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

NCT00405158 | Completed

• 1 other identifier: 84839
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastitis

Keywords

Lactation mastitis; Breast inflammation; Breastfeeding; Care interventions; Acupuncture treatment; Antibiotic therapy

Outcome Measures

Primary Outcomes (8)

• Proportion of women with lowest possible scores for symptom severity on days 3,4 and 5 in the three groups

• Comparison 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 Outcomes (4)

• Amounts of bacteria in the breast milk and correlated to erythema, increased breast tension and pain at first contact

• Type 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

Interventions

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Lactating mothers with symptoms of breast inflammation
• Any mixture of increased breast tension, fever, breast erythema, lumps in the breast

You may not qualify if:

• Non-Swedish speaking
• Psychiatric illness
• Hemorrhagic disease
• Prosthetic heart valves
• Skin infections
• Hepatitis B
• HIV positive.

Sponsors & Collaborators

• Karlstad University: lead

Study Sites (1)

Dept Obstetrics & Gynecology, Helsingborg Hospital

Helsingborg, Skåne County, 25187, Sweden

Location

Related Publications (1)

• 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. doi: 10.1016/j.midw.2006.02.003. Epub 2006 Oct 18.

  PMID: 17052823 BACKGROUND

Related Links

• Karlstad University Webb page

MeSH Terms

Conditions

Mastitis; Breast Feeding

Interventions

Acupuncture Therapy; Acetaminophen; Cefadroxil; Penicillins; Floxacillin

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cephalexin; Cephalosporins; beta-Lactams; Lactams; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cloxacillin; Oxacillin

Study Officials

• Linda J Kvist, PhD

  Karlstads University

  PRINCIPAL INVESTIGATOR

• Bodil Wilde Larsson, PhD

  Karlstad University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: January 1, 2002
• Study Completion: March 1, 2004
• Last Updated: December 4, 2006

Record last verified: 2006-11

Locations

SE (1)