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Introduction: Kyung-Ok-Ko (KOK) is a popular traditional medicine used as a natural alternative to hormone replacement therapy for treating postmenopausal symptoms in Asia. Pueraria lobata Ohwi (P. lobata) is rich in isoflavones and has been traditionally used in combination with other herbs to produce synergistic and pharmaceutical effects via a multi-target approach for disease treatment. We aimed to investigate the phytoestrogenic effects of KOK extract against postmenopausal symptoms in ovariectomized (OVX) rats and confirm its efficacy by mixing KOK and P. lobata extracts. Methods: OVX rats were daily oral administrated with KOK and KOK + P. lobata mixture extracts (300-400 mg/kg) and their body weight and tail temperature were monitored for 12 weeks. The biochemical parameters, estradiol levels, and bone turnover markers were measured in the serum samples. Moreover, the estrogen receptor, ER-α and ER-ß expression in the uterus and the uterus morphology were evaluated. AMPK, ATG1/ULK1, and mTOR protein expression in the liver were assessed. Results: The 12-week treatment with KOK and KOK + P. lobata mixture extracts did not cause liver damage or hormonal changes in the OVX rats. The treatments reduced the high lipid accumulation-related body weight gain and the tail temperature increase that was induced by ovariectomy. Further, it exhibited protective effects against hyperlipidemia and osteoporosis. No significant difference was observed in uterine weight compared to the OVX-treated group, while endometrial thickness reduction inhibition was observed due to ovariectomy. Bone mineral density (BMD) and serum osteocalcin levels, which decreased in OVX rats, increased with both treatments. Western blotting analysis showed that ER-α and ER-ß were not expressed in the treated rats, whereas these proteins were expressed in Sham-operated rats. No significant differences in the phosphorylation of AMPK were observed; however, the ATG1/ULK1 and mTOR protein phosphorylation levels were upregulated and downregulated in the treated rats compared to those of OVX rats, respectively. Conclusion: This is the first in vivo study observing the efficacy and synergistic effects of the mixture of KOK and P. lobata. Our results suggest the potential of KOK and KOK + P. lobata mixture as an alternative therapy for alleviating menopausal symptoms.
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OBJECTIVE: The description of controls is important in acupuncture clinical trials to interpret its effectiveness without fallacy. This paper aims to evaluate the reporting quality of acupuncture studies on the characteristics of sham needles. STUDY DESIGN AND SETTING: Using a checklist developed from previously published reporting guidelines, the distribution of reported items and changes of reporting rates over time were investigated. Two-way ANOVA and linear regression were conducted. RESULTS: Original articles of RCTs of any design involving sham needles as controls were eligible for assessment. 117 trials from three 2-year time periods between 2009 and 2018 were included. Seven items out of 25 were reported in more than 50% of the studies. While significant differences of reporting scores among categories were observed, there were no significant differences among time periods; no significant improvement was observed over time. CONCLUSIONS: Low reporting qualities of sham needles used in acupuncture studies may influence how researchers understand the effectiveness of acupuncture. This study evaluated previous publications from 2009 to 2018 and found that reporting qualities on sham needles did not improve over time. Further studies are required to validate the items used in this study to endorse better reporting of controls in acupuncture trials.
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BACKGROUND: The aim was to investigate the efficacy of mechanical meibomian gland squeezing combined with eyelid scrubs and warm compresses in participants with moderate and severe meibomian gland dysfunction (MGD). METHODS: In this prospective, uncontrolled, open label, intervention study, 32 eyes of 32 participants with moderate and severe MGD were treated with mechanical squeezing of meibomian glands in combination with eyelid scrubs and warm compresses. We evaluated tear film break-up time (TBUT), corneal and conjunctival fluorescein staining scores, biomicroscopic examination of lid margins and meibomian glands, Ocular Surface Disease Index (OSDI) questionnaire and tear film lipid layer thickness determined via an interferometer before initiating treatment and after one month of treatment. RESULTS: There were significant improvements in TBUT, corneal and conjunctival fluorescein staining scores, lid margin abnormality, meibum quality and expressibility, OSDI and MGD stage after mechanical meibomian gland squeezing combined with eyelid scrubs and warm compresses (p < 0.001 for TBUT, corneal fluorescein staining scores, Dry Eye Workshop score, Oxford staining score, lid margin abnormality, meibum quality, expressibility, OSDI and MGD stage and p = 0.001 for conjunctival fluorescein staining scores). There were no significant differences in lipid layer thickness or interferometer-derived parameters before treatment and after one month of treatment. Palpebral conjunctival erosion detected after the squeezing treatment resolved spontaneously in all participants. CONCLUSIONS: Mechanical squeezing of meibomian glands combined with eyelid scrubs and warm compresses can provide clinical benefits without serious adverse events.