Efficacy of a single evening dose of a syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold symptoms

In Mizoguchi 2007, five (2%) participants receiving the active medication experienced nine adverse effects, and nine (4%) participants receiving the placebo experienced 10 adverse effects.

“In Mizoguchi 2007, five (2%) participants receiving the active medication experienced nine adverse effects, and nine (4%) participants receiving the placebo experienced 10 adverse effects.”

In pooled data from two trials, measured in the morning after an evening dose, significantly more participants evaluated the active evening dose treatment as beneficial (OR 0.47, 95% CI 0.33 to 0.67; 2 studies, 548 adults; low certainty evidence due to risk of bias and imprecision).

“Measured in the morning after an evening dose, significantly more participants evaluated the active evening dose treatment as beneficial (OR 0.47, 95% CI 0.33 to 0.67; 2 studies, 548 adults; low certainty evidence due to risk of bias and imprecision; Analysis 4.1).”

In Mizoguchi 2007, more participants receiving active treatment rated their overall symptom relief during the night as 'good' or 'very good' on rising the following morning (50.2% versus 31.9%).

“more participants receiving the active treatment rated their overall symptom relief during the night as 'good' or 'very good' on rising the following morning (50.2% versus 31.9%).”

In Mizoguchi 2007, the severity rating with active treatment was significantly lower than with placebo (P < 0.001).

“The severity rating with active treatment was significantly lower than with placebo (P < 0.001)”

In Mizoguchi 2007, two participants in the active treatment group and one participant in the placebo group experienced somnolence.

“In Mizoguchi 2007, two participants in the active treatment group and one participant in the placebo group experienced somnolence.”

Adverse effects were reported in five trials and included drowsiness, somnolence, gingival swelling, hypersomnia, insomnia, dizziness, palpitations, giddiness, diarrhoea, headache, abdominal pain, and vomiting.

“Adverse effects were reported in five trials and included drowsiness, somnolence, gingival swelling, hypersomnia, insomnia, dizziness, palpitations, giddiness, diarrhoea, headache, abdominal pain, and vomiting (Blanco 2000; Mizoguchi 2007; Thackray 1978; Unuvar 2007; Zhang 2018).”

The antihistamine-decongestant-analgesic combination showed some effect on global effectiveness in two trials (Mizoguchi 2007; Thackray 1978).

“The combination showed some effect in two trials (Mizoguchi 2007; Thackray 1978).”

In Mizoguchi 2007, at both evaluation times, severity scores for cough were significantly lower with the active treatment (P = 0.0004 and P < 0.001).

“In Mizoguchi 2007, at both evaluation times, severity scores were significantly lower with the active treatment (P = 0.0004 and P < 0.001).”

In Mizoguchi 2007, the difference in severity score for nasal obstruction was at most 0.29 on a five-point severity scale.

“the difference in severity score was at most 0.29 on a five‐point severity scale (Mizoguchi 2007).”

In Mizoguchi 2007, the change in severity score for cough was at most 0.42 severity points on a five-point severity scale.

“change in severity score was at most 0.42 severity points on a five‐point severity scale.”

Two trials showed some effect of an antihistamine-decongestant-analgesic combination on cough (Mizoguchi 2007; Thackray 1978).

“Two trials showed some effect (Mizoguchi 2007; Thackray 1978).”

The combination of antihistamine-analgesic-decongestant was more effective than control in two of the five trials, one of which was large and of high methodological quality (Mizoguchi 2007).

“The combination of antihistamine‐analgesic‐decongestant was more effective than control in two of the five trials, one of which was large and of high methodological quality (Mizoguchi 2007).”

In Mizoguchi 2007, severity of runny nose was significantly lower with active treatment at both evaluation times (P = 0.017 and P = 0.001).

“At both evaluation times, severity scores were significantly lower with active treatment (P = 0.017 and P = 0.001).”

In Mizoguchi 2007, severity scores of nasal congestion were significantly lower with active treatment at both evaluation times (P = 0.012 and P = 0.002).

“Severity scores were significantly lower with active treatment at both evaluation times (P = 0.012, and P = 0.002).”

In Mizoguchi 2007, the difference in severity score for rhinorrhoea was at most 0.33 severity points on a five-point severity scale.

“the difference in severity score was at most 0.33 severity points on a five‐point severity scale.”

The review found some evidence of effectiveness in cough in adults with the combination of antihistamine-analgesic-decongestant, mainly due to one trial not included in Smith's review (Mizoguchi 2007).

“In our review we found some evidence of the effectiveness in cough in adults with the combination of antihistamine‐analgesic‐decongestant, which was mainly due to the results of one trial not included in the review by Smith (Mizoguchi 2007).”

The active treatment in the Mizoguchi 2007 trial also contained dextromethorphan.

“However, the active treatment in this trial also contained dextromethorphan.”