Efficacy and Safety of Acupuncture for the Hot Flashes in Breast Cancer Patients Taking Adjuvant Tamoxifen : A Multicenter Study in Korean Women

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1 Efficacy and Safety of Acupuncture for the Hot Flashes in Breast Cancer Patients Taking Adjuvant Tamoxifen : A Multicenter Study in Korean Women Daegu Catholic University Medical Center Department of Endocrine & Breast Sugery Herion Choi

2 Introduction Breast cancer 2 nd most common cancer in Korean women

3 Introduction Adjuvant antiestrogen therapy - Tamoxifen Hot flashes Contraindication of HRT Non-hormonal modalities for hot flashes Clonidine, SSRI, SNRI, gabapentin Complementary medicines - Acupuncture

4 Introduction THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 19, Number 8, 2013, pp

5 Introduction Prospective, single-arm, observational study 10 Korean women with breast cancer Effective relief from hot flashes Effects lasted for at least 1 month after termination of treatment

6 Purpose To evaluate the efficacy and safety of acupuncture for treatment of hot flashes in Korean women breast cancer patients taking tamoxifen as adjuvant endocrine therapy Randomized Controlled Multicenter Interventional Study

7 Patients & Method Study Period ㅣ March 2017 September 2017 Recruitment ㅣ April 2017 June 2017 Data Collection ㅣ April 2017 July Korean women breast cancer patients taking tamoxifen and reported moderate to severe hot flashes Acupuncture group(n=15) Control group(n=15)

8 Patients & Method Primary end point Peak Hot Flash 100mm VAS (Visual analogue scale) Hot Flash Score (Frequency * grade) Secondary end point EORTC QLQ C-30 QLQ BR-23

9 Patients & Method Inclusion Criteria Pre- or postmenopausal status Moderate or severe vasomotor symptoms 3 or more hot flashes / wk Karnofsky performance score of > 60 Voluntary participation Cessation of HRT or other pharmacologic or alternative treatments for hot flashes at least 4 weeks before the trial Exclusion Criteria Pharmacologic or other alternative treatment for hot flashes during the trial Serious medical or psychiatric conditions Hot flashes caused by menopause

10 Patients & Method Intervention 4 wks of treatment with 3 acupuncture sessions/wk 20 ± 5 minutes duration Performed by a traditional Korean medicine (TKM) physician 10-20mm depth 5 points using 8 disposable stainless steel needles (GV 20, M-HN-3, HT 8, KI 10, LV 2)

11 Wk Visit Sc Sc AC V/S VAS/ HFS EORTC AE Comp Sc : Screening, AC : Acupuncture, V/S : Vital Sign, HFS : Hot flash score AE : Adverse event, Comp : Compliance

12 Baseline characteristics Results Variable Group N(%) or mean±sd Acupuncture group Control group P-value Age (years) 48.73± ± Weight (Kg) 62.75± ± Height (cm) 160.6± ± Invasive cancer 14(93.3) 12(80) Duration of tamoxifen(months) 35.27± ± Premenopause 15(100) 14(93.3) 1.000

13 Effects of Acupuncture on Vital Sign Ac Ct Ac Ct DBP SBP Results Visit Visit No Statistically significant vital sign change during the treatment period in both Acupuncture group and Control group Ac Ct AC Ct BT PR Visit Visit

14 Results Effects of Acupuncture on Hot Flash VAS & Hot Flash Score Time, mean(sd) p-value Variable Group V1 1) V4 2) V7 3) V10 4) V13 5) V14 6) T G T*G * Acupuncture.000* Hot flash (18.46) (11.93) (14) (14.6) (13.56) (13.45) 1 1>2,3,4.000* VAS ,3,4,5, Control,5,6 (12.65) (14.24) (15.52) (18.21) (17.92) (22.95) * Acupuncture Hot Flash (4.29) (4.21) (4.34) (3.27) (1.91) (2.88) Score ,3,4,5, Control (5.66) (14.25) (23.04) (20.22) (30.88) (25.72) 6 * : Statistically significant with p<0.05 : Multiple comparison result by contrast

15 Results VAS Ac Ct HFS AC Ct Visit Visit Severity of hot flashes was significantly reduced in Acupuncture group during the treatment period The reduction in symptoms was maintained until week 8

16 Effects of Acupuncture on EORTC QoL Questionnaire Results Variable EQC30 Global Health status EQC30 Functional scale EQC30 Symptom scale EQBR23 Functional scale EQBR23 Symptom scale Time, mean(sd) p-value Group V1 1) V13 2) V14 3) T G T*G Acupuncture 49.44(21.01) 65.01(22.09) 69.99(16.3) Control 59.45(19.64) 58.89(16.52) 53.33(19.6) Acupuncture 71.25(15.05) 80.22(7.3) 81.26(11.98).009* Control 76.23(9.76) 76.43(11.02) 77.19(9.75) Acupuncture 29.51(16.32) 21.41(10.78) 18.65(10.62).001* Control 24.99(9.23) 22.17(12.35) 20.77(10.95) Acupuncture 41.11(17.18) 42.16(14.23) 47.33(16.04).036* Control 31.71(14.92) 31.99(16.47) 34.89(15.22) Acupuncture 33.79(17.29) 22.85(11.79) 22.55(12.96).001* Control 28.31(12.96) 23.28(12.46) 24.07(10.11) 1<2, * 1 2,3.027* 1 2,3 1>2> <2< >2, * : Statistically significant with p<0.05 : Multiple comparison result by contrast

17 Results EORTC QLQ C-30 Global Health Ac Ct EORTC QLQ C-30 Functional Scale AC Ct Visit Visit QoL of Acupuncture group is improved during the treatment period The improvement of QoL was lasted for 1month after the Tx cessation

18 Safety Results Group (N, (%)) Variable p-value Acupuncture Control AE 0(0) 0(0) N/A SAE 9(0) 0(0) N/A Medical Hx Exist 4(26.7) 3(20.0) None 11(73.3) 12(80.0) * : Statistically significant with p<0.05 AE: Adverse Event, SAE : Serious Adverse Event Acupuncture was safe in patients with underlying disease

19 Conclusions Acupuncture can be a useful and safe alternative treatment for alleviation of facial flashes in patients with breast cancer who are undergoing antiestrogen therapy The effects lasted for at least 1 month after termination of treatment Small sample size Limitations Short follow-up period Lack of the method to rule out placebo effect

20 Thank you for your attention