Effectiveness of nystatin in polysymptomatic patients. A randomized, double-blind trial with nystatin versus placebo in general practice.
BACKGROUND
Antifungal therapy has been claimed to be effective in polysymptomatic patients with diffuse symptoms from multiple body systems and even well defined diseases, traditionally not related to fungi. Hypersensitivity to fungus proteins and mycotoxins has been proposed as the cause.


METHODS
We conducted a 4-week randomized, double-blind, placebo-controlled study in 116 individuals selected by a 7-item questionnaire to determine whether the antifungal agent nystatin given orally was superior to placebo. At the onset of the study, the patients were free to select either their regular diet or a sugar- and yeast-free diet, which resulted in four different subgroups: nystatin + diet (ND); placebo + diet (PD); nystatin (N); and placebo (P).


RESULTS
Nystatin was significantly better than placebo in reduction of the overall symptom score (P < 0.003). In six of the 45 individually recorded symptoms, the improvement was significant (P < 0.01). All three active treatment groups reduced their overall symptom scores significantly (P < 0.0001), while the placebo regimen had no effect (P = 0.83). The benefit of diet was significant within both the nystatin (ND > N) and the placebo groups (PD > P).


CONCLUSIONS
Nystatin is superior to placebo in reducing localized and systemic symptoms in individuals with presumed fungus hypersensitivity as selected by a 7-item questionnaire. This superiority is probably enhanced even further by a sugar- and yeast-free diet.
Santelmann
H
H
Department of General Practice and Community Medicine, University of Oslo, 0317 Oslo, Norway. drheiko@online.no
Laerum
E
E
Roennevig
J
J
Fagertun
H E
HE
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000935:Antifungal Agents / Q000627:therapeutic use*; D019422:Dietary Sucrose / Q000009:adverse effects*; D004311:Double-Blind Method; D005194:Family Practice / Q000379:methods; D005221:Fatigue / Q000382:microbiology*; D005260:Female; D052776:Female Urogenital Diseases / Q000382:microbiology*; D005767:Gastrointestinal Diseases / Q000382:microbiology*; D006801:Humans; D008297:Male; D052801:Male Urogenital Diseases; D008487:Medical History Taking; D008569:Memory Disorders / Q000382:microbiology*; D008875:Middle Aged; D009100:Multiple Carboxylase Deficiency; D009181:Mycoses / Q000150:complications / Q000175:diagnosis / Q000178:diet therapy* / Q000188:drug therapy* / Q000276:immunology; D009761:Nystatin / Q000627:therapeutic use*; D010146:Pain / Q000382:microbiology*; D012140:Respiratory Tract Diseases / Q000382:microbiology*; D012871:Skin Diseases / Q000382:microbiology*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000935:Antifungal Agents; D019422:Dietary Sucrose; D009761:Nystatin