Randomized, single-blind, placebo-controlled trial on Hominis placenta extract pharmacopuncture for hot flashes in peri- and post-menopausal women
Background: Hominis placenta pharmacopuncture is widely used for climacteric symptoms. This study examined the efficacy and safety of pharmacopuncture with PLC (the extract of Hominis placenta) on hot flashes for perimenopausal and postmenopausal women. Methods: This study was a randomized placebo-c...
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Elsevier
2022-12-01
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| Series: | Integrative Medicine Research |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213422022000580 |
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| author | Su-Ji Choi Dong-Il Kim Sang Ho Yoon Chang-Min Choi Jeong-Eun Yoo |
| author_facet | Su-Ji Choi Dong-Il Kim Sang Ho Yoon Chang-Min Choi Jeong-Eun Yoo |
| author_sort | Su-Ji Choi |
| collection | DOAJ |
| description | Background: Hominis placenta pharmacopuncture is widely used for climacteric symptoms. This study examined the efficacy and safety of pharmacopuncture with PLC (the extract of Hominis placenta) on hot flashes for perimenopausal and postmenopausal women. Methods: This study was a randomized placebo-controlled single-blind trial, which recruited 128 perimenopausal and postmenopausal women, randomly assigned to receive pharmacopuncture with PLC or normal saline (NS) for eight weeks. The primary outcome was the mean changes in the hot flash score (HFS) and the secondary outcomes were the mean changes in the Menopause Rating Scale (MRS), follicle-stimulating hormone (FSH) levels, and estradiol (E2) levels from baseline to eight weeks. Missing values were imputed using the last-observation-carried-forward method. Results: After treatment (week 9), the HFS decreased significantly in both groups (p = 0.000). The residual HFS was 47.09 ± 41.39% and 56.45 ± 44.92 % in the PLC and control groups, respectively (p = 0.262). One month after the treatment (week 13), the score of the PLC group was reduced, but the score increased in the control group (p = 0.077). There were no statistically significant differences in the mean changes in MRS, FSH, and E2 between the two groups. No serious adverse events related to this trial were noted. Conclusion: In this study, Hominis placenta extract pharmacopuncture did not differ significantly from NS in reducing the hot flash score. While this therapy appears safe, the potential for long-term effect of PLC extract needs to be examined in a large randomized controlled trial with appropriate controls. Trial registration: Clinical Research Information Service, Republic of Korea, KCT0 0 03533. |
| format | Article |
| id | doaj-art-950f8c26b4e8412c8611718d5fb5ea3c |
| institution | OA Journals |
| issn | 2213-4220 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Integrative Medicine Research |
| spelling | doaj-art-950f8c26b4e8412c8611718d5fb5ea3c2025-08-20T01:58:23ZengElsevierIntegrative Medicine Research2213-42202022-12-0111410089110.1016/j.imr.2022.100891Randomized, single-blind, placebo-controlled trial on Hominis placenta extract pharmacopuncture for hot flashes in peri- and post-menopausal womenSu-Ji Choi0Dong-Il Kim1Sang Ho Yoon2Chang-Min Choi3Jeong-Eun Yoo4Department of Korean Obstetrics & Gynecology, College of Korean Medicine, Dong-Guk University, Korean Medicine Hospital, Goyang, Republic of KoreaDepartment of Korean Obstetrics & Gynecology, College of Korean Medicine, Dong-Guk University, Korean Medicine Hospital, Goyang, Republic of Korea; Corresponding author at: Department of Korean Obstetrics & Gynecology, College of Korean Medicine, Dong-Guk University, Korean Medicine Hospital, 27 Dongguk-ro, Ilsandong-gu, Goyang, Gyeonggi-do 10326, Republic of Korea.Department of Obstetrics and Gynecology, Dongguk University Ilsan Hospital, Goyang, Republic of KoreaDepartment of Korean Gynecology, College of Korean Medicine, Wonkwang University, Iksan, Republic of KoreaLaon Korean Medicine Clinic, Daejeon, Republic of KoreaBackground: Hominis placenta pharmacopuncture is widely used for climacteric symptoms. This study examined the efficacy and safety of pharmacopuncture with PLC (the extract of Hominis placenta) on hot flashes for perimenopausal and postmenopausal women. Methods: This study was a randomized placebo-controlled single-blind trial, which recruited 128 perimenopausal and postmenopausal women, randomly assigned to receive pharmacopuncture with PLC or normal saline (NS) for eight weeks. The primary outcome was the mean changes in the hot flash score (HFS) and the secondary outcomes were the mean changes in the Menopause Rating Scale (MRS), follicle-stimulating hormone (FSH) levels, and estradiol (E2) levels from baseline to eight weeks. Missing values were imputed using the last-observation-carried-forward method. Results: After treatment (week 9), the HFS decreased significantly in both groups (p = 0.000). The residual HFS was 47.09 ± 41.39% and 56.45 ± 44.92 % in the PLC and control groups, respectively (p = 0.262). One month after the treatment (week 13), the score of the PLC group was reduced, but the score increased in the control group (p = 0.077). There were no statistically significant differences in the mean changes in MRS, FSH, and E2 between the two groups. No serious adverse events related to this trial were noted. Conclusion: In this study, Hominis placenta extract pharmacopuncture did not differ significantly from NS in reducing the hot flash score. While this therapy appears safe, the potential for long-term effect of PLC extract needs to be examined in a large randomized controlled trial with appropriate controls. Trial registration: Clinical Research Information Service, Republic of Korea, KCT0 0 03533.http://www.sciencedirect.com/science/article/pii/S2213422022000580Hot flashesHominis PlacentaPharmacopunctureMenopauseClimacteric |
| spellingShingle | Su-Ji Choi Dong-Il Kim Sang Ho Yoon Chang-Min Choi Jeong-Eun Yoo Randomized, single-blind, placebo-controlled trial on Hominis placenta extract pharmacopuncture for hot flashes in peri- and post-menopausal women Integrative Medicine Research Hot flashes Hominis Placenta Pharmacopuncture Menopause Climacteric |
| title | Randomized, single-blind, placebo-controlled trial on Hominis placenta extract pharmacopuncture for hot flashes in peri- and post-menopausal women |
| title_full | Randomized, single-blind, placebo-controlled trial on Hominis placenta extract pharmacopuncture for hot flashes in peri- and post-menopausal women |
| title_fullStr | Randomized, single-blind, placebo-controlled trial on Hominis placenta extract pharmacopuncture for hot flashes in peri- and post-menopausal women |
| title_full_unstemmed | Randomized, single-blind, placebo-controlled trial on Hominis placenta extract pharmacopuncture for hot flashes in peri- and post-menopausal women |
| title_short | Randomized, single-blind, placebo-controlled trial on Hominis placenta extract pharmacopuncture for hot flashes in peri- and post-menopausal women |
| title_sort | randomized single blind placebo controlled trial on hominis placenta extract pharmacopuncture for hot flashes in peri and post menopausal women |
| topic | Hot flashes Hominis Placenta Pharmacopuncture Menopause Climacteric |
| url | http://www.sciencedirect.com/science/article/pii/S2213422022000580 |
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