Fonz said:
I remember posting that same study JA like 2 years ago, and got my ass hyanded to me by Ulter.
That study is not peer-reviewed and is in essence wrong.
I'm not disagreeing with you and I'm sure there's evidence out there that would contradict the conclusions from the study I just posed but what about this one?
http://www.hivandhepatitis.com/recent/hormone/032000.html
Oxandrin Plus Resistance Exercise Increases Body Weight, Muscle Mass and Body Cell Mass
By Harvey S. Bartnof, MD
During a Satellite Symposium at the 12th National HIV/AIDS Update Conference, researchers presented the results of two studies that showed benefits with Oxandrin therapy in HIV positive patients with weight loss even with anti-HIV therapy. Oxandrin (oxandrolone) is a testosterone (male hormone) analog ("anabolic" or tissue building steroid hormone) that is taken orally. The dose used in these studies was 10 mg twice daily.
The first speaker was Fred R. Sattler, MD, from the University of Southern California. He is an infectious diseases specialist who has been involved in research surrounding HIV-related weight loss and the Wasting Syndrome. Dr. Sattler reviewed some of the literature data indicating how common unexplained weight loss is, even when HAART (highly active antiretroviral therapy) leads to a lower HIV RNA viral load and an increase in the CD4 count. In this setting, "unexplained" means that weight loss is not due to an opportunistic infection, inadequate intake of calories, or poor absorption ("malabsorption") of nutrients into the bloodstream.
The second speaker was Alison Strawford, PhD, RD, from the University of California at San Francisco and Berkeley. Dr. Strawford was the lead author of a publication in last year's Journal of the American Medical Association that showed the benefits of Oxandrin for the treatment of HIV-related weight loss. That study was double-blind (medication or placebo unknown to patients, physicians, and weight trainers), placebo-controlled that enrolled 22 HIV positive men with unexplained HIV-related weight loss.
In the 8-week study, Oxandrin supplementation with regular resistance weight training 3-times weekly and weekly testosterone injections led to a significantly greater increase in lean muscle mass than the control group without Oxandrin. The weekly injections were intended to control the level of testosterone in the body, so that it was equal in all participants as a "testosterone replacement" that would suppress production of testosterone within the body. The group taking Oxandrin had "supraphysiologic" (higher than normal) levels of male hormone, while the placebo group had only physiologic or normal levels. There were two 10-day inpatient study periods to measure detailed aspects of caloric intake and output. Body composition measurements were performed with DEXA (dual energy X-ray absorptiometry). "Quality -of -life" measurements were determined by the "Medical Outcomes Study-HIV Specific" questionnaire. After the 8-week placebo-controlled study, there was an additional 12-week open label follow-up.
Before entering the study, the mean body weight loss was 9%. All men were "eugonadal," meaning they had normal blood levels male hormone. Protease inhibitor therapy was a part of the anti-HIV drug regimen in 54%. The mean baseline HIV RNA viral load was higher in the placebo group (4.9 log or 79,432 copies per milliliter) than in the Oxandrin arm (3.9 log or 7,943 copies per milliliter). The dose of Oxandrin was 10 mg twice daily. The "testosterone enanthate" injections were 100 mg weekly.
Results were as follows. All patients in the study gained weight, lean body (muscle) mass and muscle strength. However, the gains in the Oxandrin arm were greater than those in the arm without Oxandrin. There were no differences in those taking or not taking a protease inhibitor drug. Those randomized to Oxandrin did have a significant decrease in their HDL ("high density lipoprotein" or "good") cholesterol. One patient discontinued due to increased liver enzymes, a known adverse effect.
Specific results after eight weeks showed that the Oxandrin arm had a significantly greater weight increase (6.7 kilograms or 14.7 pounds) when compared to the placebo arm (4.2 kilograms or 9.3 pounds). The Oxandrin arm also had s significantly greater increase in lean body mass (muscle, 6.9 kilograms or 15 pounds) when compared to the placebo arm (3.8 kilograms or 8.4 pounds). Both the Oxandrin and placebo arms had a significant increase in bone mineral density that was not significantly different when comparing the two arms. Also, both arms had a significant loss of body fat (1.6 kilograms or 3.5 pounds) that was not significantly different when comparing the two arms.
Using a "dynamometer," increased strength of various muscle groups was significantly greater in the Oxandrin arm, when compared to the placebo arm. The quality-of-life measurements showed no overall significant differences when compared to baseline, with the exception of an increase in "physical function domain." HIV viral load levels decreased by 0.1-0.2 log copies per milliliter in both arms. CD4 counts remained essentially unchanged in both arms.
Adverse effects showed that the Oxandrin group had a significant decrease in the "HDL" (high density lipoprotein or "good") cholesterol, while the placebo arm did not. Increased liver enzymes occurred in two patients from the Oxandrin arm (one had to stop therapy) and none in the placebo arm. Both of those patients were taking a protease inhibitor anti-HIV drug that also can increase liver enzymes. "Mood swings" occurred in five patients from the Oxandrin arm and three patients from the control arm. Four patients in the Oxandrin arm experienced anxiety, while two patients in each arm reported an increase in libido (desire for sex).
The open-label component enrolled 17 of 22 participants. Results revealed significant weight and lean tissue gains among those originally in the placebo arm.
The third speaker was Nicholaos Bellos, MD, an Infectious Disease specialist from Dallas, Texas. Dr. Bellos presented interim results of a much larger study that was similar to the study above, although this one had no placebo arm and was open-label. A total of 119 HIV positive patients (10% women) with a mean weight loss of 7.5% were enrolled. One month of stable anti-HIV therapy was required. Patients took Oxandrin 10 mg twice daily and were given dietary counseling regarding daily calorie and protein intake, and exercise recommendations of resistance training using "Thera-Band" exercise bands. If men had a low blood serum (no cells) level of testosterone (less than 280 nanograms per deciliter), supplemental testosterone was given.
The interim results for the 69 patients who completed two months showed that 78% had a weight gain. For all of those patients, the mean increase was 1.8 kilograms or 4 pounds and was significant. For the 38 patients who completed four months, 76% had a weight gain. Among those 38 patients, the mean weight gain from baseline was 2.7 kilograms or 6 pounds and was significant. Body composition measurements were analyzed by using BIA (bioelectrical impedance analysis). The results showed a significant increase in "body cell mass," which is associated with increases in lean tissue.
Quality-of-life measurements also improved in the "Functional and Global Well-Being" subscore for those who completed two months. Abnormal laboratory events included mild increases in liver enzymes, total and LDL ("low density lipoprotein" or "bad") cholesterol and a mild decrease in the HDL cholesterol. The liver enzyme changes were not significant, while the LDL and HDL cholesterol changes were. No "masculinizing or virilizing" effects were noted among the women. Interim discontinuation rates, viral load changes, and CD4 count changes were not reported. This study is ongoing.
Oxandrin is available in 2.5 mg pills. Other adverse effects include the following. Longer-term administration of any "androgenic steroid" (including Oxandrin) can cause life-threatening blood-filled cysts (fluid "pockets") in the liver and spleen. These can rupture and cause life-threatening internal bleeding (hemorrhage) or lead to liver failure. Also, liver tumors (usually benign, but can be cancerous) can develop. Usually, the cysts and benign tumors regress after Oxandrin therapy is stopped. In addition, the cholesterol changes discussed above (increased LDL and decreased HDL cholesterol) are associated with an increased risk of "atherosclerosis" ("hardening" of the arteries) that is linked with an increased risk of a premature heart attack. Oxandrin should never be taken by men with prostate cancer, pregnant or breastfeeding women, women with breast cancer (and high blood calcium levels), or anyone with high calcium levels or kidney dysfunction. Oxandrin may also lead to worsened or new onset of diabetes (high blood sugar that might require treatment), acne, hair loss, smaller testicles in men, development of body hair or menstrual abnormalities in women, a deepening of the voice in women, depression, excitability, habituation (addiction risk), sleep problems, breast enlargement, fluid retention ("swelling"), impotence, priapism in men (painful, prolonged, undesired erection), nausea, vomiting, and skin color changes.
Persons taking Oxandrin should have regularly blood tests to monitor changes that might have developed. Those include: liver enzymes (AST, ALT), alkaline phosphatase (bile blockage and bone enzyme), bilirubin (bile pigment), electrolytes ("salts," including sodium, chloride, calcium, potassium, phosphate), muscle enzyme (CPK), sugar (glucose), kidney function (creatinine, BUN or blood urea nitrogen), and CBC (complete blood count). A regular urinalysis also in recommended.
03/20/00
References
Bellos N. Research translates to community practice: reversing weight loss and increasing body cell mass in HIV-associated wasting in the era of HAART. Satellite symposium "Weight Loss and Wasting: Clinical and Community-based Approaches to Treatment" at the 12th National HIV/AIDS Update Conference. March 14-17, 2000; San Francisco, California.
Product Information: Oxandrin (oxandrolone); BTG Pharmaceuticals.
Sattler FR. Overview-metabolic aspects of weight loss and wasting. Satellite symposium "Weight Loss and Wasting: Clinical and Community-based Approaches to Treatment" at the 12th National HIV/AIDS Update Conference. March 14-17, 2000; San Francisco, California.
Strawford A. Resistance exercise and supraphysiologic androgen therapy in eugonadal men with HIV-related weight loss-a randomized controlled trial. Satellite symposium "Weight Loss and Wasting: Clinical and Community-based Approaches to Treatment" at the 12th National HIV/AIDS Update Conference. March 14-17, 2000; San Francisco, California.
Strawford A and others. Resistance exercise and supraphysiologic androgen therapy in eugonadal men with HIV-related weight loss, a randomized controlled trial. Journal of the American Medical Association 1999 April 14, 281(14):1282-1290.
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