Cochrane · intervention · CD003782

Parasympathomimetic drugs for the treatment of salivary gland dysfunction due to radiotherapy

Davies, AN, Thompson, J · Cochrane Database of Systematic Reviews · 2015 · Cochrane Library

Oral Health Pain, Palliative and Supportive Care Oral medicine and oral cancer3 versionsAMSTAR 2: not assessed

Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.

Questions

8

current version

GRADE rated

0

No studies

1

Included studies

3

as reported

No studies 1 · 12.5%Ungraded 7 · 87.5%Very low 0 · 0%Low 0 · 0%Moderate 0 · 0%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Review question

Element	Planned (methods)	Found (results)
Population	Participants with radiation-induced salivary gland dysfunction; of any age, gender, or ethnic origin	All included studies conducted exclusively in people with radiation-induced salivary gland dysfunction; studies performed in adults, open to any age, gender, or ethnic origin; all conducted in the outpatient setting; two studies in the USA, one in the UK
Intervention	Parasympathomimetic drugs (choline esters, cholinesterase inhibitors); given by any route, formulation, or dose	Pilocarpine hydrochloride (n=298; tablet in 2 studies, mouthwash in 1; 5 mg tds fixed, 5/10 mg tds, or 2.5-10 mg tds titrated)
Comparison	No treatment; Placebo; Another treatment for salivary gland dysfunction; or a combination of these	Placebo (n=278, 2 studies); Artificial saliva, mucin-based (n=20, 1 study)
Outcomes	Primary: xerostomia (subjective sensation of dryness of the mouth); Secondary: salivary flow rates; adverse effects; other oral symptoms (oral discomfort, dysgeusia, dysmasesia, dysphagia, dysphonia); other oral problems; participant satisfaction; quality of life; health economics	Xerostomia (n=3); Salivary flow rates (n=2); Adverse effects (n=3); Other oral symptoms - oral discomfort, dysgeusia, dysphagia, dysphonia (n=3); Global effect of treatment (n=3); Use of other relevant treatments (n=2); Wish to continue treatment (n=1)
Study designs	Randomised controlled trials (any design: parallel group or cross-over; published or unpublished; any language)	Randomised controlled trials (n=3; 2 parallel-group, 1 cross-over)
Timing	Not specified	Three months' treatment per period; response up to 12 weeks

Search date: 2015-07. Databases: Cochrane Oral Health Group Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CINAHL

Questions and results

Current version only

Parasympathomimetic drugs (choline esters, cholinesterase inhibitors) vs No treatment

Population: Patients with radiation-induced salivary gland dysfunction

CD003782.PUB3 (current) · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR same question in other reviews	no estimate extracted	0 studies	No studies

Pilocarpine hydrochloride (parasympathomimetic) vs Placebo

Population: Patients with radiation-induced salivary gland dysfunction

CD003782.PUB3 (current) · 4 questions

Outcome	Effect	Evidence	Status / GRADE
Xerostomia (subjective dry mouth; positive response = >25 mm change in VAS score) same question in other reviews	Johnson 1993: positive response (>25 mm change in VAS score) in 25% of participants on placebo, 51% on pilocarpine 5 mg tds, 47% on pilocarpine 10 mg tds. LeVeque 1993: positive response in 7% on placebo vs 42% on…	2 studies · 278 participants	Ungraded
Other oral symptoms (oral discomfort, dysphonia) same question in other reviews	Both studies assessed oral discomfort and dysphonia (Johnson 1993; LeVeque 1993); pilocarpine reported to improve associated symptoms of salivary gland dysfunction (oral discomfort, dysphonia). No pooled data.	2 studies · 278 participants	Ungraded
Salivary flow rates same question in other reviews	Only two studies measured salivary flow rates (Johnson 1993; LeVeque 1993); no usable summary/pooled data reported.	2 studies	Ungraded
Adverse effects (side effects; treatment withdrawals) same question in other reviews	Johnson 1993 (5 mg tds): sweating 37%, headache 15%, urinary frequency 14%, vasodilatation 12%, dizziness 10%, dyspepsia 10%, nausea 8%, asthenia 8%, diarrhoea 5%; 6% withdrew at 5 mg tds and 29% at 10 mg tds. LeVeque…	2 studies · 278 participants	Ungraded

Pilocarpine hydrochloride (parasympathomimetic) vs Artificial saliva (mucin-based)

Population: Patients with radiation-induced salivary gland dysfunction

CD003782.PUB3 (current) · 3 questions

Outcome	Effect	Evidence	Status / GRADE
Other oral symptoms (dysgeusia, dysphagia) same question in other reviews	Davies 1994 assessed dysgeusia and dysphagia; pilocarpine reported more effective than mucin-based artificial saliva for dysgeusia. No pooled data.	1 study · 20 participants	Ungraded
Xerostomia (subjective dry mouth; absolute change in VAS score) same question in other reviews	Davies 1994 (cross-over, 20 participants): mean improvement in VAS score 22.5 mm with pilocarpine vs 15.2 mm with artificial saliva (100 mm scale). The improvement was greater with pilocarpine but was not statistically…	1 study · 20 participants	Ungraded
Adverse effects (side effects; treatment withdrawals) same question in other reviews	Davies 1994: main side effects with pilocarpine were nausea 20%, sweating 15%, lacrimation 10%. One participant definitely withdrew because of side effects; another may have.	1 study · 20 participants	Ungraded

Parasympathomimetic drugs (choline esters, cholinesterase inhibitors) vs No treatment

Population: Patients with radiation-induced salivary gland dysfunction

CD003782.PUB2 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR	no estimate extracted	0 studies	No studies

Pilocarpine hydrochloride (parasympathomimetic) vs Placebo

Population: Patients with radiation-induced salivary gland dysfunction

CD003782.PUB2 · 4 questions

Outcome	Effect	Evidence	Status / GRADE
Other oral symptoms (oral discomfort, dysphonia)	Both studies assessed oral discomfort and dysphonia (Johnson 1993; LeVeque 1993); pilocarpine reported to improve associated symptoms of salivary gland dysfunction (oral discomfort, dysphonia). No pooled data.	2 studies · 278 participants	Ungraded
Salivary flow rates	Only two studies measured salivary flow rates (Johnson 1993; LeVeque 1993); no usable summary/pooled data reported.	2 studies	Ungraded
Xerostomia (subjective dry mouth; positive response = >25 mm change in VAS score)	Johnson 1993: positive response (>25 mm change in VAS score) in 25% of participants on placebo, 51% on pilocarpine 5 mg tds, 47% on pilocarpine 10 mg tds. LeVeque 1993: positive response in 7% on placebo vs 42% on…	2 studies · 278 participants	Ungraded
Adverse effects (side effects; treatment withdrawals)	Johnson 1993 (5 mg tds): sweating 37%, headache 15%, urinary frequency 14%, vasodilatation 12%, dizziness 10%, dyspepsia 10%, nausea 8%, asthenia 8%, diarrhoea 5%; 6% withdrew at 5 mg tds and 29% at 10 mg tds. LeVeque…	2 studies · 278 participants	Ungraded

Pilocarpine hydrochloride (parasympathomimetic) vs Artificial saliva (mucin-based)

Population: Patients with radiation-induced salivary gland dysfunction

CD003782.PUB2 · 3 questions

Outcome	Effect	Evidence	Status / GRADE
Adverse effects (side effects; treatment withdrawals)	Davies 1994: main side effects with pilocarpine were nausea 20%, sweating 15%, lacrimation 10%. One participant definitely withdrew because of side effects; another may have.	1 study · 20 participants	Ungraded
Other oral symptoms (dysgeusia, dysphagia)	Davies 1994 assessed dysgeusia and dysphagia; pilocarpine reported more effective than mucin-based artificial saliva for dysgeusia. No pooled data.	1 study · 20 participants	Ungraded
Xerostomia (subjective dry mouth; absolute change in VAS score)	Davies 1994 (cross-over, 20 participants): mean improvement in VAS score 22.5 mm with pilocarpine vs 15.2 mm with artificial saliva (100 mm scale). The improvement was greater with pilocarpine but was not statistically…	1 study · 20 participants	Ungraded

Parasympathomimetic drugs (choline esters, cholinesterase inhibitors) vs No treatment

Population: Patients with radiation-induced salivary gland dysfunction

CD003782 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR	no estimate extracted	0 studies	No studies

Parasympathomimetic drugs (choline esters, cholinesterase inhibitors) vs Placebo

Population: Patients with radiation-induced salivary gland dysfunction

CD003782 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR	no estimate extracted	0 studies	No studies

Parasympathomimetic drugs (choline esters, cholinesterase inhibitors) vs Another treatment for salivary gland dysfunction

Population: Patients with radiation-induced salivary gland dysfunction

CD003782 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR	no estimate extracted	0 studies	No studies