 |
|
|
| Jason Sauberan, Pharm D & Nancy E. Wight MD, IBCLC, FABM, FAAP
Two recently published randomized, double-blind, placebo-controlled studies 1,2 of galactogogues for mothers of preterm newborns have suggested that the medications metoclopramide (Reglan®) and oxytocin nasal spray are no more effective than placebo in improving breastmilk volumes in the immediate postpartum period.In August of 1997, oxytocin nasal spray (Syntocinon®) was withdrawn from the U.S. market. However, it remains available in much of the rest of the world. Recently, investigators from the Institute of Child Health in the U.K. published results of their randomized double-blind trial of achieving enhanced milk production with maternal oxytocin nasal spray versus placebo in 42 mothers with premature newborn infants of 27 to 33 weeks gestation. 1 The spray was initiated on infant day of life one and continued for 5 days, being self-administered before each milk expression with a hospital-grade breast pump. Lactation consultation was provided on the post-partum and neonatal units, and also by the study research nurses who saw each mother at least daily during the study. There were no differences in baseline demographics between the two groups.Based on the mothers' daily milk volume records, milk production was slightly higher in mothers using oxytocin spray only for study day 2. There was no difference in the cumulative weight of milk produced over days 1-5 between the groups. There were also no differences in the number of or the amount of time spent pumping. In the second study 2, researchers at the University of Iowa randomized 57 mothers who delivered between 23 and 34 weeks of gestation to receive either metoclopramide 10 mg oral tablets or placebo tablets three times daily beginning within 96 hours after delivery. Treatment lasted for 10-days. During treatment, and for 7 days after treatment discontinuation, the mothers in the study continued to breastfeed and documented their milk expressions (volume of milk each time she expressed and the total minutes they expressed at each breastfeeding or pumping session) in a journal.A trained lactation specialist standardized all educational materials given to the mothers at entry into the study and hospital grade electric pumps were provided to all study subjects. Volume measurements were verified twice during the 17-day study period by study investigators. Mothers in the study were contacted once every month after delivery or until they decided to stop breastfeeding. Metoclopramide use was not associated with a significant increase in milk volume on each of the 17 days of the study, or in volume of milk produced over time between study days 10 and 17. It was also not associated with a significant increase in breastfeeding duration, which was, on average, approximately 8 1/2 weeks in both groups. Additionally, no significant differences in milk volume were found among the subgroups 23-28 weeks or 28-34 weeks of gestation, although the study was not adequately powered to detect any difference in these subgroups. There were no significant differences between metoclopramide and placebo groups in baseline obstetric characteristics, including gestational age, previous preterm birth, route of delivery, and parity. While this study is a major improvement over previous non-randomized or non-controlled studies of metoclopramide's galactogogue effects, we don't necessarily believe it challenges the utility of metoclopramide as a lactation enhancing agent. In this study, subjects were given metoclopramide prophylactically, very early in the lactation process. They did not necessarily have faltering milk supply. Subjects also delivered preterm and were dependent on a breast pump. We in the lactation community know that metoclopramide is most commonly used as a treatment (not prophylaxis) of lactation deficiency, for women with term or preterm infants, often days to weeks after birth. Although clinical experience and several prior studies 3-15 have suggested metoclopramide effective in increasing milk volumes, a prospective, randomized controlled trial of 50 mothers with partial or complete lactation failure conducted in India in 1997 (16) also found no difference in successful relactation between mothers treated with metoclopramide 10 mg orally three times a day for 10 days and those mothers given no pharmacological treatment. Infants in this study were 1 to 3 months of age and were born at term or near-term. |
|
Upon study enrollment, both groups of mothers were motivated to breastfeed by, "removing their misconceptions and educating them regarding the advantages of breastfeeding. Mothers with successful relactation were introduced as the role models for others. They were encouraged to stimulate the nipple by means of nipple stroking and massaging the breast, and to suckle the infants frequently (8-10 times/day)." Bottle-feeding and pacifiers were also discontinued and proper infant positioning techniques were taught. Nipple confusion and infant frustration was identified as the most common cause of lactation failure in both study groups prior to enrollment. Baseline demographics of mothers and infants were the same in both groups.
Success was measured by the appearance of manually expressed milk, a reduction in infant supplementation volume, and infant weight gain. All but one mother in the study achieved successful relactation and there were no differences in the rates of these successful outcomes between the treatment groups. The average time to achieve partial and complete relactation was 6 and 32 days, respectively. The authors concluded that motivation, support, and proper infant positioning are the foundations of establishing successful relactation. We are inclined to agree. 17 References |
