Spss v 19.0 software for windows

All collected data were analyzed using the SPSS v. 19.0 software for Windows (SPSS Inc., Chicago, IL, USA), and the corresponding 95% confidence intervals (CIs) were calculated. We used the intention-to-treat analysis and applied the last observation carried forward method for missing data. Descriptive statistics were used to summarize the data. To analyze the effectiveness, we compared the changes in each value with time among the groups and with time changes. For the response rate, the visit 1 (week 1) and visit 10 (week 5) values were compared. For the discrete variables (e.g., response rate), the chi-square test or Fisher's exact test were used. For the continuous variables (e.g., THI and VAS scores), if the normality test results followed a normal distribution, data were analyzed by analysis of variance (ANOVA). The Kruskal–Wallis test was used when a normal distribution was not observed.

We felt that a difference of 2 points in mean TMVS between the two groups would be clinically significant. An earlier study conducted in Thailand had used a similar scoring system and we adopted the standard deviation in their study results for our estimation[15 (link)]. The calculated sample size for each group was 24 patients (SD 2.4, 2 sample t test, P < 0.05, 80% power). Assuming that the drop-out rate could be around 10%, we aimed to recruit 27 patients per group.
All categorical variables were analysed with Pearson Chi-square test and all continuous variables were analysed with 2-sample t test, using SPSS V.19.0 software for Windows (SPSS Inc, Chicago, Illinois, United States). P < 0.05 was deemed statistically significant.