The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis

The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis: A Cross-sectional Observational Study.

Endometriosis usually occurs during the reproductive period of women and poses a significant burden on quality of life and social costs. The estimated prevalence in premenopausal women is 10% in clinical studies and the frequency rises to 50% in symptomatic patients with pelvic pain and infertility. Observational studies in Europe estimated the prevalence to be 8-15 per 1000 people.

Fibromyalgia is a common musculoskeletal chronic painful condition that may be accompanied by cognitive impairment, somatic symptoms, fatigue, and psychiatric symptoms. The population frequency is given as 20-80 per 1000 people. Fibromyalgia is most often diagnosed in women aged 20-55 years; prevalence increases with age and is associated with a higher prevalence of comorbidities, including endocrine and genitourinary disorders. Co-existance of endometriosis and fibromyalgia is a special entity that has not been enlightened in detal yet.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Endometriosis Ovary; Dienogest
• Intervention / Treatment: Drug: Dienogest

Detailed Description

Although little is known about the causes of endometriosis, it is reported that women with endometriosis have a high rate of comorbidity with other chronic pain syndromes associated with peripheral and central changes in pain processing, including fibromyalgia, migraine headaches, inflammatory bowel disease, and painful bladder syndrome. Later, various studies conducted in different years showed that cross-organ sensitivity phenomenon, defined as the spread of harmful inputs (inflammation products, mediators, pathogens, etc.) from a diseased visceral organ to a normal organ, comorbidities including IBS, IBD, interstitial cystitis and chronic pelvic pain disorders are common. Therefore, it has been suggested that patients with endometriosis may have a higher risk of developing these chronic diseases. The results of another study are inconsistent with the studies that supports the coexistence of endometriosis and fibromyalgia.

These literature data indicate the need for more data on the frequency of fibromyalgia in women with endometriosis. On the other hand, it has been reported that pain scores are correlated with daily fluctuations of progesterone and testosterone in women with fibromyalgia, and progesterone and testosterone play a protective role for fibromyalgia pain. Dienogest is a fourth-generation selective progestin that has a significant local effect on endometriotic lesions, has little androgenic, less estrogenic, low glucocorticoid or mineralocorticoid activity and minimal effect on metabolic parameters, and is used in the medical treatment of endometriosis. However, there is no data on the effects of hormonal therapy used in the treatment of endometriosis on the frequency and severity of symptoms of fibromyalgia associated with endometriosis. Therefore, in this study, it was aimed to evaluate the effects of progesterone therapy used in endometriosis patients on fibromyalgia frequency, fibromyalgia severity and quality of life.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Gaziosmanpaşa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who applied to Gaziosmanpasa Training and Research Hospital Gynecology and Obstetrics Polyclinic, previously diagnosed with fibromyalgia and diagnosed with unilateral endometrioma.

Description

Inclusion Criteria:

• 18 - 40 years old
• Nulliparity
• Women diagnosed with endometrioma (unilateral, ≤ 4cm) by physical examination and vaginal/transabdominal ultrasonography

Exclusion Criteria:

• Pelvic mass that cannot be differentially diagnosed by physical examination and imaging techniques
• Endometrioma cases with surgical treatment indication
• Any concurrent major psychiatric disorder
• Any medical condition that may interfere with sensory perception (diabetes, neurological disorder, etc.)
• Presence of any other concomitant painful condition other than fibromyalgia and endometriosis
• Currently using any hormonal therapy
• History and/or presence of malignancy
• Pregnancy
• Menopause or premature ovarian failure

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of recovery rate of participants diagnosed as in terms of fibromyalgia symptoms after dienogest use by using Visual Analog Scale (VAS).	VAS is a 10 cm labeled "No Pain" on one end and "The Most Severe Pain Possible" on the other. On a long line, the participant is asked to mark a point on this line that corresponds to the intensity of pain she feels. The distance between the starting point expressed as "No Pain" and the marked point is measured with a ruler and recorded in centimeters.	6 months
Determination of recovery rate of Symptom Severity (SS) Score in participants in terms of fibromyalgia symptoms after dienogest use by using Fibromyalgia Questionnaire Diagnostic Criteria and Symptom Severity Scale.	The first section contains 3 questions about fatigue, cognitive problems, and sleep symptoms, each scored in a likert format from 0 (no problem) to 3 (severe: persistent, life-disturbing problems) over the past week. The second part consists of 3 questions (maximum score 3) that give positive or negative answers to the following somatic complaints that have arisen in the last 6 months; abdominal pain or cramps, depression and headache. The sum of Parts 1 and 2 provides a Symptom Severity (SS) Score in the range of 0-12.	6 months
Determination of recovery rate of Widespread Pain Index (WPI) Score in participants in terms of fibromyalgia symptoms after dienogest use by using Fibromyalgia Questionnaire Diagnostic Criteria and Symptom Severity Scale	The third section is a measurement of the Widespread Pain Index (WPI) and is completed by identifying body areas where pain or tenderness has been felt during the previous 7 days. The maximum score for the WPI section is 19. Polysymptomatic distress (PSD) is defined as the sum of the (0-19) WPI and the 6-item (0-12) SS scale, ranging from 0-31.	6 months

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Endometriosis; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Dienogest
• Other Study ID Numbers: GaziosmanpaşaTREHh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No