FIELD OF INVENTION This invention relates generally to compositions comprising bee venom and an extract of a plant of the genus Capsicum, and their uses.

BACKGROUN D There are many different types of musculoskeletal conditions that can cause mild to severe pain in sufferers, resulting in poor quality of life and, in some cases, disability. Arthritis, for example, is an inflammatory disease that affects millions of people in the USA alone. It can cause severe pain and disability. Even in its milder forms it can reduce quality of life for sufferers.

Individuals who suffer from joint and/or muscle pain have, for centuries, used pain-relieving treatments derived from natural products. Capsaicin is known as a topical treatment for arthritis and other musculoskeletal conditions. This compound, as well as other capsaicinoids, is present in plants of the genus Capsicum, such as Capsicum annuum, Bee stings have also been used historically to assist with pain and inflammation. Traditionally, bee venom therapy has involved applying bees to the affected area until they sting. Modern methods of bee venom extraction mean that the venom can be extracted without bee mortality, and the venom can then be formulated and applied to patients. GB 425,543 describes a formulation that contains bee poison and pulverised capsicum fruit, together with other components. The formulation is said to be percutaneously effective. According to this document, bee poison has a therapeutic effect for treating rheumatism.

It is an object of the invention to provide a composition comprising bee venom and an extract of a plant of the genus Capsicum, or to at least provide a useful alternative.

It is another object of the invention to provide the use of a composition comprising bee venom and an extract of a plant of the genus Capsicum, for ameliorating the symptoms of arthritis or musculoskeletal disorders or conditions, or to at least provide a useful alternative. STATEMENTS OF INVENTION

In a first aspect the invention provides a composition comprising bee venom and an extract of a plant of the genus Capsicum.

In a second aspect the invention provides a composition comprising synergistically effective amounts of bee venom and an extract of a plant of the genus Capsicum.

Preferably the composition comprises:

about 0.02% - 0.08% w/w bee venom; and

about 10% - 20% w/w extract of the plant of the genus Capsicum,- based on the total amount of ingredients.

In a third aspect the invention provides a composition comprising :

bee venom; and

one or more compounds selected from the group consisting of: capsaicin (8-methyl- N-vanillyl-rrans-6-nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide.

In a fourth aspect the invention provides a composition comprising synergistically effective amounts of:

- bee venom; and

one or more compounds selected from the group consisting of: capsaicin (8-methyl- N-vanillyl-trdns-6-nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide,

Preferably the compound is capsaicin (8-methyl-N-vanillyl-irans-6-nonenamide).

Preferably, the composition further comprises one or more additional components. The one or more additional components may be, for example, one or more bio-active compounds, e.g. one or more drug compounds. The one or more additional components may be, for example, one or more medicaments useful for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition.

Preferably the composition comprises about 0.03% - 0.07% w/w bee venom, more preferably about 0.04% - 0.06% w/w bee venom, still more preferably about 0.04% - 0.05% w/w bee venom, most preferably about 0.04% w/w bee venom. Preferably the composition comprises about 11% - 19% w/w extract of the plant of the genus Capsicum, more preferably about 12% - 18% w/w extract of the plant of the genus Capsicum, still more preferably about 12% - 17% w/w extract of the plant of the genus Capsicum, still more preferably about 13% - 16% w/w extract of the plant of the genus Capsicum, still more preferably about 14% - 15% w/w extract of the plant of the genus Capsicum, most preferably about 15% w/w extract of the plant of the genus Capsicum.

Preferably the composition comprises about 0.04% w/w bee venom and about 15% w/w extract of the plant of the genus Capsicum,

Preferably the bee venom is in the form of bee venom powder.

Preferably the bee venom is from honey bees (Apis mellifera). Preferably the bee venom is in the form of bee venom powder, which powder is prepared by:

- harvesting venom from bees; and

- air drying the venom;

to produce bee venom powder.

Preferably the extract is an extract of the fruit of the plant. Preferably the plant is Capsicum annuum. Preferably the extract is a liquid extract. Preferably the extract is an alcohol extract, more preferably an ethanol extract. Alternatively preferably the extract is an aqueous alcohol extract, more preferably an aqueous ethanol extract. Preferably the extract is an ethanol or aqueous ethanol extract of Capsicum annuum. Preferably the aqueous ethanol extract contains not more than 90% v/v ethanol.

Preferably the composition further comprises one or more excipients. The one or more excipients may be one or more pharmaceutically acceptable excipients. It is preferred that the one or more excipients are selected from the group consisting of: coconut emulsifying wax, distilled water, tincture of benzoin and extra virgin olive oil.

Preferably the composition is a pharmaceutical composition. Preferably the bee venom and extract of the plant of the genus Capsicum are present in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. In another aspect, the invention provides a method of ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition, comprising administering to a patient in need thereof an effective amount of bee venom and an extract of a plant of the genus Capsicum. The bee venom and extract of the plant of the genus Capsicum may be administered to the patient separately, sequentially or simultaneously. Preferably the bee venom and extract of the plant of the genus Capsicum are administered in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition.

In another aspect, the invention provides a method of ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition, comprising administering to a patient in need thereof an effective amount of bee venom and one or more compounds selected from the group consisting of: capsaicin (8-methyl~N~vanillyl-irans-6~nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide. The bee venom and the one or more compounds may be administered to the patient separately, sequentially or simultaneously. Preferably the bee venom and the one or more compounds are administered in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition.

In yet another aspect the invention provides the use of bee venom and an extract of a plant of the genus Capsicum, for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. Preferably the bee venom and extract of the plant of the genus Capsicum are used in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition in a patient.

In yet another aspect the invention provides the use of bee venom and one or more compounds selected from the group consisting of: capsaicin (8-methyl-N-vanillyl-trans-6- nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide, for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. Preferably the bee venom and the one or more compounds are used in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition in a patient. In still another aspect the invention provides the use of bee venom and an extract of a plant of the genus Capsicum, for the manufacture of a medicament for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. Preferably the bee venom and extract of the plant of the genus Capsicum are used in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition in a patient.

In still another aspect the invention provides the use of bee venom and one or more compounds selected from the group consisting of: capsaicin (8-methyl-N-vanillyl-i ^" rans-6- nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide, for the manufacture of a medicament for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. Preferably the bee venom and the one or more compounds are used in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition in a patient.

In still another aspect the invention provides a composition comprising bee venom and an extract of a plant of the genus Capsicum, for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. Preferably the bee venom and extract of the plant of the genus Capsicum are present in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition in a patient.

In still another aspect the invention provides a composition comprising bee venom and one or more compounds selected from the group consisting of: capsaicin (8-methyl-N-vanillyl- trans-6-nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide, for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. Preferably the bee venom and the one or more compounds are present in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition in a patient.

In yet another aspect of the invention there is provided a kit for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition, the kit comprising bee venom and an extract of a plant of the genus Capsicum, together with instructions for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. Preferably the bee venom and extract of the plant of the genus Capsicum are present in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition in a patient.

In yet another aspect of the invention there is provided a kit for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition, the kit comprising bee venom and one or more compounds selected from the group consisting of: capsaicin (8-methyl-N-vanillyl-£rans-6- nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide, together with instructions for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. Preferably the bee venom and the one or more compounds are present in amounts sufficient to provide a synergistic effect in amelioration of the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition in a patient.

Preferably the patient is a human patient.

The bee venom and the extract of the plant of the genus Capsicum may be administered to a patient separately, sequentially or simultaneously. The bee venom and the one or more compounds may be administered to a patient separately, sequentially or simultaneously,

Preferably the bee venom and extract of the plant of the genus Capsicum are provided as a composition. Alternatively preferably the bee venom and the one or more compounds are provided as a composition. Preferably the composition is a composition of the first, second, third or fourth aspect of the invention.

Preferably the bee venom is in the form of bee venom powder. Preferably the bee venom is from honey bees {Apis mellifera).

Preferably the bee venom is in the form of bee venom powder, which powder is prepared by:

- harvesting venom from bees; and

air drying the venom;

to produce bee venom powder. Preferably the extract is an extract of the fruit of the plant. Preferably the plant is Capsicum annuum. Preferably the extract is a liquid extract. Preferably the extract is an alcohol extract, more preferably an ethanol extract. Alternatively preferably the extract is an aqueous alcohol extract, more preferably an aqueous ethanol extract. Preferably the extract is an ethanol or aqueous ethanol extract of Capsicum annuum. Preferably the aqueous ethanol extract contains not more than 90% v/v ethanol.

The arthritis can be osteoarthritis, rheumatoid arthritis, psoriatic or related autoimmune arthritis.

A composition as defined above is referred to herein as a "composition of the invention". DETAILED DESCRIPTION The present invention provides novel compositions comprising bee venom and an extract of a plant of the genus Capsicum and novel compositions comprising bee venom and one or more compounds selected from the group consisting of: capsaicin (8-methyl-N-vanillyl- frans-6-nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide. The compositions of the invention are suitable for use in ameliorating one or more symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. For example, the compositions may be used to reduce pain in patients suffering from arthritis. The invention further provides novel compositions comprising synergisticaiiy effective amounts of bee venom and an extract of a plant of the genus Capsicum and novel compositions comprising synergisticaiiy effective amounts of bee venom and one or more compounds selected from the group consisting of: capsaicin (8-methyl-N-vanillyl-£rans-6- nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide. Although an extract of any suitable plant of the genus Capsicum can be used in a composition of the invention, extracts of the Capsicum annuum are particularly suitable for use in the present invention. The extract is preferably an ethanol or aqueous ethanol extract of the fruit of the Caps/cum annuum. For example, the extract can be a tincture of the fruit of Capsicum annuum. Preferably the tincture contains not more than 90% ethanol.

Those skilled in the art will be familiar with the preparation of such extracts. Typically, the whole fruit is used. This may be crushed and extracted with a suitable solvent, e.g. an organic solvent such as an alcohol, e.g. ethanol. Alternatively a solution of water and ethanol may be used (e.g. about 90-95% ethanol : 5-10% water) . After extraction, the solids (of the fruit) are separated from the liquid extract, for example by filtration, to produce an extract that contains capsaicin and/or one or more other capsaicinoids. The liquid extract thus produced is used without further modification in the compositions of the invention.

Venom harvested from honey bees {Apis mellifera) is particularly preferred for use in the present invention. Upon harvesting from bees, the venom is in a substantially liquid (viscous) form. Bee venom powder is produced by air-drying the harvested venom, typically for a period of 12 to 18 hours. The bee venom powder thus produced is used without further modification in the compositions of the invention.

Those skilled in the art will also be aware that the compounds capsaicin (8-methyI-N- vanillyl-irans-6-nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and/or nonivamide can be used in the compositions of the invention. For example, topical formulations of capsaicin are known to those skilled in the art and capsaicin can be used similarly in the compositions of the present invention.

The invention further provides methods of ameliorating the symptoms of arthritis (including osteoarthritis, rheumatoid arthritis, psoriatic or related autoimmune arthritis), joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition, using bee venom and an extract of a plant of the genus Capsicum. The invention also provides methods of ameliorating the symptoms of arthritis (including osteoarthritis, rheumatoid arthritis, psoriatic or related autoimmune arthritis), joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition, using bee venom and one or more compounds selected from the group consisting of: capsaicin (8-methyl-N-vanillyl-frans-6-nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide.

Those skilled in the art will understand that the compositions of the invention may also comprise one or more additional components, such as one or more bio-active components, e.g. drug compounds or components that are useful for ameliorating the symptoms of arthritis (including osteoarthritis, rheumatoid arthritis, psoriatic or related autoimmune arthritis), joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition.

Those skilled in the art will realise that the bee venom and the extract of the plant of the genus Capsicum or the one or more compounds can be administered to patients in a number of ways, for example, topically. The bee venom and the extract of the plant of the genus Capsicum or the one or more compounds can be administered separately, sequentially or simultaneously. For example, bee venom powder and an extract of a plant of the genus Capsicum can be formulated as a composition of the invention, as described above and in Example 1. Those skilled in the art will also be aware that the compositions of the invention may further comprise one or more excipients. For example, it may be desirable to formulate the bee venom and the extract into a lotion, cream, gel or ointment for topical application. Suitable excipients include, but are not limited to, coconut emulsifying wax, distilled water, tincture of benzoin and/or extra virgin olive oil.

Dosage ranges for the compositions of the invention depend on a number of factors, such as a patient's age, sex and general overall health. For topical application, the amount also depends upon the size of the area to be treated. For a typical adult human, a suitable dosage of a composition as described in Example 1 for covering a small affected area is about 0.5-2 g, preferably about 0.5-1 g, more preferably about 0.5-0.75 g, preferably administered two or three times a day. Similarly, a suitable dosage for covering a larger affected area is about 3-9 g, preferably about 4-8 g, more preferably about 5-7 g, preferably administered two or three times a day. For topical application, it is preferred that the composition of the invention is provided in the form of a cream.

The compositions of the invention can be conveniently packaged into any suitable receptacle such as a tube, jar or other container, for use by patients.

The present invention also relates to devices and kits for patients suffering from arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition. Suitable kits comprise bee venom (preferably bee venom powder) and an extract of a plant of the genus Capsicum (or one or more compounds selected from the group consisting of: capsaicin (8-methyl-N-vanillyl-irans-6- nonenamide), dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin, homocapsaicin and nonivamide) sufficient for at least one dosage, wherein the bee venom and the extract of a plant of the genus Capsicum (or the one or more compounds) can be administered separately, sequentially or simultaneously, together with instructions for use.

The instructions for use of the kit for ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition can be in the form of labelling, which refers to any written or recorded material that is attached to, or otherwise accompanies a kit at any time during its manufacture, transport, sale or use. For example, the term "labelling" encompasses advertising leaflets and brochures, packaging materials, instructions, audio or video cassettes, computer discs, as well as writing imprinted directly on kits.

Definitions

The term "patient" includes human and non-human animals. Non-human animals include, but are not limited to, birds and mammals.

The terms "ameliorating the symptoms of arthritis, joint pain, muscle pain, sports injury, multiple sclerosis, shingles, migraine or a musculoskeletal disorder or condition" and the like refer to ameliorating one or more symptoms of the arthritis or other disorder or condition, e.g. reducing pain and/or inflammation and/or swelling and/or reducing limitation of movement. Throughout the description and the claims, the words "comprise", "comprising" and the like, are intended to be interpreted in an inclusive sense and not an exclusive or exhaustive sense, that is to say, "including, but not limited to".

Any reference or discussion in relation to prior art publications within this specification does not constitute an admission that such references form part of the common general knowledge in the art in any country or jurisdiction.

EXAMPLES The invention is further described with reference to the following examples. It will be appreciated that the invention as claimed is not intended to be limited in any way by these examples.

Preparative Example 1: Preparation of Bee Venom Powder

Bee venom is harvested from honey bees (Apis mellifera). The venom is air dried for approximately 12 hours, to give a powder. The bee venom powder is used in Example 1.

Preparative Example 2: Cayenne Extract

1 :3 tincture of an ethanol/water (approximately 90: 10 EtOH :H ₂ 0) extract of the fruit of Capsicum annuum (country of origin of the fruit: Thailand) in ethanol (not more than 90% v/v ethanol in water) .

Total aerobic microbial count: <10 cfu/mL Total yeast and mould count: <10 cfu/mL

Bile tolerant gram negative bacteria : <10 MPN/mL

Salmonella spp., S. Aureus and E. coli not detected. cfu = colony-forming unit

MPN = Most Probable Number

Example 1: Preparation of a Cream Containing Bee Venom and Liquid Cayenne Extract

Components of the cream:

0.04 g bee venom powder

15 g liquid cayenne extract (tincture in ethanol and water as described in Preparative Example 2)

10 g coconut emulsifying wax

67.46 ml_ distilled water

0.5 g tincture of benzoin

7 g extra virgin olive oil

Total : 100 g

The distilled water is heated and the coconut emulsifying wax is melted into the hot water. This mixture is allowed to cool. The bee venom is mixed with the olive oil. The bee venom and olive oil mixture is mixed with the water and coconut emulsifying wax mixture. The liquid cayenne extract is mixed with the tincture of benzoin. The cayenne and tincture of benzoin mixture is mixed with the water, wax, bee venom and olive oil mixture.

Example 2: Human Trial for Treatment of Arthritis

Participant patients are volunteers suffering from osteoarthritis, rheumatoid arthritis, psoriatic or related autoimmune arthritis. Each patient is provided with a sample of a cream containing bee venom powder and liquid cayenne extract, prepared as described in Example 1. Patients are blinded as to the composition of the cream. Patients are instructed to apply the cream to affected area(s) of their bodies two or three times daily, for 4-12 weeks. The amount applied depends on the size of the area to be treated. For finger joint pain, patients apply an amount sufficient to cover the affected area, typically about 2 cm ² (approximately 0.5-1 g cream). For knee joint pain, patients apply an amount sufficient to cover the affected area, typically about 10 cm ² (approximately 5-7 g cream). Example 3: Short-course Human Trial for Treatment of Arthritis

Participant patients are volunteers suffering from arthritis. Fifteen patients are recruited and ratings are received from nine participant patients. Each patient is provided with a sample of a cream containing bee venom powder and liquid cayenne extract, prepared as described in Example 1. Patients are instructed to apply the cream to affected area(s) of their bodies twice daily, for one week. The amount applied depends on the size of the area to be treated. For example, for finger joint pain, patients apply an amount sufficient to cover the affected area, typically about 2 cm ² (approximately 0.5-1 g cream), and for knee joint pain, patients apply an amount sufficient to cover the affected area, typically about 10 cm ² (approximately 5-7 g cream). Patients rate the cream on a scale of 1 to 10, 1 being not effective, 10 being highly effective. All nine participant patients rate the cream between 5 and 10 (effective to highly effective). Example 4: Comparative Short-course Human Trial for Treatment of Arthritis

Participant patients are volunteers suffering from arthritis. Eight patients are recruited. Each patient is provided with samples of three creams containing (1) bee venom powder, (2) liquid cayenne extract and (3) bee venom powder and liquid cayenne extract. Cream (3) is prepared as described in Example 1. Patients are instructed to apply the creams to affected area(s) of their bodies twice daily, for one week. The amount applied depends on the size of the area to be treated. For example, for finger joint pain, patients apply an amount sufficient to cover the affected area, typically about 2 cm ² (approximately 0.5-1 g cream), and for knee joint pain, patients apply an amount sufficient to cover the affected area, typically about 10 cm ² (approximately 5-7 g cream). Patients rate each cream on a scale of 1 to 10, 1 being not effective, 10 being highly effective. The results show a trend favouring cream (3) which contains bee venom powder and liquid cayenne extract.

Example 5: Panel Testing for Treatment of Musculoskeletal Disorders in Human Patients

Participant patients are volunteers suffering from pain associated with musculoskeletal disorders. Sixty patients are recruited. Each patient is provided with a sample of a cream containing bee venom powder and liquid cayenne extract, prepared as described in Example 1. Patients rate the cream based on improvement in symptoms. Table 1: Affected Areas

Table 2: Panel Results

* cream = cream containing bee venom powder and liquid cayenne extract.

INDUSTRIAL APPLICABILITY

The invention relates to compositions comprising bee venom and an extract of a plant of the genus Capsicum, methods for preparing such compositions and their uses.