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Preliminary results of using ALAnerv® in subacute motor incomplete paraplegics.

Andone I, Anghelescu A, Daia C, Onose G - J Med Life (2015 Jul-Sep)

Bottom Line: As there is actually no effective curative solution for the devastating pathology following SCI, any medical approach susceptible to bring even limited improvements, such as treatment with ALAnerv® seemed to have proven, is worth being surveyed, under strict circumstances of ethics and research methodology.Considering the necessity for more statistical power concerning primary, secondary end-points, and safety issues, as well, continuing this research is needed.SCI = spinal cord injury, TSCI = traumatic spinal cord injury, BBB = blood brain barrier, CNS = central nervous system, SC = spinal cord, NSAIDs = non-steroidal anti-inflammatory drugs, SAIDs = steroidal anti-inflammatory drugs, AIS = American Spinal Injury Association Impairment Scale, SPSS = Statistical Package for Social Sciences, BATEH = Bagdasar-Arseni Teaching Emergency Hospital.

View Article: PubMed Central - PubMed

Affiliation: "Bagdasar Arseni" Teaching Emergency Hospital (BATEH), Bucharest, Romania; "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania.

ABSTRACT

Rationale: To assess whether using ALAnerv® contributes to improvements of outcomes obtained in post SCI patients.

Objective: A prospective controlled clinical survey also to evaluate the safety and efficacy of ALAnerv® (2cps/ day for 28 days) in motor incomplete (AIS/ Frankel C) paraplegic subacute patients.

Methods and results: 59 patients divided in study (treated with ALAnerv®) and control, groups. This survey's follow-up duration was of 28 days. Most of the studied patients were mid-aged (mean 43.75 years old) and respectively, men (64,29% in the study group; 58,06% in controls). We used descriptive statistics (functions: minimum, maximum, mean, median, standard deviation) and for related comparisons, parametric (Student t) and non-parametric (Mann-Whitney, Fisher's exact, chi-square) tests. The primary end-point: AIS motor values' evolution (P= 0.015 - Mann-Whitney), showed that patients treated with ALAnerv® - vs. controls - had a statistically significant better increase of such scores at discharge. Paraclinical parameters, mainly exploring systemic inflammatory status (secondary end-point): ESR dynamics (P=0.13) had no statistical significance; the plasma leucocytes number (P=0.018), the neutrophils' percentage (P=0.001) and fibrinogenemia (P= 0,017) proved in the treated group to have a statistically significant better evolution. We used "Statistical Package for Social Sciences" (SPSS).

Discussion: As there is actually no effective curative solution for the devastating pathology following SCI, any medical approach susceptible to bring even limited improvements, such as treatment with ALAnerv® seemed to have proven, is worth being surveyed, under strict circumstances of ethics and research methodology. Considering the necessity for more statistical power concerning primary, secondary end-points, and safety issues, as well, continuing this research is needed.

Abbreviations: SCI = spinal cord injury, TSCI = traumatic spinal cord injury, BBB = blood brain barrier, CNS = central nervous system, SC = spinal cord, NSAIDs = non-steroidal anti-inflammatory drugs, SAIDs = steroidal anti-inflammatory drugs, AIS = American Spinal Injury Association Impairment Scale, SPSS = Statistical Package for Social Sciences, BATEH = Bagdasar-Arseni Teaching Emergency Hospital.

No MeSH data available.


Related in: MedlinePlus

Histograms regarding the evolution of AIS Motor scores
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Figure 8: Histograms regarding the evolution of AIS Motor scores

Mentions: The “Efficacy” of the treatment with ALAnerv® could be shown by the evolution (AIS Motor score at discharge – AIS Motor score at admission) of AIS motor score from the two groups. The bigger the difference mentioned above, the “better” the patient evolved. Histograms from the differences of scores are represented in Fig. 8. The mean in the ALAnerv® study group showed an improvement of AIS Motor score with 10.5 units and, in the control group, only with 6.9 units. Also, the median of the score differences was of 9.5 units in the group treated with ALAnerv® , and only 4 units in the control group. These data allowed us to make the affirmation that the treatment with ALAnerv® had a positive effect on patients (P=0.015 - Mann-Whitney test), improving AIS Motor score (better than in the absence of the treatment) and represented statistical significance of those data.


Preliminary results of using ALAnerv® in subacute motor incomplete paraplegics.

Andone I, Anghelescu A, Daia C, Onose G - J Med Life (2015 Jul-Sep)

Histograms regarding the evolution of AIS Motor scores
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4556909&req=5

Figure 8: Histograms regarding the evolution of AIS Motor scores
Mentions: The “Efficacy” of the treatment with ALAnerv® could be shown by the evolution (AIS Motor score at discharge – AIS Motor score at admission) of AIS motor score from the two groups. The bigger the difference mentioned above, the “better” the patient evolved. Histograms from the differences of scores are represented in Fig. 8. The mean in the ALAnerv® study group showed an improvement of AIS Motor score with 10.5 units and, in the control group, only with 6.9 units. Also, the median of the score differences was of 9.5 units in the group treated with ALAnerv® , and only 4 units in the control group. These data allowed us to make the affirmation that the treatment with ALAnerv® had a positive effect on patients (P=0.015 - Mann-Whitney test), improving AIS Motor score (better than in the absence of the treatment) and represented statistical significance of those data.

Bottom Line: As there is actually no effective curative solution for the devastating pathology following SCI, any medical approach susceptible to bring even limited improvements, such as treatment with ALAnerv® seemed to have proven, is worth being surveyed, under strict circumstances of ethics and research methodology.Considering the necessity for more statistical power concerning primary, secondary end-points, and safety issues, as well, continuing this research is needed.SCI = spinal cord injury, TSCI = traumatic spinal cord injury, BBB = blood brain barrier, CNS = central nervous system, SC = spinal cord, NSAIDs = non-steroidal anti-inflammatory drugs, SAIDs = steroidal anti-inflammatory drugs, AIS = American Spinal Injury Association Impairment Scale, SPSS = Statistical Package for Social Sciences, BATEH = Bagdasar-Arseni Teaching Emergency Hospital.

View Article: PubMed Central - PubMed

Affiliation: "Bagdasar Arseni" Teaching Emergency Hospital (BATEH), Bucharest, Romania; "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania.

ABSTRACT

Rationale: To assess whether using ALAnerv® contributes to improvements of outcomes obtained in post SCI patients.

Objective: A prospective controlled clinical survey also to evaluate the safety and efficacy of ALAnerv® (2cps/ day for 28 days) in motor incomplete (AIS/ Frankel C) paraplegic subacute patients.

Methods and results: 59 patients divided in study (treated with ALAnerv®) and control, groups. This survey's follow-up duration was of 28 days. Most of the studied patients were mid-aged (mean 43.75 years old) and respectively, men (64,29% in the study group; 58,06% in controls). We used descriptive statistics (functions: minimum, maximum, mean, median, standard deviation) and for related comparisons, parametric (Student t) and non-parametric (Mann-Whitney, Fisher's exact, chi-square) tests. The primary end-point: AIS motor values' evolution (P= 0.015 - Mann-Whitney), showed that patients treated with ALAnerv® - vs. controls - had a statistically significant better increase of such scores at discharge. Paraclinical parameters, mainly exploring systemic inflammatory status (secondary end-point): ESR dynamics (P=0.13) had no statistical significance; the plasma leucocytes number (P=0.018), the neutrophils' percentage (P=0.001) and fibrinogenemia (P= 0,017) proved in the treated group to have a statistically significant better evolution. We used "Statistical Package for Social Sciences" (SPSS).

Discussion: As there is actually no effective curative solution for the devastating pathology following SCI, any medical approach susceptible to bring even limited improvements, such as treatment with ALAnerv® seemed to have proven, is worth being surveyed, under strict circumstances of ethics and research methodology. Considering the necessity for more statistical power concerning primary, secondary end-points, and safety issues, as well, continuing this research is needed.

Abbreviations: SCI = spinal cord injury, TSCI = traumatic spinal cord injury, BBB = blood brain barrier, CNS = central nervous system, SC = spinal cord, NSAIDs = non-steroidal anti-inflammatory drugs, SAIDs = steroidal anti-inflammatory drugs, AIS = American Spinal Injury Association Impairment Scale, SPSS = Statistical Package for Social Sciences, BATEH = Bagdasar-Arseni Teaching Emergency Hospital.

No MeSH data available.


Related in: MedlinePlus