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. 2020 May 18;2020(5):CD011505. doi: 10.1002/14651858.CD011505.pub2

Mathew 2018.

Study characteristics
Methods "Randomised controlled pre‐test post‐test design" in India
Trial dates: not mentioned
Participants 30 mothers and their infants. 60% of mothers were primiparous and 93% had normal vaginal delivery.
Age of infants at start of study: 10 days to three months of life
Inclusion criteria: lactating mothers 20 to 35 years old, 10 days up to 3 months of postpartum
Exclusion criteria: none mentioned
Breastfeeding method: direct breastfeeding during the intervention period. No mention if supplemental feeding was allowed.
Interventions Arm 1: fennel tea (14 grams of in two liters of water) and 300 mL of this was given per day for seven consecutive days (n = 15)
Arm 2: fenugreek tea (14 grams in two liters of water) and 300 mL of this was given each day for seven days (n = 15)
Outcomes
  1. To compare the effects of fenugreek and fennel on lactation among lactating women.

  2. To compare the average ideal weight gain of babies according to their age and the obtained weight gain.

  3. To find an association between selected variables and lactation among lactating women.

Funding and Declaration of interest Self‐funded. The authors declared no conflict of interest.
Notes Further clarification about the study was needed but attempts to contact the authors failed.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Lottery method
Allocation concealment (selection bias) Unclear risk How this was done was not described.
Blinding of participants and personnel (performance bias)
All outcomes High risk Fennel and fenugreek are aromatic herbs. Their smell and taste are distinct. Therefore it its likely that participants would be able to guess what they were drinking.
Blinding of outcome assessment (detection bias)
Milk volume outcomes Low risk Milk volume was assessed via test weighing, thus unlikely to be affected.
Blinding of outcome assessment (detection bias)
Self reported outcomes (adverse effects and measures of maternal psychological status) Low risk This was not an outcome in the study.
Blinding of outcome assessment (detection bias)
Infant weight outcomes Low risk This was not an outcome in the study.
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants recruited were included in the analysis.
Selective reporting (reporting bias) High risk The outcomes mentioned in the methods did not match results of study. Measures of dispersion was not included in the results.
Other bias Low risk None detected