Table 2. Primary and Secondary Outcomes.
| Variable | Electroacupuncture (n = 50) | Sham electroacupuncture (n = 50) | Difference, percentage points (95% CI) | P value |
|---|---|---|---|---|
| Primary outcome | ||||
| Overall responders, % (95% CI)a | 40.1 (26.1 to 54.1) | 9.0 (0.5 to 17.4) | 31.1 (14.8 to 47.6) | <.001 |
| Secondary outcomes | ||||
| Sustained responders, No./total No. (%)b | 19/47 (40.4) | 4/45 (8.9) | 31.5 (15.2 to 47.9) | <.001 |
| Changes in the mean weekly SBMs, mean (95% CI) | ||||
| Weeks 1-8 | 1.2 (1.0 to 1.3) | 0.6 (0.4 to 0.8) | 0.6 (0.3 to 0.8) | <.001 |
| Weeks 13-16 | 0.6 (0.4 to 0.8) | 0.2 (0.04 to 0.4) | 0.4 (0.1 to 0.6) | .01 |
| Patients with ≥3 mean weekly SBMs, No./total No. (%) | ||||
| Weeks 1-8 | 19/47 (40.4) | 6/45 (13.3) | 27.1 (9.9 to 44.3) | .002 |
| Weeks 13-16 | 4/46 (8.7) | 1/41 (2.4) | 6.3 (−3.2 to 15.7) | .19 |
| Patients with an increase of ≥1 mean weekly SBM, No./total No. (%) | ||||
| Weeks 1-8 | 30/47 (63.8) | 14/45 (31.1) | 32.7 (13.4 to 52.0) | <.001 |
| Weeks 13-16 | 12/46 (26.1) | 4/41 (9.8) | 16.3 (0.7 to 31.9) | .04 |
| Changes in mean weekly CSBMs, mean (95% CI), No. | ||||
| Weeks 1-8 | 0.8 (0.7 to 1.0) | 0.4 (0.2 to 0.5) | 0.2 (0.2 to 0.8) | <.001 |
| Weeks 13-16 | 0.3 (0.1 to 0.5) | 0.1 (−0.1 to 0.3) | 0.2 (−0.1 to 0.5) | .17 |
| Patients with ≥3 mean weekly CSBMs, No./total No. (%) | ||||
| Weeks 1-8 | 0 | 0 | NA | NA |
| Weeks 13-16 | 1/46 (2.2) | 0 | NA | NA |
| Patients with an increase of ≥1 mean weekly CSBMs, No./total No. (%) | ||||
| Weeks 1-8 | 21/47 (44.7) | 9/45 (20.0) | 24.7 (6.3 to 43.1) | .009 |
| Weeks 13-16 | 10/46 (21.7) | 4/41 (9.8) | 12.0 (−3.0 to 27.0) | .12 |
| Change in stool consistency score by Bristol stool scale, mean (95% CI)c | ||||
| Weeks 1-8 | 0.5 (0.3 to 0.7) | 0.3 (0.1 to 0.5) | 0.2 (−0.1 to 0.6) | .14 |
| Weeks 13-16 | 0.3 (0.01 to 0.5) | −0.1 (−0.3 to 0.2) | 0.3 (−0.02 to 0.7) | .07 |
| Change in score for defecation straining, mean (95% CI)d | ||||
| Weeks 1-8 | −0.6 (−0.8 to −0.4) | −0.1 (−0.3 to 0.1) | −0.5 (−0.8 to −0.2) | .001 |
| Weeks 13-16 | −0.3 (−0.5 to −0.1) | 0.04 (−0.2 to 0.3) | −0.3 (−0.7 to −0.02) | .04 |
| Change in PAC-SYM total score, mean (95% CI)e | ||||
| Week 8 | −0.9 (−1.0 to −0.7) | −0.5 (−0.7 to −0.4) | −0.4 (−0.6 to −0.2) | <.001 |
| Week 16 | −0.5 (−0.6 to −0.3) | −0.1 (−0.3 to 0.04) | −0.4 (−0.6 to −0.2) | .001 |
| Change in PAC-SYM stool symptoms score, mean (95% CI) | ||||
| Week 8 | −0.7 (−0.9 to −0.5) | −0.6 (−0.8 to −0.4) | −0.1 (−0.4 to 0.2) | .37 |
| Week 16 | −0.4 (−0.7 to −0.2) | −0.2 (−0.4 to 0.02) | −0.2 (−0.5 to 0.1) | .13 |
| Change in PAC-SYM rectal symptoms score, mean (95% CI) | ||||
| Week 8 | −1.0 (−1.2 to −0.8) | −0.6 (−0.7 to −0.4) | −0.4 (−0.7 to −0.3) | <.001 |
| Week 16 | −0.5 (−0.7 to −0.3) | −0.1 (−0.3 to 0.04) | −0.4 (−0.6 to −0.1) | .004 |
| Change in PAC-SYM abdominal symptoms score, mean (95% CI) | ||||
| Week 8 | −0.7 (−0.8 to −0.5) | −0.4 (−0.6 to −0.2) | −0.3 (−0.5 to 0.01) | .06 |
| Week 16 | −0.4 (−0.6 to −0.2) | −0.04 (−0.3 to 0.2) | −0.4 (−0.7 to −0.1) | .008 |
| Change in PAC-QOL total score, mean (95% CI)f | ||||
| Week 8 | −0.6 (−0.8 to −0.5) | −0.4 (−0.5 to −0.2) | −0.3 (−0.5 to −0.1) | .01 |
| Week 16 | −0.4 (−0.5 to −0.2) | −0.1 (−0.3 to 0.1) | −0.3 (−0.5 to −0.03) | .03 |
| Patients with rescue medicine use, No./total No. (%) | ||||
| Weeks 1-8 | ||||
| Rescue medicine | 24/47 (51.1) | 30/45 (66.7) | −15.6 (−35.5 to 4.2) | .12 |
| Other rescue treatmentg | 5/47 (10.6) | 4/45 (8.9) | 1.8 (−10.4 to 13.9) | .77 |
| Weeks 9-16 | ||||
| Rescue medicine | 28/46 (60.9) | 29/41 (70.7) | −9.9 (−29.7 to 10.0) | .33 |
| Other rescue treatmenth | 5/46 (10.9) | 2/41 (4.9) | 6.0 (−5.2 to 17.1) | .29 |
| Frequency of rescue medicine use per week, mean (95% CI) | ||||
| Weeks 1-8 | ||||
| Rescue medicine | 0.4 (0.2 to 0.6) | 0.7 (0.5 to 0.8) | −0.3 (−0.5 to 0.002) | .05 |
| Other rescue treatmentg | 0.7 (0.2 to 1.3) | 1.0 (0.3 to 1.5) | −0.2 (−1.1 to 0.6) | .50 |
| Weeks 9-16 | ||||
| Rescue medicine | 0.6 (0.4 to 0.8) | 0.9 (0.7 to 1.1) | −0.2 (−0.5 to 0.1) | .10 |
| Other rescue treatmenth | 0.5 (−0.1 to 1.0) | 0.47 (−0.4 to 1.3) | −0.01 (−1.0 to 1.0) | .99 |
Abbreviations: CSBM, complete spontaneous bowel movement; NA, not applicable; PAC-QOL, Patient Assessment of Constipation Quality of Life; PAC-SYM, Patient Assessment of Constipation–Symptoms; SBM, spontaneous bowel movement.
Overall responders were defined as patients who had at least 3 SBMs per week and an increase of at least 1 SBM from baseline in the same week for at least 6 of the 8 weeks of the treatment period.
Sustained responders were defined as patients who had at least 3 SBMs per week and an increase of at least 1 SBM from baseline in the same week for at least 6 of the 8 weeks of the treatment period and at least 3 of the final 4 treatment weeks (post hoc).
Scores range from 1 to 7: 1 = separate, hard lumps, like nuts (hard to pass); 2 = sausage-shaped but lumpy; 3 = like a sausage or snake but with cracks on its surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges or a mushy stool; 7 = watery, no solid pieces (entirely liquid).
Scores range from 0 to 4; higher scores indicate more severe straining during defecation.
PAC-SYM scores are based on a 5-point Likert scale from 0 to 4; lower scores indicate better quality of life. Minimally clinically important difference: 1.0.27
PAC-QOL scores are based on a 5-point Likert scale from 0 to 4; lower scores indicate better quality of life. Minimally clinically important difference: 1.0.27
Manual maneuvers to facilitate defecations (1 in the electroacupuncture group) and Chinese herbs (4 in each group).
Lactulose (2 in the electroacupuncture group), manual maneuvers to facilitate defecations (1 in the electroacupuncture group), and Chinese herbs (2 in each group).