ATAC AFFINITY GROUP

CAM in the CCG

July 26, 2002

A group of activists, some representing Community Constituency Groups (CCG) to the Adult AIDS Clinical Trials Group (AACTG) met to discuss issues related to the use of Complementary and Alternative Medicine (CAM). See the original flyer attached for background.

We launched pretty quickly into a discussion of specific interventions that people wanted to see studied. Time was limited at around 40 minutes, but we came up with several ideas pretty quickly. Clearly, this is a discussion that needs to be broadened within the community and more specific recommendations made. There was strong interest in seeing studies being done of what is being used frequently among people with HIV/AIDS. Drug-botanical interactions were also key. The group could then consider how to approach the ACTG to urge them to fund and conduct such studies. They are the government and thus, ostensibly, they do work for us!

We started first by discussing a bit the type of interventions people have used; then we addressed the issue from the standpoint of what were the most life-threatening issues that people faced. The liver came up first and foremost as an important area, considering the problems presented by drugs like ritonavir and nevirapine, and the exacerbation of problems through liver diseases like chronic hepatitis B or C.

A suggestion was also made to suggest that the Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol (A5001) be amended to include a parameter such as mitochondrial damage, with an eye toward comparing people who suffered it worse than others and examine their supplement usage. This will be further investigated.

The following list reflects the types of interventions suggested for study.

1) Milk thistle (Silybum marianum) - a study that would compare its effect on liver function. Concerns about its interaction with Cyp450 3A4 were raised; it was noted that Jules Levin had reported that the NIH's Piscitelli's results showed no adverse effect on protease inhibitors, except for a modest increase in plasma levels. Thus, it is important to follow-up with a clinical study in PHAs. Brief discussion was raised as to the form of the study. Should we compare co-infected to HIV-only infected individuals? What are the best endpoints? Liver enzymes?

It was also important to begin the process by identifying a sympathetic physician to help to design and implement the study. There is a liver Research Agenda Committee that might be approached with this in mind.

Another possibility was to do a nested sub-study to serve as a pilot evaluation. And indeed, in the following week, we got a potential "bite" from Dr. Lynch who is interested in doing a substudy using milk thistle in a couple of trials involving HIV and Hepatitis B coinfected individuals. See the email to him attached below.

The issue of potency and purity was raised. This could be addressed through lab analysis of products available on the market to assure that they were pure (no contaminants) and potent (in this case, containing the stated 70-80% standardized level of silymarin).

2) Citrus bioflavonoids given in a three gram dose, tid to treat hyperlactatemia and lactic acidosis. [Note: people were interested in learning more about the proposed B-complex/CoQ10/carnitine study that it has been suggested the ACTG is undertaking; apparently, it is a small pilot study.]

3) The use of pancreatic enzymes with hydrochloric acid supplements to offset hypochlorhyria (not uncommon) and enhance digestive capacity.

4) Use of 50 grams of dandelion root (Taraxacum officinale). Recipe is to boil one liter of water, then add the dandelion (root). Steep it for 8 hours, strain. Drink 1 cup/day (about 4 days). May repeat about every 2 weeks if desired. Sometimes when the liver is greatly swollen, more can be taken and the process may be repeated more frequently. Not to be taken if allergic. Could a clinical study--a quick and dirty--be done to evaluate the efficacy of this?

5) A study to offset mitochondrial toxicity using CoQ10, carnitine, possibly NAC and a B complex. A substudy might include evaluation of tumor necrosis factor levels.

6) Studies for neuropathy. It was noted that Michael Youle in London's Royal Free Centre for HIV Medicine is conducting a study of acetylcarnitine. The group offered suggestions including acupressure, acupuncture (which has been studied), reflexology along with a mix that included:

  • Take one lemon: cut in2 quarters ( peel & seeds) blended up with one tbl spoon of extra virgin olive oil & your favorite frozen fruit juice. (One blender- pitcher should last three days.)
  • One tablespoon extra virgin oil
  • Mixed in fruit juice
  • Take a cup of this once a day.
  • Take also 3 capsules of lecithin containing 19 grains twice a day

This was based on the experience of one participant whose crippling neuropathy was rapidly reversed with this simple intervention.

Another participant noted that B6 supplements kept her neuropathy at bay; it would creep back when she stopped.

Alpha lipoic acid might also be evaluated along with a B complex.

Finally, a future project would be to have a list of currently enrolling and already completed studies by the NIH relating to AIDS and the use of dietary supplements and CAM would be very helpful. The Foundation for Integrative AIDS Research (FIAR) agreed to help collate such a list and publish it on their website (http://aidsinfonyc.org/fiar), as well as the ATAC website.

****

Email to Dr. Lynch:

Patrick Lynch, MD
p_lynch@northwestern.edu
Northwestern University
675 N. St. Clare
Suite 15-250
Chicago, IL 60611

Dear Dr. Lynch,

Earle Core has contacted me regarding your interest in doing a substudy of milk thistle (Silybum marianum) in studies of A5127 and/or A5167. We are very interested in helping to develop the protocol for this substudy and wished to begin a dialogue with you.

First, a few quick questions. Do you have the current protocols for each of these studies? I understand that they are studies of chronic hepatitis B. Are the participants in A5167 co-infected with HIV? Have the trials begun to enroll? I understand A5127 has begun enrolling and is among co-infected individuals.

We would like to also discuss whether individuals would be randomized to receive milk thistle or a placebo. Also issues surrounding the selection of an appropriate and standardized brand. Would it be possible to secure funding for potency and purity studies to assure the product's quality? Or better yet, are their HPLC or HPTLC facilities that could be utilized for this purpose at Northwestern?

We look forward to hearing from you and discussing this issue. This is an incredibly important step as so many of us are using these types of interventions with inadequate clinical data. This could be extremely helpful in treatment decision making.

Yours,
George M. Carter
Director, FIAR
http://aidsinfonyc.org/fiar

***

Notes on ACTG A5127 - Treatment of Hepatitis B Open mid-July

Purpose: Phase II study to evaluate adding Adefovir (ADV) or Tenofovir (TDF) to 3TC for treatment of Hepatitis B

Description: Randomized to ADV + TDF placebo added to 3TC vs. TDF + ADV placebo added to 3TC with potential to cross over if not responding

Criteria: Taking 3TC, stable antiretroviral treatment * 12 weeks, HIV RNA <= 10,000, Hep. B DNA <= 1 * 10(6), (+) Hep.B antigen, (-) Hep.C antibody within 24 weeks

******

Original flyer:

CAM stands for "Complementary and Alternative Medicine."

Complementary medicine is that used with conventional treatments. Alternative medicine refers to the use of unorthodox interventions exclusively. Integrative medicine is where we may be headed, where the best of what works is incorporated into medicine and its practice.

What relevance does this have to the National Institutes of Health (NIH), the Adult AIDS Clinical Trials Group or the Pediatric version of same? What relevance to the Community Constituency Groups?

A number of issues are relevant:

  • First, data from disparate sources support the notion that many people with HIV/AIDS use CAM (ranging from 20-70% depending on how CAM is defined, interview population, etc.);
  • Data are not always available on efficacy, limitations, toxicities;
  • Most people (95%) with HIV have NO access to antiretroviral therapy (ARV) and rely on botanical and other interventions to treat HIV;
  • Those that do have access to ARV suffer from one or more of a wide array of side effects;
  • Costs of CAM are almost always borne out-of-pocket: access for resource poor individuals is limited

Some interventions that hold promise include coenzyme Q10 (for slowing loss of mitochondria), acetylcarnitine (managing neuropathy), combination botanical therapy (to delay progression), NAC (to replenish glutathione) and alpha lipoic acid (to improve liver function, offset neuropathy). There are many other interventions--these are highlighted as examples of costly interventions (relative to the costs of dietary supplements). Indeed, New York State already covers the use of some of these such as prescription carnitine (Carnitor; but not acetylcarnitine) and glutamine. Clinical data will help people to make treatment choices as well as to provide a means of advocacy for inclusion in state ADAP and Medicaid formularies for those who otherwise cannot afford these interventions.

This affinity group is designed to discuss these issues. If you feel the study of CAM is important, please attend this session so that we can discuss:

  • HOW CCG MEMBERS CAN ADVOCATE FOR CAM STUDIES
  • DISCUSSION OF CURRENT CAM STUDIES THROUGH NIH
  • WHAT SHOULD BE STUDIED
  • APPROPRIATE CLINICAL METHODOLOGY
  • OTHER ISSUES

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