Furness Susan, Bryan Gemma, McMillan Roddy, Birchenough Sarah, Worthington Helen V
Cochrane Oral Health Group, School of Dentistry, The University of Manchester, Coupland III Building, Oxford Rd, Manchester, UK, M13 9PL.
Cochrane Database Syst Rev. 2013 Sep 5;2013(9):CD009603. doi: 10.1002/14651858.CD009603.pub3.
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.
To assess the effects of non-pharmacological interventions administered to stimulate saliva production for the relief of dry mouth.
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.
We included parallel group randomised controlled trials of non-pharmacological interventions to treat dry mouth, where participants had dry mouth symptoms at baseline.
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.
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.
AUTHORS' 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.
口干症是一种口腔干燥的主观感受。口干症的常见病因包括许多常用处方药的副作用、疾病（如干燥综合征）以及头颈部癌症的放射治疗。非药物技术如针灸或轻度电刺激可用于改善症状。
评估用于刺激唾液分泌以缓解口干的非药物干预措施的效果。
我们检索了Cochrane口腔健康组试验注册库（截至2013年4月16日）、Cochrane对照试验中心注册库（CENTRAL）（《Cochrane图书馆》2013年第3期）、通过OVID检索的MEDLINE（1948年至2013年4月16日）、通过OVID检索的EMBASE（1980年至2013年4月16日）、通过OVID检索的AMED（1985年至2013年4月16日）、通过EBSCO检索的CINAHL（1981年至2013年4月16日）以及通过PubMed检索的CANCERLIT（1950年至2013年4月16日）。还检索了对照临床试验元注册库（www.controlled-trials.com）和ClinicalTrials.gov（www.clinicaltrials.gov）以识别正在进行和已完成的试验。还检索了纳入研究的参考文献列表和相关综述。对出版物的语言或出版状态没有限制。
我们纳入了非药物干预治疗口干的平行组随机对照试验，其中参与者在基线时具有口干症状。
至少两名综述作者评估每项纳入研究，以确认其合格性、评估偏倚风险并使用预先设计的数据提取表提取数据。对于连续性结局，我们计算了平均差（MD）和95%置信区间（CI）；或者当使用不同量表评估结局时，我们计算了标准化平均差（SMD）以及95%CI。我们试图提取关于干预措施不良反应的数据。当数据缺失或不明确时，我们试图联系研究作者以获取更多信息。
本综述纳入了9项关于口干非药物干预的研究（共366名参与者被随机分组），分为三个比较组。8项研究在至少一个领域被评估为高偏倚风险，其余1项研究的偏倚风险不明确。5项小型研究（共153名参与者，放疗后出现口干）将针灸与安慰剂进行了比较。4项被评估为高风险，1项的偏倚风险不明确。两项试验以适合进行荟萃分析的形式报告了口干的结局数据。这两项试验（70名参与者，低质量证据）的汇总估计显示，针灸与对照组在口干症状方面无差异（SMD -0.34，95%CI -0.81至0.14，P值0.17，I² = 39%），置信区间包括口干症状可能减轻或可能加重的情况。针灸与更多的不良反应相关（轻微瘀伤和疲劳，程度较轻且为暂时性）。在治疗4至6周结束时，未刺激全唾液（UWS）有非常小的增加（三项试验，71名参与者，低质量证据）（MD 0.02 ml/分钟，95%CI 0至0.04，P值0.04，I² = 57%），并且这种益处在12个月的随访评估中持续存在（两项试验，54名参与者，低质量证据）（UWS，MD 0.06 ml/分钟，95%CI 0.01至0.11，P值0.03，I² = 10%）。对于刺激全唾液（SWS，三项试验，71名参与者，低质量证据）的结局，有证据支持针灸（MD 0.19 ml/分钟，95%CI 0.07至0.31，P值0.002，I² = 1%），这种效果在12个月的随访评估中也持续存在（SWS MD 0.28 ml/分钟，95%CI 0.09至0.47，P值0.004，I² = 0%）（两项试验，54名参与者，低质量证据）。两项小型研究，偏倚风险均为高，在干燥综合征患者（共101名参与者）中比较了电刺激装置与安慰剂装置的使用。另一项偏倚风险也为高的研究，在先前接受过放疗的参与者中比较了不同穴位组的类针灸电刺激。这些研究均未报告口干的结局。在一项研究中，4周治疗期结束时，电刺激与安慰剂在UWS或SWS结局方面无差异（提供这些结局数据的证据质量非常低）。未报告不良反应。一项偏倚风险高的单一研究比较了电动牙刷与手动牙刷的刺激效果，发现UWS或SWS结局无差异。
关于口干症状这一最重要的结局，低质量证据表明针灸与安慰剂针灸无差异。这可能是因为两项试验纳入的参与者不足，无法显示出可能的效果，或者可能是由于“安慰剂”针灸有一定益处，从而使效果偏向于无效。没有足够的证据来确定电刺激装置对口干症状的影响。众所周知，即使唾液分泌增加，口干症状仍可能存在问题，但评估针灸的试验中只有两项报告了口干症状，这是一个令人担忧的报告偏倚。有一些低质量证据表明，针灸可使放疗后口干患者的唾液分泌略有增加。没有足够的证据来确定电刺激装置对干燥综合征患者口干症状或唾液分泌的影响。报告的针灸不良反应轻微且持续时间短，电刺激未报告不良反应。
