Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding
Information source: Karlstad University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mastitis
Intervention: Acupuncture treatment (Procedure); Administration of oxytocin nasal spray (Procedure); Improved breast milk removal (Procedure); Warmth applied to breasts (Procedure); Breast massage (Procedure); Anti-pyretic medication, paracetamol (Drug); cefadroxil (Drug); penicillin (Drug); flucloxacillin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Karlstad University Official(s) and/or principal investigator(s): Linda J Kvist, PhD, Principal Investigator, Affiliation: Karlstads University Bodil Wilde Larsson, PhD, Study Director, Affiliation: Karlstad University
Summary
The objective of the study was to test the hypothesis that acupuncture treatment hastens
recovery time from inflammatory symptoms of the breast during breastfeeding. 205 mothers
with 210 cases of breast inflammation (commonly called "mastitis") during breastfeeding were
randomly assigned to one of three treatment groups. There were two groups where acupuncture
was used and one without acupuncture. The mothers symptoms were recorded at the onset of
health care contact and daily until recovery. All care interventions given, including
antibiotic therapy, were monitored. Women who participated were asked to leave a breast milk
sample to test for bacterial growth. It was found that acupuncture did not shorten the
women's contacts with health care services but did improve their symptoms on contact days 3
and 4. It was seen in this study that only 15 % of women were prescribed antibiotics which
was a very low rate of prescription compared to USA, Canada, Australia, Turkey and New
Zealand where up to 100% are given antibiotics. Seven women (3. 3% of those in the study)
developed a breast boil and this is a similar number to a study in Australia where many more
were treated by antibiotics. This could mean that many women throughout the world are given
antibiotics when in fact they may recover without them. This is an important finding in
relation to the fight against antibiotic resistant bacteria.
Clinical Details
Official title: A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of women with lowest possible scores for symptom severity on days 3,4 and 5 in the three groupsComparison of the three groups for mean scores for symptom severity on days 3,4 and 5 Comparison of the three treatment groups for number of contact days with health care services until recovery Proportion of mothers in the three groups with less favourable outcomes (6 or more contact days to recovery) Comparison of the three groups for proportions of women prescribed antibiotics Comparison of the three groups for proportions of mothers who developed breast abscess Proportions of women in the three groups who experienced residual symptoms within 6 weeks which required renewed health care contact Comparison of the three groups for care interventions used
Secondary outcome: Amounts of bacteria in the breast milk and correlated to erythema, increased breast tension and pain at first contactType of bacteria in breast milk related to favourable outcomes (5 or less contact days) and less favorable outcomes (6 or more contact days) Differences in care interventions used in relation to favourable/less favourable outcomes Relationship between the occurrence of residual symptoms and the use of antibiotics
Detailed description:
Objectives: to further compare acupuncture treatment and care interventions for the relief
of inflammatory symptoms of the breast during lactation and to investigate the relationship
between bacteria in the breast milk and clinical signs and symptoms.
Design: randomised, non-blinded, controlled trial of acupuncture and care interventions.
Setting: a midwife-led breast-feeding clinic in Sweden.
Participants: 205 mothers with 210 cases of inflammatory symptoms of the breast during
lactation agreed to participate. The mothers were randomly assigned to one of three
treatment groups, two of which included acupuncture amongst the care interventions and one
without acupuncture. All groups were given essential care. Protocols, which included scales
for erythema, breast tension and pain, were maintained for each day of contact with the
breast-feeding clinic. A Severity Index (SI) for each mother and each day was created by
adding together the scores on the erythema, breast tension and pain scales. The range of the
SI was 0 (least severe) to 19 (most severe).
Findings: There was no significant difference in numbers of mothers in the treatment groups
with the lowest possible score for severity of symptoms on contact days 3, 4 or 5. There
were no statistically significant differences between the treatment groups for number of
contact days needed until the mother felt well enough to discontinue contact with the
breast-feeding clinic or for number of mothers prescribed antibiotics. There were
significant differences in the mean SI scores on contact days 3 and 4 between the
non-acupuncture group and the two acupuncture groups. Mothers with less favourable outcomes
(≥ 6 contact days, n = 61) were, at first contact with the midwife more often given advice
on correction of the baby’s attachment to the breast. An obstetrician was called to examine
20 % of the mothers and antibiotic therapy was prescribed for 15 % of the study population.
The presence of Group B streptococci in the breast milk was related to less favourable
outcomes.
Key conclusions and implications for practice: If acupuncture treatment is acceptable to the
mother, this, together with care interventions such as correction of breast-feeding position
and babies’ attachment to the breast might be a more expedient and less invasive choice of
treatment than the use of oxytocin nasal spray. Midwives, nurses or medical practitioners
with specialist competence in breast feeding should be the primary care providers for
mothers with inflammatory symptoms of the breast during lactation. The use of antibiotics
for inflammatory symptoms of the breast should be closely monitored in order to help the
global community reduce resistance development among bacterial pathogens.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Lactating mothers with symptoms of breast inflammation
- Any mixture of increased breast tension, fever, breast erythema, lumps in the breast
Exclusion Criteria:
- Non-Swedish speaking
- Psychiatric illness
- Hemorrhagic disease
- Prosthetic heart valves
- Skin infections
- Hepatitis B
- HIV positive.
Locations and Contacts
Dept Obstetrics & Gynecology, Helsingborg Hospital, Helsingborg, Skane 25187, Sweden
Additional Information
Karlstad University Webb page
Related publications: Kvist LJ, Hall-Lord ML, Rydhstroem H, Larsson BW. A randomised-controlled trial in Sweden of acupuncture and care interventions for the relief of inflammatory symptoms of the breast during lactation. Midwifery. 2007 Jun;23(2):184-95. Epub 2006 Oct 18.
Starting date: January 2002
Last updated: November 30, 2006
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