The Report from the Preliminary Study - Uganda (May 2011)


This was meant to be a preliminary open-focused investigation to test a range of particular hypotheses rather than recover amounts of hard data - the questions being: whether local health workers would take to training their patients; whether patients would accept the treatment; whether they would respond as was suggested should happen from the Japanese documentation; whether interaction with existing medication would be positive; whether drug failing patients would respond positively; and whether patients co-infected with HIV might respond at all.

The initial training of 12 nurses was carried out in March 2010 at two clinics in Kampala - Kisenyi and Kiswa.

Kisenyi clinic had extremely poor facilities and was withdrawn from the program after four months due to lack of support from the Clinic Incharge, lack of motivation of the nurses to do extra work for Moxafrica, and general difficulties in organisation/communication.

At Kiswa Clinic moxa work has continued for over 12 months, though some of the nurses we trained have not been able to find time to participate. The Incharge (Molly Busingye) and TB nurse (Mary Magdalene Ichumar) have given their full support and have worked well with our co-ordinator Allen Magezi . Both are emphatic that patients should continue to be offered moxa treatment at Kiswa for as long as we can provide it.

Allen Magezi has broadly run the program and has herself taken on much of the training of patients. Such was her enthusiasm that during the first 6 months she reported that large numbers of patients were being recruited. However, we were concerned about such high numbers because of issues of patient management, and we were not convinced that Allen or the other staff would have time to carry out the monitoring and feedback that we required for so many patients. Midway through this preliminary investigative period, we therefore asked for the number to be kept below 100 and provided revised questionnaires to be completed for each patient.

Initially we hoped that patients would enrol in the program early on and stay with it for 12 months. We did not at this stage envisage a continuing enrolment of new patients, some of whom would only have been using moxa for a short period by the end of the 12 month study. However, Allen found that many patients did drop out of the program for various reasons (see below) and she wanted to replace them with other patients who seemed more suitable. As time went on and clear benefits of moxa treatment became evident, however, the staff became more and more keen on enrolling new patients, so there has been a steady rate of enrolment over the year.

During our visit in November 2010, it was obvious that staff had not been able to fill in questionnaires as regularly or as fully as we had hoped, and we were concerned the quality of information was not going to be very useful. We asked Allen to focus particularly on following the progress of a small number of patients so that we could get detailed information about them for the remaining months. She has done this very well, and we now have good follow-up data for 35 patients, most of whom we managed to talk to ourselves on at least 2 separate visits.

The data we have collected is mainly anecdotal, describing each patient’s drug regime and symptoms. Unfortunately it has not been possible to obtain results of blood tests (although we may yet be able to access to CD4 data for HIV patients).

RESULTS

Total number of patients trained is unknown but exceeds 100.


At the end of the study, around 50 patients were still enrolled and using moxa regularly. All of them had either completed a TB drug course or were still on it.

The following reasons for drop out were given:
· No buddy to do moxa treatment - many TB patients appear to be living on their own
· Moxa was too difficult/fiddly to apply
· Patient felt too ill/tired to bother.
· Patient drinking excessive alcohol
· No results at first so patient gave up
· Moxa was too painful
Two were confirmed as dead
Many TB patients appear quite commonly and frustratingly to re-register themselves at other clinics meaning that they get lost from the clinic radar


Detailed follow-up of 35 patients :

Age Male Female
21- 30 9 5
31-40 6 2
41-50 3 4
51-60 3 1
>60 1 0

23 Male; 12 female Mean age 36

18 patients were HIV+.

We were unable to ascertain any specific data on drug resistance. This is because of the lack of any available diagnostic resource locally. We were able to categorise patients as either relapsed ar apparent drug failures based on their records, and it is reasonable to assume that some, if not many of these would be drug resistant, although how drug resistant (DR, MDR or XDR) it is impossible to assess. We are hoping that our parallel studies in South Africa will unlock this for us.


Patient Compliance

Less than 10 patients were definitely using moxa on the back points. Most were only using St36, usually because they had no buddy. In most cases scars could be seen to confirm regular use of moxa. However sometimes the location of points was far from accurate and many of the leg points were too distal or too lateral. In spite of these factors, both of which we would have expected to impact negatively on the probable responses, reports of positive response were being made with these patients which were confirmed by the health workers. We believe these findings to be of possible significance to further moxa treatment of TB patients in Africa.

In two cases people were doing their own back points. The locations in these cases were not at all accurate but in one case very large scars were observed.

It was clear on checking with patients in May 2011 that most patients were using cones that were far too large in terms of height, wasting a lot of moxa and potentially increasing the risk of larger than desirable scarring. This was a reminder to us that both patients and trainers should be checked regularly to remind them of the correct size and location. Using larger cones than necessary would also possibly cause considerable pain and would put many patients off – this is perhaps one reason for the incidence of early drop out.

At the end of the study, 13 patients had been using moxa for 7 months, but some for over a year. All of them had been taking TB drugs for over 3 months, and most of them for over 6 months.

Some patients started moxa at the same time as beginning their drug regime, but many had been on the drugs for some time before starting moxa.


Patient Feedback

Patients were assessed at the start of moxa treatment and then subsequently on a monthly basis. A simple questionnaire asked about symptoms, any noticeable improvements and any problems with the moxa treatment .

In summary, the following observations were made:

· No adverse effects of moxa were reported.

· Most patients report unpleasant side effects developing after the start of their TB drug therapy; these were less marked or even entirely absent if moxa was used at the same time.

· After starting moxa, all patients reported some or all of the following: improved appetite, weight gain, reduced joint pains, reduced peripheral neuropathy, and a general increase in strength and energy.

· In patients who started moxa some time after the TB drugs, there was a reduction in side effects which began sometimes only one or two weeks after starting moxa.

· Some patients stopped using moxa when they began to feel better, but some symptoms returned. They were encouraged by the clinic to start moxa again, and the symptoms soon reduced. This had really convinced them of the benefits of moxa, and most patients wanted to continue using it after they had finished their drug course.

· Patients co-infected with HIV reported similar improvements with moxa to those having only TB.

· Clinic staff were quite clear that the patients receiving moxa treatment were recovering from TB much faster that those on TB drugs alone.

Conclusions

Whilst we are unable to draw any specific conclusions from the above, some potentially highly significant hypotheses can be construed which we believe will be worthy of further more targeted controlled research:

1. That compliance to standard TB treatment (which is one of the major problems for the containment of the disease because of the frequent pernicious side effects of the medication) might be improved if moxa were to be widely used alongside first line drugs.

2. That the infectious period of the disease might be shortened when moxa is used with drugs. This would be relatively simple to measure, and, if proved, would suggest that moxa might help reduce the spread of the disease in Africa.

3. That patients co-infected with both TB and HIV/AIDS could particularly benefit from moxa treatment. These patients are repeatedly reported in the medical literature as being particularly challenging to treat, and the combination of these two lethal diseases is a particular problem to treating TB in Africa with little existing evidence base to support the treatment methods used on the continent.

4. We have little to report concerning the response of drug resistant cases simply because we were unable to properly determine drug resistance because of lack of diagnostic resource. We are hoping to remedy this when we are able to harvest the results of the two parallel programs now started in South Africa.

5. The unfortunate and very uncomfortable fact exists that, whilst treating drug-susceptible TB with first line drugs is now cheap, treating drug resistant strains is extremely expensive (a course of second line drugs costing around 250 times as much as a course of first line medication and is generally unaffordable in Africa and likley to stay that way). The idea that the epidemic can be either contained or successfully treated in most of Africa is, in our opinion, a fantasy. Based on the responses we have seen we believe that it would be quite reasonable to test known drug resistant cases using first line medication and moxa in an environment where medical resource cannot support the supply or administration of second line drugs. We think it unlikely that cases of XDR-TB are likely to significantly respond to such treatment (for whom the best treatment in any case is most often palliative in Africa), but we seriously speculate that cases of DR- and MDR-TB might well respond to moxa treament alongside first line drugs. We fully appreciate that this might raise some complex ethical issues, but we suggest that the idea is worthy of consideration based on the enormity of the problem.