| A different kind of trial
Text of poster presentation to 1997 AIDS Impact conference, Melbourne The KM1 Herbal Formula trial is a first for Australia. Based in the community it has involved people from all walks of life, those infected and those affected by HIV/AIDS. It has built itself from the ground up and has secured support from a broad spectrum of people with an interest in HIV/AIDS including many with a background in allopathic medicine. Diverse scientific information on complementary medicine is not generally available as there are not the re-sources or - often - the motivations available to pursue such research. Yet we know that the synergism of chemical compounds found in plants far exceeds the human imagination. It is likely that potent anti-viral agents (including ones that can battle HIV) already exist in the plant world, waiting to be discovered. Medicinal plants can also contribute to the fight against viral infections through enhancement of immunity - a vital, and often overlooked aspect of HIV therapy. Improving the immune system is an central aspect of herbal therapy which has no equal in other therapeutic modalities (a homeopath would argue this). This meth-odology forms the basis of the KM1 Herbal Formula trial. This trial has been organised by people that have not had anything to do with trial organisation previously. The work involved has proven to be both daunting and large, however we have shown that it is possible if one builds networks of community support. The approach from the outset has been to have the trial available to all people with HIV/AIDS. In practice this has involved outreach to marginalised people and has proven difficult. For example, a wish to include prison-ers with HIV/AIDS has turned into a two year battle with the New South Wales Department of Corrective Services. Similarly, women have often been excluded from clinical trials. Herbs in the correct dose are safe for pregnant women and to this end women’s specific case record forms were developed by Positive Women. They deal with very complex and psychologically, sociologically and economically difficult problems which positive women have to deal with. We have taken into account that our senior citizens are a predominant part of our society. They are largely excluded in all walks of life especially when investigating HIV/AIDS. Our eighty old participant started on wave one of the trial in March 1996 and is still running. Our family was one of the first registrations and never actually started due to HIV related illness. The mother has since died of AIDS leaving the two negative (one child is not shown here) older children to return to the father from a previous marriage as well as a positive father and baby. Like many issues around HIV/AIDS one cannot avoid the politics of a given situation in order to be an effective researcher. We have taken this attitude which we call ‘inclusivity’ not only because it is the right thing to do, we also think that it will result in a better sample from which more accurate information on the formula’s effects can be drawn. The best example of this approach is with IDU, who are traditionally excluded from trials because of their often ‘chaotic’ lifestyles. Our approach is that people do use drugs and that this drug use is usually secretive. We believe that it is more useful to approach the situation sensitively with the aim of creating an confidential atmosphere in which that information will be volunteered by trial participants who would other-wise keep their drug use secret (for fear of being removed from the trial or of having their confidentiality breached). Issues around ‘chaotic’ lifestyles can then be dealt with inside a more open and less judgmental framework. Because of issues around money, power, influence, politics or simple prejudice, research into simple, common-sense, non-drug solutions to problems in HIV/AIDS therapy have become the poor cousin of ‘advanced technology’ solutions. This is not simply about bad policy in terms of the vast majority of the world’s PLWHA (a major issue at the recent international AIDS Conference in Vancouver), it is also relevant in the first world. Even though ‘combination therapy’ has received all of the attention, health solutions for people with HIV/AIDS must involve a more holistic response. We believe that the formula (and the concurrent attitudinal change which has resulted from many of the people actively participating in this trial) has a significant role to play This trial is a beginning to providing the scientific information from which people can make effective treat-ment decisions. What is needed is government funding - volunteer effort and the occasional small donation Cheque only goes so far. There is another ‘downside’ as well. Although this trial has received extensive support from all quarters it has also been opposed - both overtly and covertly. Some of this opposition has come from the blind prejudice of-ten shown to complementary solutions. Other opposition has come from those who, quite correctly, have op-posed the trial because of various aspects of its protocol, particularly the use of a placebo. The trial’s protocol was designed by ourselves following the advice of two HIV/AIDS bodies and this design has proved difficult in reality - our next trial will not have a placebo wing. We decided to proceed with the trial protocol, despite these problems and rather than stop and start again, because of the impracticality of this option. However we are aware that some of the opposition has come from people with vested interests which are opposite to the aims of the trial. This has been documented and will be another useful outcome from the trial. The success of the trial in overcoming this opposition provides a lesson to others that the promise of strong opposition must never stop anyone from proceeding to do what is right.
Technical & research advice: Community HIV/AIDS Research Network, 1/376 Victoria St, Darlinghurst NSW 2010. Herbal formula donated by Mediherb Pty Ltd., 124 McEvoy St, Warwick QLD 4370. Executive approval by South-Eastern Sydney Area Health Service Research Ethics Committee, Cnr High & Avoca St., Randwick NSW 2031. Trial Site: PWA Day Centre, 14/20 William Lane, Woolloomooloo 2011 Sydney. Poster text: Paul Canning and Jan Kneen-McDaid. |
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