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

Abstract

BackgroundA 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.ObjectiveThis study evaluated the efficacy and safety of RCM-102 for SAR.MethodsThis 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.ResultsOne 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.ConclusionThis mechanism-based RCM-102 was safe but not more beneficial than placebo for patients with SAR.

Chinese Herbal Medicine to Treat Allergic Rhinitis: Evidence From a Meta-Analysis

“…Finally, 12 trails documented in 11 articles were enrolled in the meta-analysis. 8 9 12 19 21 22 23 24 25 26 27 …”

“…Although occurrence of adverse events was one of the outcomes to be assessed in the present meta-analysis, it was not possible to perform this analysis because the occurrence of adverse events following CHM treatment was reported as an outcome measure in only one of the enrolled studies. 25 This clearly suggests that further studies on CHM treatment-associated adverse events are warranted.…”

Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis

“…A study by Hsu and colleagues 396 investigated the effect of herbal point-patch treatment in AR patients and showed that acupoint herbal point-patches were an effective treatment for improvement in quality of life in AR. Besides studies in Chinese patients, some randomized trial also assessed the efficacy of CHM in Korean, 397 Australian 398 399 402 and German 400 patients with AR. Although 2 meta-analysis of clinical trials on traditional CHM for the treatment of AR revealed that CHM interventions appeared to have beneficial effects in patients with AR, 321 402 some clinical trials subsequently provided conflicting data for the potential efficacy of CHM for AR 399 402 Particularly when the effect of CHM was assessed in combination with acupuncture for the treatment of SAR.…”

“…Besides studies in Chinese patients, some randomized trial also assessed the efficacy of CHM in Korean, 397 Australian 398 399 402 and German 400 patients with AR. Although 2 meta-analysis of clinical trials on traditional CHM for the treatment of AR revealed that CHM interventions appeared to have beneficial effects in patients with AR, 321 402 some clinical trials subsequently provided conflicting data for the potential efficacy of CHM for AR 399 402 Particularly when the effect of CHM was assessed in combination with acupuncture for the treatment of SAR. While one study from Germany 400 demonstrated that CHM combined with acupuncture significantly improved both symptoms and quality of life scores in SAR patients compared to acupuncture treatment alone, another study from Australia 402 failed to show any significant differences in symptomatic relief or improvement in quality-of-life scores in SAR patients treated with CHM + acupuncture or acupuncture alone.…”

In this issue of Asia Pacific Allergy

“…Readers may have a new idea how to set up a clinical trial of herbal preparation like RCM-102 although it was found to be not an effective preparation for seasonal allergic rhinitis [8]. …”