Hypogalactia Clinical Trial
Official title:
Effect of Acupuncture on Hypogalactia (Decreased Milk Supply): A Pilot Study
The specific aims are (1) to assess the feasibility of a RCT studying acupuncture's impact on breast milk production, and (2) to compare the difference of milk production between acupuncture and power pumping. The study approach will be a two-site prospective, non-blinded, two-arm randomized clinical trial conducted in Lubbock and Amarillo as a collaborative effort between researchers and clinicians in the departments of Family Medicine, Pediatrics and Ob/Gyn. An estimated 60 eligible mothers will be recruited and enrolled in the study from both sites. The participants will be randomized 1:1 into either the intervention group or the comparison group. The intervention group will receive three standardized acupuncture sessions, based on previous studies done in China and investigators' practice protocol, in 5 days and the comparison group will perform power pumping in 5 days per provided manual and guidance. The primary outcome is changes of breast milk production and it will be measured by weighing the grams/volume of milk expressed with an electric breast pump over time. The secondary outcome is changes of plasma prolactin and it will be measured by immunoassay. Data will be collected at baseline, right after interventions and two week after interventions to compare the difference of the outcomes. The findings of this study will provide insight to establish a RCT protocol to assess acupuncture's impact on hypogalactia. It may also help establish evidence of acupuncture use for hypogalactia.
As important and beneficial as breastfeeding is to infants and mothers, physicians often feel
lack resources to support breast milk production. Reduced breast milk production (called
hypogalactia) is the most frequent cause of breastfeeding failure, but no evidenced-based
standard care in conventional medicine is established to help mothers face the challenge. The
most frequently used natural galactogogues products including galega and silymarin are not
FDA approved. Lactation education on general breastfeeding and lactation management may help
mothers who are experiencing reduced milk supply. Complementary and alternative medicine
(CAM) including acupuncture has been used to address hypogalactia. However, there remains an
overall lack of evidence regarding the effectiveness, safety, and acceptability of many CAM
therapies including acupuncture for hypogalactia. Although several clinical observational
studies showed that acupuncture was related to the increased prolactin level and mother's
breast milk production, there are several gaps in those studies. First, most studies were
done in China and are mainly observational, hence are subject to various biases and do not
establish a causal relationship. Secondly, most of the studies only reported success rates
without reporting changes of milk volume or biomarkers. To truly assess the effect of
acupuncture on breast milk production and relevant hormone changes, a randomized clinical
trial (RCT) with better measurements is warranted.
The feasibility of an acupuncture protocol for hypogalactia is supported by the acupuncture
practice in the Family medicine clinic. The goal of this study is to establish the
feasibility of a RCT to compare the difference of breast milk production between acupuncture
and power pumping, a popular lactation practice recommended to mothers who experience
hypogalactia, using established measurement of breast milk production. Both acupuncture and
power pumping stimulate the breasts which may lead to the increased secretion of prolactin
hence increase milk production. Previous study findings and investigators' clinical
experiences indicate that a short period of acupuncture treatment may increase milk
production for several weeks. It is hypothesized that acupuncture will have equal or a
greater impact on milk production and last longer than power pumping. The study special aims
are:
1. To assess the feasibility of a RCT studying acupuncture's impact on breast milk
production. A two-arm RCT will be conducted at one site. Recruitment, enrollment,
intervention and compliance, safety and adverse events will be documented and evaluated
to assess this trial design is appropriate for further testing. Study feasibility is
defined as the successful recruitment and retention of study participants, adherence to
the intervention, identification of barriers to the intervention, and the rigorous
collection of outcome data.
2. To compare the effect difference of breast milk production between acupuncture and power
pumping. The primary outcome the changes of breast milk production will be measured by
weighing the grams/volume of milk expressed with an electric breast pump. The secondary
outcome the changes of plasma prolactin will be measured by immunoassay. Data will be
collected at baseline, right after interventions and two week after interventions.
Based on investigators' search in PubMed to present, no RCT studies have been done in the
U.S. assessing acupuncture and hypogalactia. This study may be the first to provide insights
on the feasibility. Moreover, based on investigators's clinical observations and reports from
studies done in China, this study to yield positive findings to help establish evidence of
acupuncture use for hypogalactia. The preliminary data may also help us apply for grants from
the National Center for Complementary and Integrative Health (NCCIH) or NIH Office of
Research on Women's Health. More importantly, the evidence will help clinician and mothers
make informed decisions in terms of choosing the right approach to increase breast milk
production.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03577587 -
Efficacy of Herbal Galactagogue Silitidil After Preterm Birth
|
N/A |