Adjuvant Treatment with Dienogest Significantly Reduces Postoperative Recurrence in Endometriosis

12 May, 23

Introduction

Dienogest is a 4th generation of highly selective progesterone receptor agonist and has been proved safe and effective postoperative treatment in endometriosis in Asia. However, this study will compare the efficacy of dienogest with gonadotrophin releasing hormone agonists (GnRH-a), as adjuvant drugs in endometriosis patients after laparoscopic surgery.

Aim

To compare the efficacy of Dienogest and GnRH- a after endometriosis surgery

Method

Study Design

Prospective clinical study

Treatment Strategy

A total of 81 patients with endometriosis after conservative laparoscopic surgery were randomly assigned to control and observation group

Control group comprised 40 women, treated with GnRH-a 3.75 mg on day 1 of menstrual cycle and repeated after every 28 days for 3 months
Observational group included 41 women, treated with dienogest 2 mg twice daily at 3 to 5 days after surgery and then once daily for 6 months

Endpoints

Pain evaluated by VAS score and Kupperman score
Estradiol (E2) levels at 3 and 6 months

Follicle stimulating hormone (FSH) levels at 3 and 6 months
Days of vaginal bleeding
Rate of recurrence at 3 and 6 months

Results

Age and the cyst size was comparable between the 2 groups

Both the groups had a significant reduction in pain as seen in table 1.

Table 1. Comparison of VAS and Kupperman scores before and after surgery

	Control group	Observational group
VAS score
Before treatment	5.65+2.47	4.29+2.02
3 months	1.8+1.57	1.61+1.48
6 months	0.78+0.8	0.73±0.78
P value	<0.05	<0.05
Kupperman score
Before treatment	12.4+5.62	11.88+5.47
3 months	3.9+1.84	3+1.86
6 months	3.9+1.84	1.55+1.24
P value	<0.05	<0.05

The days of vaginal bleeding significantly reduced after treatment with adjuvant GnRH-a and dienogest
Normal values of E2 and FSH were attained 6 months post-surgery with both the drugs
Postoperative recurrence was remarkably higher in the control group; p<0.05 as seen in Figure 1.
Treatment with dienogest was associated with higher efficacy 82.9% vs 77.5%; p<0.05
Overall effectiveness of treatment is shown in Figure 1.

Figure 1. Overall effectiveness of treatment

Conclusion

Postoperative adjuvant treatment with dienogest significantly reduces the postoperative recurrence as compared to gonadotrophin releasing hormone agonist (GnRH-a)
Dienogest was equally effective as GnRH-a in providing pain relief, reducing the vaginal bleeding and achieving normal estradiol and FSH levels after laparoscopic surgery

BMC Womens Health. 2023 Feb 24;23(1):85.