Flu vaccination: who next?
In the second of a two-part update on glue ear, Professor Mark Haggard and Mary Gannon detail the latest thinking on surgery and the alternatives
and Mary Gannon detail the latest thinking on surgery and the alternatives
Surgery in otitis media with effusion (OME) has been the subject of much controversy, but parental demand for it has remained high. Given the limitations on the alternatives (see box) the role of GP as gatekeeper becomes paramount. Provided surgery is used sparingly and rationally it is of more concrete value than any other presently known treatment.
It is beyond question that the placement of short-stay ventilation tubes (VTs) otherwise known as grommets does improve the condition of the ear with respect to fluid, and improves the hearing of the child. But the knock-on effects into behaviour and language appear to be slight, and in general the effect only lasts so long as the VTs are in place.
The fundamental question of whether the effect on the ear ramifies into the general health and development of the child, and into family quality of life, has not been fully answered yet. Hearing is not the only aspect of outcome leading to concerns in parents.
Who should have surgery?
In children under three who have been identified by a screen and received diagnostic confirmation (not necessarily with a persistent history) and who consequently have a high remission rate, two trials have failed to show benefits from VTs in such domains of outcome2,3. But in older children with well-established OME we have shown benefits in an auditory disability task, discriminating speech against a noise background4. This speech-in-noise measure also provides the first firm evidence for a means of saying which children should receive the treatment in order to benefit.
A combined success
With collaborators in 10 UK ENT departments, we undertook the Trial of Alternative Regimens in Glue Ear Treatment (TARGET) in the late 1990s, with chiefly MRC support. As publications are pending we cannot report detailed results here. One finding we can reveal is that for hearing as outcome, the adjuvant effect of adenoidectomy takes six-12 months to build up.
But we have recently analysed the factors in ENT re-consultation in children over a period of up to five years, even after they have been through the two-year trial with very comprehensive care, including switching from control to treatment arms where necessary.
Here, giving adjuvant adenoidectomy (AD) cuts the long-term need for ENT re-consultation to about half that for VTs alone. This durability makes the combined operation highly cost-effective. There is a complementarity in time of maximum effect, and in the domains of outcome affected (VT effects on hearing alone, but short duration of benefit; AD on hearing and
physical health, but long duration). This leads
us to recommend not withholding short-stay
VTs when giving adenoidectomy for OME.
Not all children currently considered for VTs can, will or should be given AD. At present only about 15 per cent receive AD at first VTs. We have yet to model the precise increases in cost-effectiveness for groups selected in specifiable ways (rather than just the randomised arms of the trial).
For recurrent acute otitis media (RAOM), in the absence of persistent OME, the published trial evidence on the effectiveness of VT insertion is limited, although VTs are widely used for RAOM alone in many countries.
The therapeutic hypothesis is reasonable that aeration makes survival of bacteria in the middle ear difficult, and at least inhibits flare-up from the inactive state. But the therapeutic effect is modest a reduction of about one attack per year prevented in trials5.
Meta-analyses have underlined that for OME antibiotics do not offer an effective treatment policy1. The growth of antimicrobial resistance in the
common pathogens (pneumococcus, moraxella, haemophilus influenzae) has meant that even for inter-current acute otitis media (AOM) with OME, prescription of antibiotics should be cautious and reserved mainly for those most likely to benefit (infants and
young children and those with severe AOM who are most at risk for
There is evidence these may offer a degree of benefit in OME, and they are cheap, but the possible side-effects in children have led to a UK recommendation against such use.
A possible role for topical (intra-nasal) steroids is currently under evaluation in a GP-based trial in the Southampton area, funded by the NHS R&D Health Technology Assessment programme.
The use of decongestants, with or without antihistamine, has been shown repeatedly over two decades to offer no significant benefit in clearing middle-ear fluid. Studies report some behavioural side-effects from drowsiness to insomnia and hyperactivity.
There is fragmentary evidence that present-day mucolytics can lead to a possible reduction in the need for surgery in OME, but current recommendations in the UK discourage their routine use on grounds of insufficient evidence. But new approaches to drug design and drug targeting may place new types of mucolytic on the list for serious consideration in the future. Surfactants to improve eustachian tube function, probably in combination with other treatments, are also an area to watch.
Blowing up a balloon with the nose, to inflate the middle-ear via the eustachian tube has been shown to help balance the middle ear pressure and so help clear the middle ear via the eustachian tube. But not all children can achieve the inflation, particularly younger ones. There is also a large issue over adherence (compliance).
We have seen no credible argument that complementary techniques such as homoeopathy and cranial osteopathy could reduce mucosal secretions, and as yet no trials of good quality have produced sufficiently credible evidence of efficacy or effectiveness to justify serious support of these approaches.
1 Rosenfeld RM. Clinical efficacy of medical therapy. Chap 13.
In: RM Rosenfeld and C Bluestone (Eds), Evidence-based Otitis Media (Second Edition). BC Decker Inc, Hamilton, Ontario, 2003 (ISBN 1-55009-254-5, available on CD)
2 Rovers MM et al. Otitis media in infants: Is screening and treatment with VTs necessary? Cmaj 2001; 165 Issue 8: 1055-1056
3 Paradise JL et al. Otitis media and tympanostomy tube insertion during the first three years of life: Developmental outcomes at the age of four years. Pediatrics 2003; 2:E154-E166
4 MRC Multi-centre Otitis Media Study Group. Speech reception
in noise: an indicator of benefit from ventilation tubes.
Clinical Otolaryngology, in press
5 Rosenfeld RM. Surgical prevention of otitis media.
Vaccine 2001; 19: S134-139
Mark Haggard is leader of the MRC external scientific staff team in children's middle-ear disease, Cambridge, and of the MRC multi-centre otitis media study group
Mary Gannon is health services researcher in the MRC multi-centre Otitis Media Study Group