Hager 1996.

Methods	Randomised: 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.
Participants	25 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.
Interventions	The 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.
Outcomes	Outcomes were inclusive of resolution of mastitis, namely fever, erythema and tenderness.
Notes	University 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
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method is not mentioned.
Allocation concealment (selection bias)	Low risk	Adequate concealment of allocation is mentioned inclusive of using pre‐sealed, opaque envelopes.
Blinding (performance bias and detection bias) All outcomes	Low risk	It was mentioned that investigators were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Follow‐up is described. Patients were seen for follow‐up visits in 7 days. 25 recruited and no drop‐outs.
Selective reporting (reporting bias)	Low risk	All expected outcomes appear to have been reported.
Other bias	Low risk	Groups appear balanced for baseline characteristics (apart from duration of symptoms ‐ see Table 1, page 99).