Japanese-style acupuncture for endometriosis-related pelvic pain in adolescents and young women: results of a randomized sham-controlled trial

Abstract

Study objective: To assess feasibility, and collect preliminary data for a subsequent randomized, sham-controlled trial to evaluate Japanese-style acupuncture for reducing chronic pelvic pain and improving health-related quality of life (HRQOL) in adolescents with endometriosis.

Design: Randomized, sham-controlled trial.

Settings: Tertiary-referral hospital.

Participants: Eighteen young women (13-22y) with laparoscopically-diagnosed endometriosis-related chronic pelvic pain.

Interventions: A Japanese style of acupuncture and a sham acupuncture control. Sixteen treatments were administered over 8 weeks.

Main outcome measures: Protocol feasibility, recruitment numbers, pain not associated with menses or intercourse, and multiple HRQOL instruments including Endometriosis Health Profile, Pediatric Quality of Life, Perceived Stress, and Activity Limitation.

Results: Fourteen participants (out of 18 randomized) completed the study per protocol. Participants in the active acupuncture group (n = 9) experienced an average 4.8 (SD = 2.4) point reduction on a 11 point scale (62%) in pain after 4 weeks, which differed significantly from the control group's (n = 5) average reduction of 1.4 (SD = 2.1) points (P = 0.004). Reduction in pain in the active group persisted through a 6-month assessment; however, after 4 weeks, differences between the active and control group decreased and were not statistically significant. All HRQOL measures indicated greater improvements in the active acupuncture group compared to the control; however, the majority of these trends were not statistically significant. No serious adverse events were reported.

Conclusion: Preliminary estimates indicate that Japanese-style acupuncture may be an effective, safe, and well-tolerated adjunct therapy for endometriosis-related pelvic pain in adolescents. A more definitive trial evaluating Japanese-style acupuncture in this population is both feasible and warranted.

Figure 1

Flow of study participants.

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 (full scale ranges from 0–4); and e) activity limitation (full scale ranges from 1–10). Solid lines are active group; dashed lines are sham group. Symbols indicate group means.