Eighteen patients were randomized, 10 to active acupuncture and 8 to sham acupuncture. summarizes the flow of participants through the trial.
Baseline characteristics of the 18 subjects did not differ significantly among treatment groups for any variable (P >0.05) (). All participants were diagnosed with Stage I endometriosis which is consistent with profiles of endometriosis in adolescent populations.8
A total of 4 patients discontinued treatments. One participant in the active group withdrew because of travel time. Three participants in the sham group withdrew because of the following: entered a drug rehabilitation program, travel time, unknown. Nine and 5 participants in the active and sham group, respectively, completed all 16 treatments per protocol, as well as all baseline and follow-up testing. All analyses presented below are based on these 14 participants.
Participant characteristics at baseline
Mean pain levels experienced during the four weeks preceding each assessment declined between baseline and 6 months (, ). At 4 weeks, declines were significantly greater in the active acupuncture group as compared to the control; mean=−4.8 (sd=2.4) vs −1.4 (sd=2.1), respectively, on a 11 point scale (P=0.004). After 8 weeks and 6 months, pain reduction in the active group remained slightly greater, but between group differences were not statistically significant.
Figure 2 Impact of active and sham acupuncture on: a) pain (full scale ranges from 0–10); b) endometriosis quality of life (full scale ranges from 0–100); c) pediatric quality of life (full scale ranges from 1–100); d) perceived stress (more ...)
Impact of active and sham acupuncture on pain, health related quality of life, perceived stress and activity limitation.
HRQOL assessed with both the Endometriosis Health Profile and the Pediatric Quality of Life Inventory indicate trends towards improvement in the active, but not in the sham group, however differences between groups were not statistically significant (, ).
Perceived stress improved in the active group by 0.5 (sd=0.6) points out of 4 at 4 weeks, compared to baseline; differences from baseline were similar at week 8 and at 6 months. In contrast, there was relatively little change in perceived stress in the sham group; differences between groups were not statistically significant (, . Pelvic pain-related limitations in activities showed greater improvement in the active vs. sham treatment group: at 4 weeks, limitations were reduced from baseline by 3.4 (sd=2.2) points out of 10 in the active group in compared to 0.5 (sd=1.5) points in the sham group (P=0.02). After 8 weeks and 6 months, declines in activity limitation in the active group remained greater, but between group differences were not statistically significant (, ).
There was no significant difference between the active and sham groups’ differences from baseline at either 4 weeks (Wilcoxon exact p=0.989) or at 8 weeks (p=0.647) for IL6. One subject’s initial IL6 was off the chart; this subject withdrew from the trial to enroll in a drug rehabilitation program and reported using various substances that might bias blood assays. This subject was omitted from IL6 analysis. Analysis of changes in TNFa serum cytokine levels from baseline to 4 weeks and to 8 weeks were based on 10 participants in the active and 8 participants in the sham groups. There was no significant difference between the active and sham groups’ differences from baseline at either 4 weeks (Wilcoxon exact p=0.071) or at 8 weeks (p=0.199) for TNFa.
No serious adverse events were reported by any participants. A total of 9 minor and expected adverse events related to acupuncture were reported over the course of 232 treatments. These included transient light-headedness, minor bruising, and minor burns associated with moxibustion.
The degree to which subjects were blinded to treatment allocation did not differ statistically different between groups. After 4 weeks, 5, 3, and 1 participant in the active group, respectively, stated that they were: unsure of the group they were assigned to; that they were assigned to the active group; or assigned to the sham group. In the sham group, 1, 1, and 3 participants, respectively, stated that they were: unsure; in the active group; or in the sham group (p=0.25). The pattern was largely unchanged after 8 weeks (p=0.43) and 6 months (p=0.41). Participant’s expectancy that treatments would be effective were identical at baseline () and remained similar after 4 weeks of treatment (p=0.49).