title: Interventions for the management of dry mouth: non-pharmacological interventions.
abstract: BACKGROUND
  Xerostomia is the subjective sensation of dry mouth. Common causes of xerostomia include adverse effects of many commonly prescribed medications, disease (e.g. Sjogren's Syndrome) and radiotherapy treatment for head and neck cancers. Non-pharmacological techniques such as acupuncture or mild electrostimulation may be used to improve symptoms.
  
  
  OBJECTIVE
  To assess the effects of non-pharmacological interventions administered to stimulate saliva production for the relief of dry mouth.
  
  
  METHODS
  We searched the Cochrane Oral Health Group's Trials Register (to 16th April 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 3), MEDLINE via OVID (1948 to 16th April 2013), EMBASE via OVID (1980 to 16th April 2013), AMED via OVID (1985 to 16th April 2013), CINAHL via EBSCO (1981 to 16th April 2013), and CANCERLIT via PubMed (1950 to 16th April 2013). The metaRegister of Controlled Clinical Trials (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrials.gov) were also searched to identify ongoing and completed trials. References lists of included studies and relevant reviews were also searched. There were no restrictions on the language of publication or publication status.
  
  
  METHODS
  We included parallel group randomised controlled trials of non-pharmacological interventions to treat dry mouth, where participants had dry mouth symptoms at baseline.
  
  
  METHODS
  At least two review authors assessed each of the included studies to confirm eligibility, assess risk of bias and extract data using a piloted data extraction form. We calculated mean difference (MD) and 95% confidence intervals (CI) for continuous outcomes or where different scales were used to assess an outcome, we calculated standardised mean differences (SMD) together with 95% CIs. We attempted to extract data on adverse effects of interventions. Where data were missing or unclear we attempted to contact study authors to obtain further information.
  
  
  RESULTS
  There were nine studies (total 366 participants randomised) included in this review of non-pharmacological interventions for dry mouth which were divided into three comparisons. Eight studies were assessed at high risk of bias in at least one domain and the remaining study was at unclear risk of bias.Five small studies (total 153 participants, with dry mouth following radiotherapy treatment) compared acupuncture with placebo. Four were assessed at high risk and one at unclear risk of bias. Two trials reported outcome data for dry mouth in a form suitable for meta-analysis. The pooled estimate of these two trials (70 participants, low quality evidence) showed no difference between acupuncture and control in dry mouth symptoms (SMD -0.34, 95% CI -0.81 to 0.14, P value 0.17, I(2) = 39%) with the confidence intervals including both a possible reduction or a possible increase in dry mouth symptoms. Acupuncture was associated with more adverse effects (tiny bruises and tiredness which were mild and temporary). There was a very small increase in unstimulated whole saliva (UWS) at the end of 4 to 6 weeks of treatment (three trials, 71 participants, low quality evidence) (MD 0.02 ml/minute, 95% CI 0 to 0.04, P value 0.04, I(2) = 57%), and this benefit persisted at the 12-month follow-up evaluation (two trials, 54 participants, low quality evidence) (UWS, MD 0.06 ml/minute, 95% CI 0.01 to 0.11, P value 0.03, I(2) = 10%). For the outcome of stimulated whole saliva (SWS, three trials, 71 participants, low quality evidence) there was a benefit favouring acupuncture (MD 0.19 ml/minute, 95% CI 0.07 to 0.31, P value 0.002, I(2) = 1%) an effect which also persisted at the 12-month follow-up evaluation (SWS MD 0.28 ml/minute, 95% CI 0.09 to 0.47, P value 0.004, I(2) = 0%) (two trials, 54 participants, low quality evidence).Two small studies, both at high risk of bias, compared the use of an electrostimulation device with a placebo device in participants with Sjögren's Syndrome (total 101 participants). A further study, also at high risk of bias, compared acupuncture-like electrostimulation of different sets of points in participants who had previously been treated with radiotherapy. None of these studies reported the outcome of dry mouth. There was no difference between electrostimulation and placebo in the outcomes of UWS or SWS at the end of the 4-week treatment period in the one study (very low that provided data for these outcomes. No adverse effects were reported.A single study at high risk of bias, compared the stimulatory effect of powered versus manual toothbrushing and found no difference for the outcomes of UWS or SWS.
  
  
  CONCLUSIONS
  There is low quality evidence that acupuncture is no different from placebo acupuncture with regard to dry mouth symptoms, which is the most important outcome. This may be because there were insufficient participants included in the two trials to show a possible effect or it may be that there was some benefit due to 'placebo' acupuncture which could have biased the effect to the null. There is insufficient evidence to determine the effects of electrostimulation devices on dry mouth symptoms. It is well known that dry mouth symptoms may be problematic even when saliva production is increased, yet only two of the trials that evaluated acupuncture reported dry mouth symptoms, a worrying reporting bias. There is some low quality evidence that acupuncture results in a small increase in saliva production in patients with dry mouth following radiotherapy.There is insufficient evidence to determine the effects of electrostimulation devices on dry mouth symptoms or saliva production in patients with Sjögren's Syndrome. Reported adverse effects of acupuncture are mild and of short duration, and there were no reported adverse effects from electrostimulation.
authors.affiliation: Cochrane Oral Health Group, School of Dentistry, The University of Manchester, Coupland III Building, Oxford Rd, Manchester, UK, M13 9PL.
authors.forename: Susan
authors.initials: S
authors.lastname: Furness
authors.forename: Gemma
authors.initials: G
authors.lastname: Bryan
authors.forename: Roddy
authors.initials: R
authors.lastname: McMillan
authors.forename: Sarah
authors.initials: S
authors.lastname: Birchenough
authors.forename: Helen V
authors.initials: HV
authors.lastname: Worthington
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects / Q000379:methods*; D004599:Electric Stimulation Therapy / Q000379:methods*; D015671:Electroacupuncture / Q000295:instrumentation / Q000379:methods; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012472:Salivation; D012859:Sjogren's Syndrome / Q000628:therapy; D014987:Xerostomia / Q000628:therapy*