Noar, M., Mathias, J., & Kolatkar, A. (2024). Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis. Journal of Clinical Medicine, 13(10), 2866. https://doi.org/10.3390/jcm13102866
Noar M, Mathias J, Kolatkar A. Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis. J Clin Med. 2024;13(10):2866. doi:10.3390/jcm13102866
Noar, Mark, et al. "Gastrointestinal Myoelectrical Activity (GIMA) Biomarker for Noninvasive Diagnosis of Endometriosis." Journal of Clinical Medicine, vol. 13, no. 10, 2024, pp. 2866.
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Author affiliations
2 institutions
Specialty Business Center, Integrative Ayurveda Gastroenterology and Nutrition Initiative, 202, Balewadi, Pune 411045, Maharashtra, India
Endometriosis and Neuroenterology Research Institute, 53 Loveton Circle, Sparks Glencoe, MD 21152, USA
RRM Academy Synopsis
Abdominal electrode test detected endometriosis in one 154-woman study
In one study, an abdominal electrode test separated women with and without endometriosis. The noninvasive test recorded bowel electrical activity in 154 women. Against controls, it detected 95 out of 100 surgically confirmed cases in women 35 and younger. In women 36 and older, it detected 91 out of 100.
Key Findings
Of the 154 women, 62 were controls, 43 had endometriosis confirmed by surgery and histology (Cohort 2), and 49 had abdominal pain with negative imaging (Cohort 3).
In women 35 and younger, threshold scoring gave 95% sensitivity and 96% specificity, with predictive values of 95% (positive) and 96% (negative) and a C-statistic above 99%.
In women 36 and older, sensitivity was 91% and specificity 95%, with predictive values of 91% (positive) and 95% (negative) and a 98% C-statistic.
In Cohort 3, the test predicted endometriosis in 47 of 49 women and no endometriosis in 2 of 49. Surgery confirmed both calls.
Hormonal therapy, surgical stage and pain score did not affect diagnostic accuracy.
Interpretation
The study tested one device at two sites in an open-label design with prospective enrollment. The age-group figures compare controls with women whose endometriosis was already confirmed. Cohort 3 tested predictions made before surgery. The authors say larger and more varied groups are needed, and that adenomyosis or other coexisting diseases could cause false positives. They cite surgical diagnosis as only 50 to 75% accurate, and the control group may include undiagnosed cases. The paper lists two related patents.
RRM Context
Endometriosis often goes undiagnosed for years, and treatment decisions wait on the diagnosis. Restorative reproductive medicine starts by finding the underlying cause. A less invasive way to identify disease would matter if independent groups reproduce these results. The test addresses detection only. Excision surgery remains the treatment standard once disease is found.
Our editorial summary of this paper, not the article's abstract.
Abstract
Background and Objectives
Endometriosis represents substantial direct and indirect healthcare costs impacted by an absence of uniformly accurate, non-invasive diagnostic tools. We endeavored to demonstrate gastrointestinal myoelectrical activity (GIMA) biomarkers, unique to endometriosis, will allow non-invasive, uniformly accurate diagnosis or exclusion of endometriosis.
Methods
Prospective open-label comparative study of 154 patients, age ≥ 18, with or without diagnosed endometriosis. Population included 62 non-endometriosis controls (Cohort 1), 43 subjects with surgically/histologically confirmed endometriosis (Cohort 2), and 49 subjects with abdominal pain and negative imaging (Cohort 3). Non-invasive electroviscerography (EVG) recorded GIMA biomarkers from three abdominal electrodes before and 30 min post water load protocol. Cohort 2 had postoperative EVG and Cohort 3 had preoperative EVG. Calculated specificity, sensitivity, negative predictive value (NPV), positive predictive value (PPV), and predictive probability or C-statistic used univariate, multivariate, linear, and logistical regression analyses of the area under the curve (AUC) at all frequency and time points, including age and pain covariants.
Results
The non-endometriosis cohort differed significantly from the endometriosis cohorts (p < 0.001) for median (IQR) and AUC percent frequency distribution of power at baseline, 10 min, 20 min, and 30 min post water load at all frequency ranges: 15-20 cpm, 30-40 cpm, and 40-50 cpm. The endometriosis cohorts were statistically similar (p > 0.05). GIMA biomarker threshold scoring demonstrated 95%/91% sensitivity and PPV, 96%/95% specificity and NPV, and a C-statistic of >99%/98%, respectively, for age subsets. GIMA biomarkers in Cohort 3 predicted 47/49 subjects positive and 2/49 negative for endometriosis, confirmed surgically. Hormonal therapy, surgical stage, nor pain score affected diagnostic accuracy.
Conclusions
EVG with GIMA biomarker detection distinguished participants with and without endometriosis based upon endometriosis-specific GIMA biomarkers threshold scoring.
