MastitisNCT00405158
Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding
A study testing Acupuncture treatment, Administration of oxytocin nasal spray and Improved breast milk removal in people with Mastitis, run by Karlstad University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mastitis
- What is being tested?
- Acupuncture treatment, Administration of oxytocin nasal spray and Improved breast milk removal
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2002to Mar 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lactating mothers with symptoms of breast inflammation
- Any mixture of increased breast tension, fever, breast erythema, lumps in the breast
Who cannot join
- Non-Swedish speaking
- Psychiatric illness
- Hemorrhagic disease
- Prosthetic heart valves
- Skin infections
- Hepatitis B
- HIV positive.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept Obstetrics & Gynecology, Helsingborg Hospital
Helsingborg, Skåne County, 25187
About this study
Official title: A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation
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.
Read the 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.
- Conditions
- Mastitis
- Being tested
- Acupuncture treatment, Administration of oxytocin nasal spray, Improved breast milk removal, Warmth applied to breasts, Breast massage
- Keywords
- Lactation mastitis, Breast inflammation, Breastfeeding, Care interventions, Acupuncture treatment, Antibiotic therapy
- Medical subject headings
- Mastitis, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture treatmentProcedure or surgery
Administration of oxytocin nasal sprayProcedure or surgery
Improved breast milk removalProcedure or surgery
Warmth applied to breastsProcedure or surgery
Breast massageProcedure or surgery
Anti-pyretic medication, paracetamolDrug
cefadroxilDrug
penicillinDrug
flucloxacillinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startJan 2002
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MastitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- Karlstad University
- Sponsor type
- University, hospital or other
- Investigators
- Linda J Kvist, PhD, Principal investigator, Karlstads UniversityBodil Wilde Larsson, PhD, Study director, Karlstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405158
- Sponsor's protocol ID
- 84839
- Status last verified
- Nov 2006
- First submitted
- 28 Nov 2006
- Last updated
- 4 Dec 2006
- Results posted
- No
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. doi: 10.1016/j.midw.2006.02.003. Epub 2006 Oct 18.
PubMed 17052823
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation
- ClinicalTrials.gov ID
- NCT00405158
- Acronym / sponsor ID
- 84839
- Conditions
- Mastitis
- Keywords
- Lactation mastitis, Breast inflammation, Breastfeeding, Care interventions, Acupuncture treatment, Antibiotic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants
- Lead sponsor
- Karlstad UniversityUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Mar 2004
- First posted
- 29 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Lactating mothers with symptoms of breast inflammation
- Any mixture of increased breast tension, fever, breast erythema, lumps in the breast
Key exclusion criteria (7 listed)
- Non-Swedish speaking
- Psychiatric illness
- Hemorrhagic disease
- Prosthetic heart valves
- Skin infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture treatment | Procedure or surgery | – |
| Administration of oxytocin nasal spray | Procedure or surgery | – |
| Improved breast milk removal | Procedure or surgery | – |
| Warmth applied to breasts | Procedure or surgery | – |
| Breast massage | Procedure or surgery | – |
| Anti-pyretic medication, paracetamol | Drug | – |
| cefadroxil | Drug | – |
| penicillin | Drug | – |
| flucloxacillin | Drug | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2006.
- Background: PubMed 17052823Kvist 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.
- Karlstad University Webb pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda J Kvist, PhD principal investigator
Karlstads University
Bodil Wilde Larsson, PhD study director
Karlstad University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture treatment, Administration of oxytocin nasal spray and Improved breast milk removal in people with Mastitis, run by Karlstad University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women with lowest possible scores for symptom severity on days 3,4 and 5 in the three groups. The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00405158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2006.