Adherence and side effects of three ferrous sulfate treatment regimens on anemic pregnant women in clinical trials

Abstract

The objective of this study was to analyze adherence and side effects of three iron supplement regimens (ferrous sulfate) on anemic pregnant women. The clinical trial involved 150 women between the 16th and 20th gestational weeks, at low obstetric risk and with hemoglobin concentration of between 8.0 and 11.0g/dL. Treatment was provided by ferrous sulfate with 60mg of elemental iron during 16 (± 1) weeks, in three regimens: single tablet a week (n = 48); single tablet twice a week (n = 53) or single tablet a day (n = 49). The outcomes were adherence, assessed through interviews and by counting tablets, and side effects, according to patient information. The adherence showed a declining trend (92%, 83% and 71%; p = 0.010) and the side effects revealed a growing trend (40%, 45% and 71%; p = 0.002) as the dosage increased. Diarrhea and epigastric pain were significantly associated with the dose administered (p = 0.002). These results suggest that in anemic pregnant women, complaints are directly proportional and the compliance is inversely proportional to the amount of medicinal iron.

The side-effects of different doses of iron sulfate on women of reproductive age: a randomized double-blind, placebo-controlled study

“…12,15 The present study found that the use of IS was responsible for the gastro-intestinal complaints reported by the women, corroborating previous findings. 1,9,10,23 Reported complaints were more frequent among those taking IS daily than among those taking it twice a week. This is in accordance with various other studies that suggest that two intermittent doses, when treating anemia, may be more effective in improving adherence, owing to the lower incidence of side-effects.…”

“…This is in accordance with various other studies that suggest that two intermittent doses, when treating anemia, may be more effective in improving adherence, owing to the lower incidence of side-effects. 7,12,13,15,23 The side-effects, taken in isolation show that the most frequently reported complaints were malaise, diarrhea and constipation, especially in the groups that took IS on a daily basis. Other studies have found variations in the frequency for various different complaints relating to the gastrointestinal tract that this is probably due to the fact that studies examined such effects in different sectors of the population, [21][22][23] although most complaints still refer predominantly to the gastrointestinal tract.…”

A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation

“…nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation [5,19,48,49]. In addition, the questionnaire included questions on breathlessness because this is common in anaemic patients and headache that, although not generally associated with oral iron therapy, is common with some gastrointestinal complaints [50,51].…”

“…One of the hurdles to eradicate this disorder has been the use of iron preparations, typically ferrous iron salts 65 mg Fe 2–3 times daily [4], that risk significant gastrointestinal disturbances [5-10] and systemic infection [11-14]. Data from the National Health Service shows that at least 97.5% of the prescriptions filled for oral iron in England alone are for simple ferrous salts (sulphate, fumarate or gluconate) [15].…”

Assessing Micronutrient Adherence after Bariatric Surgery: An Exploratory Study

“…Gastrointestinal (GI) side effects, such as nausea, constipation and dyspepsia, are well-documented with oral iron therapy. Research on iron supplementation tolerability and adherence has been primarily conducted in pregnant or postpartum women, in which adherence rates for iron have been found to be between 60-70% due to the side effects [26,27]. Ferrous sulfate is commonly used as the oral iron preparation because of its high elemental iron content (33%), documented efficacy, low cost, and availability without a prescription [1,28,29].…”