Evidence tables | Hyperhidrosis: oxybutynin | Advice

Study reference	Schollhammer M, Brenaut E, Menard-Andivot N et al. (2015) Oxybutynin as a treatment for generalized hyperhidrosis: a randomized, placebo-controlled trial. British Journal of Dermatology 173(5): 1163–8
Unique identifier	NCT01855256
Study type	RCT
Aim of the study	To evaluate the efficacy and safety of oxybutynin in people with hyperhidrosis
Study dates	June 2013 to January 2014
Setting	4 centres in France
Number of participants	62 randomised (58 analysed^a)
Population	Adults (mean age approximately 35 years) with generalised^b (83%) or localised hyperhidrosis (17%)^c
Inclusion criteria	HDSS score of 2 or more
Exclusion criteria	Aged less than 18 years, current pregnancy, breastfeeding, hypersensitivity to oxybutynin or any of the excipients, known prostatic disorders, intestinal occlusion, toxic megacolon, intestinal atony, severe ulcerative colitis, myasthenia and closure glaucoma of the anterior chamber angle
Intervention(s)	Oxybutynin 2.5 mg daily, increased over 8 days until an effective dose was achieved. Maximum dose 7.5 mg daily, achieved by all but 1 patient (n=32)
Comparator(s)	Placebo (n=30)
Length of follow-up	6 weeks
Outcomes	Primary outcome: Proportion of people with an improvement in HDSS score of 1 or more at week 6
	Secondary outcomes: Change in DLQI score from baseline to week 6
	Safety outcomes: Reported adverse effects
Source of funding	This study was partially funded by the French Society of Dermatology
Overall risk of bias/quality assessment (CASP RCT checklist)	Did the trial address a clearly focused issue?	Yes
	Was the assignment of patients to treatments randomised?	Yes
	Were patients, health workers and study personnel blinded?	Unclear^d
	Were the groups similar at the start of the trial?	Yes
	Aside from the experimental intervention, were the groups treated equally?	Yes
	Were all of the patients who entered the trial properly accounted for at its conclusion?	Yes
	How large was the treatment effect?	See table 8
	How precise was the estimate of the treatment effect?	See table 8
	Can the results be applied in your context (or to the local population)?	Yes
	Were all clinically important outcomes considered?	Unclear^e
	Are the benefits worth the harms and costs?	See key points
Study limitations	The study had a short duration Small study with limited statistical power to detect differences between the groups Placebo-controlled study, no active comparator An objective measure of hyperhidrosis was not used Although the authors stated that they used an intention to treat analysis it does not appear that they used an appropriate method to account for people who were lost to follow-up (for example, last observation carried forward) External factors influencing the degree of sweating were not assessed (for example, outdoor activities or vocational activities) It is not clear whether allocation was concealed
Comments	^a In the oxybutynin group, 2 participants withdraw from the study before receiving the allocated treatment. In the placebo group, 1 participant was lost to follow-up and 1 withdrew from the study on day 2. ^b Generalised hyperhidrosis was defined as excessive sweating occurring at 2 or more locations (among palmar, plantar, axillary, facial or truncal). ^c The authors defined localised hyperhidrosis as hyperhidrosis affecting only 1 location and generalised hyperhidrosis as hyperhidrosis affecting 2 or more locations. ^d Because of the anticholinergic adverse effects associated with oxybutynin, it is possible that participants were aware of the treatment. ^e No objective measures of treatment were reported.
Abbreviations: DLQI, Dermatology Life Quality Index; HDSS, Hyperhidrosis Disease Severity Scale; RCT, randomised controlled trial.

Study reference	Wolosker N, Milanez de Campos JR, Kauffman P et al. (2012) A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis. Journal of Vascular Surgery 55(6): 1696–700
Unique identifier	None identified
Study type	RCT
Aim of the study	To evaluate the efficacy and safety of oxybutynin in people with localised (palmar and axillary) hyperhidrosis
Study dates	January 2011 to June 2011
Setting	Single centre in Brazil
Number of participants	50 randomised (45 analysed^a)
Population	Adults (mean age approximately 28 years) with palmar or axillary hyperhidrosis
Inclusion criteria	Palmar or axillary hyperhidrosis with the intention of using a new medicine
Exclusion criteria	Previous glaucoma, urinary retention, gastric retention, narrow-angle glaucoma, and demonstrated hypersensitivity to the drug substance or other components of the product
Intervention(s)	Oxybutynin 2.5 mg daily, increased to 5 mg twice daily over 3 weeks (n=23)
Comparator(s)	Placebo (n=22)
Length of follow-up	6 weeks
Outcomes	Efficacy outcomes: Patient assessment of change in hyperhidrosis severity^b Patient assessment of change in quality of life^c
	Safety outcomes: Reported adverse effects^d
Source of funding	Not reported
Overall risk of bias/quality assessment (CASP RCT checklist)	Did the trial address a clearly focused issue?	Yes
	Was the assignment of patients to treatments randomised?	Unclear
	Were patients, health workers and study personnel blinded?	Unclear^e
	Were the groups similar at the start of the trial?	Yes^f
	Aside from the experimental intervention, were the groups treated equally?	Yes
	Were all of the patients who entered the trial properly accounted for at its conclusion?	Yes
	How large was the treatment effect?	See table 9
	How precise was the estimate of the treatment effect?	See table 9
	Can the results be applied in your context? (or to the local population)	Yes
	Were all clinically important outcomes considered?	Unclear^g
	Are the benefits worth the harms and costs?	See key points
Study limitations	The study had a short duration Placebo controlled study, no active comparator Small study with limited statistical power to detect differences between the groups An objective measure of hyperhidrosis was not used External factors influencing the degree of sweating were not assessed (for example, outdoor activities or vocational activities) It is not clear whether allocation was concealed
Comments	^a Two people in the oxybutynin group and 3 people in the placebo group were lost to follow-up. ^b Patient-reported improvement in hyperhidrosis on a scale from 0 (no improvement) to 10 (absence of hyperhidrosis), based on their own estimates without any intervention or advice from the interviewer. ^c The negative effect of hyperhidrosis on QOL before the treatment was classified into 5 levels and calculated as the summed total score from the protocol (range, 20 to 100). Higher levels indicated greater severity and poorer QOL. When the total was >84, the QOL was considered as very poor; from 68 to 83, poor; from 52 to 67, good; from 36 to 51, very good; and from 20 to 35, excellent. Improvement of QOL after the treatment was also classified using 5 levels. When the total was >84, the QOL was considered as much worse; from 68 to 83, a little worse; from 52 to 67, the same; from 36 to 51, a little better; and from 20 to 35, much better. ^d Patients evaluated the presence of dry mouth on a scale from 0 to 3, where 0 represented absence; 1, mild; 2, moderate; and 3, severe. ^e Because of the anticholinergic adverse effects associated with oxybutynin it is possible that participants were aware of the treatment. ^f Patients were matched for age sex and site of hyperhidrosis but no other information is reported. ^g No objective measures of treatment were reported.
Abbreviations: QOL, quality of life; RCT, randomised controlled trial.

Study reference	Costa Jr AS, Leão LEV, Succi JE et al. (2014) Randomized trial – oxybutynin for treatment of persistent plantar hyperhidrosis in women after sympathectomy. Clinics (Sao Paulo) 69(2): 101–5
Unique identifier	NCT01328015
Study type	RCT
Aim of the study	To evaluate the efficacy and safety of oxybutynin in women with localised plantar hyperhidrosis after endoscopic thoracic sympathectomy
Study dates	March 2010 to June 2010
Setting	Single centre in Brazil
Number of participants	32 randomised
Population	Women (mean age approximately 27 years) with plantar hyperhidrosis who had previously undergone endoscopic thoracic sympathectomy
Inclusion criteria	Women who had undergone G3 and G4 thoracic sympathectomy for palmar-plantar hyperhidrosis more than 6 months prior to the start of the study (mean 60.4 months in the oxybutynin group and 41.3 months in the placebo group), and were experiencing troublesome plantar hyperhidrosis
Exclusion criteria	Pregnancy, breastfeeding, glaucoma, use of tricyclic antidepressants, BMI more than 25 kg/m² and previous use of anticholinergic medicines
Intervention(s)	Oxybutynin 2.5 mg daily, increased to a maximum dose of 10 mg
Comparator(s)	Placebo (n=23)
Length of follow-up	30 days
Outcomes	Efficacy outcomes: Patient assessment of change in quality of life^a Transepidermal water loss^b
	Safety outcomes: Reported adverse effects
Source of funding	Not reported
Overall risk of bias/quality assessment (CASP RCT checklist)	Did the trial address a clearly focused issue?	Yes
	Was the assignment of patients to treatments randomised?	Unclear^c
	Were patients, health workers and study personnel blinded?	Unclear^d
	Were the groups similar at the start of the trial?	Yes
	Aside from the experimental intervention, were the groups treated equally?	Yes
	Were all of the patients who entered the trial properly accounted for at its conclusion?	Yes
	How large was the treatment effect?	See table 10
	How precise was the estimate of the treatment effect?	See table 10
	Can the results be applied in your context? (or to the local population)	Yes
	Were all clinically important outcomes considered?	Yes
	Are the benefits worth the harms and costs?	See key points
Study limitations	The study had a short duration Small study with limited statistical power to detect differences between the groups The quality of life questionnaire used was designed for palmar rather than plantar hyperhidrosis, with only 2/20 questions asking about foot sweating. Placebo controlled study, no active comparator External factors influencing the degree of sweating were not assessed (for example, outdoor activities or vocational activities) It is not clear whether allocation was concealed
Comments	^a Patient questionnaire assesses the negative impact of hyperhidrosis on quality of life. Scored from 20 to 100, with lower scores indicating better quality of life. Scores were adjusted to be scored from 0 to 100. ^bEvaluated at the feet, hands, back and abdomen using a portable device with a humidity sensor. ^c Participants drew lots for randomisation. ^d Because of the anticholinergic adverse effects associated with oxybutynin it is possible that participants were aware of the treatment (despite being reported as a double-blind study).
Abbreviations: RCT, randomised controlled trial.

Study reference	Ghaleiha A, Jahangard L, Sherafat Z et al. (2012) Oxybutynin reduces sweating in depressed patients treated with sertraline: a double-blind, placebo-controlled, clinical study. Neuropsychiatric Disease and Treatment 8: 407–12
Unique identifier	None identified
Study type	Quasi-randomised, placebo-controlled trial
Aim of the study	To evaluate the efficacy and safety of oxybutynin in adults with sertraline-induced hyperhidrosis
Study dates	Not reported
Setting	1 centre in Iran
Number of participants	140 participants randomised
Population	Adults (mean age approximately 38 years) with major depressive disorder and hyperhidrosis secondary to sertraline treatment
Inclusion criteria	Major depressive disorder treated with sertraline (average dosage 50 mg to100 mg daily) for at least 14 days, and sertraline-induced hyperhidrosis
Exclusion criteria	Physical co-morbidity (for example, hypertension, diabetes or other endocrine disorders), psychiatric morbidity, substance abuse, pregnancy and breastfeeding
Intervention(s)	Oxybutynin 5 mg tablets once daily (n=66)
Comparator(s)	Placebo (n=74)
Length of follow-up	2 weeks
Outcomes	Efficacy outcome: Change in scores using HDSS questionnaire
	Safety outcomes: Participants completed questionnaire related to side effects, for example gastrointestinal complications, sedation, dry mouth and urinary complications
Source of funding	Not reported
Overall risk of bias/quality assessment (CASP RCT checklist)	Did the trial address a clearly focused issue?	Yes
	Was the assignment of patients to treatments randomised?	Unclear^a
	Were patients, health workers and study personnel blinded?	Unclear^b
	Were the groups similar at the start of the trial?	Yes
	Aside from the experimental intervention, were the groups treated equally?	Yes
	Were all of the patients who entered the trial properly accounted for at its conclusion?	Yes
	How large was the treatment effect?	See table 11
	How precise was the estimate of the treatment effect?	See table 11
	Can the results be applied in your context? (or to the local population)	Yes
	Were all clinically important outcomes considered?	Unclear^c
	Are the benefits worth the harms and costs?	See key points
Study limitations	The study had a short duration Placebo controlled study, no active comparator Small study with limited statistical power to detect differences between the groups External factors influencing the degree of sweating were not assessed (e.g. outdoor activities or vocational activities) It is not clear whether allocation was concealed
Comments	^a Participants drew red or black chips from a ballot box, which is not a robust method of randomisation and means allocation was not concealed. ^bBecause of the anticholinergic adverse effects associated with oxybutynin it is possible that participants were aware of the treatment (despite being reported as a double-blind study). ^c No objective measures of treatment were reported.
Abbreviations: HDSS, Hyperhidrosis Disease Severity Scale.