Gajbhiye Snehalata, Koli Paresh G, Harit Maheshkumar, Chitrakar Mrudul, Bavane Vishnu, Chawda Mukesh
Pharmacology and Therapeutics, Seth Gordhandas Sunderdas Medical College - King Edward Memorial Hospital, Mumbai, IND.
Pharmacology, Seth Gordhandas Sunderdas Medical College - King Edward Memorial Hospital, Mumbai, IND.
Cureus. 2021 Apr 7;13(4):e14348. doi: 10.7759/cureus.14348.
Background and objective Iron deficiency anemia (IDA) is a common condition in women for which ferrous ascorbate (FA) is often prescribed, which can lead to multiple side effects. Abhraloha is an Ayurvedic medicine that has been used for decades in India to treat IDA. In this study, we aimed to evaluate the efficacy and safety of Abhraloha with regard to change in hemoglobin (Hb) levels as compared to the standard treatment using FA in participants with IDA. Materials and methods We conducted a single-center, pragmatic, prospective, randomized, active-controlled, two-arm, parallel-group, assessor-blind study to evaluate the efficacy and safety of Abhraloha with regard to change in Hb levels as compared to the standard treatment using FA in participants suffering from IDA. The eligible participants were randomized and were advised to take either Abhraloha (two tablets twice a day) or FA (one tablet twice a day) for eight weeks; they were asked to follow up after 14 days for re-evaluation. On visit 1 and during the study period, the physician assessed the participants on the Pandurog scale and subjective variables. Descriptive statistics were used with unpaired T-test/Mann-Whitney U test for comparison between the groups. The Wilcoxon signed-rank test was used for within-group analysis, and the chi-square test/Fisher's exact test was employed for categorical data. Results Based on our findings, Abhraloha tablets significantly increased all the variables including the Pandurog scale after eight weeks of treatment. Abhraloha reduced total iron-binding capacity (TIBC) and peripheral smear lymphocyte (PSL), which is consistent with an improvement in IDA. There was a statistically significant increase in Hb, red blood cell (RBC) count, packed cell volume (PCV), mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) in the Abhraloha group as compared with the FA group at eight weeks. The Abhraloha group also exhibited a statistically significant improvement in all the subjective variables. Abhraloha was found to be safe and well-tolerated among the participants. Conclusions Abhraloha possesses hematinic activity and it improves all the blood indices. It is associated with significantly fewer adverse effects compared to oral iron therapy, which proves that it can be safely used for the treatment of IDA.
背景与目的 缺铁性贫血（IDA）在女性中较为常见，常用抗坏血酸亚铁（FA）进行治疗，但这可能会导致多种副作用。阿布拉洛哈是一种印度草医学药物，在印度已用于治疗IDA数十年。在本研究中，我们旨在评估与使用FA的标准治疗相比，阿布拉洛哈在改善缺铁性贫血参与者血红蛋白（Hb）水平方面的疗效和安全性。材料与方法 我们进行了一项单中心、实用、前瞻性、随机、活性对照、双臂、平行组、评估者盲法研究，以评估与使用FA的标准治疗相比，阿布拉洛哈在改善缺铁性贫血参与者Hb水平方面的疗效和安全性。符合条件的参与者被随机分组，并被建议服用阿布拉洛哈（每日两次，每次两片）或FA（每日两次，每次一片），持续八周；要求他们在14天后进行随访以重新评估。在第1次就诊时以及研究期间，医生使用潘杜罗格量表和主观变量对参与者进行评估。描述性统计用于通过不成对T检验/曼 - 惠特尼U检验进行组间比较。威尔科克森符号秩检验用于组内分析，卡方检验/费舍尔精确检验用于分类数据。结果 根据我们的研究结果，阿布拉洛哈片在治疗八周后显著提高了包括潘杜罗格量表在内的所有变量。阿布拉洛哈降低了总铁结合力（TIBC）和外周血涂片淋巴细胞（PSL），这与缺铁性贫血的改善一致。与FA组相比，八周时阿布拉洛哈组的Hb、红细胞（RBC）计数、血细胞比容（PCV）、平均红细胞体积（MCV）和平均红细胞血红蛋白含量（MCH）有统计学显著增加。阿布拉洛哈组在所有主观变量上也表现出统计学显著改善。在参与者中发现阿布拉洛哈安全且耐受性良好。结论 阿布拉洛哈具有补血活性，可改善所有血液指标。与口服铁剂治疗相比，其不良反应明显较少，这证明它可安全用于治疗缺铁性贫血。
