A Non-Randomised Pilot Study to Compare Complementary and Conventional Treatments of Acute Sinusitis

Abstract

Background: It is still under discussion whether antibiotics are effective in the treatment of acute sinusitis. Moreover, they are known to have considerable side-effects. In contrast, complementary approaches are reported to have little side-effects and an equivalent efficiency. Objectives: To assess the success of conventional and complementary treatments of acute sinusitis and to estimate the patient numbers needed to confirm therapeutic equivalence. Treatment success was measured by three different scores, assessed by both patients and physicians. Methods: Multicentre (2 complementary and 3 conventional ENT centres), non-randomised, controlled clinical trial with 63 patients (complementary group 30, conventional group 33 patients). To control for confounders treatment differences were estimated by propensity score techniques. Treatments: The choice of medication was entirely left to the physician. We recommended to use antibiotics, secretolytics and symptomimetics in the conventional group and a combination of the herbal remedy Sinupret^® and the homeopathic remedy Cinnabaris 3X in the complementary group. Results: Treatment differences varied substantially depending on the outcome measure, but they were always not clinically relevant. Conventional treatment was slightly better when the outcome was assessed by the physicians (1.8 score points) but slightly worse when it was assessed by patients (0.2 score points) or in terms of the HCG-5 quality of life score (0.8 score points). p values were always > 0.3. Conclusions: Both treatments appear to be equally effective (or ineffective). Results might be biased because both treatment groups differed substantially. Randomised trials including at least 400 patients are needed to produce valid results.

An Example on the Value of Non-Randomisation in Clinical Trials in Complementary Medicine

“…Complementary treatment was suggested to comprise the homeopathic remedy Cinnabaris 3X and the phytotherapeutic remedy Sinupret ® (Bionorica, Neumarkt, Germany). For details on the study design refer to [12].…”

“…We therefore decided to set up a small NRCT in acute sinusitis or impairments of a chronically relapsing sinusitis, comparing a conventional (antibiotics and synthetic secretolytics) and a complementary (homeopathy and phytotherapy) treatment approach. A detailed description of study design and results is published elsewhere [12]. In this paper we want to concentrate on the question whether or not advanced statistical methods are helpful for interpreting the data.…”

Systematic Review of Clinical Data with BNO-101 (Sinupret?) in the Treatment of Sinusitis

“…The global benefit was most evident in cases of acute sinusitis, which accounted for the majority of the cases. However, a non-randomised pilot study with acute sinusitis failed to reveal significant differences between conventional and 'complementary' treatments, including BNO-101, but the number of patients per treatment was small and the dose employed too low [23].…”

Behandlung von Entzündungen im Bereich der oberen Atemwege – Vergleich eines homöopathischen Komplexpräparates mit Xylometazolin

“…Damit werden Schätzwerte über tatsächli-che Effekte aussagekräftiger und robuster. Auch wenn in neueren Untersuchungen von Lüdtke et al [12] und Weber et al [13] [16]. Beobachtungsstudien haben aber einen unschätzbaren Wert bei der Beurteilung von Therapiekonzepten, die sich nur schwer in randomisierten Studien untersuchen lassen und die die medizinische Praxis an Patientenkollektiven untersuchen, die nicht den Einschränkungen einer randomisierten Studie unterworfen sind [17,18].…”