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July 1990, Vol 126, No. 7 >
Article | July 1990

Crossover Study of Thalidomide vs Placebo in Severe Recurrent Aphthous Stomatitis

Jean Revuz, MD; Jean-Claude Guillaume, MD; Michel Janier, MD; Pierrick Hans, MD; Claudine Marchand, MD; Pierre Souteyrand, MD; Jean-Marie Bonnetblanc, MD; Alain Claudy, MD; Sophie Dallac, MD; C. Klene, MD; Béatrice Crickx, MD; Hélène Sancho-Garnier, MD; J. C. Chaumeil, PhD
[+] Author Affiliations

Accepted for publication February 15, 1990.

Presented at the Franco-British Reunion, Cambridge, England, July 5, 1989.

Reprint requests to Service de Dermatologie, Hôpital Henri Mondor, 94000 Créteil, France (Dr Revuz).


From the Services de Dermatologie, Centre Hôpitalier Universitaire Henri Mondor, Créteil, France (Drs Revuz and Guillaume), CHU St Louis, Paris, France (Dr Janier), CHU de Bordeaux (France) (Drs Hans and Klene), CHU de Lyons (France) (Dr Marchand), CHU deClermont Ferrand (France) (Dr Souteyrand), CHU de Limoges (Dr Bonnetblanc), CHU St-Etienne (Dr Claudy), CHU Dijon (France) (Dr Dallac), and CHU Bichat, Paris, France (Dr Crickx); the Service des Statistiques, Institut Gustave Roussy, Villejuif, France (Dr Sancho-Garnier), and the Pharmacie Centrale des Hôpitaux de l'Assistance Publique, Paris, France (Dr Chaumeil).


Arch Dermatol. 1990;126(7):923-927. doi:10.1001/archderm.1990.01670310085012
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References
Comments

• A multicentric crossover randomized trial of 100 mg of thalidomide vs placebo each for 2 months was conducted in patients with severe aphthous stomatitis of more than 6 months' duration. Seventy-three patients were included. Complete remission was obtained in 32 patients who received thalidomide and in 6 patients who received placebo. The confidence interval of the difference between the two treatments ranged from 25% to 53%. Most of the patients who did not achieve a complete remission had a dramatic improvement with regard to the number of aphthae when they were receiving thalidomide. Thirteen of 17 patients who had a complete remission while they were receiving thalidomide had a recurrence with placebo, 19 ± 9 (mean ± SD) days after stopping this drug. Side effects were significantly more frequent with thalidomide, especially drowsiness and constipation. We concluded that thalidomide in a dosage of 100 mg/d is an effective treatment of severe aphthous stomatitis but is not without some risk.

(Arch Dermatol. 1990;126:923-927)

REFERENCES

1 +
Mellin GW, Katzenstein M.  The saga of thalidomide: neuropathy to embryopathy with case reports of congenital anomalies . N Engl J Med. 1962;;267:1184-1244.
2 +
Sheskin J, Convit J.  Results of double blind study of the influence of thalidomide on the lepra reaction . Int J Lepr Other Mycobact Dis. 1969;;37:135-146.
3 +
Knop J, Bonsmann G, Happle R, et al.  Thalidomide in the treatment of sixty cases of chronic discoid lupus erythematosus . Br J Dermatol. 1983;;108:461-466.
4 +
Samsoen M, Grosshans E, Basset A.  La thalidomide dans le traitement du lupus érythémateux chronique (LEC) . Ann Dermatol Venereol. 1980;;107:515-523.
5 +
Tamayo L, Ruiz-Maldonado R.  Dermatitis solar: estudio doble ciego cruzado talidomida, hidroxicina, placebo . Proc Int Derm Congr Mex. 1978;:218-219.
6 +
Barnhill RL, McDougall AC.  Thalidomide: use and possible mode of action in reactional lepromatous leprosy and in various other conditions . J Am Acad Dermatol. 1982;;7:317-323.
7 +
Grosshans E, Illy G.  Thalidomide therapy of inflammatory dermatoses . Int J Dermatol. 1984;;23:598-602.
8 +
Mascaro JM, Lecha M, Torras H.  Thalidomide in the treatment of recurrent, necrotic and giant mucocutaneous aphthae and aphthosis . Arch Dermatol. 1979;;115:636-637.
9 +
Bowers PW, Powell RJ.  Effect of thalidomide on orogenital ulceration . BMJ. 1983;;287:799-800.
10 +
Jenkins JS, Allen BR, Maurice PDL, Powell RJ, Littlewood SM, Smith NJ.  Thalidomide in severe orogenital ulceration . Lancet. 1984;;29:1424-1426.
11 +
Kürkçüoglu N, Atakan N, Eksioglu M.  Thalidomide in the treatment of recurrent necrotic mucocutaneous aphthae . Br J Dermatol. 1985;;112:632.
12 +
Grinspan D.  Significant response of oral aphthosis to thalidomide treatment . J Am Acad Dermatol 1985;;12:85-90.
13 +
Schwartz D, Flamant R, Lellouch J. L'essai thérapeutique chez l'homme . 2nd ed. Paris, France: Flammarion Médecine-Sciences; 1981;:95-99.
14 +
Schwartz D. Méthodes statistiques à l'usage des médcins et des biologistes . 3rd ed. Paris, France: Flammarion Médecine-Sciences; 1969;.
15 +
Hamza M, Chaffai M, Ben Ayed H.  Le traitement de la maladie de Behçet par la thalidomide . Nouv Presse Med. 1982;;11:1080-1081.
16 +
Rogé J, Testas P.  Thalidomide et syndrome de Behçet . Gastroenterol Clin Biol. 1984;;8:196.
17 +
Saylan T, Saltik I.  Thalidomide in the treatment of Behçet's syndrome . Arch Dermatol. 1982;;118:536.
18 +
Torras H, Lecha M, Mascaro JM.  Thalidomide treatment of recurrent necrotic giant mucocutaneous aphthae and aphthosis . Arch Dermatol. 1982;;118:875.
19 +
Grinspan D.  Significant response of oral aphthosis to thalidomide treatment . J Am Acad Dermatol. 1985;;13:509.
20 +
Fullerton PM, Kremer M.  Neuropathy after intake of thalidomide (Distaval) . BMJ. 1961;;2:855-858.
21 +
Cohen S.  Thalidomide polyneuropathy . N Engl J Med. 1962;; 266:1268.
22 +
Fullerton PM, O'Sullivan DJ.  Thalidomide neuropathy: a clinical electrophysiological and histological follow-up study . J Neurol Neurosurg Psychiatry. 1968;;31:543-551.
23 +
Aronson IK, Yu R, West DP, Den Broek HV, Antel J.  Thalidomide induced peripheral neuropathy . Arch Dermatol. 1984;; 120:1466-1470.
24 +
Clemmensen J, Olsen PZ, Andersen KE.  Thalidomide neurotoxicity . Arch Dermatol. 1984;;120:338-341.
25 +
Wulff CH, Hoyer H, Asboe-Hansen G, Brodthagen H.  Development of polyneuropathy during thalidomide therapy . Br J Dermatol. 1985;;112:475-480.
26 +
Paschoud JM.  Bericht über die 64 Jahresversammlung der Schweizer Gesellschaft für Dermatologie . Hautarzt. 1983;;34:306-309.

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1 +
Mellin GW, Katzenstein M.  The saga of thalidomide: neuropathy to embryopathy with case reports of congenital anomalies . N Engl J Med. 1962;;267:1184-1244.
2 +
Sheskin J, Convit J.  Results of double blind study of the influence of thalidomide on the lepra reaction . Int J Lepr Other Mycobact Dis. 1969;;37:135-146.
3 +
Knop J, Bonsmann G, Happle R, et al.  Thalidomide in the treatment of sixty cases of chronic discoid lupus erythematosus . Br J Dermatol. 1983;;108:461-466.
4 +
Samsoen M, Grosshans E, Basset A.  La thalidomide dans le traitement du lupus érythémateux chronique (LEC) . Ann Dermatol Venereol. 1980;;107:515-523.
5 +
Tamayo L, Ruiz-Maldonado R.  Dermatitis solar: estudio doble ciego cruzado talidomida, hidroxicina, placebo . Proc Int Derm Congr Mex. 1978;:218-219.
6 +
Barnhill RL, McDougall AC.  Thalidomide: use and possible mode of action in reactional lepromatous leprosy and in various other conditions . J Am Acad Dermatol. 1982;;7:317-323.
7 +
Grosshans E, Illy G.  Thalidomide therapy of inflammatory dermatoses . Int J Dermatol. 1984;;23:598-602.
8 +
Mascaro JM, Lecha M, Torras H.  Thalidomide in the treatment of recurrent, necrotic and giant mucocutaneous aphthae and aphthosis . Arch Dermatol. 1979;;115:636-637.
9 +
Bowers PW, Powell RJ.  Effect of thalidomide on orogenital ulceration . BMJ. 1983;;287:799-800.
10 +
Jenkins JS, Allen BR, Maurice PDL, Powell RJ, Littlewood SM, Smith NJ.  Thalidomide in severe orogenital ulceration . Lancet. 1984;;29:1424-1426.
11 +
Kürkçüoglu N, Atakan N, Eksioglu M.  Thalidomide in the treatment of recurrent necrotic mucocutaneous aphthae . Br J Dermatol. 1985;;112:632.
12 +
Grinspan D.  Significant response of oral aphthosis to thalidomide treatment . J Am Acad Dermatol 1985;;12:85-90.
13 +
Schwartz D, Flamant R, Lellouch J. L'essai thérapeutique chez l'homme . 2nd ed. Paris, France: Flammarion Médecine-Sciences; 1981;:95-99.
14 +
Schwartz D. Méthodes statistiques à l'usage des médcins et des biologistes . 3rd ed. Paris, France: Flammarion Médecine-Sciences; 1969;.
15 +
Hamza M, Chaffai M, Ben Ayed H.  Le traitement de la maladie de Behçet par la thalidomide . Nouv Presse Med. 1982;;11:1080-1081.
16 +
Rogé J, Testas P.  Thalidomide et syndrome de Behçet . Gastroenterol Clin Biol. 1984;;8:196.
17 +
Saylan T, Saltik I.  Thalidomide in the treatment of Behçet's syndrome . Arch Dermatol. 1982;;118:536.
18 +
Torras H, Lecha M, Mascaro JM.  Thalidomide treatment of recurrent necrotic giant mucocutaneous aphthae and aphthosis . Arch Dermatol. 1982;;118:875.
19 +
Grinspan D.  Significant response of oral aphthosis to thalidomide treatment . J Am Acad Dermatol. 1985;;13:509.
20 +
Fullerton PM, Kremer M.  Neuropathy after intake of thalidomide (Distaval) . BMJ. 1961;;2:855-858.
21 +
Cohen S.  Thalidomide polyneuropathy . N Engl J Med. 1962;; 266:1268.
22 +
Fullerton PM, O'Sullivan DJ.  Thalidomide neuropathy: a clinical electrophysiological and histological follow-up study . J Neurol Neurosurg Psychiatry. 1968;;31:543-551.
23 +
Aronson IK, Yu R, West DP, Den Broek HV, Antel J.  Thalidomide induced peripheral neuropathy . Arch Dermatol. 1984;; 120:1466-1470.
24 +
Clemmensen J, Olsen PZ, Andersen KE.  Thalidomide neurotoxicity . Arch Dermatol. 1984;;120:338-341.
25 +
Wulff CH, Hoyer H, Asboe-Hansen G, Brodthagen H.  Development of polyneuropathy during thalidomide therapy . Br J Dermatol. 1985;;112:475-480.
26 +
Paschoud JM.  Bericht über die 64 Jahresversammlung der Schweizer Gesellschaft für Dermatologie . Hautarzt. 1983;;34:306-309.

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