Discussion
toxicity, congenital anomalies, hepatic and renal functions, anemia
ANEMIA IN PREGNANCY, STILL, ADVERSE EVENTS, RECRUITMENT, ANEMIA, WORMS, PRETERM LABOR, DISEASES
This trial which is the first positive randomized trial involving Mojeaga therapy in women with anemia shows that Mojeaga therapy improves anemia compared with the use of standard of care alone. Until now, treatment recommendations for moderate and severe anemia in pregnancy and gynecological patients were based on the use of parenteral therapy and blood transfusion and occasionally oral therapy. The findings of this study suggest that concomitant use of standard iron therapy with Mojeaga improves efficacy with significant rise in hematocrit and higher hematocrit level.In this study, the median rise in hematocrit values at two weeks follow-up was significantly higher in Mojeaga group compared to the standard-of-care group (10.00±7.00% vs 6.00±4.00%; p<0.001). Also, the mean hematocrit values at two weeks follow-up were significantly higher in Mojeaga group (p<0.001). The apparent anemia recovery benefit of Mojeaga regardless of pregnant or no-pregnant status suggests that Mojeaga is promising adjuvant therapy for anemia. This benefit could be due to high amount of natural iron in the Mojeaga formulations. Similarly, the previous case report by Eleje et al on the use of Mojeaga re-counted improvements in anemia symptoms in women that received Mojeaga remedy [The findings of our study raise the question of the mechanism of action of Mojeaga in the treatment of anemia in obstetrics population. Although the exact mechanism of action is not known, Mojeaga may work by accelerating a rapid turn-over of the bone-marrow erythropoiesis. This possible mechanisms was revealed by the findings of Idu et al that showed that the histo-architectural structure of the bone marrow of the experimental animals showed a stimulating effect of myeloid/erythroid cell ratio > 60 in the treatment (Mojeaga) groups when compared with control groups [Our randomized controlled clinical trial showed that Mojeaga has a favorable safety profile, and also when combined with the conventional oral iron therapy. The frequency of adverse events, abnormal laboratory analysis, vital signs, and physical findings was similar across the two treatment groups. Although serum bicarbonate level was different in both study groups, the overall bicarbonate levels were within the normal limits. Similarly, in a recent preclinical study by Idu et al that evaluated the toxicological profile of Mojeaga herbal remedy on male and female animal models, acute and chronic toxicity of Mojeaga herbal remedy in male and female Wistar rats were investigated through thorough examination of mortality rate, body and organ weight changes, hematological indexes, biomarkers of hepatic and renal functions and histopathological study across all treatment groups using standard protocol [One clinical implications of our study findings was that in the study, we adopted the two weeks assessment for efficacy of intervention of anemia because, a prior case report reported a two week therapy [Additionally, our protocol for assessing efficacy of intervention of anemia in two weeks was similar to a French study by Broche et al on iron use in pregnancy [It is noteworthy of the issues related to the clinical benefit and risks of adding a product during pregnancy that has unknown mechanism of action and which was associated with a greater hematocrit improvement at two weeks but little difference in clinical symptoms. Anecdotal report has revealed that the majority of pregnant women use the Mojeaga medication during pregnancy despite the unavailability of evidence-based information about its teratogenic risks. Still, this medication use during pregnancy will continue to raise uncertainty and concern among pregnant women and their health care providers. This is one of the impetus for this present study.Whilst interpreting the results of this study, several strengths and shortcomings arose which required consideration. The strengths of the study include the good uptake and inclusion of a representative sample of participants from obstetrics units across a range of socioeconomic groups and hospitals, the near-complete follow-up period allowing complete case analysis, and limiting bias in the results. Therapeutic options for women with anemia especially those who refuse blood transfusion have been scarce, in part because recruitment challenges have made randomized controlled trials in cases with anemia requiring oral therapy infeasible. Our study has overcome this challenge. This study was the first randomized trial to evaluate the effectiveness, safety and tolerability of Mojeaga as adjunct to conventional oral iron therapy for correction of anemia in obstetrics population. One potential weakness of this study was the bias of individual investigators to open label nature of the trial. To control this, the protocol required blinded intervention sequence and computer-generated random numbers. Additionally, the intention-to-treat analysis was employed with resultant marked benefit associated with Mojeaga, supporting the evidence for improvement in anemia symptoms. This study did not control for worms or helminthic diseases which could be attributable as one of the causes of anemia in pregnancy, as the participants did not routinely receive antihelminthic therapy such as mebendazole during pregnancy. Although during the study, the two groups experienced comparable decrease in fetal adverse events, there were no recorded congenital anomalies and no changes in incidence of preterm labor, and low birth weight in either group. This finding should be interpreted with caution because our study is a very small study with only 44 women given the investigational product in pregnancy. Therefore, an absence of adverse events in such a small cohort does not establish safety. There are also some limitations of prior safety and mechanistic data and the limitations of the study design and outcomes. For example, the present study is an open label trial as phase I and phase II trials are often open label [