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Rapid responses are electronic letters to the editor. They enable our users to debate issues raised in articles published on thebmj.com. Although a selection of rapid responses will be included online and in print as readers' letters, their first appearance online means that they are published articles. If you need the url (web address) of an individual response, perhaps for citation purposes, simply click on the response headline and copy the url from the browser window. Letters are indexed in PubMed.

Re: Food allergy Carsten Bindslev-Jensen. 316:doi 10.1136/bmj.316.7140.1299

Professor Bindslev-Jensen dismisses the potential use of oral sodium cromoglycate in the management of food allergy as being " generally unhelpful" and that clinical trials have given " conflicting results". These comments may result form early trials that either did not select patients with food allergy or an inadequate dose was used.

Oral sodium cromoglycate can often be a useful support to diet in the management in two ways, by giving improved symptomatic control when diet alone is inadequate and by allowing small amounts of the foods to which the patient is sensitive to be consumed. Thes uses do the correct diagnosis to have been made and the main causative foods to have been identified. Adequate doses must be used. In his original case study report Kingsley (1) showed that single doses of up to 400 mg may be required to give adequate protection against reasonable amounts of food.This was confirmed in a double-blind trial by Basomba et al. who showed that to be sure of providing good protection against food challenge doses of between 400 - 800 mg are needed. In the one case of anaphylaxis reported in this latter trial a dose of 800mg did not provide complete protection which indicates that this use of the drug should not be contemplated if anaphylactic reactions are involved. Doses of 400-500 mg were used in trials reported by Dahl (3), Papageorgiou et al. (4) and by Carini et al (5). All of these trials reported positive results but trials in which lower dose were used were more likely to give negative results.

Recent positive trials of the beneficial uses of continuous treatment in irritable bowel syndrome due to food allergy have used daily doses of 1600-2000mg/day (6,7). Positive results have been in patients who have a psoitive history of foods exacerbating symptoms and who demonstrate positive skin tests or RAST to foods.

Whilst an elimination diet remains the primary management of food allergy, this has become increasingly difficult at a time when many foods hae multi-ingredients. In these circumstances the selected use of oral sodium cromoglycate can be very beneficial.

Alan M Edwards
19 May 1998.

References

1.Kingsley PJ. Oral sodium cromoglyate in gastrointestinal allergy. Lancet 1974; 2: 1011.

2. Basomba A, Campos A, Villalmanzo IG, Pelaez A. The effect of sodium cromoglycate (SCG) in patients with food allergy. Acta Allergol; 1977; 32(Suppl13): 96-101.

3.Dahl R. Disodium cromoglycate and food allergy. Allergy 1978; 33:120-124.

4.Papageorgiou N, Lee Th, Nagakura T, Cromwell O, Wraith DG, Kay AB. neutrophil chemotactic activity in milk-induced asthma. J Allergy Clin Immunol 1983;72: 75-82.

5. Carini C, Brostoff J. Evidence for circulating IgE complexes in food allergy. Ric Clin Lab 1987; 17(4):309-322.

6. Lunardi C, Bambara LM, Biasi D, Cortina P, Peroli P, Nicolis F, Favari F, Pacor M. Double-blind cross-over trial of oral sodium cromoglycate in patients with irritable bowel syndrome due to food intolerance. Clin Exp Allergy 1991;21: 569-572.

7. Stefanini GF, Saggioro A, Alvisi V, et al. Oral cromolyn sodium in comparison with elimination diet in the irritable Bowel Syndrome, diarrhoeic type. Scand J Gastroenterol 1995; 30: 535-541.

Competing interests: No competing interests

20 May 1998
Alan M Edwards
Honorary Clinical Assistant
Southampton General Hospital
Re: Sex and death: are they related? Findings from the Caerphilly cohort study George Davey Smith, Stephen Frankel, John Yarnell. 315:doi 10.1136/bmj.315.7123.1641

Dear Sirs:

Over the years I have found an effective method of educating my patients is to make a copy of the first page of selected journal articles regarding topics which I feel are important to their health.

This has proven to be a useful way to motivate patients to make changes in their lifestyle, or to accept new therapies. There is something about seeing a recommendation in writing with the title of the journal at the top of the page that seems to motivate patients better than just the doctor's word.

I recently made a copy of Dr. George Smith's article on "sex and death", and presented a copy to several of my married female patients for their opinion as to it's usefulness.

I was caught completely off guard by their response. I was informed in no uncertain terms that if their husbands were ever made aware of this article or given a copy, I would have a very unhappy patient on my hands.

I have since taken a random survey of several more married female patients and hospital employees, and have found almost unanimous agreement with the sentiments of my initial group of patients. Several individuals felt this information might even lead to a deterioration in their marital relationship.

Hence, although this article presents some very interesting statistical data, it may not have a lot of practical significance in the real world, at least in one area of rural USA.

Sincerely,

Gary W. Berger, M.D.

Competing interests: No competing interests

20 May 1998
Gary W Berger
Family Practice Physician
Office
Re: Resolution of peanut allergy: case-control studyScience commentary: Why do some children grow out of peanut allergy? Jonathan O'B Hourihane, Abi Berger, Stephen A Roberts, John O Warner. 316:doi 10.1136/bmj.316.7140.1271

The letters posted so far typify the problem parents of allergic children face in trying to protect and care for them.

One father reports the results of a blood test and seeks more info about the significance of the reported levels of IgE. I do not think tests of antigen mixtures are useful. One needs to know about individual nuts to base advice on the relative risk. Having said that, nut and peanut allergic people need to avoid all nuts, unless they have eaten them safely before and they are CERTAIN that there is no possibility of confusion or mix up of one nut (a risk) for another(previously safe).

The 2nd letter is about testing before school entry. This is the time of greatest parental fear, as the child will be away from them for long periods. One cannot predict resolution of peanut allergy in any individual without a consultation,tests (skin prick and blood) and a challenge if necessary. My practice is to challenge children before school entry, if they have not had a reaction for about 2-3 years and if the reaction described was not life-threatening (see article). If the challenge is negative, dietary and lifestyle restrictions can be relaxed. If the challenge is positive, nothing has been lost. Anecdotally, families are usually reassured by the mild reaction elicited in positive challenges and with reinforcement of response strategies, feel more confident sending the child to school.

I am aware of only very few severe reponses among 1000s of formal food challenges. Nevertheless they must be done in hospital. Our paper reflects the experience of 2 of the very rare centres that frequently do such challenges. More allergists and allergy clinics need to be provided by the NHS to meet the already huge and increasing demand for advice and expertise. The BMJ's current series/book "ABC of allergy" should make a huge contribution to the advice available to the public via GPs and clinics not dealing with severe allergies every day

Competing interests: No competing interests

20 May 1998
Jonathan Hourihane
Lecturer, Immunobiology
Institute of Child health, London
Re: Developed countries could pay for hepatitis B vaccination in developing countries N J Gay, W J Edmunds. 316:doi 10.1136/bmj.316.7142.1457

Immunisation Awareness Society,
P.O. Box 56048,
Auckland,
NEW ZEALAND.

14th May, 1998.

Gay and Edmunds (1) suggest that Hepatitis B could be controlled more effectively if highly endemic areas were targetted, using as an example that it would be four times more effective for the UK to buy a huge number of doses for Pakistan at #0.75, than a smaller number of doses to introduce its own universal programme at #9.00 a jab. Same money, more jabs.

New Zealand was one of the earliest countries to introduce the Hepatitis B. For those who paid out of their own pocket, it cost $45.00 an injection plus the doctor's costs.

It was explained that a vaccine always cost a lot initially as the company had to recoup all the development costs, plant buildings, manufacturing bills, advertising, wages etc.

Some years later, when manufacturers were asked why it was that developing countries in Asia paid $1.00 per shot, and some countries even less, they explained that the only way that price structure could be accommodated was because Western countries with plenty of money not only paid off the initial costs, but also continue to pay the bulk of the ongoing wages/maintenance/ manufacturing bill. Standard business - someone has to foot the cost.

Hepatitis B in 1995, was/is the only vaccine to exceed 1 billion dollars in world-wide sales revenue, a fact proclaimed loudly in business magazines. These amounts encourage the Wall Street entourage, and that is why pharmaceuticals exist.

One harsh reality of shareholders' needs is that if all developing countries were to "sponsor" a programme in poor countries, Hepatitis B vaccine would not cost $0.75 a dose - it would cost far more to make up for lost sales elsewhere. Without ongoing current profits, the idea is a non-starter. The other harsh reality is that countries that do not really need the vaccine (as so eloquently explained by Gay and Edmunds) will continue to be targetted if only to justify the costs of manufacture for poorer countries.

To Gay and Edmunds, reality is Pakistan; to the manufacturers, Pakistan is not a consideration if it costs them something. The purpose of free "donor" programmes where vaccine is "given" away is not altruism. These are exercises equivalent to branding, (or sports sponsorship) where the "provider" get free-to-air time, often greater than the value of the product, telling them how good they are - to generate more money for Wall Street. It could be said that the love of money is the root of all inequity.

Sincerely

Peter Mancer and Hilary Butler

(1) BMJ 1998;316;1457 (9 May)

Competing interests: No competing interests

20 May 1998
Hilary Butler
Researcher
Immunisation Awareness Society
Re: Screening for Chlamydia trachomatis Fiona Boag, Frank Kelly. 316:doi 10.1136/bmj.316.7143.1474

The efforts of the British chief medical officer and advisory committee to develop a plan for chlamydia screening and treatment in the United Kingdom are to be applauded. Their forward thinking and aggressive stance has the potential to dramatically decrease the incidence of this important pathogen in the United Kingdom. In designing a screening plan, however, they have limited themselves to the screening only women, and then only at doctor's offices. Such an approach misses the opportunities created by the new DNA amplification technology for Chlamydia screening.

Using PCR techniques, chlamydial can be reliably detected in urine specimens from both men and women (1,2), and in specimens from the vaginal introitus in women (3,4). We recently demonstrated that women and adolescents, using only an illustrated brochure as an instructional aid, are capable of obtaining their own specimens from the vaginal intoitus, and that these specimens are as good as, if not better, than those obtained by a clinician from the endocervix (5). Together, these data mean that we need no longer confine Chlamydia screening to the doctor's office, thus greatly expanding the opportunities for community-based screening. In fact, urine-based screening has recently been successfully used in a local school-based chlamydial screening program in the United States.(6) Others have successfully used peer-educators to seek obtain urine specimens from their high-risk peers in the community, thus capturing a population of infected males unlikely to ever visit a doctor's office. (7)

New technologies create new opportunities. I urge the advisory committee to expand their pilot plan for chlamydia screening by adding both community and school-based screening sites for both young men and women. We in the United States must also begin a nationwide approach to Chlamydia screening. By combining creative and aggressive screening with effective partner notification and use of single-dose therapy for infection, the potential exists to markedly reduce rates of infection with this serious pathogen.

(1) Higgins SP, Klapper PE, Struthers JK, Bailey AS, Gough AP, Moore R, Corbitt G, Bhattacharyya MN. Detection of male genital infection with Chlamydia trachomatis and Neisseria gonorrhoeae using an automated multiplex PCR system (Cobas Amplicor). Int J STD AIDS 1998 Jan;9(1):21-24.

(2) Gaydos CA, Howell MR, Quinn TC, Gaydos JC, McKee KT JrJ Use of ligase chain reaction with urine versus cervical culture for detection of Chlamydia trachomatis in an asymptomatic military population of pregnant and nonpregnant females attending Papanicolaou smear clinics. Clin Microbiol 1998 May;36(5):1300-1304

(3) Witkin SS, Inglis SR, Polaneczky M. Detection of Chlamydia trachomatis and Trichomonas vaginalis by Polymerase Chain Reaction in Introital Specimens from Pregnant Women. Am J Obstet Gynecol 1996; 175: 165-7.

(4) Wiesenfeld HC, Rideout A, Macio I, DiBasi F, Sweet RL. The Vaginal Intoitus:A Novel Site for Chlamydia trachomatis Testing in Women. Am J Obstet Gynecol 1996; 174: 1542-6.

(5) Polaneczky MM, Witkin SS, Pollock L, Quigley C, Dulko D. "Self-Testing for Chlamydia Trachomatis Infection in Women." Obstetrics and Gynecology. 1998; 91 (3): 375-378.

(6) Cohen DA, Nsuami M, Etame RB, Tropez-Sims S, Abdalian S, Farley TA, Martin DH. A School-based Chlamydia Control Program Using DNA Amplification Technology. Pediatrics 1998 Jan 1;101(1):E1

(7) Gunn RA, Podschun GD, Fitzgerald S, Hovell MF, Farshy CE, Black CM, Greenspan JR. Screening high-risk adolescent males for Chlamydia trachomatis infection. Obtaining urine specimens in the field. Sex Transm Dis 1998 Jan;25(1):49-52

Competing interests: No competing interests

18 May 1998
Margaret Polaneczky
Assistant professor of obstetrics and gynecology
The New York Hosital - Cornell Medical Center
Re: Can students learn comparable clinical skills in general practice and hospital settings? . 316:doi 10.1136/bmj.316.7143.1531a

In response to the above article it is interesting to note that the Methods section does not state that ethical approval was sought from an independent body, nor does it tell us whether informed consent was obtained from all individual students. This raises issue of violation of student Autonomy by those in the medical school who arranged this trial while being responsible for their welfare.

yours sincerly,

Matthew Miller FRCS

Competing interests: No competing interests

18 May 1998
Matthew Miller
Senio SHO General Surgery
Victoria Infirmary, Glasgow
Re: Netlines . 316:doi 10.1136/bmj.316.7140.1294

After reading Netlines by Mark Pallen I enquired about his concern regarding newsgroups at my academic computer service at the University of Nottingham, UK.

I got the impression that this was an area for concern but not for the reasons expressed by Mark Pallen.

Can a service provider be expected to know about any particular file in the middle of the million others? If an offensive file exists can a service provider be considered to be publishing that material? If this applies to newsgroups then it would also apply to email and email file attachments: the email comes in to the a mail system and is then delivered to the server of the recipient awaiting their collection: if this material is offensive or illegal can the service provider be considered party to the publication of it simply because it exists as one of several hundreds of thousands on a computer server?

It is my understanding that the legal position of service providers in this respect is still uncertain. The postal and telephone services are presently regarded as what is legally known as a "common carrier" and are not legally responsible for the content of what they carry. If this was not the case we would have all mail opened and vetted before it was delivered. My understanding is that, at present, internet service providers do not have common carrier status. This is the main issue that lies at the core of concerns about carrying newsgroups and holding email on servers.

It is my impression that most institutions do also vet the main content of what they carry. The University of Nottingham, like several other academic computer service units in the UK, subscribe to the JANET (Joint Academic Network) news service, details of which can be seen on http://www.ja.net/usenet/service.html. These details include a list of all banned newsgroups and the policy of JANET with regard to offensive material. It is worth looking at their pages.

Ultimately it is the reponsibility of the individual not to send or use offensive material by any medium. There is nothing special about electronic media in this respect. We should all support the idea of common carrier staus being applied to internet service providers.

Competing interests: No competing interests

18 May 1998
Jim Lowe
Professor of Neuropathology
University of Nottingham Medical School
Re: Medical and psychosocial effects of early discharge after surgery for breast cancer: randomised trial Paul I M Schmitz, Marinus A Paul, Theo Wiggers, et al. 316:doi 10.1136/bmj.316.7140.1267

Editor,

While one welcomes randomised trials, the study by Bonnema et al fails to answer the questions they have sought to address. Firstly, the two groups being compared contain a mixed cohort of patients undergoing breast-conserving surgery and modified radical mastectomy. They therefore have made the fundamental assumption that women undergoing both procedures behave exactly the same way in terms of their post-operative complication rate for eg, volume of seroma fluid drainage and suffer the same degree of psychological morbidity. They should have been stricter in their inclusion criteria and only recruited patients who underwent the same surgical procedure. This would have made their results more meaningful.

The concept of keeping patients in hospital for 9-12 days post-operatively is archaic. In our practice, which probably reflects the practice in the rest of the UK, the mean post-operative hospital stay is in the region of 4 days with drains being removed on day 5, irrespective of volume of drainage of fluid.

One of their aims was to address the complication rate following early discharge. However,in discussion, they state that "the number of patients in this study was too small to detect a difference of 5% in rates of wound complication" and subsequently claim that recruitment of 800 patients, which is what would have been required, would not have been "feasible in this type of research". Why?

It is vital that any study examining shorter hospital stay must involve a detailed analysis of costs with the help of a health economist to calculate in-hospital and community costs. This is particularly important for the UK where NHS funding is central.

The follow-up period to assess psychological morbidity is too short. At 3 months patients may be undergoing adjuvant therapy, loco-regional radiotherapy and systemic chemotherapy, which add to their morbidity. It is essential that such studies are designed to assess psychological morbidity at completion of treatment to provide a more meaningful result. In this study, a further set of questionnaires to be completed at one year would have been necessary.

These issues are currently being addressed in a randomised trail in our institution, funded by the Scottish Office, which will complete recruitment at the end of 1998. Results from this study will hopefully clarify all the issues raised above.

Competing interests: No competing interests

18 May 1998
A D Purushotham
Senior Lecturer in Surgery
Western Infirmary, Glasgow, G11 6NT
Re: Vulval Pain Society provides information on vulval symptoms David Nunns, Diane Hamdy. 316:doi 10.1136/bmj.316.7132.706b

Dear David Nunns

Your article on the Vulval Pain Society states that several support groups exist. Could you please advise me if a support group for suffers with vulval symptoms exists in Australia or particulary Western Australia.

Thankyou

Competing interests: No competing interests

Re: New method of expressing survival in cancer is popular Jayant S Vaidya, Indraneel Mittra. 316:doi 10.1136/bmj.316.7137.1092

Nearly one year ago, Vaidya and Mittra proposed a new method that expresses survival in cancer patients by determining the "normal remaining life" of all individuals that belong to the cohort under examination (1,2). This method requires the calculation, for each subject of the cohort, of the ratio between survival after diagnosis and life expectancy after diagnosis (or, more in general, survival and life expectancy after the event that defines the time zero in the follow-up).

In comparison with traditional survival calculations, the change introduced by this new method intervenes at the level of handling individual patient data. In non-censored patients (e.g. patients who die), the new method constructs the foregoing ratio by placing measured survival at the numerator and remaining life-expectancy at the denominator. For example, if one assumes that diagnosis represents the time zero in the follow-up, the fractional survival time for each individual is calculated as: fractional survival time = (survival from diagnosis to death )/ (normal remaining life after diagnosis). This fractional survival time is then introduced in standard survival-curve calculations.

While there is no problem in managing non-censored patients through the above procedure, in the case of censored patients (e.g. patients who are alive at the date of closure of the study) the new method uses the same value at the denominator (i.e. normal remaining life after diagnosis), but is forced to use censored survival (i.e. survival from diagnosis to the last contact with the patient) at the numerator (because uncensored survival -i.e. survival from diagnosis to death- is unknown). Unfortunately, Vaidya and Mittra have not realised that censored survival can be a macroscopic underestimation of uncensored survival, particularly in young patients. In traditional survival-curve calculations, uncensored and censored survival times are not divided by any denominator and the subsequent statistics can appropriately handle terminations of follow-up. In the new method, survival times are divided by an appropriate denominator in cases of uncensored patients, but censored survival times are divided by a disproportionally large denominator; the subsequent statistics can try to handle terminations of follow-up, but the data already contain a heavy bias that tends to worsen the survival curve of cohorts containing many censored patients.

These arguments explain why Marubini and Mariani (3) have found a very small probability of cure (13%) in their cohort of 30-year-old, node-negative women. This 13% value, that was obtained by application of the new method, was probably an artifact that resulted from the use of censored survival instead of uncensored survival (that was unavailable). Fortunately, these young patients have a probability of cure much higher than 13% (even though no precise calculation can be made because of the censored nature of these data).

In conclusion, the new method proposed by Vaidya and Mittra (1,2) produces reliable results only when the investigators examine data where all subjects have died during the follow-up. Its application is grossly misleading when considering cohorts with censored patients.

The method of Vaidya and Mittra seems to be -in most cases- inapplicable, but the underlying idea is interesting. Further research is needed in devising other survival analyses that account for normal remaining life.

Andrea Messori, Sabrina Trippoli

Laboratorio di Farmacoeconomia
Drug Information Centre
Azienda Careggi
50134 Firenze, Italy (E-mail: md3439@mclink.it)

REFERENCES

1. Vaidya JS, Mittra I. Fraction of normal remaining life span: a new method for expressing survival in cancer. BMJ 1997; 314: 1682-1684.

2. Vaidya JS, Mittra I. New method of expressing survival in cancer is popular BMJ 1998;316:1092

3. Marubini E, Mariani L. New method for expressing survival in cancer (Letter). BMJ 1997;315:1375-6.

Competing interests: No competing interests

18 May 1998
Andrea Messori
Coordinator, Drug Information Centre
Azienda Careggi Hospital, Florence, 50134 Italy

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