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From the Clinical Inquiries Family Physicians Inquiries Network

Virginia B. Kalish, MD Dewitt Army Community What is the best treatment Hospital-National Capital Consortium Residency Program, Fort Belvoir, Va for chronic Bridget Loven MLIS Carolinas Healthcare System, in the elderly? Charlotte, NC Evidence-based answer There is no one best evidence-based sold in the US have not been treatment for chronic constipation in the sufficiently studied in controlled trials to elderly. While the most common first-line make a recommendation (SOR: A, based treatments are dietary and exercise, on systematic review). the evidence is insufficient to support An abdominal kneading device can be this approach in the geriatric population used to treat chronic constipation, but the (strength of recommendation [SOR]: for evidence is limited (SOR: B, based on 1 :A , based on a systematic cohort study.) review; for exercise: SOR: B, based on Polyethylene glycol has not been 1 good- and 1 fair-quality randomized studied in the elderly. A newer agent, controlled trial [RCT]). (Amitiza), appears to be Herbal supplements (such as aloe), effective for the treatment of chronic fast track alternative treatments (biofeedback), constipation for elderly patients (SOR: B, Inconsistent lubricants (mineral ), and combination based on subgroup analysis of RCTs.) research findings cast doubt on the Clinical commentary Is the patient truly constipated? followed by a trial of stool softeners and efficacy of fiber Many older people feel that if they do not stimulant laxatives, if needed. If all of these treatment have a bowel movement every day they methods fail, I consider trying polyethylene for constipation are constipated. However, constipation is glycol, which can be titrated to effect. As defined as fewer than 3 bowel movements with all use by the elderly, it is per week. So, the first thing we must do is to important to titrate cautiously (“start low confirm that the patient is truly constipated. and go slow”) and add other before I start my patients on any only when necessary. , I suggest a trial of increased daily Mandi Sehgal, MD Department of Family Medicine/Geriatrics, and fiber intake along with exercise, University of Cincinnati

z Evidence summary 2 RCTs on the effect of exercise, and Few well-designed studies have focused 1 before-after cohort study on abdominal on constipation treatment among the massage. These studies were all conducted elderly. Our search located 1 systematic among geriatric patients with constipa- review of pharmacologic management, a tion. Two high-quality systematic reviews systematic review of fiber management, regarding chronic constipation manage-

1050 vol 56, No 12 / December 2007 The Journal of Family Practice ment for adults of all ages included man- table agement options not studied in exclu- How well do these interventions work sively geriatric populations, such as herbal for older patients with chronic constipation? supplements, biofeedback, , and polyethylene glycol. Intervention Stool frequency vs comparison (stools per week) NNT‡ Laxatives, fiber, and exercise: Agiolax* vs 4.5 vs 2.2 43 Studies are inconclusive Agiolax* vs lactulose 5.6 vs 4.2 71 Two good-quality systematic reviews † vs placebo 4.9 vs 3.6 77 looked at 10 RCTs comparing laxatives Lactitol† vs lactulose 5.5 vs 4.9 160 with placebo, and 10 RCTs comparing Lactulose vs † 7.0 vs 6.7 330 1,2 1 with another. The studies External abdominal 3.9 vs 1.4 40 generally had few participants, were of kneading (before-after) short duration, and were conducted in * Agiolax is a combination bulk and stimulant laxative not readily found in the institutional settings. Most lacked power United States. to make valid conclusions. These studies † Lactitol and sorbitol are sugar used as replacement sweeteners and varied in the reported outcome measures, approved by the FDA as food additives. including stool frequency, stool con- ‡ Number needed to treat (NNT) for 1 person to have 1 more stool per week. sistency, straining, decrease in laxative use, and symptom scores. The reviews Alternative TXs not well studied concluded that the best pharmacologic A high-quality systematic review6 of con- treatment for chronic constipation in the stipation management among adults of elderly has not been established. all ages in North America found a lack of Five of the higher-quality studies quality RCTs examining herbal supple- attained statistical significance. They ment treatment. Biofeedback has been showed a small but significant improve- studied in adult populations, but no RCTs ment in bowel movement frequency with with placebo or sham-controls have been a laxative when compared with placebo published. or another laxative (Table). The authors One before-after cohort study7 inves- fast track noted that multiple poor-quality stud- tigated an external kneading mechanical 2 RCTs showed no ies have shown nonsignificant trends for device (Free-Lax) that was applied to the improved constipation symptoms with abdomen for 20 minutes once daily in 30 improvement of laxatives compared with placebo. randomly selected chronically constipated constipation from Inconsistent findings on fiber.A good- nursing home residents. Researchers found exercise in older quality systematic review3 of dietary fiber significant improvements in bowel move- patients in the treatment of constipation for older ment frequency, stool consistency and vol- patients located 8 moderate- to high- ume, and colonic transit time without side quality studies (6 RCTs and 2 blinded effects (Table). before-after studies), with 269 study par- ticipants in institutional settings. Results A look beyond geriatric patients among studies were inconsistent, casting Polyethylene glycol, tegaserod, and lu- doubt on the efficacy of fiber treatment biprostone have not been studied in tri- for constipation in the institutionalized als of exclusively geriatric populations. elder. Two high-quality systematic reviews,6,8 Two RCTs4,5 investigating the effect including medium- to high-quality RCTs of exercise on 246 institutionalized older of pharmacologic management of chron- patients showed no improvement in con- ic constipation, found good evidence to stipation. One study was of good qual- support treatment with polyethylene gly- ity, reporting adequate power and used col and tegaserod in adults of all ages. an intention-to-treat analysis. The other Of the 8 RCTs looking at polyethylene was of fair quality. glycol, only 1 of the studies—a high-

www.jfponline.com vol 56, No 12 / December 2007 1051 es i r i qu n

I quality crossover comparison of poly- patients with pelvic floor dysfunction. glycol vs placebo with 37 out- The Registered Nurses Association of al

c patient subjects—included a population Ontario guidelines for constipation pre- with a mean age >60 years (mean age 62, vention in the older adult population rec- range 42–89 years). ommend fluid and dietary fiber, regular Clini A subgroup analysis9 of 331 elderly exercise, and consistent toileting.14 n patients enrolled in 2 RCTs of tegaserod found no difference in outcomes between References treatment with tegaserod and placebo, al- 1. Petticrew M, Watt I, Brand M. What’s the “best buy” though this analysis was limited by inad- for treatment of constipation? Results of a systematic review of the efficacy and comparative efficacy of laxa- equate power. tives in the elderly. Br J Gen Pract 1999; 49:387–393. Tegaserod linked to ischemic events. 2. Petticrew M, Watt I, Sheldon T. Systematic review A recent analysis of clinical trials found a of the effectiveness of laxatives in the elderly. Health statistically significant increase in cardio- Technol Assess 1997; 1:i–iv,1–52. 3. Kenny KA, Skelly JM. Dietary fiber for constipation in vascular ischemic events associated with older adults: a systematic review. Clinical Effective- tegaserod. The manufacturer took the ness in Nursing 2001; 5:120–128. product off the market in compliance with 4. chin APMJ, van Poppel MN, van Mechelen W. Effects an FDA request in March 2007. of resistance and functional-skills training on habitual activity and constipation among older adults living in Lubiprostone offers promise. Lubipro- long-term care facilities: a randomized controlled trial. stone, a chloride channel activator ap- BMC Geriatr 2006; 6:9. proved by the FDA for the treatment of 5. simmons SF, Schnelle JF. Effects of an exercise and scheduled-toileting intervention on appetite and con- chronic idiopathic constipation, has been stipation in nursing home residents. J Nutr Health Ag- studied in 6 placebo-controlled, double- ing 2004; 8:116–121. blind, randomized Phase II and III clinical 6. brandt LJ, Prather CM, Quigley EM, Schiller LR, Schoenfeld P, Talley NJ. Systematic review on the trials. In 2 unpublished pooled analyses of management of chronic constipation in North Amer- 3 of the trials, lubiprostone was found to ica. Am J Gastroenterol 2005; 100 Suppl 1:S5–S21. be effective in a total of 220 elderly pa- 7. mimidis K, Galinsky D, Rimon E, Papadopoulos V, tients 65 years of age and older.10,11 Zicherman Y, Oreopoulos D. Use of a device that ap- plies external kneading-like force on the abdomen fast track for treatment of constipation. World J Gastroenterol There was good Recommendations from others 2005; 11:1971–1975. The American College of Gastroenterology 8. ramkumar D, Rao SS. Efficacy and safety of tradition- evidence al medical therapies for chronic constipation: system- Chronic Constipation Task Force evi- atic review. Am J Gastroenterol 2005; 100:936–971. to support the use dence-based guidelines make no refer- 9. baun RF, Levy HB. Tegaserod for treating chronic con- of polyethylene ence to age, but state that evidence is best stipation in elderly patients. Ann Pharmacother 2007; 41:309–313. glycol in adults for treatment with , tegaserod, polyethylene glycol, and lactulose.12 They 10. ueno R, Joswick TR, Wahle A, et al. Efficacy and safety of lubiprostone for the treatment of chronic of all ages found insufficient evidence to support use constipation in elderly vs non-elderly subjects. Gas- of stimulants, stool softeners, lubricants, troenterology 2006; 130(Suppl 2):A189. herbal supplements, biofeedback, and al- 11. ueno R, Panas R, Wahle A, et al. Long-term safety and efficacy of lubiprostone for the treatment of ternative treatments. chronic constipation in elderly subjects. Gastroenter- The American Gastroenterological ology 2006; 130(Suppl 2):A188. Association guidelines on constipation are 12. American College of Gastroenterology Chronic Consti- 13 pation Task Force.An evidence-based approach to the primarily based on expert opinion. Age management of chronic constipation in North America. is not specified in their recommendations. Am J Gastroenterol 2005; 100 Suppl 1:S1–S4. Dietary and exercise modifications are 13. locke GR, 3rd, Pemberton JH, Phillips SF. American recommended as first-line treatments, fol- Gastroenterological Association Medical Position Statement: guidelines on constipation. Gastroenterol- lowed by laxatives. Laxatives are recom- ogy 2000; 119:1761–1766. mended based on cost, in order from the 14. registered Nurses Association of Ontario (RNAO). least to most expensive agents. Supposito- Prevention of constipation in the older adult popula- tion. Toronto, Ontario: RNAO; 2005. Available at: www. ries, , biofeedback, and (in refrac- guideline.gov/summary/summary.aspx?ss=15&doc_ tory cases) are recommended for id=7004&nbr=4213. Accessed on November 8, 2007.

1052 vol 56, No 12 / December 2007 The Journal of Family Practice