Efficacy of an Herbal Dietary Supplement (Smooth Move) in the Management of Constipation in Nursing Home Residents: A Randomized, Double-Blind, Placebo-Controlled Study

doi:10.1016/j.jamda.2006.06.001

Journal of the American Medical Directors Association

Volume 7, Issue 9, November 2006, Pages 556-561

https://doi.org/10.1016/j.jamda.2006.06.001 Get rights and content

Objective

To investigate the efficacy and cost effectiveness of an herbal tea, Smooth Move, in nursing home residents with chronic constipation.

Design

Double-blind, placebo-controlled, 2-armed, parallel-group clinical trial.

Setting

A 483-bed nursing home in Allentown, Pennsylvania, operated by Lehigh County Government.

Participants

A total of 86 nursing home residents with chronic constipation.

Interventions

Participants (n = 86) were randomly assigned to receive Smooth Move (n = 42) or a placebo (n = 44), once daily, in addition to standard treatment for chronic constipation. The study period was 28 days.

Measurements

The primary efficacy parameter was the difference in total number of bowel movements. Secondary parameters included the difference in average number of standard treatment doses dispensed, and the difference in total medication costs.

Results

Compared to placebo, in the intention to treat (ITT analysis) there was a statistically significant increase in the number of bowel movements in the Smooth Move group. The Smooth Move group (n = 42) compared with the placebo group (n = 44) experienced an average of 4.14 more bowel movements during the 28-day study period versus the 28-day pre–study period (P = .017).

Conclusion

Smooth Move herbal tea, when added to the standard treatment regimen for nursing home residents with chronic constipation, increased the average number of bowel movements compared to the addition of a placebo tea.

Section snippets

Study Design

The study was designed as a randomized, double-blind, placebo-controlled, single center study. The participants were randomly assigned to receive either Smooth Move tea or placebo tea. Residents continued to be administered their existing laxative medications and/or enemas in addition to the investigational product. At the discretion of the nursing staff and physician, the dosage of the laxatives could be adjusted according to bowel function. For all residents already using Smooth Move, there

Results

Of the 476 total nursing home residents, 200 qualified for the study. Of those, 58 refused participation and another 50 were determined by the attending physicians to be inappropriate candidates for this study for various reasons. Therefore, a total of 92 residents were recruited (Figure 1); 45 randomly assigned to the Smooth Move group and 47 to the placebo group. Within the Smooth Move group, there were 2 dropouts and 1 expiration (prior to study start). Within the placebo group there were 2

Discussion

The results of this study show that Smooth Move herbal tea has proven to be superior to placebo. It would appear that one of the shortcomings of this study was that the tea was given on day shift while the effects occurred on the later shifts. The nurses on those shifts did not recommend reducing the usual laxatives and not enough emphasis was placed on a protocol for day shift to reduce laxatives. This is probably the main reason for the continued use of the standard regimen even though some

Conclusion

Smooth Move, a traditional herbal tea formula for relieving constipation, has proven to be superior to placebo as determined by a clinically relevant difference in the average number of bowel movements.

Although we encountered no adverse events with the daily use of the laxative tea, it is recommended that it be used no more than 3 times per week when bulk or osmotic laxatives fail. The tea can be used alone or in combination with the previously mentioned laxatives.⁷ If a stimulant laxative is

Acknowledgments

The authors express their appreciation to Douglas W. Walther, administrator of Cedarbrook Nursing Homes, for allowing us to conduct the research; Barbara H. Lupole, RN, MSN, Sacred Heart Hospital Clinical Research Center, who, with Barbara Valentine, assistant director of nursing, Cedarbrook Nursing Home, took over the coordination of the study as well as the monitoring tasks; and Corrine Rennig, research assistant, Muhlenberg College. The authors also thank Katie Huggins, vice president of

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Original studyEfficacy of an Herbal Dietary Supplement (Smooth Move) in the Management of Constipation in Nursing Home Residents: A Randomized, Double-Blind, Placebo-Controlled Study

Objective

Design

Setting

Participants

Interventions

Measurements

Results

Conclusion

Section snippets

Study Design

Results

Discussion

Conclusion

Acknowledgments

J Am Med Dir Assoc

J Am Med Dir Assoc

J Pain Symptom Manage

J Pain Symptom Manage

The management of constipation

Prescribing Nurse Bulletin

Systematic review of the effectiveness of laxatives in the elderly

Health Technol Assess

Management of constipation in institutionalized, immobilized, and elderly patients

Clinical consensus: The constipation crisis in long-term care

Ann Long-Term Care

Is chronic use of stimulant laxatives harmful to the colon?

J Clin Gastroenterol

Original study
Efficacy of an Herbal Dietary Supplement (Smooth Move) in the Management of Constipation in Nursing Home Residents: A Randomized, Double-Blind, Placebo-Controlled Study