What is the stepwise approach for managing chronic constipation?

From the Guidelines

The stepwise approach for managing chronic constipation begins with lifestyle modifications, including increasing dietary fiber intake and ensuring adequate hydration, followed by the use of over-the-counter fiber supplements, osmotic laxatives, and stimulant laxatives, with prescription medications like linaclotide being considered for refractory cases, as recommended by the most recent guidelines 1. The management of chronic constipation involves a gradual escalation of treatment options, starting with non-pharmacological interventions. Key lifestyle modifications include:

• Increasing dietary fiber intake to 25-30 grams daily
• Ensuring adequate hydration with 6-8 glasses of water daily
• Establishing a regular exercise routine
• Developing a consistent toilet routine, ideally 30 minutes after meals when the gastrocolic reflex is strongest If these measures are insufficient, the next steps involve:
• Over-the-counter fiber supplements like psyllium (Metamucil) 1 teaspoon 1-3 times daily or methylcellulose (Citrucel)
• Osmotic laxatives such as polyethylene glycol (Miralax) 17 grams daily, magnesium hydroxide (Milk of Magnesia) 30-60 ml daily, or lactulose 15-30 ml daily
• Stimulant laxatives like bisacodyl (Dulcolax) 5-10 mg daily or senna (Senokot) 8.6-17.2 mg daily for short-term use For patients not responding to these interventions, prescription medications such as linaclotide (Linzess) 145-290 mcg daily are recommended over management without linaclotide, based on strong recommendation and moderate certainty of evidence 1. These prescription medications work by increasing intestinal fluid secretion and accelerating transit time. For severe cases unresponsive to medical therapy, biofeedback therapy or surgical interventions may be considered, as outlined in guidelines for the management of fecal incontinence and defecatory disorders 1.

From the FDA Drug Label

The efficacy of LINZESS for the treatment of CIC was established in two double-blind, placebo-controlled, randomized, multicenter clinical trials in adult patients (Trials 3 and 4) A total of 642 patients in Trial 3 and 630 patients in Trial 4 [overall mean age of 48 years (range 18 to 85 years), 89% female, 76% white, 22% black, 10% Hispanic] received treatment with LINZESS 145 mcg, 290 mcg, or placebo once daily and were evaluated for efficacy. All patients met modified Rome II criteria for functional constipation Modified Rome II criteria were less than 3 Spontaneous Bowel Movements (SBMs) per week and 1 of the following symptoms for at least 12 weeks, which need not be consecutive, in the preceding 12 months: Straining during greater than 25% of bowel movements Lumpy or hard stools during greater than 25% of bowel movements Sensation of incomplete evacuation during greater than 25% of bowel movements

The stepwise approach for managing Chronic Constipation is not explicitly outlined in the provided drug label. However, the label does describe the modified Rome II criteria used to diagnose functional constipation, which includes:

• Less than 3 Spontaneous Bowel Movements (SBMs) per week
• At least one of the following symptoms for at least 12 weeks:
  • Straining during greater than 25% of bowel movements
  • Lumpy or hard stools during greater than 25% of bowel movements
  • Sensation of incomplete evacuation during greater than 25% of bowel movements Based on the information provided, a conservative clinical approach would involve assessing patients for these criteria and considering treatment with LINZESS 145 mcg if they meet the modified Rome II criteria for functional constipation 2.

From the Research

Stepwise Approach for Managing Chronic Constipation

The management of chronic constipation involves a stepwise approach, with the initial steps focusing on lifestyle modifications and the use of bulk and fiber products.

• The first step includes dietary changes, such as increased fluid and fiber intake, and bowel habit training 3.
• If these measures are not successful, the next step involves the use of laxatives, such as polyethylene glycol, sodium picosulfate, bisacodyl, prucalopride, lubiprostone, and linaclotide 4, 5.
• For patients with opioid-induced constipation, peripherally acting µ-opioid antagonists, such as prolonged-released oral naloxone, oral naloxegol or naldemedine, and subcutaneous methylnaltrexone, may be used effectively 4.
• In cases of refractory constipation, further diagnostic testing, such as endoscopy or colonic transit study, may be necessary to identify underlying causes, such as colonic inertia or outlet inertia 3.
• Biofeedback treatment may be recommended for patients with outlet inertia, while surgery may be necessary in a few cases of colonic inertia 3.

Identification of Underlying Causes

It is essential to identify underlying causes of chronic constipation, including secondary causes, to provide effective treatment.

• The Rome IV criteria categorize disorders of chronic constipation into four subtypes: functional constipation, irritable bowel syndrome with constipation, opioid-induced constipation, and functional defecation disorders 6.
• A logical step-wise approach towards the diagnosis of chronic constipation and its individual subtypes allows clinicians to tailor therapy accordingly and improve symptoms, quality of life, and patient satisfaction 6.

Treatment Options

Various treatment options are available for chronic constipation, including:

• Bulk and fiber products, such as dietary fiber and medicinal bulk 7.
• Laxatives, such as saline osmotic laxatives, lactulose, and stimulants like senna or bisacodyl 7.
• Modern medical therapies, such as prokinetic prucalopride or secretagogues linalotide or lubiprostone, for refractory patients 4.
• Peripherally acting µ-opioid antagonists for opioid-induced constipation 4.