• delayed type reaction;
  • Proctolog®;
  • trimebutine;
  • urticaria

A 40-year-old nonatopic woman presented with generalized pruritic and erythematous hives without angioedema, 7 days after initiating a therapy with Nolotil® (Boehringer Ingelheim GmbH, Ingeleeim am Rhein, Germany) and Proctolog® (Juste, Madrid, Spain) cream for hemorroids.

Nolotil® and Proctolog® cream were stopped and the patient was successfully treated with intramuscular corticosteroid (6-Metil-prednisolone).

Proctolog® cream contains trimebutine and ruscogenin.

We present a case of delayed reaction urticaria induced by trimebutin.

Patch tests were performed on the upper back with the European Standard Series, Proctolog® cream and its components (trimebutine and ruscogenin).

Oral provocation tests were realized with Nolotil® and trimebutine

European Standard Series were all negative, but the patch tests with Proctolog® cream and trimebutine were positive at 48 (++) and 96 h (+++) (Fig.  1). Twenty controls were entirely negative.


Figure 1. A positive result was found with Polibutin® cream.

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Seventy-two hours after oral provocation test with trimebutine the patient presented generalized urticaria. Oral provocation test with Nolotil® was negative

Trimebutine [2-dimethylamino-2-phenylbutyl 3,4,5-trimethoxybenzoic acid], is an antispasmodic used orally to treat functional bowel disorders (1), and rectally and topically for anal fissures and hemorrhoids (2).

The first adverse effects from topical application were reported by Maffioli et al. in 1975 (3) and Chebanon in 1976 (4), both reports being erythema and/or burning. There is only one article published in the literature about contact allergic dermatitis caused by trimebutine (5).

To our knowledge, delayed-type hypersensitivity urticaria from trimebutine has not previously been reported. The patch test has been demonstrated as a good way for the diagnostic of a type IV hypersensitivity reaction to trimebutine.

We would like to thank our nurse Ms Rosa García for her valuable collaboration.


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  2. References
  • 1
    Kamiya T, Nagao T, Andou T, Misu N, Kobayashi Y, Hirako H et al. Effects of trimebutine maleate on gastric motility in patients with gastric ulcer. J Gastroenterol 1998;33: 823827.
  • 2
    Ho YH, Seow-Choen F, Low JY, Tan M, Leong APKF. Randomized controlled trial of trimebutine (and sphincter relaxant) for pain after hemorrhoidectomy. Br J Surg 1977;84: 377379.
  • 3
    Maffioli G, Brunetaud JM, Geoffroy H. Utilisation de l'association ruscogenines-trimebutine en patologie anale. Ann Med de Reims 1975;12: 361363.
  • 4
    Chabanon R. Experimentation du Proctolog dans les hemorroides et les fissures anales. Gaz Med de France 1976;83: 30.
  • 5
    Jiménez Reyes J, Fariña MC. Allergic contact dermatitis due to trimebutine. Contact Dermatitis 2001;45: 164.