Table 3. Adjusted Percentages of Outcomes by Group and Adjusted Relative Risk Pairwise Comparisons Between Groups for All Binary Secondary Outcomes.
| Outcome | Adjusted % (95% CI) | Omnibus P valuea | Adjusted relative risk (95% CI) | ||||
|---|---|---|---|---|---|---|---|
| UMC | SA | EA | SA vs UMC | EA vs UMC | EA vs SA | ||
| RMDQ, 30% reduction from baselineb | |||||||
| 3 mo | 29.9 (24.9-36.0) | 42.0 (38.0-46.4) | 42.0 (38.0-46.4) | <.001 | 1.40 (1.15-1.72) | NA | NA |
| 6 mo | 29.4 (24.3-35.5) | 39.1 (33.1-46.1) | 43.8 (38.0-50.4) | .002 | 1.33 (1.04-1.70) | 1.49 (1.19-1.86) | 1.12 (0.88-1.43) |
| 12 mo | 28.4 (23.4-34.4) | 37.7 (33.6-42.3) | 43.8 (39.0-49.2) | <.001 | 1.33 (1.06-1.66) | 1.54 (1.25-1.91) | 1.16 (0.98-1.37) |
| PEG, 30% reduction from baseline | |||||||
| 3 mo | 23.3 (18.7-29.1) | 41.1 (37.6-44.9) | 41.1 (37.6-44.9) | <.001 | 1.76 (1.39-2.24) | NA | NA |
| 6 mo | 29.4 (24.4-35.5) | 35.0 (30.5-40.2) | 40.5 (35.6-46.1) | .02 | 1.19 (0.94-1.50) | 1.38 (1.10-1.73) | 1.16 (0.94-1.42) |
| 12 mo | 29.5 (24.5-35.5) | 35.9 (31.3-41.0) | 35.8 (30.4-42.2) | .18 | 1.22 (0.97-1.52) | 1.21 (0.95-1.55) | 1.00 (0.80-1.25) |
| Pain intensity, 30% reduction from baseline | |||||||
| 3 mo | 22.3 (17.6-28.1) | 43.3 (39.3-47.7) | 43.3 (39.3-47.7) | <.001 | 1.95 (1.52-2.49) | NA | NA |
| 6 mo | 24.2 (19.4-30.2) | 34.8 (28.7-42.2) | 41.3 (35.5-48.0) | <.001 | 1.44 (1.07-1.93) | 1.71 (1.31-2.22) | 1.19 (0.90-1.56) |
| 12 mo | 27.8 (22.8-33.9) | 35.0 (30.0-40.8) | 35.6 (30.2-41.9) | .10 | 1.26 (0.98-1.61) | 1.28 (1.00-1.64) | 1.02 (0.80-1.29) |
| Patient global impression of change in pain, much or moderately better | |||||||
| 3 mo | 18.5 (14.0-24.3) | 50.2 (45.0-56.0) | 50.2 (45.0-56.0) | <.001 | 2.72 (2.04-3.64) | NA | NA |
| 6 mo | 19.5 (15.0-25.4) | 37.5 (32.6-43.2) | 54.5 (48.0-61.9) | <.001 | 1.92 (1.43-2.59) | 2.80 (2.10-3.73) | 1.45 (1.22-1.74) |
| 12 mo | 24.2 (19.2-30.3) | 35.6 (30.9-41.0) | 43.3 (38.0-49.3) | <.001 | 1.47 (1.13-1.92) | 1.79 (1.39-2.32) | 1.22 (0.99-1.50) |
| Patient global impression of change in general, much or moderately better | |||||||
| 3 mo | 17.8 (13.6-23.5) | 49.8 (44.4-55.9) | 49.8 (44.4-55.9) | <.001 | 2.79 (2.08-3.75) | NA | NA |
| 6 mo | 22.6 (17.9-28.7) | 36.3 (32.6-40.4) | 51.8 (46.3-57.8) | <.001 | 1.60 (1.24-2.07) | 2.29 (1.77-2.95) | 1.43 (1.23-1.65) |
| 12 mo | 24.6 (19.8-30.5) | 36.4 (31.3-42.4) | 39.9 (33.7-47.2) | .002 | 1.48 (1.13-1.94) | 1.62 (1.24-2.13) | 1.10 (0.87-1.38) |
| PHQ-2 score ≥3 | |||||||
| 3 mo | 11.8 (9.0-15.4) | 8.6 (6.6-11.3) | 8.6 (6.6-11.3) | .048 | 0.73 (0.53-1.00) | NA | NA |
| 6 mo | 12.8 (10.0-16.4) | 8.5 (6.8-10.8) | 7.9 (5.7-10.8) | .02 | 0.67 (0.49-0.92) | 0.61 (0.42-0.89) | 0.92 (0.65-1.29) |
| 12 mo | 8.8 (6.4-12.1) | 7.0 (5.4-9.1) | 7.8 (5.5-11.2) | .47 | 0.79 (0.54-1.15) | 0.88 (0.55-1.42) | 1.12 (0.72-1.75) |
| GAD-2 score ≥3 | |||||||
| 3 mo | 15.8 (12.4-20.1) | 12.2 (10.1-14.7) | 12.2 (10.1-14.7) | .06 | 0.77 (0.59-1.02) | NA | NA |
| 6 mo | 17.4 (13.7-22.2) | 10.7 (8.3-13.8) | 10.9 (8.5-14.1) | .003 | 0.61 (0.44-0.86) | 0.63 (0.45-0.87) | 1.02 (0.71-1.48) |
| 12 mo | 16.2 (12.5-20.9) | 9.5 (7.5-12.1) | 9.4 (6.9-12.9) | .006 | 0.59 (0.42-0.82) | 0.58 (0.39-0.87) | 0.99 (0.74-1.33) |
Abbreviations: EA, enhanced acupuncture; GAD-2, General Anxiety Disorder 2-item scale; NA, not applicable; PEG, pain intensity, interference with enjoyment of life, and interference with general activity; PHQ-2, Patient Health Questionnaire-2; RMDQ, Roland-Morris Disability Questionnaire; SA, standard acupuncture; UMC, usual medical care.
a
To account for multiple comparisons, pairwise inference was only performed if the omnibus P value was significant.
b
The unadjusted percentage of participants with 30% improvement in RMDQ is presented in eTable 17 in eAppendix 3 in Supplement 3.