Clinical effectiveness of progesterone in acute traumatic spinal cord injury

Abstract

Aim: With only limited treatment options in acute spinal cord injury (SCI) currently available, we aimed to investigate the effect of progesterone on neurological recovery after acute SCI. Material and Methods: Randomised double-blind placebo-controlled single-centre trial on 128 patients of acute SCI (within 24 hours of injury) was conducted at our institute with the approval of the ethics committee. Eligible patients were allocated to the progesterone or placebo arm. Of 133 eligible patients, one from the placebo arm expired in the acute phase while 4 were lost to follow-up, leaving 128 patients in the study.68 patients remained in the progesterone arm and 60 in placebo. Patients in the progesterone arm received intramuscular progesterone while those in the placebo received intramuscular isotonic saline twice daily for five consecutive days. Neurological assessment was done at baseline, day six, first and sixth months using the American Spinal Injury Association (ASIA) score and motor and sensory actual neural recovery (ANR) scores. Results: Baseline characteristics were comparable between the groups. At the end of six months, significant improvement occurred in motor and sensory ASIA scores in the progesterone arm (p=<0.01). Compared with the placebo, motor scores were significantly higher in the progesterone arm at 6 months while sensory scores were not (p= <0.01 and p= 0.59 respectively). Additionally, at 6 months, motor ANR was significantly higher in the progesterone arm vs placebo (p=<0.01 vs 0.65). Early progesterone administration (within six hours of injury) was associated with significantly higher motor and sensory ASIA scores at 6 months (p= <0.01vs0.04 respectively). Conclusion: Administration of intramuscular progesterone within 24 hours in acute SCI was associated with better neurological recovery. Further multicentric studies are required to shed more light on the strength and consistency of this improved outcome.