Abstract
PURPOSE: To evaluate traditional Chinese medicine (TCM) and acupuncture in addition to estrogen/progesterone therapy in the post-operative management of intrauterine adhesions. PATIENTS AND METHODS: A single center, randomized, non-blinded, controlled trial in which participants received either estrogen/progesterone (group 1), or estrogen/progesterone combined with TCM (group 2), or estrogen/progesterone combined with TCM and navel acupuncture (group 3) for 3 months following transcervical resection of adhesions. The primary outcome was the difference in the uterine adhesion (American Fertility Society, AFS) score at 3 months post hysteroscopy assessed on days 3-7 post menses. The secondary outcomes included endometrial thickness and traditional Chinese medicine score at 3 months, and pregnancy rate at 6 months after hysteroscopy. RESULTS: 120 participants were recruited. There were no differences in AFS at baseline but at 3 months AFS scores were [(4.53 (95 % CI 3.85-5.20) vs. 3.58 (95 % CI 2.94-4.21) vs. 2.70 (95 % CI 2.14-3.26), p < 0.001, pairwise comparison p < 0.05)]. Endometrial thickness increased in all groups [6.20 (95 % CI 5.67-6.72) vs. 6.88 (95 % CI 6.38-7.38) vs. 7.82 (95 % CI 7.26-8.38), pairwise comparison p < 0.05)]. There was a statistically significant difference in pregnancy rates between groups 3 and 1 [42.5 % vs. 10.0 %, p < 0.05)], and group 3 and 2 [ 42.5 % vs. 20.0 %, p < 0.05)], but not between group 1 and group 2 (p > 0.05). CONCLUSION: This pilot randomized controlled trial provides provisional data that the addition of TCM and acupuncture to estrogen therapy following the surgical treatment of intrauterine adhesions may improve outcomes. TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry (ITMCTR2024000258) (http://itmctr.ccebtcm.org.cn/en-US), a member of the WHO Primary Network of ICTRP.