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Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00405158
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : December 4, 2006
Information provided by:
Karlstad University

Brief 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.

Condition or disease Intervention/treatment Phase
Mastitis Procedure: Acupuncture treatment Procedure: Administration of oxytocin nasal spray Procedure: Improved breast milk removal Procedure: Warmth applied to breasts Procedure: Breast massage Drug: Anti-pyretic medication, paracetamol Drug: cefadroxil Drug: penicillin Drug: flucloxacillin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation
Study Start Date : January 2002
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Proportion of women with lowest possible scores for symptom severity on days 3,4 and 5 in the three groups
  2. Comparison of the three groups for mean scores for symptom severity on days 3,4 and 5
  3. Comparison of the three treatment groups for number of contact days with health care services until recovery
  4. Proportion of mothers in the three groups with less favourable outcomes (6 or more contact days to recovery)
  5. Comparison of the three groups for proportions of women prescribed antibiotics
  6. Comparison of the three groups for proportions of mothers who developed breast abscess
  7. Proportions of women in the three groups who experienced residual symptoms within 6 weeks which required renewed health care contact
  8. Comparison of the three groups for care interventions used

Secondary Outcome Measures :
  1. Amounts of bacteria in the breast milk and correlated to erythema, increased breast tension and pain at first contact
  2. Type of bacteria in breast milk related to favourable outcomes (5 or less contact days) and less favorable outcomes (6 or more contact days)
  3. Differences in care interventions used in relation to favourable/less favourable outcomes
  4. Relationship between the occurrence of residual symptoms and the use of antibiotics

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00405158

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Dept Obstetrics & Gynecology, Helsingborg Hospital
Helsingborg, Skane, Sweden, 25187
Sponsors and Collaborators
Karlstad University
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Principal Investigator: Linda J Kvist, PhD Karlstads University
Study Director: Bodil Wilde Larsson, PhD Karlstad University

Additional Information:
Layout table for additonal information Identifier: NCT00405158    
Other Study ID Numbers: 84839
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: December 4, 2006
Last Verified: November 2006
Keywords provided by Karlstad University:
Lactation mastitis
Breast inflammation
Care interventions
Acupuncture treatment
Antibiotic therapy
Additional relevant MeSH terms:
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Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents