Acute exacerbation of pain in irritable bowel syndrome: efficacy of phloroglucinol/trimethylphloroglucinol. A randomized, double-blind, placebo-controlled study.
BACKGROUND
Abdominal pain is the predominant symptom in irritable bowel syndrome patients. Phloroglucinol and its methylated derivative are antispasmodic agents acting on smooth muscle.


OBJECTIVE
To evaluate the efficacy of phloroglucinol/trimethylphloroglucinol on pain intensity during an acute exacerbation of pain of irritable bowel syndrome over a 1-week period treatment.


METHODS
Irritable bowel syndrome Rome II patients seeking medical advice for an acute exacerbation of abdominal pain were randomized to phloroglucinol/trimethylphloroglucinol (62.2 mg P + 80 mg TMP) two pills three times daily or placebo for 7 days. Patients were included if they had a pain with a minimal intensity of 40 on a 100-mm visual analogue scale, and if pain occurred at least 2 days during the week previous inclusion.


RESULTS
Three hundred and seven patients were included by 78 general practitioners. The intent-to-treat population included 300 patients, aged of 46.9 +/- 14.8 years (73% female). The relative decrease of pain intensity at day 7 was 57.8 +/- 31.7% vs. 46.3 +/- 34.7% (Delta = 11.5 +/- 3.8%, [CI(95%): 4.0 ; 19.1], P = 0.0029) and the percentage of patients with at least a 50% decrease of pain intensity was 62% vs. 47% (Delta = 15.3 +/- 5.7%, [CI(95%): 4.1 ; 26.5], P = 0.0078) in phloroglucinol/trimethylphloroglucinol and placebo groups, respectively.


CONCLUSIONS
A 1-week phloroglucinol/trimethylphloroglucinol treatment significantly reduces pain intensity in irritable bowel syndrome patients consulting their general practitioners for pain exacerbation.
Chassany
O
O
Département de la Recherche Clinique et du Développement, AP-HP, Hôpital Saint-Louis, University Paris 7, Paris, France. olivier.chassany@sls.aphp.fr
Bonaz
B
B
Bruley DES Varannes
S
S
Bueno
L
L
Cargill
G
G
Coffin
B
B
Ducrotté
P
P
Grangé
V
V
D015746:Abdominal Pain / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010696:Phloroglucinol / Q000008:administration & dosage* / Q000031:analogs & derivatives; D016896:Treatment Outcome
D004338:Drug Combinations; C015560:1,3,5-trimethoxybenzene; D010696:Phloroglucinol