A study published in BMJ Open investigated the efficacy and safety of an over-the-counter cough treatment containing diphenhydramine, ammonium chloride and levomenthol in a cocoa-based demulcent.

This was a multicenter, randomized, parallel group, controlled, single-blinded study that enrolled patients with acute upper respiratory tract infection-associated cough. Overall, 163 individuals aged ≥18 years (mean age 38 years) who self-reported to a GP or pharmacist with acute cough of <7 days duration, were selected. Participant inclusion criterion was cough severity ≥60 mm on a 0-100 mm visual analogue scale (VAS).

Participants were randomised to CS1002 or simple linctus (SL) – a widely used cough treatment, and treatment duration was 7 days or until resolution of cough.

The results showed that at day-4, the adjusted mean difference in cough severity VAS between CS1002 and SL was -5.9 mm. At the end of the seventh day, the mean difference in cough severity VAS was -4.2 mm. It was found that CS1002 was associated with a greater reduction in cough sleep disruption and cough frequency compared to SL. There was greater improvement in Leicester Cough Questionnaire (LCQ-acute)-acute quality of life scores with CS1002 compared with SL after 5 days treatment. In addition, more participants prematurely stopped treatment due to cough improvement in the CS1002 group (24.4%) compared with SL (10.7%). Adverse events (AEs) were comparable between CS1002 (20.5%) and SL (27.6%). However, six participants (7%) in the CS1002 group reduced the dose of medication due to drowsiness/tiredness, which subsequently resolved.

The findings indicated that CS1002 was associated with greater reductions in cough frequency, sleep disruption and improved health status compared with SL.

 

Source: BMJ Open. 2017 Jan 16;7(1):e014112. doi: 10.1136/bmjopen-2016-014112.