Quality of life scale and impact of a topical treatment on symptoms of gastro-esophageal reflux without severe esophagitis.
OBJECTIVE
Restoring a normal quality of life (QOL) should be the goal of treatments of gastro-esophageal reflux (GER) without severe esophagitis. In this analysis, carried out within the frame of a clinical study comparing a topical anti-inflammatory gel to a placebo, we assessed the relevance of the MOS SF-36 questionnaire in patients suffering from GER without severe esophagitis, and compared the scores of the studied patients to those of a representative sample of the French general population.


METHODS
The patients had to suffer from GER symptoms for at least 2 months, with no or mild (< or =grade 1) esophagitis endoscopy. They were randomized to be given a 4 week treatment either with a topical gel containing gaïazulene and dimeticone or a placebo gel. Patients were asked to complete a symptom diary during the study, which allowed the calculation of mean symptom scores. The MOS SF-36 questionnaire was administered at baseline (d0) and after 4 weeks of treatment (d28).


RESULTS
Two hundred and thirty three patients were enrolled in the study. At baseline, QOL scores were impaired in both groups. After 4 weeks of treatment: the treated patients displayed better improvement in all MOS SF-36 domains compared with the placebo group. The QOL profile in the treated group reached the level of the French reference population, while it remained impaired in the placebo group.


CONCLUSIONS
This analysis evidenced the relevancy of the MOS SF-36 questionnaire to assess the impact of GER without severe esophagitis on QOL. Moreover, it demonstrated the capacity of the studied topical treatment to restore a normal QOL to the patients.
Leplège
Alain
A
Université Picardie Jules Verne, UFR Philosophie, Sciences Humaines et Sociales, Chemin du Thil, 80025 Amiens, France. alain.leplege@u-picardie.fr
Mackenzie-Schliacowsky
Nadine
N
Eacute Cosse
Emmanuel
E
Ruszniewski
Philippe
P
D000287:Administration, Topical; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D004129:Dimethylpolysiloxanes; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011788:Quality of Life; D012720:Severity of Illness Index; D012833:Siloxanes / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004129:Dimethylpolysiloxanes; D010919:Placebos; D012833:Siloxanes; C501844:dimethicone