Ann Rehabil Med.  2012 Aug;36(4):447-457. 10.5535/arm.2012.36.4.447.

The Effect of Recombinant Human Growth Hormone Therapy in Patients with Completed Stroke: A Pilot Trial

• Song J
• Park K
• Lee H
• Kim M

• KMID: 2266714
• DOI: http://doi.org/10.5535/arm.2012.36.4.447

Abstract

OBJECTIVE
To evaluate the safety and potential efficacy of "recombinant human growth hormone (rhGH)" on the functional recovery of completed stroke patients. METHOD: Completed stroke patients were recruited. All participants were randomly assigned to the GH group (rhGH injection and rehabilitative therapy) or the control group (only rehabilitative therapy). Above all, they were closely monitored for safety. Further, for the efficacy measurement, Korean Modified Barthel Index (K-MBI), Manual Muscle strength Test (MMT), and Fugl-Meyer assessment (FMA) were assessed to determine the changes of functional recovery during 6-months of the study period. Along with it, diffusion tensor image was taken as the baseline, and a followed-up study to observe the changes in diffusion tensor tractography (DTT), during the period, and one patient in the GH group was also examined with functional MRI (fMRI). Index of fatigue on 5 point scale for the study period was also assessed.
RESULTS
Twenty-two patients were enrolled, and 15 completed the study and were included in the analysis. No harmful adverse events were observed in the GH group. By comparison between the groups, the GH group showed more improvement in K-MBI than the control group (p<0.05). DTT showed less decrement of fibers in the GH group than in the control group, without statistical significance. fMRI showed an increment in the activated area. Patients in the GH group expressed no fatigue at all, during the study period (p=0.00).
CONCLUSION
The administration of rhGH in long term resulted in the improvement in K-MBI, and subjectively less tiredness during the injection period.

Keyword

Stroke; Growth hormone; IGF-1; Recovery

MeSH Terms

Diffusion
Fatigue
Growth Hormone
Human Growth Hormone
Humans
Insulin-Like Growth Factor I
Magnetic Resonance Imaging
Muscle Strength
Stroke
Growth Hormone
Human Growth Hormone
Insulin-Like Growth Factor I

Figure

• 

  Fig. 1 Changes of glucose levels of the GH group. In the GH group, glucose levels were all within normal ranges during the rhGH therapy. FBS: Fasting blood sugar.

• 

  Fig. 2 Comparison of the changes in functional outcome within and between each group. (A) The GH group and the control group showed an increment of scores in K-MBI during 6 months of study period (p<0.05). The GH group showed more increment in the K-MBI score than the control group (p<0.05). (B) The GH group showed increment of scores in Fugl-meyer test of upper extremity during 6 months of study period (p<0.05). The control group did not show any difference during 6 months of the study period. (C) Both groups did not show any difference in the K-MMSE during 6 months of the study period. (D) The control group showed an increment of scores in the summated scores of MMT of the affected extremity during 6 months of the study period (p<0.05), however the GH group did not show any difference during the study period. K-MBI: Korean modified barthel index (K-MBI), K-MMSE: Korean version of the mini-mental status examination, MMT: Representative scores of manual muscle strength test (MMT) from six muscle groups: shoulder flexor; elbow flexor; 3rd finger proximal interphalangeal flexor; hip flexor; knee extensor; and ankle dorsiflexor in five grades (Zero=0, Trace=1, Poor=2, Fair=3, Good=4, Normal=5), that made the full score, 30 (affected extremities).

• 

  Fig. 3 Comparisons of changes of K-MBI between the GH group and the control group. When K-MBI was divided into the daily activity domain (personal hygiene, bathing, toilet, feeding, dressing, bowel and bladder control) and the ambulation domain (ambulation, stair climbing, chair/bed transfer), both showed increased K-MBI scores in each domain, the GH group showed more increment than the control group in the ambulation domain. K-MBI: Korean modified barthel index (K-MBI).

• 

  Fig. 4 Changes of IGF-1 levels of GH group (n=5).

• 

  Fig. 5 Changes in DTT of GH group and control group. (A-a) DTT change in A1 patient; increased fibers in bilateral frontal areas at 6 months compared to the baseline study. (A-b) DTT change in A2 patient; decreased fibers in bilateral frontal areas at 6 months, compared to the baseline study. (A-c) DTT change in A3 patient; decreased fibers in the left frontal areas at 6 months compared to the baseline study. (A-d) DTT change in A4 patient; increased fibers in the left frontal and posterior parietal areas at 6 months compared to the baseline study. (A-e) DTT change in A5 patient; mild increased fibers in the left parietal areas at 6 months compared to the baseline study. (B-a) DTT change in B1 patient; mild increased fibers in the left frontal and parietal areas at 6 months compared to the baseline study. (B-b) DTT change in B4 patient; mild decreased fibers in the right parietal areas and corpus callosum at 4 months compared to the baseline study. (B-c) DTT change in B6 patient; obvious decreased fibers in the right frontal areas at 4 months compared to the baseline study. (B-d) DTT change in B9 patient; obvious decreased fibers in the right frontal and parietal areas at 1 year compared to the baseline study. Red arrows: increased fibers, yellow arrow: decreased fibers.

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