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 (s.d.=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.

Development of Protocols for Randomized Sham-Controlled Trials of Complex Treatment Interventions: Japanese Acupuncture for Endometriosis-Related Pelvic Pain

“…Further details regarding the study design, outcome measures, and results of the clinical trial are presented elsewhere. 4 …”

“…We reported no acupuncture-related adverse events with the use of this device. 4 The Streitberger device has been previously validated 19 but not in JA trials. Since in JA minimal contact of needles with the skin is believed to be therapeutic, we conducted a preliminary evaluation of this device to modify it by eliminating direct skin contact and minimizing stimulation.…”

“…As part of a pilot, randomized, sham-controlled study to evaluate the potential application of JA in treating endometriosis-related chronic pelvic pain in young women, 4 we designed a multimodal intervention based on a style of JA. In addition, we designed a parallel sham control employing the nonpenetrating Streitberger sham needling device 5 and sham moxibustion.…”

Gynecologic Pain in Adolescents

“…Acupuncture has been well studied and appears to reduce pain in both primary dysmenorrhea and endometriosis patients [1,4,[34][35][36][37]. Adolescents may benefit from acupuncture therapy from a trained, certified provider.…”

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement

“…The specific acupuncture protocols employed in this study are briefly described later and discussed in greater detail in a companion paper(ref) (25). (ii) We based point selection on individualized Western acupuncture techniques by using a list of points previously reported as being effective in neck pain (refs) and by reaching a consensus according to our own clinical and teaching practice.…”