Electroacupuncture for Women with Chronic Severe Functional Constipation: Subgroup Analysis of a Randomized Controlled Trial

Table 2

Outcome measures of intention-to-treat population.

Outcomes	EA group	SA group	Between-group Difference	P Value
	(n=415)	(n=407)	Value (95%CI)
Primary Outcome
Sustained responders (%)	101 (24.34)	33 (8.11)	13.10% (6.50% - 19.70%)	<0.001
Secondary Outcomes
Overall responders (%) ^†	103 (24.82)	35 (8.60)	12.45% (7.26% -17.64%)	<0.001
Responders at week 8 (%) ^‡	212 (51.08)	80 (19.65)	28.31% (21.86% - 34.73%)	<0.001
Responders for ≥ 9 of 12 weeks of follow-up weeks ^§	158 (38.07)	46 (11.30)	23.90% (18.02% - 29.78%)	<0.001
Change in mean CSBMs/week from baseline, mean (95%CI)
Weeks 1-8	1.73 (1.40 - 2.06)	0.80 (0.47 - 1.13)	0.93 (0.52 - 1.33)	<0.001
Weeks 9-20	1.92 (1.59 - 2.25)	0.80 (0.47 - 1.13)	1.13 (0.73 - 1.53)	<0.001
Change in mean SBMs/week during weeks 1-8, mean (95% CI)^‖	2.29 (2.13 - 2.45)	1.31 (1.15 - 1.47)	0.98 (0.75 - 1.20)	<0.001
Change in stool consistency of SBMs during weeks 1-8, mean (95% CI)^‖	0.85 (0.77 - 0.93)	0.64 (0.56 - 0.71)	0.21 (0.11 - 0.33)	<0.001
Change in straining of SBMs during weeks 1-8 mean (95% CI)^‖	-0.71 (-0.76 to -0.66)	-0.48 (-0.53 to -0.43)	-0.22 (-0.29 to -0.16)	<0.001
Change in PAC-QOL score, mean (95% CI)
Week 4	-0.50 (-0.54 to -0.45)	-0.35 (-0.40 to -0.30)	-0.15 (-0.21 to -0.08)	<0.001
Week 8	-0.87 (-0.93 to -0.82)	-0.56 (-0.62 to -0.51)	-0.31 (-0.38 to -0.24)	<0.001
Patients using other treatments
Weeks 1-8
Rescue medicine	121 (29.20)	137 (33.70)	-5.50% (-11.90% - 0.90%)	0.09
Others	12 (2.90)	12 (3.00)	0.80% (-6.90% - 8.50%)	0.83
Weeks 9-20
Rescue medicine	77 (18.60%)	88 (21.60%)	-3.3% (-10.20% - 3.60%)	0.35
Others	9 (2.20%)	12 (3.00%)	-0.4% (-8.70% - 8.00%)	0.93
Weekly frequency of other treatments used, median (IQR)
Weeks 1-8
Rescue medicine	0.63 (0.25 - 1.25)	0.75 (0.38 - 1.50)	NA	0.12
Others	0.44 (0.19 - 1.00)	0.19 (0.13 - 0.69)	NA	0.23
Weeks 9-20
Rescue medicine	0.75 (0.33 - 1.42)	0.75 (0.33 - 1.67)	NA	0.50
Others	0.25 (0.17 - 0.42)	0.42 (0.83 - 1.63)	NA	0.83

Data are n (%) unless otherwise stated.
Abbreviations: EA, electro-acupuncture; SA, sham acupuncture; CSBMs, complete spontaneous bowel movements; SBMs, spontaneous bowel movements; BMI, body mass index; PAC-QOL, Patient Assessment of Constipation Quality of Life questionnaire; SD, standard deviation; IQR, interquartile range, NA, not applicable.
Sustained responders were defined as responders for treatment for ≥ 6 of 8 weeks, including 3 of 4 final treatment weeks according to the guideline of European Medicines Agency [13], 12 participants in the EA group and 26 in the SA group were treated as non-responders.
^† Overall responders were defined as responders for treatment for ≥ 6 of 8 treatment weeks according to the guideline of European Medicines Agency [13], 12 participants in the EA group and 26 in the SA group were treated as non-responders.
^‡ Responders were defined as patients achieving at least 3 CSBMs/week and, at the same time, an increase of at least 1 CSBM/week compared to baseline according to the guideline of European Medicines Agency [13], 12 participants in the EA group and 26 in the SA group were treated as non-responders.
^§ 15 participants in the EA group and 27 in the SA group were treated as non-responders.
‖ Stool consistency and straining were evaluated based on the stools from spontaneous bowel movements. We could not obtain data from participants who had no SBMs during the baseline and/or the treatment period. These two outcomes were both missing on 37 participants in the EA group and 35 in the SA group at baseline. Therefore, data for these two outcomes were from 378 participants in the EA group and 372 in the SA group.
The weekly frequency of other treatments used was assessed in the patients who used other treatments for constipation.