Wageningen Academic P u b l i s h e r s
Beneficial Microbes, 2015; 6(3): 253-262
http://www.wageningenacademic.com/doi/pdf/10.3920/BM2014.0076 - Thursday, September 21, 2017 9:04:35 AM - Göteborgs Universitet IP Address:130.241.16.16
Effect of fermented milk containing Lactobacillus casei strain Shirota on constipationrelated symptoms and haemorrhoids in women during puerperium T. Sakai1,2*, H. Kubota1,2, A. Gawad1, L. Gheyle3, S. Ramael3 and K. Oishi1,2 1Yakult
Honsha European Research Center for Microbiology ESV, Technologiepark 4, 9052 Zwijnaarde, Belgium; 2Yakult Central Institute, 5-11 Izumi, Kunitachi-shi, Tokyo, 186-8650 Japan; 3SGS Life Science Services, Clinical Pharmacology Unit Antwerpen, Lange Beeldekensstraat 267, 2060 Antwerp, Belgium; [email protected] Received: 6 June 2014 / Accepted: 19 September 2014 © 2014 Wageningen Academic Publishers
RESEARCH ARTICLE Abstract Constipation and haemorrhoids are common complaints after childbirth. The objective of this pilot study was to evaluate impact of fermented milk containing Lactobacillus casei strain Shirota (LcS) on stool consistency and frequency, constipation-related symptoms and quality of life, and incidence of haemorrhoids in women during puerperium. Forty women who had natural childbirth were randomised to group consuming either one bottle/day of fermented milk containing at least 6.5×109 cfu of LcS, or placebo, for 6 weeks after childbirth. Subjects filled in a diary on their bowel habits including number of bowel movement, stool consistency and incidence of haemorrhoids, and answered questionnaires on constipation-related symptoms (PAC-SYM) and quality of life (PAC-QOL) during the study period. The probiotic group showed the better scores on overall PAC-SYM (P=0.013), PAC-SYM subscales of abdominal symptoms (P=0.043) and rectal symptoms (P=0.031), and PAC-QOL satisfaction subscale (P=0.037) in comparison with the placebo group. In the probiotic group, two to four subjects experienced haemorrhoids during the first 3 weeks of treatment. The number decreased in week 4 and no one had haemorrhoids on most days in week 5-6. In the placebo group, on average four subjects had haemorrhoids from the beginning, and no obvious change was observed until week 6. No statistically significant effect was observed on stool consistency and frequency. The study products did not cause any adverse event in the subjects. Results of this study indicate that continuous consumption of fermented milk containing LcS might alleviate constipation-related symptoms, provide satisfactory bowel habit and result in earlier recovery from haemorrhoids in women during puerperium. Nonetheless, there are several limitations in interpretation of the results attributed to the study design, including lack of baseline data. Further study is required in order to confirm the efficacy. Keywords: Probiotics; Lactobacillus casei strain Shirota; puerperium; haemorrhoids; constipation
1. Introduction Pregnancy may cause physical and psychological inconveniences for women. The changes in health conditions are not limited to the pregnancy period, but also persist after childbirth. Puerperium is a period following childbirth, lasting approximately six weeks, during which the physiological condition of the mother returns to the condition as before pregnancy. This period is especially stressful for mothers because of the childcare stress, hormonal changes, lack of sleep, and so forth.
Constipation is one of the common gastrointestinal complaints that women suffer from during pregnancy (Bradley et al., 2007; Cullen and O’Donoghue, 2007; Derbyshire et al., 2007; Marshall et al., 1998; Saha et al., 2011; Seymour and Chadwick, 1979) and after childbirth (Bradley et al., 2007; Derbyshire et al., 2007; Gjerdingen et al., 1993; Marshall et al., 1998; Saurel-Cubizolles et al., 2000). Haemorrhoids are also common after childbirth (Abramowitz et al., 2002; Avsar and Keskin, 2010; Gjerdingen et al., 1993; Saurel-Cubizolles et al., 2000), and constipation and related symptoms such as straining are considered as risk factors for developing
ISSN 1876-2833 print, ISSN 1876-2891 online, DOI 10.3920/BM2014.0076253
http://www.wageningenacademic.com/doi/pdf/10.3920/BM2014.0076 - Thursday, September 21, 2017 9:04:35 AM - Göteborgs Universitet IP Address:130.241.16.16
T. Sakai et al.
haemorrhoids (Abramowitz et al., 2002; Avsar and Keskin, 2010; Dennison et al., 1996; Hibberts and Schizas, 2010). Some investigators suggested that onset of haemorrhoids could be the cause of constipation (Loder et al., 1994). Constipation and haemorrhoids would be additional stresses for the mothers with a new-born. Relieving these disorders may improve mothers’ quality of life and give a favourable influence on baby-care. First line approach for treatment of constipation is dietary/ lifestyle adjustment. Prenatal education focusing on nutritional knowledge and healthy lifestyles would be one of the effective ways to cope with postnatal constipation (Liu et al., 2009). This approach is in line with the evidence that indicates association between dietary factors and occurrence of constipation (Derbyshire et al., 2006). Moderate exercise, increasing fibre intake or water intake are generally considered as beneficial, however, evidences for such ways are weak or contradictory (Tack et al., 2011; Wanitschke et al., 2003). If the dietary/lifestyle change is not effective, laxatives are used for the therapy. Among variety of laxatives, osmotic laxatives, stool softeners and bulk forming agents are recommended for the primary use (Tack et al., 2011). These are acceptable for use during pregnancy, however, some might be associated with adverse events such as bloating, cramping or electrolyte imbalances (Trottier et al., 2012). Stimulant laxatives are used for secondary therapy. Standardised senna treatment is shown to be effective in having early postpartum bowel movement. However, there is a concern for experiencing abdominal cramps as an adverse reaction (Shelton, 1980). Considering stressful environment as mother, a safe, nonstressful approach is desired for dealing with postnatal constipation, especially in early stage such as puerperium. Accumulated scientific evidences suggest that some probiotic strains are promising for alleviating constipation (Chmielewska and Szajewska, 2010). Among such strains, Lactobacillus casei strain Shirota (LcS) has a long history of a safe use in commercially available food products for more than 75 years in Japan and more than 15 years in Europe. Several reports indicate that fermented milk containing LcS is of potential benefit in improving bowel habits and relieving constipation-related symptoms (Koebnick et al., 2003; Matsumoto et al., 2006; Mazlyn et al., 2013; Sakai et al., 2011; Tilley et al., 2014). The product can be easily taken as a part of regular diet. Based on that available information, we hypothesised that fermented milk containing LcS could be an ideal option for management of postnatal constipation as well as haemorrhoids. This randomised, double-blind, placebo-controlled pilot study aimed to evaluate the impact of fermented milk containing LcS on stool consistency and frequency, constipation-related symptoms and quality of life (QOL), and incidence of haemorrhoids during puerperium.
254
2. Materials and methods Participants The study participants were recruited by a clinical unit, SGS Life Science Services (SGS LSS) in Antwerp, Belgium. Healthy pregnant women within 8 weeks before estimated delivery date were invited for screening. Eligible candidates were further assessed by the childbirth-related criteria. Inclusion criteria were: age between 18 and 40 years, inclusive; Bristol Stool Form Scale (BSFS) score 1 or 2 for describing usual stool condition during pregnancy, and natural childbirth. Subjects were excluded if they were under the age of legal consent or who were mentally or legally incapacitated; had BSFS score 3 or more for describing usual stool condition during pregnancy; delivered by Caesarean section or preterm before 37 gestational weeks; had baby with a low birth weight (
Beneficial Microbes, 2015; 6(3): 253-262
http://www.wageningenacademic.com/doi/pdf/10.3920/BM2014.0076 - Thursday, September 21, 2017 9:04:35 AM - Göteborgs Universitet IP Address:130.241.16.16
Effect of fermented milk containing Lactobacillus casei strain Shirota on constipationrelated symptoms and haemorrhoids in women during puerperium T. Sakai1,2*, H. Kubota1,2, A. Gawad1, L. Gheyle3, S. Ramael3 and K. Oishi1,2 1Yakult
Honsha European Research Center for Microbiology ESV, Technologiepark 4, 9052 Zwijnaarde, Belgium; 2Yakult Central Institute, 5-11 Izumi, Kunitachi-shi, Tokyo, 186-8650 Japan; 3SGS Life Science Services, Clinical Pharmacology Unit Antwerpen, Lange Beeldekensstraat 267, 2060 Antwerp, Belgium; [email protected] Received: 6 June 2014 / Accepted: 19 September 2014 © 2014 Wageningen Academic Publishers
RESEARCH ARTICLE Abstract Constipation and haemorrhoids are common complaints after childbirth. The objective of this pilot study was to evaluate impact of fermented milk containing Lactobacillus casei strain Shirota (LcS) on stool consistency and frequency, constipation-related symptoms and quality of life, and incidence of haemorrhoids in women during puerperium. Forty women who had natural childbirth were randomised to group consuming either one bottle/day of fermented milk containing at least 6.5×109 cfu of LcS, or placebo, for 6 weeks after childbirth. Subjects filled in a diary on their bowel habits including number of bowel movement, stool consistency and incidence of haemorrhoids, and answered questionnaires on constipation-related symptoms (PAC-SYM) and quality of life (PAC-QOL) during the study period. The probiotic group showed the better scores on overall PAC-SYM (P=0.013), PAC-SYM subscales of abdominal symptoms (P=0.043) and rectal symptoms (P=0.031), and PAC-QOL satisfaction subscale (P=0.037) in comparison with the placebo group. In the probiotic group, two to four subjects experienced haemorrhoids during the first 3 weeks of treatment. The number decreased in week 4 and no one had haemorrhoids on most days in week 5-6. In the placebo group, on average four subjects had haemorrhoids from the beginning, and no obvious change was observed until week 6. No statistically significant effect was observed on stool consistency and frequency. The study products did not cause any adverse event in the subjects. Results of this study indicate that continuous consumption of fermented milk containing LcS might alleviate constipation-related symptoms, provide satisfactory bowel habit and result in earlier recovery from haemorrhoids in women during puerperium. Nonetheless, there are several limitations in interpretation of the results attributed to the study design, including lack of baseline data. Further study is required in order to confirm the efficacy. Keywords: Probiotics; Lactobacillus casei strain Shirota; puerperium; haemorrhoids; constipation
1. Introduction Pregnancy may cause physical and psychological inconveniences for women. The changes in health conditions are not limited to the pregnancy period, but also persist after childbirth. Puerperium is a period following childbirth, lasting approximately six weeks, during which the physiological condition of the mother returns to the condition as before pregnancy. This period is especially stressful for mothers because of the childcare stress, hormonal changes, lack of sleep, and so forth.
Constipation is one of the common gastrointestinal complaints that women suffer from during pregnancy (Bradley et al., 2007; Cullen and O’Donoghue, 2007; Derbyshire et al., 2007; Marshall et al., 1998; Saha et al., 2011; Seymour and Chadwick, 1979) and after childbirth (Bradley et al., 2007; Derbyshire et al., 2007; Gjerdingen et al., 1993; Marshall et al., 1998; Saurel-Cubizolles et al., 2000). Haemorrhoids are also common after childbirth (Abramowitz et al., 2002; Avsar and Keskin, 2010; Gjerdingen et al., 1993; Saurel-Cubizolles et al., 2000), and constipation and related symptoms such as straining are considered as risk factors for developing
ISSN 1876-2833 print, ISSN 1876-2891 online, DOI 10.3920/BM2014.0076253
http://www.wageningenacademic.com/doi/pdf/10.3920/BM2014.0076 - Thursday, September 21, 2017 9:04:35 AM - Göteborgs Universitet IP Address:130.241.16.16
T. Sakai et al.
haemorrhoids (Abramowitz et al., 2002; Avsar and Keskin, 2010; Dennison et al., 1996; Hibberts and Schizas, 2010). Some investigators suggested that onset of haemorrhoids could be the cause of constipation (Loder et al., 1994). Constipation and haemorrhoids would be additional stresses for the mothers with a new-born. Relieving these disorders may improve mothers’ quality of life and give a favourable influence on baby-care. First line approach for treatment of constipation is dietary/ lifestyle adjustment. Prenatal education focusing on nutritional knowledge and healthy lifestyles would be one of the effective ways to cope with postnatal constipation (Liu et al., 2009). This approach is in line with the evidence that indicates association between dietary factors and occurrence of constipation (Derbyshire et al., 2006). Moderate exercise, increasing fibre intake or water intake are generally considered as beneficial, however, evidences for such ways are weak or contradictory (Tack et al., 2011; Wanitschke et al., 2003). If the dietary/lifestyle change is not effective, laxatives are used for the therapy. Among variety of laxatives, osmotic laxatives, stool softeners and bulk forming agents are recommended for the primary use (Tack et al., 2011). These are acceptable for use during pregnancy, however, some might be associated with adverse events such as bloating, cramping or electrolyte imbalances (Trottier et al., 2012). Stimulant laxatives are used for secondary therapy. Standardised senna treatment is shown to be effective in having early postpartum bowel movement. However, there is a concern for experiencing abdominal cramps as an adverse reaction (Shelton, 1980). Considering stressful environment as mother, a safe, nonstressful approach is desired for dealing with postnatal constipation, especially in early stage such as puerperium. Accumulated scientific evidences suggest that some probiotic strains are promising for alleviating constipation (Chmielewska and Szajewska, 2010). Among such strains, Lactobacillus casei strain Shirota (LcS) has a long history of a safe use in commercially available food products for more than 75 years in Japan and more than 15 years in Europe. Several reports indicate that fermented milk containing LcS is of potential benefit in improving bowel habits and relieving constipation-related symptoms (Koebnick et al., 2003; Matsumoto et al., 2006; Mazlyn et al., 2013; Sakai et al., 2011; Tilley et al., 2014). The product can be easily taken as a part of regular diet. Based on that available information, we hypothesised that fermented milk containing LcS could be an ideal option for management of postnatal constipation as well as haemorrhoids. This randomised, double-blind, placebo-controlled pilot study aimed to evaluate the impact of fermented milk containing LcS on stool consistency and frequency, constipation-related symptoms and quality of life (QOL), and incidence of haemorrhoids during puerperium.
254
2. Materials and methods Participants The study participants were recruited by a clinical unit, SGS Life Science Services (SGS LSS) in Antwerp, Belgium. Healthy pregnant women within 8 weeks before estimated delivery date were invited for screening. Eligible candidates were further assessed by the childbirth-related criteria. Inclusion criteria were: age between 18 and 40 years, inclusive; Bristol Stool Form Scale (BSFS) score 1 or 2 for describing usual stool condition during pregnancy, and natural childbirth. Subjects were excluded if they were under the age of legal consent or who were mentally or legally incapacitated; had BSFS score 3 or more for describing usual stool condition during pregnancy; delivered by Caesarean section or preterm before 37 gestational weeks; had baby with a low birth weight (
