Table 3.
Characteristics of Included Studies (Ordered by Intervention Type and Quality Assessment)
| Study, year, country, quality assessment, care facility, funding | Population and sample | Intervention | Efficacy parameters | Results for primary efficacy parameters Statistically significant difference (⊕/⊖) |
Differences between male and female subgroups |
|---|---|---|---|---|---|
| George et al, 2008, United Kingdom,14 Primary care GOOD 18/20 Funded by pharmaceutical industry |
Male (54) and female (455) patients diagnosed with IBS-C according to Rome II criteria n=509 |
Renzapide 1 mg Renzapide 2 mg Renzapide 4 mg Placebo |
1. Adequate pain relief of abdominal pain/discomfort 2. Number of stools passed per day 3. Stool consistency |
1. Adequate pain relief of abdominal pain/discomfort ⊖ for overall population receiving any dose of renzapide vs placeboThe response was dose dependent, with only the 4 mg dose group showing a consistent improvement vs. placebo, yet not significant 2. Number of stools passed per day ⊕ for overall population receiving 2mg and 4mg renzapide versus placebo Treatment difference vs placebo: weeks 1-4: renzapide 2mg (p=0.0003) and renzapide 4mg (p<0.0001), weeks 5-12: renzapide 2mg (p=0.001) and renzapide 4mg (p<0.0046) 3. Stool consistency ⊕ for overall population receiving 2mg and 4mg renzapide versus placebo in weeks 1-4 and for 4mg in weeks 5-12Treatment difference vs placebo: weeks 1-4: renzapide 2mg (p=0.0154) and renzapide 4mg (p<0.0048), weeks 5-12: renzapide 4mg (p=0.0106) |
1. Adequate pain relief of abdominal pain/discomfort Full analysis set (456 of 510), compared to the overall study cohort, a greater average weekly treatment difference vs. placebo was observed in females (8% and 12% respectively) |
| Matsueda et al, 2008, Japan15 Multiple centers, primary/secondary unclear GOOD (17/20) Funded by pharmaceutical industry |
Male (n=310) and female (n=91) patients diagnosed with IBS-D according to Rome II criteria n=418 |
1 µg Ramosetron 5 µg Ramosetron 10 µg Ramosetron Placebo |
1. Relief of IBS symptom 2. Relief of abdominal discomfort/pain 3. Improvement of abnormal bowel habits |
1. Relief of IBS symptoms ⊕ for overall population receiving 5- or 10µg ramosetron versus placebo Placebo: 26.92%, 1µg ramosetron (p=1.00), 5µg ramosetron 42.57% (p=0.027) and 10µg ramosetron 43.01% (p=0.026). 2. Relief of abdominal discomfort/pain ⊕ for overall population receiving 10µg ramosetron versus placebo at the final pointplacebo: 25.96%, 1µg ramosetron 37.62 (p=0.091), 5µg ramosetron 37.62% (p=0.100) and 10µg ramosetron 48.39% (p=0.002). 3. Improvement of abnormal bowel habits ⊕ for overall population receiving 10µg ramosetron versus placebo at the final point Placebo: 29.81%, 1µg ramosetron (p=0.367), 5µg ramosetron 43.56% (p=0.058) and 10µg ramosetron 45.16% (p=0.038). |
Monthly response rate (%)⊖ response rate comparable for males and females Final point: placebo: females 38.10%, males 24.10%, 1µg ramosetron: females 30.00%, males 25.30%, 5µg ramosetron ramosetron: females 53.33%, males 38.03% and 10µg ramosetron: females 50.00%, males 41.10% |
| Camilleri, 1999, United States16 FAIR (15/20) Funded by the pharmaceutical industry |
Male (100) and female (202) patients with IBS-D or IBS-M diagnosed according to Rome criteria n=302 |
Alosetron 1 mg Alosetron 2 mg Alosetron 4 mg Alosetron 8 mg Placebo |
1. Adequate relief (for at least 6 weeks) 2. Improvement of bowel function 3. Urgency |
Data for overall population not shown. | 1. Adequate relief (for at least 6 weeks) ⊕ for female (not male) patients at 1mg or 2mg of alosetron versus placeboPlacebo: females 33%, males 53%, 1mg alosetron: females 60% (p=0.015), males 20%, 2mg alosetron: females 59% (p=0.023), males 50%, 4mg alosetron females 51%, males 54%, 8mg alosetron females 52%, males 52%. 2. Bloating ⊖ in males or females with any dose of alosetron compared to placebo 3. Bowel related functions: Bloating, hardened stool and decreased stool frequency ⊕ for female (not male) patients at any dose of alosetron versus placebofemales: p<0.05 vs placebo at 1, 2, 3 months for all doses. Males not significant. |
| Bardhan et al., 2001, United Kingdom,17 hospital out-patient clinics, primary care practice and private physician clinics FAIR (14/20) Funded by pharmaceutical industry |
Male (127) and female (335) patients diagnosed with IBS according to the Rome criteria n=462 |
Alosetron 0.1 Alosetron 0.5 Alosetron 2 mg Placebo |
1. Proportion of pain-free days 2. Proportion of patients with >10% improvement in VAS score 3. Stool consistency 4. Number of actions 5. Improvement in diarrhea |
1. Proportion of pain-free days ⊕ for the overall population receiving 2mg alosetron versus placebo in weeks 5-8 and -12.Treatment differences (alosetron versus placebo): 0.1mg alosetron: 9.2 (-1.5-19.8), 0.5 mg alosetron: 1.1 (-9.7 – 12.0), 2mg alosetron: 9.1 (-1.1 – 19.4) (p<0.05) 2. Proportion of patients with >10% improvement in VAS score ⊕ for the overall population receiving 2mg alosetron versus placeboTreatment differences (alosetron versus placebo): 0.1mg alosetron:-3 (-16-10), 0.5 mg alosetron: -5 (-18-9), 2mg alosetron: 12(-1-25) (p<0.05)) 3. Stool consistency ⊕ for overall population receiving 0.5mg or 2mg alosetron versus placebop<0.05 4. Number of actions ⊕ for overall population receiving 0.5mg or 2mg alosetron versus placebop<0.055. improvement in diarrhea ⊕ for overall population receiving 2mg alosetron versus placebo Placebo: 36%, 2mg alosetron 50% (p=0.03) |
1. Proportion of pain-free days ⊕ for female (but not male) patients receiving 2mg alosetron versus placebo Treatment differences (alosetron versus placebo): 0.1mg Alosetron: Female: 6.1 (-6.7 – 19.0) and male: 15.4 (-3.9-34.7), 0.5 mg alosetron: female: 0.2 (-12.4 – 12.8) and male: 3.5(-17.9-24.9), 2mg alosetron: female 12.0 (-0.3 – 23.7) (p<0.05) and male: -1.9 (23.1-19.3) 2. Proportion of patients with >10% improvement in VAS score ⊖ for both male and female patients receiving any dose of alosetron versus placebo, no difference between groups Treatment differences (alosetron versus placebo): 0.1mg alosetron: Female -7 (-23-9) and male: 4(-20-27), 0.5 mg alosetron: female: -12(-27-3) and male: 16(-8-41), 2 mg alosetron: female 9 (-6-24) (p<0.05) and male: 23 (-1-48) (p=<0.05) 3. Stool consistency ⊕ for both female and male patients receiving 0.5mg or 2mg alosetron versus placebo, no difference between groupsweek 12: females: 38% improvement over placebo, males: 50% improvement over placebo (P<0.002) 4. Stool frequency ⊖ for both female and male patients receiving any dose of alosetron versus placebo 5. Improvement in diarrhea ⊕ for female (but not male) patients receiving 2mg alosetron versus placebo Females: placebo: 34%, 2mg alosetron 51% (p=0.033). Males: placebo: 41%, 2mg alosetron 46% |
| Tack et al., 2016, Belgium18 GOOD (20/20) Funded by the pharmaceutical industry |
Male (n=226) and female (n=333) patients with IBS-D according to Rome III criteria. n = 559 |
Ibodutant 1 mg Ibodutant 3 mg Ibodutant 10 mg Placebo |
1. Responders with satisfactory relief of overall IBS symptoms and abdominal pain/discomfort – 75% rule 2. FDA weekly response for stool consistency and abdominal pain 3. FDA weekly response for stool consistency 4. Relief of overall symptoms and abdominal pain – 50% rule 5. Relief of overall symptoms – 75% rule6. Relief of abdominal pain – 75% rule |
1. Responders with satisfactory relief of overall IBS symptoms and abdominal pain/discomfort-75% rule ⊖ for overall population receiving any dose of ibodutant versus placeboData not shown, p = 0.032 for ibodutant 10mg. 2. FDA weekly response for stool consistency and abdominal pain ⊕ for overall population receiving 10mg of ibodutant versus placeboPlacebo: 37.4%, 1mg ibodutant 42.5% (p=0.39), 3mg ibodutant 38.4% (p=0.86), 10mg ibodutant 49.3% (p=0.050) 3. FDA weekly response for stool consistency ⊕ for overall population receiving 10mg of ibodutant versus placeboPlacebo: 53.2%, 1mg ibodutant 58.3% (p=0.40), 3mg ibodutant 54.4% (p=0.85), 10mg ibodutant 67.7% (p=0.014) 4. Relief of overall symptoms and abdominal pain – 50% rule ⊕ for overall population receiving 10mg of ibodutant versus placeboPlacebo: 38.7%, 1mg ibodutant 51.4% (p=0.35), 3mg ibodutant 44.2% (p=0.032), 10mg ibodutant 67.7% (p=0.015) 5. Relief of overall symptoms – 75% rule ⊖ for overall population receiving any dose of ibodutant versus placeboPlacebo: 37.3%, 1mg ibodutant 41.4% (p=0.48), 3mg ibodutant 39.1% (p=0.75), 10mg ibodutant 48.2% (p=0.066) 6. Relief of abdominal pain – 75% rule ⊖ for overall population receiving any dose of ibodutant versus placeboPlacebo: 32.4%, 1mg ibodutant 37.9% (p=0.34), 3mg ibodutant 42.0% (p=0.096), 10mg ibodutant 47.5% (p=0.009) |
1. Responders with satisfactory relief of overall IBS symptoms and abdominal pain/discomfort-75% rule ⊕ for females (not males) receiving 10mg of ibodutant versus placebo Placebo: 24.4% of females, 31.2% of males, 1 mg ibodutant 36.0% of females, 25.5% of males, 3mg ibodutant 40.2% of females and 21.6% of males, 10mg ibodutant 46.8% of females (p=0.003), 30.0% of males (p=0.881). 2. FDA weekly response for stool consistency and abdominal pain ⊕ for females (not males) receiving 10mg of ibodutant versus placeboPlacebo: 31.2% of females and 45.2% of males, 1mg ibodutant 44.9% of females (p=0.70) and 38.0% of males (p=0.45), 3 mg ibodutant 38.4% of females (p=0.86) and 27.5% of males (p=0.054), 10mg ibodutant 54.4% of females (p=0.003) and 42.4% of males (p=0.76) 3. FDA weekly response for stool consistency ⊕ for females (not males) receiving 10mg of ibodutant versus placeboPlacebo: 49.4% of females, 58.1% of males, 1mg ibodutant 58.4% of females (p=0.24) and 58.0% of males (p=0.99), 3 mg ibodutant 58.9% of females (p=0.18) and 45.1% of males (p=0.17), 10mg ibodutant 74.0% of females (p=0.0017) and 59.3% of males (p=0.025) 4. Relief of overall symptoms and abdominal pain – 50% rule ⊕ for females (not males) receiving 10mg of ibodutant versus placeboPlacebo: 41.0% of females, 35.9% of males, 1mg ibodutant 56.2% of females (p=0.051) and 43.1% of males (p=0.43), 3 mg ibodutant 51.7% of females (p=0.17) and 31.4% of males (p=0.61), 10mg ibodutant 60.8% of females (p=0.0014) and 43.3% of males (p=0.40) 5. Relief of overall symptoms – 75% rule ⊖ for both male and females receiving any dose of ibodutant versus placeboPlacebo: 38.5% of females, 35.9% of males, 1mg ibodutant 44.9% of females (p=0.40) and 35.3% of males (p=0.94), 3 mg ibodutant 46.0% of females (p=0.33) and 27.5% of males (p=0.33), 10mg ibodutant 53.2% of females (p=0.065) and 41.7% of males (p=0.51)6. Relief of abdominal pain – 75% rule ⊕ for females receiving 3mg or 10mg of ibodutant versus placeboPlacebo: 28.2% of females, 37.5% of males, 1mg ibodutant 41.6% of females (p=0.072) and 31.4% of males (p=0.49), 3 mg ibodutant 4.4% of females (p=0.055) and 29.4% of males (p=0.36), 10mg ibodutant 51.9% of females (p=0.0025) and 41.7% of males (p=0.64) |
| Pimentel et al., 2003, United States,19 Recruited via newspaper GOOD (19/20) Funded by private foundation |
Male (50) and female (61) patients with diagnosed IBS according to Rome I criterian=111 | Neomycin 500mg Placebo |
1. Composite score (CS) calculated from the three main IBS symptoms (abdominal pain, diarrhea, and constipation) 2. Overall percent bowel normalization 3. True clinical response (>50% reduction of CS) |
1. Composite score (CS) reduction ⊕ for overall population receiving 500mg neomycin versus placebo Placebo: 11.4±9.3% reduction, neomycin 35.0±5.0% reduction (p<0.05) 2. Overall percent bowel normalization ⊕ for overall population receiving 500mg neomycin versus placebo Placebo: 15.1±3.6% normalization, neomycin 40.1±5.3% normalization (p=0.001) 3. True clinical response (>50% reduction of CS) ⊕ for overall population receiving 500mg neomycin versus placebo Placebo: 23%, neomycin 45% (OR: 4.3, CI: 1.05-6.3, p=0.05 |
2. Overall percent bowel normalization ⊖ between male and female patients in any responsePlacebo: female 10.9% and male 18.8%, neomycin 500mg: female 43.6% (p<0.05) and male 37.6% (p<0.01). No significant difference between the groups was observed in any response. |
| Mangel & Chaturvedi, 2008, United States,20 Private or university based practices GOOD (18/20) Funded by the pharmaceutical industry |
Male (25%) and female (75%) patients diagnosed with IBS-D according to Rome II criteria n=245 |
Crofelemer 125 mg Crofelemer 250mg Crofelemer 500 mg Placebo |
1. Stool consistency responders 2. Stool frequency 3. Urgency 4. Adequate relief 5. Pain score 6. Pain-free days |
1. Stool consistency responders (%) ⊖ for overall population receiving any dose of crofelemer versus placeboPlacebo: 48%, 125mg crofelemer: 49% (p=0.9), 250mg crofelemer: 40% (p=0.39) 500mg crofelemer: 46% (p=0.88) 2. Stool frequency improvement ⊖ for overall population receiving any dose of crofelemer versus placeboPlacebo: -0.98 ± 1.646, 125mg crofelemer: -1.05 ± 1.333 (p=0.84), 250mg crofelemer: -0.58±0.937 (p=0.89), 500mg crofelemer: -0.43±1.86 (p=0.03) 3. Urgency ⊖ for overall population receiving any dose of crofelemer versus placeboPlacebo: 30.8±34.8, 125mg crofelemer: 30.8±31.2 (p=0.99), 250mg crofelemer: -99 22.2±32.3 (0.41), 500mg crofelemer: 23.1±32.7 (0.46)4. Adequate relief (%) ⊖ for overall population receiving any dose of crofelemer versus placeboPlacebo: 53%, 125mg crofelemer: 57% (p=0.74), 250mg crofelemer: 40% (p=0.19), 500mg crofelemer: 54% (p=0.89)5. Pain score ⊖ for overall population receiving any dose of crofelemer versus placeboPlacebo: -0.73±0.92, 125mg crofelemer: -0.82±0.88 (p=0.38), 250mg crofelemer: -0.62.2±0.70 (0.94), 500mg crofelemer: -0.83±0.85 (0.26) 6. Pain-free days ⊕ for overall population receiving 500mg crofelemer versus placebo after 3 months Placebo: 13.1%, 125mg crofelemer: 19.4% (p=0.23), 250mg crofelemer: 13.2% (p= 0.99), 500mg crofelemer: 24.3% (p=0.03) |
6. Pain-free days ⊕ ITT significance was driven by female population Females: placebo 10.6%, 125mg crofelemer 20.5% (p=0.078), 250mg crofelemer: 13.3% (p=0.62), 500mg crofelemer: 26.1% (p=0.0076) |
| Lacy et al., 2019, United States,21 Health centers GOOD (17/20) Funded by the pharmaceutical industry |
Male (n = 821) and female (n = 1602) patients with IBS-D according to Rome III criteria. Two trails included (IBS-3001 and IBS-3002) n = 2423 |
Eluxadoline 75 mg Eluxadoline 100mg Placebo |
1. Composite responders (i.e., patients who recorded a reduction of ≥30% from their average baseline score for their worst abdominal pain on ≥50% of the days and a stool-consistency score of <5 on the same days)2. Abdominal pain (improvement >30%)3. Stool consistency (meets stool consistency criterion >50% of days) | 1. Composite responders ⊕ for both doses of eluxadoline 75mg and eluxadoline100mg versus placebo Pooled data: eluxadoline 75 mg: 26.2%, eluxadoline 100 mg: 27.0% and as compared with placebo 16.7%, P<0.001 2. Abdominal Pain ⊖ for both doses of eluxadoline 75mg and eluxadoline 100mg versus placebo in both IBS-3001 and IBS-3002 trials IBS-3001: placebo 39.6%; eluxadoline 75mg: 42.4% (p=0.40); eluxadoline 100mg: 43.2% (p=0.28).IBS-3002: placebo 45.3%; eluxadoline 75mg: 48.0% (p=0.45), eluxadoline 100mg: 51.0% (p=0.11). 3. Stool consistency ⊕ for both doses of eluxadoline 75mg and eluxadoline 100mg versus placebo in both IBS-3001 and IBS-3002 trialsIBS-3001: placebo 22.0%; eluxadoline 75mg: 30.0% (p=0.008), eluxadoline 100mg: 34.3% (p<0.001).IBS-3002: placebo 20.9%; eluxadoline 75mg: 37.0% (p<0.001), eluxadoline 100mg: 35.6% (p<0.001). |
1. Composite responders ⊖ between males and females receiving 100mg of eluxadolinePlacebo: 17.5% of females and 15.2% of males, 100mg eluxadoline: 27.5% of females, 26.1% of males. 2. Abdominal pain response ⊖ between males and females receiving both doses of eluxadoline or placeboPlacebo: 45.0% of females and 42.2% of males, 75mg eluxadoline: 46.9% of females and 45.0% of males, 100mg eluxadoline: 48.0% of females, 48.9%. 3. Stool consistency responders ⊖ between males and females receiving both doses of eluxadoline or placeboPlacebo: 24.1% of females and 23.4% of males, 75mg eluxadoline 30.5% of females and 32.1% of males, 100mg eluxadoline 36.4% of females and 37.7% of men. |
| Kennedy et al., 2006, United Kingdom,13 Primary care GOOD (16/20) |
Male (43) and female (192) patients diagnoses with IBS according to their GPn=235 | Mebeverine 270mg Mebeverine 270mg + 6 sessions of CBT No therapy |
1. SSSa 2. HADSa 3. WASAa 4. BS-IBSa 5. CS-FBDa |
1.SSSa ⊕ time by treatment interaction for overall population receiving CBT+meb vs meb only at 1.5 and 3 monthsDifference in means meb+CBT vs meb only: 1.5 months: -68 (-104 to -32), 3 months: -71 (-109 to -32), 6 months: -14 (-51 to 23), 12 months: 3 (-35 to 40). Significant treatment by time interaction p<0.0001. 2. HADSa ⊖ time by treatment interaction for overall population receiving CBT+meb vs meb only.There was no significant treatment by time interaction (p = 0.12). 3. WASAa ⊕ time by treatment interaction for overall population receiving CBT+meb vs meb only. Difference in means meb+CBT vs meb only: 1.5 months: -4.1 (-6.4 to -1.8), 3 months: -5.0 (-7.5 to -2.6), 6 months: -1.7 (-4.1 to 0.7), 12 months: -2.8 (-5.2 to 0.4). There was a significant time by treatment interaction (p = 0.03). 4. BS-IBS ⊕ time by treatment interaction for overall population receiving CBT+meb vs meb only.Difference in means meb+CBT vs meb only: 1.5 months: -32.0 (-43.7 to -0.4), 3 months: -26.6 (-35.4 to -7.9), 6 months: -16.0 (-23.4 to -8.6), 12 months: 5.4 (-14.6 to 25.3). There was a significant treatment by time interaction (p = 0.01). 5. CS-FBDa ⊕ time by treatment interaction for overall population receiving CBT+meb vs meb only.Difference in means meb+CBT vs meb only: 1.5 months: -16 (-25 to -7), 3 months: - 21 (-31 to -12), 6 months: -6 (-15 to 4), 12 months: -8 (-17 to 2). There was a significant treatment by time interaction (p = 0.001). |
Linear regression with the mean (of values at 3, 6 and 12 months) outcome on the WASAMale gender was a significant predictor of a negative outcome: β coefficient (95% CI): 3.49 (0.46-6.52) (p=0.025) |
| Farnham et al., 2014, Iran,22 Out-patient clinic FAIR (15/20) |
Male (n=36) and female (n=34) patients with IBS diagnosed according to Rome III criteria n=70 |
Medical treatment (MT) Medical treatment + emotional awareness (EMT) | 1. VAS intensity of pain 2. Frequency of pain |
1. VAS intensity of pain ⊕ for overall population receiving EMT versus MT only MT: 61.36± 23.52 mm pre-treatment to 41.67 ± 31.20 mm posttreatment, EMT: 66.87 ± 23.45 mm pre-treatment to 26.10 ± 25.93 mm at posttreatment. Significant group x time interaction (F =8.99; p = 0.004) 2. Frequency of pain ⊖ for overall population receiving EMT versus MT onlyMT: 5.41 ± 1.91 per week pre-treatment to 3.65 ± 2.55 post-treatment, EMT: 4.93 ± 2.12 pre-treatment to 1.88 ± 2.48 post-treatment (effect 0.7), not significant. |
Gender had no effect on the outcome of pain severity (p = 0.317) or pain frequency (p = 0.438). |
| Tack et al., 2011, United States23 GOOD (19/20) |
Male (42) and female (73) patients with IBS-C diagnosed according to Rome III criteria n=115 |
AST-120 2g tds Placebo |
1. Pain-free days (50% reduction) 2. Pain severity 3. Bloating 4. Proportion of subjects with global relief, HADSa, IBS-QOLa, BSFSa |
1. Pain-free days (50% reduction) ⊕ for overall population receiving AST-120 versus placebo at week 4, ⊖ at week 8. Week 4: placebo 10.2%, AST-120: 26.8% (p=0.029), week 8: placebo 25.4%, AST-120: 32.1% (not significant) 2. Pain severity ⊖ for overall population receiving AST-120 versus placebo 3. Bloating ⊕ for overall population receiving AST-120 versus placebo at week 2 and week 4placebo: 2.2mm, AST-120: 11.9mm (p=0.007) 4. Proportion of subjects with global relief, HADS, IBS-QOL, BSFS ⊖ for overall population receiving AST-120 versus placebo |
The likelihood of response was not gender-dependent (data not shown). b |
| Hong et al., 2011, Korea,24 Secondary care GOOD (18/20) |
Male (n=22) and female (n=51) patients diagnosed with IBS according to Rome III criteria n=73 |
Probiotic Yoghurt Milk (Lactobacillus sp, Bifidobacterium longus, and Lactobacillus Brevis)Placebo |
1. Sum of symptom scores (abdominal pain, bloating and defecation discomfort) 2. Abdominal pain 3. Bloating 4. Defecation discomfort 5. Stool frequency 6. Stool consistency 7. 1H NMRa metabolic profiling of serum and fecal samples |
1. Sum of symptom scores ⊕ for overall population receiving probiotics versus placebo after 8 weeks4 weeks: placebo -53.5, probiotics -78.9 (p=0.1142); 8 weeks: placebo -51.9, probiotics -85.6 (p=0.0217) 2. Abdominal pain ⊖ for overall population receiving probiotics versus placebo after 4 and 8 weeks 4 weeks: placebo: -22.0, probiotics -26.0 (p=0.55); 8 weeks: placebo -19.8, probiotics -29.5 (p=0.15) 3. Bloating ⊖ for overall population receiving probiotics versus placebo after 4 and 8 weeks 4 weeks: placebo: -14.3, probiotics -24.9 (p=0.12); 8 weeks: placebo -15.9, probiotics -26.1 (p=0.12) 4. Defecation discomfort ⊕ for overall population receiving probiotics versus placebo after 8 weeks 4 weeks: placebo: -17.3, probiotics -27.9 (p=0.14); 8 weeks: placebo -16.3, probiotics -30.1 (p=0.0314) 5. Stool frequency ⊕ for overall population receiving probiotics versus placebo after 8 weeks8 weeks: placebo 0.5, probiotics -1.5 (p=0.0410) 6. Stool consistency ⊖ for overall population receiving probiotics versus placebo after 8 weeks 8 weeks: placebo 0.23, probiotics 0.14 (p=0.2224) 7. 1 H NMR metabolic profiling Visual inspection of human serum 1H NMR spectra showed marked increases in lactate levels and decreases in glucose levels after probiotics administration. |
1H NMR metabolic profiling ⊕ significant differentiation in females, not in malesfemales: The OPLS-DA scoreplot shows significant differentiation of female sera before and after probiotics administration (R2X=0.856, R2Y=0.393, Q2=0.279) Males: OPLS-DA models were unable to discriminate probiotic- administered and placebo-administered male sera from controls, resulting in poor predictabilities (Q2 values -0.263 and -0.364) |
Notes: a1H NMR, proton nuclear magnetic resonance; AST, spherical carbon adsorbent; BSFS, Bristol Stool Form Scale; BS-IBS, Behavior Scale for irritable bowel syndrome; CBT, cognitive behavioural therapy; CSFBD, Cognitive Scale for Functional Bowel Disorders; EMT, medical treatment + emotional awareness protocol; HADS, Hospital Anxiety and Depression Scale; IBS-SSS, IBS Symptom Severity Scale; MT, medical treatment; QOL, quality of life; SSS, symptom severity score; VAS, Visual Analogue Scale; WASA, Work and Social Adjustment Score. bAuthors were approached for data on this likelihood of response; unfortunately, no response was given despite reminders.