| Objective:To observe and analyse the clinical effect and health economic of treating perimenopausal syndrome (PMS) with acupuncture and auricular-plaster, we tried to find an effective and cheap therapy for PMS.Methods:1. Therapeutic effect evaluation:According to the inclusion criteria and exclusion criteria,66 patients with PMS were selected in this study. And the subjects were randomly divided into acupuncture group (33 subjects were treated by acupuncture and auricular-plaster) and drug group (33 subjects were offered with Climen). The subjects needed to be observed for 38 weeks. Evaluated the clinical effect at the end of the-2-0th,4th,12th,16th,24th and 36th week by menopause rating scale (MRS) and menopause-specific quality of life questionnaire (MENQOL)2. Health economic evaluation:The MRS score and MENQOL score were compared with COST to acquire the CER and ICER. In addition, the sensitivity analysis was conducted to validate the reliability of the results further.Results:1. Results of therapeutic evaluation:(1) According to consistent baselines, two groups of subjects were comparable.(2) ①Comparison within each group:results of the MRS score and MENQOL score had significant difference in the therapeutic period compared with the baseline period (P<0.05). At the end of the 12th week, the scores reached the troughs. However, they rose again in the follow-up period, and almost returned to baseline levels at the end of the 36th week. ② Comparison between 2 groups:in the therapeutic period, the MRS score was significantly different between 2 groups, and acupuncture group had higer scores than drug group (P<0.05). But there was an opposite situation at the end of the 16th week and the 24th week, and the difference was significant (P< 0.05). And the difference faded away at the last evaluation time point. On the other hand, the results of MENQOL score was almost as same as the MRS’s, except for the comparison at the end of the 12th week. At this evaluation time point, there was no significant difference between 2 groups in the aspect of the MENQOL score.2. Results of health economic evaluation:(1) The total COST of acupuncture group was always higher than drug group (P< 0.05), no matter in the therapeutic period or in the follow-up period.(2) Compared with drug group: ①From the perspective of CER, to decrease each point of the MRS score, acupuncture group needed additional cost were ¥464.62 at the end of the therapeutic period, ¥82.36 at the end of the 16th week and ¥10760.06 at the end of the 36th week. However, at the end of 24th week, acupuncture group reduced the cost of ¥1549.62. Meanwhile, acupuncture group needed additional cost were ¥161.52, ¥71.84 and 16866.11 respectively at the end of the 12th, the 16th and the 36th week to decrease each point of the MENQOL score, and it might reduce the cost of ¥849.40 at the end of the 24th week. ② From the perspective of ICER, at the end of the therapeutic period and the 36th week, ICER was less than zero, because of the acupuncture group’s much higher cost and lower effect than the drug group’s. Moreover, at the rest evaluation time points, the acupuncture group needed ¥906.42 and ¥849.40 respectively to decrease addition 1 point of the MRS score, and ¥443.61 and ¥468.12 respectively to decrease addition 1 point of the MENQOL score.(3) The sensitivity analysis supported the results when the effect value of each group was change in the therapeutic period, but not in the follow-up period. And it didn’t support the result of the MRS score when the price of intervention measure were intervened at the end of the 16th week, but supported the result of the MENQOL score the whole study period.Conclusions:Acupucture as a therapy for PMS is safe and effective. Compared with Climen: acupuncture treatment for PMS may have worse short-term effect, but better long-term effect. And acupuncture treatment for PMS may have no economic advantages from the perspective of CER and ICER in the therapeutic period and within 4 weeks after treatment, but may have economic advantages in the 4-12 weeks after treatment. And by enhancing the therapeutic effect and reduce the cost of acupuncture may improve the Cost-Effect advantages or the duration of the Cost-Effect advantages could be extended. |