Breastfeeding is recognized as the ideal way to nourish an infant, providing benefits to both the breastfed infant and breastfeeding mother (1–6). Currently, efforts to promote breastfeeding are widespread and include the WHO/UNICEF initiative to establish baby friendly hospitals—a program to certify hospitals as baby friendly that comply with the WHO/UNICEF Ten Steps to Successful Breastfeeding recommendations for care of breastfeeding infants and mothers (7). As a participant in this hospital initiative, facilities avoid the use of formula company-produced discharge samples and educational materials.
Despite such efforts, the dispensing of commercial formula materials and samples to breastfeeding women remains widespread in United States hospitals, with many facilities receiving formula for use in their nurseries at no cost. As competition between formula companies for access to hospitals and physicians' offices intensifies, discharge materials seem to undergo continual modifications. Hospital administrators and directors of maternity services are besieged by formula company representatives with the newest “breastfeeding” discharge pack that can be offered to patients at no charge to the hospital.
As health care professionals we must ask ourselves: Is there any harm in dispensing these materials? A number of studies, including eight randomized clinical trials, have been conducted in recent years to answer this question (8–17). The preceding study by Bliss et al represents another iteration of the question: Does the distribution of formula company advertising at hospital discharge influence breastfeeding duration? The authors concluded that “relative to other known influences on the choice of infant feeding method and on breastfeeding duration, discharge packs do not merit great concern.” Several aspects of this statement are worrisome and debatable.
The gold standard for research remains the prospective, randomized, blinded, clinical trial (RCT). The Bliss et al study is a prospective trial, however, in which randomization and blinding are both problematic. “A RCT is a true experiment in which patients are assigned, by a mechanism analogous to a coin flip, to either the putative causal agent or some alternative experience (either another agent or no exposure at all). Investigators then follow the patients forward in time and assess whether they have experienced the outcome of interest” (18). True randomization of study subjects did not occur in the Bliss et al trial; rather, a quasirandomization technique was used in which women were dispensed different packs depending on the week of delivery. Thus we are less than sure that the study groups are similar for important determinants of breastfeeding and for other unknown factors. In reporting the results, it is therefore especially important that the authors provide the reader with some evidence that the study groups were similar. Since such analyses are not given, the results must be viewed in this context. Are the results due to the intervention, or are they due to some other factor that is different between the study groups and confounds the results of this study?
Blinding is also an issue in this trial. Since study packs were distributed by nurses on the postpartum unit, subjects and nurses were not blinded to the study intervention (both parents and nurses knew the discharge pack contents). Although it is impossible to blind women receiving the discharge packs as to their contents, nurses on the postpartum unit should have been blinded. Could a nurse's knowledge of the discharge pack contents have influenced her care of women in a particular study group? For example, did the inclusion of a breast pump in the discharge pack cause nurses to spend more time teaching mothers about breastfeeding? The issue of blinding for those conducting the follow-up interviews is also of concern. The interviewers could easily become unblinded as to group assignment because members of the same study group would become due for sequential postpartum interviews at the same time. Hopefully, the authors took precautions to blind both nurses and interviewers to the hypothesis of the study, thus minimizing the potential for bias. However, this study is vulnerable to bias from both sources.
Turning from the issue of study design and validity, what does the published literature have to tell us about the effects of discharge packs on breastfeeding duration? Viewed in isolation, data from Bliss et al's study tend to support the conclusion that discharge packs have little effect on breastfeeding duration. These data, however, should not be viewed in isolation, but must be examined in the context of other empiric evidence (8–17). Increasingly, scientists and clinicians recognize the value of combining the data from well-designed studies of a particular intervention. Such meta-analysis is a new discipline that critically reviews and statistically combines the results of research in a specific area. Advantages include, first, an increase in statistical power for primary study endpoints and for subgroups analyses, second, the ability to resolve uncertainty when reports disagree, and third, the ability to improve estimates as to the effect of a particular intervention (19–22).
Most studies evaluating discharge packs were randomized clinical trials and are well suited to meta-analytical techniques (19–22). An excellent meta-analysis of studies of hospital practices and their effect on breastfeeding addressed the effects of discharge packs on breastfeeding (15). Figure 1, adapted from that meta-analysis, displays the results of several published clinical trials with regard to the effect of discharge packs on exclusive and overall breastfeeding duration. For each study cited, the cross hatch on the vertical line indicates the odds ratio that women who receive commercial materials will cease breastfeeding compared with women who do not receive such materials. Studies to date have demonstrated somewhat varied results, but the preponderance of evidence indicates that women who receive commercial formula materials or samples are more likely to experience negative breastfeeding outcomes. Using meta-analytical techniques to combine data from these studies, women who receive commercial materials are 1.1 times (95% CI, 1.0–1.3) more likely to cease full breastfeeding by one month and 1.2 times (95% CI, 1.0–1.5) more likely to cease overall breastfeeding by four months than women who receive noncommercial materials.
Although the Bliss et al study failed to demonstrate detrimental effects from discharge packs containing formula compared with those without formula, packs with formula when compared with packs containing a breast pump resulted in detrimental effects on full and exclusive breastfeeding outcomes. Whereas these data do not demonstrate dramatic effects due to commercial discharge packs, the observation of Frank et al remains unchallenged that “Studies to date have failed to demonstrate any positive effects from commercial formula discharge packs” (12).
Discharge packs may not exert as large an influence on breastfeeding duration as some other determinants, but many of the other more powerful influences are not readily amenable to change. As health caregivers, we have little control over a woman's parity, education, race, income, marital status, or return to work. However, we can easily avoid passing out advertising materials. To minimize the fact that supplementation rates are increased by passing out formula or that supplying breastfeeding women with supportive aids like breast pumps increases exclusive breastfeeding duration, is negating an opportunity to make a small but real difference. When incorporated into maternity services across the United States, such small differences may result in thousands of infants breastfeeding exclusively for longer periods of time. Breastfeeding is so important to the health of women and children throughout the world that opportunities to make even small improvements in every country must not be neglected.
Finally, the broader issue of the Baby Friendly Hospital Initiative must be addressed. This study was conducted in a hospital that had already undergone the process of applying for intent to become a baby friendly facility. This is an involved process that incorporates not only the examination of all aspects of care provided to breastfeeding mothers and infants, but involves the training and orientation of staff and the examination of a diversity of institutional policies as they apply to breastfeeding mothers and infants. It has been our experience that the Baby Friendly Hospital Initiative is a powerful tool for change. The significance of participating in a worldwide initiative should not be dismissed for its ability to overcome resistance among caregivers (both physicians and nurses) and for engendering support among hospital administrators. Perhaps individual steps may be less vital than the process of a hospital staff assessing and implementing a program that strives to provide excellent care to breastfeeding mothers and infants. We can, however, recount our own and the nursing staff's surprise at how much formula company-produced stuff we threw out in the process of applying the Ten Steps in our parent institution. It was an eye-opening experience, and one that we believe was a turning point in our hospital's change process.
As Bliss et al acknowledge, possibly because their intervention was conducted in a breastfeeding supportive environment, effects of the intervention were minimized. At present hospitals that have applied for intent to become baby friendly number only about 320, with one having received baby-friendly certification in the United States (M. Lazarov, personal communication, March, 1997). We must ask if splitting apart the Baby Friendly Hospital Initiative into components is a valid process. Are the parts equal to the whole, or does some additional benefit occur when a hospital and staff commit to becoming a baby-friendly facility? Does the facility that implements only a portion of the recommendations deliver optimal supportive care? Such questions remain unanswered.
Certainly, we do not intend to imply that the avoidance of commercial formula discharge materials is the only change that needs to occur to promote successful breastfeeding. Obstacles to breastfeeding are complicated and multifaceted, involving not only the medical system but the normative value associated with formula feeding in United States culture. We must work to modify a multitude of barriers in all aspects of our culture that prevent women from choosing and continuing to breastfeed their infants (5). We believe, however, that the preponderance of evidence indicates detrimental effects from the dispensing of formula samples and advertising materials, and we further believe that such practices should be eliminated (23,24).
The question we pose to readers of this commentary is why should a physician or nurse routinely dispense formula and formula advertising to a breastfeeding woman? What benefit does this bring to the mother or infant? If there is no benefit, let us stop the practice and get on with other more difficult-to-solve problems. Certainly much work remains to be done in ensuring that every woman who chooses to breastfeed her infant is given optimal care and support.