title: Treatment of constipation in long-term care with Chinese herbal formula: a randomized, double-blind placebo-controlled trial.
abstract: OBJECTIVE
  This study is aimed to evaluate the therapeutic efficacy and safety of CCH1, modified from an ancient herbal formula in Traditional Chinese Medicine, for the residents with constipation in long-term care.
  
  
  METHODS
  In this randomized, double-blind, placebo-controlled trial, 90 residents from three long-term care units were randomized to 8 weeks of treatment with CCH1 or placebo and then the subjects were followed up for an additional 4 weeks.
  
  
  RESULTS
  The mean numbers of weekly spontaneous bowel movement in the CCH1 group were greater than in the placebo group during the treatment phase of 8 weeks (p < 0.05); the greatest difference was during weeks 1-4 (6.2 ± 2.2 versus 3.4 ± 2.1, p < 0.001). Smaller mean numbers of weekly rectal treatments were observed with CCH1 compared with placebo during weeks 1-8 (p < 0.05). The mean numbers of weekly rescue laxative tablets of magnesium oxide were significantly less in the CCH1 group than in the placebo group during the entire 12-week period (p < 0.01), with the greatest difference during weeks 5-8 (14.4 ± 16.3 versus 33.4 ± 23.5, p < 0.001). No significant safety concerns were noted.
  
  
  CONCLUSIONS
  The six-herb formula (CCH1), compared with placebo, is effective on the treatment of constipation in long-term care. However, its maintenance effect needs further trial. Comparison of efficacy or cost-effectiveness with current laxatives is encouraged.
authors.affiliation: Department of Community and Family Medicine, National Taiwan University Hospital Yun-Lin Branch, Yun-Lin, Taiwan.
authors.forename: Chien-Hsun
authors.initials: CH
authors.lastname: Huang
authors.forename: Yi-Chang
authors.initials: YC
authors.lastname: Su
authors.forename: Tsai-Chung
authors.initials: TC
authors.lastname: Li
authors.forename: Shih-Chang
authors.initials: SC
authors.lastname: Lee
authors.forename: Jui-Shan
authors.initials: JS
authors.lastname: Lin
authors.forename: Tai-Yuan
authors.initials: TY
authors.lastname: Chiu
authors.forename: Hung-Chi
authors.initials: HC
authors.lastname: Lue
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003248:Constipation / Q000188:drug therapy* / Q000628:therapy; D003672:Defecation / Q000187:drug effects*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D054368:Laxatives / Q000627:therapeutic use*; D008134:Long-Term Care; D008277:Magnesium Oxide / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; D054368:Laxatives; D008277:Magnesium Oxide