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Interventions for the management of dry mouth: non-pharmacological interventions

  1. Susan Furness1,*,
  2. Gemma Bryan1,
  3. Roddy McMillan2,
  4. Sarah Birchenough3,
  5. Helen V Worthington1

Editorial Group: Cochrane Oral Health Group

Published Online: 5 SEP 2013

Assessed as up-to-date: 16 APR 2013

DOI: 10.1002/14651858.CD009603.pub3


How to Cite

Furness S, Bryan G, McMillan R, Birchenough S, Worthington HV. Interventions for the management of dry mouth: non-pharmacological interventions. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD009603. DOI: 10.1002/14651858.CD009603.pub3.

Author Information

  1. 1

    School of Dentistry, The University of Manchester, Cochrane Oral Health Group, Manchester, UK

  2. 2

    Eastman Dental Hospital, London, UK

  3. 3

    Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK

*Susan Furness, Cochrane Oral Health Group, School of Dentistry, The University of Manchester, Coupland III Building, Oxford Rd, Manchester, M13 9PL, UK. Susan.Furness@manchester.ac.uk. suefurness@gmail.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 5 SEP 2013

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Characteristics of included studies [ordered by study ID]
Blom 1992

MethodsLocation: Sweden

Number of centres: 1

Recruitment period: Not stated

Funding source: Not stated

Trial design: Parallel group RCT


ParticipantsInclusion criteria: Severe xerostomia "mostly associated with systemic diseases". 12 (57%) had either primary or secondary Sjögren's Syndrome, 9 (43%) hypothyroidism, and remainder xerostomia following radiation therapy or of unknown aetiology

Exclusion criteria: Not stated

Age range: 33-72

Number randomised: 21

Number evaluated: 20


InterventionsComparison: Acupuncture versus placebo (superficial acupuncture)

Group A (n = 11): Acupuncture twice weekly for 6 weeks then 2 week break and further 6 weeks treatment

Group B (n = 10): Superficial acupuncture (designed to act as placebo)

Duration of follow-up: 12 months


OutcomesStimulated and unstimulated salivary flow rates (median and range reported), mean and SD calculable at 7 weeks, minor adverse effects noted


NotesSample size calculation: Not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomly assigned"

Comment: No method of sequence generation described

Allocation concealment (selection bias)Unclear riskComment: Insufficient information to determine

Blinding of participants (performance bias)Low riskQuote: "Neither the person who evaluated salivary flow nor the patients themselves knew whether they received acupuncture or superficial needling"

Comment: Probably done

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Neither the person who evaluated salivary flow nor the patients themselves knew whether they received acupuncture or superficial needling"

Comment: Probably done

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: 1/21 lost to follow-up after 3 months. This was judged unlikely to have introduced a bias

Selective reporting (reporting bias)Unclear riskComment: No patient-reported symptoms included. Outcome measure is objective salivary flow

Other biasLow riskComment: No other sources of bias identified

Blom 1996

MethodsLocation: Sweden

Number of centres: 1

Recruitment period: Not stated

Funding source: 3 grants. Swedish Patent Revenue Research Fund, Swedish Dental Society and King Gustav V Research Fund

Trial design: Parallel group RCT


ParticipantsInclusion criteria: Xerostomia following radiation therapy

Exclusion criteria: None stated

Number randomised: 41

Number evaluated: Between 32 and 38 depending on outcome


InterventionsComparison: Acupuncture versus placebo (superficial acupuncture)

Group A (n = 21): Classical acupuncture, 12 x 20-minute treatments during which 5-8 points were stimulated manually until the appearance of a needling reaction (Q1). 2 sessions per week for 6 weeks, then 2-week break then further 6 weeks of treatment

Group B (n = 20): Superficial acupuncture delivered to 5-8 points on same schedule as above

Duration of follow-up: 12 months


OutcomesStimulated and unstimulated salivary flow rates (median and range reported), mean and SD calculable at 8 weeks, minor adverse effects noted


NotesSample size calculation: Not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomly assigned"

Comment: No method of sequence generation described

Allocation concealment (selection bias)Unclear riskComment: Insufficient information to determine

Blinding of participants (performance bias)Low riskQuote: "double blind"

Comment: Patients and outcome assessors. Probably done

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "double blind"

Comment: Patients and outcome assessors. Probably done

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: 41 patients randomised 38 patients evaluated and 1/20 and 4/18 patients lost to follow-up in acupuncture and placebo groups respectively. No reasons for drop-out/withdrawal described

Selective reporting (reporting bias)Unclear riskComment: No patient-evaluated outcomes of xerostomia reported

Other biasHigh riskComment: In the discussion section study authors suggest that superficial needling is not reliable as placebo because it has some activity in some people

Cho 2008

MethodsLocation: South Korea

Number of centres: Unclear. Konyang University Hospital, Daejon and Dunsan Oriental Hospital of Daejon University both approved study

Recruitment period: Not stated

Funding source: Acupuncture, Moxibustion and Meridian Research Project (K06070) of Korean Institute of Oriental medicine R&D Project (B050018) Ministry of Health and Welfare, Republic of Korea

Trial design: Parallel group pilot study


ParticipantsInclusion criteria: Patients with xerostomia with history of radiation therapy (minimum dose 38 Gy and at least 50% of parotid glad exposed to radiation)

Exclusion criteria: Patients with distant metastases, and inflammatory disease or ECOG scores > 2

Number randomised: 12

Number evaluated: 12


InterventionsComparison: Acupuncture versus placebo (sham acupuncture)

Group A (n = 6): Acupuncture delivered to 4 points in 2 sessions per week for 6 weeks

Group B (n = 6): Sham acupuncture delivered to 4 points at least 2 cm away from 'real' acupoints, in 2 sessions per week for 6 weeks

Duration of follow-up: 6 weeks


OutcomesXerostomia Questionnaire, stimulated and unstimulated salivary flow rates at end of treatment


NotesSample size calculation: Pilot study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "allocated using block randomization"

Comment: Random component not described

Allocation concealment (selection bias)Unclear riskComment: Insufficient information to determine

Blinding of participants (performance bias)Low riskComment: Patients likely to be blinded because placebo acupuncture used

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: Insufficient information to determine 'yes' or 'no'

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: All randomised participants included in outcome evaluations

Selective reporting (reporting bias)Low riskComment: Xerostomia questionnaire (patient-evaluated measure) and UWS, SWS reported

Other biasHigh riskGroups very unbalanced at baseline

List 1998

MethodsLocation: Sweden

Number of centres: 1

Recruitment period: Not stated

Funding source: Swedish National Social Insurance Board

Trial design: Parallel group RCT


ParticipantsInclusion criteria: Patients diagnosed with primary Sjögren's Syndrome

Exclusion criteria: None stated

Age range: 44-78 years (mean 65 years)

Number randomised: 21

Number evaluated: 20


InterventionsComparison: Acupuncture versus placebo (manual stimulation only)

Group A (n = 10): 30-minute session twice weekly with both electrical and manual stimulation for a total of 10 weeks

Group B (n = 10): No treatment during the first 10 weeks and then acupuncture as above weeks 11-20

Duration of follow-up: 20 weeks


OutcomesUWS, SWS, median mouth dryness (10-point VAS scale), adverse effects


NotesSample size calculation: Not reported

Email sent to author 29 April 2013


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomized into 2 groups"

Comment: Random component not described

Allocation concealment (selection bias)Unclear riskComment: Insufficient information to determine

Blinding of participants (performance bias)High riskComment: Blinding not possible. Manual versus electrical stimulation. Electrical stimulation evoked visible muscle contractions

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskQuote: "The evaluation was performed by one person, treatment by another"

Comment: Unclear if person evaluating patients was blinded to the treatment allocation

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: 1/21 patients excluded from evaluation

Selective reporting (reporting bias)Low riskComment: UWS, SWS, VAS scores (patient-evaluated outcome) reported

Other biasLow riskComment: No other sources of bias identified

Papas 2006

MethodsLocation: Boston, USA

Number of centres: 1

Recruitment period: Not stated

Funding source: Philips Oral Healthcare provided the Sonicare Advance Toothbrushes

Trial design: Parallel group with control group crossing over to powered toothbrush after 9 weeks


ParticipantsInclusion criteria: Participants aged 40-80 years, on a medication (list reported) of medications likely to result in dry mouth, > 10 natural teeth, UWS < 0.3 ml/min

Exclusion criteria: Advanced periodontitis, infection, wasting diseases requiring premedication, participation in another clinical trial, on a chronic antibiotic regimen

Number randomised: 61

Number evaluated: 58


InterventionsComparison: Powered versus manual toothbrush

Group A (n = 29): Sonicare Advance Toothbrush used according to directions given by investigators. Daily diaries to record toothbrushing, flossing and type of dentifrice used

Group B (n = 29): Manual toothbrush (Oral B) used according to directions given by investigators. Daily diaries to record toothbrushing, flossing and type of dentifrice used


OutcomesUWS, SWS, patient's preference, microbiology of oral cavity, changes in VAS for responders and non-responders


NotesSample size calculation: Not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomized to each of the treatment groups"

Comment: Method of sequence generation not described

Allocation concealment (selection bias)Unclear riskInsufficient information to determine 'yes' or 'no'

Blinding of participants (performance bias)High riskComment: Blinding not possible

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: Not mentioned

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: 3 participants lost to follow-up

Selective reporting (reporting bias)High riskVAS for responders and non-responders planned as an outcome but not reported

Other biasHigh riskStudy funded by Philips who provided the toothbrushes. Unclear whether participants were aware that they would all be given a Sonicare electric toothbrush at the end of the research

Pfister 2010

MethodsLocation: New York, USA

Number of centres: 1

Recruitment period: 2004-2007

Funding source: NIH grant CA098792

Trial design: Parallel group RCT


ParticipantsInclusion criteria: Patients who had undergone neck dissection for cancer, with pain and dysfunction likely to be attributable to neck dissection, at least 3 months post neck dissection and radiation, with moderate to severe pain on Constant-Murley score </= 70

Exclusion criteria: Those who had received acupuncture in previous 6 weeks

Cause of xerostomia: Radiation treatment for cancer

Number randomised: 58

Number evaluated: 58


InterventionsComparison: Acupuncture versus usual care

Group A (n = 28): Acupuncture once a week for 4 weeks. Needles were placed at both standard and customised points to "optimise efficacy while facilitating reproducibility". Additional 5th treatment was added to improve compliance with assessment visit after 4th treatment

Group B (n = 30): Usual care - antiinflammatory and analgesic medication

Duration of follow-up: 4 weeks


OutcomesPain on constant Murley scale, pain (numerical rating scale), Xerostomia Inventory, adverse effects


NotesSample size calculation: Not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"...random assignment was stratified by neck (surgical) procedure type (selective, modified or radical), and baseline Constant-Murley score, using blocks of random length"

Allocation concealment (selection bias)Low risk"..random assignment was implemented via a secure computerised database, ensuring full allocation concealment"

Blinding of participants (performance bias)High riskOpen trial, no placebo used

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskPatients self assessed main outcomes but attempts were made to use blinded clinical assessment of objective components of Constant-Murley scale

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll 58 randomised participants are included in the outcome assessment

Selective reporting (reporting bias)Low riskPlanned primary and secondary outcomes are reported

Other biasLow riskNo other sources of bias identified

Steller 1988

MethodsLocation: USA

Number of centres: 1

Recruitment period: Not stated

Funding source: Not stated

Trial design: Parallel group RCT


ParticipantsInclusion criteria: Participants aged > 18 years with dry mouth, focal sialoadenitis in labial salivary gland biopsy specimen

Exclusion criteria: On medication known to affect saliva production, presence of pacemaker, pregnancy, UWS < 0.2 gram/minute

Cause of xerostomia: Sjögren's Syndrome

Number randomised: 29

Number evaluated: 24


InterventionsComparison: Electrical stimulation versus placebo

Group A (n = 14): Electrical stimulation used for 3 minutes under supervision, then at home 3 times daily for 4 weeks

Group B (n = 15): Placebo electrical stimulation used under supervision for 3 minutes then at home 3 times daily for 4 weeks

The electronic stimulation device consisted of a hand held probe, tipped with 2 electrodes, and a control console box which housed the battery and controls

Duration of follow-up: 4 weeks


OutcomesMean UWS and SWS


NotesSample size calculation: Not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "using a table of random numbers"

Comment: Random number table. Probably done

Allocation concealment (selection bias)Unclear riskComment: Insufficient information to determine

Blinding of participants (performance bias)Low riskQuote: "double blind"

Comment: Probably done

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "double blind"

Comment: Probably done

Incomplete outcome data (attrition bias)
All outcomes
High riskComment: 5/29 patients withdrew (1 per intervention arm, 4 per control arm) (17%)

Selective reporting (reporting bias)Low riskComment: SWS, visual examination, patient evaluation of any increase in saliva

Other biasLow riskComment: No other sources of bias identified

Talal 1992

MethodsLocation: USA

Number of centres: 3

Recruitment period: Not stated

Funding source: Biosonics

Trial design: Parallel group RCT


ParticipantsInclusion criteria: Participants aged > 18 years with Sjögren's Syndrome plus 1 other rheumatic condition (from specified list) and maximum saliva production of 0.4 g saliva/2 minutes

Exclusion criteria: None stated

Cause of xerostomia: Sjögren's Syndrome

Number randomised: 77

Number evaluated: Unclear


InterventionsComparison: Active electrostimulation device versus sham device

Group A (n = 40): Active electrostimulation device

Group B (n = 37): Sham electrostimulation device

System comprised a control module plus a hand held stimulus probe with 2 electrodes, to be placed between the tongue and the roof of the mouth. Patients were instructed on the use of the system, supervised and then instructed to use it at home 3 times daily for 4 weeks

Duration of follow-up: 4 weeks


OutcomesSWS, symptom relief


NotesSample size calculation: Not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "..assignment was performed according to a statistical table of random numbers"

Comment: Random number table

Allocation concealment (selection bias)Low riskQuote: "...neither the technician nor the physician/investigator were provided with the code for active and placebo devices"

Comment: Probably done

Blinding of participants (performance bias)Low riskQuote: "double blind"

Comment: Probably done

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "double blind"

Comment: Probably done

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: Numbers of participants included in outcome evaluations unclear

Selective reporting (reporting bias)High riskComment: Salivary output data reported per group but no estimates of variance and data for symptom improvement not provided

Other biasLow riskGroups similar at baseline with regard to salivary output

Wong 2003

MethodsLocation: Canada

Number of centres: 1

Recruitment period: Not stated

Funding source: Hamilton Health Sciences Corporation Foundation and equipment provision by EHM Rehabilitation Technologies Inc

Trial design: Parallel (3 groups) RCT


ParticipantsInclusion criteria: Patients treated with radiotherapy for head and neck cancer who had symptoms of xerostomia. Those who had no response to pilocarpine were also included after a 1 month washout period

Exclusion criteria: Patients taking medications that may induce xerostomia, those with unstable cardiac disease, with a pacemaker, those taking pilocarpine

Cause of xerostomia: Radiotherapy

Number randomised: 46

Number evaluated: 37


InterventionsComparison: Transcutaneous nerve stimulation to different acupuncture points

Group A (n = 13): Sp6, St36, L14 (active electrode) and CV 24 (indifferent electrode)

Group B (n = 10): Sp6, St36, P6 (active electrode) and CV 24 (indifferent electrode)

Group C (n = 14): Sp6, St 5 and 6, P6 (active electrode) and CV 24 (indifferent electrode)

All 3 groups had twice weekly stimulation sessions to the prespecified points for 6 weeks, followed by a 2-week break and then a second 6-week phase of treatment

Duration of treatment: 14 weeks

Follow-up: At 3, 6 and 12 months after the end of treatment


OutcomesTotal xerostomia symptom score, patient-reported improvement in tongue dryness, speech, swallowing and overall mouth comfort. UWS, SWS, adverse effects


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Randomized into 3 groups"

Comment: Random component not described

Allocation concealment (selection bias)Unclear riskComment: Insufficient information to determine

Blinding of participants (performance bias)High riskComment: Not described

Blinding of outcome assessment (detection bias)
All outcomes
High riskComment: Not described

Incomplete outcome data (attrition bias)
All outcomes
High riskComment: 9 (9/46) of those randomised did not complete the trial. No information as to which groups they were from. 13, 10 and 14 described in groups A, B and C respectively

Selective reporting (reporting bias)High riskComment: Results reported as means and SDs for the whole cohort only, or on graphs for VAS scores - unclear whether the randomisation to different groups had any effect

Other biasLow riskNo other sources of bias identified

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Blom 2000Retrospective study

Braga 2011Participants did not have xerostomia at baseline

Cheville 2006Not randomised. No control group

Deng 2008Participants did not have xerostomia at baseline

Fontanesi 1991Not randomised. No control group. 6 patients received hyperbaric oxygen therapy in a non-randomised, non-controlled pilot study. The authors also report the results of a retrospective uncontrolled study in 5 patients

Garcia 2009Not RCT

Loncar 2011Not RCT

Meng 2012Participants did not have xerostomia at baseline

Niemtzow 2007Not RCT

Schiff 2009Not RCT

Simcock 2009Not RCT

Simcock 2013Cross-over study

Simoes 2010Participants did not have xerostomia at baseline

Strietzel 2007Cross-over study with 158 different treatment sessions tested on 20 patients with only 90 minutes between treatments

Strietzel 2011Cross-over study where participants experienced both active (mechanical and electrical stimulation) and sham (mechanical only) device effects for 1 month in a random order. A carry-over effect cannot be discounted

Weiss 1986Not RCT

Wong 2010Participants did not have xerostomia at baseline

Wong 2012Non-randomised phase II feasibility trial of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS)

 
Characteristics of ongoing studies [ordered by study ID]
NCT01141231

Trial name or titleAcupuncture in treating dry mouth caused by radiation therapy in patients with head and neck cancer

MethodsRandomised controlled trial

ParticipantsPatients with grade 2 or 3 xerostomia following radiotherapy for head and neck cancer. No prior use of acupuncture and at least 9 months after last radiotherapy treatment

InterventionsAcupuncture twice weekly for 4 weeks (2 regimens) versus standard oral hygiene care

OutcomesXerostomia, saliva production

Starting dateNovember 2012

Contact informationDr Lorenzo Cohen (lcohen@mdanderson.org)

Notes

 
Comparison 1. Acupuncture versus placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Mouth dryness270Std. Mean Difference (IV, Fixed, 95% CI)-0.34 [-0.81, 0.14]

    1.1 Xerostomia Inventory
158Std. Mean Difference (IV, Fixed, 95% CI)-0.21 [-0.72, 0.31]

    1.2 Xerostomia Questionnaire (change)
112Std. Mean Difference (IV, Fixed, 95% CI)-1.09 [-2.34, 0.16]

 2 Unstimulated whole saliva (end of treatment)371Mean Difference (IV, Fixed, 95% CI)0.02 [0.00, 0.04]

 3 Stimulated whole saliva (end of treatment)371Mean Difference (IV, Fixed, 95% CI)0.19 [0.07, 0.31]

 4 Unstimulated whole saliva (12 months)254Mean Difference (IV, Fixed, 95% CI)0.06 [0.01, 0.11]

 5 Stimulated whole saliva (12 months)254Mean Difference (IV, Fixed, 95% CI)0.28 [0.09, 0.47]

 
Comparison 2. Electrical stimulation versus placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Unstimulated whole saliva (end of treatment)1Mean Difference (IV, Fixed, 95% CI)Subtotals only

 2 Stimulated whole saliva (end of treatment)1Mean Difference (IV, Fixed, 95% CI)Subtotals only

 
Comparison 3. Powered versus manual toothbrush

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Unstimulated whole saliva (45 minutes after brushing)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Stimulated whole saliva (5 minutes after brushing)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Summary of findings for the main comparison. Acupuncture versus placebo

Acupuncture compared with placebo for dry mouth symptoms

Patient or population: People with dry mouth due to either radiotherapy or Sjögren's Syndrome

Settings: Outpatients

Intervention: Acupuncture

Comparison: Placebo (sham acupuncture)

OutcomesRelative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Mouth dryness

Different scales

(at the end of treatment 4-6 weeks)
SMD -0.34 (-0.81 to 0.14)70
(2 RCTs*)
⊕⊕⊝⊝
low 1
*Participants had dry mouth following radiotherapy treatment for head and neck cancers

Unstimulated whole saliva

millilitres/minute

(end of treatment)
MD 0.02 (0 to 0.04)71
(3 RCTs**)
⊕⊕⊝⊝
low 2
**Most of the participants in these trials had dry mouth following radiotherapy treatment

Stimulated whole saliva (end of treatment)

millilitres/minute

(end of treatment)
MD 0.19 (0.07 to 0.31)71
(3 RCTs**)
⊕⊕⊝⊝
low 2
**Most of the participants in these trials had dry mouth following radiotherapy treatment

Unstimulated whole saliva (12 months)

millilitres/minute

(1 year follow-up)
MD 0.06 (0.01 to 0.11)54
(2 RCTs**)
⊕⊕⊝⊝
low 3
**Most of the participants in these trials had dry mouth following radiotherapy treatment

Stimulated whole saliva (12 months)

millilitres/minute

(1 year follow-up)
MD 0.28 (0.09 to 0.47)54
(2 RCTs**)
⊕⊕⊝⊝
low 3
**Most of the participants in these trials had dry mouth following radiotherapy treatment

CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; SMD: standardised mean difference

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

 1Quality of the body of evidence is downgraded due to risk of bias (2 very small RCTs at high risk of bias), and also because three trials which evaluated this comparison did not report the outcome of dry mouth
2Quality of the body of evidence is downgraded due to high risk of bias (2 studies at high risk of bias and 1 unclear), and heterogeneity (I2 = 57%)
3Quality of the body of evidence is downgraded due to risk of bias (1 high, 1 unclear risk of bias) and small number of participants
 
Summary of findings 2. Electrostimulation versus placebo

Electrostimulation compared with placebo for dry mouth symptoms

Patient or population: People with dry mouth due to Sjögren's Syndrome

Settings: Outpatients

Intervention: Electrostimulation

Comparison: Placebo

OutcomesRelative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Unstimulated whole saliva

millilitres/minute

(end of treatment)
MD 0.02 grams/2 minutes

(95% CI -0.12 to 0.16)
24
(1 RCT*)
⊕⊝⊝⊝
very low 1
*Participants had Sjögren's Syndrome

Stimulated whole saliva

millilitres/minute

(end of treatment)
MD 0.16 grams/2 minutes

(95% CI -0.05 to 0.37)
24
(1 RCT*)
⊕⊝⊝
very low 1
*Participants had Sjögren's Syndrome

CI: confidence interval; MD: mean difference; RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

 1Quality of the body of evidence downgraded due to high risk of bias, imprecision (confidence intervals include both a potential benefit and a potential negative effect on saliva production), and estimate based on a single small study. This study did not report the primary outcome of this review
 
Table 1. Additional outcome data from included studies

Study IDOutcomeIntervention groupNControl groupN

List 1998

Acupuncture versus placebo

 

 
Mouth dryness

10-point VAS
Median 5.5 (Range 3.2 to 10)10Median 6.8 (Range 0 to 9.5)11

UWS

(ml/15 minutes)
Median 0.0 (Range 0.0 to 0.6)10Median 0.0 (Range 0 to 0.2)11

SWS

(ml/5 minutes)
Median 1.2 (Range 0.05 to 2.6)10Median 0.6 (Range 0.1 to 2.5)11

Talal 1992

Electrostimulation versus placebo
SWS (ml/min)Mean 0.38540Mean 0.19637

 SWS = stimulated whole saliva; UWS = unstimulated whole saliva; VAS = visual analogue scale