| Purpose1.To investigate the efficacy of short-term intramuscular injection of oryzanol in the treatment of menopausal syndrome.2.To observe the safety of short-term intramuscular injection of oryzanol in the treatment of menopausal syndrome.MethodThis study adopts a randomized controlled trial method.Twenty patients with menopausal syndrome admitted to Peking Union Medical College Hospital were recruited from July 2021 to March 2022.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 menopausal syndrome;the baseline physical examination,the routine laboratory test and the auxiliary examination were recorded;the baseline sex hormone level were tested;modified Kupperman index(modified K index),Pittsburgh sleep quality index(PSQI)and menopausal specific quality of life(MENQOL)were accomplished.The twenty patients were randomly divided into two groups using a random number table method,with ten patients in each group.One group was given intramuscular injection of oryzanol once a day for five consecutive days on the basis of routine health education(5-day group),another group was given intramuscular injection of oryzanol once a day for ten consecutive days on the basis of routine health education(10-day group).The two groups of patients completed a total of six visits before treatment and on day 5,10,30,60 and 90 of treatment.The sex hormone level of the two groups of patients were compared before and after treatment.The overall symptoms of menopausal syndrome were evaluated by the modified K index;the quality of sleep was evaluated by the PSQI score;the quality of life was evaluated by the MENQOL score.The efficacy was compared using appropriate statistical methods at each time point.The degree of pain at the injection site was evaluated by the visual analogue score(VAS),and the patients were examined again by physical examination,routine laboratory test and auxiliary examination.The adverse reactions were recorded throughout the entire treatment period.The measurement data conforming to the normal distribution was expressed in x±s,the comparison between the two groups was performed by independent-sample t test,the comparison within the group was performed by pairedsample t test,the change trend of the two groups at each time point was compared by repeated measurement analysis of variance,and the distribution of scores at different time points was compared by cross linked table chi square test.The measurement data not conforming the normal distribution was expressed in M(Q1,Q3),the comparison between the two groups was performed by Kruskal Wallis test,and the comparison within the group was performed by Wilcoxon rank sum test.The counting data was represented by the number of cases(%),Fisher’s exact probability test was used for inter group comparison.The Wilcoxon rank sum test was used for rank data comparison.Result1.The weight of the 5-day group was higher than that of the 10-day group[(62.50±11.88)kg vs(52.90±4.28)kg,t=2.40,P=0.027];the alanine aminotransferase of the 5-day group was higher than that of the 10-day group[(22.30±8.74)U/L vs(13.50±5.34)U/L,t=2.77,P=0.014];there was no statistical difference between the two groups in other baseline information(including demography data,menstruation,past history,surgical history,drug allergy and the main symptoms of menopausal syndrome,the baseline physical examination,the routine laboratory test,the auxiliary examination,the sex hormone level,modified K index,PSQI score and MENQOL score)(P>0.05).2.Compared to baseline data,there was no significant difference in the sex hormone levels of the two groups of patients(P>0.05).3.Compared to the baseline,the modified K index,PSQI score and MENQOL vascular dilation and contraction,psychological state,physiological state and the 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,all P<0.001).4.There was no statistically significant difference between the groups in modified K index,PSQI score or MENQOL score at each time point(all P>0.05).5.There was no statistically significant difference in VAS score between the two groups of patients(P>0.05).The physical examination,the routine laboratory test and the auxiliary examination of the two groups of patients were normal after treatment.6.No adverse reaction was observed during the treatment period.Conclusion1.Short-term intramuscular injection of oryzanol(40mg Qd,injection for 5 days or 10 days)may improve the menopausal symptoms,the sleep quality and the menopausal quality of life in patents,and this efficacy can last for at least three months.2.The efficacy of intramuscular injection of oryzanol in treatment of menopausal syndrome may not be achieved by regulating sex hormone levels.3.The efficacy of intramuscular injection of oryzanol in treatment of menopausal syndrome for 10 days may not be improved compared to treatment for 5 days.4.Short-term intramuscular injection of oryzanol is a safe way to treat the menopausal syndrome.Innovation1.This study provided more information in non-hormonal treatment of menopausal syndrome,and compensated for the inadequate efficacy of menopausal hormone therapy in improving the quality of sleep.2.This study provided more information in the delivery route of oryzanol(intramuscular injection)in the treatment of menopausal syndrome.3.This study explored the short-term intramuscular injection of oryzanol in the treatment of menopausal syndrome,improved the convenience of patients receiving oryzanol injection therapy.In the meantime,this study compared the efficacy of intramuscular injection of oryzanol in treatment of menopausal syndrome between the 5day group and the 10-day group,provided different options for the short-term treatment.4.This study lied the foundation for the research on the combination of oryzanol and menopausal hormone therapy in the future. |
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