New Galactogogue Protocol–New Attitude??

Today a new ABM protocol was published in Breastfeeding Medicine: ABM Clinical Protocol #9: Use of Galactogogues in Initiating or Augmenting the Rate of Maternal Milk Secretion (First Revision January 2011).    I am posting today having my hat on as ABM Protocol Committee Chairperson.  When we wrote the first version of this protocol in 2004, the basic message of the document was that galactagogues were a definite second-tier therapy for increasing milk supply, after all the mechanical and physical and otherwise treatable etiologies were investigated and adequately treated. That they are second-tier has not changed in this newest version.

What has subtly shifted is the attitude toward the use of the galactogogues themselves.  In 2004 there was an almost laissez–faire attitude—if the mechanical changes and medical work-up did not yield the hoped-for increased results in milk production, then galactogogues were effective, and thus should be, and were, used.  Although one should think (briefly) about potential side-effects, they were really quite rare, and the use of galactogogues were essentially (although not definitively stated as such) standard of care.  The protocol proceeded to tell us how to use them.

The 2011 revision gives us a different message.  It is a prime example of why protocols need to be reviewed, and revised, with all the blood, sweat and tears that involves for the primary contributors and for so many of us, every 5 years (or as you can see here, it often takes 6 for the process to be completed.)  In this case, the careful searching out and evaluation of interim evidence-based studies and emerging information regarding more serious potential side effects of some galactogogues resulted in a shift in the ABM’s recommendations regarding these drugs and herbs.  This newer data suggests that we should exercise more caution in recommending these drugs to induce or increase the rate of milk secretion in lactating women, particularly in women without specific risk factors for insufficient milk supply.  There have been more significant side effects documented for some of them.

We are also now using Levels of Evidence when stating recommendations.  The Levels of Evidence are based on the United States Preventive Services Task Force ‘‘Quality of Evidence’’  (last accessed February 12, 2011).  Each study reviewed is classified by the authors according to these Levels, and when a recommendation is made in the protocol, we give the Level of Evidence so that the reader has an idea how strongly the recommendation can/should be taken (e.g. Level I is a randomized, controlled study).  In this way, we feel we give you a better idea of how strong the recommendation is, based on how strong the data behind it is.

Consequently, as you read this revised protocol, you may be surprised to realize that the evidence for using pharmacologic and herbal galactagogues has grown weaker.  There are still some clinical situations that appear to warrant their use.  But there clearly also appears to be a knowledge gap, and yet another area ripe for research.  Check out the new protocol.  What do you think?

Kathleen Marinelli MD, IBCLC, FABM is a neonatologist a Board member of the Academy of Breastfeeding Medicine, and Chair of the ABM Protocol Committee.

Posts on this blog reflect the opinions of individual ABM members, not the organization as a whole.