Clinical Research

Summary of Clinical Studies into efficacy of GOPO a key component of Rosa canina

The galactolipid GOPO is a key component of Afrigetics flagship complex RosaLipids ™4:1. This natural anti-inflammatory compound is derived from both the seeds and fruits of Rosa canina, in Afrigetics’ unique and patented extraction process. GOPO is the only rosehip derived compound to have been rigorously evaluated in randomised controlled clinical trials (NICE, 2014). This natural anti-inflammatory is emerging as a promising treatment for osteoarthritis (Cohen, 2012).

Osteoarthritis is an inflammatory condition typified by damage to cartilage, underlying bone and inflammation of the tissue lining the joint. It mostly occurs in the knees, hips and small joints of the hands. The pain affects mood and mobility, leaving sufferers disabled and markedly reducing their quality of life. It is estimated that over 8 million people have sought treatment for osteoarthritis in the UK alone. This represents about one third of the population over the age of 45 years (Arthritis Research UK, 2015).

A variety of different treatments exist for the condition, however, an alternative to over-the-counter analgesics is needed, due to new evidence of their toxicity. According to Arthritis Research UK, over 60% of people with arthritis have tried complementary and alternative medications, this reflects the chronic nature of the condition and the dissatisfaction with long term use of prescribed treatments.

The efficacy of the GOPO extract as a natural anti-inflammatory has been well researched.

This extract has been the subject of a number of double blind, placebo controlled trials involving hundreds of osteoarthritis sufferers (Christensen et al, 2008). A meta-analysis of data from three prominent studies confirmed that GOPO offers “significant and robust joint pain relief, enabling a reduction in the consumption of rescue medications” (NICE, 2014). The following is a summary of some of the clinical data available:

Odd Warholm MD, treated 100 end-stage arthritis patients, in a placebo-controlled trial in the Vestfold Central Hospital in Norway in 2003. All were on a waiting list for hip or knee replacement. He treated approximately half the osteoarthritis sufferers with a standardized preparation of rose hip powder containing GOPO and the remainder with a placebo. The patients took 5g of the preparation per day, for 4 months. Researchers in this study monitored mobility, activities of daily living, quality of life and pain. Warholm et al. (2003) confirmed that rosehip containing GOPO is superior to the placebo.

The study demonstrated the ability of GOPO to improve hip joint mobility and decrease pain. 64% of the treatment group reported a reduction in pain while receiving GOPO treatment (Warholm et al., 2003). Although Warholm’s study participants were instructed not to change their intake of rescue medication, those receiving GOPO reduced their consumption of non-steroidal anti-inflammatory medication, while a slight increase in rescue medicine intake was observed with placebo. This is particularly significant as numerous side effects have been associated with prolonged use of aspirin, NSAIDS and corticosteroids.

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A successive study by Rein et al. in 2004 examined the efficacy of GOPO in the treatment of early stage osteoarthritis. 112 patients with osteoarthritis of the hand, shoulder, hip, knee, or neck were included in this cross-over study. Rose hip powder (5 g daily) or a placebo was given for 3 months. After this period, the group receiving active treatment was swapped to the placebo and vice versa. The patients assessed changes in joint pain and stiffness after each treatment period. General wellbeing, including mood, sleep quality and energy were also assessed and recorded.

Rein et al. (2004) found that GOPO was superior in efficacy compared to placebo in the treatment of stiffness and pain in osteoarthritis and that it continues to alleviate symptoms for months after it was administered. The results in the two arms of the crossover illustrate this strong “carryover” effect. The group which got the placebo first only showed significant improvement during the last 3 month period when they were administered the rose hip powder. By contrast, the second group which got active treatment first showed a very positive effect during treatment, but retained the improvement during their placebo phase (Rein et al., 2004). The same pattern was observed when general levels of well-being were evaluated from the diary records. A corresponding decrease in consumption of rescue medication such as paracetamol, codeine and synthetic opioids was also observed in the GOPO group. 

Two further studies conducted by Winther et al., in 2005 and 2013 at Danish hospitals further support the use of GOPO in osteoarthritis treatment. The earlier study examined the effect of rosehip powder on 94 patients suffering from osteoarthritis of the knee or hip. Treatment with the rosehip resulted in a significant reduction in pain and consumption of rescue medications after as little as 3 weeks. Reduction in disability, stiffness and severity of disease was observed after 3 months of active treatment (Winther et al., 2005).

Winther’s 2013 clinical trial focussed on patients with osteoarthritis of the dominant hand. 90% of the subgroup taking rosehip containing GOPO reported reductions of pain in the hand while on active treatment. Active treatment also resulted in a 33% reduction in the consumption of rescue medication. Symptom reduction was still present 3 weeks after a switch to the placebo, further evidencing the long duration of GOPO’s action (Winther et al., 2013).

Examination of data Christensen (2008) from three independent studies by confirms that GOPO offers superior joint pain relief compared to other medications. A comparison of pain ‘effect size’ scores shows the magnitude of efficacy for Rosehip GOPO (refer Figure 2) is three times greater than for paracetamol and significantly better than glucosamine sulphate or NSAIDs (Christensen, 2008).

In summary, rosehip preparations have been shown to exhibit anti-inflammatory and pain reducing properties. Furthermore, chronic or long-term administration of rosehip does not result in the gastric bleeding as is frequently observed with the use of ASA and NSAIDs (Marstrand, K. Campbell-Tofte, J. 2016). Furthermore, Dr Rod Hughes, a rheumatologist at St. Peter’s Hospital in Surrey (UK), when looking at rosehip said; “We know that osteoarthritis is an inflammatory condition, rather than simply ‘wear and tear’, therefore the anti-inflammatory effects of GOPO may be of benefit”. Dr John Dickson, a GP Community rheumatologist and advisor to the National Institute for Health and Care Excellence, UK commented; “A three month trial of GOPO is certainly worthwhile”. The evidence for rosehip was reviewed by Arthritis Australia in 2011 and is now included in the Arthritis Australia complementary medicine information sheet (Arthritis Australia, 2011).

A natural solution for osteoarthritis & joint pain.

Arthritis Australia. 2017, Arthritis Information Sheet Complementary Therapies, viewed 7 May 2019, available at <https://arthritisaustralia.com.au/wordpress/wp-content/uploads/2018/02/ComplementaryTherapies_0118.pdf>

Christensen, R. Bartels, EM. Altman, RD. Astrup, A. and Bliddal, H. 2008, ‘Does the hip powder of Rosa canina (rose hip) reduce pain in osteoarthritis patients? – a meta-analysis of randomized controlled trials’, Osteoarthritis Cartilage, Vol. 16, no. 1, pp965–972.

Cohen, M.2012, ‘Rosehip; An evidence base herbal medicine for inflammation and arthritis’, Australian Family Physician, Vol. 41, no. 7, pp495-498

Marstrand, K. Campbell-Tofte, J. 2016 ‘The role of rose hip (Rosa canina L) powder in alleviating arthritis pain and inflammation – part II animal and human studies’, Botanics; Targets and Therapy, Vol. 6, no.1, pp59—73

National Institute for Health Care and Excellence (NICE). 2014, Over-the-Counter options for osteoarthritis joint pain, reviewing the latest evidence. Clinical guidelines CG177

Rein, E. Kharazmi, A. and Winther, K. 2004, ‘A herbal remedy, Hyben Vital (stand. powder of a subspecies of Rosa canina fruits), reduces pain and improves general wellbeing in patients with osteoarthritis–a double-blind, placebo-controlled, randomised trial’, Phytomedicine, Vol.11, no.5, pp383-91.

Warholm, O. Skaar, S. Hedman, E, Molmen HM. Eik, L. 2003, ‘The Effects of a Standardized Herbal Remedy Made from a subtype of Rosa canina in Patients with Osteoarthritis; A Double-Blind, Randomized, Placebo-Controlled Clinical Trial’, Current Therapeutic Research, Vol. 64, no.1, pp21-31

Winther, K. Campbell-Tofte, J. and Hansen, P. 2013, ‘Rose hip powder that contains the natural amount of shells and seeds alleviates pain in osteoarthritis of the dominant hand – a randomised double-bind, placebo-controlled, cross over clinical trial’, Open Journal of Rheumatology and Autoimmune Diseases, NB NB

Winther, K. Apel, K.and Thamsborg, G. 2005, ‘A powder made from the seeds and shells of a rose-hip subspecies (Rosa canina) reduces symptoms of knee and hip osteoarthritis: a randomised double-bind, placebo-controlled, clinical trial’, Scandinavian Journal of Rheumatology, Vol. 34, no. 4, pp302-308

Pharmacological Action

Pelargonium acts by preventing bacteria from sticking to the cells lining the respiratory system and by stimulating white blood cells to attack and destroy these invading bacteria. The chemicals contained in this medicine also help to support the immune system by producing specific proteins, called defensins, to protect cells from invasion. The antiviral properties of P. sidoides lies in its ability to stimulate the body’s cells to produce interferon, a chemical that ‘interferes’ with virus replication. Its antibacterial effect is attributed to chemicals in the extract causing the tiny hair-like projections which line our respiratory tract, called cilia, to beat faster and to expel mucous. In addition, chemicals found in the plant have a mucolytic effect, helping to dissolve thick mucus in the airways.

There is no cure for the common cold, since it is spread by a virus, but Pelargonium has been proven to aid healing. This herbal medicine has been shown to be safe and effective and may form an important alternative to antibiotics. Many pharmaceutical companies use ethanol to extract the active ingredients from the pelargonium root. These extracts have proven effective for the treatment of respiratory tract infections including bronchitis, tonsillitis, sinusitis and the common cold. Clinical trials have shown the medicine to reduce both the duration and everity of these illnesses.

One such preparation, Eps7630, prepared by Schwabe Pharmaceuticals has been the subject of over 20 clinical studies, involving 9000 people.

Three-Way Effect

Pelargonium has been shown to have a three-way effect.

afrigetics-botanicals-pelargonium-sidoides-three-way-effect

Antibacterial

The Pelargonium Sidoides extract prevents bacteria from attaching to cells in mucous membranes.

Pelargonium sidoides extracts inhibit the adherence of bacteria such as Streptococcus pyogenes and Helicobacter pylori to epithelial cells in vitro.

Furthermore, ciliated cells isolated from the nasal epithelium enhanced their ciliary beat frequency in the presence of these extracts, which should allow better removal of excess mucous and bacteria.

Antiviral

Similarly, Pelargonium Sidoides prevents viruses from attaching to the mucous membrane cells and stimulates the body’s immune system in such a way that both bacteria and viruses are prevented from multiplying.

Invitro, the extracts show efficacy against cellular infections with influenza virus, HSV, EMCV, RSV, coronavirus, parainfluenza virus, and Coxsackie virus, and this appears to be mainly mediated indirectly by inhibition of virus attachment and spreading.

Expectorant

The extract acts as an expectorant, allowing the body to expel contaminated mucous, making conditions less suitable for the multiplication of the bacteria and viruses – can only find animal data.

The three-way effect attacks the acute infection at its root, the stabilisation of the immune system prevents a reinfection and the vicious circle of infection, a short recovery phase and new infection is broken.

Treatable Conditions

afrigetics-botanicals-pelargonium-sidoides-treatable-conditions

Read more about the research done
on Pelargonium sidoides

afrigetics-botanicals-pelargonium-sidoides-products-whole-dried-pieces
Pelargonium sidoides

Whole Dried Pieces

Product Description

Dark brown to reddish pieces of shredded whole pelargonium root, cut and sifted according to customer specification.

Active Ingredient

Not less than 100ppm umckalin

Sterilisation

Steam Sterilisation

*optional

Packaging Description

Inner package
2 PVC plastic liner (Food grade)

Outer Packaging
White polypropylene agricultural weaved bag

Pack Size

15 kg raw material

afrigetics-botanicals-pelargonium-sidoides-products-milled-powder
Pelargonium sidoides

Milled Powder

Product Description

Dark brown to reddish pieces of shredded whole pelargonium root, cut and sifted according to customer specification.

Active Ingredient

Not less than 100ppm umckalin

Sterilisation

Steam Sterilisation

*optional

Packaging Description

Inner package
2 PVC plastic liner (Food grade)

Outer Packaging
White polypropylene agricultural weaved bag

Pack Size

20 kg raw material

afrigetics-botanicals-pelargonium-sidoides-products-powder-extract-pelapower
Pelargonium sidoides

Powder Extract

Product Description

Pelargonium sidoides powder extract, standardized for umckalin for greater accuracy in formulating your products.

Features

A dry powder extract standardized for umckalin content. This powder can be used as an ingredient in formulations for liquid drops, cough syrups or sprays and can also be pressed into tablets or encapsulated.

Active Ingredient

NLT 160ppm, 800ppm and 1100ppm Umckalin

Packaging Description

Foil gusset bag, ziplock closure

Pack Size

1 kg and 5 kg bags

afrigetics-botanicals-pelargonium-sidoides-products-liquid-extract-glycerine-cough-syrup
Pelargonium sidoides

Ethanolic Liquid Extract 1:8-10

Product Description

Pelargonium sidoides ethanolic extract 1:10 (Alcohol 16-19%)

Features

An ethanolic extract made according to the pharmacopoeia monograph on Pelargonium sidoides. This tincture can be used as an ingredient in formulations for liquid drops, cough syrups or sprays or as a ready-to-use product.

Active Ingredient

15ppm umckalin (or to customer specification)

Packaging Description

PVC bucket with tamper-proof closure.

Pack Size

5 litre or 25 litre

afrigetics-botanicals-pelargonium-sidoides-products-liquid-extract-glycerine-cough-syrup
Pelargonium sidoides

Glycerine Extract

Product Description

Pelargonium sidoides vegetable glycerine tincture

Features

A non-alcoholic, sugar-free extract of Pelargonium sidoides. This tincture can be used as an ingredient in formulations for liquid drops, cough syrups or sprays or as a ready-to-use product.

Active Ingredient

NLT 15ppm umckalin (or to customer specification)

Packaging Description

PVC bucket with tamper-proof closure.

Pack Size

5 litre or 25 litre

afrigetics-botanicals-pelargonium-sidoides-products-cough-syrup-mint
Pelargonium sidoides

Cough Syrup Formulation with Mint

Product Description

Alcohol-free and sugar-free. Pelargonium sidoides vegetable glycerine tincture formulated with mint oil.

Features

A non-alcoholic, sugar-free glycerine extract of Pelargonium sidoides that is ready to use as a cough syrup.

Active Ingredient

NLT 15ppm umckalin (or to customer specification)

Packaging Description

PVC bucket with tamper-proof closure.

Pack Size

5 litre or 25 litre

Research Papers

Information Resources

This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of pelargonium root. The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing pelargonium root.

This summary is not intended to provide practical advice on how to use medicines containing pelargonium root. For practical information about using pelargonium root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.

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