[Efficacy of a combination therapy with vitamins B6, B12 and folic acid for general feeling of ill-health. Results of a non-interventional post-marketing surveillance study].
OBJECTIVE
In the present non-interventional postmarketing surveillance study, patients with symptoms of an inadequate supply of vitamins were tested for how a treatment with a combination vitamin injection consisting of vitamins B6, B12 and folic acid affects mood and fitness. The evaluation of the efficacy and tolerability as well as the documentation of adverse drug reactions were carried out by the physician.


METHODS
The patient collective included 1430 patients (70.8% women, average age 67.1 years, average BMI 25.5 kg/m2). The average duration of treatment was 4.5 weeks with an average of 8.3 intramuscular injections. The principal method for determining the efficacy was the self-assessment scale of well-being (Bf-S) according to Zerssen (sum score with a value range between 0 and 56 points).


RESULTS
The sum score of the Bf-S decreased from 37.5 (+/-10.1) points at admission to 15.6 (+/- 9.4) points after four weeks of treatment. The subjective impression improved correspondingly in 96.3% of the patients. The improvement of the Bf-S was equally good in women and men. The number of injections correlated with the improvement in the sum score. The tolerability was mainly rated as very good or good.


CONCLUSIONS
Eight vitamin infections over four weeks led to a clear improvement in the mood and vitality of patients with symptoms of intracellular vitamin B deficiency.
Engels
A
A
MEDICE Arzneimittel Pütter GmbH & Co. KG, Iserlohn. a.engels@medice.de
Schröer
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U
Schremmer
D
D
D000368:Aged; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005221:Fatigue / Q000209:etiology / Q000523:psychology; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage*; D005494:Folic Acid Deficiency / Q000188:drug therapy*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology; D014805:Vitamin B 12 / Q000008:administration & dosage*; D014806:Vitamin B 12 Deficiency / Q000188:drug therapy*; D025101:Vitamin B 6 / Q000008:administration & dosage*; D026681:Vitamin B 6 Deficiency / Q000188:drug therapy*
D004338:Drug Combinations; D025101:Vitamin B 6; D005492:Folic Acid; D014805:Vitamin B 12