Satisfaction of Patients After Treatment With Botulinum Toxin for Dynamic Facial Lines
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1 Satisfaction of Patients After Treatment With Botulinum Toxin for Dynamic Facial Lines BORIS SOMMER, MD, n INA ZSCHOCKE, PHD, w DOROTHEE BERGFELD, MD, n GERHARD SATTLER, MD, n AND MATTHIAS AUGUSTIN, MD,PHD z n Rosenparkklinik Center for Aesthetic Dermatologic Surgery, Darmstadt, w IFKS, Institute for Research Management and Clinical Studies, University Hospital Freiburg, and z Department of Dermatology, Freiburg, Germany OBJECTIVE. To gain first evidence on the patient satisfaction after treatment with botulinum toxin type A (BTX-A) and to check for differences in satisfaction with respect to clinical, psychologic, and sociodemographic parameters. METHODS. In this pilot study, 30 patients who had been treated with BTX-A within the last 3 months answered a standardized questionnaire (the Freiburg questionnaire on aesthetic dermatology and cosmetic surgery). The items assessed were attitudes on beauty and body, satisfaction with treatment outcome, and general quality of life. A prospective study consisting of the same items runs parallel and will be published later. RESULTS. More than 80% of the patients answered that the treatment had been beneficial to them. All patients would recommend treatment completely or mostly. Only a very small part of the patients was moderately stressed by the treatment. CONCLUSION. Injections with BTX-A is a satisfying and welltolerated treatment of dynamic facial lines for all patients in this pilot study. B. SOMMER, MD, I. ZSCHOCKE, PHD, D. BERGFELD, MD, G. SATTLER, MD, AND M. AUGUSTIN, MD PHD HAVE INDICATED NO SIGNIFICANT INTEREST WITH COMMERCIAL SUPPORTERS. BOTULINUM TOXIN type A type A (BTX-A) has been in medical use for muscle hyperactivity disorders for more than 20 years. Jean and Alastair Carruthers from Vancouver, Canada, first published in 1990 the beneficial effects in the treatment of facial folds and wrinkles. 1 According to statistics from various medical associations, an injection of BTX-A has become by far the most popular cosmetic procedure. To our knowledge, no scientific studies have been performed nor valid data have been published on this question. Thus, a study was performed in order to address these aims: (1) to get first evidence on the patient satisfaction after treatment with BTX-A and (2) to evaluate differences in treatment satisfaction with respect to clinical, psychologic, and sociodemographic parameters. Methods Patients In this retrospective pilot study, 30 consecutive, nonselected patients addressing for the treatment of facial wrinkles with BTX-A injections were included. All patients had been treated previously by B.S. at the Address correspondence and reprint requests to: Boris Sommer, MD, Rosenparkklinik Darmstadt, Heidelberger Landstr. 20, Darmstadt, Germany, or b.sommer@rosenparkklinik.de. Center for Aesthetic Dermatologic Surgery (Rosenparkklinik, Darmstadt, Germany). Informed consent was obtained from all patients before treatment and investigation. The mean age was years (range, 28 to 63 years); 27 of the patients (90.0%) were women, and 3 (10.0%) were men. Treatment All patients were treated with Botox (Allergan Inc., Irvine, CA). The vial containing 100 U was diluted with 2.5 ml of physiologic saline. All dosage figures are Botox mouse units (mu). Areas treated included glabella, the periocular region ( crow s feet ), the forehead, and suborbicular areas. Dosage for the different areas was 24 or 30 mu for the glabella, 20 mu for both sides of the periocular region, 10 or 12 mu for the forehead, and 6 mu for both suborbicular areas. All patients were treated as described previously. 2 4 No serious side effects were noted, aside from minor bleeding, which could be controlled by local compression for 1 minute. Evaluation Standardized questionnaires were sent to the patients 8 to 12 weeks after the injections. The following major parameters were assessed: (1) sociodemographic and r 2003 by the American Society for Dermatologic Surgery, Inc. Published by Blackwell Publishing, Inc. ISSN: /03/$15.00/0 Dermatol Surg 2003;29:
2 Dermatol Surg 29:5:May 2003 SOMMER ET AL.: SATISFACTION WITH COSMETIC BTX TREATMENT 457 clinical data (age, gender, body mass index, injection sites of BTX, and cosmetic pretreatment), (2) patient attitudes on beauty and body (scales of the Freiburg questionnaire on aesthetic dermatology and cosmetic surgery [FQAD], part I), (3) treatment outcome for the patient (satisfaction, effects on different areas of life; scales of the FQAD, part II), and (4) generic quality of life (Freiburg Life Quality Assessment, core version [FLQA-c]). Patient Questionnaire The patient questionnaires (FQAD I and II) were developed and validated by a group of experienced dermatologists and psychologists. The procedure of development has been reported previously. 5 Structure of the FQAD The FQAD consists of two parts. Part I (44 items) assesses aspects of body, social contacts, and outer appearance. The following scales were constructed: 1. Body experience (19 items, e.g., I like my skin ). 2. Body care (8 items, e.g., I spend a lot of time on body care ). 3. Social contacts and avoidance (11 items, e.g., Sometimes I feel that others are staring at my body ). 4. Self-confidence (6 items, e.g., I have difficulties accepting my appearance ). Part II (20 items) evaluates the outcome of treatment with aesthetic procedures: botulinum toxin. The scales are as follows: 1. Effects of treatment on body and mind (eight items; e.g., I feel more comfortable ). 2. Social effects (six items; e.g., I now feel better when I am with other people ). 3. Satisfaction with treatment (six items; e.g., I can recommend the treatment ). Statistics The statistical procedures were performed using SPSS 10.1 for Windows. The level of significance was 5%. Varimax rotated factor analyses were performed for both parts of the FQAD in order to test the scale construction. Here, the factor loadings confirmed the scales postulated. In a correlation test using Pearson s coefficient, the association of patient satisfaction with sociodemographic, clinical, and psychologic parameters was investigated. Furthermore, a multivariate regressions analysis was undertaken in order to find major predictors of patient satisfaction with treatment. Quality of Life Quality of life was assessed by the FLQA in a generic, not disease-related, core version (FLQA-c). The FLQA-c has been validated and published in a variety of studies. 6,7 Results Patients and Treatment The patients undergoing BTX-A treatment were an average height, weight, and body mass index (Table 1). The most frequently treated sites were glabella (N 5 28) and the periocular region (N 5 15) (Table 2). Quality of Life and Health Status The patients showed a normal distribution of quality of life in all dimensions (Figure 1). Also, the average global assessments of quality of life and of health status were within normal range (Figure 2). Table 1. Clinical Basic Data of the BTX-A Patients (N 5 30) Patients Undergoing BTX-A Treatment Height (cm) Mean Range Weight (kg) Mean Range Body mass index Mean Range Table 2. Sites of BTX-A Injections in 30 Patients (Multiple Sites Possible) Sites of Injection N % Mean (mu) Median (mu) Maximum (mu) Minimum (mu) Glabella Periocular region Forehead Suborbicular area Dosage in mouse units (mu) of Botox.
3 458 SOMMER ET AL.: SATISFACTION WITH COSMETIC BTX TREATMENT Dermatol Surg 29:5:May 2003 Figure 1. Quality of life of patients undergoing BTX-A treatment (N 5 30) compared with healthy control subjects (N 5 240). High values indicate reductions of quality of life. No significant differences between the groups were found. Figure 2. Global Health Scales of study patients (N 5 30) compared with normal control subjects (N 5 240). Patient Satisfaction A high proportion of patients (more than 80%) answered that the treatment had been beneficial to them (Figure 3). All patients would recommend treatment completely (83.3%) or mostly (16.7%). In contrast, only a very small proportion of patients (3.3%) was moderately stressed by the treatment (Table 3). Regarding the impact on attractiveness, 55.1% answered to feel completely or mostly attractive (Figure 4). Even more patients (76.7%) reported to Table 3. Patient Satisfaction Between Patients Undergoing BTX-A (N 5 30) Answer BTX-A (%) Figure 3. Satisfaction with treatment and stress by treatment of patients undergoing BTX-A (N 5 30). The data refer to single items of the questionnaire on cosmetic surgery. I recommend the treatment The treatment was beneficial to me 80.0 I was stressed by treatment 0.0 I feel more attractive 55.1 I feel more comfortable with my body 76.7 My emotional well-being is better 30.0 I have more confidence in my appearance 44.8 I can profit from the treatment in my job 20.6 I don t like to tell others about the treatment 13.3
4 Dermatol Surg 29:5:May 2003 SOMMER ET AL.: SATISFACTION WITH COSMETIC BTX TREATMENT 459 Table 4. Predictors of Patient Satisfaction, Assessed by Multivariate Regression Analysis (N 5 30) No effects Predictive value Age Quality of life scales Previous treatments (number of) Body mass index FQAD scale aesthetic feeling T , F P Figure 4. Treatment effects of BTX-A on attractiveness, body, and mind (N 5 30). Figure 5. Social effects of BTX-A on body and mind (N 5 30). feel more comfortable with their body. However, only 30.0% answered that their emotional well-being was completely or mostly better. With respect to social contacts, 44.8% confirmed completely or mostly to have more confidence in their outer appearance (Figure 5); 20.6% expected to profit from the treatment in their job, and 13.3% would not like at all to tell others about the treatment. Predictors of Patient Satisfaction In order to get information on the typical patient who is satisfied with treatment, a correlation analysis was performed. Patient satisfaction was measured by a composite score, which included all single outcome variables. No single psychological, clinical, or demographic parameters with significant correlation with patient satisfaction were found (data not shown). For this, a multiple regression analysis was performed. It suggests that the aesthetic feeling of the patients is the only but strong predictor of patient satisfaction (Table 4). This means that patients being more focused on their outer appearance and being more conscious about aesthetics are more likely to be satisfied with treatment. Discussion Surgeons performing cosmetic procedures have a distinct feeling about patient satisfaction. One injection of BTX-A has a paralytic effect on the mimic muscle lasting 4 months on average, depending on the dosage and individual patient. In order to maintain the desired clinical effect, the injection has to be repeated on a regular basis. Most patient return regularly to receive follow-up injections. This fact obviously indicates a high degree of satisfaction with the treatment. To obtain a scientific background addressing this subject, this study aimed at gaining first data on the extent and predictors of satisfaction with treatment in patients undergoing BTX-A treatment. Because there have not yet been published any data on this topic, the methods were adapted from a study on patients undergoing liposuction 5 and other aesthetic treatments. The questionnaires were developed and applied according to national 5 and international 8 11 guidelines on the assessment of health status and quality of life. The results of the study correlate to a very high degree with clinical experience. More than 80% of patients answered that the treatment had been beneficial to them. All patients would recommend treatment completely or mostly. Interestingly, 76.7% of patients reported that they felt more comfortable with their body after the treatment. This indicates a great importance of dynamic facial lines and their treatment for the whole-body self-image. Thirty percent of the patients stated that their emotional well-being was better after the treatment; no patients were stressed by the procedure. In clinical experience, patients who are very aware about their outer appearance seem to be more critical about surgical treatment results and thus represent patients with less overall satisfaction. In contrast to this, the multiple regression analysis that was performed in order to get information on the typical patient who is satisfied with treatment suggests that patients who are more conscious about aesthetics and outer appearance are the ones that are more likely to be satisfied with treatment. The fact that the aesthetic
5 460 SOMMER ET AL.: SATISFACTION WITH COSMETIC BTX TREATMENT Dermatol Surg 29:5:May 2003 feeling of the patients is a strong predictor of patient satisfaction could have an important impact on clinical practice. The prospective study that runs parallel using the same questionnaire will provide more data on these questions and will demonstrate changes in the quality of life before and after treatment. References 1. Carruthers A, Carruthers J. The treatment of glabellar furrows with botulinum A exotoxin. J Dermatol Surg Oncol 1990;16: Carruthers A, Carruthers J. Clinical indications and injection technique for the cosmetic use of botulinum A exotoxin. Dermatol Surg 1998;24: Carruthers A, Carruthers J. Cosmetic uses of botulinum toxin. In: Klein AW, ed. Tissue Augmentation in Clinical Practice (1st ed.). New York, Basel, Hong Kong: Marcel Dekker, 1998: Sommer B, Sattler G, eds. Botulinum Toxin in Aesthetic Medicine. Berlin, Vienna, Boston: Blackwell Science, Augustin M, Zschocke I, Sommer B, Sattler B. Sociodemographic profile and satisfaction with treatment of patients undergoing liposuction in tumescent local anesthesia. Dermatol Surg 1999;25: Augustin M, Zschocke I, Seidenglanz K, Lange S, Schiffler A, Amon U. Validation and clinical results of the FLQA-d, a quality of life questionnaire for patients with chronic skin diseases. Dermatol Psychosom 2000;1: Augustin M, Amon U, Bullinger M, Gieler U. Recommendations for the assessment of quality of life in dermatology. Dermatol Psychosom 2000;1: Sackett DL, Chambers LW, MacPherson AS, Goldsmith CH, McAuley RG. The development and application of indices of health: general methods and summary of results. Am J Public Health 1977;67: Guyatt GH, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chron Dis 1987;40: Deyo RA, Diehr P, Patrick D. Reproducibility and responsiveness of health status measures: statistics and strategies for evaluation. Control Clin Trials 1991;12:142S 158S. 11. Finlay AY. Quality of life measurement in dermatology: a practical guide. Br J Dermatol 1997;136:
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