Efficacy of Lactulose versus Senna Plus Ispaghula Husk Among Patients with Pre-Dialysis Chronic Kidney Disease and Constipation: A Randomized Controlled Trial

Figures & data

Figure 1 Study protocol.

Table 1 Baseline Characteristics

Characteristics	Total (N= 22)
Male (N, %)	13 (59.1)
Age; years	72.7±12.9
Body mass index (kg/m^2)	23.8±3.7
Chronic kidney disease stage 4 (N, %)	16 (72.7)
Chronic kidney disease stage 5 (N, %)	6 (27.3)
Diabetic mellitus (N, %)	10 (45.5)
Hypertension (N, %)	20 (90.9)
Dyslipidemia (N, %)	19 (86.4)
Ischemic heart disease (N, %)	6 (27.3)
Phosphate binders (N, %)	9 (40.9)
Ferrous (N, %)	6 (22.7)
Calcium channel blockers (N, %)	13 (59.1)

Note: Data in the table are shown with mean ± standard deviation and percentage.

Table 2 Outcomes Between Two Groups

Parameters	Lactulose (N = 22)			Senna with Ispaghula Husk (N = 22)			Mean Change Differences with 95% CI Between Groups
	Baseline	At 2 Weeks	Mean Change with 95% CI	Baseline	At 2 Weeks	Mean Change with 95% CI
CSBM (time/week)	3.4±1.4	4.7±1.9	1.3 (0.32 to 2.36) *	3.4±1.4	5.5±2.6	2.1 (0.86 to 3.41) *	0.7 (−1.94 to 0.35)
BFSF	2.3±1.2	3.9±1.6	1.6 (0.75 to 2.44) *	2.3±1.2	4.0±2.3	1.2 (0.85 to 2.61) *	0.4 (−1.23 to 0.96)
Rectal enema (time/week)	0.0±0.0	0.2±0.9	0.2 (−0.16 to 0.61)	0.0±0.0	0.5±1.5	0.5 (−0.01 to 0.92)	0.3 (−0.82 to 0.36)
eGFR (mL/min/1.73 m^2)	20.9±5.6	21.0±5.5	0.1 (−0.18 to 0.31)	20.9±5.6	20.8±5.5	−0.1 (−0.48 to 0.19)	0.2 (−0.19 to 0.60)
Sodium (mEq/L)	138.0±2.3	137.8±2.0	−0.2 (−0.74 to 0.38)	138.0±2.3	138.2±1.9	0.2 (−0.59 to 0.95)	−0.4 (−1.29 to 0.56)
Potassium (mEq/L)	4.1±0.4	4.1±0.3	0 (−0.07 to 0.07)	4.1±0.4	4.1±0.2	0 (−0.10 to 0.11)	−0.1 (−0.13 to 1.20)
Chloride (mEq/L)	97.8±3.4	98.1±2.6	0.4 (−0.68 to 1.41)	97.8±3.4	97.7±2.8	−0.1 (−1.29 to 1.11)	0.5 (−1.09 to 2.00)
Bicarbonate (mEq/L)	23.5±1.8	23.6±1.4	0.1 (−0.64 to 0.83)	23.5±1.8	23.9±1.3	0.4 (−0.29 to 1.01)	−0.3 (−1.23 to 0.68)
Phosphate (mg/dL)	4.4±0.8	4.4±0.6	−0.1 (−0.19 to 0.10)	4.4±0.8	4.3±0.6	−0.1 (−0.23 to 0.05)	0.1 (−0.15 to 0.23)
Calcium (mg/dL)	9.3±0.6	9.3±0.5	−0.1 (−0.12 to 0.11)	9.3±0.6	9.2±0.7	−0.1 (−0.17 to 0.02)	0.1 (−0.07 to 0.21)
Magnesium (mg/dL)	2.1±0.3	2.1±0.2	0 (−0.14 to 0.16)	2.1±0.3	2.1±0.1	0 (−0.16 to 0.03	0.04 (−0.07 to 0.16)

Notes: Data in the table are shown with mean ± standard deviation and mean change with 95% Confidence interval (CI). *P<0.05.

Abbreviations: BSFS, change of stool appearance using the Bristol stool form scale; CSBM, Complete spontaneous bowel movement; eGFR, estimated glomerular filtration rate.