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Dorn, M. Dr. (1987).

Introduction:

Digestive complaints are relatively frequent, particularly those associated with disorders of bowel emptying or sluggish bowels, loss of appetite, meteorism, flatulence, and nausea.  Two of the sources are lack of exercise and lack of ballast in the food.  The situation frequently leads to undesired laxative abuse.  Preparations that affects boeth dyspepsia and constipation are desirable, particularly phytopharmaceuticals which usually have a broad therapeutic safety.

The preparation Swedish Bitters has been successfully employed in this field of application for a considerable time.  Furthermore, it has proved advantageous for prophylexis against these complaints and as a supportive measure in cases of gastric and duodenal ulcers.

Planning and Execution

The intention was to investigate the efficacy of the preparation in a clinical trial against placebo.  For ethical reasons it was necessary that the patients treated should receive a certain therapeutic effect.  For this reason and active placebo was chosen.

A total of 50 patients were treated with Swedish Bitters and 30 with the placebo.  The patients were randomized according to a key which was unknown to the two investigating physicians.  The physicians received identical test protocols for all patients for documenting the results.  The criteria for success were regular, problem free bowel movements over four weeks altogether with the improvement of any symptoms that were present.

Results

The means make it quite evident that the intestinal symptoms preponderated over the gastric ones.  While the changes in the means at the final examination reveal a distinctly better result on the part of the test preparation than for the placebo preparation, whereby the placebo preparation did not produce any change at all in the intestinal symptoms.  In comparison with the values obtained at the control examination taken as 100% the gastric symptoms were improved by:

            -64.1% in the case of the test preparation

            -40.7% in the case of the placebo

In the case of the intestinal symptoms the improvements were correspondingly more evident:

            -50% in the case of the test preparation

            -2.6% in the case of the placebo

Conclusions

The comparison with placebo reveals that the preparation Swedish Bitter possesses an appreciable efficacy on the symptoms described.  A comparison was made of the findings at the zero examination and those at the final examination and hypothesis that the results were different was subjected to test.  A significance level was not laid down; the calculation was carried out with the t-test for paired random samples.  The results show that, in the case of the test preparation, the results were significant compared with placebo at the p<0.001 level.  The simple analysis of variance was then used to cross-check and test whether the results obtained could be fortuitous.  Here it was found that with F=16.4 the value was greatly about that required for a significance level of p<0.001.  The differences are thus not fortuitous but are indeed the result of the action of the preparation.

Concerning the question of side effects, it is of importance that none were recorded and that there were no dropouts in this investigation.  The preparation was taken without complaint.

Summary

A gastro-intestinal preparation has been tested double-blind against an active placebo.  The results reveal an improvement both in terms of the gastric and of the intestinal symptoms; this is particularly apparent in the case of the latter.  The efficacy was distinctly apparent as compared with the placebo.  The differences in the intestinal symptoms were statistically significant.  The preparation was well tolerated and there were no undesired side effects or dropouts from the investigation.

Author's Information

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