KFDA requests for the study of HPE role on Fatigue recovery

For the readers of this blog we have come up with the following study recently conducted by a Korean team on the efficacy and safety of Human Placental Extract solution on fatigue. Fatigue is a common symptom, but only a few effective treatments are available. This study was supported by a grant from Unimed Pharm., INC. and was conducted at the requests of the Korea Food and Drug Administration (KFDA).

                                                                                                                                  

Evidence-Based Complementary and Alternative Medicine

Volume 2012 (2012), Article ID 130875, 6 pages
doi:10.1155/2012/130875

Research Article

Efficacy and Safety of Human Placental Extract Solution on Fatigue: A Double-Blind, Randomized, Placebo-Controlled Study

Kang-Kon Lee,¹ Whan-Seok Choi,^1,2 Keun-Sang Yum,¹ Sang-Wook Song,¹ Sun-Myeong Ock,¹ Sat-Byul Park,³ and Moon-Jong Kim⁴

¹Department of Family Medicine, The Catholic University of Korea School of Medicine, Seocho-gu 137-701, Republic of Korea²Department of Family Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, 505 Banpo-dong, Seocho-gu 137-701, Republic of Korea³Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon 443-721, Republic of Korea

⁴Department of Family Medicine, Pundang CHA General Hospital, College of Medicine, Pochun Chung-mun University, Seongnam, Republic of Korea


Received 24 May 2011; Revised 28 July 2011; Accepted 30 July 2011
Academic Editor: Pradeep Visen
Copyright © 2012 Kang-Kon Lee et al. 


Abstract
Introduction:
Fatigue is a common symptom, but only a few effective treatments are available. This study was conducted to assess the efficacy and safety of the human placental extract solution, which has been known to have a fatigue recovery effect. 

Methods:

A total of 315 subjects were randomly assigned to three groups: group 1 (with Unicenta solution administration), group 2 (with exclusively human placental extract administration, excluding other ingredients from the Unicenta solution), and the placebo group. Subsequently, solutions were administered for four weeks. 

Results:

The fatigue recovery rate was 71.00% in group 1, 71.72% in group 2, and 44.21% in the placebo group, which show statistically significant differences between the group 1 and the placebo group (P value = 0.0002), and between group 2 and the placebo group (P value = 0.0001). 

Conclusion:

The oral human placental extract was effective in the improvement of fatigue. The adverse event frequency in the experimental groups was similar to that in the placebo group.

It is likely that more comprehensive results that can address the limitations of this study can be obtained if a study that has a sufficient period of study process and precisely classifies the subjects’ ages and degrees of fatigue is conducted.

Citation:
Kang-Kon Lee, Whan-Seok Choi, Keun-Sang Yum, et al., “Efficacy and Safety of Human Placental Extract Solution on Fatigue: A Double-Blind, Randomized, Placebo-Controlled Study,” Evidence-Based Complementary and Alternative Medicine, vol. 2012, Article ID 130875, 6 pages, 2012. doi:10.1155/2012/130875


Read the full article here

Courtesy:

Hindawi Publishing Corporation