Evidence map›Paper›PMID 20433751›Full record

Trial reportBMC complementary and alternative medicine2010

Randomized clinical trial of a phytotherapic compound containing Pimpinella anisum, Foeniculum vulgare, Sambucus nigra, and Cassia augustifolia for chronic constipation.

Paulo D Picon, Rafael V Picon, Andry F Costa, Guilherme B Sander, Karine M Amaral, Ana L Aboy, Amélia T Henriques

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary and alternative medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00872430 (Laxative Effectiveness of a Phytotherapeutic Tea), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00872430 phase2completednot on this map

Laxative Effectiveness of a Phytotherapeutic Tea: A Randomized Placebo-Controlled Clinical Trial

TypeinterventionalSponsorHospital de Clinicas de Porto AlegreRan2002 to 2003Enrolled20ConditionsChronic ConstipationArmsPlacebo, Klein Laxative Tea
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Antidiabetic effects of fennel leaf aqueous extract in alloxan-induced diabetic rats.Journal of pharmaceutical health care and sciences · 2025
    Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Emerging Biopharmaceuticals fromMolecules (Basel, Switzerland) · 2023
    Review
  8. Review
  9. Article
  10. Article
  11. Pimpinella anisum in the treatment of functional dyspepsia: A double-blind, randomized clinical trial.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2015
    Article
  12. Pimpinella anisum in modifying the quality of life in patients with functional dyspepsia: A double-blind randomized clinical trial.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2014
    Article
  13. Article
  14. Review
  15. Article
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Paulo D PiconDepartment of Internal Medicine and Chief of the Clinical Research Unit at Hospital de Clínicas, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. paulopicon@gmail.com
Rafael V Picon
Andry F Costa
Guilherme B Sander
Karine M Amaral
Ana L Aboy
Amélia T Henriques

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA phytotherapic compound containing Pimpinella anisum L., Foeniculum vulgare Miller, Sambucus nigra L., and Cassia augustifolia is largely used in Brazil for the treatment of constipation. However, the laxative efficacy of the compound has never been tested in a randomized clinical trial. The aim of this study was to evaluate the efficacy and safety of the product.

methodsThis randomized, crossover, placebo-controlled, single-blinded trial included 20 patients presenting with chronic constipation according to the criteria of the American Association of Gastroenterology. The order of treatments was counterbalanced across subjects: half of the subjects received the phytotherapic compound for a 5-day period, whereas the other half received placebo for the same period. Both treatment periods were separated by a 9-day washout period followed by the reverse treatment for another 5-day period. The primary endpoint was colonic transit time (CTT), measured radiologically. Secondary endpoints included number of evacuations per day, perception of bowel function, adverse effects, and quality of life.

resultsMean CTT assessed by X ray was 15.7 hours (95%CI 11.1-20.2) in the active treatment period and 42.3 hours (95%CI 33.5-51.1) during the placebo treatment (p < 0.001). Number of evacuations per day increased during the use of active tea; significant differences were observed as of the second day of treatment (p < 0.001). Patient perception of bowel function was improved (p < 0.01), but quality of life did not show significant differences among the study periods. Except for a small reduction in serum potassium levels during the active treatment, no significant differences were observed in terms of adverse effects throughout the study period.

conclusionsThe findings of this randomized controlled trial allow to conclude that the phytotherapic compound assessed has laxative efficacy and is a safe alternative option for the treatment of constipation.

trial registrationClinicalTrial.gov NCT00872430.

Indexed as

MagnoliopsidaPhytotherapyAdultCassiaColonConstipationDefecationFemaleFoeniculumGastrointestinal TransitHumansLaxativesMaleMiddle AgedPatient SatisfactionPimpinellaLaxativesPlant ExtractsPotassium

Identifiers

PMID20433751
PMCPMC2874511

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.