Lack of efficacy of a herbal preparation (RCM-102) for seasonal allergic rhinitis: a double blind, randomised, placebo-controlled trial

Abstract

Background: A herbal preparation, known as RMIT Chinese Medicine 102 (RCM-102) consisting of eight herbs which demonstrates inhibition of the release of key inflammatory mediators associated with seasonal allergic rhinitis (SAR) was used. This study evaluated the efficacy and safety of RCM-102 for SAR.

Objective: This study evaluated the efficacy and safety of RCM-102 for SAR.

Methods: This randomised placebo-controlled trial involved subjects aged between 18 and 65 who were randomly assigned to either RCM-102 or a placebo group. After a two-week baseline period, all subjects took either RCM-102 or placebo capsules (two capsules each time, three times daily with a four hour interval) for a period of eight weeks. The primary end-points were the Five-Point Scale symptom scores. Rhinoconjunctivitis Quality of Life Questionnaire, relief medication usage, adverse events, kidney and liver function tests and full blood examination were secondary end-points. Intention-to-treat analysis was applied.

Results: One hundred and four subjects were randomised with 52 in each group. Ninety-five subjects (47 and 48 subjects in RCM-102 and placebo groups) completed the trial. Nine subjects withdrew from the study prior to the end of the second treatment week. At the end of the trial, there were no significant differences between the two groups with respect to all outcome measures. There were no liver or kidney function abnormalities reported.

Conclusion: This mechanism-based RCM-102 was safe but not more beneficial than placebo for patients with SAR.

Keywords: Herbal medicine; RCM-102; Seasonal allergic rhinitis.

Fig. 1

The clinical trial profile.

Fig. 2

Two-week mean total nasal (NSS) and non-nasal symptom scores (NNSS) with total fortnight pollen counts during the trial. Line graphs: Data plotted means ± SEM of fortnightly total NSS of RCM-102 (♦) and placebo (◊) groups, RCM-102 fortnightly total NNSS of RCM-102 (▪) and placebo (□) groups. The vertical bars show the fortnightly pollen counts. Baseline: day 14, Visit 1: day 28, Visit 2: day 42, Visit 3: day 56 and Visit 4: day 70.