Effects of Testosterone Replacement Patients with Moderate to Severe Head Injury and Persistent Hypogonadotropic Hypogonadism: An Open-label Randomized Controlled Trial
Chandan H Anandegowda, Srivatsan Thirumalai Vasu, Kanishk Parmar, Vishnu PS, Lakshay Raheja, Haroon Manadath Pillay, Venkidesh Krishnamoorthy and Rahul Srinivasan
Department of Neurosurgery, Medical Trust Hospital, Pallimukku, Kochi, Kerala, India
*Corresponding Author: Chandan H Anandegowda, Department of Neurosurgery, Medical Trust Hospital, Kochi, India.
July 14, 2021; Published: August 12, 2021
Background: Traumatic brain injury (TBI) pertains to the significant potential for brain parenchymal lesions after suffering cranial trauma. Individuals with TBI are at high risk for developing neuroendocrine dysfunction, especially moderate and severe types. This study was conducted to understand relationships between hypogonadism and outcomes at 6 months post-TBI and to study the effect of testosterone supplementation in patients with persistent hypogonadism on the outcome of moderate to severe TBI.
Methods: The study was conducted as an open-label, randomized trial. Males aged 16 - 70 years post-moderate-severe TBI either received injection testosterone 200 mg intramuscularly (IM) every 4 weeks for 3 months in addition to standard care or standard care alone. They were followed up for 6 months. Functional independence measure scoring was used as an outcome measure.
Results: Of 98 patients screened, 62 were initially included. 11 patients expired and 4 did not develop hypogonadism at 3 months and were excluded subsequently from the analysis. Forty-seven patients were randomized to the intervention (n = 24) and control groups (n = 23). There was no significant difference between groups in the improvement on the FIM scores at discharge, 3 and 6 months (p = 0.509, 0.609, and 0.632 respectively). The Treatment group demonstrated the greatest absolute improvement in FIM scores although the results were not significant.
Conclusion: There were no significant differences in functional independence, the intervention group showed greater absolute functional improvement compared to the control group.
Keywords: Testosterone; Traumatic Brain Injury; Persistent Hypogonadotropic Hypogonadism; Functional Outcome
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