LONDON The UK's National Institute for Clinical Excellence (NICE) — which produces guidance for the National Health Service (NHS) on medicines, on the basis of clinical and cost effectiveness — has recommended that the use of methylphenidate (Ritalin/Equasyn) is appropriate for the treatment of severe Attention Deficit/Hyperactivity Disorder (ADHD). But it has cautioned that the amphetamine should only be prescribed after diagnosis of ADHD by a specialist and as part of a comprehensive treatment programme, with regular monitoring.
The NICE guidance clarifies how ADHD should be diagnosed and when Ritalin should be given. This should overcome concerns about the potential for overuse of Ritalin, which has resulted in legal actions in the US alleging that the manufacturer, Novartis, together with the American Psychiatric Association, has encouraged over-diagnosis of behavioural disorders in children. The company has denied this, calling the charges "unfounded and preposterous."
The NICE guidelines recommend that ADHD should only be diagnosed by a child/adolescent psychiatrist or a paediatrician with expertise in ADHD and should involve children, parents and carers, together with the child's school. They also suggest that Ritalin should only be used as part of a comprehensive treatment programme for children with a diagnosis of severe ADHD.
The need for careful follow-up was emphasised in the NICE recommendation that children on Ritalin should receive regular monitoring, with the suggestion that treatment should be discontinued at intervals to assess the need for further treatment.
The Royal College of Psychiatrists welcomed the guidelines, noting that they support what the majority of child and adolescent psychiatrists believe to be good practice.
Dr Stephen Kingsbury — Honorary Secretary of the Faculty of Child Psychiatry at the Royal College of Psychiatry and consultant child and adolescent psychiatrist at East and North Hertfordshire NHS Trust — said: "The NICE guidance is excellent. Any professional practising good ADHD diagnosis and management is probably already doing most of what the guidance suggests." He added: "ADHD should only be diagnosed by someone with experience in the condition, and should be multicontextual — looking at the child in different situations, such as at home and at school. A range of treatments should be considered, which may include Ritalin if appropriate."
The NICE guidance clarifies the diagnosis, suggesting that ADHD can only be diagnosed by observing the child in different situations although acknowledging there is, as yet, no validated diagnostic test. ADHD is diagnosed by identifying three core signs — inattention, hyperactivity and impulsiveness, when they have the following features:
• Persisting for at least six months to a degree that is impairing the child's development
• Clear evidence of clinical significant impairment in social or academic functioning
• Some impairment in two or more settings (usually at home and at school)
• Some of the signs were present before the age of seven
• The signs can not be accounted for by other mental disorders, such as depression or anxiety.
The NICE report points out that the consequences of severe ADHD for children and their families can be very serious. Children can develop poor self-esteem, emotional and social problems. Their educational progress is often severely impaired.
Treatments for ADHD include a range of social, psychological and behavioural interventions, which may be focussed on the child, parents or teachers and may include giving of information through to formal psychotherapeutic interventions. Dietary interventions have been found to be useful in some cases, where a particular food seems to aggravate hyperactivity.
Ritalin (methylphenidate) is one of only two medications currently prescribed for ADHD in the UK — the other is Dexedrine (dexamphetamine). Tricyclic and other antidepressants are used by some clinicians, although they are not licensed for ADHD.
Part of the reluctance by some psychiatrists to diagnose ADHD and to use Ritalin has been the relative lack of scientific studies underpinning the condition and its treatment. However, some clues are starting to emerge.Several brain-imaging studies have found localised foci that seem to be affected in children with ADHD. Most of these are in the frontostriatal cortex, in regions associated with attention control. "It is also fairly well established that the dopamine system is the most relevant neurotransmitter network implicated in ADHD," reported Dr Kingsbury. Ritalin acts on the dopamine system — inhibiting dopamine reuptake — providing a scientific rationale for its use in this condition.
The genetic basis of ADHD is also being unravelled. UK research has shown substantial genetic influences, of the order of 60% heritability. One study showed that relatives of ADHD sufferers were 5.6 times more likely to have ADHD.
The collaborative multimodal treatment study of children with ADHD was the largest, most rigorous randomised controlled trial in the condition so far (
A systematic review of 77 randomised controlled trials, including the multimodal treatment study, concluded that stimulants were effective in the short term, were more effective than placebo, and seemed to be more effective than tricyclics and non-drug treatments. But the team from McMaster University who carried out the review noted that many studies were small.
The review found that the short-term benefits of stimulants seemed to continue as long as they were taken, but there was limited evidence on what happened when treatment is stopped. There was also little information on longer term outcomes such as educational achievement, employment or social functioning.
It seems a paradox that hyperactive children should improve on treatment with a stimulant. The reason for this is that children with ADHD find normal life understimulating. "They have what could be called 'boreditis'. This makes them look for outside stimulation to make things more interesting. Amphetamines work in ADHD by stimulating children so that they take more interest in things around them. This helps them to settle down because they don't have to stimulate themselves," explained Dr Kingsbury.
There has been much concern about possible side-effects with Ritalin, with some media reports suggesting that children became 'zombie like' on the drug. But a systematic review of available research has shown that adverse reactions are usually dose-related and there is no evidence of harmful long-term effects. "The commonest side-effects in clinical practice are loss of appetite, insomnia and headache. But these tend to improve with time," Dr Kingsbury said. He suggested that the 'zombie like' state is extremely rare and is a sign of overdosage. "The solution is to cut the dose of Ritalin," he pointed out.
The sticking point for successful implementation of the NICE guidance in the UK is likely to be access to specialist ADHD care. It is estimated that severe ADHD, meeting agreed diagnostic criteria, affects roughly 1% of school-age children. This totals around 73,000 children in England and Wales. The NICE report suggests that roughly 48,000 of these are not currently on Ritalin.
"These guidelines will have a significant impact on the over-stretched resources currently available in Child and Adolescent Mental Health Services and paediatric services and this will urgently need to be addressed," warned Dr Kingsbury.
It is hoped that the NICE guidance will lead to rational use of Ritalin in ADHD in the UK. This may prevent the problems that have occurred in the US, where prescribing is estimated to be 10–30 times the level in the UK. Treatment rates for hyperactivity in some American schools have been claimed to be as high as 30–40% and children as young as one year have been given the drug.