Controversial Techniques in Allergy

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American Academy of Pediatrics.

PEDIATRICS

Vol. 82

No. 6 December 1988 935

COMMENTARY

Opinions expressed in this commentary are those of the authors and not necessarily those of the American Academy of Pediatrics or its Committees.

Controversial

Techniques

in

Allergy

Ten years ago a commentary appeared in

Pedi-atrics entitled “Allergy Skin Testing: Science or

Quackery?” This statement was a rejoinder to a

commentary in Pediatrics in 19752 that included allergy skin testing in a list oflaboratory procedures

that are abused for financial gain. The gist of the

reply was that allergy skin tests themselves were

not the problem because they were valid bioassays for IgE antibody to specific antigens. Abuse and quackery set in when numerous, indiscriminately

chosen skin tests were performed instead of an

appropriate history, physical examination, and

carefully selected tests based on that evaluation.

The allergy skin test was at that time and

re-mains today the most sensitive test for specific

allergic antibody in the skin, its presence there

reflecting its presence in the blood and respiratory

tract. An alternative method for assessing specific

IgE is the radioallergosorbent (RAST) test, for

which a blood specimen is used; currently the

pro-cedure is “less sensitive and more costly than skin

testing.” In clinical practice it is used less often

than skin testing for assessing patients’ allergic

sensitivities.

Ten years after the publication of that article,

allergy skin testing and the RAST test remain

valuable diagnostic tools that can be rightfully used or wrongfully abused, at the physician’s discretion

or indiscretion. Unfortunately, although newer,

valid procedures have not supplanted these tests, a

number of unproven, scientifically unsubstantiated

techniques have appeared to frustrate physician

and patient. It is a sad wonder that scientific

prog-ress in the development of new methods has moved

so much more slowly than has the creation of

methods marked by exaggerated and groundless claims of greater validity and ease. Unfortunately, the latter is a lucrative business.

Pediatricians need to be aware of the unproven

techniques and practices that are available in the

community. In this way they may steer vulnerable

patients away from these expensive, unvalidated methods. A number of articles have appeared in the

literature in which the pitfalls ofthese controversial

techniques are explained.38 These recent papers in

JAMA prepared by the Council of Scientific

Af-fairs of the American Medical Association

sum-marize the current status of procedures used in the

diagnosis and treatment of allergic disease. There

have been no such updates specifically in the

pedi-atric literature. The brief summary that follows is

a succinct presentation that some might wish to

supplement by reading the references that are cited.

1. Cytotoxic allergy testing. This technique is

based on the theory that the addition of specific

antigen in vitro to whole blood or to serum-WBC

suspensions will result in a decreased WBC count

or to death of cells if an individual is allergic to the

antigen. Results of numerous controlled trials

in-dicate that the procedure is ineffective for diagnosis

of food and inhalant allergy. In certain states the

promulgators of such testing have been forced to

close their laboratories. The Food and Drug

Admin-istration has taken the position that cytotoxic test

kits for use in diagnosis of allergic diseases are

misbranded devices.

2. Provocative and neutralization testing

(sub-cutaneous). This is a technique for diagnosis and

treatment of allergic disease in which a

subcuta-neous injection of antigen is administered to see

whether the antigen will elicit the patient’s

com-plaints. That injection is followed by a second

in-jection of a weaker or stronger dilution of the same antigen to relive the symptoms.

Currently, there is no immunologic rationale for

this procedure, and a number of controlled trials have shown no correlation of clinical symptoms

with antigen injection. Preliminary reports have

cited evidence that subcutaneous injection of cat or

dog allergenic extract in doses fivefold less than the

dosage eliciting an intradermal skin test can

de-crease the response to bronchoprovocation with the

specific animal extract. Although these preliminary

reports are interesting, they are incomplete and do

not confirm the validity of the repetitive use of

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936 PEDIATRICS Vol. 82 No. 6 December1988 neutralizing injections with a variety of unstudied

allergenic extracts that are being advocated

cur-rently by some clinicians.

3. Provocative and neutralization testing

(sub-lingual). Following the method described by Hansel

in 1941 for diagnosis and treatment of

food-in-duced respiratory, gastrointestinal, and other

sys-temic symptoms, the physician or care-giver places

three drops of 1:100 aqueous antigen extract under the patient’s tongue. Ten minutes later symptoms are assessed, after which the next antigen is simi-larly tested. When the physician is satisfied that he or she has determined the cause of symptoms, three

drops of dilute solution of the same extract are

given for neutralization.

There is no understood immunologic basis for

this and several controlled trials fail to verify it.

One report of sublingual dust mite therapy decreas-ing rhinitis symptoms6 and another of birch pollen therapy reducing hay fever symptoms9 indicate the need for more and larger scale evaluations.

4. Skin titration method of immunotherapy

(Rinkel technique). Increasing concentrations of antigen extract are applied to the skin by the

intra-dermal method. The weakest dilution producing a

positive skin test reaction is used as the dosage for

immunotherapy. The starting dose is 0.01 to .15

mL of this concentration and the ending dose is 0.5

mL of the same weak dilution. Prompt relief within

four hours of reaching this end point is claimed.

Controlled trials have shown that standard

Rin-kel immunotherapy is no different from placebo. A controlled study of standard Rinkel v conventional

immunotherapy (which aims toward injection of the strongest tolerated dilution of antigen) for rag-weed pollenosis shows conventional immunother-apy to be more effective than standard Rinkel or

placebo, which were equally ineffective. Numerous

studies show the effectiveness of conventional

im-munotherapy to be directly proportional to the amount of antigen administered.

5. Urine autoinjection (autogenous urine

immu-nization). Urine is collected, sterilized by boiling or filtration, and injected intramuscularly at various

time intervals into the patient at doses such as 0.25 to 5.0 mL.

Although autoimmune disease is a potential com-phication, there is no rationale or clinical evidence

of effectiveness.

6. Remote practice of allergy, ie, allergy analysis

by mail. A patient’s blood is sent to an allergy

laboratory for RAST tests, often in a laboratory the quality control of which is unvalidated, and an

allergy extract for injection therapy is prescribed. This system separates the patient’s clinical reality

from the final conclusion concerning which

anti-gens are truly relevant and, also, what therapy is

most appropriate.

Only the well-trained clinician can piece together the patient’s unique variables, combining his or her

knowledge of the patient with the results of

proce-dures that complement the patient-physician

inter-action and cannot replace it. In most situations,

with proper allergy consultation, avoidance of

of-fending allergens and proper pharmacologic

inter-vention preclude the need for immunotherapy.

7. Assessment of serum IgG to specific foods.

Recently, some laboratories have performed assays for IgG directed against foods. Patients are told

that the presence of these indicates allergy to the

foods that are involved. Production of IgG to food

antigens is a normal phenomenon. There are no

controlled trials suggesting that this is pathologic.

8. Candidiasis hypersensitivity syndrome.

Pro-ponents of the opinion that this is a disease claim that symptoms such as fatigue, depression, skin problems, headache, gastrointestinal upset, respi-ratory symptoms, and genitourinary tract

symp-toms may be due to an overgrowth of Candida.

Allegedly, this overgrowth occurs as a result of diets rich in carbohydrates and yeast as well as to a

number of medications. Treatment involves a

reg-imen of exercise, mental health counseling,

avoid-ance of pollutants, use of antioxidants, special diet, and use of antifungal agents.

The concept is unproven, as is its treatment. This

treatment regimen adds great complexity to the patient’s life without the likelihood of gain being proven through any sort of controlled trial. Addi-tionally, there are the potentially adverse effects of long-term antifungal therapy.

9. Clinical ecology. The subgroup known as din-ical ecologists have gathered a following through

their interest in adverse environmental factors that

seem to cause a range of negative effects on the

host such as fatigue, depression, weakness, and so

on.

There is no certifying body for clinical ecology that is approved by the National Board of Medical Specialties; ie, it is a not recognized medical

spe-cialty. Ecology practitioners are appealing because

they focus on those frustrating symptoms that often

defy specific organic disease-related diagnosis. They become controversial when they channel their

charisma toward convincing patients that unproven

factors cause their discomfort and, similarly, that

unproven remedies will improve their lives. By lack

of proof, we mean that these practitioners lack

critical data to connect cause and effect as well as

to assess the benefits of intervention. Double-blind

placebo controlled trials are avoided in favor of anecdotes.

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COMMENTARY

937

placebo controlled trials are avoided in favor of anecdotes.

For their patients’ benefit, it is desirable that in

the future those practicing clinical ecology will

sep-arate those concepts that have been validated by

scientific method from those that have not. Hope-fully, allergists and pediatricians who are involved

in managing allergic disease will do the same.

GAIL G. SHAPIRO, MD

Department of Pediatrics

University of Washington School of Medicine Seattle

JOHN

A.

ANDERSON, MD

Department of Pediatrics

Division of Allergy and Immunology Henry Ford Hospital

Detroit

REFERENCES

1. Shapiro GG, Bierman CW, Furukawa CT, et a!: Allergy skin testing: Science or quackery? Pediatrics 1977;59:495-498 2. Bergman AB: Let’s stop looking over our shoulders.

Pedi-atrics 1975;56:345

3. American Academy of Allergy: Position statements:

Contro-versial techniques. J Allergy Clin Immunol 1981;67:333-338

4. Grieco M: Controversial practices in allergy. JAMA

1982;247:3106-3111

5. American Academy of Allergy and Immunology: Position statement: Candidiasis hypersensitivity syndrome. J Allergy Clin Immunol 1986;78:271

6. Allergy Panel. Council on Scientific Affairs: In vivo

diag-nostic testing and immunotherapy for allergy. Report I. Part

1.JAMA 1987;258:1363-1367

7. Allergy Panel. Council on Scientific Affairs: In vivo

diag-nostic testing and immunotherapy for allergy. Report 1. Part 2.JAMA 1987;258:1505-1508

8. Allergy Panel. Council on Scientific Affairs: In vitro testing

for allergy. Report 2. JAMA 1987;258:1639-1643

8a. Hansel FK: Coseasonal intracutaneous treatment of hay fever.JAllergy 1941;12:457-461

9. Taudorf E, Laursen LC, Lanner A, et al: Oral

immunother-apy in birch pollen hay fever. J Allergy Clin Immunol

1987;80:153-161

ET TU PEDMTRICS?

The BMJ now expects scientific papers submitted to it to contain confidence

intervals when appropriate. It also wants a reduced emphasis on the

presenta-tion of P values from hypothesis testing. The Lancet, the Medical Journal of

Australia, and the American Journal of Public Health have implemented the

same policy, and it has been endorsed by the International Committee of

Medical Journal Editors.

Submitted by Student

From Gardner MJ, Altman DG: Estimating with confidence. Br Med J 1988;296:1210-1211.

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1988;82;935

Pediatrics

GAIL G. SHAPIRO and JOHN A. ANDERSON