The efficacy of short-term intramuscular injection of oryzanol for 5 days and 10 days in the treatment of menopausal syndrome: results from an exploratory study / 中国综合临床

ABSTRACT

Objective:To explore the clinical effects of intramuscular injection of oryzanol for 5 and 10 days in the treatment of menopausal syndrome.Methods:This study adopts a case-control study method.Twenty patients with menopausal syndrome admitted to Peking Union Medical College Hospital from July 2021 to March 2022 were selected and randomly divided into a control group and an observation group using a random number table method, with 10 patients in each group. The control group was given intramuscular injection of oryzanol once a day for 5 consecutive days on the basis of routine health education; On the basis of routine health education, the observation group was given intramuscular injection of oryzanol once a day for 10 consecutive days. Two groups of patients completed a total of 6 visits before treatment and on days 5, 10, 30, 60, and 90 of treatment. Baseline survey was conducted to record the basic information of patients, including demography data, menstruation, past history, surgical history, drug allergy and the main symptoms of climacteric syndrome, and the baseline hormone level of patients was detected. Compare the menopausal symptoms by modified K-score, Pittsburgh sleep quality index (PSQI) score, menopausal specific quality of life (MENQOL) score, post treatment injection site pain by visual analog score (VAS), and observe adverse reactions during treatment between the two groups of patients at each visit time point.The measurement data conforming to the normal distribution is expressed in xˉ± s. The comparison between the two groups is performed by t test, and the change trend of the two groups at each time point is compared by repeated measurement analysis of variance; The measurement data that do not conform to the normal distribution are represented by M( Q1, Q3), and the Kruskal Wallis test is used for comparison between groups; Counting data is represented by examples(%), Fisher's exact probability method is used for inter group comparison, and Wilcoxon rank sum test is used for rank data comparison. Results:The body mass of the control group was higher than that of the observation group [(62.50±11.88) kg vs (52.90±4.28) kg, t=2.40, P=0.027]. There was no statistical difference between the two groups in other demography data and previous history, sex hormone levels, menopausal symptoms, and menstrual conditions (all P>0.05). Compared with the baseline, the modified K-score, PSQI score, and MENQOL vascular dilation and contraction, psychological state, physiological state, and sexual life scores of the two groups of patients on the 5th, 10th, 30th, 60th, and 90th day of treatment were significantly reduced, and showed a gradually decreasing trend with the extension of observation time (the values in Group F were 36.37, 12.40, 18.69, 24.73, 40.77, and 18.39, respectively, P<0.001), but there was no statistically significant difference between the groups (all P>0.05). After treatment, the VAS score of the control group was 1 point in 2 cases, 2 points in 4 cases, and 3 points in 4 cases; The VAS score of the observation group was 1 in 4 cases, 2 in 3 cases, and 3, 5, and 6 in 1 case each. There was no statistically significant difference in VAS scores between the two groups ( Z=0.43, P=0.664), and no adverse events or serious adverse events were observed during the treatment period. Conclusions:Intramuscular injection of oryzanol injection for 5 and 10 days can improve menopausal symptoms, improve sleep quality and overall quality of life in patients with menopausal syndrome, and the overall effect is similar.