Double Blind Trial in General Practice Comparing the Efficacy of “Benylin Day and Night” and Paracetamol in the Treatment of the Common Cold

In Middleton 1981, significantly more participants receiving active nighttime medication compared with paracetamol responded affirmatively to the question about whether the tablets helped: 73% versus 52% (OR 0.35, 95% CI 0.18 to 0.70; 191 adults; moderate certainty evidence).

“In Middleton 1981, overall subjective assessment was measured at the end of the study by asking “on the whole do you think the tablets have helped you?”. Significantly more participants receiving the active nighttime medication compared with the control group (paracetamol) responded affirmatively to the question: 73% versus 52% (OR 0.35, 95% CI 0.18 to 0.70; 191 adults; moderate certainty evidence”

In Middleton 1981, the severity of nasal obstruction was not significantly different between treatment and placebo groups.

“In Middleton 1981, the severity of nasal obstruction was not significantly different between treatment and placebo groups.”

In three trials, dry mouth occurred in 2.6% of participants in the active treatment group and 1.8% in the control group (OR 1.43, 95% CI 0.53 to 3.83; 3 studies, 764 adults; low certainty evidence).

“In three trials dry mouth was noted as an adverse effect (Eccles 2006a; Middleton 1981; Sperber 2000), occurring in 2.6% of participants in the active treatment group and 1.8% of participants in the control group (OR 1.43, 95% CI 0.53 to 3.83; 3 studies, 764 adults; low certainty evidence due to imprecision and inconsistency; Analysis 3.4).”

Both Gwaltney 2002 and Middleton 1981 failed to show a significant effect of active treatment compared with placebo or paracetamol on mean severity scores for nasal obstruction, rhinorrhoea, and cough.

“Both trials failed to show a significant effect of the active treatment compared with placebo or paracetamol on mean severity scores for nasal obstruction, rhinorrhoea, and cough.”

In Middleton 1981, 11 of 79 participants receiving paracetamol and 9 of 82 receiving active treatment mentioned adverse effects (P = 0.57).

“In Middleton 1981, both combinations (day and night) were evaluated together: 11 of 79 participants receiving paracetamol and nine of 82 participants receiving the active treatment mentioned adverse effects (P = 0.57).”

In Middleton 1981, drowsiness was mentioned by five participants receiving paracetamol and four receiving combination therapy (P = 0.68).

“In Middleton 1981, drowsiness was mentioned by five participants receiving paracetamol and four participants receiving the combination therapy (P = 0.68).”

In Middleton 1981, significantly more participants receiving active daytime medication compared with paracetamol responded affirmatively to the question about whether the tablets helped: 73% versus 52% (OR 0.28, 95% CI 0.15 to 0.52; 181 participants; moderate certainty evidence).

“Significantly more participants receiving the active daytime medication compared with the control group (paracetamol) responded affirmatively to the question: 73% versus 52% (OR 0.28, 95% CI 0.15 to 0.52; 181 participants; moderate certainty evidence) (Analysis 3.1).”

In four trials, 3.8% of participants in the active treatment group and 0.8% in the control group suffered from dizziness; the difference was significant (P = 0.009); OR 2.86 (95% CI 1.02 to 8.01; 4 trials, 1287 adults; high certainty evidence).

“In four trials, 3.8% of participants in the active treatment group and 0.8% of participants in the control group suffered from dizziness (Loose 2004; Middleton 1981; Sperber 1989; Sperber 2000). This difference was significant: P = 0.009. The OR of dizziness in the active treatment group was 2.86 (95% CI 1.02 to 8.01; 4 trials, 1287 adults; high certainty evidence; Analysis 3.6).”

There was no significant effect of an analgesic-decongestive combination on the subjective severity of sneezing.

“There was no significant effect.”

The same two trials evaluated the effect on cough and found no effect.

“The same two trials also evaluated the effect on cough, finding no effect (Middleton 1981; Sperber 2000).”

None of the three trials assessing subjective severity of rhinorrhoea showed a favourable treatment effect.

“None of these trials showed a favourable treatment effect.”