Which Endometriosis Treatment is Better: NETA or Extended-cycle OC (Seasonique®)?

Norethindrone acetate (NETA) and Extended-cycle oral contraceptive (OC) can effectively treat endometriosis-related pain symptoms and both treatments have similar patient satisfaction ratings.

Key Points

Highlights:

• This study compared extended-cycle oral contraception (OC) with norethindrone acetate (NETA). The researchers wanted to gauge satisfaction with the two drugs in women with endometriosis.

Importance:

• Before this study, there was no study that investigated the effectiveness of extended-cycle OC in women with endometriosis. Thus, it was imperative that someone tests the efficacy of the drug above as it would give health care providers a better idea of the best treatment regimen for their patients with endometriosis.

What’s done here?

• The researchers recruited women with endometriosis who were histologically diagnosed with endometriosis during surgery and were ultrasonographically diagnosed, using standardized ultrasound criteria, with deep endometriosis and endometriomas.
• The participants were not looking to undergo surgery or get pregnant in the year following their inclusion in the study.
• Participants were not included in the study if:
  • Estrogens and progestogens intake could be harmful
  • They have uropathy or symptomatic bowel stenosis
  • They use drugs that could potentially interfere with the contraceptive metabolism
  • There were abnormal findings concerning the breast examination and mammary ultrasound scan
  • They have psychotic disturbances
  • They have a history of substance, drug and alcohol, abuse
• The participants were split into two groups according to their treatment preference and given one of the following treatments:
  • Group A was given NETA (2.5 mg/day, Primolut-Nor1; Bayer Pharma AG, Berlin, Germany) orally.
  • Group B was given an extended cycle OC (LNG/EE 150/30 mcg for 84 days and EE 10 mcg for seven days, Seasonique1, Teva, Assago, Italy) for 91 days.
• The researchers paid particular attention to patient satisfaction with the treatments. They used an intention-to-treat analysis at 12 months to assess the overall degree of comfort with the procedure. The study consisted of two parts. The first part was administered to all patients regardless of how long they underwent treatment. The second part was only applied to patients who underwent treatment for 12 months.
• The researchers also made a note of changes in pain symptoms, endometrioma volume, rectovaginal nodule volume, and quality of life.
• The study also had a bleeding assessment, which was different depending on if the participant was in Group A or B.
• The data from the study was subject to statistical analysis.

Key results:

• The results show that at 12 months there was no significant difference in the rate of satisfied patients between the two treatment groups. The percentage of satisfied participants in Group A was 82.2%, and in Group B it was 68.4%.
• Participants in both groups noted an improvement in pain at 6 and 12 months.
• There was more unscheduled bleeding during the first cycle in Group B than there was in Group A.
• In short, both treatments are efficient when it comes to treating endometriosis-related pain and patients are nearly equally satisfied with both treatment choices.

Limitations of the study:

• This study was not randomized.
• The healthcare provider discussed both treatments with the participant, and that could have affected the participant’s choice of therapy.
• The participants were given the price of the two treatments, which may further influence their choice of treatment.
• The sample size of this study is relatively small, which could affect the significance of the results.  

Lay Summary

Scala et al. recently shared the findings of their patient preference prospective study in a journal article titled “Norethindrone acetate versus extended-cycle oral contraceptive (Seasonique®) in the treatment of endometriosis symptoms: A prospective open-label comparative study,” which was published in the European Journal of Obstetrics & Gynecology and Reproductive Biology in 2018. The article compares extended-cycle oral contraception (OC) with norethindrone acetate (NETA). The dependent variable in their study was patient satisfaction. It is important to note that all the participants in the study were women suffering from endometriosis. 

The researchers recruited women who were diagnosed with endometriosis. The participants were then split up into two treatment groups: NETA (2.5 mg/day, Primolut-Nor1; Bayer Pharma AG, Berlin, Germany) or extended cycle OC (LNG/EE 150/30 mcg for 84 days and EE 10 mcg for 7 days, Seasonique1, Teva, Assago, Italy). The participants could choose which treatment group they would like to be a part of. At 12 months, the researchers analyzed patient satisfaction with each treatment. Participants that withdrew from the study before 12 months’ time were asked to assess their satisfaction with their treatment at the time of withdrawal. The study also evaluated changes in pain symptoms, endometrioma volume, rectovaginal nodule volume, and quality of life. Furthermore, the participants were subject to a bleeding assessment, which changed depending on their treatment group. The data from the study was subject to statistical analysis.

The study revealed no statistically significant difference in patient satisfaction rate between the two treatment groups at 12 months. Additionally, participants in both groups noticed an improvement in pain at 6 months and 12 months. The bleeding assessment revealed more unscheduled bleeding in the first cycle in Group B. In conclusion, the two treatments, extended cycle OC and NETA, had similar satisfaction ratings and are effective in combatting endometriosis-related pain symptoms.

Research Source: https://www.ncbi.nlm.nih.gov/pubmed/29408753