Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial.
BACKGROUND
There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the treatment of acute maxillary sinusitis (AMS).


OBJECTIVE
The objective of this clinical trial was to demonstrate the efficacy of a complex homeopathic medication (Sinfrontal) compared with placebo in patients with AMS confirmed by sinus radiography.


METHODS
A prospective, randomized, double-blind, placebo-controlled, phase III clinical trial was conducted for a treatment period of 22 days, followed by an eight-week posttreatment observational phase.


METHODS
The clinical trial was conducted at six trial sites in the Ukraine.


METHODS
One hundred thirteen patients with radiography-confirmed AMS participated in the trial.


METHODS
Fifty-seven patients received Sinfrontal and 56 patients received placebo. Additionally, patients were allowed saline inhalations, paracetamol, and over-the-counter medications, but treatment with antibiotics or other treatment for sinusitis was not permitted.


METHODS
Primary outcome criterion was change of the sinusitis severity score (SSS) from day zero to day seven. Other efficacy assessments included radiographic and clinical cure, improvement in health state, ability to work or to follow usual activities, and treatment outcome.


RESULTS
From day zero to day seven, Sinfrontal caused a significant reduction in the SSS total score compared with placebo (5.8 +/- 2.3 [6.0] points vs 2.3 +/- 1.8 [2.0] points; P < .0001). On day 21, 39 (68.4%) patients on active medication had a complete remission of AMS symptoms compared with five (8.9%) placebo patients. All secondary outcome criteria displayed similar trends. Eight adverse events were reported that were assessed as being mild or moderate in intensity. No recurrence of AMS symptoms occurred by the end of the eight-week posttreatment observational phase.


CONCLUSIONS
This complex homeopathic medication is safe and appears to be an effective treatment for acute maxillary sinusitis.
Zabolotnyi
Dmitriy I
DI
Research Institute for Ear, Nose, and Throat Diseases, Kiev, Ukraine.
Kneis
Kyra C
KC
Richardson
Andy
A
Rettenberger
Reinhard
R
Heger
Marianne
M
Kaszkin-Bettag
Marietta
M
Heger
Peter W
PW
D000208:Acute Disease; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D008297:Male; D015523:Maxillary Sinusitis / Q000188:drug therapy*; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014455:Ukraine
D000900:Anti-Bacterial Agents; D010936:Plant Extracts