ProIBS – Does it really work?

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Posted 31 November 2016

ProIBS is being fairly extensively advertised on Radio 702 daily. It claims to be effective for IBS (Irritable Bowel Syndrome).

It claims that its efficacy has been confirmed by a clinical study.

Are these claims true?

Well, . . . . . not really, not factually.

The study in question does not fully support the claims being made in the advert.

 

The published study that the advertisement refers to is the following:

[note note_color=”#f2fffe”]J Gastrointestin Liver Dis. 2015 Sep;24(3):275-80. doi: 10.15403/jgld.2014.1121.243.sst.

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.

Størsrud S1, Pontén I2, Simrén M2.

BACKGROUND AND 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.

https://www.ncbi.nlm.nih.gov/pubmed/26405698

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Notice that although there was a difference between the placebo group versus those receiving the treatment, it was not statistically significant.

Specifically it states:

“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).”

A p value of 0.09 and 0.12 argues that the results are not adequately proven to be absolutely confirmed.

“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).”

The study even concludes that “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”. In fact, this is supported by the title of the study: “A Pilot Study”

A pilot study, pilot project or pilot experiment is a small scale preliminary study conducted in order to evaluate feasibility, time, cost, adverse events, and effect size (statistical variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to performance of a full-scale. https://en.wikipedia.org/wiki/Pilot_experiment

The final conclusion of the paper states: “However, further larger studies are warranted to assess the efficacy of aloe vera products in IBS patients, before these treatment regimens can be recommended for clinical use”. http://www.jgld.ro/2015/3/3.pdf

At best, the product can claim that in a pilot study, results that were not statistically proven, that about 24 out of 100 people with IBS may benefit from this product. 

The product is being sold by BGM Pharmaceuticals.

These claims are also being made in a video available on YouTube and reproduced on the BGM website:

Note also that the video on the company’s website (http://www.bgmpharma.co.za/#products) and YouTube claiming that the product was effective in 55% vs 30% but in fact the results were actually 55% vs 31%.

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