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Evidence of effectiveness of anaphylaxis management plans: are we waiting for godot?

Anaphylaxis is defined as a life-threatening allergic reaction [1]. The annual incidence of anaphylaxis is 8.4/ 100 000 [2]. Single-centre studies show that anaphylaxis can represent up to 1% of emergency department attendances [3]. Hospital admissions for anaphylaxis have increased by 700% in the United Kingdom since 1990, probably reflecting both an increased awareness as well as a real increase in incidence [4]. There are understandable concerns regarding the evidence base for the practice of providing subjects at risk of anaphylaxis with rescue kits of adrenaline injections, although these concerns have largely been expressed by non-allergists [5, 6]. It is necessary to examine why most allergists are keen to provide such kits [7] and why some doctors are uncertain of their benefit [6]. Adrenaline is the treatment of choice for anaphylaxis [8, 9] and it is used regularly and safely for this indication as well as other life-threatening emergencies. The intramuscular route is preferred to the subcutaneous route and children tolerate intramuscular adrenaline well, even if they do not have an allergic reaction [10]. Animal studies show that if use of adrenaline is delayed until anaphylaxis is fully established, full recovery is less likely than if adrenaline is given earlier [11]. Case series report that delay of adrenaline use appears to be associated with a worse outcome in allergic reactions [12] but even its correct use does not guarantee survival [13, 14]. Opponents of widespread availability point to the rarity of anaphylaxis and the absence of certain effectiveness of adrenaline [15]. It is also difficult to administer in an emergency if not using preloaded autoinjectors [16]. Misuse has been reported: dropping an autoinjector or not firing it correctly [17], digital self-injection by inexperienced users [18] and adverse cardiac events from intravenous overdose [15, 19]. Incorrect use in fatal cases has also been reported [13], emphasizing the need for prescription and training to be equal parts of the medical transaction [20]. Anecdotal reports of adrenaline provision causing anxiety appear to have more to do with lack of allergy awareness on the part of the prescribing doctors of how and when to use it than adrenaline kits themselves being directly responsible for the heightened anxiety [21]. The medium of the message has been blamed for the increased awareness of allergy risks that comes parri passu with the need to carry adrenaline. The rarity of anaphylaxis on a population base, the possibility (albeit remote) of death from anaphylaxis, coupled with the inability of allergists to categorically identify those at highest risk all raise practical and ethical problems in the design of trials of rescue kit provision as part of a self-management plan. Physicians must currently base decisions about the long-term care of anaphylaxis patients on observation and clinical experience. In this context, it is perhaps worth noting that the great majority of fatal cases of anaphylaxis in the United Kingdom occur in subjects who have not been under the care of a recognized allergy service (H. Gowland, Allergy Action, UK, personal communication) and less than half had received any allergy specific advice from any health professional, let alone an allergist [14]. Furthermore, case series studies have suggested that detailed anaphylaxis plans can reduce the number and severity of reactions in patients with peanut and nut allergy [22]. However, in an increasingly evidence-based world, is such observational evidence sufficient to inform decisions about the usefulness of anaphylaxis management plans? Choo and Sheikh’s [23] rigorously performed Cochrane-style systematic review suggests that it is not. Having found no studies that met their stringent inclusion criteria – a so-called ‘empty’ review – they conclude that ‘randomized controlled trials of anaphylaxis action plans are urgently needed’ . Correspondence: Prof. Jonathan O’B. Hourihane, Department of Paediatrics and Child Health, University College Cork, Ireland. E-mail: j.hourihane@ucc.ie doi: 10.1111/j.1365-2222.2007.02754.x Clinical and Experimental Allergy, 37, 967–969