Granulocyte Colony-Stimulating Factor for Amyotrophic Lateral Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study of Iranian Patients

BACKGROUND AND PURPOSE: The aim of this study was to determine the efficacy and tolerability of granulocyte colony-stimulating factor (G-CSF) in subjects with amyotrophic lateral sclerosis (ALS). METHODS: Forty subjects with ALS were randomly assigned to two groups, which received either subcutaneous G-CSF (5 microg/kg/q12h) or placebo for 5 days. The subjects were then followed up for 3 months using the ALS Functional Rating Scale-Revised (ALSFRS-R), manual muscle testing, ALS Assessment Questionnaire-40, and nerve conduction studies. CD34+/CD133+ cell count and monocyte chemoattractant protein-1 (MCP-1) levels were evaluated at baseline. RESULTS: The rate of disease progression did not differ significantly between the two groups. The reduction in ALSFRS-R scores was greater in female subjects in the G-CSF group than in their counterparts in the placebo group. There was a trend toward a positive correlation between baseline CSF MCP-1 levels and the change in ALSFRS-R scores in both groups (Spearman's rho=0.370, p=0.070). CONCLUSIONS: With the protocol implemented in this study, G-CSF is not a promising option for the treatment of ALS. Furthermore, it may accelerate disease progression in females.

review of psychosocial issues in patients with chronic hepatitis B

Psychosocial issues and health-related quality of life [HRQOL] are important components of care in patients diagnosed with chronic hepatitis B [CHBV]. In this review, we searched Medline, ISI Web of Knowledge, Google Scholar and the American Association for the Study of Liver Diseases [AASLD] website [until January 2012] using relevant terms and we categorized the retrieved content into three areas: HRQOL, mental health, and psychosocial issues such as stigma and coping. Increasing severity of CHBV leads to a decline in HRQOL. Cirrhosis worsens HRQOL, whereas treatment and psycho-education improves it. Frequency of mood disorders seems to be increased in patients with CHBV, although not all studies have shown this trend. Some factors such as alcohol consumption and low social support negatively impact patients' mental health. Those with CHBV generally have better HRQOL and mental health than their hepatitis C [HCV] counterparts. Patients with psychiatric disorders, particularly those with prolonged institutionalization, have a generally higher risk of acquiring CHBV infection compared to the general population. Robust studies regarding the stigma in patients with CHBV are lacking, although some studies have suggested a higher degree of perceived stigma in these patients. HRQOL and mental health are significantly affected in CHBV patients, particularly in those with more severe forms of the disease. There are few studies that addressed the effects of intervention in CHBV patients with psychosocial problems. Other subjects necessitating additional research include stigma, coping mechanisms, and other less common, yet important psychosomatic disorders

Validity, reliability and factor structure of hepatitis B quality of life questionnaire version 1.0: findings in a large sample of 320 patients

Background: Quality of life is of significant importance in chronic hepatitis B [CHBV]. We aimed to assess the psychometric properties of the Hepatitis B Quality of Life Questionnaire v1.0 [HBQOL] in a large sample of 320 Iranian patients with CHBV

Methods: After adapting the Iranian version through forward-backward translation and expert panel discussion, we administered HBQOL together with Short-Form 36 [SF-36], Medical Outcome Study Social Support Questionnaire [MOS-SS], Hospital Anxiety and Depression Scale [HADS], and the Iowa Fatigue Scale [IFS] to 320 non-cirrhotic Iranian patients. We used principal component analysis with Varimax rotation to determine the factor structure. To evaluate the psychometric properties of HBQOL, test-retest and internal consistency reliabilities, divergent and convergent validity with other instruments, and discriminatory power were calculated

Results: Thirty-one questions loaded on to six factors [Anticipation anxiety, Stigma, Psychological well-being, Vitality, Transmissibility and Vulnerability] which explained 63.6% of total variance. Test-retest reliability was 0.66. Cronbach's alpha was 0.94 for the overall scale and between 0.7 and 0.9 for subscales, with the exception of the Vulnerability subscale. HBQOL and its subscales showed acceptable convergent and divergent validity with other instruments. Furthermore, Vulnerability subscale of HBQOL discriminated between patients with chronic active and chronic inactive hepatitis

Conclusion: The Iranian version of HBQOL is reliable, valid, and sensitive to the clinical conditions of the patients. This instrument has acceptable factor structure to measure several aspects of quality of life in patients with chronic HBV