September 5th 2012 - The RCT has begun
At of the end of august the Phase II Randomised Control Trial on the adjunctive use of moxa for the treatment of TB formally and finally began. We hope you won’t mind if we recap – it’s a study with two arms of ninety patients each which has been painstakingly and collaboratively designed to maximise possible outcomes in terms of data interpretations, is being led by a professor of pharmacology, and is being executed by a carefully chosen team of Africans consisting of a highly astute young doctor, a committed young data manager, a couple of feisty TB nurses and a laboratory expert. They’re taking this very seriously.
Professor Paul Waako, Richards Musiba (data manager), Rehena Kigogo (senior TB sister), and Geoffrey Omiah (lab boss)
To our knowledge, nothing like this has ever been attempted before, investigating the complete immune response from small cone direct moxa treatment for patients infected with tuberculosis, and certainly never with cases co-infected with HIV/AIDS - which we know many in the study will be. The nearest was Dr Shimetaro Hara’s Japanese research into the recovery tendencies of guinea pigs infected with TB back in 1929. That’s a long time gone, but it gave us the first real clue as to how to set about this.
Back then Japan was facing a serious TB epidemic with incidence rates approaching 300 people per 100,000, and that was considered serious. South Africa (which has the best surveillance resource so is the most accurate in Africa) today has an incidence rate of around a thousand per hundred thousand – a lot higher even in some hotspots. No-one actually has any real idea of what the incidence rate may be in Uganda today, but it is certainly still rising and has been tragically complicated this year by an unbelievable three month hiatus in drug supply which will have fed a current spurt in rates of drug resistance, creating lethal strains of disease which are pharmaceutically untreatable in Uganda and indeed in almost all of Africa.
We’ve still only raised 50% of the necessary $60,000 to complete the trial, so we’re into yet another journey of trust to get the study completed. As importantly, we’re now totally in the hands of science and scientists. Up to this point we’ve been working with health workers and TB patients who’ve consistently reported positive results from daily moxa treatment – certainly enough to interest the scientific team at Makerere University; but this is certainly nowhere near enough to convince the rightfully sceptical world of modern hi-tech medicine. Why should it? This is why we need these scientists.
What’s exactly at stake? A desperate battle against newly-morphed drug-resistant versions of mankind’s oldest, most feared and most lethal bacteriological foe, a disease which used to carry off more humans century after century than wars, than plagues, than natural disasters – as it still does in Africa where it has developed an even more terrifying face than ever before.
The trial is being conducted at Kiswa Health Centre in downtown Kampala - at the same TB clinic where we conducted our very first pilot study. The clinic can see as many as eight newly diagnosed cases of TB a day.
There is a brand new laboratory just ten yards from the TB office where one hundred-and-eighty patients’ sputum and blood samples will be carefully and regularly analysed and where liver and renal functions can be monitored. A short walk down the road will take the patient to a small x-ray facility giving further data.
Africans have an amazing capacity to smile in adversity – and if any one of these possible outcomes turns into reality we will be smiling alongside every one of them. We also believe that the venerable Dr Hara will be smiling down on Uganda and Africa as well, because he believed back in the 1930s that moxa was a therapy for ordinary vulnerable people infected with TB who had no medical resource to fight it with.
But we have to remind you that we do still need that second 50%. We need help to do this. We do not want to financially bleed friends and colleagues, but we have to ask you for help. We HAVE to complete this research now it’s underway. If you can think of any way at all that you can help – by doing sponsored events, by doing garage sales, by talking with your local church groups, by approaching philanthropic contacts – anything! – please talk to us, and we’ll do everything we can to help you in your efforts.
Meanwhile we are also already looking at possible future developments if the study works out well.
We’re still maintaining treatments in two townships in South Africa, a country that may hold the key to further research because of their more sophisticated diagnostics.
We’ve been facilitating a plant trial of four strains of mugwort in South Africa (with two being reported as flourishing which are being re-seeded), and we may even try repeating this in the western highlands of Uganda with a view to developing a cottage industry to process the mugwort for moxa.
And we are tentatively developing a collaborative relationship with a Ugandan NGO called The “Community Holistic Approach to Health” (CHAH) with whom we intend to roll out treatment into the countryside at the earliest opportunity if we possibly can.
A non-negotiable part of this project has been the implicit idea of its earliest possible africanisation. This research is being conducted by Africans, and the training is now being run by Africans, something which we see as being immensely important. It may soon be being rolled out by Africans as well.
And we may have outreach moxa projects starting in both Haiti and Thailand this autumn of which we may have more news soon.