily functioning and quality of life. Aim To evaluate the effect of rifaximin on health-related quality of life (HRQL) in cirrhotic patients with HE. Methods Patients with cirrhosis in remission from HE (Conn score = 0 or 1) and a documented history of recurrent HE episodes (≥2 within 6 months of screening) were randomised to rifaximin 550 mg twice daily (N = 101) or placebo (N = 118) for 6 months. Concomitant lactulose was permitted during the study. The Chronic Liver Disease Questionnaire (CLDQ) was administered every 4 weeks, and time for occurrence of HE breakthrough was recorded. A longitudinal analysis using time-weighted averages of the CLDQ scores normalised by days on study therapy was used to evaluate the effect of treatment on HRQL, and between HE outcomes (HE recurrence, yes/no) irrespective of treatment. Results The time-weighted averages of the overall CLDQ score and each domain score were significantly higher in the rifaximin group vs. placebo (P-values ranged from 0.0087 to 0.0436); and were significantly lower in patients who experienced HE breakthrough compared to those who remained in remission (P-values were <0.0001). Conclusion Rifaximin significantly improved HRQL in patients with cirrhosis and recurrent hepatic encephalopathy. A lower HRQL may predict recurrence of hepatic encephalopathy. © 2011 Blackwell Publishing Ltd.


Patterson A.L.,Portland Medical Center | Morasco B.J.,Portland Medical Center | Morasco B.J.,Oregon Health And Science University | Fuller B.E.,Portland Medical Center | And 6 more authors.
General Hospital Psychiatry | Year: 2011

Objective: The objective of the study was to evaluate the validity of the Beck Depression Inventory-II (BDI-II) when used to measure depression in patients with hepatitis C virus (HCV). Method: Factor analysis was utilized to validate the BDI-II in a sample of 671 patients with HCV recruited from a large Veterans Affairs medical center. The data were split randomly: the first half was subjected to exploratory factor analysis, and confirmatory factor analysis was used with the second half to confirm the model. Diagnostic data were retrieved from the electronic medical records. Results: Subjects were 97.0% male, average age was 52.8 years, 16.1% had a cirrhosis diagnosis, 62.9% had a current major depressive disorder diagnosis, and 42.3% endorsed significant depressive symptoms on the BDI-II. A two-factor model was an excellent fit for the data; the factors were labeled Cognitive-Affective and Somatic. Patients scored significantly higher on the Somatic factor than on the Cognitive-Affective factor (P<001), and this discrepancy increased when comparing patients based on whether they had a diagnosis of cirrhosis. Conclusions: When screening for depression in HCV patients, questions targeting cognitive and affective symptoms of depression may provide a more valid measurement of depression than questions targeting somatic symptoms of depression, particularly for patients with more advanced liver disease. © 2011.


Ejskjaer N.,Aarhus University Hospital | Wo J.M.,Indiana University | Esfandyari T.,University of Kansas Medical Center | Mazen Jamal M.,Long Beach Medical Center | And 8 more authors.
Neurogastroenterology and Motility | Year: 2013

Background Gastroparesis causes significant morbidity and treatment options are limited. TZP-102 a novel, macrocyclic, selective, oral ghrelin receptor agonist, was evaluated in a randomized, double-blind, placebo-controlled trial in patients with diabetic gastroparesis. Methods A total of 92 outpatients were randomized to once-daily administrations of 10-mg (n=22), 20-mg (n=21), 40-mg (n=23) TZP-102 or placebo (n=26). The primary endpoint was the change from baseline in gastric half-emptying time (T1/2) utilizing 13C-breath test methodology and secondary endpoints included symptom improvement using patient-reported gastroparesis symptom scores (PAGI-SYM questionnaire) and patient and physician overall treatment evaluations (OTE). Key Results Gastric T1/2 changes were not statistically significant between TZP-102 and placebo after 28days of treatment at any dose. Clinical improvements (-1.0 to -1.4 point mean decrease in symptom severity) occurred in the Gastroparesis Cardinal Symptom Index (GCSI) component of the PAGI-SYM, which was significant vs placebo for all TZP-102 doses combined. Improvements became evident after 1week of treatment. Significantly, more patients given TZP-102 (any dose) had a 50% reduction in baseline GCSI score (28.8%vs 7.7% placebo). Safety profiles were similar across groups. All TZP-102 doses were well-tolerated with no adverse cardiac, weight, or glucose control outcomes. Conclusions & Inferences TZP-102 for 28days, at doses of 10-40mg once daily, was well-tolerated and resulted in a reduction in symptoms of gastroparesis. The lack of correlation between symptom improvement and gastric emptying change is consistent with previous studies in diabetic gastroparesis, and emphasizes the value of patient-defined outcomes in determining therapeutic benefit. © 2012 Blackwell Publishing Ltd.


Levin E.R.,University of California at Irvine | Levin E.R.,Long Beach Medical Center
Hormones and Cancer | Year: 2014

The existence and function of extranuclear steroid receptors (SR) to rapidly modulate signal transduction is now acknowledged as present in cells and organs throughout the body. Work over the past 15 years has defined key mechanisms that are required for sex steroid receptors to traffic to the plasma membrane, but mechanisms of localization in other cell organelles such as mitochondria is still unclear. Signaling by membrane-localized SR has now been reported to impact many aspects of adult organ functions, while the roles in organ development are under investigation. In hormone-responsive cancers, both extranuclear and nuclear sex steroid receptors appear to collaborate in the regulation of some key genes that promote malignancy. Here, I review what is understood about the impact of extranuclear steroid receptor signaling to mitigate or promote disease processes. © 2014 Springer Science+Business Media New York (outside the USA).


Spritzler F.,Long Beach Medical Center
Diabetes Spectrum | Year: 2012

Some patients want to try a low-carbohydrate eating pattern for various reasons, and, as clinicians, we should find ways to help patients safely and effectively achieve glycemic control. Although a low-carbohydrate diet may not be the best method for everyone, fors ome, it may be the key to finally achieving recommended blood glucose targets. Clinicians are recognizing that an "optimal" diet is one that is highly individualized; in the future, personalized nutrition may take individualization to a new level. Diabetes health care professionals must be open-minded and consider multiple options for diabetes management. The primary aim should be to collaborate with patients to assist them in meeting their goals in a way that works best for them.


Lambrecht N.W.G.,Long Beach Medical Center
Current Gastroenterology Reports | Year: 2011

Ménétrier's disease is a rare hyperproliferative protein-losing gastropathy of the gastric foveolar epithelium. Most common symptoms include epigastric pain with fullness and vomiting, and generalized peripheral edema with hypoalbuminemia. Radiologically, the wall of the gastric body and fundus is diffusely thickened, often with antral sparing. Giant rugal edematous folds are seen on gastroscopy, and histology of biopsy material shows diffuse foveolar hyperplasia with cystic dilatation of the glandular portion of the gastric mucosa in the absence of significant inflammatory infiltrate. The recent discovery of transforming growth factor α overexpression opens the way of epidermal growth factor receptor blockade with cetuximab as first-line treatment modality in severe cases of Ménétrier's disease. © 2011 Springer Science+Business Media, LLC (outside the USA).


McMaster W.C.,Long Beach Medical Center | Patel J.,Hospital for Special Surgery
Journal of Arthroplasty | Year: 2013

Modularity in arthroplasty components has increased options for solving complex issues in primary and revision procedures. However, this technology introduces the risk of accelerated metal ion release as a result of fretting or passive crevice corrosion within the Morse taper junction. Cobalt toxicity locally and systemically has been described with hip metal bearing surfaces and may be accentuated with ion release from Morse tapers. This is a case report of a knee adverse local tissue response lesion associated with corrosion within the Morse taper of a revision knee arthroplasty in the absence of systemic metal allergy. © 2013.


Chen H.,Long Beach Medical Center | Onishi K.,Long Beach Medical Center
International Journal of Rehabilitation Research | Year: 2012

The aim of our study was to assess the effect of the frequency of home exercise program (HEP) performance on pain [10-point visual analog scale (VAS)] in patients with osteoarthritis of the spine or knee after more than 6 months discharge from physical therapy (PT). We performed a retrospective chart review of 48 adult patients with a clinical diagnosis of knee or spine osteoarthritis and had been discharged from PT of the spine or the knee for at least 6 months with provision of HEP from a physical therapist. Adult patients who were younger than 50 years of age, taking more than one medication to control pain, participating in worker's compensation, or had a history of drug abuse were excluded from the study. We recorded patient demographics, pain level (10-point VAS scale), and the number of days that a HEP was performed per week. The mean VAS score of patients who performed 0 days of HEP per week was 6.90. The mean VAS score of patients who performed HEP 1-3 times per week was 6.36. The mean VAS score of patients who performed HEP 4-7 times per week was 5.00. Single-factor analysis of variance analysis indicated a P-value of less than 0.01. Post-hoc comparison of the mean VAS using Fisher's least significant difference test showed a significant difference between the mean VAS score of 4-7 days per week of HEP versus 0 days per week (P<0.01) and 1-3 days per week (P<0.01) of HEP. There was no significant difference in the mean VAS score between 0 days of HEP and 1-3 days of HEP (P>0.05). Patients who performed 4-7 days per week of HEP had statistically significant lower mean VAS scores than patients who performed 0 days per week of HEP and 1-3 days per week of HEP. Therefore, after 6 months of discharge from PT, patients should be encouraged to perform at least 4 days of HEP per week. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Do A.H.,Long Beach Medical Center
Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Conference | Year: 2012

Gait impairment due to foot drop is a common outcome of stroke, and current physiotherapy provides only limited restoration of gait function. Gait function can also be aided by orthoses, but these devices may be cumbersome and their benefits disappear upon removal. Hence, new neuro-rehabilitative therapies are being sought to generate permanent improvements in motor function beyond those of conventional physiotherapies through positive neural plasticity processes. Here, the authors describe an electroencephalogram (EEG) based brain-computer interface (BCI) controlled functional electrical stimulation (FES) system that enabled a stroke subject with foot drop to re-establish foot dorsiflexion. To this end, a prediction model was generated from EEG data collected as the subject alternated between periods of idling and attempted foot dorsiflexion. This prediction model was then used to classify online EEG data into either "idling" or "dorsiflexion" states, and this information was subsequently used to control an FES device to elicit effective foot dorsiflexion. The performance of the system was assessed in online sessions, where the subject was prompted by a computer to alternate between periods of idling and dorsiflexion. The subject demonstrated purposeful operation of the BCI-FES system, with an average cross-correlation between instructional cues and BCI-FES response of 0.60 over 3 sessions. In addition, analysis of the prediction model indicated that non-classical brain areas were activated in the process, suggesting post-stroke cortical re-organization. In the future, these systems may be explored as a potential therapeutic tool that can help promote positive plasticity and neural repair in chronic stroke patients.

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