Comparison of a Chinese Herbal Medicine (CCH1) and Lactulose as First-Line Treatment of Constipation in Long-Term Care: A Randomized, Double-Blind, Double-Dummy, and Placebo-Controlled Trial

Table 4

Comparison of the treatment effect between CCH1 and lactulose.

Variables	Group, mean (95% CI)
	CCH1 (𝑛=44)	Lactulose (𝑛=49)	Adjusted 𝑃^‡
Frequency of spontaneous bowel movement (SBM/wk)^§
Baseline (weeks −2~0)	2.7 (1.9, 3.4)	2.6 (2.0, 3.2)	0.907
Treatment (weeks 1~4)	6.9^† (6.1, 7.6)	4.5^† (3.5, 5.4)	<0.001
Treatment (weeks 5~8)	6.8^† (6.0, 7.7)	5.5^† (4.5, 6.6)	0.159
Follow-up (weeks 9~12)	3.7* (3.1, 4.4)	5.2^† (4.0, 6.4)	0.084
Frequency of rectal treatment (RT/wk)^||
Baseline (weeks −2~0)	1.4 (1.1, 1.8)	1.4 (1.1, 1.7)	0.958
Treatment (weeks 1~4)	0.5^† (0.4, 0.7)	0.9^† (0.7, 1.2)	0.030
Treatment (weeks 5~8)	0.3^† (0.2, 0.5)	0.6^† (0.4, 0.8)	0.051
Followup (weeks 9~12)	1.0* (0.8, 1.3)	0.8^† (0.5, 1.1)	0.561
Amount of rescue laxative use (MgO/wk)
Baseline (weeks −2~0)	0 (0, 0)	0.4 (−0.1,0.8)	0.083
Treatment (weeks 1~4)	0.2 (−0.1, 0.5)	2.4* (1.1, 3.8)	0.005
Treatment (weeks 5~8)	1.7 (−0.4, 3.9)	10.4^† (6.1, 14.7)	0.002
Followup (weeks 9~12)	19.1^† (14.9, 23.2)	20.0^† (14.5, 25.4)	1.000
Laxative cost (USD/wk)^¶
Treatment (weeks 1~4)	1.4 (1.2, 1.5)	4.7 (4.2, 5.2)	<0.001
Treatment (weeks 5~8)	1.5 (1.3, 1.7)	5.0 (4.4, 5.7)	<0.001

Pairwise comparisons were performed for each treatment group with its baseline.
* 𝑃<0.01; ^†𝑃<0.001.
^‡P value was adjusted by Bonferroni adjustment.
^§SBM (spontaneous bowel movement) defined as stool passage without digital maneuver and without the use of suppository or enema on the same day.
^||RT (rectal treatment) including enema, suppository use, or digital maneuver.
^¶Laxative cost including the acquisition costs of study medication and rescue laxative.