You don’t have to be a detective to make sense of clinical trials of complementary therapiesA broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, Traditional Chinese Medicine, etc. — but it helps.
“I don’t know where to start,” said Craig* as he walked into my office, carrying a bundle of internet printouts. “Most of these reports say that NAC is good for you if you have HIV but others say the opposite. How do you sort them out?”
A friend of Craig’s, also HIV-positive, had been taking an amino acid supplement called NAC (short for n-acetyl-cysteine) and believed it had helped his CD4 count increase. He’d suggested that Craig try it too. Craig believes in checking out information for himself — hence the bundle of internet reports.
Doctors have used NAC for many years to counteract poisoning from paracetamol and to help liquefy thick phlegm in cases of serious lung disease. In the early 1990s, some American research suggested that NAC may also have some particular benefit for people with HIV and it began to be used widely in the HIV community.
Craig’s bundle contained over 50 research reports — a lot to wade through. “First, lets separate out the trials done on human beings from those done just in the lab,” I suggested. Test tube experiments, called in vitro(Latin: within the glass) refers to the technique of performing a given experiment in a controlled environment outside of a living organism; for example in a test tube. research, can throw up interesting leads but may be totally irrelevant to what actually happens in a live human being.
Craig found reports of 17 human trials of NAC in people with HIV. The earliest was from 19941 and showed that NAC appeared to prevent a decline in CD4 counts. However, this was a small, one-month, uncontrolled trial and, while it was interesting, it certainly wasn’t conclusive.
A later trial, from 1996, was more encouraging: it used a placeboA dummy medical treatment, designed to have no pharmacological effect, administered to the control group of a clinical trial. group and ran over four months2. In this trial, it was observed that people taking 800mg of NAC a day had a slower decline in CD4 cells than people taking a placebo. Encouraged by this, the researchers called for more trials to be conducted.
Unfortunately, Craig’s findings showed that no definitive research has been reported — but several intriguing, small-scale trials suggest that NAC shouldn’t be written off.
For instance, when investigators at Podova University in Italy gave 600mg of NAC per day to 16 HIV-negative volunteers, they found that 12 of the 16 significantly increased their production of anti-HIV chemokines3 (chemicals that help the body resist HIV).
Other researchers discovered that NAC improved immune function (how well the immune system was doing its job) for both 40 people taking anti-HIV drugs and a group of 29 people not using these drugs4 . These researchers concluded that “studies showed consistently that NAC causes a marked increase in immunological functions … Because immune reconstitution is a widely accepted aim of HIV treatment, NAC treatment may be recommended for patients with and without anti-retroviral treatment.”
A different approach was taken by researchers who looked at the role of cysteine in maintaining the body’s antioxidant levels. Cysteine helps make a crucial antioxidant called glutathione. Low levels of glutathione — the most important antioxidant inside cells — are bad news. A (pre-HAARTHighly Active AntiRetroviral Therapy ??? aggressive treatment of HIV infection using several different drugs together.) Stanford University study found that people with relatively high glutathione levels had a three-year survival rate of between 60 and 80 percent, compared with as low as 20 percent survival for those with low glutathione5.
One thing Craig hadn’t searched for was any problems with NAC. None of the studies had observed any, but naturopaths have always been wary of prescribing cysteine to people with diabetes[Diabetes mellitus] A disorder in which sugars in the diet cannot be metabolised into energy due to a lack of the enzyme insulin. Late-onset diabetes mellitus may be a long-term side effect of some anti-HIV drugs., as it is believed to interfere with injected insulin.
A recent trial of vitamins C, E and NAC by 10 people with HIV who were on treatment and had either lipoatrophy or high lactic acid levels found that the fasting blood glucose levels of the participants rose significantly6 . This was despite trends in improvements in waist-to-hip ratios and cholesterolAn essential component of cell membranes and nerve fibre insulation, cholesterol is important for the metabolism and transport of fatty acids and the production of hormones and Vitamin D. Cholesterol is manufactured by the liver, and is also present in certain foods. High blood cholesterol levels have been linked to heart disease and may be a side effect of some anti-HIV medications. values and despite studies in HIV-negative people showing that NAC has no effect on fasting blood glucose and actually improves sensitivity to insulin7 . This means that people taking some anti-HIV drugs may not be able to use NAC or, if they do, should get regular monitoring of glucose levels.
What did Craig decide? “Well, my friend’s been using NAC for five years without any problems and I think the balance of these reports shows its pretty interesting. I’m going to give it a try for a few months and see how it goes. It’d be great to have better research though,” he said.
Unfortunately, that’s unlikely, I told him, showing him a quote from Dr Steve de Rosa at Stanford University.
“The problem with commonly available NAC is that no pharmaceutical company will fund a study since it can’t have a patent on the product,” De Rosa has said.
* — not his real name.
Jim Arachne is the Complementary Therapy Treatment Officer for the Victorian AIDS Council.
References
1 FASEB J 8(6), 1994 Apr 1, pg. 448-51
2 Walmsley SL., et al. J Acquired Immune Defic Syndr Hum Retrovirol, 19(5):498-505 1998 Dec 15
3 Cavallini L., et al. Life Sci 2000;67(2):147-54
4 Breitkreutz R., et al. J Mol Med 2000;78(1):55-62
5 James JS. AIDS Treat News. 1997 Mar 7;(No 266):1-5.
6 McComsey G, et al. J Acquir Immune Defic Syndr. 2003 Aug 15;33(5):605-7.
7 Fulghesu AM, et al. Fertil Steril. 2002 Jun;77(6):1128-35.
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