Table 1.
Author | Study Design | Participants | Intervention | Main Findings |
---|---|---|---|---|
Sallon et al. (2002) [11] | Randomized, double-blind, placebo-controlled clinical trial | 61 patients with IBS-C | Padma Lax vs. placebo for 12 weeks 2 tablets/day or 1 tablet/day if diarrhea or loose stools occurred. 1 tablet (482 mg) contained: Aloes standardized extract (12 mg) Calumbae root (10 mg) Condurango bark (10 mg) Frangula bark (52.5 mg) Gentian root (35 mg) Elecampane rhizome (35 mg) Tropical almond fruit (35 mg) Long pepper (3.5 mg) Cascara bark (52.5 mg) Chinese rhubarb root (70 mg) Nux vomica seed (1.75 mg) Ginger root (70 mg). It also contained 3 non-herbal elements: Heavy kaolin (25 mg) Sodium bicarbonate (15 mg) Sodium sulfate (35 mg). The excipients used were: Silicium dioxide (2.4 mg) Magnesium stearate (4.6 mg). |
Statistically significant improvements were found in: Constipation severity Number of daily bowel movements Abdominal pain affecting daily activities Presence of moderate or severe pain Abdominal distention severity Incomplete evacuation Flatulence. There were no significant improvements in: Abdominal distention prevalence Abdominal pain severity. 10 patients complained of mild side effects: Slight headache (1 patient) Nausea (1 patient) Hoarseness (1 patient) Diarrhea or loose stools (7 patients) with rapid resolution when lowering dose from 2 tablets/day to 1 tablet/day. |
Bensoussan et al. (2015) [12] | Two-arm, randomized, double-blind, placebo-controlled clinical trial | 125 patients with IBS-C | CHM vs. placebo for 8 weeks 10 capsules (4.2 g)/day, 5 in the morning and 5 in the night containing: Paeonia lactiflora PALL., radix (23%) Citrus aurantium L., Fructus immaturas (20%) Magnolia officinalis REHD. and WILS., cortex (14.5%) Citrus reticulata L., pericarpi-um (14.5%) Glycyrrhiza uralensis FISCH., root (11%) Rheum palmatum L., radix (10%) Atractylodes lancea (THUNB.) DC, rhizome (7%). |
There were statistically significant changes at 8 weeks in: Adequate relief (PP) Bowel habits Frequency of hard lumpy stools Bothersomeness of hard lumpy stools Straining during bowel movement Stool form Physical functioning. There were statistically significant changes at 16 weeks in: Physical functioning. There was no significant improvement at 8 weeks in: Adequate relief (ITT). There was no significant improvement at 16 weeks in: Adequate relief (PP, ITT) Bowel habits Frequency of hard lumpy stools Bothersomeness of hard lumpy stools Straining during bowel movement Stool form Abdominal pain Abdominal distension Interference with life Overall quality of life Depression Anxiety Stress Work productivity. 6 patients complained of moderate side effects: Diarrhea (3 patients) Blood in urine (1 patient) Increased bloating (1 patient) Dizziness and headaches (1 patient). |
Pazhouh et al. (2020) [13] | Block-randomized, double-blind, placebo-controlled clinical trial | 70 patients with IBS-C | PHS vs. placebo for 6 weeks 5 mL every 8 h of the syrup prepared with: Artemisia Absinthium (100 mg) Cuscuta Campestris (100 mg) Cassia Fistula (230 mg) Echium Amoenium (270 mg) Mellisa Officinalis (190 mg) British Pharmacopoeia syrup to make the mixture 100 mL. |
There was a significant improvement in: Positive responses to treatment Severity score Bristol Stool Score. There was no significant improvement in: Anxiety score Depression score. 4 patients complained of negligible side effects: Headache (2 patients) Drowsiness (1 patient) Increase in menstrual bleeding (1 patient). |
Pourmasoumi et al. (2019) [14] | Single-blind, randomized, placebo-controlled clinical trial | 142 patients with IBS-C | Flixweed vs. fig vs. placebo for 4 months 60 g flixweed and 90 g fig/day, half before breakfast and half before lunch. |
Statistically significant improvements were found in: IBS Severity Score System Quality of life Abdominal pain frequency Interference of life Dissatisfaction with bowel habits. No significant difference was found in: Abdominal pain severity C-reactive protein levels. There was no statistically significant difference between flixweed and fig. No adverse effects were reported. |
Brown et al. (2015) [15] | Single-site, randomized, double-blind, placebo-controlled clinical trial | 16 patients with IBS-C | Blended extract of Quebracho, Conker Tree, and M. balsamea Willd vs. placebo for 2 weeks Extract consisting of: Quebracho (150 mg) Conker Tree (470 mg) M. balsamea Willd oil (0.2 mL). |
There was a significant improvement in: Constipation Bloating. No side effects were reported. |
Chang et al. (2010) [16] | Restricted randomization (3:1), placebo-controlled clinical trial | 76 patients, 60 with IBS-C and 16 healthy | Kiwifruit vs. placebo for 4 weeks 2 Hayward green kiwifruits/day. |
Statistically significant improvements were found in: Defecation frequency Colon transit time. No significant improvement was found in: Fecal volume change Life stress Post-defecation feelings. No adverse effects were reported. |
Yu et al. (2005) [17] | Randomized, placebo-controlled clinical trial | 47 patients with IBS-C | Modified Sinisan formula vs. Cisapride for 8 weeks 1 dose divided into 2 portions consisting of: Thorowax root (10 g) Immature bitter orange (10 g) Aucklandia root (10 g) Spice-bush root (10 g) Bighead atractylodes rhizome (20 g) White peony root (10 g) Ligusticum chuanxiong rhizome (10 g) Chinese angelica root (10 g) Licorice (5 g) water decocted. |
Statistically significant differences were found in: Efficacy Symptom scoring Recurrence rate Rectal threshold feeling Maximal tolerance volume Rectum compliance. No significant difference was found in: Anal resting pressure Anal systolic pressure Anal diastolic pressure. No side effects are mentioned. |
Ricci et al. (2022) [18] | interventional, prospective, multicentric, randomized, double-blinded, placebo-controlled trial | 56 patients with IBS | Geraniol vs. placebo for 4 weeks 1 capsule (470 mg)/day consisting of: Palmrose EO high geraniol (90 mg) Pulverized Zyngiber officinalis root (360 mg). The excipients used were: Vegetal magnesium stearate (10 mg) Silicon dioxide (10 mg). IBS-SSS GM composition Inflammatory markers |
There was a statistically significant difference in: Abdominal Pain Days with abdominal Pain in the last 10 Bloating Satisfaction bowel habits IBS-SSS Score IBSS-SSS Score variations Responders (reduction 50 points IBS-SSS). There was no difference in: Interference with daily activities. 2 patients complained of side effects, 1 of which were unspecified gastric symptoms. Significant reduction in IBS-SSS in the geraniol group. Increase in the Ruminococcaceae and Oscillospira species and decrease in the Erysipelotrichaceae and Clostridiaceae families. No changes when it comes to inflammatory biomarkers. |
CHM: Chinese Herbal Medicine; IBS-SSS: IBS Symptom Severity Scale; PHS: Persian herbal syrup; GM: Gut Microbiota.