SUMMARY
We report the results of an open study of the tolerance to a deproteinized natural rubber latex (NRL) condom amoung 19 latex allergic adults who had previously had an allergic reaction caused by a natural rubber latex condom during sexual intercourse. All the patients used at least 12 of these condoms during a six-week period without incurring any allergic reaction.
Immediate hypersensitivity to NRL was recognized as an important clinical condition a little more than 10 years ago.1 Typical immediate hypersensitivity reactions can be experienced by latex allergic people upon contact with a wide variety of NRL-containing products, including condoms. Condoms are widely used as a means of contraception and/or to prevent sexually transmitted diseases, especially since the development of AIDS prevention programs in the mid-1980s.2
In 1989, Turjanmaa and Reunala reported that 24% of a group of 29 latex allergic women reported having had an allergic reaction to an NRL condom.3 Recently, we reported that among latex allergic individuals who use or have used such condoms more than 80%, mostly women, have had an allergic reaction, including systemic reactions, during or immediately after sexual intercourse.4
Since 1997, deproteinized NRL condoms (DLC; Manix Crystal®), which meet national standards, are marketed in several European countries by Ansell France (Cergy-Pontoise, France). However, at present there are no published reports of the tolerance to these condoms when used by latex allergic people. Therefore, after obtaining the agreement of the local Ethics Committee, we conducted an open trial to investigate this concern.
From among more than 400 of the latex allergic patients seen in our consultation service, we selected 94 who use or had used "classical" NRL condoms. Among them, 19 (14 women, 5 men; 21-60 yrs; including 13 healthcare workers) consented to participate in this study. All 19 reported having had genital pruritus, 8 reported genital edema, 4 reported non-genital urticaria, 4 reported rhinoconjunctivitis and 1 reported respiratory distress on previous contact with NRL condoms.
All 19 patients had a positive skin prick test to a standardized latex extract (Stallergenes, Antony, France). Seventeen of them had a positive reaction to a puncture skin test through a "classic" NRL condom; 1 had a doubtful (2mm wheal) reaction to a puncture through a deproteinized latex condom (DLC). None reacted to a DLC placed on a finger for 15 minutes.
The patients were required to use at least 12 Manix Crystal® DLC over a period of six weeks and to keep a record of any adverse events that occurred during or within the minutes after sexual intercourse. These records were reviewed with each patient at the end of the six weeks by the participating clinician (Dr. Moudiki).
All 19 patients did use at least the 12 DLC during the study period and none had an allergic reaction or any other adverse event on or after contact with the DLCs. During the same period, one patient reported having had an allergic reaction on contact with latex gloves and another a systemic allergic reaction induced by contact with small adhesive stickers; neither event was related to the use of the DLCs.
In comparison with our previous findings,5 the present results indicate that Manix Crystal® DLCs induce significantly fewer reactions to latex than classical NRL condoms (x2=45; p<0.0001). Moreover, when compared to Turjanmaa and Reunala's results,6 they also support this conclusion (p<0.02, Fisher's exact test). The lack of anecdotal reports of allergic reactions to these DLC condoms since they were first marketed in Europe a little more than two years ago (personal communication, Ansell France) also implies that they are safe.
In conclusion, Manix Crystal® deproteinized NRL condoms did not induce immediate hypersensitivity reactions in a small group of latex allergic patients. For such patients, these condoms appear to be a safe alternative to abstinence for the prevention of sexually transmitted diseases and pregnancy. We encourage physicians to routinely question their latex allergic patients, including adolescents, about their use of condoms and to advise them about the possibility of adverse reactions associated with latex condoms.
This study was supported in part by funds from Ansell France and from the Assistance Publique/Hôpitaux de Paris.
REFERENCES
- Levy DA, Charpin D, Pecquet C, Leynadier F, Vervloet D. Allergy to latex. Allergy 1992 47:579-87.
- Dubois-Arber F, Jeannin A, Konings E, Paccoud F. Increased condom use without other major changes in sexual behavior among the general population in Switzerland. Am J Public Health 1997;87:558-66.
- Turjanmaa K, Reunala T. Condoms as a source of latex allergen and cause of contact urticaria. Contact Dermatitis 1989; 20:360.
- Levy DA, Khouader S, Leynadier F. Allergy to latex condoms. Allergy 1998; 53:1107-8.
- Levy DA, Khouader S, Leynadier F. Allergy to latex condoms. Allergy 1998; 53:1107-8.
- Turjanmaa K, Reunala T. Condoms as a source of latex allergen and cause of contact urticaria. Contact Dermatitis 1989; 20:360.
