Treatment of dyspeptic symptoms with YamatoGast. A non-interventional study of a registered traditional herbal Rikkunshito extract product from Japanese Kampo Medicine in routine practice in Germany.

INTRODUCTION: Dyspeptic symptoms belong to the most frequent reasons to seek medical advice and are a burden both for the individual affected and the healthcare system. In Japan, the traditional herbal Kampo prescription rikkunshito has proven benefit for this indication. METHODS: In a prospective, multicentre, non-interventional study (NIS), the effectiveness, safety, and tolerability of a two-week treatment with the registered rikkunshito extract product YamatoGast was assessed in German patients with an acute episode of dyspeptic symptoms of functional origin under real-world conditions. The primary endpoint was the responsiveness to treatment assessed by the overall treatment effect (OTE) score. Secondary endpoints were the change in severity of dyspeptic symptoms and the change in quality of life (QoL). Safety evaluation was based on reported adverse drug reactions, drug compliance, and ratings of tolerability by physicians and patients. RESULTS: Sixty-six patients were enrolled (mean age 48.9 years, 74% females). The treatment was well tolerated and highly beneficial, as expressed by pronounced responder rates of 78.9% for the primary endpoint OTE. All secondary endpoints were also met. The severity of dyspeptic symptoms significantly improved by 62-77% compared to baseline, confirmed by a remarkable improvement of QoL. Significant symptom relief started from the third day of treatment onwards. CONCLUSION: In this non-interventional study, two-week treatment with YamatoGast resulted in a significant improvement of dyspeptic symptoms and was associated with high patient response and satisfaction. YamatoGast was confirmed as a safe and clinically relevant therapeutic option for patients suffering upper gastrointestinal complaints in routine practice.

Efficacy and Safety of ELOM-080 as Add-On Therapy in COVID-19 Patients with Acute Respiratory Insufficiency: Exploratory Data from the Prospective Placebo-Controlled COVARI Trial.

INTRODUCTION: Enhancement of mucociliary clearance (MCC) might be a potential target in treating COVID-19. The phytomedicine ELOM-080 is an MCC enhancer that is used to treat inflammatory respiratory diseases. PATIENTS/METHODS: This randomised, double-blind exploratory study (EudraCT number 2020-003779-17) evaluated 14 days' add-on therapy with ELOM-080 versus placebo in patients with COVID-19 hospitalised with acute respiratory insufficiency. RESULTS: The trial was terminated early after enrolment of 47 patients as a result of poor recruitment. Twelve patients discontinued prematurely, leaving 35 in the per-protocol set (PPS). Treatment with ELOM-080 had no significant effect on overall clinical status versus placebo (p = 0.49). However, compared with the placebo group, patients treated with ELOM-080 had less dyspnoea in the second week of hospitalisation (p = 0.0035), required less supplemental oxygen (p = 0.0229), and were more often without dyspnoea when climbing stairs at home (p < 0.0001). CONCLUSION: These exploratory data suggest the potential for ELOM-080 to improve respiratory status during and after hospitalisation in patients with COVID-19.

Autologous fat grafting seems to alleviate postherpetic neuralgia - a feasibility study investigating patient-reported levels of pain.

BACKGROUND: Postherpetic neuralgia (PHN) is a relatively common side effect after an outbreak of herpes zoster (HZ), characterized by chronic neuropathic dermal pain. No effective treatment exists today. Fat grafting has shown promise in alleviating neuropathic pain, yet the exact mechanism of action, at a biological level, is not yet known. We report on the first human study using autologous fat grafting for treating PHN. Our hypothesis was that fat grafting can alleviate pain and improve the quality of life (QoL) in patients suffering from PHN. If successful, this could be a safe, cost-effective alternative to analgesics. This safety and feasibility study aimed to investigate the possible pain-relieving effect of autologous fat grafting on PHN. METHODS: Ten adult patients suffering from PHN underwent autologous fat grafting to a dermal area of neuralgia, with a 12-week follow up. The primary endpoint was patient-reported pain. Secondary endpoints were patient-reported changes in QoL, and the degree and quality of the neuropathic pain. RESULTS: The pain was measured by using a visual analog scale (range: 0-10). We observed improvements in both the average and maximum level of pain with a reduction of (-4.0 ± 3.1) and (-5.1 ± 3.9), respectively, (Δ mean ± SD), P<0.05. All parameters investigating neuropathic pain were significantly reduced. No improvement was seen in the QoL. The average amount of fat grafted was 208 ml. We observed no serious adverse effects. CONCLUSION: This study suggests that autologous fat grafting can relieve chronic pain resulting from HZ. The next step toward routine clinical translation is to perform a randomized, blinded, placebo-controlled trial with a more extended follow-up period.

ELOM-080 as Add-On Treatment for Respiratory Tract Diseases - A Review of Clinical Studies Conducted in China.

ELOM-080, also known as Myrtol, represents a distillate of a mixture of 4 rectified essential oils: eucalyptus oil, sweet orange oil, myrtle oil, and lemon oil. ELOM-080 is an approved herbal medicinal product for the secretolytic therapy and facilitation of expectoration in acute and chronic bronchitis and for the secretolytic therapy of sinusitis. Its clinical efficacy has been reported by several randomized control trials. Interestingly, in the recent past, a considerable number of clinical studies on the use of ELOM-080 as add-on treatment of different respiratory tract diseases has been conducted and published in China. As these publications were only available in Chinese, the international attention in the literature was limited. Based on the translation of these studies into English, this review aims to provide a brief overview of the studies' major results, which contribute to the knowledge on the efficacy of ELOM-080 in the treatment of respiratory tract diseases: ELOM-080 was shown to be of great value as add-on treatment not only for the well-established indications bronchitis and sinusitis, but also for pharyngitis, asthma, chronic obstructive pulmonary disease, and, most importantly, otitis media. Besides this clinical evidence, this review also summarizes the great progress in deciphering the mode of action of ELOM-080 that has been made by Chinese publications.