A pilot study on the use of andrographolide to treat symptomatic adenomyosis

Abstract

Objective: To evaluate the efficacy of andrographolide in treating adenomyosis and to test the hypothesis that its efficacy may depend on the nuclear factor-kappa-light-chain enhancer of activated B cells (NF-κB) activation status in eutopic endometrium, which may be a proxy for the status in adenomyotic foci. Materials and methods: Twenty-four patients with transvaginal ultrasound-confirmed adenomyosis (excluding ovarian endometriomas) were recruited for this study after informed consent. All patients had dysmenorrhea and/or heavy menstrual bleeding. All received andrographolide pill orally for 3 months and were followed up for an additional 3 months. The primary outcome measures included the severity of dysmenorrhea, as measured by the visual analog scale (VAS), and menstrual characteristics, such as the amount of menses, all measured before and 3 and 6 months after the drug treatment. In addition, the patients completed Clinical Global Impression rating scales at the end of the 6th month. Immunostaining of the phosphorylated NF-κB p65 (p-p65) subunit was also performed for eutopic endometrium. Results: Andrographolide treatment appeared to be well tolerated by the patients. Six months after taking andrographolide, the average dysmenorrhea VAS score was decreased from the baseline level of 5.3 to 3.5. Twelve patients (50.0%) reported “marked” or “much” improvement, seven (29.2%) reported “minimal improvement” and five (20.8%) reported “unchanged or worse”. The eutopic endometrial p-p65 staining levels were closely correlated with the satisfaction rating. Conclusion: Andrographolide is effective in some patients with symptomatic adenomyosis, who have a higher endometrial expression of the activated form of the NF-κB p65 subunit. Future independent validation studies or randomized clinical trials may be needed to more precisely evaluate the efficacy of andrographolide.

Keywords

• adenomyosis
• Clinical Global Impression scale
• dysmenorrhea
• heavy menstrual bleeding
• nuclear factor-κB p65 subunit