Introduction
Opioids and many other chronic medications are risk factors for constipation [1]. Lifestyle changes and second-line treatment with laxatives are not enough to solve the problem [2]. Indeed, most laxative agents show limited efficacy for chronic use, especially in people under concomitant medication, in addition to potential adverse effects [3].
Intermittent colonic exoperistalsis (ICE) administered with the MOWOOT medical device, is a non-invasive, non-drug solution for chronic constipation. It has been developed to facilitate natural bowel movements and reduce the burden of laxatives, enemas, and other invasive approaches. ICE has been proven safe and effective in a previous multicentric clinical trial [4].
Aims & Methods
The aim of the present study was to assess the effect of ICE treatment on those people included in the previous clinical trial [4] who were under constipation-inducing medication (CIM).
The patients under CIM were identified by searching the clinical trial data base for concomitant medication. A medication was considered as constipation-inducing (CIM) when its medical leaflet indicated constipation as secondary adverse event occurring with a frequency >10%.
The ICE device was used daily for 20 minutes over 4 weeks at home without the direct supervision of a medical professional.
The difference after ICE-treatment (V2) respect to baseline (V1) was assessed for the number of complete bowel movements/week (CBM/w; primary outcome), the constipation symptoms (KESS score [5]), and the quality of life (PACQoL [6]).
Results
Out of the total 92 participants [4], there were n=42 under CIM, which include opioids (n=6; 14.29%), antidepressants (n= 29; 69.05%), antipsychotics (n=3; 7.14%), anticonvulsants (n=2; 4.76%), antihypertensives (n=13; 30.95%), and other CIM (n=9; 21.43%). Most people were women (78.57%), aged 53’86 (10.16) yr, with BMI: 27,68 (5,25). The rest of the sample not taking CIM were also mostly women (82.61%), aged 49.64 (13.12) yr, with BMI: 24.23 (4.83).
All the constipation-related assessed parameters significantly improved after ICE treatment, both in people taking CIM or not (Table). The number of CMB/w in the CIM sample after 4 weeks of ICE treatment increased to 7.1 (5.4), while participants not taking CIM increased to 5.9(3.3). Although this difference between groups did not reach statistical significance (Table), the clinical impact was notable for people taking CIM who achieved the goal of a daily deposition. The symptoms of chronic constipation and the quality of life were similarly ameliorated in both CIM and no-CIM groups.
| CIM | V2-V1
mean (SD) | *P V2-V1 | **P Yes vs No |
| Complet Bowel Movements/week | Yes | 2.4 (3.1) | <0.0001 | 0.0517 |
| No | 1.3 (2.1) | 0.0002 |
| KESS score | Yes | -3.6 (5.3) | 0.0001 | 0.6402 |
| No | -4.2 (4.8) | <0.0001 |
| PAC-QoL | Yes | -0.6 (0.7) | <0.0001 | 0.3360 |
| No | -0.7 (0.8) | <0.0001 |
KESS (0 to 39) & PAC-QoL (0 to 4): the lower value, the better result. The Wilcoxon test (*paired, **unpaired) was used. Statistical significance reached at P<0.05.
Conclusion
The results favour the use of intermittent colonic exoperistalsis (ICE) with the MOWOOT medical device to treat constipation at home, without direct supervision of a medical professional, in people under constipation-inducing medication. As a non-invasive and non-drug solution, ICE would offer important advantages over the current standard of care (laxatives, enemas…) to CIM patients and the healthcare system.
References
1. Camilleri, M., et al., Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil, 2014. 26(10): p. 1386-95.
2. Holzer, P., Non-analgesic effects of opioids: management of opioid-induced constipation by peripheral opioid receptor antagonists: prevention or withdrawal? Curr Pharm Des, 2012. 18(37): p. 6010-20.
3. Prichard, D.O. and A.E. Bharucha, Recent advances in understanding and managing chronic constipation. F1000Res, 2018. 7.
4. McClurg, D., L. Booth, and I. Herrero-Fresneda, Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial. Clin Transl Gastroenterol, 2020. 11(12): p. e00267.
5. Knowles, C.H., et al., Linear discriminant analysis of symptoms in patients with chronic constipation: validation of a new scoring system (KESS). Dis Colon Rectum, 2000. 43(10): p. 1419-26.
6. Marquis, P., et al., Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol, 2005. 40(5): p. 540-51.
Disclosure
IHF works at USMIMA S.L., the manufacturer of MOWOOT.