Impact of Botulinum Toxin A on the Quality of Life of Subjects Following Treatment of Facial Lines

By Dr Ravi Jandhyala / 01 Feb 2014

Demand for treatment of facial lines continues to rise, botulinum toxin (BoNT-A) is especially popular due to its efficacy and tolerability BoNT-A is now used in a wide range of aesthetic applications in many areas of the face.

Demand for treatment of facial lines continues to rise, botulinum toxin (BoNT-A) is especially popular due to its efficacy and tolerability1,2 BoNT-A is now used in a wide range of aesthetic applications in many areas of the face.3 As such, full quantification of the benefits of BoNT-A treatment is becoming increasingly important. A key area of interest is whether treatment actually improves a patient’s day-to-day life. Improvements in satisfaction, appearance, mood, and related outcomes have been well reported,4–13 but to date, data on whether these improvements translate to or correlate with changes in quality of life (QoL) are scarce.
Dayan et al14 recently reported that onabotulinumtoxinA treatment of facial wrinkles significantly improved QoL and self-esteem as compared to both treatment with placebo and pre- treatment baseline values using the Quality of Life Enjoyment and Satisfaction Questionnaire—Short Form and the Heatherton and Polivy State Self-Esteem measurement. In the present study, an investigation of QoL in patients treated with BoNT-A was undertaken by using patient rather than questionnaire-defined criteria to measure QoL, before and after treatment, using the Schedule for the Evaluation of Individual Quality of Life Direct-Weighting (SEIQoL-DW) tool.15 Furthermore, the hope was to establish whether there is any correlation between patient satisfaction and changes in QoL.

METHODS

The study prospectively measured patient QoL data using the SEIQoL-DW tool15 immediately before and 28 days after treatment with BoNT-A (Bocouture®, Merz Pharmaceuticals GmbH, Frankfurt, Germany). Satisfaction with treatment was also assessed by patients using standardised photos taken during pre- and post-treatment assessments. All new patients aged 18 to 65 years presenting at the Jandhyala Institute for incobotulinumtoxinA treatment for moderate-to-severe wrinkles of the glabella, forehead, or crow’s feet (as measured by Carruthers’ Scale16,17)were eligible for inclusion. Patientswere excluded on the basis of previous treatment with, or contraindications to, BoNT-A treatment or a history of migraine. Patient history was taken and routine assessment carried out at the initial visit, and standardised photos were taken at both visits. Ethical review was deemed unnecessary according to the National Research Ethics Service (NRES) guidance document, and the study was considered a service evaluation.18

The SEIQoL-DW tool was administered according to protocol.15 At the first visit, a standardised question was used to stimulate patients to independently identify the five life areas (cues) of most importance to them at that time. A list of potential areas was available for use as a prompt for patients who had difficulty completing this task. Patients then quantified their present status in each of their five identified cue areas by drawing a bar for each area against a 100mm scale, with a taller bar indicating better current status (the cue score). Finally, the patients weighted the five areas as to their relative importance using the direct weighting instrument, effectively producing a five-segment pie chart, with each segment indicating the importance of the corresponding cue area (cue weight). Patients were also asked to assess their overall QoL using a visual analogue scale (VAS) of 0 to 100 (0 being the worst possible, 100 the best possible). To produce the final SEIQoL-DW index score, which provides an overall measure of QoL for comparison, each of the five cue scores was multiplied by the corresponding cue weight and the products of these calculations summed together.

The cue score (range 0–100) was derived from the length of the bar (in millimetres) drawn by the patient for that particular cue. The cue weight was derived from the proportion of weighting the patient had assigned, using the direct-weighting instrument, to that particular cue (range 0.00–1.00).
At the follow-up visit, patients completed the SEIQoLDW procedure using both newly defined cues (subsequently labelled ‘new cues’) and the cues defined at their pre-treatment visit (subsequently labelled ‘old cues’). Cues are defined at each visit to ensure that the QoL scores derived are maximally relevant to the patient at that time. As a consequence, it is possible that a patient may define markedly different cues at the follow-up visit as compared to the initial visit. To account for this, the SEIQoL-DW protocol also recommends assessment of the patients using the old cues as defined at the initial visit.1

The use of new cues gives a measure of QoL using the cues that the patient feels are of greatest importance to them currently, while the use of the old cues facilitates direct comparison of QoL at each visit. Marked differences in the cues identified or the importance ascribed to these cues may necessitate further investigation and consideration in the interpretation of the results. However, some variation is inevitable as patients’ priorities and concerns inevitably change over time, and a key strength of the SEIQoL-DW approach is its ability to take account of these changes.
Patients also assessed their satisfaction with their appearance before and after treatment from the standardised digital photographs taken at each visit using a VAS ranging from 0 (not satisfied at all) to 10 (completely satisfied).

RESULTS

Cue Area Visit 1Visit 2
Family 96.2%90.6%
Work62.3%69.8%
Finance52.8%58.5%
Relationships52.8%45.3%
Health50.9%60.4%
Appearance43.4%43.4%
Social life35.8%13.2%
Living conditions34.0%20.8%
Leisure activities32.1%13.2%
Marriage13.2%7.2%
Pets13.2%7.5%
Partner11.3%11.3%
Divorce3.8%1,9%
Religion3.8%0.0%
Education1.9%1.9%
Friends1.9%1.9%
Mother0.0%1.9%

TABLE 1: Frequency of nomination as areas of importance

53 patients (aged 22–62 years [median age: 39.5 years]; 87% women) were enrolled in this study. All patients successfully completed the independent nomination of five important areas of their lives and allocated current status and relative importance to each.
Family, work, finance, relationships, and health were the five most frequently identified cues at each assessment (Table 1). According to the cue weights ascribed (and considering only those cues identified by more than 10 patients), the five cues deemed to be most important were family, appearance, health, relationships, and finance at both visits (Table 2). QoL before and after treatment was significantly improved following incobotulinumtoxinA treatment according to the SEIQoL index scores generated using both the old (P =0.0006) and new cues (P =0.0235) (Table 3).

Cue Number of patients 
who nominated
cue at visit 1
Mean weighting
visit 1
Family5133.9
Appearance2321.5
Health2719.8
Relationships2818.5
Finance2818.3
Work3313.9
Living conditions1813.6
Social life1912.9
Leisure activities1911.7
Marriage722.2
Pets716.6
Partner614.7
Friends117.0
Religion221.0
Divorce220.0
Education111.0
Mother00.0

TABLE 2a: Mean weight ascribed to nominated areas at Visit 1

Overall QoL as measured by VAS following identification and weighting of the SEIQoL cue areas was also found to significantly improve after treatment when assessed after consideration of both the old (P <0.0001) and new cues (P <0.0001) at Visit 2 (Table 3).
Satisfaction increased significantly following treatment (median satisfaction score post vs. pre-treatment: 9.2 vs. 4.3, P <0.0001), but evidence of any positive correlation between satisfaction score and QoL or SEIQoL score was minimal. Only QoL as defined by VAS following the use of the old cues at Visit 2 was found to significantly correlate to satisfaction score at the same visit (P =0.0404, all other correlations P >0.05). When considering the change in these scores, 100% of patients indicated that their satisfaction with their appearance had increased. However, not all patients indicated that their QoL had increased.
Following elicitation of the new cues, 79 and 64% rated their QoL as improved according to their overall assessment and using SEIQoL, respectively. Using the old cues, these figures increased to 91 and 75%. No evidence of any correlation between the change in satisfaction score and the change in QoL (as measured by VAS or SEIQoL) was found (all P >0.05).

Cue Number of patients
 who nominated
cue at visit 2
Mean weighting
visit 2
Family4831.5
Appearance2318.2
Health3219.8
Relationships2417.6
Finance3116.3
Work3715.3
Living conditions1114.9
Social life1611.8
Leisure activities714.1
Marriage424.0
Pets416.3
Partner611.2
Friends112.0
Religion00.0
Divorce128.0
Education122.0
Mother130.0

TABLE 2. Mean weight ascribed to nominated areas Visit 2

Measure ComparisonVisit 1 meanVisit 2 meanP-Value
QoL (VAS) scoresvs. old cues58.772.3P<0.0001

vs. old cues
58.770.6P<0.0001
SEIQoL indiciesvs. old cues
63.770.1P<0.0006

vs. old cues
63.7
67.9P<0.0235

TABLE 3. Quality-of-life scores pre- and post-treatment

DISCUSSION

The results of this study demonstrate that QoL is significantly improved following incobotulinumtoxinA treatment. Both overall QoL as assessed by VAS and SEIQoL scores were consistently higher following treatment, irrespective of whether the old or new cues had been considered during the SEIQoL process. While the recognised procedure is to elicit new cues at the second visit, it is also to use the old cues to facilitate direct comparison15It is reassuring to note that overall, the same cue areas were identified as being most important at Visit one and Visit two, suggesting that as a whole, the patient population was relatively stable in terms of non-treatment influences on their QoL. It is also interesting to note that while, perhaps surprisingly, ‘appearance’ was not one of the five most frequently selected cues in determining QoL, among those patients who did identify it as important, it could be considered a fundamental driver of QoL, as evidenced by its prominent weighting.

Perhaps surprisingly, the present study found no consistent evidence of correlation between the level of patient satisfaction and their SEIQoL or overall QoL scores at either visit, despite all patients having an increase in satisfaction and the majority showing an improvement in QoL, particularly when assessed following use of the old cues at their follow-up visit. It is also of interest to note that when the change in satisfaction score following treatment was analysed against change in SEIQoL or overall QoL, there was no evidence of a correlation in the size of the change of the two measures. This may in part be explained by the fact that satisfaction with appearance is one of many factors that contribute to QoL and, as already alluded to, less than half of patients identified appearance as a major determinant of their QoL. As such, it is clear that while appearance is undoubtedly important to many patients receiving BoNT-A, the use of satisfaction scores alone may be an unreliable surrogate for QoL in day-to-day practice. These results, in combination with those of Dayan et al,1 suggest that serious consideration should be given to incorporating the measurement of QoL as an outcome measure following BoNT-A treatment. Further research is warranted in this area to further quantify the impact BoNT-A treatment has on patients beyond the observed changes in appearance.

DISCLOSURE
The author has received research funding from Merz Pharma in relation to other studies. The study received support for medical writing and medicinal products from Merz Pharmaceuticals.

References

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