Treatment of acute otitis media with probiotics in otitis-prone children—A double-blind, placebo-controlled randomised study

A randomised, double-blind, placebo-controlled study was conducted to determine whether probiotics might be effective in reducing the risk of infections in infancy. Infants requiring formula before the age of 2 months were recruited from community well-baby clinics. Infant formula supplemented with the probioticsLactobacillus rhamnosusGG andBifidobacterium lactisBb-12 or placebo was administered daily until the age of 12 months. Incidence of early infections (before the age of 7 months) and incidence of recurrent (three or more) infections during the first year of life were recorded as the main outcome measures of the study. During the first 7 months of life, seven out of thirty-two (22 %) infants receiving probiotics and twenty out of forty (50 %) infants receiving placebo experienced acute otitis media (risk ratio (RR) 0·44 (95 % CI 0·21, 0·90);P = 0·014) and antibiotics were prescribed for ten out of thirty-two (31 %) infants receiving probiotics and twenty-four out of forty (60 %) infants receiving placebo (RR 0·52 (95 % CI 0·29, 0·92);P = 0·015). During the first year of life, nine out of thirty-two (28 %) infants receiving probiotics and twenty-two out of forty (55 %) infants receiving placebo encountered recurrent respiratory infections (RR 0·51 (95 % CI 0·27, 0·95);P = 0·022). These data suggest that probiotics may offer a safe means of reducing the risk of early acute otitis media and antibiotic use and the risk of recurrent respiratory infections during the first year of life. Further clinical trials are warranted.

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Topical lignocaine for pain relief in acute otitis media: results of a double-blind placebo-controlled randomised trial

Archives of Disease in Childhood ◽

10.1136/adc.2006.110429 ◽

2008 ◽

Vol 93 (1) ◽

pp. 40-44 ◽

Cited By ~ 22

Author(s):

P. Bolt ◽

P. Barnett ◽

F. E Babl ◽

L. N Sharwood

Keyword(s):

Pain Relief ◽

Otitis Media ◽

Randomised Trial ◽

Acute Otitis Media ◽

Double Blind ◽

Double Blind Placebo

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A randomized, double-blind, placebo-controlled noninferiority trial of amoxicillin for clinically diagnosed acute otitis media in children 6 months to 5 years of age

Canadian Medical Association Journal ◽

10.1503/cmaj.1040771 ◽

2005 ◽

Vol 172 (3) ◽

pp. 335-341 ◽

Cited By ~ 60

Author(s):

N. Le Saux

Keyword(s):

Otitis Media ◽

Acute Otitis Media ◽

Double Blind ◽

Double Blind Placebo ◽

Noninferiority Trial

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Single-dose (30 mg/kg) azithromycin compared with 10-day amoxicillin/clavulanate for the treatment of uncomplicated acute otitis media: a double-blind, placebo-controlled, randomized clinical trial

Current Therapeutic Research ◽

10.1016/j.curtheres.2003.09.006 ◽

2003 ◽

Vol 64 ◽

pp. 30-42 ◽

Cited By ~ 18

Author(s):

Stan L Block ◽

Antonio Arrieta ◽

Matthew Seibel ◽

Samuel McLinn ◽

Stephen Eppes ◽

...

Keyword(s):

Clinical Trial ◽

Single Dose ◽

Randomized Clinical Trial ◽

Otitis Media ◽

Acute Otitis Media ◽

Double Blind ◽

Double Blind Placebo ◽

Amoxicillin Clavulanate

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Faculty Opinions recommendation of Probiotics and prebiotics in preventing episodes of acute otitis media in high-risk children: a randomized, double-blind, placebo-controlled study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.717985436.793474137 ◽

2013 ◽

Author(s):

Direk Limmathurotsakul ◽

Cherry Lim

Keyword(s):

High Risk ◽

Otitis Media ◽

Acute Otitis Media ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

High Risk Children

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Penicillin and Acute Otitis

Annals of Otology Rhinology & Laryngology ◽

10.1177/00034894800890s363 ◽

1980 ◽

Vol 89 (3_suppl) ◽

pp. 271-274 ◽

Cited By ~ 18

Author(s):

J. Thomsen ◽

K. I. Meistrup-Larsen ◽

P. K. Larsen ◽

H. Sørensen ◽

N. Mygind

Keyword(s):

Placebo Group ◽

Haemophilus Influenzae ◽

Otitis Media ◽

Acute Otitis Media ◽

Double Blind ◽

Analgesic Treatment ◽

Double Blind Placebo ◽

Penicillin V ◽

Symptom Scores

The effect of peroral penicillin V (55 mg/kg/day) on acute otitis media was investigated in 149 children between the ages of one and ten years in a double-blind, placebo-controlled investigation. The parameters of the disease employed were symptom scores for earache, the use of analgetics, otoscopy, as well as tympanometry. The children were followed up for three months. Penicillin had a significant effect on pain on the second day of treatment. The acute course of the disease was satisfactory in 69% of the children in the placebo group and in 86% in the penicillin group. In patients with pneumococci or hemolytic streptococci in the rhinopharynx, the pain already disappeared after one to two doses of penicillin, whereas the treatment had no effect on the patients with Haemophilus influenzae. There was no difference between the penicillin and placebo groups with regard to the results of otoscopy and tympanometry after one week, one month and three months. No serious complications were observed. It is concluded that an attitude of “masterful inactivity” with regard to the treatment of acute otitis media is justifiable, and in the majority of cases advisable, provided sufficient analgesic treatment is given and also that the patient can be closely followed. As there are still many unanswered questions more controlled investigations are warranted.

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