“I now took pains to achieve a statistically certain proof, from a group of 850 patients suffering from dyspepsia, that it is possible to prevent recurrence of peptic ulcers by depressing the vegetative nervous system…
…324 men [who had had at least two previously confirmed gastric or duodenal ulcers within the previous 2-2 1/2 years] were inevitably forced to be in identical conditions in a coastal defence unit. Their diet was identical and can be defined in one catchword – Schonkost [light diet]. There were no severe restrictions. Occasional Dieaetfehler [deviations] by acquisition of unsuitable food will have been approximately equally distributed among all the groups to be described below, as was the case for the very various kinds of mental stress during the last years of the war [study was done in 1944 and published in 1949]. The physical demands on these men were very similar, as was sleep. There was prohibition of alcohol and smoking, which may have been infringed, [but] equally frequently in all the [comparison] groups.
These 324 men, living to a great extent under the same external conditions, were divided into three groups: to be precise, according to their [? place on] an alphabetical list, the first in Group I, the second in Group II, the third in Group III, etc. This division resulted in such an even distribution that the largest difference in the average age, which was between Groups II and III, amounted only to 9/12 of a year. In Group I the average age was 32 4/12 years, in Group II 31 10/12 years, and in Group III, 32 7/12 years. The average weights and the heights were also so similar that there is no point in showing numbers…”
“…Each group comprised 108 men. The 27 who dropped out during the period of observation (because of other diseases, transfers, etc) were distributed roughly equally: 11 in Group I, 6 in II, and 10 in III, so that the final composition was 97 in I, 102 in II, and 98 in III. Group I had no treatment whatsoever. Group II received one tablet of Bellergal [a mixture of belladonna, ergotamine, and phenobarbital] three times a day and a Luminalette [phenobarbital] 3 three times a day, and, occasionally (because of lack of Bellergal) 2 Luminalettes 3 times a day, to be precise, always during three weeks and then a 1-week interval. In Group III, the same medication was only given if there was a loss of weight (of more than 300 g per week) or a notable increase of the vegetative dystonia was observed. The observations were made from 1/3/1944 to 1/12/1944. In order to exclude as far as possible any subjectivity of the doctor, the latter was unaware to which of the three groups individual patients belonged. A reliable member of the military health unit arranged the prescribed treatments according to each patient’s group membership. Therefore, even if, for instance, I prescribed one of the above drugs for a member of Group I because of an increase in vegetative dystonia, nothing was actually administered. The men of Groups II and III were unaware of the reasons they had to swallow their tablets. These were distributed every day to each of them by one of the numerous members of the military health unit, and were taken under supervision. – When a patient was more closely examined because of dyspepsia I did not know to which group he belonged. As soon as an ulcer was diagnosed, the patient dropped out of further group monitoring [for appropriate treatment]. This was equally the case if he was unfit for duty for longer than ten days…”
“…I am completely convinced that the experimental design described above chiefly has a theoretical meaning. I meant to prove that it is possible to diminish the tendency of [peptic] ulcer recurrence by influencing the vegetative nervous system with drugs affecting the brainstem. Thereby an essential factor in the development of ulcers has been shown. There were no cases of undesired outcomes resulting from long term administration of Luminal and Bellergal. The extraordinarily favourable conditions described above for such an investigation, as they then presented themselves to me, provides the authority to still publish the results today [five years after the study].”
Translation by Ulrich Tröhler