botox injections

ORIGINAL ARTICLE

Treatment of Axillary Hyperhidrosis With Botulinum Toxin: A Single Surgeon’s Experience With 53 Consecutive Patients

Melissa A. Doft • Jennifer L. Kasten •

Jeffrey A. Ascherman

Received: 18 December 2010 / Accepted: 7 April 2011 / Published online: 11 May 2011

� Springer Science+Business Media, LLC and International Society of Aesthetic Plastic Surgery 2011

Abstract

Background Axillary hyperhidrosis is a debilitating dis-

ease that affects the social and occupational lives of many

Americans. It can be treated with subdermal injections of

botulinum toxin. This study aimed to determine the interval

between injections during which patients are symptom free

and whether that interval varies depending on the number

of treatments a patient has received.

Methods The study enrolled all the patients treated with

botulinum toxin for axillary hyperhidrosis by the senior

author between 2004 and 2010. Patient responses to the

treatment with regard to both satisfaction and length of the

symptom-free interval were collected prospectively and

analyzed. An in-depth PubMed search was performed

through July 2010 to compile the published data on using

botulinum toxin injections to treat axillary hyperhidrosis.

These data served as a benchmark to which the trends at our

institution were compared.

Results The 53 patients included in the study had an

average age of 29 years, and 64% were women. Of the 53

patients, 23 (43%) underwent multiple injections of botu-

linum toxin. The average symptom-free interval was

261 days. There was no statistically significant difference

in symptom-free intervals after multiple treatments. Patient

satisfaction rates were very high, similar to the high

degrees of satisfaction found in the published data.

Conclusion Botulinum toxin injections provide an effec-

tive treatment for axillary hyperhidrosis with a rapid onset

and high patient satisfaction. Many patients have a symp-

tom-free interval of 6–9 months after each botulinum toxin

injection. This interval does not change significantly after

multiple treatments.

Keywords Axillary hyperhidrosis � Botox � Botulinum

toxin

Hyperhidrosis is a debilitating disease affecting 2.8% of the

American population. About half of these patients have

axillary hyperhidrosis, a condition in which a person’s

perspiration is more than necessary for a response to

environmental stimuli. A survey in 2004 demonstrated that

as many as 1.3 million individuals have severe hyperhi-

drosis, defined as hyperhidrosis with symptoms that fre-

quently or always interfere with daily activities and are

intolerable or barely tolerable [1]. These patients are sig-

nificantly hindered in social and occupational situations.

They experience difficulty in personal relationships,

decreased physical and emotional well-being, and social

stigmatization [2–6].

Presented at the Faces of Jerusalem, a joint meeting of the multi-

specialty Foundation for Aesthetic Surgical Excellence (FASE) and

the Israeli Society of Plastic Surgery (ISPS) in Jerusalem, Israel (11/3/

10) and at the American Association of Plastic Surgery meeting in

Boca Raton, Florida (4/10/11).

M. A. Doft � J. A. Ascherman

Combined Divisions of Plastic Surgery at the University

Hospitals of Cornell and Columbia, New York-Presbyterian

Hospital, New York, NY, USA

J. L. Kasten

Division of Plastic Surgery, Department of Surgery, Columbia

University College of Physicians and Surgeons, New York, NY,

USA

J. A. Ascherman (&)

Columbia University Medical Center, 161 Fort Washington

Avenue, Fifth Floor, New York, NY 10032, USA

e-mail: [email protected]

123

Aesth Plast Surg (2011) 35:1079–1086

DOI 10.1007/s00266-011-9738-4

Primary axillary hyperhidrosis is defined as idiopathic,

visible, excessive sweating that lasts for at least 6 months

and has at least two of the following features: bilateral and

relatively symmetric sweating, impairment of daily activ-

ities, frequency of at least once per week, age of onset

younger than 25 years, positive family history, and cessa-

tion of focal sweating during sleep [6]. Most cases of

hyperhidrosis are focal, restricted to the palms, axillas, and

soles. Although symptoms are worsened by emotional

triggers, hyperhidrosis is not considered a psychiatric dis-

order, nor does it involve a more widespread autonomic

dysfunction.

The etiology of hyperhidrosis is unclear, but the disorder

is believed to result from hyperstimulation of eccrine sweat

glands by cholinergic nerve fibers of the sympathetic ner-

vous system [7]. Family history analyses indicate that

hyperhidrosis can be an inherited disorder [8].

Treatment options for primary axillary hyperhidrosis are

both surgical and nonsurgical. First-line nonsurgical ther-

apy involves topical agents such as aluminum chloride,

which often is found to be ineffective, short-acting, and

intolerable [9]. Surgical procedures, including endoscopic

transthoracic sympathectomy, not only are more invasive,

but can be associated with high rates of serious compli-

cations including Horner’s syndrome, pneumothorax,

phrenic nerve damage, and death, as well as life-changing

complications such as compensatory sweating (68–88%)

[10, 11], recurrence rates reaching 65% [12], and extremely

dry hands, which interfere with daily activities including

counting money and turning the page of a newspaper.

Although useful for palmer hyperhidrosis, endoscopic

transthoracic sympathectomy is not generally recommended

for axillary hyperhidrosis due to the high recurrence rate and

rate of compensatory sweating. Surgical excision of the

sweat glands may lead to poor wound healing, infection,

hidradenitis, and decreased shoulder range of motion sec-

ondary to scarring. Newer surgical procedures, including an

arthroscopic shaver technique, have received positive

reviews boasting a 91% to 96% satisfaction rate but still

require invasive surgery, 4 to 5 days leave from work, and

operative fees [13, 14]. Therefore, it is important to have a

treatment plan available that is safer than surgery, more

durable and tolerable than topical agents, and associated with

high patient satisfaction rates.

Botulinum toxin type A (BOTOX Cosmetic, Allergan,

Inc. Irvine, CA, USA) has emerged as an important treat-

ment option for patients plagued with axillary hyperhi-

drosis. The toxin temporarily inhibits the release of

acetylcholine from the cholinergic neurons that innervate

eccrine sweat glands, chemically denervating the glands

and leading to decreased sweat production. Although first

noted in healthy patients to inhibit sweat production,

researchers proposed that botulinum toxin type A

injections could be beneficial for patients with hyperhi-

drosis [15]. Several studies in Europe and the United States

have demonstrated that botulinum toxin type A is both

effective and safe for treating patients with primary axillary

hyperhidrosis [16–21].

Randomized studies have shown botulinum toxin injec-

tions to be more durable than topical agents for primary

axillary hyperhidrosis [9]. Patients who have undergone

botulinum toxin type A injections claim a significant

decrease in excess sweat production and improvement in

quality of life [3]. Furthermore, botulinum toxin type A also

may have an attenuation effect. One study suggests that the

levels of sweating significantly decrease during the second

treatment period compared with the first period [22].

Given this background information together with the

desire to help guide practitioners treating axillary hyper-

hidrosis and the simultaneous need to provide patients with

realistic expectations, we desired to determine how satis-

fied patients are with botulinum toxin treatments, how

many treatments are needed, and how the duration between

injections changes after multiple treatments.

Methods

Subject Population

The 53 subjects in this study were at least 14 years old and

had persistent bilateral primary (idiopathic) axillary

hyperhidrosis. Nearly all the patients had an unsatisfactory

response to previous local or systemic drug therapy and

severe hyperhidrosis, as determined by a Hyperhidrosis

Disease Severity Scale (HDSS) score of 3 or 4 (Table 1)

[23]. All the patients were treated by the senior author

(J.A.A.) between 2004 and 2010.

Patients were excluded from the study if they had

hyperhidrosis secondary to an underlying disease, an

infection at the injection site or systemic infection, or

previous surgical debulking of sweat glands. Patients also

were excluded if they had an existing medical condition

Table 1 Hyperhidrosis Disease Severity Scale (HDSS)

Score Patient response

1 My underarm sweating is never noticeable and never interferes

with my daily activities

2 My underarm sweating is tolerable but sometimes interferes

with my daily activities

3 My underarm sweating is barely tolerable and frequently

interferes with my daily activities

4 My underarm sweating is intolerable and always interferes

with my daily activities

Scale is based on the question: ‘‘How would you rate the severity of

your hyperhidrosis?’’ [21]

1080 Aesth Plast Surg (2011) 35:1079–1086

123

that could interfere with neuromuscular function such as

myasthenia gravis, Eaton-Lambert syndrome, or amyotro-

phic lateral sclerosis. None of the female patients were

pregnant or breastfeeding. The patients underwent standard

pretreatment counseling concerning risks, benefits, and

alternative treatment options.

Study Design

Data were collected prospectively as patients were treated

in the senior author’s office. The hyperhidrotic area of each

axilla was identified by the hair-bearing area. A 26- or

30-gauge needle was used for the injections. For most of

the patients, 40 evenly distributed sites were injected

subdermally in each axilla. The injection volume per axilla

was 50 units of reconstituted botulinum toxin type A. For

most of the patients, these 50 units were diluted in 2 ml of

normal saline, but for larger axillas, up to 3 ml were

occasionally used to dilute the 50 units.

All the patients were eligible for retreatment once their

symptoms returned. The patients self-referred themselves

for repeat treatment. The senior author questioned each

patient about his or her satisfaction with the treatment. The

patients also were asked when the results of the toxin wore

off in relation to when they made their appointment. The

senior author was able to give nearly all the patients an

appointment within 2 weeks of their request.

Efficacy Evaluation

We aimed to measure a 2-point change from the patient’s

baseline disease severity score as defined by the Hyperhi-

drosis Disease Severity Scale (HDSS). The HDSS is a

validated 4-point scale on which the subject rates the tol-

erability of his or her axillary sweating and its interference

with daily life (Table 1) [23]. Higher HDSS scores indicate

increased intolerability and a greater interference with

daily activities. The primary efficacy end point was the

proportion of treatment responders, defined as the subjects

who reported a 2-point improvement from the baseline

HDSS score 4 weeks after each treatment session.

Safety Evaluations

The patients were monitored for signs and symptoms of

adverse events. They were encouraged to report to the

senior author any adverse events that occurred after treat-

ments and between follow-up visits.

Literature Search

A PubMed search was conducted from 1990 through July

2010 using the terms ‘‘axillary hyperhidrosis,’’ ‘‘botulinum

toxin type A,’’ ‘‘Botox,’’ ‘‘patient satisfaction,’’ and ‘‘sub-

dermal injections.’’ The retrieved articles and the refer-

ences within them were reviewed, yielding 12 reports that

examined the questions ‘‘What is the length of time one

injection of botulinum toxin leaves a patient with axillary

hyperhidrosis symptom free?’’; ‘‘What is the length of time

between botulinum toxin injections for patients who have

undergone multiple treatments?; and ‘‘Does that interval

change with more injections?’’

We also reviewed patient satisfaction rates among

treating physicians. Only English-language randomized

and observational studies were included. Due to the dif-

ferences in data collection, a meta-analysis was deemed not

feasible by our Biostatistics Department.

Statistical Analysis

The summary statistics, number of patients, mean and

median treatment intervals, standard deviations, and min-

imum and maximum treatment intervals were computed for

each injection time point using R version 2.10.1 (R

Foundation for Statistical Computing, Vienna, Austria)

[24]. Treatment intervals are the times between injections.

These intervals were calculated for each patient and aver-

aged for the group. A review by a biostatistician at the

Columbia University Medical Center did not find any

significant statistical differences between treatment inter-

vals, and thus further analysis was not indicated.

Results

We treated 53 patients with primary axillary hyperhidrosis

whose symptoms warranted intervention based on an

HDSS score of 3 or 4. Their mean age was 29 years, and

64% were female. The senior author performed 220 axil-

lary injection procedures on these 53 patients over the

course of 5.6 years.

Through verbal communications either in follow-up

visits or by telephone, nearly all the 53 patients reported an

improvement in their symptoms and quality of life as

defined by a 2-point improvement in the HDSS scale

within the first 2 weeks after treatment. Patients reported

less occupational and emotional impairment, less time

spent managing their hyperhidrosis, and less difficulty in

social and occupational situations.

Of the 53 patients enrolled in the study, 23 (43%)

returned for multiple injections. Figure 1 shows how many

treatments each patient received. Most of the patients

underwent one to three treatment sessions, but one patient

was injected nine times.

For the patients who returned for multiple visits, the

interval between treatments is graphed in Fig. 2 and

Aesth Plast Surg (2011) 35:1079–1086 1081

123

summarized in Table 2. The patients who underwent only

one injection were not included in Fig. 2 and Table 2. The

average interval overall between treatments was 261 days

(8.7 months), and the median interval was 221 days

(7.4 months). The average interval between the first and

second treatments was 294 ± 158 days. This group had a

large range of responses, from a minimum period of

112 days to a maximum period of 731 days. The median

for the symptom-free interval between the first two injec-

tions was 266 days. The bold line in Fig. 2 shows the

average number of days between treatments. We were

unable to define a statistically significant trend among all

the patient treatment intervals with regard to increasing or

decreasing times between treatments. However, the

patients who underwent more than four treatments tended

to have an increased frequency of injections, as indicated

by the downward slope of the bold line in Fig. 2, but this

difference was not statistically significant.

Table 3 shows the results from an in-depth examination

of the current literature conducted to compare the trends at

our institution with other practices. In randomized studies

that had both a botulinum toxin group and a placebo group,

only the patients in the botulinum groups were included in

Table 3. The data presented in these studies were quite

varied in terms of how patients were evaluated (with

questionnaires, interviews, or gravimetry), when they were

evaluated (self-referral vs scheduled follow-up visits), and

study design (prospective, retrospective, randomized, or

observational). Therefore, it was not possible to create a

metaanalysis of these data, but the data are helpful for

drawing observational conclusions.

The time between injections ranged from 4.7 to

8.7 months. Our data also demonstrate that the interval

between injections fell in this range because our average

interval between injections was 8.7 months, and our med-

ian interval was 7.4 months. Similarly, treatment intervals

did not differ statistically with multiple treatments,

although some studies reported an increase in frequency of

treatments as patients underwent more sessions. Although

patient satisfaction was measured using several different

methods, all studies demonstrated high patient satisfaction

rates.

Fig. 1 Number of treatments per patient (53 patients). Graph shows

how many patients had at least a given number of injections (e.g., 53

patients had at least 1 injection; 23 patients had at least 2 injections;

12 patients had at least 3 injections . . . up to 1 patient who had 9

injections)

Fig. 2 Patient treatment schedule: a plot of each patient and his or

her individual treatment schedule. The bold line connects the average

number of days between each treatment for all the patients studied.

By analysis of the slope showing each patient’s treatment schedule, it

was determined that there was no statistically significant trend in

frequency of treatments. However, although not statistically signif-

icant, patients receiving more than four treatments tended to require

more frequent injections, as indicated by the downward slope of the

bold line

Table 2 Time (days) between current and previous botulinum toxin

injection

Injection no. n Mean SD Min Max Median

2 23 294 158 112 731 266

3 12 243 127 111 562 210

4 7 307 122 174 536 270

5 5 240 78 172 371 214

6 4 148 55 91 216 144

7 2 224 178 98 350 224

8 1 168 168

9 1 119 119

n number of patients treated with a given number of injections, Mean mean number of days between injections, SD standard deviation, Min and Max minimal and maximum time interval between injections,

Median median number of days between injections

1082 Aesth Plast Surg (2011) 35:1079–1086

123

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Aesth Plast Surg (2011) 35:1079–1086 1083

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Discussion

Botulinum toxin injections are a safe, rapid, durable, and

effective way to treat symptomatic axillary hyperhidrosis,

with minimal side effects for most patients. Similar to

previous studies, our study demonstrated high patient sat-

isfaction. The effects of the toxin are rapid, with most

patients reporting an improvement within several days after

treatment. The efficacy was sustained for an average of

261 days by patients who required multiple injections.

Several studies have examined whether the dose of

botulinum toxin injected affects the length of anhidrosis. A

minimum botulinum toxin dose of 50 units per axilla is

necessary to cause anhidrosis in healthy volunteers [15].

Research demonstrates no difference in sweat reduction

when the dose of Dysport (botulinum toxin A; Ipsen Ltd,

Slough, UK) is doubled, from 100 to 200 U per axilla [20].

Wollina et al. [25] opposes these data, stating that in his

series the duration of anhidrosis increased when 200 U on

botulinum toxin was used. He states that some patients

were symptom free for up to 29 months. The goal of our

study was not to identify the dose of botulinum toxin that is

most effective, but rather to use the most common dose, 50

units per axilla, to evaluate whether multiple doses have an

effect on a patient’s treatment regimen, leading to a pos-

sible attenuation effect.

The gold standard for quantitatively measuring a

decrease in sweat production has been gravimetry. Gravi-

metric measurement is not practical or routine in clinical

practice and is associated with high intra-patient variability

over time. It therefore is not an ideal standard when used in

isolation. Data support the observation that the symptom

relief assessments determined by improvement in HDSS

scores and subject-reported measures correlate with phys-

ical changes in sweat production as measured by gravim-

etry [21].

With these data, we decided to use patient satisfaction as

measured by HDSS as our end point because the goal in

treating axillary hyperhidrosis is not to inhibit all sweat

production but rather to improve significantly the func-

tional and social quality of life for patients. The HDSS is

easy to use in clinical practice and quantifies the patient-

perceived severity of symptoms and disability. We found

that 100% of our 23 patients who came for at least one

repeat injection had an improvement in his or her symp-

toms. Similar high satisfaction rates were observed in the

published literature.

Effective treatment is a function of patients’ perceived

impairment [3]. Studies have demonstrated that treatment

with botulinum toxin reduces the marked functional

impairment associated with hyperhidrosis and improves

quality of life. Significant improvements in time spent

managing the condition, emotional well-being, interpersonal

relationships and social situations, and occupational func-

tioning all have been demonstrated in the literature [2, 3]. In

randomized placebo-controlled trials with botulinum toxin,

patient satisfaction markedly increased after treatment with

botulinum toxin compared with placebo (93% vs 30%) [26].

Patients also report increased satisfaction with botulinum

toxin treatment over nonsurgical options for hyperhidrosis

such as topical agents [2, 21].

In our patient population, 43% of the patients returned

for multiple treatments. Patient satisfaction with the treat-

ments was very high. The interval between injections did

not change significantly over time for those patients who

had multiple treatments. However, although not statisti-

cally significant, the patients who underwent more than

four treatments tended to have an increased frequency of

injections.

We compared these data with the published literature to

find trends that could help guide practitioners. A meta-

analysis of the studies was not conducted because the

methods of data collection were too varied. In the litera-

ture search compilation, we included observational and

randomized studies, studies of patients given predeter-

mined follow-up appointments, studies of self-referred

patients, and studies of patients with varying lengths of

follow-up periods and number of treatments. Patient sat-

isfaction with the procedure ranged from 66% to 100%,

indicating that overall, patients were very happy with this

treatment. Similar to our results, we found that the average

duration of efficacy ranged from 4.7 to 8.7 months.

Although the number of patients receiving multiple

injections was small in each study, some patients tended to

require an increased frequency of injections as they

underwent more treatments, mirroring our results. This

made us question whether these patients could have

developed antibodies to botulinum toxin treatments,

thereby generating an attenuated affect.

The literature contains several published cases of botu-

linum toxin antibodies. Experts estimate that these affect

3% of the population. Patients with these antibodies may

show no response to botulinum injections or may require a

different dose or dosage schedule [27, 28].

More than half of our patients did not have a repeat

injection. Similar numbers were published in previous

studies. It is unclear why these patients did not seek a

second injection. Although proposed in the literature, it is

unlikely that one dose cured their symptoms and more

likely that patients did not return for other reasons such as

pain, expense, or inconvenience. Although we did not have

long-term follow-up evaluation for these patients, short-

term follow-up assessment demonstrated that nearly all of

them did receive relief with botulinum treatment.

Critics of self-referral-based treatment have argued that

barriers to outpatient appointments result in delay of

1084 Aesth Plast Surg (2011) 35:1079–1086

123

treatment, lengthening the intervals between injections

[29]. In this study, nearly all the patients were able to

schedule an appointment with the senior author within

2 weeks of calling. Furthermore, at each appointment, the

time when the previous treatment had worn off was

recorded and compared with the time when the patient had

scheduled his or her appointment. In a previous study with

patients either returning during a fixed interval or self-

referring between appointments, the authors concluded that

self-referral is an effective method for managing patients

and for understanding the trends for treatment durability

[30].

Although this univariate, open-label study provides

useful information for counseling patients who seek relief

from hyperhidrosis, it has several shortcomings. The study

population was only 53 patients, making it a small group

upon which to draw conclusions. However, it does dem-

onstrate trends in a cohort population. We followed the

patients for up to 5.6 years, which is longer than the fol-

low-up period in previously published studies.

To qualify patient satisfaction, we used the HDSS,

demonstrated to be effective in the literature [21]. Patients

seek treatment for axillary hyperhydrosis based on

symptoms not on a quantitative amount of sweat, making

the HDSS a more useful measurement for our end point

than objective data such as gravimetry or starch iodine

testing.

It is possible that seasonality and geography could have

altered our results. All patients were seen in New York

City, which has four seasons. Seasonality did not appear to

effect the time when patients returned for follow-up visits.

The goal of this study was to examine how repeated

doses of botulinum toxin injections affect a patient’s

treatment schedule. Wollina states that 200 units of botu-

linum toxin may lead to longer-lasting periods of anhi-

drosis than lower doses, so it would be interesting to

examine whether multiple large doses affect the treatment

schedule of patients with continued symptoms [25].

In summary, this study demonstrated that patients who

undergo botulinum toxin injections for primary axillary

hyperhidrosis are very satisfied. The duration of symptom-

free intervals did not vary significantly with increased

treatment sessions. This information is useful for physi-

cians treating patients with severe primary axillary hyper-

hidrosis, helping them to decide on treatment options and

manage patient expectations.

Acknowledgments We thank Jimmy Duong, MPH, from Columbia

University’s Irving Institute and Department of Biostatistics for his

assistance in the statistical analysis of our results. There was no

funding for this project.

Conflict of interest None.

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