Table 3.
Outcomes | Group | P value for EA × CBZ × time 3-way interactiona | P value for EA × CBZ interactiona | P value for main effect of EAa | P value for main effect of CBZa | P value for main effect of timea |
---|---|---|---|---|---|---|
Other outcomes to assess efficacy | ||||||
SF-MPQb | ||||||
PRI | EA + CBZ | 0.041* | 0.022* | < 0.001* | 0.011* | < 0.001* |
SEA + CBZ | ||||||
EA + P | ||||||
SEA + P | ||||||
PPI | EA + CBZ | 0.026* | 0.196 | < 0.001* | 0.057 | < 0.001* |
SEA + CBZ | ||||||
EA + P | ||||||
SEA + P | ||||||
The total number of pain attacksc | EA + CBZ | 0.319 | 0.065 | < 0.001* | 0.208 | < 0.001* |
SEA + CBZ | ||||||
EA + P | ||||||
SEA + P | ||||||
Quality of life assessment | ||||||
SF-36 | EA + CBZ | 0.002* | 0.284 | 0.002* | 0.023* | < 0.001* |
SEA + CBZ | ||||||
EA + P | ||||||
SEA + P | ||||||
BPI-Faciald | ||||||
General interference items | EA + CBZ | 0.237 | 0.046* | < 0.001* | 0.048* | < 0.001* |
SEA + CBZ | ||||||
EA + P | ||||||
SEA + P | ||||||
Facial interference items | EA + CBZ | 0.006* | 0.189 | < 0.001* | 0.009* | < 0.001* |
SEA + CBZ | ||||||
EA + P | ||||||
SEA + P | ||||||
PGICe | EA + CBZ | 0.071 | 0.025* | < 0.001* | < 0.001* | < 0.001* |
SEA + CBZ | ||||||
EA + P | ||||||
SEA + P |
aMultiple comparisons between the groups were compared by using Sidak test
bIncluding PRI and PPI. The PRI was comprised of sensory and affective scale, each selected word was scored from 0 (none) to 3 (severe). The total PRI score was obtained by summing the item scores. The PPI range from 0–5, with higher scores indicating greater pain
cThe total number of pain attacks was calculated by summing the number of pain attacks in the past two weeks prior to the every assessment time-point
dIncluding general interference items and facial interference items. The total score of general interference items was sum of the 7 questions that address pain interference with general activities of daily living (ADL), score range is from 0 to 70, with higher scores indicating greater impact. The total score of facial interference items was sum of the 7 questions that address pain interference with face-specific daily activities, score range is from 0 to 70, with higher scores indicating greater impact
eThe PGIC evaluated overall health status as perceived by the patient in a seven-point single-item scale ranging from ‘very much worse’ to ‘very much improved’. For descriptive purposes, patients were classified into three categories according to the PGIC score: disease deterioration (0–3 points), stable disease (4 points) or disease improvement (5–7 points) since the initial baseline visit
*P < 0.05
Abbreviations: VAS visual analog scale, SF-MPQ Short-Form McGill pain questionnaire, PRI pain rating index, PPI present pain intensity, BPI-Facial brief pain inventory-facial scale, SF-36 Short-Form 36 questionnaire, PGIC patient global impression of change, EA + CBZ electroacupuncture plus carbarmazepine (at the dosage of 300 mg/day), SEA + CBZ sham electroacupuncture plus carbarmazepine (at the dosage of 300 mg/day), EA + P electroacupuncture plus placebo, SEA + P sham electroacupuncture plus placebo