To evaluate the efficacy and safety of PLC in perimenopausal or postmenopausal women with Hot Flashes: study protocol for a randomized controlled trial.

BACKGROUND: Hot flashes are the most frequent symptoms of the menopause, with 10-20% of all postmenopausal women reporting nearly intolerable occurrences. Although pharmacopuncture with hominis placenta extract is one of the new acupuncture therapies popular in East Asian medicine with a known efficacy in treating facial flushing, there has been little research on the efficacy and safety of this extract. This study, therefore, aims to evaluate the efficacy and safety of pharmacopuncture with hominis placenta extract (PLC) compared to injections of normal saline, in perimenopausal and postmenopausal women in Korea. METHODS/DESIGN: This study is a randomized placebo-controlled single-blind multi-center parallel-design trial. In total, 128 perimenopausal or postmenopausal women who meet the inclusion criteria will be recruited. The treatment group will receive PLC pharmacopuncture twice a week, for a total of 18 sessions over 9 weeks. The control group will receive injections of normal saline at the same acupoints during the same period. The post-treatment follow-up assessment will occur 4 weeks after the participant has completed the treatment. DISCUSSION: We believe that this trial will provide evidence for the efficacy and safety of PLC pharmacopuncture as a treatment for hot flashes in perimenopausal and postmenopausal women. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, ID: KCT0003533 , Registered on 20 February 2019.

Maternal Placentophagy as a Possible Cause of Breast Budding and Vaginal Bleeding in a Breast-Fed 3-Month-Old Infant.

BACKGROUND: Placentophagy, or the practice of placental consumption, has grown in popularity over the past decade. Although advocates endorse prevention of postpartum depression, increased breast milk production, reduction in postpartum bleeding, and provision of nutrients postpartum, scientific studies have failed to show benefit. No studies have explored the effect of placental hormone consumption on the hypothalamic-pituitary-ovarian axis of the offspring. CASE: We present a case of vaginal bleeding and breast budding in a 3-month-old infant whose mother was exclusively breastfeeding. Maternal history was notable for placentophagy. Upon discontinuation of consuming encapsulated placenta, the infant's vaginal bleeding resolved. SUMMARY AND CONCLUSION: Our case raises concerns regarding placentophagy and infant endocrine function. More research is needed to assess maternal and infant exogenous estrogen exposure with maternal placental consumption.

Human Placental Extract as a Subcutaneous Injection Is Effective in Chronic Fatigue Syndrome: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study.

Chronic fatigue (CF) is a common reason for consulting a physician due to affecting quality of life, but only a few effective treatments are available. The aim of this study was to examine the effectiveness of subcutaneous injection of the human placental extract (HPE) on medically indescribable cases of CF and safety in a randomized, double-blind, placebo-controlled clinical trial. A total of 78 subjects with CF were randomly assigned to either a HPE group or a placebo group. Subjects in the HPE group were treated with HPE three times a week subcutaneously for 6 weeks, whereas those in the placebo group with normal saline. Then, the fatigue severity scale (FSS), visual analog scale (VAS) and multidimensional fatigue inventory (MFI) were measured in both CF group and chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) subgroup. The FSS, VAS and MFI score at baseline were not different between the HPE and placebo group in total subjects with CF. In CFS group, the FSS (p=0.0242), VAS (p=0.0009) and MFI (p=0.0159) scores measured at the end of the study period decreased more in the HPE group than in the placebo group when compared with those at the baseline. There were no significant differences between the HPE group and placebo group in the mean change from baseline in FSS, VAS, and MFI in subjects with ICF during the study period. The subcutaneous injection of HPE was effective in the improvement of CFS.

Infectious Achilles Tendinitis After Local Injection of Human Placental Extracts: A Case Report.

Local injections of corticosteroids or human placental extracts are sometimes used for the treatment of resistant tendinitis or fasciitis. We report a case of infectious Achilles tendinitis complicated by calcaneal osteomyelitis after injection of human placental extracts for the Achilles tendinitis. She was treated with excision of the infected bone and tendon, followed by V-Y lengthening of the proximal portion of the Achilles tendon in a single stage. At 2 years postoperative, she remained symptom free without any signs of recurrence, and the follow-up magnetic resonance imaging scan demonstrated a well-maintained Achilles tendon with normal signal intensity.

Efficacy of porcine placental extract on wrinkle widths below the eye in climacteric women.

OBJECTIVE: Injections of human placental extract, which is known to play a role in skin regulation, have long been used for the treatment of skin wrinkles and non-healing wounds. Porcine placental extract (PPE), an oral supplement, was recently developed for this purpose. The aim of this study was to assess whether PPE has a positive effect on the improvement of fine wrinkles below the eye in climacteric women. METHODS: We first non-invasively measured wrinkle widths with a skin analyzer in a cross-section of 185 healthy adult Japanese women. Next, 44 climacteric women with mild or few climacteric symptoms were enrolled into an open-label, randomized, controlled study of the effect of PPE on wrinkle widths. A retrospective comparison of wrinkle widths in 123 climacteric women with climacteric symptoms with or without PPE treatment was also performed. RESULTS: Wrinkle widths below the eye in women ≥ 30 years of age were significantly higher than in women 20-29 years of age. Treatment with three capsules of PPE per day was significantly (p < 0.05) effective in reducing wrinkle widths at 24 weeks compared with control subjects. Retrospective analysis showed that subjects treated with three (p < 0.05) and six (p < 0.01) capsules of PPE per day observed a significant reduction in wrinkle widths compared with untreated subjects. CONCLUSION: Oral PPE treatment is a possible option for improving the appearance of fine wrinkles below the eye in climacteric women.

[A case of reversible cerebral vasoconstriction syndrome (RCVS) triggered by human placenta extract].

We present a case of a female patient with reversible cerebral vasoconstriction syndrome (RCVS) arising after receiving subcutaneous injection of human placenta extract. A 44-year-old woman started taking human placenta extract with the aim of improving her menopausal symptoms, fatigue, and beauty. However, 18 days after taking human placenta extract, she had three episodes of thunderclap headache. Repeated cranial CT did not show subarachnoid hemorrhage; CSF examination showed neither xanthochromia nor inflammation. Brain diffusion weighted and FLAIR images were normal. However, magnetic resonance angiography showed multifocal segmental stenosis of the right middle cerebral artery and bilateral anterior cerebral arteries. Follow-up angiography, which performed 12 days after the oncet of thunderclap headache, revealed almost normalized flow in all cerebral arteries; we made a diagnosis of RCVS. She has had no symptoms and signs since the third attack of headache. The only identified etiologic factor was subcutaneous injection of human placenta extract started 18 days prior to onset. This is the first report of RCVS triggered by human placenta extract.

Efficacy of porcine placental extracts with hormone therapy for postmenopausal women with knee pain.

OBJECTIVES: Knee pain related to osteoarthritis increases with age and is more common in middle-aged women. Although hormone replacement therapy (HRT) improves knee pain, women unresponsive to HRT need an effective adjunctive therapy. The aim of this study was to assess whether oral porcine placental extracts (PPE) have an impact on patients with knee pain as an adjunctive therapy combined with HRT. METHODS: Forty-eight postmenopausal women with knee pain receiving HRT were enrolled into this open-label, randomized, controlled study. Subjects were randomized into Group 1 (n= 24) or Group 2 (n=24). Subjects in Group 1 were given 3 months open treatment with calcium (260 mg/day) as adjunctive therapy combined with HRT. Group 2 received PPE (9 capsules/day) as adjunctive therapy combined with HRT. Changes in the degree of knee pain were evaluated by the Visual Analog Scale (VAS). RESULTS: Treatment with PPE was significantly effective in reducing the VAS score for knee pain at 4 weeks (p < 0.05), at 8 weeks (p< 0.01) and at 12 weeks (p<0.01), compared with the control group. Interestingly, the effects continued for 4 weeks after cessation of treatment in the PPE group (p< 0.01) compared with the control group. The PPE treatment had no significant adverse effects on blood biochemical and metabolic profiles, especially related to the risk factors for cardiovascular disease. CONCLUSION: PPE is a possible option as an adjunctive oral supplement in the case of HRT-resistant, long-lasting knee pain.

Premature sexual development in children following the use of estrogen- or placenta-containing hair products.

Four African-American girls aged 14 months to 93 months developed breast or pubic hair 2 to 24 months after starting the use of estrogen or placenta-containing hair products. Discontinuing the use of the hair products resulted in regression of the breast or pubic hair. Serum gonadotropins and estradiol levels were variable. No other cause for early sexual development was noted in these girls.

Placental extract injections in the treatment of loss of hair in women.

Placental extract injections were used with success in case of loss of hair in women during the period following confinement and outside this period. The overall rate of improvement was 74%; total recovery occurred in 43% of cases. In postpartum cases the rate of improvement was 91%, recovery 64%. The results obtained in 65 cases are reported. A double-blind study is planned.