Combination preparations (herbal)

Fixed combinations of herbal substances or preparations in herbal medicinal products are not only traditionally used, but have also proven themselves many times in the practice of medicine. Drug combinations can also be used as individual formulations if (as is often the case) the desired fixed combination is not available.

Numerous fixed combinations are authorised as herbal medicinal products or registered as traditional herbal medicinal products. They have been monographed by Commission E as positive if the following effects are present:

• improvement of the main action of a combination partner (additive or super-additive and/or synergistic effect)
• Reduction of adverse drug reactions (ADRs) of a combination partner
• Improvement of therapy safety through the combination

Examples of such applications are the standard approvals for bladder and kidney tea infusions, gastrointestinal teas or teas for colds.

Disadvantages of medicinal herbal combinations are the loss of individual treatability and possible complications with pharmacokinetics.

Fixed herbal medicinal product combinations positively monographed by Commission E:

• Adonis herb + Lily of the valley herb
• Adonis herb + Lily of the valley herb + Sea onion dry extract + Oleander leaves
• Adonis herb + lily of the valley herb + sea onion dry extract + oleander leaves + homeopathic tuber.
• Adonis herb + Lily of the valley herb + Sea onion dry extract+/Oleander leaves + non-heart drugs
• Adonis herb + Lily of the valley herb + Sea onion dry extract + Oleander leaves + Ammi-visnaga fruit.
• Adonis herb + Lily of the valley + Sea onion dry extract + Oleander dry extract
• angelica root + gentian root + caraway
• angelica root+ gentian root+ fennel
• angelica root+ gentian root+ bitter orange peel
• angelica root+ gentian root+ wormwood
• angelica root+ gentian root+ wormwood+ peppermint oil
• anise+ ivy leaves+ fennel+ liquorice root
• anise+ marshmallow root+ eucalyptus oil+ liquorice root
• Anise + marshmallow root + Icelandic moss + liquorice root
• anise+ marshmallow root+ primrose root + sundew
• anise+ fennel+ caraway
• anise+ lime blossom+ thyme herb
• Anise oil + Icelandic moss
• Anise oil + fennel oil + caraway oil
• Anise oil + fennel oil + liquorice root + thyme herb
• Anise oil + primrose root + thyme herb
• Atropa belladonna + other drugs
• bearberry leaves + goldenrod + orthosiphon leaves
• Valerian root + hop cone
• Valerian root + hop cone + lemon balm leaves
• Valerian root + hop cone + passion flower herb
• birch leaves + goldenrod + orthosiphon leaves
• Camphor + eucalyptus oil + purified turpentine oil
• ivy leaves + liquorice root + thyme herb
• marshmallow root + fennel + Iceland moss + thyme herb
• marshmallow root + primrose root + liquorice root + thyme oil
• Eucalyptus oil + pine needle oil
• Eucalyptus oil + primrose root + thyme herb
• Grindelia + primrose root + thyme
• Ginger root stick + gentian root + wormwood
• Javanese turmeric + peppermint leaves + wormwood
• caraway + fennel
• caraway + fennel + camomile flowers
• Caraway oil + fennel oil
• Caraway oil + fennel oil + camomile flowers
• Dandelion root with -weed + peppermint leaves + artichoke leaves
• Dandelion root with -weed + celandine + wormwood
• Lily of the valley herb + sea onion
• Milk thistle fruits + peppermint leaves + wormwood
• Passion flower herb + valerian root + lemon balm leaves
• peppermint leaves+ fennel
• peppermint leaves + caraway
• peppermint leaves + fennel + camomile flowers
• peppermint leaves + camomile flowers + caraway
• peppermint leaves + caraway + fennel
• peppermint leaves + caraway + fennel + camomile flowers
• peppermint leaves + caraway + camomile flowers + bitter orange peel
• Peppermint oil + fennel oil
• peppermint oil + caraway oil
• Peppermint oil + fennel oil + camomile blossoms
• Peppermint oil + caraway oil + fennel oil
• Peppermint oil + caraway oil + camomile flowers
• Peppermint oil + caraway oil + fennel oil + camomile flowers
• Primrose root + marshmallow root + aniseed
• Primrose root + thyme herb
• Primrose root + Sundew + Thyme
• Senna leaves + Indian flea seed husks
• Senna leaves + peppermint oil + caraway oil
• Sundew + thyme
• star anise + thyme
• liquorice root + chamomile flowers
• liquorice roots + peppermint leaves and camomile flowers
• liquorice root + primrose root + marshmallow root + aniseed
• Thyme herb + white soap root
• Thyme + ivy leaves

With regard to quality requirements, the same requirements apply in principle as for herbal medicinal products containing only one drug or for a non-herbal medicinal product containing only one active substance. A substantial part of the herbal combination preparations were refused a marketing authorisation by the BfArM, as cost-intensive multi-arm GCP studies on their efficacy could not be carried out for cost reasons. In these cases only the individual formulation remains.