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a Division of Thoracic Surgery, Policlinico Tor Vergata University, Rome, Italy
b Division of Dermatology, Policlinico Tor Vergata University, Rome, Italy
Accepted for publication April 1, 2009.
* Address correspondence to Dr T. Mineo, Cattedra di Chirurgia Toracica, Università Tor Vergata, Policlinico Tor Vergata, Via Oxford, 81, Rome, 00133, Italy (Email: mineo{at}med.uniroma2.it).
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Abstract |
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Methods: Patients suffering primary palmar hyperhidrosis were treated by either bilateral T2 to T3 thoracoscopic sympathectomy (n = 68) or by injection of botulinum toxin-A (n = 86). The groups were homogeneous for relevant demographic, physiologic, and clinical data. Quantification of sweat production was performed by Minor's iodine starch and glove tests. Subjective changes were assessed by quality of life questionnaires (Hyperhidrosis, Dermatology Life Quality Index, Short Form-36, Nottingham's Health Profile) and patient's satisfaction self-assessment. A cost comparison between groups was also carried out.
Results: No operative mortality or major morbidity was recorded in either group. Minor's test showed a more significant reduction in the surgical group: +94% versus +63% at 6 months and +94% versus +30% at 12 months. Compensatory sweating was significantly greater and long-lasting in the surgical group. All subjective tests improved rapidly and significantly in both groups. After 6 months, results mildly worsened in the surgical group and more significantly in the botulinum group. Patient's satisfaction was initially greater in the botulinum group (p = 0.03), but after 6 months it significantly reversed (p = 0.04). Surgical treatment cost approximately as much as four botulinum treatments.
Conclusions: Thoracoscopic sympathectomy is superior to botulinum toxin-A injection. The greater initial costs and discomfort are offset by a greater reduction in compensatory sweating.
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Introduction |
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Botulinum toxin-A injection is a promising new therapeutic option for hyperhidrosis that is administered on an outpatient basis, with minimal adverse reactions, low invasiveness, and high efficacy [8–10]. However, the duration of the effect of botulism is usually limited to about 6 to 12 months [8]. This study evaluated immediate and mid-term results achieved by the two different treatments in a series of selected patients from a single center to demonstrate comparative merits and incidence of complications as well as economic impact.
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Material and Methods |
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Patients
Between November 2001 and December 2007, 154 consecutive patients (91 women), ranging in age from 20 to 45 years (median, 30 years; interquartile range, 26 to 33 years) exhibiting primary palmar hyperhidrosis entered the study. All patients had severe palmar hyperhidrosis since childhood and were socially, professionally, and psychologically handicapped. Almost two thirds of them (64.2%) had failed to improve their symptoms with conservative local (ie, antiperspirants) and systemic agents (ie, anticholinergic, β-blockers, anxiolytic, antidepressant drugs) or iontophoresis.
Study Design
The study was designed as a prospective and comparative (surgery versus botulinum) investigation. All patients were given the choice between undergoing bilateral T2 to T3 one-stage thoracoscopic sympathectomy (n = 68) or botulinum toxin-A injection (n = 86). Patients gave their consent after having been fully informed about the more frequent side effects of each procedure, such as compensatory sweating and especially those after surgery: interscapular pain, transient pneumothorax, and Horner's syndrome. Crossover from one group to another was authorized after a minimum period of 1 year from the beginning of the treatment. However, these patients were not considered as part of the new group. As already stated, the study was approved by the specific institutions.
Objective Sweating Assessment
Objective assessment was performed by Minor's iodine starch test [11] and pad glove test [12]. Minor's iodine starch test is a diagnostic criterion performed by painting the affected surface with iodine staining and waiting for it to dry. This area is subsequently powdered with starch, which renders visible the sweating reaction. The starch–iodine combination turns a dark blue color wherever there is excessive sweat. Test results were quantified by a digital photograph of both hands taken 5 minutes after powder application at a steady distance of 0.70 meters. The image was then processed with graphic software (Photoshop CS4, Adobe System Inc, San Jose, CA). The mean intensity of sweating for the entire palm surface, directly proportional to the palm brightness in the picture, was scored according to a modified gray scale provided by the same software. It attributed the value 0 (black) to the maximum sweating and 240 (white) to the minimum. To also objectively determine compensatory sweating the test was repeated before and periodically after treatment in axilla, facial, lumbar, and plantar regions.
Pad gloves of adequate size made from gauze material and surgical gloves were prepared and weighed on an electronic scale with 0.001-gram sensitivity (Mettler P1210, Instrumente AG, Zurich, Switzerland). The patients then put on the pad gloves and then surgical gloves over these. They waited in a comfortable, stress-free room for 1 hour. The temperature and humidity of the room ranged between 19° and 22°C and 45% and 55%, respectively. At the end of this period, we carefully removed the gloves, to avoid sweat evaporation, and immediately reweighed them. Differences between initial and final measurements of both gloves were noted in terms of grams per hour for sweat intensity of the hands.
Temperature of the forefinger in a 20°C room was also determined starting from 1 hour after treatment using a fluoroptic thermometer.
Subjective Sweating and Quality of Life Assessment
Subjective sweating changes were assessed by the Hyperhidrosis Quality of Life Questionnaire [2] and the Dermatology Life Quality Index [13].
Hyperhidrosis quality of life questionnaire [2] evaluates with 20 questions (subjectively scored from 1 = poor to 5 = high) the quality of life during actions influenced by sweating; at hot temperatures, under physical or emotional stress, and during social, working, and sexual activities. A final cumulative score was obtained by adding the score for each single question (maximum = 100, minimum = 20). The questionnaire was not only focused on palmar hyperidrosis and thus compensatory sweating could be taken into account.
The Dermatology Life Quality Index [13] consists of 10 questions investigating the impact of dermatologic problems on symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the more quality of life is impaired. Just as the previous one, this questionnaire considers compensatory sweating.
General health status was evaluated by the Short Form-36 (SF-36) [14] and the Nottingham Health Profile [15] questionnaires. These questionnaires were chosen because of their relative simplicity and availability in validated versions for the Italian population [16, 17]. Furthermore, values of a normative same-age and same-sex Italian population were available and they were matched with baseline data of our study sample.
The Nottingham Health Profile [14, 16] contains 38 dichotomic-choice questions (positive-negative) relating to six health domains (mobility, energy, pain, social isolation, sleep disturbance, and emotional reactions). The Short Form 36-item, [15, 17] consists of 36 multiple-choice questions that cover eight health concepts (physical functioning, social functioning, physical role, emotional role, vitality, bodily pain, mental health, general health perception) and two main cumulative summaries (physical and mental).
Sympathectomy
All patients were given the choice between undergoing general anesthesia with double-lumen intubation (n = 35) or epidural anesthesia (n = 29). The remaining 4 patients were initially approached through epidural anesthesia and thereafter converted to general anesthesia because of intolerance of pneumothorax (n = 2) or anxiety (n = 2).
The operation was a one-stage, two-port, T2 to T3 bilateral thoracoscopic sympathectomy with patients placed in the semiprone position and mild anti-Trendelenburg inclination [18]. Intraoperative monitoring included arterial and venous accesses, electrocardiogram, pulse oximetry, and forefinger temperature. Epidural anesthesia was administered through a percutaneous three-space intercostal block at the level of the thoracic incisions by infiltration of ropivacaine 0.75%, 4 mL for each intercostal space. These patients maintained spontaneous breathing, and supplementary oxygen was administered by means of a face mask as required. Additional injections were performed with 10 mL of mepivacaine 2% in each 5-mm port. The camera port was sited in the fourth intercostal space on the midaxillary line and the operative port, in the third intercostal space anterior to midaxillary line. The surgical technique usually consisted of opening the parietal pleura, identifying the T2 to T3 sympathetic chain, and dividing by cautery communicating branches. Subsequent dissection at the T2 level was always performed by endoscopic scissors to avoid possible heat injury to stellate ganglion whereas the T3 section was made with the cautery. Careful dissection of accessory branches and Kuntz nerve was performed to prevent relapses. Lung reexpansion was video-controlled at the end of each procedure and enhanced by positive pressure administered in patients through a "to-and-fro" valve. A temporary 10F thoracic drain was set in place and connected to mild suction while the patient's position was changed to allow approach on the other side.
Botulinum Toxin-A Injection
Botulinum toxin-A (Botox; Allergan Inc, Irvine, CA) was always administered in a unique session. One ampule of Botox (100 U) was diluted with 5 mL of nonconserved sterile physiologic saline solution, resulting in a concentration of 2 units per 0.1 mL of solution.
After regional median and ulnar nerve block with infiltration of ropivacaine 0.75%, botulinum toxin-A was injected intradermally in 28 sites in each palm in the same session, using 1-mL tuberculin syringes and 27-gauge needles. A total amount of 0.1 mL equivalent to 2 units was injected in each of the 28 sites. The injection site corresponded to the area of the 14 phalanges and 3 along each metacarpus, with only two for the first one.
Follow-Up
Follow-up included periodical outpatient visits performed at 1, 3, 6, and 12 months during which all objective and subjective evaluations were repeated. Owing to rapid response, forefinger temperature was also determined 1 hour after treatment.
Patient's satisfaction with the procedure was assessed starting from 24 hours after treatment by asking to choose one out of five possible responses, as applicable: very poor, poor, good, very good, and excellent (scored 1–5).
A cost comparison in euro (1 euro = 1.3 US dollar) between groups concerning devices, drugs, global time in operating room, medical personnel, and hospital stay was also carried out.
Statistical Evaluation
Throughout, data were expressed as mean ± standard deviation, and posttreatment changes were indicated as the median percentage of the baseline value. Nonparametric tests were prudentially chosen because the distribution of some variables was not normal for the specific tests. The Wilcoxon or the Mann-Whitney tests were used for paired and unpaired data, respectively. Significance level was 0.05.
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Results |
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Pathologic examination confirmed the presence of sympathetic ganglia in all specimens. No operative mortality was recorded in the surgical group. Minor postoperative complications were observed: persistent intercostal pain (n = 2) and slight pneumothorax (<30%; n = 4), which spontaneously resolved without chest tube requirement. Mean hospital stay was 1.3 ± 0.4 days, and 31 patients were treated on an outpatient basis. Complications of botulinum injection were persistent hand pain (n = 2) and grasp weakening (n = 2).
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Objective Evaluation
Results of objective sweating assessment are summarized in Table 2. At the first month, Minor's test values were significantly improved in both groups. On the other hand, the values at 6 months started to diverge owing to a significant deterioration in the botulinum group (+94% versus +63%; p = 0.036). This difference became more significant at 12 months (+94% versus +30%; p = 0.011). A similar trend was documented with the pad glove test although the differences were earlier and more significant between groups. The increment in hand temperature was immediate in both groups without significant intergroup differences, but changes became significant after 3 months (+30% versus +15%; p = 0.049) and progressively greater.
A compensatory sweating in at least one site was experienced in 98% of the patients belonging to the surgical group and 90% of the botulinum group. Entity and evolution of the compensatory sweating are shown in Figure 1 and revealed a mean increment in all sites except the face. As expected the phenomenon was greater and more persistent in the surgical group.
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At 3 months, almost all domains of the SF-36 improved in both sympathectomy and botulinum groups. Decrement was progressive in the botulinum group, reaching after 1 year the baseline values. On the contrary, values of sympathectomy presented only a mild deterioration, likely owing to the effect of compensatory sweating, with a significant increment of intergroup difference (Fig 2; Appendix). The same trend was documented by the Nottingham Health Profile (Fig 2; Appendix).
Patient's satisfaction was initially greater in botulinum group (p = 0.03), but after 6 months it significantly reversed (p = 0.04), and this difference became more evident after 1 year (p < 0.001; Table 4).
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Comment |
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Since 2001, we have performed both treatments depending on the patient's choice. We thus have the possibility of investigating on a nonrandomized basis the specific merits of each treatment with objective and subjective scales of evaluation.
From 2002 we introduced epidural anesthesia for sympathectomy with the patient awake with breathing lungs. In our experience the operation was feasible and results were comparable to the operation administered under general anesthesia.
Patients initially preferred botulinum injection, because of the fear of a surgical procedure with either general or epidural anesthesia. Notwithstanding, after 1 year many patients who were dissatisfied with the botulinum injection treatment reconsidered the option of surgical procedure with a high degree of acceptance.
The impact of postoperative pain was rarely significant. In the early postoperative period the pain was adequately controlled by intravenous medications. Afterward no patient presented with such a significant pain to be referred during outpatient control or to worsen the score of the generic questionnaires.
With objective evaluation we found that both methods were significantly effective: reduction of quantity of sweat was experienced with Minor's iodine starch and pad glove tests. As expected, the effect of botulinum weakened after 6 months and, at the same time, the compensatory sweating decreased. On the other hand, compensatory sweating, especially in the lumbar area, remained almost constant in the surgical group.
The subjective analysis showed a significant improvement of all questionnaires in both groups. These effects tended to decrease starting from the third month with a more evident decrement in the botulinum arm owing to objective disappearance of the effects. In the surgical group the decrement of the score was explained with the onset of compensatory sweating, which affected the answers in all the questionnaires used in the study. At any result, the presence of compensatory sweating had a minor influence on quality of life compared with the effect of the reprise of palmar sweating.
In accordance to the existing evaluation of quality of life in literature [2, 19–23], we noted that psychosocial domains improved more than physical ones. This was valid for both procedures even if the difference was more evident in the surgical arm. This trend was common to other studies [20, 23] using the SF-36 questionnaire and it is probably owing to the great social impact of this disorder involving the hands.
The satisfaction score was initially superior in the botulinum group. This is justified by the better acceptance of a medical procedure compared with a surgical one. However, with the progressive weakening of the toxin injection effects, the acceptance became greater in the sympathectomy group.
The economic consideration revealed an evident lower cost for botulinum injection, but these data should be counterbalanced with the periodic need for reinjection.
We acknowledge three major limitations in our study. First, the nonrandomized nature is a limitation. Patients had the choice between surgery or botulinum toxin, so they may be influenced by the physician's presentation on technique and complications. On the other hand, the patient's psychology is an important factor. This limit is easily justifiable by the wide difference of the two procedures that makes a pure randomization almost unacceptable to the patient. Another limitation may be represented by the difficulty of matching a surgically definitive therapy with a medical and short-lasting method requiring periodic reinforcements. However, evaluation of quality of life also takes into account compensatory sweating, and it can compensate this a priori bias.
The study group includes both patients who underwent surgery under general and epidural anesthesia. This might affect subjective evaluation, but not an objective one, and for this reason those patients were considered in a unique group.
The inclusion of T2 ganglion for palmar hyperhidrosis is related to greater compensatory sweating with T2 and worse patient satisfaction, and this is evident also from our paper. We have already started a program with only T3 sympathectomy (section without removal), and data will be the subject of further investigations.
The final limitation concerns the relatively short time of observation, restricted to 1 year, but this is related to the need of allowing a crossover from one group to another. As a matter of fact, after 1 year 14 patients initially belonging to the botulinum group underwent sympathectomy.
In conclusion, our results suggest that the definitive advantages of sympathectomy are superior to the temporary ones warranted by botulinum toxin-A injection, thus replacing the greater economic costs and discomfort caused by greater compensatory sweating. This study emphasizes the need for new prospective randomized trials comparing sympathectomy with botulinum.
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Appendix |
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Acknowledgments |
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TopAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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References |
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This article has been cited by other articles:
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  F. J. Baumgartner, M. Reyes, G. G. Sarkisyan, A. Iglesias, and E. Reyes Thoracoscopic Sympathicotomy for Disabling Palmar Hyperhidrosis: A Prospective Randomized Comparison Between Two Levels Ann. Thorac. Surg., December 1, 2011; 92(6): 2015 - 2019. [Abstract] [Full Text] [PDF]
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