Journal List > Korean J Gastroenterol > v.57(2) > 1006769

Park, Shin, Myung, Huh, Choi, Jung, Choi, Sohn, Choi, and The Korean Society of Neurogastroenterology and Motility: Guidelines for the Treatment of Constipation

Abstract

While constipation is a common symptom in Korea, there are no existing treatment guidelines. Although constipation may occur as a result of organic cause, there is no obstructive mucosal or structural cause in the vast majority of patients with constipation. The present paper deals with only the management of functional constipation: lifestyle changes; bulking agents and stool softeners; osmotic agents; stimulant laxatives; prokinetics; biofeedback and surgical treatments. Exercise and dietary fiber are helpful in some patients with constipation. Laxatives including bulking agents, stool softeners, osmotic agents, and stimulant laxatives have been found to be more effective than placebo at relieving symptoms of constipation. New enterokinetic agents that affect peristalsis through selective interaction with 5-hydroxytryptamine-4 receptors can be effective in patients with constipation who cannot get adequate relief from current laxatives. Biofeedback can relieve symptoms in selected patients with pelvic floor dyssynergia. Surgical treatments can be helpful in some patients with refractory constipation.

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Table 1.
Grading Recommendations7
Grade of recommendation/description Benefit vs. risk and burdens Methodological quality of supporting evidence Implications
1A. Strong recommendation, high-quality evidence Benefits clearly outweigh risk and burden, or vice versa RCTs without important limitations or overwhelming evidence from observational studies Strong recommendation, can apply to most patients in most circumstances. Further evidence is unlikely to change our confidence in the estimate of effect
1B. Strong recommendation, moderate-quality evidence Benefits clearly outweigh risk and burden, or vice versa RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Strong recommendation, can apply to most patients in most circumstances. Higher quality evidence may well change our confidence in the estimate of effect
1C. Strong recommendation, low-quality or very low-quality evidence Benefits clearly outweigh risk and burden, or vice versa Observational studies or case series Strong recommendation, can apply to most patients in most circumstances. Higher quality evidence is very likely to change our confidence in the estimate of effect
2A. Weak recommendation, high-quality evidence Benefits closely balanced with risk and burden RCTs without important limitations or overwhelming evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients' or societal values. Further evidence is unlikely to change our confidence in the estimate of effect
2B. Weak recommendation, moderate-quality evidence Benefits closely balanced with risk and burden RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients' or societal values. Higher quality evidence may well change our confidence in the estimate of effect
2C. Weak recommendation, low-quality or very low-quality evidence Uncertainty in the estimates of benefits, risks and burden; benefits, risk and burden may be closely balanced Observational studies or case series Very weak recommendations; other alternatives may be equally reasonable. High quality evidence is very likely to change our confidence in the estimate of effect

RCT, randomized controlled trial.

Table 2.
Summary of Clinical Trials for Prucalopride in Patients with Chronic Constipation
Reference Design Patients Treatment Efficacy measures Results ADRs
Camilleri et al.95 Phase III, multicenter, RCT, parallel group N=620 Placebo 2, 4 mg/day 12 weeks Primary endpoint: ≥3 CSBM Secondary endpoint: ≥1 CSBM time to first CSBM pt's satisfaction Significant increase of ≥3 CSBM/week with 2 and 4 mg/day vs. placebo (30.9%, 28.4% vs. 12.0%, p<0.001) Increase in number of ≥1 CSBM/week (47.3%, 46.6% vs. 25.8%, p<0.001) Time to first CSBM (1.3, 1.0 vs. 12.6 hrs, p<0.001) Headache, nausea, abdominal pain
          Reduced the severity of constipation symptoms (p<0.001)  
Tack et al.96 Phase III, multicenter, RCT, parallel group N=713 Placebo 2, 4 mg/day 12 weeks Primary endpoint: ≥3 CSBM Secondary endpoint: ≥1 CSBM time to first CSBM pt's satisfaction Significant increase of ≥3 CSBM/week with 2 and 4 mg/day vs. placebo (19.5%, 23.6% vs. 9.6%, p<0.01, p<0.001) Increase in number of ≥1 CSBM/week (38.1%, 44.1% vs. 20.9%, p<0.001) Time to first CSBM (4.7, 2.1 vs. 20.5 hrs, p<0.001) Headache, nausea, abdominal pain
          Reduced the severity of constipation symptoms (p<0.001)  
Quigley, et al.97 Phase III, multicenter, RCT, parallel group N=641 Placebo 2, 4 mg/day 12 weeks Primary endpoint: ≥3 CSBM Secondary endpoint: ≥1 CSBM time to first CSBM pt's satisfaction QOL Significant increase of ≥3 CSBM/week with 2 and 4 mg/day vs. placebo (23.9%, 23.5% vs. 12.0%, p<0.01) Increase in number of ≥1 CSBM/week (42.6%, 46.6% vs. 27.5%, p<0.001) Time to first CSBM (2.3, 1.9 vs. 13.0 hrs, p<0.001) Headache, nausea, abdominal pain
          Reduced the severity of constipation symptoms (p<0.001)  
          Improved constipation-related QOL  

ADR, adverse drug reactions; SBM, spontaneous bowel movement; CSBM, complete, spontaneous bowel movement; RCT, randomized controlled trial; QOL, quality of life.

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Seung-Jae Myung
https://orcid.org/http://orcid.org/0000-0003-0585-4016

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