Eleven patients were included in the Dong Quai group and 11 in the placebo arm. The patient demographics were similar for both groups (). The patients’ ages ranged from 72.5 to 74.0. The mean values at study entry for PSA, INR and PTT were 0.25, 1.04 and 31.4, respectively. Five patients, 3 from the placebo group and 2 patients from the Dong Quai group, withdrew from the study for reasons including gastrointestinal upset, headache, no perceived benefits, unrelated head injury and scheduling conflicts. No patient reported taking the active study drug from an over-the-counter preparation.
To understand the magnitude of the patients’ symptoms, all patients completed questionnaires which revealed that 47.6% had trouble sleeping due to hot flashes. Only 4.8% had tried alternative treatments to resolve their hot flashes prior to their participation in this trial.
In the initial 1-month run-in, the placebo group had an average of 3.42 ± 1.42 vasomotor episodes per day while the Dong Quai group had 6.80 ± 4.33 episodes (p = 0.02). The severity of the episodes averaged 3.64 ± 1.37 in the placebo group versus 3.76 ± 1.67 in the Dong Quai group. The duration of the vasomotor symptoms lasted on average 4.83 ± 3.38 minutes in the placebo group and 3.33 ± 1.45 minutes in the Dong Quai group ().
The average number of vasomotor events experienced by the placebo group was 3.55 in the first month, 3.58 in the second and 2.84 in the third. The average number of vasomotor episodes for the Dong Quai group was 6.9 in the first month, 6.86 in second month and 6.43 in third month. Comparatively, there was no significant change in the daily number of vasomotor events in either group ().
Vasomotor events per day. Overall the Dong Quai group experienced more hot flashes than the Placebo group (p = 0.02). There was no change in the number of daily vasomotor events in either group (p = not significant).
The mean duration of hot flashes in the placebo group in the first month was 4.07 minutes, 4.1 minutes in the second and 3.52 in the third. Patients in the Dong Quai group experienced hot flashes for a mean time of 2.99 minutes in the first month, 3.28 in the second and 2.82 in the third. Neither group experienced a significant change in the average duration of their vasomotor events ().
Duration of vasomotor event. Hot flashes were of similar duration in both the placebo and Dong Quai groups (p = 0.19). There was no change in the duration of vasomotor events in either group (p = not significant).
The average hot flash severity subjectively recorded by patients in the placebo group in the first month was 3.66, in the second month was 3.66 and in the third month was 2.47. The patients in the Dong Quai group experienced 3.87 in severity of hot flashes in the first month, 3.27 in the second month and 3.71 in the third month. Vasomotor events were of similar severity in both groups (p = 0.79) (). The calculated percent change in perceived hot flash severity was similar in both groups ranging from 78 to 112% for the placebo group and 93 to 116% for the Dong Quai group ().
Percent change in perceived hot flash severity. Vasomotor events were of similar severity in both groups (p = 0.79). There was no change in the severity of hot flashes experienced by either group (p = not significant).
Coagulation studies were obtained for each patient in both groups before starting the study and at completion. Baseline and follow-up studies were normal in all patients. There were no clinical bleeding problems during the study interval.
The average baseline serum PSA for the placebo group was 0.21, however this increased to 1.11 at the end of the study due to one patient’s progression to androgen refractory disease while in the study. In the Dong Quai group the mean baseline PSA was 0.3 and 0.39 at the end of the study ().