One of the most common ambulatory care conditions in adults in Germany and many other countries is acute sinusitis.[1,2] Although acute maxillary sinusitis (AMS) generally has a short, self-limiting course of up to 4 weeks, it may significantly impair a patient's health status and lead to a decreased ability or temporary inability to work. Acute and chronic sinusitis was responsible for $US3.5 billion in direct healthcare expenditures in the US in 1996, and causes significant loss of workplace productivity.
In the treatment of ear, nose and throat (ENT) and respiratory tract infections, herbal and homeopathic medications have become more popular in the past years. However, only a few of these medications have undergone high-quality clinical research on their efficacy and safety. In addition, there are only a few cost-effectiveness analyses (CEAs) of herbal and homeopathic medications, and, until now, no internationally published CEAs on their use in the treatment of sinusitis including AMS.
A popular homeopathic medication for the treatment of acute and chronic ENT and respiratory tract infections in children and adults in Germany is Sinfrontal® , which has been on the German market since 1952. Its active ingredients are Cinnabaris Trit. D4, Ferrum phosphoricum Trit. D3, and Mercurius solubils Hahnemanni Trit. D6.
Contrary to many other homeopathic or herbal medications, the efficacy and safety of Sinfrontal® have been investigated in two non-randomized, placebo-controlled trials[8,9] and two open observational studies.[10,11] These included a total of 2642 patients with a diagnosis of acute or chronic sinusitis. In the two placebo-controlled trials,[8,9] the efficacy of Sinfrontal® was significantly higher than placebo, and in the two observational studies,[10,11] Sinfrontal® appeared to be safe and well tolerated. Recently, these findings were supported by a randomized, placebo-controlled phase III clinical trial.
The trial was conducted at six ENT clinics and outpatient departments in Kiev, Ukraine, following the International Conference on Harmonization Good Clinical Practice guideline. The trial took place from February 2004 to May 2005. A total of 113 patients with AMS between 18 and 59 years of age were enrolled. AMS was confirmed by sinus radiography, which has a high sensitivity and specificity in the diagnosis of AMS (87% and 89%, respectively). One of the following three criteria had to be fulfilled: mucosal thickening >6 mm measured at the upper border of the maxillary sinus, or air-fluid level or complete opacification on the most AMS-affected side. Exclusion criteria included obstructive anatomical lesions in the nose and nasopharynx such as nasal polyps as well as severe cardiovascular disease or unstable diabetes mellitus (for the complete list of exclusion criteria see the clinical trial publication). Patients were randomized according to computer-generated blocks of four. Baseline patient data were comparable in both groups (table I). Both patients and investigators as well as the data monitoring committee were blinded with regard to the individual treatment allocation. Patients were treated for 22 days and thereafter followed up for 8 weeks in order to detect recurrences of AMS. Only paracetamol (acetaminophen) 500 mg and saline (sodium chloride) inhalations were allowed as concomitant medications. During the 22-day treatment period, one patient in the Sinfrontal® group and five patients in the placebo group withdrew, essentially due to non-efficacy or adverse events. However, no serious adverse event occurred.
Table I. Overview of the most relevant patient baseline characteristics (reproduced from Zabolotnyi et al. with permission) [Table omitted.]
The trial found Sinfrontal® to have significant efficacy, compared with placebo. The primary outcome measure in the clinical analysis was the Sinusitis Severity Score (SSS), which evaluates six symptoms and signs associated with AMS. …