Effect of Lactobacillus rhamnosus HN001 in Pregnancy on Postpartum Symptoms of Depression and Anxiety: A Randomised Double-blind Placebo-controlled Trial

Slykerman RF; Hood F; Wickens K; Thompson JMD; Barthow C; Murphy R; Kang J; Rowden J; Stone P; Crane J; Stanley T; Abels P; Purdie G; Maude R; Mitchell EA; Probiotic in Pregnancy Study Group

doi:10.1016/j.ebiom.2017.09.013

Effect of Lactobacillus rhamnosus HN001 in Pregnancy on Postpartum Symptoms of Depression and Anxiety: A Randomised Double-blind Placebo-controlled Trial

Slykerman RF, Hood F, Wickens K, Thompson JMD, Barthow C, Murphy R, Kang J, Rowden J, Stone P, Crane J, Stanley T, Abels P, Purdie G, Maude R, Mitchell EA, Probiotic in Pregnancy Study Group

Published October 2017 EBioMedicine, 24, 159-165

DOI 10.1016/j.ebiom.2017.09.013 PMID 28943228 PMC PMC5652021

RRM Academy Synopsis

Probiotic HN001 in pregnancy lowered postpartum anxiety scores

In a trial of 423 New Zealand women, the probiotic HN001 lowered postpartum anxiety and depression scores compared with placebo. About 16 out of 100 women on HN001 scored above the anxiety cutoff, against about 29 out of 100 on placebo.

Key Findings

The trial enrolled 423 women in early pregnancy, at 14 to 16 weeks. Of these, 212 received HN001 and 211 received placebo, and 380 women (89.8%) completed the mood questionnaires.
Depression scores averaged 7.7 with HN001 and 9.0 with placebo (effect size -1.2, 95% CI -2.3 to -0.1, p = 0.037), adjusted for infant colic and time since birth.
Anxiety scores averaged 12.0 with HN001 and 13.0 with placebo (effect size -1.0, 95% CI -1.9 to -0.2, p = 0.014), with the same adjustment.
Scores above the anxiety cutoff occurred in 30 of 192 women on HN001 (15.6%) and 55 of 187 on placebo (29.4%). The adjusted odds ratio was 0.44 (95% CI 0.26 to 0.73).
Scores above the depression cutoff occurred in 32 women on HN001 (16.5%) and 44 on placebo (23.5%). The adjusted odds ratio was 0.65 (95% CI 0.38 to 1.10, p = 0.11).

Interpretation

This double-blind, placebo-controlled trial measured mood as a secondary outcome. The main thing the larger trial measured was eczema in the children at 12 months. Eligible women spoke English, planned to breastfeed, and had either their own or the child's biological father's history of asthma, hay fever or eczema requiring medication. Mothers completed the questionnaires later, recalling months 1 to 2 after birth. The authors note the scales screen for symptoms and do not diagnose. They write that, if other studies replicate the result, the probiotic may be useful for preventing or treating postpartum symptoms of depression and anxiety. Fonterra Co-operative Group co-funded the trial and supplied the capsules.

RRM Context

The authors write that major depression during pregnancy and after birth affects 10 to 15 percent of women in New Zealand. Restorative reproductive medicine evaluates a woman's health across the whole childbearing year, and mood belongs in that picture. The trial adds randomized evidence on one gut-related supplement. Earlier probiotic trials gave mixed results, the authors say.

Our editorial summary of this paper, not the article's abstract.

Abstract

Background

Probiotics may help to prevent symptoms of anxiety and depression through several putative mechanisms.

Objective

The aim of this study was to evaluate the effect of Lactobacillus rhamnosus HN001 (HN001) given in pregnancy and postpartum on symptoms of maternal depression and anxiety in the postpartum period. This was a secondary outcome, the primary outcome being eczema in the offspring at 12months of age.

Design, Setting, and Participants

A randomised, double-blind, placebo-controlled trial of the effect of HN001 on postnatal mood was conducted in 423 women in Auckland and Wellington, New Zealand. Women were recruited at 14-16weeks gestation.

Intervention

Women were randomised to receive either placebo or HN001 daily from enrolment until 6months postpartum if breastfeeding.

Outcome Measures

Modified versions of the Edinburgh Postnatal Depression Scale and State Trait Anxiety Inventory were used to assess symptoms of depression and anxiety postpartum.

Trial Registration

Australia NZ Clinical Trials Registry: ACTRN12612000196842.

Findings

423 women were recruited between December 2012 and November 2014. 212 women were randomised to HN001 and 211 to placebo. 380 women (89.8%) completed the questionnaire on psychological outcomes, 193 (91.0%) in the treatment group and 187 (88.6%) in the placebo group. Mothers in the probiotic treatment group reported significantly lower depression scores (HN001 mean=7·7 (SD=5·4), placebo 9·0 (6·0); effect size -1·2, (95% CI -2·3, -0·1), p=0·037) and anxiety scores (HN001 12·0 (4·0), placebo 13·0 (4·0); effect size -1·0 (-1·9, -0·2), p=0·014) than those in the placebo group. Rates of clinically relevant anxiety on screening (score>15) were significantly lower in the HN001 treated mothers (OR=0·44 (0·26, 0·73), p=0·002).

Interpretation

Women who received HN001 had significantly lower depression and anxiety scores in the postpartum period. This probiotic may be useful for the prevention or treatment of symptoms of depression and anxiety postpartum.

Funding

Health Research Council of New Zealand (11/318) and Fonterra Co-operative Group Ltd.

Topics

Postpartum › Mental Health › Postpartum Depression · Pregnancy › Prenatal Care › Nutrition in Pregnancy

PMID 28943228 28943228 DOI 10.1016/j.ebiom.2017.09.013 10.1016/j.ebiom.2017.09.013 Slykerman et al. 2017, Slykerman 2017

Keywords

Adult, Anxiety/prevention & Control/psychology, Depression, Postpartum/prevention & Control/psychology, Double-Blind Method, Female, Humans, Lacticaseibacillus Rhamnosus/physiology, Male, Maternal Nutritional Physiological Phenomena, New Zealand, Pregnancy, Probiotics/administration & Dosage/therapeutic Use, Treatment Outcome, Anxiety, Depression, Microbiome-gut-brain Axis, Probiotic, Randomised Controlled Trial

Effect of Lactobacillus rhamnosus HN001 in Pregnancy on Postpartum Symptoms of Depression and Anxiety: A Randomised Double-blind Placebo-controlled Trial

Probiotic HN001 in pregnancy lowered postpartum anxiety scores

Key Findings

Interpretation

RRM Context

Abstract

Topics

By this author

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Keywords