A Pilot Study of the Effect of Aloe barbadensis Mill. Extract (AVH200®) in Patients with Irritable Bowel Syndrome: a Randomized, Double-Blind, Placebo-Controlled Study

2015 ◽  
Vol 24 (3) ◽  
pp. 275-280 ◽  
Author(s):  
Stine Størsrud ◽  
Irina Pontén ◽  
Magnus Simrén
Keyword(s):  
Irritable Bowel Syndrome ◽  
Placebo Group ◽  
Pilot Study ◽  
Aloe Vera ◽  
Gastrointestinal Symptoms ◽  
Controlled Study ◽  
Aloe Barbadensis ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Irritable Bowel

Background & Aims: Few effective treatment options exist for patients with irritable bowel syndrome (IBS), and many patients state the use of aloe vera products reduce their symptoms. The aim of this pilot study was to investigate the effect of Aloe barbadensis Mill. Extract (AVH200®) in adult patients with IBS in a randomized, double-blind, placebo controlled study. Methods: Sixty-eight adult patients diagnosed with IBS according to the Rome III criteria were randomized to receive AVH200® or matching placebo for four weeks. Symptom questionnaires were completed on a weekly basis and the patients were asked if they had had adequate relief of their gastrointestinal symptoms. Results: A tendency towards a higher proportion of responders in the aloe vera group (55%) vs. placebo (31%), (p=0.09) was observed, and the proportion of subjects who reported adequate relief at least 50% of the weeks during the treatment period tended to be larger in the aloe vera vs. placebo group (33% vs. 14%; p=0.12). The overall severity of the gastrointestinal symptoms was reduced in the aloe vera group (314±83 vs. 257±107; p=0.003) but not the placebo group (276±88 vs. 253±100; NS), without difference between the groups (p=0.10). AVH200® was well tolerated and no serious adverse events were observed. Conclusion: Even though the primary endpoint was not met, AVH200® seems to be a promising treatment option for patients with IBS owing to the positive results seen within the secondary endpoints. This study may have been underpowered to detect a clinically meaningful difference between the treatment groups, and therefore larger randomized, controlled studies are required to confirm these results and to elucidate potential mechanisms explaining its effect.

scholarly journals USING BREWER’S YEAST AND GINGER IN THE MANAGEMENT OF CONSTIPATION-PREDOMINANT IRRITABLE BOWEL SYNDROME: A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

2019 ◽  
pp. 372-376 ◽  
Author(s):  
ZAINAB G AL-JASSIM
Keyword(s):  
Irritable Bowel Syndrome ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Abdominal Distention ◽  
Controlled Study ◽  
Brewer’S Yeast ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Brewer's Yeast ◽  
Irritable Bowel

Objective: The objective of the present study is to confirm and/or prove the beneficial outcomes from using Brewer’s yeast and Ginger in constipation-predominant irritable bowel syndrome (IBS-C) subjects compared to placebo. Methods: A total of 45 patients suffering from IBS-C were enrolled in a double-blind placebo-controlled study as defined by Rome III criteria. Parallel groups were randomly assigned in this study: A placebo group, Brewer’s yeast group, and ginger group, taken daily for 20 days. IBS severity scale and visual analog scale for IBS (VAS-IBS) were used to assess the severity of pain, abdominal distention, and constipation (IBS-C) subjects. The data were measured at 3 times: At 0 time (T0), after 10 days of treatment (T10), and after 20 days of treatment (T20) for the three treatment groups. Results: Intragroup analysis showed a clinically significant reduction in the symptoms of abdominal pain, distention, and constipation, in the Brewer’s yeast group compared to placebo after the 20 days of the study. There was also a significant reduction of abdominal distention and constipation symptoms in the ginger group throughout the study. Conclusion: This study reveals the beneficial effects of Brewer’s yeast and ginger in reducing troublesome gastrointestinal symptoms in subjects with IBS-C and holds the promise to use them in IBS-C patient.

scholarly journals A Randomised, Cross-Over, Placebo-Controlled Study of Aloe vera in Patients with Irritable Bowel Syndrome: Effects on Patient Quality of Life

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
H. A. Hutchings ◽  
K. Wareham ◽  
J. N. Baxter ◽  
P. Atherton ◽  
J. G. C. Kingham ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Short Form ◽  
Aloe Vera ◽  
Gastrointestinal Symptoms ◽  
Controlled Study ◽  
Double Blind ◽  
Irritable Bowel ◽  
Drop Outs

Background. Irritable bowel syndrome (IBS) is a chronic, difficult to treat condition. The efficacy of Aloe vera in treating IBS symptoms is not yet proven. The purpose of this study was to determine if Aloe vera is effective in improving quality of life. Methods. A multicentre, randomised, double-blind, cross-over placebo controlled study design. Patients were randomised to Aloe vera, wash-out, placebo or placebo, washout, Aloe vera. Each preparation (60 mL) was taken orally twice a day. Patient quality of life was measured using the Gastrointestinal Symptoms Rating Score, Irritable Bowel Syndrome Quality of Life, EuroQol and the Short-Form-12 at baseline and treatment periods 1 and 2. Results. A total of 110 patients were randomised, but only 47 completed all questionnaires and both study arms. Statistical analysis showed no difference between the placebo and Aloe vera treatment in quality of life. Discussion. This study was unable to show that Aloe vera was superior to placebo in improving quality of life. Drop outs and other confounding factors may have impacted on the power of the study to detect a clinically important difference. Conclusion. This study failed to find Aloe vera superior to placebo in improving quality of life proven Irritable Bowel Syndrome patients.

Double-blind placebo-controlled study of mesalamine in post-infective irritable bowel syndrome – a pilot study

2012 ◽  
Vol 47 (10) ◽  
pp. 1159-1164 ◽  
Author(s):  
Ashok K. Tuteja ◽  
John C. Fang ◽  
Manal Al-Suqi ◽  
Gregory J. Stoddard ◽  
Devon C. Hale
Keyword(s):  
Irritable Bowel Syndrome ◽  
Pilot Study ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Irritable Bowel

scholarly journals Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study

Gut ◽  
2019 ◽  
Vol 69 (5) ◽  
pp. 859-867 ◽  
Author(s):  
Magdy El-Salhy ◽  
Jan Gunnar Hatlebakk ◽  
Odd Helge Gilja ◽  
Anja Bråthen Kristoffersen ◽  
Trygve Hausken
Keyword(s):  
Irritable Bowel Syndrome ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Rrna Gene ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Link Type ◽  
Irritable Bowel

ObjectiveFaecal microbiota transplantation (FMT) from healthy donors to patients with irritable bowel syndrome (IBS) has been attempted in two previous double-blind, placebo-controlled studies. While one of those studies found improvement of the IBS symptoms, the other found no effect. The present study was conducted to clarify these contradictory findings.DesignThis randomised, double-blind, placebo-controlled study randomised 165 patients with IBS to placebo (own faeces), 30 g FMT or 60 g FMT at a ratio of 1:1:1. The material for FMT was obtained from one healthy, well-characterised donor, frozen and administered via gastroscope. The primary outcome was a reduction in the IBS symptoms at 3 months after FMT (response). A response was defined as a decrease of 50 or more points in the total IBS symptom score. The secondary outcome was a reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing, at 1 month following FMT.ResultsResponses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively. These were accompanied by significant improvements in fatigue and the quality of life in patients who received FMT. The intestinal bacterial profiles changed also significantly in the groups received FMT. The FMT adverse events were mild self-limiting gastrointestinal symptoms.ConclusionsFMT is an effective treatment for patients with IBS. Utilising a well-defined donor with a normal DI and favourable specific microbial signature is essential for successful FMT. The response to FMT increases with the dose.Trial registrationwww.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).

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