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Serostim- How to best use it
Nov 22, 2010

I just got a prescription for Serostim since I cannot seem to be able to regain weight I lost a year ago with PCP but I am afraid to use the 6 mg that doctor tells me to use. Can you tell me the best way to use it for the least side effects and maximum benefits? Thanks Nelson.

Frank

Response from Mr. Vergel

Dear Frank:

Serostim (human growth hormone) is the only product approved for reversing wasting syndrome in HIV. It is effective at making people gain weight, but you have to be very careful with side effects like joint aches, high blood sugar (which could lead to diabetes in some), and carpal tunnel syndrome. So it is imperative that you read the following information from my first book "Built to Survive" (available on amazon link for Built to Survive )

The Politics of Serostim Growth Hormone

While appropriately prescribed human growth hormone can be another valuable tool in HIV-therapy for the war against wasting and especially lipodystrophy as fat gain, we have considerable philosophical problems with the financial politics related to GH, and are quite critical of its exorbitant price and the deceptive way that it is marketed to the HIV community. Serostim, the GH product that has been approved for AIDS wasting therapy, costs over $6000 per month for a full 6 mg daily dose. This is about 35 times as expensive as the PoWeR cycle that employs high doses of testosterone and nandrolone. But is GH as effective for lean body mass gains for HIV(+) people? The study comparison table above indicates that it is not. We also note that while compassionate use patient access programs from BTG and UNIMED are easy to work with, Serono's compassionate use program for people who do not have insurance is not.

Serostim Growth Hormone Has No Preservative

Even if the high cost of Serostim for the relatively small increase in lean body mass was not important, another problem with Serostim is. Serono omits including a bacteriostatic agent in the sterile water that Serostim is reconstituted with, so it must be used within 24 hours after mixing or thrown away because bacteria might grow in the solution. This makes Serostim much more profitable for Serono, while it effectively takes away your option of reducing common side effects by rationing out part of the vial every day to get a lower side effect-free daily dose.

If Serono did include a preservative like benzyl alcohol or metacresol in the mixing water, then you could use whatever dose was found to be appropriate, and store the unused GH in the refrigerator for up to two weeks. Currently, HIV(+) individuals who cannot tolerate the severe side effects that the full 4, 5, or 6 mg doses can cause may end up throwing away any GH that they cannot use. More drug is wasted and thus more drug is sold.

Serono clearly knows about this issue, as their GH product called Saizen, which is sold in Mexico and Italy and prescribed to children in the U.S., does have benzyl alcohol in its mixing water. We had a discussion about this with Serono's director of research in 1997 and were told that it was too difficult to access an effective preservative. To this day Serono representatives have been evasive about the lack of a preservative.

Extending Serostim's Lifespan

One way to correct Serostim's lack of a preservative is to get your doctor to give you a prescription for bacteriostatic water that includes benzyl alcohol (made by Abbott Labs and other companies). An insider at Serono admitted that mixing Serostim with bacteriostatic water would allow it to be used for up to two weeks after mixing. After all Serostim is essentially the same product as the other GH called Saizen, except that Saizen comes with bacteriostatic water that contains benzyl alcohol. Using bacteriostatic water allows you to find your own side effect-free individual daily dose without waste.

Reducing Side Effects

If GH is given as a replacement hormone to HIV-negative people who are GH deficient or are experiencing an age-related decrease in GH production, the typical daily dose is around .5 mg (1.5 IU) per day. Bodybuilders know about safe, side effect-free doses and typically limit their use of GH to under 1.4 mg (about 4 IU) per day.

Serostim is currently packaged in doses of 4, 5, or 6 mg vials, and a study of the medical literature show that these doses are overdoses for many people. Doses that are this high can cause significant side effects including arthralgia (joint pains), carpal tunnel syndrome, edema (water retention), elevated blood sugar, elevated pancreatic enzymes, gynecomastia, body hair growth, and high blood pressure.

Serono's dosing recommendations are lacking in that they instruct patients to use one full vial per day. If this causes side effects the doctor often tells the person to use the full vial every other day, or use only part of the vial every other day, and throw the rest away. These instructions are inadequate. Doctors who work with GH for anti-aging purposes tell us that GH has very little potential for side effects if it is administered in smaller doses more often, with the best effect being seen with twice-a-day administration. Without the peak blood levels that high doses every other day create, there will be fewer side effects. In general, with any drug, smaller doses given more often work better with fewer side effects than large doses given less often. Our recommendation for best effect is to administer GH first thing in the morning and once before bed. If this is too much trouble, administer it before bedtime.

Growth Hormone and Joint Inflammation

Significant research shows that high dose GH may cause joint pains because it can promote excess super oxide secretion by neutrophils, which causes inflammation. This effect has a known association with inflammatory joint problems, such as rheumatoid arthritis, so high dose GH appears to be inducing a state like rheumatoid arthritis.

Growth Hormone Gains: Little Muscle, Lots of Water

When all things are considered, it appears that Serono recommends what amounts to an overdose of GH because an ultra-high overdose is necessary to come close to producing lean body mass (LBM) gains that seem to be almost equal to the anabolic effects of low doses of anabolic steroids. Using GH to grow muscle is an incorrect use; the increase in LBM may very well consist primarily of water, with some connective tissue, a little organ tissue, and only a little, if any, muscle tissue.

Indeed, one carefully designed study of high-dose GH with HIV-negative young men used sophisticated techniques to closely examine the composition of the lean tissue gained and concluded that it consisted of lean tissue other than muscle.250 This could mean water, connective tissue, and organ tissue. At least five other studies with other populations have also shown an increase in LBM, but a lack of muscle growth.251 252 It should be noted that Dr. Kathleen Mulligan stated that GH-induced lean body mass gains for HIV patients were "comparable" to the healthy HIV(-) controls in her study, so comparisons with studies of HIV(-) subjects may very well be valid.

Indeed, the first HIV study that looked at Serostim using magnetic resonance imaging (MRI), a sophisticated technology that actually looks at what is happening to the body's tissues, indicated that growth hormone may have little or no affect on muscle. At the Third International Conference on Nutrition and HIV Infection at Cannes, France, in April, 1999, Dr. Donald Kotler reported the results of an interim analysis of a 6-month open-label trial of Serostim growth hormone that showed that 6 mg per day did not promote a significant change in muscle tissue during the first 12 weeks in the 8 subjects for whom repeat MRI data were available. Final study results showed what appeared to be an increase. However, this study's lack of a placebo control makes its data inconclusive. It appears that if Serostim does actually have an effect on increasing muscle tissue through direct on indirect means, it does so erratically and only for a very few HIV(+) people, not for the majority.

Human Growth Hormone and Gynecomastia

Gynecomastia is the growth of breast tissue in men. It is sometimes seen in males who use high doses of anabolic steroids that aromatize into estrogen, as estrogen stimulates breast tissue growth. Gynecomastia appears to be a very rare phenomenon in HIV(+) men, at least partially because impaired insulin-like growth factor-1 (IGF-1) production and GH deficiency are common in HIV, and IGF-1 is a necessary cofactor with estrogen for breast tissue growth in gynecomastia. GH stimulates production of IGF-1 by the liver, and our observation is that HIV(+) males who use growth hormone appear to have a much higher incidence of gynecomastia than those who don't. Indeed, older studies with young HIV(-) boys and senior men who receive growth hormone therapy have documented incidence of gynecomastia. GH can also stimulate breast tissue growth by binding to prolactin receptors.

Measurements: Finding the Right GH Dosage

Analysis of the available data causes us to assert that GH should be considered for replacement purposes based on blood tests, rather than as a muscle growth stimulant, and prescribed accordingly. However no studies have been done to ascertain what blood levels are appropriate for HIV(+) males and females. Until this is done, our suggestion is that the physician consider testing IGF-1, which is a more consistent measurement than plasma GH, and try to arrive at an IGF-1 measurement of approximately 350 ng/mL, which is the target reading for optimal GH replacement for anti-aging purposes. Because hormonal resistance is common in HIV, it is possible that some HIV(+) people will require higher blood levels to experience the potential improvements in fat metabolism and quality of life. To date we have seen doses of between 0.5 mg and 3 mg per day produce optimal effects for HIV(+) men, so we suggest starting at 0.5 mg per day, and retesting to work toward determining an appropriate dose. Also listen to your patient's subjective reports of their status to determine what is optimal, and be willing to experiment until you find what is appropriate.

Growth Hormone's Benefits

While the available data suggests that GH is not anabolic to muscle tissue like anabolic steroids, and it is clear that GH's price and Serono's lack of a preservative do not serve the HIV(+) population, GH does have unique benefits. If GH has more effect on increasing the growth of lean tissue other than muscle, as the studies suggest, does it promote the regeneration of organ tissue like the thymus, kidneys, and liver? This is an area that needs to be researched. Wasting in HIV is not limited to muscle tissue, and regeneration of critical organs in the body may be an important reason for GH replacement therapy in HIV. As was said, it may be that the rare anecdotal reports of a small amount of increased muscle growth in severely wasted HIV(+) individuals are the result of improved function of organs that indirectly affect muscle growth.

And while anabolic steroids can reduce the net ratio of fat to muscle that is gained and can have some effect on increasing the loss of fat, GH's most important effect may be its role in fat cell metabolism; it increases lipid oxidation (fat burning), which gives it a role in possible therapies to reduce some of the symptoms of the bodyfat redistribution called lipodystrophy. Dr. Gabe Torres documented that GH can reduce bodyfat gained in the abdominal area and this is an area that we feel should be investigated thoroughly.

However, we caution that GH may increase the loss of subcutaneous fat on the arms, legs, and face, which is the part of lipodystrophy syndrome called lipoatrophy.

GH's role is also interesting when we consider that a phenomenon of early AIDS wasting is the loss of muscle, while fat is gained, described as de novo lipogenesis by Dr. Marc Hellerstein. This kind of catabolism of muscle and anabolism of fat is somewhat unique to AIDS, and it may be in part caused by a resistance to GH and reduced production of IGF-1. So GH appears to have a unique role in a problem that is somewhat specific to AIDS.

We also have anecdotal reports that GH use sometimes stops chronic diarrhea. GH is known to increase tissue regeneration in the intestine and improve intestinal water and ion absorption, so this is possible.

GH Combined with Anabolic Steroids

GH may have valuable adjunctive benefits when used to address GH deficiency when it is combined with testosterone replacement therapy. Appropriately-dosed GH replacement may also enhance the effectiveness of any of the PoWeR anabolic steroid cycles, just as nutritional supplementation that addresses nutrient deficiencies does. We invite the research community to consider studying combination therapy that employs GH replacement and anabolic steroids.

Hyperplasia

When GH is added to a regimen of anabolic steroids and weight training it seems that what muscle is gained is more permanent than when anabolic steroids are used alone. This may be because GH's effect of increasing IGF-1 can increase the number of nuclei in muscle cells by causing satellite cells to fuse to adjacent muscle cells or differentiate into muscle cells. This might result in hyperplasia, an increase in the number of muscle cells and hypertrophy, an increase in cell size. Observation of bodybuilders suggests that this effect may be potentiated by proper exercise stimulus, and optimal levels of androgens. (Note: GH used by itself does not appear to produce lasting lean tissue gains after administration is stopped. This would be true if most of the weight that was gained was water.)

I hope this long answer helped to give you more information about a hormone that should not be used without proper eduction.

Nelson



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