Subjects A total of 327 subjects were recruited with 162 and 165 patients wind-cold and wind-heat syndrome, respectively. In the wind-cold syndrome group, 153
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FIGURE 1 Patient randomization and follow-up ﬂow chart
Treatment effectiveness of two CHM formulae in URTIs CHM formulae in URTIs Treatment
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(94%) completed the study. In the wind-heat syndrome group, 158 (96%) patients completed the study (Fig. 1). Twelve patients were lost to contact, two patients withdrew from the treatment on Day 2 because they thought the treatments were ineffective and two patients withdrew from the trial because of adverse effects that subsided immediately after the medication was stopped. Compliance with study medication was high as measured by patient report and by sachets counts (72.0% for wind-cold treatment, 62.5% for wind-cold placebo, 85.4% for wind-heat treatment and 78.3% for wind-heat placebo). Patient baseline characteristics are shown in Table 1. There were no signiﬁcant differences between treatment and placebo groups in socio-demographic distributions, the mean number of URITs contracted in previous year, smoking history or severity of symptoms. Symptoms resolution. Overall, 70% and 90% of patients had complete resolution of symptoms on Day
10 and Day 21, respectively. There was no statistically signiﬁcant difference between the treatment and placebo groups in individual symptoms or days with complete symptom resolution overall or by wind-cold or wind-heat syndrome groups (Table 2). The proportion of patients’ resolution did not reach any statistical signiﬁcance between treatment or placebo groups. Most symptoms resolved in a median of 3 days and completely subsided by Day 10. Cough was the symptom that persisted for the longest with a median of 4 days (Table 3). But 7.2% of patients in the treatment group still had cough by Day 21....