Journal of Neurogastroenterology and Motility

Table. 1. Table 1

Characteristics of Studies Comparing Laxative With Placebo or Comparing Laxatives of Same Types

Study, country	Comparison	Design	Eligible population	Constipation criteria	Intervention and duration	Number of patients and mean age	Primary outcome	Results
Bulk laxatives
Ewerth et al¹⁸ (1980), Sweden	Bulk vs Placebo	Double-blind cross-over study	Constipated patients with diverticuli	Infrequent (3-4 day interval) and painful defecation	A: Psyllium 6 g bid B: Placebo 8 wk for each (4-wk washout)	9 (F 6) Mean age 68 (range 62-77) yr	Transit time BMs/wk Abdominal symptoms	No significant difference A: 6.9 B: 7.1 (NS) Symptoms improved with psyllium^a
Finlay¹⁹ (1988), UK	Bulk vs Placebo	Open, randomized, placebo-controlled, parallel study	Elderly patients with chronic constipation in continuing care	Chronic constipation with need for regular laxative, suppositories and/or manual evacuation	A: Bran 1.5-4.5 g qd B: Regular diet 6 wk	A: 6 (F 6) B: 6 (F 6) Mean age 80 ± 5 yr	Stool consistency Bowel frequency Suppository usage	1. Significantly improved with treatment 2. BMs/wk A: 2.83 ± 0.91 B: 2.25 ± 0.82 (NS) SBMs/wk A: 2.63 ± 1.10 B: 0.02 ± 1.92^a 3. No difference for laxative use
Rajala et al²⁰ (1988), Finland	Bulk vs Placebo	Randomized, double-blind study	Hospitalized elderly patients	Defecation less than once daily and with difficulty	A: Yoghurt + Bran, 150 mL bid B: Yoghurt bid 2 wk	A: 18 B: 15 Mean age 78 yr	BMs/wk Abdominal pain and overall symptoms Need for laxatives	A: 5.8 B: 4.5 Abdominal pain and overall symptoms improved in group A Need for laxative: A: 1.3 B: 1.7
Cheskin et al²¹ (1995), USA	Bulk vs Placebo	Single-blind, randomized, placebo-controlled, crossover study	Community-living older men and women with chronic constipation	< 3 BMs/wk and/or feeling of incomplete evacuation and/or hard stool with straining > 25% of time	A: Psyllium 6 g qid B: Placebo 4 wk for each	(F 5, M 5) Mean age 66 (range 66-87) yr	Total gut transit time BMs/wk Consistency	A: 30.0 hr B: 53.9 hr^a A: 9.1 B: 5.6 Consistency did not improve significantly
Chokhavatia et al²² (1988), USA	Bulk vs Bulk	Unblinded, randomized study	Outpatients age range 55-81 yr	Regular laxative use	A: Calcium polycarbophil 2 g qd B: Psyllium 9.5 g qd 3 wk	42 Age range 55-81 yr	BMs/wk Consistency Preference	A: 8.3 B: 9.1 Consistency score was significantly high in A More patients preferred A as it produced less gas^a
Osmotic laxatives
Wesselius-De Casparis et al²³ (1968), Netherland	Osmotic vs Placebo	Multicenter, randomized, double-blind, placebo-controlled, parallel study	Elderly patients with chronic constipation	Regular laxative use	A: lactulose syrup 15 mL qd B: Placebo 3 wk	A: 54 B: 49 Mean age > 60 yr	Treatment success if the patient needed no laxatives at all or only once in 21 day	A: 86% B: 60%a
Sanders²⁴ (1978), USA	Osmotic vs Placebo	Randomized, double-blind, placebo-controlled, parallel study	Elderly constipated patients living in nursing home	≤ 3 BM/wk and ≥ 1 constipation related symptom	A: lactulose syrup 30 mL qd B: Placebo 12 wk	A: 20 (F 17) B: 25 (F 22) Mean age 84.7 yr in A 86.8 yr in B	BM/wk Reduction in symptoms	A: 4.9 B: 3.6^a Significantly improved with lactulose^a
Vanderdonckt et al²⁵ (1990), Belgium	Osmotic vs Placebo	Double-blind, cross-over study	Elderly patients with chronic constipation	≤ 3 BMs per wk without laxative use and ≥ 1 symptom such as hard stools, pain	A: Lactitol 20 g qd B: Placebo 4 wk for each	46 Mean age 84 yr	BMs/wk Consistency Need for laxatives	BMs/wk increased with lactitolc Consistency improved with lactitolc Less need for rectally administered laxatives^a
Dipalma et al²⁶ (2007), USA	Osmotic vs Placebo	Double-blind, placebo-controlled, parallel study	Adults and elderly who met defined criteria for chronic constipation	Modified Rome criteria	A: PEG 3350 17 g qd B: Placebo 6 mo	A: 204 (F 175) B: 100 (F 83) (elderly: 75) Mean age of elderly were not specified	Relief of modified Rome criteria for constipation for 50% or more	Total: A 61.4% B 21.8%^b Elderly patients: A 56% vs B 11%^b
Lederle et al²⁷ (1990), USA	Osmotic vs Osmotic	Randomized, double-blind, cross-over study	Men aged 65 yr to 86 yr with chronic constipation	≤ 3 SBM/wk, ≤1 BM/day with current laxatives and at least one related chronic symptom such as straining, hard stool	A: Lactulose syrup 30-60 mL qd B: Sorbitol 30-60 mL qd 4 wk for each(2-wk washout)	30 (M 30) Mean age 72 (range 65-86)	BM/wk Number of day/wk with BM Consistency	A: 7.02 B: 6.71 (NS) A: 5.31 B: 5.23 (NS) 60% vs 67% of BM reported normal
Seinelä et al²⁸ (2009), Finland	Osmotic vs Osmotic	Randomized, double-blind, parallel-group study	Elderly institutionalized, constipated patients who have used PEG with electrolyte at a stable dose	Regular use of PEG	A: PEG 4000 without electrolyte 12 g qd B: PEG 4000 with electrolyte 12 g qd 4 wk	A: 30 (F 18) B: 32 (F 23) Mean age A: 86.4 yr B: 84.8 yr	BM/wk at week 4 Proportion of normal stool consistency	A: 8.5 ± 4.5B: 8.4 ± 3.6 (NS) A: 70% B: 52% (NS)
Chassagne et al²⁹ (2017), France	Osmotic vs Osmotic	Randomized, single-blind, parallel-group study	Patients aged 70 yr and older with a history of chronic constipation	Rome I criteria	A: PEG 4000 10-30 g qd B: Lactulose 10-30 g qd 6 mo	A: 118 (F 90) B: 127 (F 96) Mean age A: 82.7 ± 7.4 yr B: 81.8 ± 7.9 yr	BMs/wk Consistency AEs	A:7.0-7.3 B:5.5-6.2^a Improved consistency with PEG 4000 See Table 4
Softener
Hyland and Foran³⁰ (1968), UK	Softener vs Placebo	Randomized, double-blind, placebo-controlled, cross-over study	Hospitalized elderly patients in geriatric ward	Chronic constipation	A: DSS 100 mg tid B: Placebo 4 wk for each	40 Mean age over 60 yr	BMs/wk Overall symptom improvement	A: 3.3 B: 2.5 Symptom significantly improved with DSS^a
Fain et al³¹ (1978), USA	Softener vs Softener	Randomized, single-blinded, parallel study	Institutionalized elderly patients	Chronic functional constipation dependent on laxative use	A: DSS 100 mg qd B: DSS 100 mg bid C: DCS 240 mg qd Placebo 2 wk → treatment 3 wk for each	A: 13 (F 12) B: 17 (F 15) C: 16 (F 13) Mean age A: 83.4 yr B: 82.2 yr C: 80.8 yr	BMs/wk Laxative use/ wk	A: 1.50 ± 1.06 → 1.95 ± 1.79 B: 1.76 ± 1.26 → 2.29 ± 1.14 C: 1.75 ± 1.33 → 2.83 ± 1.73^a A: 1.38 → 1.05 B: 1.03 → 0.92 C: 1.38 → 0.85^a

^aP < 0.05, ^bP < 0.01, ^cP < 0.001.

F, female; M, male; qd, once a day; bid, 2 times a day; tid, 3 times a day; qid, 4 times a day; BMs, bowel movements; NS, not significant; AEs, adverse effects; SBMs, spontaneous bowel movements; PEG, polyethylene glycol; DSS, dioctyl sodium sulfosuccinate; DCS, dioctly calcium sulfosuccinate.

J Neurogastroenterol Motil 2021;27:495~512 https://doi.org/10.5056/jnm20210