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Clinical Trial Watch II

A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy. Sponsor: Genentech Inc. Status: Terminated. Available from http://www.clinicaltrials.gov/ct/show/NCT00086606?order=22. 2006-01-26.

Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study on the Effects of Garlic on Hyperlipidemia Induced by HAART in HIV-Positive Individuals. Sponsor: National Center for Complementary and Alternative Medicine. Status: Terminated. Available from http://www.clinicaltrials.gov/ct/show/NCT00029250?order=4. 2005-12-08.

Related   Garlic Supplements Can Impede HIV Medication. National Institutes of Health Press Release. 2001-12-05. Available from http://nccam.nih.gov/news/2001/120501.htm

Ancient History: Phase I Study of Adenoviral Vector Mediated Gene Transfer for Ornithine Transcarbamylase in Adults With Partial Ornithine Transcarbamylase Deficiency. Sponsors: FDA Office of Orphan Products Development and the University of Pennsylvania. Status: No longer recruiting. Available from http://www.clinicaltrials.gov/ct/show/NCT00004498?order=50. Undated.

A pilot study of the effect of inhaled buffered reduced glutathione on the clinical status of patients with cystic fibrosis. Chest. 2005;127:308-317.   Bishop C, Hudson VM, Hilton SC, Wilde C.   Utah Valley Regional Medical Center and Brigham Young University. Clark Bishop, MD, FCCP, 1034 North 500 West, Provo, UT 84605-0390; e-mail: UVCBISHO@ihc.com

Study objectives: To assess the impact of inhaled, buffered reduced glutathione (GSH) on clinical indicators of cystic fibrosis (CF) pathophysiology.

Design and patients: A randomized, double-blind, placebo-controlled pilot study was conducted over an 8-week period. Nineteen subjects, age 6 to 19 years, with CF status documented by positive sweat chloride test results (> 60 mEq/L) were recruited for the trial. After matching on age and sex, 10 patients were randomly assigned to the treatment group and 9 patients to the placebo group. Primary outcomes were FEV1, FVC, forced expiratory flow at 25 to 75% of vital capacity, and peak flow; secondary outcomes were body mass index, 6-min walk distance, and self-reported cough frequency, mucus production/viscosity/color, wellness, improvement, and stamina.

Interventions and analysis: Treatment was buffered GSH, and placebo was sodium chloride with a hint of quinine. The total daily dose of buffered GSH was approximately 66 mg/kg of body weight, and the total daily dose of placebo was approximately 15 mg/kg of body weight (quinine, 25 to 30 g/kg). Doses were distributed across four inhalation sessions per day and spaced 3- to 4-h apart. General linear mixed models were used to analyze the data. The final sample size was nine subjects in the treatment group and seven subjects in the placebo group.

Results: Mean change for peak flow was – 6.5 L/min for the placebo group and + 33.7 L/min for the GSH group (p = 0.04), and self-reported average improvement on a scale from 1 to 5 (1 being much worse and 5 being much better) was 2.8 for placebo and 4.7 for GSH (p = 0.004). Of the 13 primary and secondary outcomes examined, 11 outcomes favored the treatment group over the placebo group (p = 0.002), indicating a general tendency of improvement in the GSH group. No adverse events in the treatment group were noted.

Conclusion: This pilot study indicates the promise of nebulized buffered GSH to ameliorate CF disease, and longer, larger, and improved studies of inhaled GSH are warranted.

Accessed 2005-07-02 from http://www.findarticles.com/p/articles/mi_m0984/is_1_127/ai_n9474678/print
See alternate URL at: http://www.chestjournal.org/cgi/content/abstract/127/1/308

Rhoads JL. FDA Warning Letter to Clark Bishop M.D. Available from http://www.fda.gov/foi/warning_letters/g5365d.pdf. 2005-06-07


Randomised double-blinded trial evaluating silymarin for chronic hepatitis C in an Egyptian village: study description and 12-month results. Dig Liver Dis. 2004 Nov;36 (11):752-9.   Tanamly MD, Tadros F, Labeeb S, Makld H, Shehata M, Mikhail N, Abdel-Hamid M, Shehata M, Abu-Baki L, Medhat A, Magder LS, Afdhal NH, Strickland GT.   International Health Division, Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, 660 West Redwood St. Suite 100, Baltimore, MD 21201, USA.

BACKGROUND/AIMS: A double-blinded trial evaluating silymarin, an herbal supplement for liver disease, to prevent complications of chronic hepatitis C virus infection has not been done. SUBJECTS: One hundred and seventy-seven consenting residents of an Egyptian village with chronic hepatitis C virus were randomly assigned to receive either silymarin or multivitamin supplements. METHODS: Participants had baseline and follow-up clinical, ultrasound, blood tests and quality-of-life assessments. Community nurses visited weekly to ascertain compliance, distribute supplements and record adverse effects. RESULTS: At 12 months almost all of 141 remaining subjects reported feeling better, although symptoms and quality-of-life scores did not differ between the silymarin and multivitamin groups. Both the silymarin and vitamins were tolerated equally well; and >95% of supplements were taken by >95% of subjects. One in each group had no detectable hepatitis C virus antibodies while two in the silymarin group and three receiving multivitamins had undetectable hepatitis C virus RNA. Serum alanine aminotransferase elevations did not differ between groups. Serum hepatic fibrosis marker, hyaluronic acid and YKL-40, and abdominal ultrasound results were similar in both groups and may have progressed slightly at 12 months. CONCLUSIONS: The recommended dose of silymarin can be safely taken for 1 year and improves symptoms and general well-being, but has no effect upon hepatitis C virus viremia, serum ALT, or serum and ultrasound markers for hepatic fibrosis. More prolonged evaluation and a higher dose may be required to ascertain whether milk thistle supplements prevent complications of chronic hepatitis C virus.

PMID: 15571006

Accessed 2005-06-05 from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15571006&dopt=Abstract


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Massage treatment in HIV-1 infected Dominican children: a preliminary report on the efficacy of massage therapy to preserve the immune system in children without antiretroviral medication. J Altern Complement Med. 2004 Dec;10 (6):1093-5.   Shor-Posner G, Miguez MJ, Hernandez-Reif M, Perez-Then E, Fletcher M.   Division of Disease Prevention, Department of Psychiatry and Behavioral Sciences, University of Miami School of Medicine, Miami, FL.

OBJECTIVES: More than 1.4 million children are living with HIV and global access to antiretrovirals is not yet readily available. Massage therapy, which has been shown to improve immune function in HIV+ adults and adolescents, may provide an important complementary treatment to boost immune status in young children living with HIV disease, especially those without access to antiretroviral medications. No studies have been conducted, however, that specifically target massage therapy to enhance immune function in HIV+ children. DESIGN: Clinical trial with eligible, consented HIV+ children randomized to receive either massage therapy or a friendly visit (controls). SETTINGS/LOCATION: CENISMI/Robert Reid Cabral Hospital, Santo Domingo, Dominican Republic. SUBJECTS: HIV+ children ages 2-8 years. INTERVENTION: Massage therapy sessions (20 minutes, twice weekly, for 12 weeks), conducted by trained nurses, following a structured protocol of moderate pressure stroking and kneading of muscles, using a non-scented oil. The friendly visit control group, (reading, talking, playing quiet games), met with the nurse twice weekly for 12 weeks. OUTCOME MEASURES: At the initial evaluation, and following the 12-week intervention, blood was drawn to determine absolute helper (CD4/T4) and suppressor (CD8/T8) counts. RESULTS: Children in the control arm had a greater relative risk of CD4 count decline (>20%) than massage-treated children (RR = 5.7, p = 0.03). Lymphocyte loss was also more extensive in the controls (p < 0.02), and more of the control group than the massage group lost >50 CD8 lymphocytes (p = 0.03). CONCLUSIONS: The efficacy of massage therapy in maintaining immunocompetence may offer a viable alternative to the thousands of children worldwide without antiretroviral access.

PMID: 15674006

Accessed 2005-06-05 from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15674006&query_hl=20

Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV. Sponsor: National Center for Complementary and Alternative Medicine. Status: Completed. Available from http://www.clinicaltrials.gov/ct/show/NCT00070980?order=1. 2005-12-08.



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Last Updated: 2006-10-13

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