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Phase II/III placebo-controlled randomized trial of safety and efficacy of growth hormone treatment in incomplete chronic traumatic spinal cord injury.
Esclarin-Ruz, Ana; Rodríguez-Carrión, Inmaculada; Ceruelo-Abajo, Silvia; Palazón-Garcia, Ramiro; Ayuga-Loro, Fernando; Carrasco-Lopez, Carmen; Alcobendas-Maestro, Monica; Casado-Lopez, Rosa M; Talavera-Diaz, Francisco; Soto-León, Vanesa; Campolo, Michela; Romero-Ganuza, Francisco J; Florensa-Vila, Jose; Garcia-Marco, David; Rotondi, Mario; Oliviero, Antonio.
Afiliação
  • Esclarin-Ruz A; Physical and Rehabilitation Medicine Department, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Rodríguez-Carrión I; Clinical Neurophysiology Unit, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Ceruelo-Abajo S; Physical and Rehabilitation Medicine Department, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Palazón-Garcia R; Physical and Rehabilitation Medicine Department, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Ayuga-Loro F; Neurology Department, Hospital Virgen de la Salud, SESCAM, Toledo, Spain.
  • Carrasco-Lopez C; FENNSI group, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Alcobendas-Maestro M; Physical and Rehabilitation Medicine Department, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Casado-Lopez RM; Physical and Rehabilitation Medicine Department, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Talavera-Diaz F; Physical and Rehabilitation Medicine Department, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Soto-León V; FENNSI group, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Campolo M; FENNSI group, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Romero-Ganuza FJ; Internal Medicine Department, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Florensa-Vila J; Radiology Department, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Garcia-Marco D; Pharmacy, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain.
  • Rotondi M; Unit of Internal Medicine and Endocrinology, ICS-Maugeri I.R.C.C.S., Laboratory for Endocrine Disruptors and University of Pavia, Pavia, Italy.
  • Oliviero A; FENNSI group, Hospital Nacional de Parapléjicos, SESCAM, Toledo, Spain. antonioo@sescam.jccm.es.
Spinal Cord ; 59(8): 917-924, 2021 Aug.
Article em En | MEDLINE | ID: mdl-34226654
STUDY DESIGN: This is a double blind phase II/III placebo-controlled randomized trial of the safety and efficacy of GH treatment in incomplete chronic traumatic spinal cord injury. OBJECTIVE: The aim of this study was to investigate the possibility to use exogenous GH administration for motor recovery in chronic traumatic incomplete human SCI. The objectives were to establish safety and efficacy of a combined treatment of subcutaneous GH (or placebo) and rehabilitation in this population. SETTING: Hospital Nacional de Parapléjicos METHODS: The pharmacological treatment was a subcutaneous daily dose of growth hormone (GH, Genotonorm 0.4 mg, Pfizer Pharmaceuticals) or placebo for one year. The pharmacological treatment was performed, during the first six months under hospitalization and supervised rehabilitation. RESULTS: The main findings were that the combined treatment of GH plus rehabilitation treatment is feasible and safe, and that GH but not placebo increases the ISNCSCI motor score. On the other hand, the motor-score increment was marginal (after one-year combined treatment, the mean increment of the motor-score was around 2.5 points). Moreover, we found that intensive and long-lasting rehabilitation program per se increases the functional outcome of SCI individuals (measured using SCIM III and WISCI II). CONCLUSIONS: It is important to highlight that our aim was to propose GH as a possible treatment to improve motor functions in incomplete SCI individuals. At least with the doses we used, we think that the therapeutic effects of this approach are not clinically relevant in most subjects with SCI.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Traumatismos da Medula Espinal Idioma: En Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Espanha

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Traumatismos da Medula Espinal Idioma: En Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Espanha