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Antibiotics for mastitis in breastfeeding women

  1. Shayesteh Jahanfar1,*,
  2. Chirk Jenn Ng2,
  3. Cheong Lieng Teng3

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 28 FEB 2013

DOI: 10.1002/14651858.CD005458.pub3


How to Cite

Jahanfar S, Ng CJ, Teng CL. Antibiotics for mastitis in breastfeeding women. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD005458. DOI: 10.1002/14651858.CD005458.pub3.

Author Information

  1. 1

    University of British Columbia, School of Population and Public Health, Vancouver, British Colombia, Canada

  2. 2

    University of Malaya, Department of Primary Care Medicine, Kuala Lumpur, Malaysia

  3. 3

    International Medical University Jalan Rasah, Department of Family Medicine, Seremban, Negeri Sembilan Darul Khusus, Malaysia

*Shayesteh Jahanfar, School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, British Colombia, VT6 1Z3, Canada. jahanfar2000@yahoo.com. shayeste@interchange.ubc.ca.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 28 FEB 2013

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Characteristics of included studies [ordered by study ID]

MethodsRandomised: method of randomisation is not mentioned.
Adequate concealment of allocation is mentioned inclusive of using pre-sealed, opaque envelopes.
Double blind: no. It was mentioned that investigators were blinded.
Intention-to-treat not mentioned.
Follow-up is described. Patients were seen for follow-up visits in 7 days.
25 recruited and no drop-outs.
Design: parallel.


Participants25 lactating mothers with Sporadic Acute Puerperal Mastitis (SAPM) were recruited for this study.
Inclusion criteria: 3 criteria of oral temperature of 37.56ºC, tenderness on palpation of the breast and segmental erythema was needed to include a participant.
Exclusion criteria: maternal age of < 18 years, documented allergy to penicillins or cephalosporins, and antibiotic therapy within the previous 30 days.
Baseline characteristics such as age, parity, history of mastitis, or history of diabetes mellitus was similar between the 2 groups.


InterventionsThe treatment regimens were oral amoxicillin, 500 mg every 8 h for 7 days, or oral cephradine, 500 mg every 8 h for 7 days. Continuation of breastfeeding and usage of warm and moist compresses to the involved breast every 4-6 h was recommended for all patients.

All patients presented to outpatient clinic and visited by single physician. Patients were instructed to notify the physician if their temperature remained > 37.56ºC (> 99.6ºF) after 48 hrs or if they were unable to comply with the antibiotic regimen.


OutcomesOutcomes were inclusive of resolution of mastitis, namely fever, erythema and tenderness.


NotesUniversity of Kentucky Medical Center Outpatient Clinic patients enrolled from July 1991 until December 1993.
Informed consent signed by all patients. Historical information and study data were recorded on pre-coded data sheet.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod is not mentioned.

Allocation concealment (selection bias)Low riskAdequate concealment of allocation is mentioned inclusive of using pre-sealed, opaque envelopes.

Blinding (performance bias and detection bias)
All outcomes
Low riskIt was mentioned that investigators were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow-up is described. Patients were seen for follow-up visits in 7 days.
25 recruited and no drop-outs.

Selective reporting (reporting bias)Low riskAll expected outcomes appear to have been reported.

Other biasLow riskGroups appear balanced for baseline characteristics (apart from duration of symptoms - see Table 1, page 99).


MethodsRandomised: method of randomisation is not mentioned.
Allocation concealment: there is no mention of patient allocation. Antibiotic therapy was rather directed by susceptibility tests of the isolated bacteria. Unit of allocations was "mothers" but the unit analysed in the results was shown as "breasts".
Double blind: no. It is unclear whether patient or outcome assessor was blinded.
Intention-to-treat not mentioned.
Follow-up is not described clearly. From definition of bad outcome it can be implied that patients have been visited 2 weeks after the attack.
No drop-outs.
Design: parallel.


Participants213 nursing women with the diagnosis of infective mastitis (presence and persistence of tenderness, swelling, redness, heat, and decreased milk secretion) were recruited for this study. Diagnosis was made based on clinical symptoms, leucocyte count and anaerobic/aerobic bacteria cultivation. The unit of analysis in this study was not women but rather single breasts (339 breasts). There were 3 groups. Group 1 included those with milk stasis (< 106 leucocytes and < 103 bacteria) (number of breasts = 126) and group 2 were inclusive of non-infective mastitis (> 106 leucocytes and < 103 bacteria) (number of = 48). Group 3 consisted of 165 inflammatory breasts with proven infective mastitis (> 106 leucocytes and > 103 bacteria).

This final group (included in this review) was then randomly assigned to 3 subgroups with 55 cases in each group:

Those with no therapy (subgroup 1), standard of care therapy (subgroup 2) and finally cases of antibiotic therapy (subgroup 3).

Inclusion criteria: the presence and persistence of tenderness, swelling, redness, heat, and decreased milk secretion.
Exclusion criteria were not mentioned.
Baseline characteristics were not mentioned.
All patients presented to Kommune hospital, Aarhus in Denmark. There is no mention if patients were visited in outpatient clinic.


InterventionsThe treatment regimens contained penicillin 500,000 IU 3 per day for 6 days, oral ampicillin 500 mg, 4 per day for 6 days or erythromycin 500 mg 2 times per day for 6 days. In control group non-intervention therapy was adopted which consisted of emptying the breast every 6 h by nursing the baby followed by expression by hand or mechanical suction.


OutcomesOutcome was considered as good if symptoms of mastitis disappeared followed by normal lactation throughout 2 weeks after the attack.


NotesStudy was done in 1983 (no exact date is mentioned) in Department of Obstetrics and Gynecology, Kommunehospital, Aarhus in Denmark.
There is no mention if patient signed any consent form. Study had been approved by local ethical committee.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod is not mentioned.

Allocation concealment (selection bias)Unclear riskAntibiotic therapy was rather directed by susceptibility tests of the isolated bacteria.

Blinding (performance bias and detection bias)
All outcomes
High riskIt is unclear whether women or outcome assessors were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskFollow-up is not described clearly. From the definition of bad outcome it can be implied that patients were visited 2 weeks after the attack. There is no report of drop-outs or for any of the subgroups.

Selective reporting (reporting bias)Unclear riskUnclear from study report. No study protocol.

Other biasUnclear riskNo baseline characteristics table.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Amir 2004bAllocation is not clear.
Randomisation: yes.
Participants: 10 randomised breastfeeding women with cracked nipples colonised with Staphylococcus aureus were recruited out of 135 women who were originally found to be eligible.
In the placebo arm, 2 out of 5 women continued to take the capsules.
Intervention: 7-day course of either an oral antibiotic (flucloxacillin) or identical placebo capsules.
Researcher did not complete the study due to logistic problems. This study is therefore an unfinished RCT.

Arroyo 2010One study arm used antibiotic but the two control groups used different forms of oral lactobacilli and did not use placebo, no treatment, or other supportive treatments such as breast emptying or another antibiotic of a different class.

Fernandez 2008Bacteriocin nisin was used for treatment group and no report of antibiotic usage was studied.

Gerstner 1987Information in this briefly presented study is more concentrated on postpartum infections in general rather than mastitis.

Jimenez 2008Lactobacillus strains isolated from breast milk were used as a mode of treatment and there was no report of antibiotic therapy.

 
Characteristics of studies awaiting assessment [ordered by study ID]

MethodsRandomised controlled trial.

Parallel.

Participants198 women with acute mastitis for Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, China.

99 cases in each group.

InterventionsTreatment group: oral cefradine.

Control group: kneading and dispersing manipulation.

OutcomesLocal breast lump size; clinical symptoms; adverse reactions.

NotesInformation available from English abstract, full report in Chinese and currently being translated.

 
Comparison 1. Amoxicillin versus cephradine

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Symptom improvement assessed by clinician125Risk Ratio (M-H, Fixed, 95% CI)0.85 [0.65, 1.12]

 
Comparison 2. Antibiotic therapy with breast emptying versus no treatment

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Symptom improvement assessed by clinician and continuous breastfeeding1110Risk Ratio (M-H, Fixed, 95% CI)6.63 [3.48, 12.60]

 
Comparison 3. Antibiotic therapy with breast emptying versus breast emptying alone

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Symptom improvement assessed by clinician and continuous breastfeeding1110Risk Ratio (M-H, Fixed, 95% CI)1.89 [1.45, 2.47]

 
Comparison 4. Sensitivity analyses: antibiotic therapy versus no treatment

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Assuming that in both groups both breasts are infected: symptom improvement assessed by a clinician156Risk Ratio (M-H, Fixed, 95% CI)6.75 [2.72, 16.77]

 2 Assuming that in both groups 60% of women have 2 breasts infected and 40% 1 infected168Risk Ratio (M-H, Fixed, 95% CI)6.4 [2.84, 14.44]

 
Comparison 5. Sensitivity analyses: antibiotic therapy versus breast emptying

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Assuming that in both groups both breasts are infected: symptom improvement assessed by a clinician156Risk Ratio (M-H, Fixed, 95% CI)1.93 [1.32, 2.81]

 2 Assuming that in both groups 60% of women have 2 breasts infected and 40% 1 infected168Risk Ratio (M-H, Fixed, 95% CI)1.88 [1.33, 2.66]