Parallel RCTs | | | | |
Ashraf et al (USA)41 | Ambulant patients, mean age 51 years, 64% female (n=14) | Bulk v placebo I: Metamucil (n=11) 5 g/day, C: placebo (n=11), 8 weeks | Frequency: I: increase in BM/week from 2.9 (0.1) to 3.8 (0.4) (p<0.05); C: no data given, estimated from graph: 2.7 v 2.9 Pain score (range 1-7): I: Decreased from 2.6 (0.5) to 2.0 (0.4), p<0.05; C: slight increase (from Fig 3c): 2.7 v 2.8. No significant group differences in consistency, straining, evacuation, or side effects | Quality score: 3 Randomisation: stated Double blind Description of dropouts Funding: Proctor and Gamble |
Howard et al (USA)42 | Institutionalised men from a single care centre; mean age intervention goup 73 years, mean age comparator group 74 years | Bulk v usual care I: Bran mixture: (n=6) 3 cups apple sauce, 2 cups coarse wheat bran, 1.5 cups prune juice, C: Usual care (n=6) normal diet, laxatives and enemas as needed, 4 months | Frequency (BM/week): end of treatment: I=2.3 (0.39), C=2.7 (0.79) (NS) Number of bowel medications/week: end of treatment: I=1.39 (1.08), C=13.28 (5.68) (p=0.03). Reduction of bowel medication with bran at maximum dose (p=0.03) | Quality score: 1 Randomisation: not stated Open study Funding: not stated |
Sculatti and Giampiccoli (Italy)31 | Ambulant patients, mean age 67.4 years, 83% female | Bulk v water I: Fibraform (n=20) 7 g/day+400 ml water, C: water (n=20) 400 ml, 30 days | Overall effectiveness: % non-constipated at 15 days: I=30%, C=5% p=0.09; at 30 days: I=74%, C=15% p=0.001. Consistency: % with soft faeces at 15 days: I=25%, C=20% p=0.9; at 30 days:I=84%, C=25% p=0.0001 Painful defaecation: % pain free at 15 days: I=73%, C=64% p=0.5; at 30 days: I=90%, C=67% p=0.13. | Quality score: 2 Randomisation: not stated Not blind Description of dropouts Funding: not stated |
Corazziari et al (Italy)47 | Outpatients, mean age 41.8 years, 77% female | Osmotic v placebo I: PMF-100 (Normopeg) (n=25) 14.6 g PEG 4000, 1.42 g anhydrous sodium sulphate, 0.42 g sodium bicarbonate, 0.18 g potassium chloride, 0.01 simethicone, flavoured, C: placebo (flavoured maltodextrine) (n=23), 4 week run in, then 8 weeks PMF-100 or placebo twice daily in 250 ml of water | Frequency (BM/week): end of 4 week run in: I=2.2 (0.5), C=1.9 (0.8); end of 8 week treatment period: I=4.8 (2.3), C=2.8 (1.6). Bowel frequency normalised: I=64%, C=22% (p<0.008; per ITTanalysis p<0.04) Consistency: % with hard stools: I=12%, C=50% (per ITT analysis p<0.07) Use of laxatives: I=16%, C=48% (p<0.03; per ITT analysis p<0.1) Straining: I=8%, C= 41% (p<0.03). No group differences in occurrence or severity of other symptoms | Quality score: 4 Randomisation: stated Double blind Description of dropouts ITT Funding: not stated |
Corazziari et al (Italy)48 | Outpatients, mean age intervention group 42.4 years, mean age comparator group 43.2 years, 82.9% female | Osmotic v placebo I: PMF-100 (Normopeg) (n=33) as in Corazziari et al,47 C: placebo (flavoured maltodextrine) (n=37), 4 week run in, then 20 weeks of PMF or placebo as above | Frequency (BM/week): week 4 (end of run in): I=8.3 (4.0), C=7.7 (4.3); week 12: I=7.4 (3.1), C=4.3 (2.5); week 24: I=7.4 (3.2), C=5.4 (2.1) Mean consumption of non-study laxatives, previous 4 weeks: week 4: I=1.1 (2.8), C=0.31 (0.74); week 12: I=0.7 (2.7), C=2.2 (3.3); week 24: I=0.2 (0.8), C=1.4 (2) Mean number of drug sachets, previous 4 weeks: week 4: I=38 (12) C=38 (15), week 12: I=33 (13), C=43 (12); week 24: I=33 (13), C=44 (12) Number of adverse events: I=57, C=41 | Quality score: 4 Randomisation: Double blind Description of dropouts Funding: not stated |
DiPalma et al (USA)49 | Participants recruited from gastroenterology practices and local advertising, mean age intervention group 46.7 years, mean age comparator group 45.8 years, overall mean age 45 years, 87% female | Osmotic v placebo I: Braintree PEG 3350 (Miralax) (n=80) 17 g/day in approx 8 oz water or juice, C: dextrose powder placebo (n=71) same size scoop/day as I in 8 oz water or juice, 14 days | Frequency (BM/week): week 1: I=4.2 (2.8), C=2.9 (1.9); week 2: I=4.5 (3.0), C=2.7 (1.8) Treatment success (>3 BM/week): weeks 1 and 2: I=72.2%, C=49.6% (p<0.001; p<0.05 on ITT analysis). Patient rated effectiveness: I=68%, C=40% (p<0.001) Investigator rated effectiveness: I=71.4%, C=47.1% (p<0.005) Other: wignificant improvements in self-reported consistency, straining passage, cramping and flatus (all p=0.001) | Quality score: 3 Randomisation: stated Single blind Description of dropouts ITT Funding: Braintree Laboratories |
Huys and Van Vaerenbergh (Belgium)53 | Hospital inpatients, mean age not stated, M:F ratio not stated | Softener/stimulant v placebo I: Softener (n=15) 60 mg DSS, 50 mg 1.8-dioxyanthraquinone, C: placebo (n=15), 10 days “preparation” then 20 days treatment | Frequency: % patients with daily stools: I: pre: 32%; post: 72%. C: pre: 33%; post: 47%. Significant group difference, no alpha stated. No difference in diarrhoea incidence | Quality score: 2 Randomisation: not stated Double blind Description of dropouts Funding: not stated |
Crossover RCTs | | | | |
Marsicano (Venezuela)43 | Hospital cardiology patients, mean age 40.1 years, all female | Bulk v placebo I: Glucomannan fibre 3 g/day and 4 g/day , C: placebo (n=60), 5 weeks (2 weeks washout) | Frequency: I: 3 g: increase of 0.47 BM/day compared with 4 g: increase of 0.83 BM/day; C: change of –0.2 to 0.1 Straining: 9 cases with placebo (15%), 5 (8.3%) with 3 g and 6 (10%) with 4 g glucomannan Diarrhoea: I: glucomannan 3 g: 6 (10%), 4 g: 5 (8.3%), placebo: 1 (2%) Flatulence: Glucomannan 3 g: 10 (17%), 4 g: 13 (22%), placebo: 11 (18%) | Quality score: 3 Randomisation: stated Double blind Description of dropouts Funding: not stated |
Andorsky (USA)32 | Outpatients, mean age 62 years, 76% female | Osmotic v placebo I: PEG 8 or 16 oz daily , C: placebo (n=37), 5 days (2 day washout) | Frequency (BM/5 day period): I (8oz)=5.81 (3.92), C=4.36 (2.8); I (16oz): 9.56 (4.41), C=5.38 (2.44). Overall, PEG significantly more effective than placebo and 2 glasses more effective than 1. Consistency score (range 1-4): PEG significantly more effective than placebo (2.6 v 1.2; p<0.05) and 2 glasses more effective than 1 (2.7 v 0.8; p<0.05). Side effects: Problems with cramps, gas, nausea, loose stools and taste with PEG but none resulted in termination of trial. 9/37 (24%) had transient gas/cramps. | Quality score: 2 Randomisation: stated Double blind No ITT Authors note that greater effect of 16 oz may be due to fluid intake Funding: drugs donated by Reed and Carnrick Pharmaceuticals |
Castillo (Argentina)61 | Ambulant, mean age not stated, M/F ratio unclear | Osmotic v placebo I: Lactulose 30 ml/day , C: placebo, 4 weeks (2 weeks washout) | Overall effectiveness: Number of satisfactory or partially satisfactory treatments at 1 week: I=23, C=17 (p<0.01) at 1 week; I=22, C=8 (p<0.01) at 4 weeks Adverse effects: number of patients with meteorism: I=3, C=6, p not stated; flatulence: I=5, C=3, p not stated | Quality score: 1 Randomisation: not stated Double blind No ITT analysis Funding: not stated |
Lemann et al (France)50 | Patients with chronic constipation, mean age 48 years, 85% female | Osmotic v placebo I: PEG 3350 13–39 g/day; C: placebo (n=32) | Frequency (BM/week): I: 9.4 (4.3), C:4.7 (3.4) (p<0.001) Straining score (range not stated): Lower with PEG (0.7 (0.7) v 1.6 (0.7), p<0.001). Overall improvement: greater with PEG (score 6.4 v 1.6, p<0.001; score range not stated) | Quality score:2 Randomisation: not stated Double blind No dropouts reported Funding: Norgine Pharma |