Public Healthcare Professionals

Clinical evidence

Clinical evidence on DifflamTM

Considerable evidence from randomised, controlled trials has shown that Difflam™ fulfils many of the requirements of an ideal oral anti-inflammatory, analgesic, and anaesthetic agent. 1 Topical Benzydamine Hydrochloride is widely used, well tolerated and has minimal risk of side effects. 1,3 It is also suitable for the treatment of children and adults of all ages. 4 


Studies Supporting Difflam™

The information below outlines the findings of a number of studies supporting Difflam™
and its active ingredient, Benzydamine Hydrochloride:

Difflam™ contains the active ingredient Benzydamine Hydrochloride which, after topical administration,
is absorbed locally becoming concentrated in the inflamed tissue. 1

Benzydamine Hydrochloride is classed as a locally acting, non-steroidal anti-inflammatory drug (NSAID),
but has a different mechanism of action from other NSAIDs. In fact, Benzydamine Hydrochloride has local
anaesthetic effects and gastroprotective effects (where topical administration is not associated with the
gastrointestinal irritation seen with systemic NSAIDs). Benzydamine Hydrochloride exerts an anti-
inflammatory and analgesic effect by stabilising the cellular membrane and inhibiting prostaglandin
synthesis. Studies have shown that the analgesic action of Benzydamine Hydrochloride is independent
from its anti-inflammatory action. 2-5 


For the treatment and prevention of sore throats
Topical Benzydamine Hydrochloride has been shown to provide significant symptom relief as measured by reduced pain, reduced inflammation, and a reduced use of analgesics in patients. 1.6

For post-tonsillectomy and post-operative sore throat
Benzydamine Hydrochloride has also been shown to prevent sore throat post-operatively for as long as 24 hours, whilst evidence supports the use of Difflam™ in both adults and children. 6,7

Routine prophylactic use of Difflam™ has been shown to help prevent ulceration and pain during radiotherapy 8,9

Topical Benzydamine Hydrochloride has been shown to have significant effects in preventing ulceration and pain during radiotherapy, even on severe mucositis with severe pain. 8,9

After dental surgery
Studies have supported the anti-inflammatory, analgesic and anaesthetic effects of Difflam™ after dental surgery. The anti-inflammatory effects of Benzydamine Hydrochloride have also been suggested to accelerate the healing process. 1,10

For relief from pains and sprains, strains and sports injuries
Studies have supported the anti-inflammatory and analgesic effects of Difflam™ 3% Cream and Difflam™ - P 3% Cream associated with an excellent penetration of the skin and an early reduction in odema and pain as a consequence. 11

Difflam™ acts fast to provide lasting relief from pain 3-7


Difflam™ Oral Rinse is indicated for the relief of painful inflammatory conditions of the throat including pharyngitis (sore throat). Difflam™ Oral Rinse contains the active ingredient Benzydamine Hydrochloride. The other ingredients are ethanol (96% v/v), glycerol, saccharin sodium BP, mouthwash flavour, 52 503/T, polysorbate 20, methyl hydroxybenzoate quinoline yellow (E104), patent blue V (E131), purified water. 5

This site is designed for UK healthcare professionals only. If you are not a UK healthcare professional please contact your GP or click here to return to the Difflam™ homepage for more information.

References

1. Alamazan NA. Benzydamine HCI 0.15% for oropharyngeal diseases and surgeries: a review of clinical trials. Philippine Scientific Journal 2010; 42: 37-42.

2. Quane PA et al. Pharmacology of benzydamine. Inflammopharmacology 1998; 6(2): 95-107.

3. Difflam™ Sore Throat Rinse, Summary of Product Characteristics. March 2015. 

4. Difflam™ Spray, Summary of Product Characteristics. March 2015.

5. Difflam™ Oral Rinse, Summary of Product Characteristics. March 2015.

6. Agarwal A et al. An evaluation of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective sore throat: a prospective, randomized, single-blind study. Anesth Analg 2006; 103(4): 1001-1003.

7. Hung NK et al. Effect on postoperative sore throat of spraying the endotracheal tube cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine. Anesth Analg 2010; 111(4): 882-886. 

8. Epstein JB et al. Benzydamine HCI for prophylaxis of radiation-induced oral mucositis: results from a multicentre, randomized, double-blind, placebo-controlled clinical trial. Cancer 2001; 92(4):875-885. 

9. Kazemian A et al. Benzydamine for prophylaxis of radiation-induced oral mucositis in head and neck cancers: a double-blind placebo controlled randomized clinical trial. Eur J Cancer Care (Engl) 2009; 18(2): 174-178. 

10. Fedorowicz Z et al. Oral rinses, mouthwashes and sprays for improving recovery post tonsillectomy. Cochrane Review; 2010.

11. Alonso-Barajas Martinez, Ricardo. Clinical trial on 3% Benzydamine ointment, used for the topical treatment of inflammatory processes, in 827 patients. Medicamenta 1969, 51 (No 463): 365 - 372