Planta Med 2003; 69(5): 390-395
DOI: 10.1055/s-2003-39710
Original Paper
Clinical Study
© Georg Thieme Verlag Stuttgart · New York

Effectiveness and Tolerability of a Standardized Phytodrug Derived from Solanum chrysotrichum on Tinea pedis: A Controlled and Randomized Clinical Trial

Armando Herrera-Arellano1 , Artemio Rodríguez-Soberanes2 , Maria de los Angeles Martínez-Rivera3 , Eugenia Martínez-Cruz3 , Alejandro Zamilpa1 , Laura Alvarez4 , Jaime Tortoriello1
  • 1Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social, Morelos, México
  • 2Hospital General Regional No. 1, Instituto Mexicano del Seguro Social, Morelos, México
  • 3Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Cd. de México, México
  • 4Centro de Investigaciones Químicas, Universidad Autónoma del Estado de Morelos, Morelos, México
Further Information

Publication History

Received: September 18, 2002

Accepted: January 25, 2003

Publication Date:
12 June 2003 (online)

Abstract

Superficial mycosis such as Tinea pedis affects between 10 and 15 % of the population and is amongst the top ten reasons for visiting the doctor in Mexico. The vegetal species Solanum chrysotrichum has been, for many years, widely used in Mexican traditional medicine for the treatment of fungal foot infections. This paper illustrates the results of a controlled and randomized, double-blind clinical trial, which compared the therapeutic effect and the tolerability of a standardized phytodrug from S. chrysotrichum (experimental group) with 2 % ketoconazole (control group), applied externally (4 weeks) to 101 patients diagnosed with Tinea pedis. After the treatment, the results showed a clinical effectiveness (≥ 75 % improvement of signs and symptoms) of 96.08 % for the group treated with the S. chrysotrichum extract and 91.67 % for the ketoconazole group (χ2, p > 0.38); the mycologic effectiveness (direct examination and negative culture) was 78.43 % and 77.78 %, respectively (χ2, p > 0.94); whilst the tolerability was 100 % for both treatments. The therapeutic successes (clinical and mycologic effectiveness plus tolerability) was 74.51 % with the experimental treatment and 69.44 % with the control (χ2, p > 0.60). These results support the safety and effectiveness of Solanum chrysotrichum standardized phytodrug for the treatment of Tinea pedis.

References

  • 1 Schaffner A. Fungal infections in primary care.  Schweiz Rundsch Med Prax. 1996;  85 1236-9
  • 2 Schmutz J L, Barbaud A, Contet A N. Superficial mucocutaneous mycosis.  Rev Prat. 1996;  46 1617-22
  • 3 Marchisio V F, Preve L, Tullio V. Fungi responsible for skin mycoses in Turin (Italy).  Mycoses. 1996;  39 141-50
  • 4 Omidynia E, Farshchian M, Sadjjadi M, Zamanian A, Rashidpouraei R. A study of dermatophytoses in Hamadan, the governmentship of west Iran.  Mycopathologia. 1996;  133 9-13
  • 5 Arenas R. Dermatología: Atlas, diagnóstico y tratamiento. México; McGraw-Hill 1991: 379-88
  • 6 López M R, Sánchez P E, Hernández H F, Gayosso M P, Méndez-Tovar J L. Aportaciones al estudio epidemiológico de las dermatofitosis.  Rev Med IMSS. 2000;  38 455-8
  • 7 Cuadro básico de medicamentos del Sector S alud. Comisión Interinstitucional del Cuadro Básico de Insumos del Sector Salud. México; 1989: 110
  • 8 Del Palacio A, Cuétara S, Pérez A, Garau M, Calvo T, Sánchez-Alor G. Topical treatment of dermatophytosis and cutaneous candidosis with flutrimazole 1 % cream: double blind, randomized comparative trial with ketoconazole 2 % cream.  Mycoses. 1999;  42 649-55
  • 9 Cauwenbergh G, Degreef H, Verhoeve I. Topical ketoconazole in dermatology: a dermatological and clinical review.  Mykosen. 1984;  27 395-401
  • 10 Greer D L, Jolly H W. Comparative trial of a two-dosage schedule of ketoconazole 2 % cream for the treatment of Tinea pedis .  J Am Acad Dermatol. 1987;  17 53-6
  • 11 Kwon-Chung K J, Bennett J E. Medical mycology. Lea and Febiger Philadelphia; 1992: 81-102
  • 12 Haria M, Bryson H M, Goa K L. Itraconazole. A reappraisal of its pharmacological properties and therapeutic use in the management of superficial fungal infection.  Drugs. 1996;  51 585-620
  • 13 Evans E G. Tinea pedis: clinical experience and efficacy of short treatment.  Dermatology. 1997;  194 ( 1) 3-6
  • 14 Van Heerden J S, Vismer H F. Tinea corporis/cruris: new treatment options.  Dermatology. 1997;  194 ( 1) 14-8
  • 15 Berete S, Bissuel F, Longuet P, Pocidalo M A, Leport C, Vilde J L. Agranulocytosis during a treatment with terbinafine.  Rev Med Interne. 1997;  18 258-9
  • 16 Shiloah E, Horowiz M, Zecler E. Terbinafine-induced cholestatic liver injury.  Harefuah. 1997;  133 11-2, 80 - 1
  • 17 Lozoya X, Aguilar A. Encuesta sobre el uso actual de plantas en la medicina tradicional Mexicana.  Rev Med IMSS. 1987;  25 283-91
  • 18 Lozoya X, Navarro V, García M, Zurita M. Solanum chrysotrichum (Schldl.) a plant used in Mexico for the treatment of skin mycoses.  J Ethnopharmacol. 1991;  36 127-32
  • 19 Alvarez L, Pérez M C, González J L, Navarro V, Villareal M L, Olson J O. SC-1 an antimycotic spirostan saponin from Solanum chrysotrichum .  Planta Med. 2001;  67 372-4
  • 20 Zamilpa A, Tortoriello J, Navarro V, Delgado G, Alvarez L. Five new steroidal saponins from Solanum chrysotrichum leaves and their antimycotic activity.  J Nat Prod. 2002;  65 1815-9
  • 21 López-Martínez R, Méndez-Tovar M J, Hernández-Hernández F, Castrejón-Olivares R. Micología Médica. Procedimientos para el diagnóstico de laboratorio. Ed. Trillas México; 1995
  • 22 Satchell A C, Saurajen A, Bell C, Barnetson R S. Treatment of interdigital Tinea pedis with 25 % and 50 % tea tree oil solution: a randomized, placebo-controlled, blinded study.  Australas J Dermatol. 2002;  43 175-8

Dr. A. Herrera-Arellano

Centro de Investigación Biomédica del Sur

Instituto Mexicano del Seguro Social

Argentina 1

Xochitepec

Mor

México 62 790

Phone: +777 3612155, 3612194

Fax: 3612194

Email: armandoha_mx@yahoo.com.mx