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Pain Medicine 2014; 15: 410–417 Wiley Periodicals, Inc.

CANCER PAIN & PALLIATIVE CARE SECTION Original Research Article Management of Hot Flushes in Breast Cancer Survivors: Comparison Between Stellate Ganglion Block and Pregabalin Ahmed H. Othman, MD,* and Amen H. Zaky, MD† *Anesthesia, ICU and Pain Relief; †

Medical Oncology, South Egypt Cancer Institute, Assiut University, Assiut, Egypt Reprint requests to: Ahmed H. Othman, Anesthesia Department, South Egypt Cancer Institute, Assiut University, 11 Elmethak Street, 171516 Assiut, Egypt. Tel: 002-01005098394; Fax: 002-88-2348609; E-mail: [email protected] Conflict of interest: The authors declare no conflict of interest.

Abstract Background. Women who have survived breast cancer have hot flushes that are “significantly more frequent, severe, distressing, and of greater duration” than in other women. We compared the efficacy and safety of stellate ganglion block and pregabalin for the relief of hot flushes in breast cancer survivors. Patients and Methods. Forty patients who were breast cancer survivors and were suffering from hot flushes to the degree that they seeked for treatment were included in the study and randomly divided into two groups: group I: (N = 20) stellate ganglion block was done for the patients of this group; and group II: (N = 20) in this group, the patients received 75 mg pregabalin twice daily. In both groups selfcompleted daily hot flush diaries and monthly symptom questionnaires were obtained at baseline and for the following 3 months. Results. Our results showed that group I (stellate ganglion block) had significant (P < 0.05) decline in the frequency of mild, moderate, very severe, and total hot flushes in comparison with group II 410

(pregabalin 75 mg twice daily) throughout the 3 months of follow up period. Conclusion. The stellate ganglion block had superior efficacy in the management of hot flushes in breast cancer survivors. Key Words. Stellate Ganglion Block; Pregabalin; Hot Flushes; Breast Cancer

Introduction Hot flushes occur in up to 90% of perimenopausal women [1–3] and significantly impact a woman’s quality of life and functional ability [2–4]. Hot flushes are especially problematic in breast cancer patients because menopause can occur prematurely as a result of chemotherapy or tamoxifen therapy. Carpenter and colleagues [4] report that women who have survived breast cancer have hot flushes that are “significantly more frequent, severe, distressing, and of greater duration” than in other women. Prior to the present decade, the best established alternative was clonidine, which reduces hot flushes by about 35–40% [5,6], slightly better than the 20–25% reduction that is commonly seen with a placebo [7]. Newer antidepressants have been shown to be helpful, with the first publication of a randomized trial occurring in 2000 [8–14]. In addition, randomized controlled trials of gabapentin demonstrate that this agent, at a target dose of 900 mg/ day, and pregabalin, at a target dose of 75 mg twice a day, also decreases hot flushes to a similar degree [15–17]. Although these results are encouraging, the efficacy of these agents is still significantly below the 80% reduction seen with hormonal agents. In addition, each of these therapies has toxicities that limit its use [18]. The stellate ganglion block is a selective sympathetic blockade that has been used for at least 60 years for the treatment of multiple pain syndromes including migraines and upper extremity pain [19–21]. In 2005, Lipov et al. published a case series report involving six women, none

Comparison of Efficacy Between Stellate Ganglion Block and Pregabalin for Hot Flushes Management of whom had breast cancer, but all of whom had trouble with hot flushes [22]. In 2008, Lipov et al. also reported the effectiveness of stellate ganglion blockade in alleviating hot flushes in breast cancer survivors. [23]. In both of these manuscripts, these authors reported a marked diminution of hot flushes in the treated patients. In addition, an update to the 2008 pilot trial was published and reported a sustained decrease in hot flushes lasting the duration of the follow-up, 10 months. Of note, most of the patients required a repeat stellate ganglion block at a median time of 11 weeks [24]. Haest et al. have also reported similar results from a recent pilot trial involving 24 women [25]. The aim of our study was to compare between stellate ganglion block and pregabalin for the relief of hot flushes in breast cancer survivors as regard the efficacy and safety. Patients and Methods The research was carried out according to the principles set out in the Declaration of Helsinki 1964. After Hospital Ethics Committee approval and written informed consent, 40 patients who were breast cancer survivors and were suffering from hot flushes to the degree that they sought for treatment were included in the study and randomly divided into two groups (randomized sampling was done by lottery method): Group I: (N = 20) stellate ganglion block was done for the patients of this group using 10 ml bupivacaine 0.5%. Group II: (N = 20) the patients of this group received 75 mg pregabalin twice daily. The stellate ganglion block and pregabalin administration were done by the first author. The second author, who was blinded to the patients, assessed them throughout the period of the study. Inclusion Criteria

mise at the time of assessment, or an American Society of Anesthesiologists physical status score of III or higher were excluded from the study. Method of Stellate Ganglion Block Group I patients received stellate ganglion block at the anterolateral aspect of the C7 vertebra on the right side under fluoroscopy. On a fluoroscopy table, the patient was placed in the supine position with the neck slightly extended (a pillow was placed beneath the shoulders), the head rotated slightly to the side opposite to the side to be blocked. Patients were monitored with electrocardiogram, pulse oximetry, and blood pressure monitoring throughout the procedure. The skin temperatures were recorded in the distal portion of both the upper extremities at identical locations. The neck was prepared and draped in a standard sterile way using Betadine (Pyramids Scientific Office, Cairo, Egypt). Furthermore, meaningful verbal contact without head and neck movement with the patient was maintained throughout the procedure to recognize any adverse reactions (mild sedation was used in some cases using 50 ug fentanyl and 1.5 mg midazolam). The fluoroscope was directed in an anterior to posterior direction to visualize C7 vertebral body, T1 transverse process, and first rib as landmarks. The skin over the target point that is the junction of C7 transverse process with its corresponding vertebral body was marked. Then the skin entrance over the target point (marked skin) was anesthetized with 1% lidocaine, and a 2.5-inch, 22-gauge needle was advanced toward the target point until bone was encountered. When the needle contacted the bone, it was drawn back 1 mm, after which 1 mL of iohexol contrast dye (180 mg/mL) was injected with real-time fluoroscopic imaging to confirm needle placement (the site of stellate ganglion) and to rule out intravascular or subarachnoid spread (Figure 1). Ten milliliters of 0.5% bupivacaine was subsequently injected next to the stellate ganglion to produce sympathetic block.

Patients who suffered from hot flushes for at least 1 month prior to study entry, women who were 21 years old or more, and women who had a life expectancy of at least 6 months were included in the study. They were permitted to receive tamoxifen, raloxifene, or aromatase inhibitors. Exclusion Criteria Patients were not included in the study if they were receiving antineoplastic chemotherapy, androgens, estrogens, or progesterone analogs. The use of other agents for treating hot flushes including vitamin E, antidepressants, or gabapentin was not allowed prior to study initiation. Patients who were pregnant, nursing, or were of childbearing potential and unwilling to employ adequate contraception were excluded. In addition, patients were not included if they were currently using anticoagulants or if they had a diagnosis of or problems with bleeding disorders. Women who had acute infections, cardiac compro-

Figure 1 Confirmation of needle placement. 411

Othman and Zaky After completion of the procedure, each patient was assessed for signs of sympathetic block, which included presence of Horner’s syndrome (facial anhydrosis, enophthalmos, ptosis, swelling of the lower eyelid, miosis, and blood-shot conjunctiva) and elevation of the temperature of the ipsilateral upper limb. All individual patients were observed for a minimum of 1 hour to assess for any signs of complications. In both groups, self-completed daily hot flush diaries and monthly symptom questionnaires were obtained at baseline (for 1 month prior to the stellate ganglion block in group I and prior to start of pregabalin treatment in group II) and for the duration of the study (posttreatment months 1 through 3). The hot flush score, devised by Sloan and colleagues [7], was used to quantify recorded hot flushes for analytical assessment after all data were collected. A system, described by Finck and co-workers [3] for defining four levels of severity of hot flushes (mild, moderate, severe, and very severe), was used to categorize recorded hot flushes for analysis. The hot flush score had been verified as reliable by both Sloan and colleagues and Finck and co-workers [3,7]. The hot flush score was not selective to hot flushes at night or during the day; instead, it looked at the total number of hot flushes and their intensity during the 24-hour period. The side effects of pregabalin used for the treatment of hot flushes in the group II were assessed.

Table 1 groups

Patient characteristics of the studied

Variable Age (years) Weight (kg) Height (cm) BMI Menopause years

Group I (Stellate Block)

Group II (Pregabalin)

P Value

47.20 ± 5.49 74.80 ± 6.56 166.50 ± 3.87 27.04 ± 2.83 2.10 ± 1.08

41.70 ± 7.01 76.70 ± 6.78 169.80 ± 6.14 26.68 ± 2.94 2.20 ± 0.92

0.088 0.595 0.339 0.650 0.693

Data are expressed as mean ± standard deviation (SD). BMI = body mass index.

There was no statistically significant difference between the two groups as regard demographic data. All patients had mastectomy except one case in the group I. All patients received chemotherapy and were on tamoxifen hormonal therapy. No patient had hysterectomy. All patients of group I suffered from mild Horner’s syndrome, which disappeared after 12–18 hours. One case suffered from severe blood-shot conjunctiva, which also relieved after 24 hours. The presence of Horner’s syndrome was often used as a marker of a successful stellate ganglion block. No other complications occurred in group I except one case of hoarseness of voice, which relieved after 24 hours. Only one patient in group I required a repeat block that was done after 15 days. In group II, the only complication was mild dizziness, which occurred in five patients.

Statistical Analysis

• Mild hot flushes (Table 2)

Mann–Whitney test was used to analyze the personal data and the hot flushes difference between the two groups. Wilcoxon signed-rank test was used to analyze the hot flushes progression in each group throughout the 3 months of study period. Statistical significance was considered when P < 0.05.

As regard mild attacks of hot flushes, there were no significant baseline differences between the two groups. Also there were no significant differences between the two groups after the first and second months of treatment while after the third month, the number of mild hot flushes was significantly lower in group I (10.00 ± 2.11) than in group II (17.20 ± 8.44) (P = 0.028).

Results In group I, the number of mild hot flushes increased during the first month after the procedure from a mean of

• Patient characteristics (Table 1)

Table 2

Number of mild attacks

Variable

Group I

Group II

P Value

Baseline After the first month After the second month After the third month P value (Baseline vs first month) P value (Baseline vs second month) P value (Baseline vs third month)

28.00 ± 6.53 51.60 ± 13.91 11.60 ± 3.50 10.00 ± 2.11 0.007* 0.005* 0.005*

32.40 ± 8.32 38.00 ± 17.10 20.80 ± 10.96 17.20 ± 8.44 0.258 0.010* 0.007*

0.244 0.073 0.067 0.028*

*statistical significant difference (P < 0.05). Data are expressed as mean ± standard deviation (SD).

412

Comparison of Efficacy Between Stellate Ganglion Block and Pregabalin for Hot Flushes Management 90

60 Group I Group II

Group I Group II

80 70

40

Mean ± SD

Mean ± SD

50

30

60 50 40 30

20

20

10

10 0

0 Baseline

After the first month

After the second month

Baseline

After the third month

After the first month

After the second After the third month month

Figure 2 Comparison between group I (stellate ganglion block) and group II (pregabalin) for mild hot flushes.

Figure 3 Comparison between group I (stellate ganglion block) and group II (pregabalin) for moderate hot flushes.

28.00 ± 6.53 to a mean of 51.60 ± 13.91 (P = 0.007), but then decreased to reach 11.60 ± 3.50 in the second month (P = 0.005) and 10.00 ± 2.11 in the third month of follow-up period (P = 0.005). In group II, the number of mild hot flushes increased during the first month after start of pregabalin but not to a significant degree, while in the third month the number decreased significantly from 32.40 ± 8.32 (baseline) to 17.20 ± 8.44 (P = 0.007) (Figure 2).

the severe attacks in both groups was significant throughout the 3 months of follow-up period (Figure 4).

• Moderate hot flushes (Table 3) In Table 3, moderate hot flushes showed no baseline differences between the two groups, which was also the same after the first month of treatment. After the second and third months, there were significant decreases in group I than in group II (P = 0.016 and 0.013, respectively). In both groups, there were significant decreases of moderate hot flushes throughout the 3 months of follow-up period when compared with the baseline values (Figure 3). • Severe hot flushes (Table 4) We found that there were no significant differences in severe hot flushes between both groups. The reduction of

Table 3

• Very severe hot flushes (Table 5) In both groups, there were no differences for very severe hot flushes at baseline. In the 3 months of follow-up, group I showed the disappearance of very severe hot flushes. Group II showed significant reduction in very severe hot flushes throughout the 3 months of follow-up but still significantly higher than group I (Figure 5). • Total hot flushes (Table 6) In group I, the total number of hot flushes declined from a mean of 239.20 ± 26.92 before the procedure to a mean of 80.00 ± 17.89 during the first month after the procedure (P = 0.005). After the first month, the total number of hot flushes continued to decline over the remaining follow-up period and stabilized at a mean of 30.00 ± 2.11 during the third month after the procedure (P = 0.005). In group II, the total number of hot flushes declined from a mean of 206.80 ± 45.76 before the start of pregabalin treatment to a mean of 77.20 ± 22.47 during the first month after start of pregabalin treatment (P = 0.005). After the first month, the total number of hot flushes continued

Number of moderate attacks

Variable

Group I

Group II

P Value

Baseline After the first month After the second month After the third month P value (Baseline vs first month) P value (Baseline vs second month) P value (Baseline vs third month)

83.20 ± 12.62 15.20 ± 7.01 8.80 ± 2.53 8.00 ± 0.00 0.005* 0.005* 0.005*

71.20 ± 23.69 24.00 ± 16.00 16.00 ± 7.54 19.20 ± 14.70 0.008* 0.007* 0.011*

0.355 0.134 0.016* 0.013*

*statistical significant difference (P < 0.05). Data are expressed as mean ± standard deviation (SD).

413

Othman and Zaky Discussion

90 Group I Group II

80

Mean ± SD

70 60 50 40 30 20 10 0 Baseline

After the first After the second month month

After the third month

Figure 4 Comparison between group I (stellate ganglion block) and group II (pregabalin) for severe hot flushes.

to decline over the remaining follow-up period and stabilized at a mean of 53.20 ± 25.93 during the third month after start of pregabalin treatment (P = 0.005). There was no statistically significant difference between the two groups for total hot flushes except at the third month in which the total hot flushes were significantly lower in group I than in group II (P = 0.006) (Figure 6).

Table 4

This is the first study to compare the effect of stellate block and pregabaline for the treatment of hot flushes in breast cancer survivors, and our study is a comparative prospective single-blinded study. The main finding of our study was that the stellate ganglion block had superior efficacy in the management of hot flushes in breast cancer survivors as the frequency of mild, moderate, very severe, and total attacks of hot flushes were significantly lower in group I throughout the 3 months of follow-up period when compared with the other group. A 2007 publication reviewed the use of retrorabies virus (a neuro-labeling technique) to demonstrate a direct neurological connection between the stellate ganglion and the insular cortex, a cortical structure that is highly active during a hot flush, as demonstrated by functional magnetic resonance imaging [20]. The theory was advanced further in 2009 when the complex chemical cascade triggered by estrogen decrease was clarified: the perimenopausal estrogen decrease causes increased concentrations of nerve growth factor (NGF), which, in turn, leads to sympathetic nerve sprouting in the cortex and increased brain norepinephrine (NE) concentrations. (Increased NE concentrations in a rat model do trigger hot

Number of severe attacks

Variable

Group I

Group II

P Value

Baseline After the first month After the second month After the third month P value (Baseline vs first month) P value (Baseline vs second month) P value (Baseline vs third month)

76.80 ± 19.76 16.80 ± 6.20 12.00 ± 0.00 12.00 ± 0.00 0.005* 0.005* 0.005*

60.00 ± 16.96 18.00 ± 6.33 12.00 ± 0.00 14.40 ± 5.06 0.004* 0.005* 0.005*

0.090 0.661 1.000 0.146

Variable

Group I

Group II

P Value

Baseline After the first month After the second month After the third month P value (Baseline vs first month) P value (Baseline vs second month) P value (Baseline vs third month)

51.20 ± 21.07 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.005* 0.005* 0.005*

43.20 ± 21.40 6.40 ± 8.26 6.40 ± 8.26 6.40 ± 8.26 0.005* 0.005* 0.005*

0.395 0.029* 0.029* 0.029*

*statistical significant difference (P < 0.05). Data are expressed as mean ± standard deviation (SD).

Table 5

Number of very severe attacks

*statistical significant difference (P < 0.05). Data are expressed as mean ± standard deviation (SD).

414

Comparison of Efficacy Between Stellate Ganglion Block and Pregabalin for Hot Flushes Management 60

300 Group I Group II

40 30 20

Group I Group II

250

Mean ± SD

Mean ± SD

50

200 150 100

10

50

0 Baseline

After the first month

After the second month

0

After the third month

Figure 5 Comparison between group I (stellate ganglion block) and group II (pregabalin) for very severe hot flushes. flushes.) The stellate ganglion block is known to reduce NGF, leading to the reversal of the process leading to hot flushes symptom resolution [19]. Stellate ganglion blocks were relatively commonly used for the treatment of chronic regional pain syndromes, vascular insufficiency, postherpetic neuralgia, and other forms of neuropathic pain [26]. In our study, we found that the two types of treatment were effective in the management of hot flushes in breast cancer survivors. But as it appeared from Table 6 and Figure 5, the group (I) of stellate ganglion block had significantly lower total hot flushes score than the group (II) of pregabalin.

Baseline

After the first After the second month month

After the third month

Figure 6 Comparison between group I (stellate ganglion block) and group II (pregabalin) for total hot flushes. hot flushes. The results of our study as regards the stellate block were similar to those of Lipov et al., who reported a significant decrease in hot flushes in patients who underwent this therapy [22,23]. But in our study, only one patient required another stellate block, which is different from Lipov et al. who reported that many of the patients received a second block 2–10 weeks after the first [23]. Also we were different from the same study in that we injected 10 mL of bupivacaine 0.5% at the site of stellate ganglion instead of the 7 mL used by Lipov et al., which might explain that only one patient required second block.

We chose the dose of 75 mg of pregablin twice daily, which was used by Loprinzi et al. in a double blind study in which they used pregabalin at a target dose of 75–150 mg twice daily, and they found that they were clinically useful means of treating hot flushes in women, and they found that the lower dose appeared to be as beneficial as the higher dose, with less toxicity [16]. This explained the low incidence of side effects in the pregabalin group in our study.

Overall, stellate ganglion blocks were considered to be relatively safe procedures, with severe complications being quite rare. The more common side effects include temporary hoarseness, neuralgia along the chest wall, and central nervous system effects from injection into a vertebral artery. More serious and less common complications include brachial plexus injury, phrenic nerve injury, pneumothorax, infection, allergy, and hematoma [27,28]. These complications are much less likely in a fluoroscopic guided procedure, which was used in this current study. Neither of these complications occurred in our study.

Overall, data from our trial supported the prestudy hypothesis that stellate ganglion blocks were helpful in reducing

The results of our study were similar to the results of Lipov et al. [23]. and Pachman et al. [29], which supported the

Table 6

Total hot flush score

Total Hot Flush Score

Group I

Group II

P Value

Baseline After the first month After the second month After the third month P value (Baseline vs first month) P value (Baseline vs second month) P value (Baseline vs third month)

239.20 ± 26.92 80.00 ± 17.89 32.40 ± 5.15 30.00 ± 2.11 0.005* 0.005* 0.005*

206.80 ± 45.76 77.20 ± 22.47 55.20 ± 24.28 53.20 ± 25.93 0.005* 0.005* 0.005*

0.063 0.403 0.057 0.006*

*statistical significant difference (P < 0.05). Data are expressed as mean ± standard deviation (SD).

415

Othman and Zaky efficacy and safety of the use of stellate ganglion block as a method for the management of hot flushes in breast cancer survivors and were similar to the results of Loprinzi et al. [16] as regards the efficacy and safety of 75 mg pregabalin twice daily for the management of hot flushes. But as it appeared from our results, the stellate ganglion block had superior efficacy in the management of hot flushes in breast cancer survivors as the frequency of mild, moderate, and very severe attacks of hot flushes were significantly lower throughout the 3 months of follow-up period. At the same time, it improved the compliance of the patient as there was no need for oral intake of drugs. The drawbacks of our study were small sample size and the difficulty to follow-up the patients weekly. We concluded that the stellate block was better than the pregabalin in the management of hot flushes in breast cancer survivors on hormonal therapy. We recommend large randomized multi-institutional study to confirm our novel data.

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Management of hot flushes in breast cancer survivors: comparison between stellate ganglion block and pregabalin.

Women who have survived breast cancer have hot flushes that are "significantly more frequent, severe, distressing, and of greater duration" than in ot...
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