Objective: Uncontrolled intervention studies, including studies involving breast cancer survivors, have demonstrated improvements in vasomotor symptoms (VMS) after stellate ganglion blockade (SGB) with a local anesthetic. This study presents the first randomized sham-controlled trial of SGB for the treatment of VMS.
Methods: Participants included 40 postmenopausal women, aged 30 to 70 years, with moderate to severe VMS. The study was a randomized sham-controlled trial comparing the effects of SGB versus sham injection on the frequencies of total and moderate to severe VMS, as measured by daily diaries. Image-guided SGB was performed with 5 mL of 0.5% bupivacaine. Sham injection of saline was performed in subcutaneous tissues in the neck. VMS were recorded at baseline and for 6 months thereafter. Objective VMS were recorded using ambulatory sternal skin conductance monitoring during a 24-hour period at baseline and on 3-month follow-up.
Results: There were no significant group differences in overall VMS frequency, but the frequency of moderate to very severe VMS was reduced more in the active group compared with the sham treatment group (event rate ratio, 0.50; 95% CI, 0.35-0.71; P < 0.001). The frequency of objective VMS was also reduced to a greater degree in the SGB group than in the sham group (event rate ratio, 0.71; 95% CI, 0.64-0.99; P < 0.05). There were no study-related serious adverse events.
Conclusions: SGB may provide effective treatment of VMS in women who seek nonhormonal treatments because of safety concerns and personal preference. The finding that SGB significantly reduces objectively measured VMS provides further evidence of efficacy. A larger trial is warranted to confirm these findings.
From the 1Department of Anesthesiology, The Feinberg School of Medicine of Northwestern University, Chicago, IL; 2Department of Psychiatry, The University of Illinois at Chicago College of Medicine, Chicago, IL; 3Department of Obstetrics and Gynecology, The Feinberg School of Medicine of Northwestern University, Chicago, IL; and 4Department of Psychology, The University of Illinois at Chicago College of Medicine, Chicago, IL.
Received September 6, 2013; revised and accepted January 15, 2014.
Funding/support: Funding was provided by the Department of Obstetrics and Gynecology, Northwestern University. L.H.R. was supported by grant K12HD055892 from the National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health.
Financial disclosure/conflicts of interest: L.P.S. has received honoraria from Shionogi for consulting and speaking engagements on nonhormonal treatment of vulvovaginal atrophy and from Noven Pharmaceuticals for speaking engagements on hormonal treatments in symptomatic postmenopausal women. P.M.M. has received honoraria from Noven Pharmaceuticals and DepoMed for consulting on nonhormonal treatments of vasomotor symptoms. D.R.W., L.H.R., and S.B. declare no conflicts of interest.
Address correspondence to: David R. Walega, MD, Department of Anesthesiology, The Feinberg School of Medicine of Northwestern University, Suite 5-704, 251 East Huron Street, Chicago, IL 60611. E-mail: firstname.lastname@example.org