Summary of Clinical Studies into Efficacy of Pelargonium sidoides extract EPs 7630

The efficacy of the Pelargonium sidoides extract EPs 7630 against a number of bacterial and viral infections has been well researched. This extract has been the subject of over 20 clinical studies involving more than 9,000 patients, including children as young as one year (Brown, 2009). It has been shown to safely and effectively treat acute upper respiratory tract infections such as bronchitis, tonsillopharyngitis, sinusitis and the common cold. The following is a summary of some of the clinical data available: 

Tonsillitis

Professor V.V. Bereznoy MD, treated over 140 children with bacterial tonsillitis in a placebo-controlled trial in Kiev in 2003. His treated approximately half the children with Eps 7630 (manufactured by Schwabe Pharmaceuticals) and the remainder with a placebo. The children took 3ml of the extract per day for 6 days. Researchers in this study monitored pain, difficulty swallowing, salivation, redness, fever and headache, using a ‘tonsillitis severity score’. Bereznoy’s study confirmed the superiority of EPs 7630 compared to the placebo. The study demonstrated the ability of EPs 7630 to reduce the severity of all five symptoms, shortened the duration of the illness and protected patients from complications. 

Rapid recovery was observed in three quarters of the patients treated with Eps 7630 and a third of those treated with the placebo. Bereznoy (2003) points out that more than half of the EPs 7630 group were able to get out of bad after two days of treatment. In the placebo group, however, more than half the patients were either still in bed on day 4 or had abandoned the study because of a lack of efficacy. This reduction in bed rest of 48 hours under EPs 7630, compared with the placebo, shows the benefit of this treatment. Indeed, it is more than double the reported benefit of antibiotic treatment at 16 hours (Del Mar, 2001). Six days after beginning treatment, 80% of the EPs 7630 group were back at school, whereas only 20% of the placebo group were able to resume school (Bereznoy et al, 2003). 

Bronchitis

Matthys et al, (2003) studied the efficacy of EPs 7630 in adults with acute bronchitis. The group of researchers conducted a randomized, double-blind, placebo-controlled trial on over 450 patients. This study found that EPs 7630 was superior in efficacy compared to placebo in the treatment of adults with acute bronchitis. Treatment with EPs 7630 clearly reduced the severity of symptoms, duration of illness and shortened the time taken off work by nearly 2 days (Matthys et al, 2003).

Further observational studies by Haidvogl and Heger (2007) examined the effect of EPs 7630 on over 740 children with acute bronchitis. The researchers monitored treatment with the herbal extract for up to 14 days. Five ‘bronchitis specific symptoms’ were summed up to give an overall measure of disease severity. Haidvogl and Heger concluded that EPs 7630 is a safe and effective treatment for acute bronchitis. In addition, they note that in 88.3% of cases, the responsible physician rated the treatment as successful. Adverse events were minor and transitory.

Sinusitis

A randomized, double-blind, placebo-controlled study of 103 adult patients with acute sinusitis was conducted by Bachert et al at 11 clinics, in Kiev, in 2009. The patients were studied for 21 days and assessed on 6 symptoms of sinusitis including headache, nasal obstruction and discharge. Bachert et al (2009) report that by day 7, 63% of the EPs 7630 group were back to work compared with 37% in the placebo group. By day 21, sinus x-rays were normal in more than 90% of the EPs 7630 group compared with 10% for the placebo group. The researchers highlighted “improvements shown in the patients’ health-related quality of life, activity level and general well-being”, they further observed a quicker return to work. Bachert et al (2009) conclude that “EPs7630 should be considered as a possible first line treatment even in patients suffering from an acute rhinosinusitis of presumably bacterial origin”. 

Common Cold 

Lizogub, Riley and Herger (2009) examined the efficacy of EPs 7630 on patients with the common cold, one of the most prevalent illness in the world. The study compared EPs 7630 to a placebo over 10 days. Over 100 patients were tracked according to their cold symptoms including; nasal discharge, sore throat, nasal congestion, sneezing, hoarseness, cough, headache, muscle aches, and fever. Lizogub, Riley and Herger (2009) report that EPs 7630 represents an effective treatment of the common cold.  After 10 days, 78.8% of the EPs group was clinically cured compared with 31.4% in the placebo group. The EPs group returned to work on average of 2 days earlier than the placebo group.  

In conclusion, clinical trials have shown that P. sidoides extract 7630 is an effective treatment for a number of upper respiratory tract infections. Kolodziej (2011) points to the reasons for its therapeutic effects; antibacterial activity, antiviral activity, immune stimulation and an increase in ciliary beat frequency.

(Afrigetics Botanicals PelaPower TM is a powder extract made according to the EMA monograp and comparable to EPS7630 – read more here)

Bibliography 

Bachert, C. et al. 2009, ‘Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: A randomized, double-blind, placebo-controlled trial’, Rhinology, Vol. 47, no. 1, pp 51-58

Bereznoy, V. et al. 2003, ‘Efficacy of extract of Pelargonium sidoides in children with acute non-group A Beta-Hemolytic Streptococcal Tonsillopharyngitis; A randomised, double-blinded, placebo-controlled trial’, Alternative Therapies, Vol. 9, no. 5, pp 68-79

Brown, D. 2009, ‘Pelargonium sidoides Extract (EPs 7630) Alternative Treatment of Acute Upper Respiratory Tract Infections’, Natural Medicine Journal, Vol. 1, issue 12, 

Del Mar, C. Glasziou, P. Spinks, A. 2001, ‘Antibiotics for Sore Throat’, The Cochrane Library, Issue 1 

Haidvogl, M. and Heger, M. 2007, ‘Treatment effect and safety of EPs 7630 solution in acute bronchitis in childhood: Report of a multicentre observational study’, Phytomedicine, Vol. 14, supp. 1, pp 60-64

Kolodziej, H. 2011, ‘Antimicrobial, Antiviral and Immunomodulatory Activity Studies of Pelargonium sidoides (Eps 7630) in the context of Health Promotion’, Pharmaceuticals, Vol. 4, no. 10, pp 1295-1314

Lizogub, V. Riley, D. Heger, M. 2007, ‘Efficacy of a Pelargonium sidoides preparation in patients with the common cold: A randomized, double-blind, placebo-controlled clinical trial’, Explore, Vol. 3, Issue. 6, pp 573-584.

Matthys, H. et al, 2003, ‘Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis: A randomised, double-blind, placebo-controlled trial’, Phytomedicine, Vol. 10, supp. 4, pp 7-17