### Therapy Scenario

#### Therapy: Clinical Scenario

A woman comes to see you concerning her son who has attention deficit disorder with hyperactivity. As she does not like the thought of medication, the child is currently untreated. She has obtained leaflets from a parents’ group called “Action on Hyperactivity” which suggests that hyperactivity can be caused by “hidden allergies” to common foods. They recommend a “few foods, low sugar, diet”. The mother asks whether she should put her son on the diet. You are tempted to say “try it and see” but take into consideration that restricting a child’s diet unnecessarily is generally unwise for both health and social reasons. Also, you know of some other children with hyperactivity in your practice and are interested in the possibility of any treatment which would be inexpensive, safe and have good parent acceptability. You pose the questions “In children with hyperactivity, does any form of dietary modification improve behaviour?”

Searching terms and evidence source:

You search the Cochrane Library for “diet” or “food” or “allergy” with “hyperactivity” or “attention deficit”.

You find bibliographic details of one review but this is from 1983. There are a number of randomised trials listed in the Cochrane Controlled Trials Register so you decide to have a look at these. Many concern the exclusion of food additives (the “Feingold” diet). You don’t consider these pertinent to the task in hand. One trial (Wolraich ML, Lindgren SD, Stumbo PJ, Stegink LD, Appelbaum MI, Kiritsy MC. Effects of diets high in sucrose or aspartame on the behavior and cognitive performance of children. N Engl J Med 1994;330:301-7) shows no effect of sugar and artificial sweeteners on behaviour of either normal children or those said by their parents to be “sugar-sensitive.” This casts some doubt on the low sugar element of the suggested diet.

However, you also find a number of articles which look interesting from the point of view of food exclusion. Scanning the abstracts, you find four papers in which children are first tried on an exclusion diet and then “responders” tested with double-blind, placebo-controlled food challenges. Response rates for the uncontrolled exclusion diet are up to 85% and food sensitivity is usually confirmed in the double-blind trial. (Boris M, Mandel FS . Foods and additives are common causes of the attention deficit hyperactive disorder in children. Ann Allergy 1994;72:462-8; Carter CM, Urbanowicz M, Hemsley R, Mantilla L, Strobel S, Graham PJ, Taylor E. Effects of a few food diet in attention deficit disorder. Arch Dis Child 1993;69:564-8; Egger J, Carter CM, Graham PJ, Gumley D, Soothill JF. Controlled trial of oligoantigenic treatment in the hyperkinetic syndrome. Lancet 1985;1:540-5)

You also find two trials which seem to compare a dietary approach to control on a randomised basis. One of these is in German. The abstract suggests a positive result but language difficulties prevent you reading further. (Schulte Korne G, Deimel W, Gutenbrunner C, Hennighausen K, Blank R, Rieger C, Remschmidt H . The influence of an oligoantigenic diet on the behavior of children with attention-deficit hyperactivity disorders. Zeitschrift Fur Kinder Und Jugendpsychiatrie Und Psychotherapie 1996;24:176-183) The other trial is in English and seems to be just what you are looking for. You order this paper from the library.

• Is the evidence from this randomised trial valid?
• If valid, is this evidence important?
• If valid and important, can you apply this evidence in caring for your patient?

### Completed Therapy Worksheet for Complementary Medicine

#### Citation

Schmidt MH, Mocks P, Lay B, Eisert HG, Fojkar R, Fritz Sigmund D, Marcus A, Musaeus B.
Does oligoantigenic diet influence hyperactive/conduct-disordered children – a controlled trial.

#### Are the results of this systematic review of therapy valid?

Was the assignment of patients to treatments randomised?
Yes
And was the randomisation list concealed?
Unclear, but trial was crossover in design
Were all patients who entered the trial accounted for at its conclusion? And were they analysed in the groups to which they were randomised?
No dropouts reported in this in-patient trial
Were patients and clinicians kept “blind” to which treatment was being received?
Yes: two diets were prepared, a real diet and a “placebo” diet. Children were unable to tell them apart; other relevant staff were not allowed on ward at mealtimes
Aside from the experimental treatment, were the groups treated equally?
Yes, see above
Were the groups similar at the start of the trial?
Yes (crossover trial)

#### Are the valid results of this randomised trial important?

Calculations:

Less than a 25% better response on two of three behavioural outcomes comparing phases Relative Risk Reduction (RRR) Absolute Risk Reduction (ARR) Number Needed to Treat (NNT)
CER EER (CER – EER)/CER CER – EER 1/ARR
96% 76% (96% – 76%) / 96%
= 21%
96% – 76%
= 20%
1/20%
= 5 pts

#### Can you apply this valid, important evidence about a treatment in caring for your patient?

##### Do these results apply to your patient?
Severity is probably less than those in the trial, but otherwise child is similar
How great would the potential benefit of therapy actually be for your individual patient?
Assume that we do not expect improvement in this child
Method I: f
Risk of the outcome in your patient, relative to patients in the trial.
Expressed as a decimal:_1____
NNT/f = __5_/__1_ = 5
(NNT for patients like yours)
##### Are your patient’s values and preferences satisfied by the regimen and its consequences?
Do your patient and you have a clear assessment of their values and preferences?
Need to find out.
Are they met by this regimen and its consequences?
Need to discuss whether family is prepared to deal with social consequences of a restricted diet. Possible need for referral to dietician.

### Children with hyperactivity: Restricted diet controls reduces behavioural problems in some

#### Clinical Bottom Line

An oligoantigenic diet improves behaviour scores by more than 25% in 1 in 5 children with attention deficit disorder and / or conduct disorder.

#### Citation

Schmidt MH, Mocks P, Lay B, Eisert HG, Fojkar R, Fritz Sigmund D, Marcus A, Musaeus B.
Does oligoantigenic diet influence hyperactive/conduct-disordered children–a controlled trial.

#### Clinical Question

In children with hyperactivity, does any form of dietary modification improve behaviour?

#### Search Terms

Cochrane Library for “diet” or “food” or “allergy” with “hyperactivity” or “attention deficit”

#### The Study

• Children admitted to a psychiatric ward for hyperactivity or problem behaviour. 60% of sample had severe attention deficit hyperactivity disorder or severe conduct disorder or both.
• Randomised, crossover trial
• In treatment phase, subjects fed an “oligoantigenic diet” consisting of lamb, turkey, rice, potatoes, cabbage, carrots, apple and banana. In control phase, ate foods assumed to be antigenic (e.g. cereals) and to which food additives had been added.
• All foods cooked by same dietician; subjects unable to distinguish the diets; teachers and observers not allowed on ward during meals.
• Behavioural outcomes measured in ward, classroom and test situations.
• Successful outcome was defined as 25% better response on at least two situations.

#### The Evidence

Outcome Time to Outcome RRR ARR 95% CI NNT 95% CI
Lack of response During treatment week 21% 20% 7% to 33% 5 3 to 14