Table 1. Baseline Characteristics.
Characteristic | Patients, No. (%) | |
---|---|---|
Electroacupuncture (n = 50) | Sham electroacupuncture (n = 50) | |
Age, mean (SD), y | 63.6 (10.4) | 65.1 (10.6) |
Sex | ||
Male | 29 (58.0) | 27 (54.0) |
Female | 21 (42.0) | 23 (46.0) |
Educational level | ||
High school diploma or less | 41 (82.0) | 40 (80.0) |
Associate degree | 6 (12.0) | 8 (16.0) |
Bachelor degree | 3 (6.0) | 2 (4.0) |
BMI, mean (SD) | 21.9 (2.7) | 21.9 (3.2) |
Occupational status | ||
Employed | 4 (8.0) | 4 (8.0) |
Retired | 22 (44.0) | 20 (40.0) |
Other | 24 (48.0) | 26 (52.0) |
Marital status | ||
Married | 48 (96.0) | 46 (92.0) |
Unmarried | 2 (4.0) | 0 |
Widowed | 0 | 4 (8.0) |
ECOG performance statusa | ||
0 | 0 | 1 (2.0) |
1 | 3 (6.0) | 7 (14.0) |
2 | 36 (72.0) | 22 (44.0) |
3 | 11 (22.0) | 20 (40.0) |
Type of primary cancer | ||
Lung | 17 (34.0) | 21 (42.0) |
Liver | 6 (12.0) | 4 (8.0) |
Breast | 5 (10.0) | 3 (6.0) |
Pancreas | 4 (8.0) | 2 (4.0) |
Uterine cervix | 2 (4.0) | 3 (6.0) |
Nasopharynx | 3 (6.0) | 1 (2.0) |
Colorectal | 2 (4.0) | 1 (2.0) |
Stomach | 2 (4.0) | 1 (2.0) |
Otherb | 9 (18.0) | 14 (28.0) |
Time since the primary cancer diagnosis, mean (SD), mo | 22.4 (23.6) | 23.0 (22.0) |
Patients with cancer metastasis on enrollment | 21 (42.0) | 27 (54.0) |
Type of treatment received at baseline | ||
Radiotherapy | 3 (6.0) | 8 (16.0) |
Chemotherapy | 33 (66.0) | 19 (38.0) |
Chemotherapy plus radiotherapy | 5 (10.0) | 8 (16.0) |
Targeted therapy | 7 (14.0) | 11 (22.0) |
Other | 2 (4.0) | 4 (8.0) |
Type of opioid administered | ||
Oxycodone | 25 (50.0) | 39 (78.0) |
Morphine | 10 (20.0) | 6 (12.0) |
Otherc | 15 (30.0) | 5 (10.0) |
Opioid dose | ||
Mean duration of current opioid use (SD), wk | 14.0 (10.7) | 20.8 (26.2) |
Mean total daily dose of opioid at baseline (SD), mgd | 84.2 (83.8) | 73.5 (50.9) |
No. of patients stratified by opioid dose | ||
30-100 mg | 37 (74.0) | 38 (76.0) |
>100 mg | 13 (26.0) | 12 (24.0) |
Time since OIC diagnosis, mean (SD), mo | 2.9 (2.3) | 4.3 (5.3) |
History of chronic functional constipation | 0 | 4 (8.0) |
Comorbidities | ||
Hypertension | 14 (28.0) | 15 (30.0) |
Diabetes | 7 (14.0) | 5 (10.0) |
Other | 12 (24.0) | 11 (22.0) |
No. of SBMs/wk, mean (SD) | 1.6 (0.5) | 1.5 (0.5) |
No. of CSBMs/wk, mean (SD) | 0.4 (0.5) | 0.3 (0.6) |
Stool consistency score by Bristol stool scale, mean (SD)e | 2.2 (0.6) | 2.2 (0.8) |
Defecation straining score, mean (SD)f | 2.9 (0.5) | 2.8 (0.7) |
PAC-SYM, mean (SD) | ||
Total scoreg | 2.3 (0.8) | 2.3 (0.7) |
Stool symptoms score | 2.9 (0.7) | 2.9 (0.7) |
Rectal symptoms score | 2.4 (0.9) | 2.4 (0.8) |
Abdominal symptoms score | 1.7 (0.9) | 1.6 (0.9) |
PAC-QOL total score, mean (SD)h | 2.2 (0.8) | 2.3 (0.8) |
Dissatisfied with previous treatment, No./total No. (%)i | 23/24 (95.8) | 21/25 (84.0) |
Patients who used rescue medicine at baseline | ||
Rescue medicine | 24 (48.0) | 26 (52.0) |
Other rescue treatmentj | 3 (6.0) | 4 (8.0) |
Frequency of rescue medicine used per week at baseline, mean (SD) | ||
Rescue medicine | 2.0 (1.6) | 2.9 (3.8) |
Other rescue treatmentj | 4.7 (4.7) | 5.0 (3.5) |
NRS score for cancer-related pain intensity at baseline, mean (SD)k | ||
Mean cancer intensity | 3.1 (1.5) | 3.4 (1.6) |
Worst cancer intensity | 4.7 (1.5) | 4.9 (1.5) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CSBM, complete spontaneous bowel movement; ECOG, Eastern Cooperative Oncology Group; NRS, Numerical Rating Scale; OIC, opioid-induced constipation; PAC-QOL, Patient Assessment of Constipation Quality of Life; PAC-SYM, Patient Assessment of Constipation–Symptoms; SBM, spontaneous bowel movement.
Values for ECOG performance status range from 0 to 5; higher scores indicate greater disability.
Other types of cancer in the electroacupuncture group include kidney cancer (2 cases) and bile duct cancer, testis cancer, bone cancer, lymphoid cancer, ovarian cancer, tongue cancer, and esophageal cancer (1 case of each type). Other types of cancer in the sham electroacupuncture group include prostate cancer (3 cases); lymphoid cancer (2 cases); and gallbladder cancer, bile duct cancer, soft-tissue sarcoma cancer, osteosarcoma cancer, ovarian cancer, esophageal cancer, penis cancer, bladder cancer, and ureter cancer (1 case of each type).
Other opioids administered include fentanyl (3 in the electroacupuncture group and 2 in the sham group), hydrocodone (1 in each treatment group), tramadol (11 in the electroacupuncture group and 1 in the sham group), and codeine (1 in the sham group).
Oral morphine equivalent.
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.
PAC-QOL scores are based on a 5-point Likert scale from 0 to 4; lower scores indicate better quality of life.
Data were based on patients with treatments for OIC in the previous week.
Manual maneuvers to facilitate defecations (1 in the sham electroacupuncture group) and Chinese herbs (3 in each group).
The NRS is an 11-point scale from 0 to 10; 0 indicates no pain and 10 indicates the maximum pain imaginable.