1
LETTERS NOTES & COMMENTS Liposuction for axillary hyperhidrosis: Reconciling trial results and expert opinion To the Editor: We would like to thank Dr Coleman 1 for his insightful comments regarding our article and for sharing his expertise in the use of liposuction for treatment of axillary hyperhidrosis. As Dr Coleman notes, and as we have discussed else- where, 2,3 one of the major challenges of comparative effectiveness studies of procedural interventions is so-called ‘‘dose-finding.’’ That is, selection of the appropriate settings, intensity, and precise surgical technique for each treatment arm is needed to ensure that a fair, apples-to-apples comparison of the pro- cedures is performed. The more complex the in- terventions, the more numerous the variables that need to be managed, and the harder this is to accomplish. A similar challenge occurs when tech- niques are not standardized, or when they are highly operator-dependent. Dr Coleman notes that he performs a more aggressive procedure than we selected, and we could have certainly included one such in our study. But then another commentator could have asserted that our very aggressive liposuction procedure was outside the norm, and biased our results in favor of liposuction. Yet another consideration is the institu- tional review board process, including informed consent and subject risk reduction. Botulinum toxin injections pose extremely low risks, and while liposuction is also very safe, it is an invasive procedure with a slightly elevated risk profile, including the possibility of postoperative edema and erythema, scars, and hyperpigmentation. This is another reason we chose to use a slightly less aggressive procedure. We also agree with Dr Coleman’s observation that the duration of our study precluded long-term outcome assessment. This is a limitation of many studies, including ours, and is a particular issue in studies of cosmetic or lifestyle interventions, 2,3 in which patients are often reluctant to return for additional follow-up visits years later. That being said, we believe that randomized controlled trials do offer information that is supple- mentary to expert opinion. Assuming they are reasonably well designed, randomized controlled trials do mitigate biases inherent to observational studies or uncontrolled trials. Therefore, large effect sizes that are sometimes seen in observational studies often shrink when randomized controlled trials are performed. Additional strengths of our study include the split-body design, which is useful for minimizing unknown confounders, and rare in procedural studies such as ours that involve an invasive treatment. Also, while no study is entirely free of investigator biases or conflicts of interest, we tried to minimize these by avoiding any direct or indirect corporate sponsorship. We are grateful to Dr Coleman for sharing his expertise as one of the foremost international experts on the procedures we studied, and on dermatologic surgery study design. As Dr Coleman implies, treatment decisions should be based on the totality of the evidence, not the results of any one study or trial. Like Dr Coleman, we look forward to the results of additional studies, including additional comparative effectiveness trials examining micro- wave technology. Omer Ibrahim, MD, a,d,e and Murad Alam, MD, MSCI a,b,c Departments of Dermatology, a Otolaryngology Head and Neck Surgery, b and Surgery, c North- western University, Chicago; Department of Dermatology, Yale University School of Medicine, New Haven d ; and Department of Dermatology, Cleveland Clinic Foundation, Cleveland e Funding sources: None. Disclosure: Dr Alam has been an investigator for other studies with Allergan (Botox), but no compensation was received from these earlier, unrelated studies. Dr Ibrahim declared no conflicts of interest. Correspondence to: Murad Alam, MD, MSCI, Department of Dermatology, Northwestern University, 676 N St Clair St, Suite 1600, Chicago, IL 60611 E-mail: [email protected] REFERENCES 1. Coleman WP. Liposuction for axillary hyperhidrosis. J Am Acad Dermatol 2013;69:1062. 2. Alam M. Evidence-based procedural dermatology. In: Maibach H, Gorouhi F, editors. Evidence-based dermatology. 2nd ed. Shelton (CT): PMPH; 2011. pp. 539-46. 3. Alam M, Olson JM, Asgari MM. Needs assessment in cosmetic dermatologic surgery. Dermatol Clin 2012;30:177-87. http://dx.doi.org/10.1016/j.jaad.2013.10.016 384 FEBRUARY 2014 JAM ACAD DERMATOL

Liposuction for axillary hyperhidrosis: Reconciling trial results and expert opinion

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LETTERS

NOTES & COMMENTS

Liposuction for axillary hyperhidrosis:Reconciling trial results and expert opinion

To the Editor: We would like to thank Dr Coleman1

for his insightful comments regarding our articleand for sharing his expertise in the use of liposuctionfor treatment of axillary hyperhidrosis. As DrColeman notes, and as we have discussed else-where,2,3 one of the major challenges of comparativeeffectiveness studies of procedural interventions isso-called ‘‘dose-finding.’’ That is, selection of theappropriate settings, intensity, and precise surgicaltechnique for each treatment arm is needed to ensurethat a fair, apples-to-apples comparison of the pro-cedures is performed. The more complex the in-terventions, the more numerous the variables thatneed to be managed, and the harder this is toaccomplish. A similar challenge occurs when tech-niques are not standardized, or when they are highlyoperator-dependent.

Dr Coleman notes that he performs a moreaggressive procedure than we selected, and wecould have certainly included one such in our study.But then another commentator could have assertedthat our very aggressive liposuction procedure wasoutside the norm, and biased our results in favor ofliposuction. Yet another consideration is the institu-tional review board process, including informedconsent and subject risk reduction. Botulinum toxininjections pose extremely low risks, and whileliposuction is also very safe, it is an invasiveprocedure with a slightly elevated risk profile,including the possibility of postoperative edemaand erythema, scars, and hyperpigmentation. Thisis another reason we chose to use a slightly lessaggressive procedure.

We also agree with Dr Coleman’s observation thatthe duration of our study precluded long-termoutcome assessment. This is a limitation of manystudies, including ours, and is a particular issue instudies of cosmetic or lifestyle interventions,2,3 inwhich patients are often reluctant to return foradditional follow-up visits years later.

That being said, we believe that randomizedcontrolled trials do offer information that is supple-mentary to expert opinion. Assuming they arereasonably well designed, randomized controlledtrials do mitigate biases inherent to observationalstudies or uncontrolled trials. Therefore, large effectsizes that are sometimes seen in observationalstudies often shrink when randomized controlledtrials are performed.

384 FEBRUARY 2014

Additional strengths of our study include thesplit-body design, which is useful for minimizingunknown confounders, and rare in proceduralstudies such as ours that involve an invasivetreatment. Also, while no study is entirely free ofinvestigator biases or conflicts of interest, we tried tominimize these by avoiding any direct or indirectcorporate sponsorship.

We are grateful to Dr Coleman for sharing hisexpertise as one of the foremost internationalexperts on the procedures we studied, and ondermatologic surgery study design. As Dr Colemanimplies, treatment decisions should be based on thetotality of the evidence, not the results of any onestudy or trial. Like Dr Coleman, we look forward tothe results of additional studies, including additionalcomparative effectiveness trials examining micro-wave technology.

Omer Ibrahim, MD,a,d,e and Murad Alam, MD,MSCIa,b,c

Departments of Dermatology,a OtolaryngologyHead and Neck Surgery,b and Surgery,c North-western University, Chicago; Department ofDermatology, Yale University School of Medicine,New Havend; and Department of Dermatology,Cleveland Clinic Foundation, Clevelande

Funding sources: None.

Disclosure: Dr Alam has been an investigator forother studies with Allergan (Botox), but nocompensation was received from these earlier,unrelated studies.

Dr Ibrahim declared no conflicts of interest.

Correspondence to: Murad Alam, MD, MSCI,Department of Dermatology, NorthwesternUniversity, 676 N St Clair St, Suite 1600,Chicago, IL 60611

E-mail: [email protected]

REFERENCES

1. Coleman WP. Liposuction for axillary hyperhidrosis. J Am Acad

Dermatol 2013;69:1062.

2. Alam M. Evidence-based procedural dermatology. In: Maibach

H, Gorouhi F, editors. Evidence-based dermatology. 2nd ed.

Shelton (CT): PMPH; 2011. pp. 539-46.

3. Alam M, Olson JM, Asgari MM. Needs assessment in cosmetic

dermatologic surgery. Dermatol Clin 2012;30:177-87.

http://dx.doi.org/10.1016/j.jaad.2013.10.016

J AM ACAD DERMATOL