NAPWA

A groundbreaking trial being conducted in Melbourne is investigating a promising herbal compound for people with HIV. Trial participant BERNIE SLAGTMAN reports.

When I was growing up, ‘medicine’ was a term that I understood as a prescription that you got from the doctor when you were sick. But when one probes further into the realms of integrative medicine, the term has a much broader meaning.

Integrative medicine for HIV is all about combination therapyHighly Active AntiRetroviral Therapy ??? aggressive treatment of HIV infection using several different drugs together. but with a much broader coverage. It is a holistic approach to treatment and management, combining natural, orthodox, mind and body concepts into an overall treatment style.

Prescribing pharmaceutical medicines has a logical purpose to it, however the holistic approach to care is a multidimensional and complex way to treat and look after our bodies. Things such as diet, exercise, relaxation and stress management are all part of our own integrative medication approach. At the end of the day, the best prescribers of our own medicine are ourselves: we prescribe ourselves time with our GP, naturopath, gym, relaxation, diet, and so on.

Well, what’s new about that? When you look at studies and surveys, many HIV-positive people are combining natural products with their antiretroviralA medication or other substance which is active against retroviruses such as HIV. programs. But how many of us know exactly which product to use and how much, or whether it interacts with other drugs? There are numerous types of different programs around for relaxation such as yoga, Reiki, meditation, and so on. But which is best for me and my integrative HIV management?

I recall with great trepidation my diagnosis of being HIV positive. Like most, my life was thrown into turmoil, especially with a life expectancy of less than 12 months as my CD4 count at the time was below 30 and I had cryptosporidium infection. Friends and family gathered around my hospital bedside saying all the supportive things that one probably doesn’t want to hear at such times. But what I remember most was a kind friend coming with a suitcase full of natural herbs, vitamins and immune stimulants.

The ward doctors freaked out. “Not in this hospital!” they said.

That was my first experience of the integrative treatment approach, a negative attitude by those health care personnel entrusted with my life. Ever since that day, I have been in search of the best ways to select what treatments are right for me.

I have heard of many vitamin and mineral supplements as well as herbal preparations that could assist in my health management of my HIV disease. The advice usually came from friends’ experiences or unsubstantiated literature. Over the years I had developed this idea of not expecting more reliable information, due to the heavy financial costs associated with trials that only large pharmaceutical companies could afford. I never really felt comfortable with this scenario, trying untested products backed by questionable research and with uncertain benefits.

There have been many changes in HIV management over the years. Interestingly, the use of integrative medicine has made significant progress into the mainstream, albeit in small steps. My cardiologist now prefers to prescribe up to 10 grams of Max EPA (fish oils) for the management of my blood 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. and triglycerides rather than the statin range of medicines with all their reported side effects. All on a hospital script as well. Other examples of integrative medicine include occupational therapists who provide relaxation classes; and physiotherapy departments that conduct gym programs.

Research led me to Swinburne University of Technology in Melbourne, and its Graduate School of Integrative Medicine. The primary role of this school is to train doctors in integrative medicine techniques including nutritional medicine, herbal medicine, acupuncture and mind-body medicine.

The school has developed a special interest in HIV integrative medicine and is currently involved with a herbal trial with HIV-positive people as well as developing and undertaking research into what types of things HIV-positive people do to maintain their health and quality of life. With this research they hope to be able to provide guidance to the HIV-positive community on which techniques seem to be most effective and in what dosages herbs may assist with HIV management.

The integrative medicine trial really interested me. It is the first fully audited phase two clinical trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. in Australia to evaluate the safety and efficacy(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. of a herbal combination known as CKBM-A01 in HIV/AIDS patients. It is being conducted on a similar audited basis to the drug trials that many of us have become accustomed to, with appropriate ethics(In clinical trials) The process of determining that a proposed clinical trial conforms to a wide range of moral, scientific and ethical standards, to ensure that participants in the trial are not abused, mistreated or unfairly taken advantage of. Before a clinical trial can go ahead, it must be given approval via an independent ethics process. and quality control procedures and standards. The idea of natural products being formally tested and integrated into my health management attracted me to the trial.

As with all trials, you need to qualify for consideration and hence adhere to certain inclusion and exclusion criteriaThe medical or social standards determining whether a person may be disqualified from entering a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe., particularly a CD4 count between 100 and 500. Viral loadA measurement of the quantity of HIV RNA in the blood. Viral load blood test results are expressed as the number of copies (of HIV) per milliliter of blood plasma. is not an entry criterion. The usual pre-selection procedures of trial documentation, consent forms, blood tests and examinations apply. Participants need to live in or near Melbourne to take part, and are not allowed to take any other herbal or complementary medicines during the trial period.

The study is open-labelA clinical trial in which doctors and participants know which drug or vaccine is being administered. and has three arms. Participants not currently taking antiretroviral medications automatically receive the herbs; those on HAART are randomisedA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant into two groups, one receiving herbs in addition to their antiviralsA medication or substance which is active against one or more viruses. May include anti-HIV drugs, but these are more accurately termed antiretrovirals. and one continuing with current therapies alone.

At the conclusion of the trial, if any beneficial effects are demonstrated, an additional six-month supply of the product is available to all trial participants (including those on the non-treatment arm).

The herbal combination, as with all trials, has been given the complicated-looking code name CKBM-A01. It is an oral liquid developed by a Hong Kong-based company, CK Life Sciences Development Inc. The major ingredients are ginseng, wuweizu, jujube, hawthorn, soybean, mung bean, apple, honey and baker’s yeast.

The research team, led by Dr Luis Vitetta, has extensively reviewed the available scientific information on these components and found no contraindicationA specific circumstance when the use of certain treatments could be harmful. for HIV patients taking antiretroviral therapy.

As a participant in the trial I have not experienced any side effects other than a slight deterioration in my normal diarrhoea and an initial minor toe rash.

The herbs are taken four times a day. Whilst this is manageable, it goes against the trend of reduced dosing regimes and requires a real commitment. Being a liquid is also somewhat more inconvenient than tablets as you need to measure up a 45ml quantity and, as with most natural products, it doesn’t have a really sweet appetising taste. But then again, as I often say, no pain no gain.

Early results indicate that some trial participants are showing increases in CD4 counts, however of course we will have to wait until the end of the trial for the results to be fully analysed. There have also been some reported improvements in liverA large organ, located in the upper right abdomen, which assists in digestion by metabolising carbohydrates, fats and proteins, stores vitamins and minerals, produces amino acids, bile and cholesterol, and removes toxins from the blood. function.

The trial remains open for a limited time and those interested should contact Doctor Luis Vitetta at the Graduate School of Integrative Medicine located at Swinburne University (Hawthorn Campus). He can be contacted by telephone 03 9214 5975.