A second criticism is that treatment with intranasal steroid aerosols was deliberately withheld from all subjects. It is now generally accepted that this form of treatment is so effective for seasonal allergic rhinitis that if it is allowed immunotherapy cannot produce a significant improvement in symptom scores. Nevertheless, for severe hay fever steroid aerosols are the standard treatment with which immunotherapy must be compared (together with its risks). To give suboptimal supportive treatment to patients treated with placebo might be acceptable in a trial of some exceedingly important new form of treatment, provided the position was made clear to the volunteers. In a trial of yet another formulation of conventional vaccine for hay fever the ethics seem dubious. The third point of criticism concerns the discussion of the reactions experienced by patients in the trial. Although 523 active injections were administered, there were only 21 actively treated patients. The necessary courses of injection that they received provoked an episode of anaphylaxis in one and generalised urticaria in another: a reaction rate of nearly 10%. The instances of fatal anaphylaxis following immunotherapy that led to the Medicines' Commission warning occurred as isolated events, nearly always after several previous injections that had been well tolerated. A much safer and more economical form of immunotherapy exists: the trial of enzyme potentiated desensitisation by Fell and Brostoff is open to none of the above criticisms.2 There were no reported side effects. The actively treated patients used about a third of the dose of intranasal beclomethasone aerosol required by the control group, making this method cost effective. L M McEWEN
Allergy Unit, London Medical Centre, London WIN IAH 1 Varney VA, Gaga M, Frew AJ, Aber VR, Kay AB, Durham SR. Usefulness of immunotherapy in patients with severe summer hay fever uncontrolled by antiallergic drugs. BMrJ 1991j302: 265-9. (2 February.) 2 Fell P, Brostoff J. A single dose desensitisation for summer hay fever: results of a double blind study. Eur J Clin Pharmacol
1990;38:77-9.
SIR, -Dr V A Varney and colleagues have shown that immunotherapy is of value to patients with severe grass pollen allergy uncontrolled by standard antiallergic drugs, but their patients had 15 injections and one of their 21 actively treated patients required adrenaline.' Fell and Brostoff have also shown benefit, double blind, with no generalised adverse reactions and using only one injection of McEwen's enzyme potentiated desensitisation.2 In an open trial by Ortolani in Milan there was a 5% incidence of generalised reactions in the conventionally treated group but none in the 1400 patients treated with enzyme potentiated desensitisation.3 There were fewer local reactions (5% compared with 15%), and the improvement achieved in the two groups was much the same. Moreover, enzyme potentiated desensitisation contains multiple allergens and can be used for other inhalant allergies and other conditions, such as food sensitivity in hyperkinetic children and children with migraine (J Egger, unpublished data).45 The conclusion is obvious. SYBIL BIRTWISTLE
Allergy Clinic, London Medical Centre, London WIN IAH 1 Varney VA, Gaga M, Frew AJ, Aber VR, Kay AB, Durham SR. Usefulness of immunotherapy in patients with severe summer hay fever uncontrolled by antiallergic drugs. BMJ 1991;302: 265-9. (2 February.) 2 Fell P, Brostoff J. A single dose desensitisation for summer hay fever: results of a double blind study. Eur J Clin Pharmacol 1990;38:77-9. 3 Brostoff J, Challacombe SJ. Food allergy and intolerance. London: Bailliere Tindall, 1987:991-2.
BMJ
VOLUME
302
2
MARCH
1991
4 McEwen LM. Enzyme potentiated desensitisation: five case reports of patients with acute food allergy. Ann Allergy 1975;35:98-103. 5 McEwen LM. A double blind controlled trial of enzyme potentiated desensitisation for the treatment of ulcerative colitis. Clinical Ecology 1987;5:47-5 1.
AUTHORS' REPLY,-Had Dr L M McEwen read our paper carefully he would have realised that the coordinator was concerned only with outcome measures (symptoms, drug usage, and provocation tests) and was purposely shielded from the operators, who carried out the immunotherapy procedure, recorded the reactions, and adjusted the dose of vaccine where necessary.' Thus this design was truly double blind in nature and had the added advantage of maximising patient safety. This study compared immunotherapy with placebo-not with intranasal corticosteroids. It was inappropriate for patients to use intranasal steroids as this is not a rescue medication. How immunotherapy compares with intranasal steroids is a separate question, but it should be noted that a criterion for entry into our study was poor symptom control in previous years despite regular antiallergic treatment including intranasal and systemic corticosteroids. It is well known that immunotherapy has an attendant risk ofimmediate anaphylactic reactions. Our experience of one in 532 injections is probably about average. However, it is important to appreciate that the deaths reported in the 1986 "CSM update" seemed to have been from acute severe asthma rather than general anaphylaxis.2 3 Clearly these patients were poorly selected as, having chronic asthma, they should not have been given this form of treatment in the first place. We do not share Dr McEwen's enthusiasm for enzyme potentiated desensitisation. This seems to be yet another form of alternative allergy treatment founded on dubious scientific principles. The single controlled trial referred to is a brief description that is impossible to interpret through lack of detail.4 Nevertheless, it is noteworthy that this report showed no significant differences in global symptom scores between active treatment and placebo, so the claim that enzyme potentiated desensitisation gave good protection throughout the grass pollen season does not seem to have been substantiated. Dr Birtwistle is impressed by the lack of adverse reactions with enzyme potentiated desensitisation. Perhaps this is not surprising as the treatment itself consisted of nanogram amounts of protein given as a single injection. Her conclusion regarding multiple allergens is not obvious at all. There is no scientific basis for treatment involving the administration of mixtures of unstandardised extracts, and this practice was specifically criticised by the working group of the WHO and International Union of Immunological Societies on
allergen immunotherapy.' A B KAY V A VARNEY S R DURHAM
Department of Allergy and Clinical Immunology, National Heart and Lung Institute and Royal Brompton National Heart and Lung Hospital (Chelsea), London SW3 6LY 1 Varney VA, Gaga M, Frew AJ, Aber VR, Kay AB, Durham SR. Usefulness of immunotherapy in patients with severe summer hay fever uncontrolled by antiallergic drugs. BMJ3 1991;302: 265-9. (2 February.) 2 CSM Update. Desensitising vaccines. BMJ 1986;293:948. 3 Rawlins MD, Wood SM, Mann RD. Hazards with desensitising vaccines. In: Kurth R, ed. Regtlatorcontrol and standardization of allergenic extracts. Stuttgart: Springer-Verlag, 1988:147-51. (Fifth international Paul-Ehrlich seminar, September 1987.) 4 Fell P, Brostoff J. A single dose desensitisation for summer hay fever: results of a double blind study. EurJ7 Clin Phtartnacol 1990;38:77-9. S World Health Organisation/International Union of Immunological Societies Working Group. Current status of allergen immunotherapy. Shortened version of a World Health Organisation/International Union of Immnunological Societies Working Group report. Lancet 1989;i:259-61.
Reducing junior doctors' hours SIR,-The arguments for reducing junior doctors' hours of work have been clearly stated.' The introduction of a shift system reported by Mr D G Nasmyth and colleagues2 is an attractive method of achieving this aim and of reducing the social and psychological damage associated with traditional work patterns. Their unit is a well staffed single specialty unit, which avoids the problems of cross specialty cover. Standard operating procedures are important safeguards to overcome problems generated by the idiosyncratic practice of individual consultants. In this unit the consultants had informally integrated their practice and were not otherwise required to modify their own activities. Protected time for a formal handover is essential for shift working, and in this unit handover time was not eroded by duties outside the ward but did enforce a minimum 10½12 hour working day for all house officers on the day shift irrespective of workload. Despite the inherent advantages already present in this unit, the experiment must be deemed to have fallen short of its mark. The misery of a 58 5 hour shift was abolished only by the proposal to work split weekends. This would leave an individual doctor with very few days each month that were totally free of hospital duties. The shift system reduced working time by only 10 hours a month when compared with a conventional one in four rota, although my calculation does not include extra hours that may have been worked under the old system. This small reduction in working time would be further eroded by the unpredictable collapse of the shift system during 20 weeks of the year when a house officer may be on leave, especially if a medical student is unavailable. I conclude that such a shift system can succeed only with a change in the working practice of more senior doctors, additional junior staff,' holiday locums, or extra non-medical staff to relieve juniors of time consuming clerical duties,3 and giving drugs intravenously.4 M D FLYNN
Bristol BS6 7NG 1 Delamothe T. Juniors' hours of work. BMJ 1990;300:623-4. 2 Nasmyth DG, Pickersgill A, Hogarth M. Reducing hours of work of preregistration house officers: report on a shift system. BMJ 1991;302:93-4. (12 January.) 3 Leslie PJ, Williams JA, McKenna C, Smith G, Heading RC. Hours, volume, and type of work of preregistration house officers. BMJ 1990;300:1038-41. 4 Cunningham S, Ventors G, Dobson A, Roberston N. Workload of preregistration house officers. BMJ 199;300:1342.
SIR, -The recent interest in shift systems as a way of reducing continuous hours of duty among junior doctors has encouraged us to describe a partial shift system that has been in operation with the medical unit of St John's Hospital in Livingston since 1 August 1990. The unit itself is structured around four consultant led medical teams and includes a 12 bed critical care unit. Out of hours cover is also provided for a 30 bed geriatric assessment unit and 60 continuing care geriatric beds in another hospital. A fixed allocation of holidays within the system results in only six of the seven contracted residents being present at any one time, obviating the need for unpopular cross covering. Residents are distributed one per consultant unit, one to coronary care, and the final member working a night shift. The night shift starts at 6 pm and ends at 8 am with a brief handover to incoming day residents. Good communication is aided by the use of desk top diaries in which all the night's important events are summarised, including any management instigated and further investigations required. While on duty the night staff are considered "first on" and assume responsibility for all new
531
Allergy Unit, London Medical Centre, London WIN IAH 1 Varney VA, Gaga M, Frew AJ, Aber VR, Kay AB, Durham SR. Usefulness of immunotherapy in patients with severe summer hay fever uncontrolled by antiallergic drugs. BMrJ 1991j302: 265-9. (2 February.) 2 Fell P, Brostoff J. A single dose desensitisation for summer hay fever: results of a double blind study. Eur J Clin Pharmacol
1990;38:77-9.
SIR, -Dr V A Varney and colleagues have shown that immunotherapy is of value to patients with severe grass pollen allergy uncontrolled by standard antiallergic drugs, but their patients had 15 injections and one of their 21 actively treated patients required adrenaline.' Fell and Brostoff have also shown benefit, double blind, with no generalised adverse reactions and using only one injection of McEwen's enzyme potentiated desensitisation.2 In an open trial by Ortolani in Milan there was a 5% incidence of generalised reactions in the conventionally treated group but none in the 1400 patients treated with enzyme potentiated desensitisation.3 There were fewer local reactions (5% compared with 15%), and the improvement achieved in the two groups was much the same. Moreover, enzyme potentiated desensitisation contains multiple allergens and can be used for other inhalant allergies and other conditions, such as food sensitivity in hyperkinetic children and children with migraine (J Egger, unpublished data).45 The conclusion is obvious. SYBIL BIRTWISTLE
Allergy Clinic, London Medical Centre, London WIN IAH 1 Varney VA, Gaga M, Frew AJ, Aber VR, Kay AB, Durham SR. Usefulness of immunotherapy in patients with severe summer hay fever uncontrolled by antiallergic drugs. BMJ 1991;302: 265-9. (2 February.) 2 Fell P, Brostoff J. A single dose desensitisation for summer hay fever: results of a double blind study. Eur J Clin Pharmacol 1990;38:77-9. 3 Brostoff J, Challacombe SJ. Food allergy and intolerance. London: Bailliere Tindall, 1987:991-2.
BMJ
VOLUME
302
2
MARCH
1991
4 McEwen LM. Enzyme potentiated desensitisation: five case reports of patients with acute food allergy. Ann Allergy 1975;35:98-103. 5 McEwen LM. A double blind controlled trial of enzyme potentiated desensitisation for the treatment of ulcerative colitis. Clinical Ecology 1987;5:47-5 1.
AUTHORS' REPLY,-Had Dr L M McEwen read our paper carefully he would have realised that the coordinator was concerned only with outcome measures (symptoms, drug usage, and provocation tests) and was purposely shielded from the operators, who carried out the immunotherapy procedure, recorded the reactions, and adjusted the dose of vaccine where necessary.' Thus this design was truly double blind in nature and had the added advantage of maximising patient safety. This study compared immunotherapy with placebo-not with intranasal corticosteroids. It was inappropriate for patients to use intranasal steroids as this is not a rescue medication. How immunotherapy compares with intranasal steroids is a separate question, but it should be noted that a criterion for entry into our study was poor symptom control in previous years despite regular antiallergic treatment including intranasal and systemic corticosteroids. It is well known that immunotherapy has an attendant risk ofimmediate anaphylactic reactions. Our experience of one in 532 injections is probably about average. However, it is important to appreciate that the deaths reported in the 1986 "CSM update" seemed to have been from acute severe asthma rather than general anaphylaxis.2 3 Clearly these patients were poorly selected as, having chronic asthma, they should not have been given this form of treatment in the first place. We do not share Dr McEwen's enthusiasm for enzyme potentiated desensitisation. This seems to be yet another form of alternative allergy treatment founded on dubious scientific principles. The single controlled trial referred to is a brief description that is impossible to interpret through lack of detail.4 Nevertheless, it is noteworthy that this report showed no significant differences in global symptom scores between active treatment and placebo, so the claim that enzyme potentiated desensitisation gave good protection throughout the grass pollen season does not seem to have been substantiated. Dr Birtwistle is impressed by the lack of adverse reactions with enzyme potentiated desensitisation. Perhaps this is not surprising as the treatment itself consisted of nanogram amounts of protein given as a single injection. Her conclusion regarding multiple allergens is not obvious at all. There is no scientific basis for treatment involving the administration of mixtures of unstandardised extracts, and this practice was specifically criticised by the working group of the WHO and International Union of Immunological Societies on
allergen immunotherapy.' A B KAY V A VARNEY S R DURHAM
Department of Allergy and Clinical Immunology, National Heart and Lung Institute and Royal Brompton National Heart and Lung Hospital (Chelsea), London SW3 6LY 1 Varney VA, Gaga M, Frew AJ, Aber VR, Kay AB, Durham SR. Usefulness of immunotherapy in patients with severe summer hay fever uncontrolled by antiallergic drugs. BMJ3 1991;302: 265-9. (2 February.) 2 CSM Update. Desensitising vaccines. BMJ 1986;293:948. 3 Rawlins MD, Wood SM, Mann RD. Hazards with desensitising vaccines. In: Kurth R, ed. Regtlatorcontrol and standardization of allergenic extracts. Stuttgart: Springer-Verlag, 1988:147-51. (Fifth international Paul-Ehrlich seminar, September 1987.) 4 Fell P, Brostoff J. A single dose desensitisation for summer hay fever: results of a double blind study. EurJ7 Clin Phtartnacol 1990;38:77-9. S World Health Organisation/International Union of Immunological Societies Working Group. Current status of allergen immunotherapy. Shortened version of a World Health Organisation/International Union of Immnunological Societies Working Group report. Lancet 1989;i:259-61.
Reducing junior doctors' hours SIR,-The arguments for reducing junior doctors' hours of work have been clearly stated.' The introduction of a shift system reported by Mr D G Nasmyth and colleagues2 is an attractive method of achieving this aim and of reducing the social and psychological damage associated with traditional work patterns. Their unit is a well staffed single specialty unit, which avoids the problems of cross specialty cover. Standard operating procedures are important safeguards to overcome problems generated by the idiosyncratic practice of individual consultants. In this unit the consultants had informally integrated their practice and were not otherwise required to modify their own activities. Protected time for a formal handover is essential for shift working, and in this unit handover time was not eroded by duties outside the ward but did enforce a minimum 10½12 hour working day for all house officers on the day shift irrespective of workload. Despite the inherent advantages already present in this unit, the experiment must be deemed to have fallen short of its mark. The misery of a 58 5 hour shift was abolished only by the proposal to work split weekends. This would leave an individual doctor with very few days each month that were totally free of hospital duties. The shift system reduced working time by only 10 hours a month when compared with a conventional one in four rota, although my calculation does not include extra hours that may have been worked under the old system. This small reduction in working time would be further eroded by the unpredictable collapse of the shift system during 20 weeks of the year when a house officer may be on leave, especially if a medical student is unavailable. I conclude that such a shift system can succeed only with a change in the working practice of more senior doctors, additional junior staff,' holiday locums, or extra non-medical staff to relieve juniors of time consuming clerical duties,3 and giving drugs intravenously.4 M D FLYNN
Bristol BS6 7NG 1 Delamothe T. Juniors' hours of work. BMJ 1990;300:623-4. 2 Nasmyth DG, Pickersgill A, Hogarth M. Reducing hours of work of preregistration house officers: report on a shift system. BMJ 1991;302:93-4. (12 January.) 3 Leslie PJ, Williams JA, McKenna C, Smith G, Heading RC. Hours, volume, and type of work of preregistration house officers. BMJ 1990;300:1038-41. 4 Cunningham S, Ventors G, Dobson A, Roberston N. Workload of preregistration house officers. BMJ 199;300:1342.
SIR, -The recent interest in shift systems as a way of reducing continuous hours of duty among junior doctors has encouraged us to describe a partial shift system that has been in operation with the medical unit of St John's Hospital in Livingston since 1 August 1990. The unit itself is structured around four consultant led medical teams and includes a 12 bed critical care unit. Out of hours cover is also provided for a 30 bed geriatric assessment unit and 60 continuing care geriatric beds in another hospital. A fixed allocation of holidays within the system results in only six of the seven contracted residents being present at any one time, obviating the need for unpopular cross covering. Residents are distributed one per consultant unit, one to coronary care, and the final member working a night shift. The night shift starts at 6 pm and ends at 8 am with a brief handover to incoming day residents. Good communication is aided by the use of desk top diaries in which all the night's important events are summarised, including any management instigated and further investigations required. While on duty the night staff are considered "first on" and assume responsibility for all new
531
