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Silicea gastrointestinal gel improves gastrointestinal disorders: a non-controlled, pilot clinical study.

Uehleke B, Ortiz M, Stange R - Gastroenterol Res Pract (2012)

Bottom Line: A responder showed reduction of score of >50%.Conclusions.Responses are relevant for chronic functional disorders, but it remains unclear, how much of that might be placebo-effect.

View Article: PubMed Central - PubMed

Affiliation: Department for Natural Medicine, Charité-Universitätsmedizin Berlin, Immanuel Hospital, 14109 Berlin, Germany.

ABSTRACT
Aim. To investigate efficacy and tolerability of Silicea Gastrointestinal Gel in patients with gastrointestinal disorders. Methods. Open, prospective pivotal phase IV study with oral Silicea Gastrointestinal Gel over 6 weeks. Symptom score was part 1 of the Nepean Dyspepsia Index: 15 questions addressing intensity, frequency and impact of upper abdominal symptoms. 10 lower abdominal symptoms were asked analogously. A responder showed reduction of score of >50%. Results. 62 of 90 patients were evaluated per protocol. Upper and lower abdomen sum scores decreased already in the first three weeks (P < 0.001), which continued the following three weeks (P < 0.01). Mean symptom score for upper abdomen decreased from 52.2 ± 31.0 to 33.7 ± 28.7 (or by 35.4%; responder rate 37%); for lower from 39.6 ± 24.7 to 22.6 ± 21.7 (by 42.9%; responder rate 46%). Subgroups with diarrhea, IBS and GERD presented highest responder rates. 6% of patients reported adverse reactions with probable or possible relationship to the test product. Conclusions. Silicea Gastrointestinal Gel seems suitable beyond infectious acute gastrointestinal disorders. Responses are relevant for chronic functional disorders, but it remains unclear, how much of that might be placebo-effect. Controlled studies are recommended in gastrointestinal syndromes like IBS or GERD.

No MeSH data available.


Related in: MedlinePlus

Mean of total symptom score, upper abdomen score, and lower abdomen score in the course of the study: standard error of the mean (n = 62).
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fig2: Mean of total symptom score, upper abdomen score, and lower abdomen score in the course of the study: standard error of the mean (n = 62).

Mentions: The mean score for the upper abdomen symptoms decreased after 6-week treatment from 52.2 ± 31.0 to 33.7 ± 28.7 and the mean score for the lower abdomen decreased from 39.6 ± 24.7 to 22.6 ± 21.7. The total gastrointestinal score decreased from 91.8 before therapy to 56.3 after the 6-week treatment (see Figure 2).


Silicea gastrointestinal gel improves gastrointestinal disorders: a non-controlled, pilot clinical study.

Uehleke B, Ortiz M, Stange R - Gastroenterol Res Pract (2012)

Mean of total symptom score, upper abdomen score, and lower abdomen score in the course of the study: standard error of the mean (n = 62).
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3303575&req=5

fig2: Mean of total symptom score, upper abdomen score, and lower abdomen score in the course of the study: standard error of the mean (n = 62).
Mentions: The mean score for the upper abdomen symptoms decreased after 6-week treatment from 52.2 ± 31.0 to 33.7 ± 28.7 and the mean score for the lower abdomen decreased from 39.6 ± 24.7 to 22.6 ± 21.7. The total gastrointestinal score decreased from 91.8 before therapy to 56.3 after the 6-week treatment (see Figure 2).

Bottom Line: A responder showed reduction of score of >50%.Conclusions.Responses are relevant for chronic functional disorders, but it remains unclear, how much of that might be placebo-effect.

View Article: PubMed Central - PubMed

Affiliation: Department for Natural Medicine, Charité-Universitätsmedizin Berlin, Immanuel Hospital, 14109 Berlin, Germany.

ABSTRACT
Aim. To investigate efficacy and tolerability of Silicea Gastrointestinal Gel in patients with gastrointestinal disorders. Methods. Open, prospective pivotal phase IV study with oral Silicea Gastrointestinal Gel over 6 weeks. Symptom score was part 1 of the Nepean Dyspepsia Index: 15 questions addressing intensity, frequency and impact of upper abdominal symptoms. 10 lower abdominal symptoms were asked analogously. A responder showed reduction of score of >50%. Results. 62 of 90 patients were evaluated per protocol. Upper and lower abdomen sum scores decreased already in the first three weeks (P < 0.001), which continued the following three weeks (P < 0.01). Mean symptom score for upper abdomen decreased from 52.2 ± 31.0 to 33.7 ± 28.7 (or by 35.4%; responder rate 37%); for lower from 39.6 ± 24.7 to 22.6 ± 21.7 (by 42.9%; responder rate 46%). Subgroups with diarrhea, IBS and GERD presented highest responder rates. 6% of patients reported adverse reactions with probable or possible relationship to the test product. Conclusions. Silicea Gastrointestinal Gel seems suitable beyond infectious acute gastrointestinal disorders. Responses are relevant for chronic functional disorders, but it remains unclear, how much of that might be placebo-effect. Controlled studies are recommended in gastrointestinal syndromes like IBS or GERD.

No MeSH data available.


Related in: MedlinePlus