Effective care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Nnewi, Nigeria.
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria.
PLoS One. 2023 May 8;18(5):e0285474. doi: 10.1371/journal.pone.0285474. eCollection 2023.
To our knowledge, there is no prior randomized trial on the efficacy of Mojeaga remedy (a special blend of Alchornea cordifolia, Pennisetum glaucum and Sorghum bicolor extracts) when co-administered with standard-of-care for correction of anemia in obstetrics practice. This study determined the efficacy, safety and tolerability of Mojeaga as adjunct to conventional oral iron therapy for correction of anemia in obstetric population.
A pilot open-label randomized clinical trial. Participants with confirmed diagnosis of anemia in three tertiary hospitals in Nigeria were studied. Eligible participants were randomized 1:1 to either Mojeaga syrups 50 mls (200mg/50mls) administered three times daily in conjunction with conventional iron therapy (Mojeaga group) for 2 weeks or conventional iron therapy alone without Mojeaga (standard-of-care group) for 2 weeks. Repeat hematocrit level were done 2 weeks post-initial therapy. Primary outcome measures were changes in hematocrit level and median hematocrit level at two weeks post therapy. Maternal adverse events and neonatal outcomes (birth anomalies, low birthweight, preterm rupture of membranes and preterm labor) were considered the safety outcome measures. Analysis was by intention-to-treat.
Ninety five participants were enrolled and randomly assigned to the Mojeaga group (n = 48) or standard-of-care group (n = 47). The baseline socio-demographic and clinical characteristics of the study participants were similar. At two weeks follow-up the median rise in hematocrit values from baseline (10.00±7.00% vs 6.00±4.00%;p<0.001) and median hematocrit values (31.00±2.00% vs 27.00±3.00%;p<0.001) were significantly higher in the Mojeaga group. There were no treatment-related serious adverse events, congenital anomalies or deaths in the Mojeaga group and incidence of other neonatal outcomes were similar (p>0.05).
Mojeaga represents a new adjuvants for standard-of-care option for patients with anemia. Mojeaga remedy is safe for treating anemia during pregnancy and puerperium without increasing the incidence of congenital anomalies, or adverse neonatal outcomes.
www.pactr.samrc.ac.za: PACTR201901852059636 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822).
据我们所知，目前尚无关于 Mojeaga 疗法（一种由 Alchornea cordifolia、Pennisetum glaucum 和 Sorghum bicolor 提取物组成的特殊混合物）与产科常规护理联合用于纠正贫血的疗效的随机对照试验。本研究旨在确定 Mojeaga 作为常规口服铁剂治疗产科人群贫血的辅助治疗的疗效、安全性和耐受性。
这是一项试点开放标签随机临床试验。在尼日利亚的三家三级医院中，对确诊为贫血的参与者进行了研究。符合条件的参与者被随机分为 1:1 比例，分别接受 Mojeaga 糖浆 50 毫升（200mg/50 毫升），每日三次，联合常规铁剂治疗（Mojeaga 组）2 周，或单独接受常规铁剂治疗（标准护理组）2 周。初始治疗后 2 周重复进行血细胞比容水平检测。主要观察指标为治疗后 2 周时血细胞比容水平的变化和中位数血细胞比容水平。母体不良事件和新生儿结局（出生异常、低出生体重、胎膜早破和早产）被视为安全性观察指标。分析采用意向治疗。
共纳入 95 名参与者，并随机分配至 Mojeaga 组（n=48）或标准护理组（n=47）。研究参与者的基线社会人口学和临床特征相似。在 2 周随访时，Mojeaga 组的血细胞比容从基线的中位数升高（10.00±7.00% vs 6.00±4.00%；p<0.001）和中位数血细胞比容值（31.00±2.00% vs 27.00±3.00%；p<0.001）均显著高于标准护理组。Mojeaga 组无治疗相关严重不良事件、先天性异常或死亡，其他新生儿结局的发生率相似（p>0.05）。
Mojeaga 是一种治疗贫血的新标准护理选择的新辅助药物。Mojeaga 治疗剂在治疗妊娠和产褥期贫血时是安全的，不会增加先天性异常或不良新生儿结局的发生率。
www.pactr.samrc.ac.za: PACTR201901852059636（https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822）。
