In these trials a six week or three month period is divided into three fortnights or six weeks. During three of these periods the patient receives the medication to which his or her response is being tested. During the other three periods the patient receives a placebo - a pill, capsule, etc. which is identical in appearance and packaging to the actual medication but contains no active agent. During any given period neither the patient, nor parents, nor teachers, nor the treating doctor know whether the patient is receiving the drug or the placebo. The patient, parents and teachers keep a structured diary in which they record details of behaviour and symptoms.

At the conclusion of the trial these observations are carefully assessed to determine whether the patient appeared noticeably better during the periods on medication, or little different, or worse. The participants are also invited to guess which were the periods during which the patient was on medication and which were the periods on placebo. The idea is that if the patient is a "responder" - i.e. someone who derives clear benefit from the medication, the observations will clearly show an improvement during the periods on medication and a worsening of symptoms during the periods on placebo. Further, if there is clear benefit, all concerned should be expected to be able to guess accurately which were the periods on medication and which were the periods on placebo.

This project is ongoing but to the most recent date for which information is available eight general practitioners and four paediatricians had enrolled thirty patients with clinically diagnosed ADD. Of these, twenty had completed the IMET, three withdrew and seven were ongoing. Of the twenty, seven had proved to be "responders" and another two probable responders - in total 45%.

The responders generally continued on medication and were satisfied that the test had demonstrated to them its effectiveness. There were instances where the child patients indicated that they themselves had observed they had fewer problems while on the medication and they were therefore much more motivated to take it regularly, an important advantage of this methodology, since compliance is an issue; some children dislike being on medication.

Of the eleven non-responders, four ceased taking stimulant medications, three elected to continue but after three months one of these had ceased and was trying other strategies.

Numbers involved at this stage are small and it would be unwise to draw too many conclusions. We will follow this research with interest and will try to update this page as more information becomes available. Provisionally, the following observations can be made:

Firstly, results to date suggest that stimulant medications may be effective in less than fifty percent of cases. We note that round the world millions of children are being prescribed these medications; we wonder how many of them are receiving the medications to no good effect.

Secondly, the medications concerned are - in Australia at least - classed as S8 drugs, the manufacture, supply, distribution, possession and use of which must be controlled in order to reduce abuse, misuse, physical and psychological dependence. They are also popular on the black market and known to be traded in some school playgrounds for purposes other than those for which they have been prescribed. Pointless prescription of such medications is obviously to be avoided wherever possible.

Thirdly, families in Australia and elsewhere may be interested to know that these IMET's may be available to you, to better inform the management of your family's ADD/ADHD condition. It is good for all concerned to be able to find out, if a medication is proposed, that it actually is beneficial.

Fourthly, a growing body of studies seems to be indicating that these medications do not cure ADD/ADHD; they mainly only suppress the symptoms. If the medication is ceased, the symptoms soon return in full force. Medication generally succeeds only in rendering children more docile and perhaps reducing the educational and other damage; it does not seem to fix the intellectual deficit. In this context the following statement, found recently on an ADD-related website, is important: "Long term studies have now shown that although medication may improve hyperactivity and on-task behaviour, it does not improve the impaired cognitive skills (information processing ability) of ADHD children."

Since ADD/ADHD are now recognized in many cases to be lifelong conditions, the implications and costs of maintaining individuals on medication for maybe as long as fifty years are well worth considering. We invite families to work out the current cost per month of prescriptions of these medications, and of associated general practitioner and specialist visits, and to multiply these out over twenty or fifty years. The totals will be very considerable in most countries. In some countries public health budgets may cover some of the costs but they are costs that nonetheless have to be borne by society through taxation provisions.

There are also known side effects of stimulant medications to be taken into account. If dietary management, as proposed by Hafer, is a viable alternative which avoids all these costs and undoes the damage, it is plainly well worth a serious trial. For those reluctant to have young children or other family members indefinitely on medication and for those for whom medication gives no or little benefit, this approach should have strong appeal. The only known side effect of the diet proposed is improved overall family health. Percy Weston's story, reported on our Supportive Evidence page, suggests the diet will give valuable protection against cancer, another scourge which few families can afford to ignore.

Our plea is that you try Hertha Hafer's minimal phosphate diet and other alternatives first and turn only to stimulant medication as a final resort. If at all possible, we should avoid giving children as young as three the message that if you have a problem, the answer is to throw a drug at it. It is a real danger that they will internalise this message and when they strike problems as teens or young adults - as they inevitably will - they will look around for drugs to provide an answer. And - as concerned parents are all too well aware - there will be plenty of dealers willing to offer them drugs then. And regrettably, under the influence of peer pressure and the many subtle forces which promote the drug culture, they may not discriminate as clearly as we might wish between prescription, recreational and illegal drugs.

Acknowledgements
C Jane Nikles, Senior Research Officer and PhD student, Centre for General Practice, The University of Queensland.
Prof Paul Glasziou, Professor of Evidence Based Health Care and Head of Department of Social and Preventive Medicine, The University of Queensland.

References
Duggan, Cate M et al, Managing ADHD in General Practice: N of 1 Trials Can Help: Australian Family Physician Vol 29, No 12, December 2000, p 1205
Nikles, C Jane et al, Preliminary Experiences with a Single-Patient Trials Service in General Practice, Medical Journal of Australia, Vol 173, 17 July 2000, p 100.
Nikles, C Jane et al, N of 1 Trials: Practical Tools for Medication Management, Australian Family Physician, Vol 29, No 11, November 2000, p 1109.