{"product_id":"laser-acupuncture-for-dry-mouth-in-sjogrens-disease-what-a-new-randomized-trial-found","title":"Laser Acupuncture for Dry Mouth in Sjögren's Disease: What a New Randomized Trial Found","description":"\u003cp\u003eThis randomized, double-blind clinical trial tested whether laser acupuncture — applying low-level infrared light to specific acupuncture points — could relieve dry mouth (xerostomia) in 50 patients with Sjögren's Disease. At week 8, 64.29% of patients receiving real laser acupuncture improved on a dry-mouth symptom scale. In comparison, 33.33% of patients receiving a sham (inactive) treatment improved on the same scale. This difference showed only a marginal trend toward benefit (p = 0.0974). The difference did not reach statistical significance. A similar marginal trend appeared for resting salivary flow rate (p = 0.0996). By week 12, no differences remained between the two groups for any measured outcome. The authors conclude that laser acupuncture may offer a slight, short-lived benefit and appears safe and noninvasive, but larger and longer trials are needed.\u003c\/p\u003e\n\n\u003ch1\u003eLaser Acupuncture for Dry Mouth in Sjögren's Disease: What a New Randomized Trial Found\u003c\/h1\u003e\n\n\u003ch2\u003eTable of Contents\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#ddn-key-points\"\u003eKey Points\u003c\/a\u003e\u003c\/li\u003e\n\n  \u003cli\u003e\u003ca href=\"#background\"\u003eBackground: Why This Research Matters\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#study-methods\"\u003eHow the Study Was Conducted\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#participants\"\u003eWho Took Part in the Study\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#intervention\"\u003eThe Treatment: Laser Acupuncture Explained\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#outcomes\"\u003eWhat the Researchers Measured\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#key-findings\"\u003eKey Findings: Detailed Results\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#clinical-implications\"\u003eWhat These Results Mean for Patients\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#limitations\"\u003eLimitations: What the Study Could Not Prove\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#recommendations\"\u003eRecommendations and Next Steps\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#ddn-faq\"\u003eFrequently Asked Questions\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#source\"\u003eSource Information\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003c!-- ddn:keypoints:start --\u003e\n\u003ch2 id=\"ddn-key-points\"\u003eKey Points\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eIn a trial of 50 patients with Sjögren's Disease, laser acupuncture produced only a marginal, non-significant improvement in dry mouth symptoms at week 8 (p = 0.0974).\u003c\/li\u003e\n\u003cli\u003eAny benefit seen at week 8 had disappeared by week 12, suggesting effects may be short-lived if they occur at all.\u003c\/li\u003e\n\u003cli\u003eThe treatment was reported as safe and noninvasive, with no serious adverse events in this small, short-term study.\u003c\/li\u003e\n\u003cli\u003eThe trial was small, single-center, all-female, and used per-protocol analysis, so results may not apply to all patients.\u003c\/li\u003e\n\u003cli\u003eLarger, longer trials are needed before laser acupuncture can be recommended as a standard treatment for dry mouth in Sjögren's Disease.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"background\"\u003eBackground: Why This Research Matters\u003c\/h2\u003e\n\n\u003cp\u003eSjögren's Disease (SjD) is one of the most common rheumatic disorders, affecting between 0.1% and 4.8% of people. It is an autoimmune condition, meaning the body's immune system mistakenly attacks its own tissues. Sjögren's Disease primarily affects middle-aged women.\u003c\/p\u003e\n\n\u003cp\u003eThe disease is characterized by lymphocytic infiltration of the salivary and lacrimal glands. In plain language, this means immune cells called lymphocytes build up inside the glands that produce saliva and tears. This buildup reduces saliva and tear production.\u003c\/p\u003e\n\n\u003cp\u003eAs a result, patients experience distressing symptoms of dry eyes (xerophthalmia) and dry mouth (xerostomia). Together, these symptoms are known as sicca syndrome. The symptoms of Sjögren's Disease are often non-specific and resemble those of other conditions. This similarity frequently leads to delayed diagnosis.\u003c\/p\u003e\n\n\u003cp\u003eAccurate diagnosis relies on a combination of clinical and laboratory criteria. These include labial salivary gland biopsy, which takes a small tissue sample from a salivary gland in the lip. They also include Anti-Ro\/SSA antibodies, a blood marker of the disease. Other tests are ocular staining and Schirmer's test, which measures tear production. Resting salivary flow rate is also included.\u003c\/p\u003e\n\n\u003cp\u003eExtra-glandular manifestations — symptoms affecting parts of the body beyond the glands — occur in approximately 50% of cases. Because of this, treatment primarily focuses on three goals:\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eRelieving symptoms\u003c\/li\u003e\n  \u003cli\u003eManaging complications associated with reduced saliva and tear production\u003c\/li\u003e\n  \u003cli\u003eStimulating any remaining gland function\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eHowever, medications used for these purposes, such as pilocarpine and cevimeline, are frequently associated with adverse events like sweating and nausea. These drugs often provide limited clinical benefit, particularly in advanced stages of glandular dysfunction.\u003c\/p\u003e\n\n\u003cp\u003eGiven the limitations of conventional treatments, researchers have explored alternative approaches. One of these is Traditional Chinese Medicine (TCM), one of the oldest healing systems in the world. TCM treatment modalities include acupuncture, massage, dietary therapy, and physical exercise.\u003c\/p\u003e\n\n\u003cp\u003eStudies have demonstrated that acupuncture exerts physiological, anatomical, and neurochemical effects, supporting its application as a medical approach. In a systematic review, Assy and Brand (2018) reported that studies evaluating acupuncture for xerostomia and hyposalivation (reduced saliva production) exhibited a high risk of bias. Despite these limitations, current evidence still supports the potential of acupuncture to increase salivary flow, particularly in patients undergoing radiotherapy.\u003c\/p\u003e\n\n\u003cp\u003eThe most recent guidelines for managing xerostomia in cancer patients have indicated that acupuncture may be an effective treatment option for this cancer population. Evidence for acupuncture in Sjögren's Disease-related xerostomia is scarce. However, a sham-controlled randomized controlled trial (RCT) demonstrated its efficacy for dryness relief after 4 weeks of completing the treatment (Gomes-Silva et al. 2025).\u003c\/p\u003e\n\n\u003cp\u003ePhotobiomodulation (PBM) is another therapeutic approach. PBM uses nonthermal red or infrared light to stimulate or suppress biological processes. It works primarily through mitochondrial activation, enhanced ATP production (ATP is the energy currency of cells), modulation of inflammatory pathways, and improved microcirculation. These effects lead to cellular repair and functional restoration.\u003c\/p\u003e\n\n\u003cp\u003eIn oral medicine, PBM has been investigated as a treatment option for various conditions, including oral mucositis, herpes simplex, oral lichen planus, recurrent aphthous stomatitis, and hyposalivation. Studies have demonstrated positive outcomes of PBM for xerostomia and hyposalivation, particularly when these symptoms are associated with medication use, diabetes, and head and neck cancer treatment. However, only a limited number of studies have explored its efficacy in Sjögren's Disease patients.\u003c\/p\u003e\n\n\u003cp\u003eCombining PBM and acupuncture is not new. Laser irradiation can induce cellular effects at subthermal thresholds (below the level that produces heat). This combination has been used in several clinical conditions, including osteoarthritis, Bell's palsy, and Sjögren's Disease, with promising results. There appears to be a synergistic rationale for combining acupuncture and PBM to potentially enhance their therapeutic benefits.\u003c\/p\u003e\n\n\u003cp\u003eGiven these considerations, the present study aimed to conduct a randomized clinical trial. The trial evaluated the efficacy of PBM applied to acupuncture points for managing xerostomia in patients diagnosed with Sjögren's Disease. The goal was to contribute a new alternative to the clinical arsenal.\u003c\/p\u003e\n\n\u003ch2 id=\"study-methods\"\u003eHow the Study Was Conducted\u003c\/h2\u003e\n\n\u003cp\u003eThis was a single-center, randomized, double-blind clinical trial. \"Single-center\" means all participants were treated at one location. \"Randomized\" means participants were assigned to treatment groups by chance. \"Double-blind\" means neither the participants nor the outcome assessors knew which treatment each participant received.\u003c\/p\u003e\n\n\u003cp\u003eThe trial was conducted at the Rheumatology Unit of Hospital das Clínicas — Universidade Federal de Pernambuco (UFPE), in Recife, Brazil. The study ran between October 2023 and December 2024.\u003c\/p\u003e\n\n\u003cp\u003eThe study was registered in the Brazilian Registry of Clinical Trials. It received ethical approval from the Research Ethics Committee of Hospital das Clínicas — UFPE (approval number 7.126.862). The study adhered to the principles of the Declaration of Helsinki, an international ethical standard for medical research. Written informed consent was obtained from all participants.\u003c\/p\u003e\n\n\u003ch3\u003eRandomization and Blinding\u003c\/h3\u003e\n\n\u003cp\u003eSimple randomization with equal allocation was employed. Participants were randomly assigned to either the placebo group or the intervention group. Randomization was performed using a random computer-generated list from 1 to 60, created at www.random.org.\u003c\/p\u003e\n\n\u003cp\u003eOdd numbers were assigned to the laser group, and even numbers to the sham-laser group. Following the sequence of the randomization list, each participant received an opaque, sealed, and numbered envelope. The envelope contained their assigned treatment group and was opened after the participant signed the informed consent form.\u003c\/p\u003e\n\n\u003cp\u003eBoth the participant and the outcome assessor were blinded to the treatment. The professional administering PBM was the only member of the clinical team aware of the allocation. All outcomes were recorded by an independent examiner who was also blinded to the intervention.\u003c\/p\u003e\n\n\u003ch3\u003ePilot Study\u003c\/h3\u003e\n\n\u003cp\u003eBefore the randomized clinical trial, a pilot study was conducted with healthy volunteers. The purpose was to determine the most effective acupuncture points for improving resting salivary flow rate (RSFR). This was a single-center, cross-sectional study.\u003c\/p\u003e\n\n\u003cp\u003eParticipants had their RSFR measured before treatment and immediately after treatment with laser acupuncture. The intervention was performed using a Gallium Aluminum Arsenide (GaAlAs) laser with a wavelength of 808 nm (infrared). The laser had an output power of 100 mW and a laser spot area of 0.03 cm². Irradiation time was 30 seconds for extra-auricular points (3 J per point). Irradiation time was 10 seconds for auricular points (1 J per point). This totaled 60 J per session.\u003c\/p\u003e\n\n\u003cp\u003eThe results from each group were analyzed using the paired Wilcoxon test to compare pre-test and post-test results. Protocol A had a p value of 0.693. In Protocol A, the RSFR median before treatment was 0.55 mL, and the RSFR median after treatment was 0.65 mL.\u003c\/p\u003e\n\n\u003cp\u003eProtocol B had a p value of 0.088. In Protocol B, the RSFR median before treatment was 0.60 mL, and the RSFR median after treatment was 0.80 mL. Even though no statistically significant value was seen in any group, Protocol B was selected given its marginal trend toward significance.\u003c\/p\u003e\n\n\u003ch2 id=\"participants\"\u003eWho Took Part in the Study\u003c\/h2\u003e\n\n\u003cp\u003eParticipants were recruited from the Sjögren's Disease outpatient clinic at the Rheumatology Unit of Hospital das Clínicas (UFPE). Inclusion criteria comprised patients diagnosed with Sjögren's Disease according to the 2016 American College of Rheumatology\/European League Against Rheumatism (ACR\/EULAR) classification criteria who were 18 years or older.\u003c\/p\u003e\n\n\u003cp\u003eExclusion criteria included the following:\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eCurrent pharmacological treatment for Sjögren's Disease symptoms\u003c\/li\u003e\n  \u003cli\u003eCoexistence of another autoimmune rheumatic disease\u003c\/li\u003e\n  \u003cli\u003ePrevious head and neck radiation therapy\u003c\/li\u003e\n  \u003cli\u003eHepatitis B or hepatitis C infection\u003c\/li\u003e\n  \u003cli\u003eHIV infection\u003c\/li\u003e\n  \u003cli\u003eSarcoidosis\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eAs this was a preliminary study, no formal sample size calculation was performed. A convenience sample was used.\u003c\/p\u003e\n\n\u003cp\u003eA total of 52 patients were initially recruited. Two patients were excluded for not meeting the diagnostic criteria, resulting in 50 eligible participants. These participants were then randomized to receive either laser acupuncture (n = 22) or sham laser acupuncture (n = 28).\u003c\/p\u003e\n\n\u003cp\u003eAt week 4, eight participants withdrew from the laser acupuncture group, and thirteen withdrew from the sham laser acupuncture group. All withdrawals were due to loss of contact. At week 12, one participant from each group withdrew, also due to loss of contact.\u003c\/p\u003e\n\n\u003ch3\u003eBaseline Characteristics\u003c\/h3\u003e\n\n\u003cp\u003eThe two groups were well matched at the start of the study. The mean age was 53.14 years (standard deviation 8.5) in the laser acupuncture group and 50.46 years (standard deviation 10.7) in the sham laser acupuncture group. The age range was 36 to 76 years in the laser group and 26 to 65 years in the sham group.\u003c\/p\u003e\n\n\u003cp\u003eAll participants in both groups were female (100%). Alcohol consumption was reported by 0% of the laser group and 7.14% of the sham group. Tobacco consumption was reported by 4.54% of the laser group and 3.57% of the sham group.\u003c\/p\u003e\n\n\u003cp\u003eXerostomia (dry mouth) was present in 100% of the laser group and 96.43% of the sham group. Xerophthalmia (dry eyes) was present in 95.45% of the laser group and 89.28% of the sham group.\u003c\/p\u003e\n\n\u003cp\u003eMean sialometry (saliva measurement) was 0.063 mL (standard deviation 0.075) in the laser group and 0.074 mL (standard deviation 0.105) in the sham group. Mean Schirmer's test result was 5.59 mm (standard deviation 9.11) in the laser group and 3.86 mm (standard deviation 7.75) in the sham group.\u003c\/p\u003e\n\n\u003cp\u003eAnti-Ro antibodies were positive in 59.09% of the laser group and 64.28% of the sham group. Salivary gland biopsy was positive in 54.54% of the laser group and 32.14% of the sham group. Parotid enlargement was present in 27.27% of the laser group and 42.86% of the sham group.\u003c\/p\u003e\n\n\u003cp\u003eArthralgia (joint pain) was reported by 72.73% of the laser group and 78.57% of the sham group. Vaginal dryness was reported by 59.09% of the laser group and 82.14% of the sham group. Raynaud phenomenon was present in 68.19% of the laser group and 57.14% of the sham group. Dyspnea (shortness of breath) was reported by 59.09% of the laser group and 60.71% of the sham group.\u003c\/p\u003e\n\n\u003cp\u003eThe mean number of drugs used was 6 (standard deviation 2.76) in the laser group and 5.86 (standard deviation 2.9) in the sham group. The mean Xerostomia Inventory score was 41.95 (standard deviation 7.59) in the laser group and 43.36 (standard deviation 8.09) in the sham group. The mean ESSPRI score was 8.5 (standard deviation 1.05) in the laser group and 8.46 (standard deviation 1.21) in the sham group.\u003c\/p\u003e\n\n\u003ch2 id=\"intervention\"\u003eThe Treatment: Laser Acupuncture Explained\u003c\/h2\u003e\n\n\u003cp\u003eFor the randomized clinical trial, PBM was performed using a gallium aluminum arsenide laser (GaAlAs, DMC Photon Lase III). The device emitted infrared light at 808 nm, with an output power of 100 mW and a beam area of 0.03 cm².\u003c\/p\u003e\n\n\u003cp\u003eThe irradiance was 3.33 W\/cm². The irradiation time was 30 seconds for extra-auricular points and 10 seconds for auricular points. The fluence (energy delivered per unit area) was 100 J\/cm² for extra-auricular points and 33.33 J\/cm² for auricular points.\u003c\/p\u003e\n\n\u003cp\u003eA total energy of 3 J per extra-auricular point and 1 J per auricular point was applied. This totaled 60 J per session and a cumulative dose of 240 J per treatment course.\u003c\/p\u003e\n\n\u003cp\u003eThe acupuncture protocol was developed by a dentist specialized in Traditional Chinese Medicine. Each point was irradiated bilaterally (on both sides of the body).\u003c\/p\u003e\n\n\u003cp\u003ePatients allocated to the placebo group received the same acupuncture protocol. However, no light was emitted from the laser device. This is called a \"sham\" treatment. It allows researchers to compare real treatment against an inactive treatment while keeping participants unaware of which they received.\u003c\/p\u003e\n\n\u003cp\u003eParticipants received weekly PBM sessions for four consecutive weeks. Evaluations were conducted at baseline, week 8, and week 12.\u003c\/p\u003e\n\n\u003cp\u003eBlinding effectiveness was assessed at the end of the trial by directly questioning both patients and the investigator.\u003c\/p\u003e\n\n\u003ch2 id=\"outcomes\"\u003eWhat the Researchers Measured\u003c\/h2\u003e\n\n\u003cp\u003eThe primary outcome was a subjective assessment of dry mouth symptoms using a Visual Analogue Scale (VAS). A VAS is a scale on which patients mark how severe their symptoms feel. A clinically significant improvement was defined as a change greater than 14 mm on this scale.\u003c\/p\u003e\n\n\u003cp\u003eSecondary outcomes included objective and patient-reported measures:\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eXerostomia Inventory (XI):\u003c\/strong\u003e a questionnaire measuring dry mouth symptoms. A difference of 6 points or more was considered clinically significant.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eResting salivary flow rate (RSFR):\u003c\/strong\u003e an objective measure of saliva production. An improvement of salivary flow greater than 0.1 mL\/min was regarded as clinically significant.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eEULAR Sjögren's Syndrome Patient Reported Index (ESSPRI):\u003c\/strong\u003e a questionnaire measuring the overall impact of Sjögren's symptoms. A difference of 1 point or more was considered clinically significant.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eOutcome values were collected at baseline and post-treatment (weeks 8 and 12). The VAS, XI, and ESSPRI are validated xerostomia-related, patient-reported outcome measures. They assess the impact of these symptoms on patient quality of life.\u003c\/p\u003e\n\n\u003ch3\u003eStatistical Analysis\u003c\/h3\u003e\n\n\u003cp\u003eStatistical analyses were performed using Graphpad Prism software (version 10.4.2). All analyses were carried out on a per-protocol basis, meaning only participants who completed the study as planned were included in the final analysis.\u003c\/p\u003e\n\n\u003cp\u003eProportions were compared using Fisher's exact test and odds ratio with corresponding 95% confidence intervals. Given the sample size, non-parametric tests were applied. The Mann–Whitney test was used to compare the median value between two groups. The Kruskal-Wallis test was used to compare medians among three groups.\u003c\/p\u003e\n\n\u003cp\u003eThe number needed to treat (NNT) was calculated using the formula: NNT = 1\/ARR (Absolute Risk Reduction). The NNT tells you how many patients need to receive a treatment for one additional patient to benefit. The null hypothesis was rejected at a significance level of p \u0026lt; 0.05.\u003c\/p\u003e\n\n\u003ch2 id=\"key-findings\"\u003eKey Findings: Detailed Results\u003c\/h2\u003e\n\n\u003cp\u003eAt week 8, the laser acupuncture group showed a marginal trend toward improvement on the primary outcome compared with the sham group. However, no statistically significant differences were observed between groups at week 12 for any of the assessed outcomes.\u003c\/p\u003e\n\n\u003ch3\u003ePrimary Outcome: Dry Mouth Symptoms (VAS)\u003c\/h3\u003e\n\n\u003cp\u003eAt week 8, 64.29% of patients in the PBM acupuncture group achieved the primary outcome endpoint. In comparison, 33.33% in the sham-PBM acupuncture group achieved the endpoint. These results demonstrated a marginal trend toward benefit for VAS score (p = 0.0974).\u003c\/p\u003e\n\n\u003cp\u003eThe number needed to treat was 3.231. The odds ratio was 1.929, with a 95% confidence interval of 0.8939 to 4.525. An odds ratio of 1.929 suggests the laser group was nearly twice as likely to improve, but the confidence interval crosses 1.0, which means the result could also reflect no true difference.\u003c\/p\u003e\n\n\u003cp\u003eHowever, no improvement was observed at week 12. Interestingly, the variance test also showed a marginal trend toward benefit in the VAS score for the laser acupuncture group.\u003c\/p\u003e\n\n\u003ch3\u003eSecondary Outcome: Resting Salivary Flow Rate (RSFR)\u003c\/h3\u003e\n\n\u003cp\u003eFor the RSFR endpoint, 21.43% of patients in the PBM acupuncture group achieved the endpoint at week 8. In comparison, 0.00% of the sham-PBM acupuncture group achieved the endpoint. These results sustained a marginal trend toward benefit (p = 0.0996) at week 8.\u003c\/p\u003e\n\n\u003cp\u003eThe number needed to treat was 4.667. The odds ratio was +infinity, with a 95% confidence interval of 0.9363 to infinity. An infinite odds ratio arises because no patients in the sham group improved, which makes the ratio mathematically undefined. Similar to the primary outcome, no sustained effect was detected at week 12.\u003c\/p\u003e\n\n\u003ch3\u003eSecondary Outcome: Xerostomia Inventory (XI)\u003c\/h3\u003e\n\n\u003cp\u003eFor the XI score, 14.29% of patients in the PBM acupuncture group achieved the endpoint at week 8. In comparison, 20.00% in the sham-PBM acupuncture group achieved the endpoint. There was no clear benefit (p = 0.5394).\u003c\/p\u003e\n\n\u003cp\u003eAs with the previous outcomes, a decrease in statistical significance was observed at week 12 (p = 0.6167).\u003c\/p\u003e\n\n\u003ch3\u003eSecondary Outcome: ESSPRI Score\u003c\/h3\u003e\n\n\u003cp\u003eFor the ESSPRI score, 14.29% of participants in the PBM acupuncture group reached the endpoint at week 8. In comparison, 26.67% in the sham-PBM acupuncture group reached the endpoint. No statistically significant differences were observed at week 8 (p = 0.3605) or week 12 (p = 0.5424).\u003c\/p\u003e\n\n\u003ch3\u003eSummary of Results at Week 12\u003c\/h3\u003e\n\n\u003cp\u003eAt week 12, the results for all outcomes were as follows:\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eVAS:\u003c\/strong\u003e 6 of 14 patients (42.86%) in the laser group and 7 of 15 patients (46.67%) in the sham group achieved the endpoint (p = 0.5664).\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eXI:\u003c\/strong\u003e 4 of 14 patients (28.57%) in the laser group and 4 of 15 patients (26.67%) in the sham group achieved the endpoint (p = 0.6167).\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eRSFR:\u003c\/strong\u003e 0 of 14 patients (0%) in the laser group and 2 of 15 patients (13.33%) in the sham group achieved the endpoint (p = 0.2586).\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eESSPRI:\u003c\/strong\u003e 3 of 14 patients (21.43%) in the laser group and 4 of 15 patients (26.67%) in the sham group achieved the endpoint (p = 0.5424).\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2 id=\"clinical-implications\"\u003eWhat These Results Mean for Patients\u003c\/h2\u003e\n\n\u003cp\u003eThis study aimed to investigate the efficacy of PBM on patient-perceived xerostomia in individuals with Sjögren's Disease and its subsequent impact on quality of life. It is among the few studies reported in the literature to address this issue. Additionally, it evaluated factors associated with disease activity.\u003c\/p\u003e\n\n\u003cp\u003eOverall, the present trial demonstrated that PBM had a marginal effect on patient quality of life and a potential benefit on VAS score and RSFR at week 8.\u003c\/p\u003e\n\n\u003cp\u003eThe management of xerostomia in Sjögren's Disease remains challenging due to the limited availability of effective treatment options. The overall efficacy of pharmacological therapies has been modest, although some agents have shown promising results.\u003c\/p\u003e\n\n\u003cp\u003eSialagogues (medications that stimulate saliva production) such as pilocarpine have demonstrated some benefit in increasing salivary flow. However, their effect on lacrimal gland function is limited and based on a small number of studies with methodological concerns. Pilocarpine is also associated with a high frequency of adverse events, which can preclude its use and limit its overall clinical impact.\u003c\/p\u003e\n\n\u003cp\u003eAmong immunobiological therapies (treatments that target specific parts of the immune system), rituximab has shown some benefit. Belimumab and abatacept have demonstrated potential efficacy in improving glandular function in patients with Sjögren's Disease. Novel immunobiologicals, such as ianalumab and iscalimab, have shown promising results and may become optimal therapeutic options in the near future. Nevertheless, these strategies are associated with high cost and potentially severe adverse events. This underscores the clinical need for alternative therapeutic approaches.\u003c\/p\u003e\n\n\u003cp\u003ePBM has also been investigated as a treatment for xerostomia. In a systematic review, Sousa et al. (2020) reported that PBM may be effective in improving salivary flow and relieving xerostomia symptoms in Sjögren's Disease patients. PBM was found to be both safe and well-tolerated. However, other studies have not observed positive effects of PBM therapy in this population.\u003c\/p\u003e\n\n\u003cp\u003eFidelix and colleagues (2018) reported no significant improvement in salivary gland function or salivary flow rate. The low baseline salivary flow rates observed in their study population were suggested as a possible explanation for this lack of benefit.\u003c\/p\u003e\n\n\u003cp\u003eOther non-pharmacological therapies have been investigated for their effectiveness in alleviating dry mouth symptoms. In a Cochrane review, Furness et al. (2013) evaluated a range of interventions with variable results. The authors reported that acupuncture increased saliva production in patients experiencing xerostomia following radiotherapy. However, the review found insufficient evidence to determine the effects of electrostimulation on xerostomia or salivary production in patients with Sjögren's Disease. Although both acupuncture and electrostimulation showed some promising results, adverse events from these interventions were generally mild and transient.\u003c\/p\u003e\n\n\u003cp\u003eIn a systematic review, Hackett et al. (2015) reported that neither intra-oral lubricating devices nor psychodynamic group therapy improved the quality of life of patients diagnosed with Sjögren's Disease.\u003c\/p\u003e\n\n\u003cp\u003eSeveral studies have investigated the efficacy of acupuncture in managing xerostomia in Sjögren's Disease patients, yielding varying results. Given the holistic nature of Traditional Chinese Medicine, which considers the interplay of multiple factors in health and disease, the optimal approach to managing Sjögren's Disease may vary considerably. This diversity in therapeutic strategies may explain the variability observed in acupuncture outcomes among patients with Sjögren's Disease, particularly regarding the selection of acupuncture points.\u003c\/p\u003e\n\n\u003cp\u003eZhou et al. (2022) did not observe a satisfactory improvement in symptoms compared with placebo treatment. In contrast, Liu et al. (2023) reported that Traditional Chinese Medicine produced better clinical outcomes than Western medicine.\u003c\/p\u003e\n\n\u003cp\u003eFor the secondary outcome in the present study, 21.43% of patients in the PBM group showed improvement in RSFR, compared to no improvement in the sham-PBM group at week 8. This finding is consistent with a previous study by Cafaro et al. (2015), which also used laser acupuncture to treat patients with Sjögren's Disease. Their results demonstrated that PBM increased saliva production compared to the placebo group.\u003c\/p\u003e\n\n\u003ch2 id=\"limitations\"\u003eLimitations: What the Study Could Not Prove\u003c\/h2\u003e\n\n\u003cp\u003eThe study has several important limitations that patients and clinicians should consider.\u003c\/p\u003e\n\n\u003cp\u003eFirst, the results did not reach statistical significance. The p values for the primary outcome (0.0974) and for resting salivary flow rate (0.0996) were both above the 0.05 threshold. This means the observed differences could have occurred by chance. The findings are described as a \"marginal tendency\" rather than a proven benefit.\u003c\/p\u003e\n\n\u003cp\u003eSecond, the benefits did not persist. Any potential advantage of laser acupuncture seen at week 8 had disappeared by week 12. This suggests that even if the treatment helps, its effects may be short-lived.\u003c\/p\u003e\n\n\u003cp\u003eThird, the study was small. As a preliminary study, no formal sample size calculation was performed. Only 50 patients were randomized, and the per-protocol analysis included even fewer — 14 patients in the laser group and 15 in the sham group. A small sample size reduces the ability to detect real differences and increases the chance of random variation affecting results.\u003c\/p\u003e\n\n\u003cp\u003eFourth, there was substantial dropout. At week 4, eight participants withdrew from the laser acupuncture group and thirteen from the sham group, all due to loss of contact. This high dropout rate further reduced the number of patients available for analysis.\u003c\/p\u003e\n\n\u003cp\u003eFifth, the study was conducted at a single center in Brazil. Results may not be generalizable to other populations or settings.\u003c\/p\u003e\n\n\u003cp\u003eSixth, all participants were female, reflecting the known female predominance of Sjögren's Disease. However, this means the findings may not apply to male patients.\u003c\/p\u003e\n\n\u003cp\u003eFinally, the study used a per-protocol analysis rather than an intention-to-treat analysis. Per-protocol analysis excludes patients who did not complete the study as planned. This approach can overestimate treatment effects because it does not account for participants who dropped out.\u003c\/p\u003e\n\n\u003ch2 id=\"recommendations\"\u003eRecommendations and Next Steps\u003c\/h2\u003e\n\n\u003cp\u003eThe authors conclude that PBM at acupuncture points demonstrated a slight short-term benefit at week 8 in improving xerostomia symptoms and resting salivary flow rate. However, these effects did not persist at 12 weeks.\u003c\/p\u003e\n\n\u003cp\u003eThese preliminary results suggest a potential role for PBM at acupuncture points as a safe, noninvasive adjunctive therapy for xerostomia in patients with Sjögren's Disease. \"Adjunctive\" means it would be used alongside other treatments, not as a replacement.\u003c\/p\u003e\n\n\u003cp\u003eThe authors state that further validation in larger, long-term trials is warranted. This means that before laser acupuncture can be recommended as a standard treatment, more research with more patients and longer follow-up is needed.\u003c\/p\u003e\n\n\u003cp\u003eFor patients considering laser acupuncture for dry mouth, the current evidence suggests the following:\u003c\/p\u003e\n\n\u003col\u003e\n  \u003cli\u003eThe treatment appears safe and noninvasive, with no serious adverse events reported in this study.\u003c\/li\u003e\n  \u003cli\u003eAny benefit may be modest and short-lived, based on this preliminary research.\u003c\/li\u003e\n  \u003cli\u003eLaser acupuncture should be discussed with your rheumatologist or oral medicine specialist as a potential complementary approach.\u003c\/li\u003e\n  \u003cli\u003eIt should not replace proven treatments for Sjögren's Disease without medical guidance.\u003c\/li\u003e\n  \u003cli\u003eLarger studies are needed before firm conclusions can be drawn about its effectiveness.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003cp\u003eThe study was registered in The Brazilian Registry of Clinical Trials (U1111-1298-9891).\u003c\/p\u003e\n\n\u003c!-- ddn:faq:start --\u003e\n\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eWhat is laser acupuncture for dry mouth?\u003c\/h3\u003e\n\u003cp\u003eLaser acupuncture applies low-level infrared light to specific acupuncture points. In a trial of 50 patients with Sjögren's Disease, this treatment was given weekly for four weeks. It is noninvasive and was reported as safe, with no serious side effects. The trial tested whether it could relieve dry mouth, but results showed only a slight, short-lived benefit.\u003c\/p\u003e\n\u003ch3\u003eDid laser acupuncture significantly improve dry mouth in the trial?\u003c\/h3\u003e\n\u003cp\u003eAt week 8, 64.29% of patients receiving real laser acupuncture improved on a dry-mouth symptom scale, compared with 33.33% receiving a sham treatment. However, this difference did not reach statistical significance (p = 0.0974). By week 12, no differences remained between the groups for any measured outcome. The authors call this a marginal, short-lived benefit.\u003c\/p\u003e\n\u003ch3\u003eWhat does the p-value of 0.0974 mean?\u003c\/h3\u003e\n\u003cp\u003eA p-value of 0.0974 means the difference between the laser and sham groups could have occurred by chance. Researchers typically require a p-value below 0.05 to call a result statistically significant. Because 0.0974 is above that threshold, the trial did not prove that laser acupuncture worked better than the inactive treatment for dry mouth symptoms.\u003c\/p\u003e\n\u003ch3\u003eWho was included in this trial?\u003c\/h3\u003e\n\u003cp\u003eThe trial included 50 adults aged 18 and older with Sjögren's Disease, diagnosed by standard criteria. All participants were female, reflecting the disease's known predominance in women. People with other autoimmune rheumatic diseases, previous head and neck radiation, hepatitis B or C, HIV, or sarcoidosis were excluded. Participants were recruited from a single outpatient clinic in Brazil.\u003c\/p\u003e\n\u003ch3\u003eWhat were the side effects or risks of laser acupuncture?\u003c\/h3\u003e\n\u003cp\u003eThe trial reported no serious adverse events from laser acupuncture. The treatment is described as safe and noninvasive. However, the study was small and short, so rare or longer-term risks cannot be ruled out. Any new treatment should be discussed with your rheumatologist or oral medicine specialist before starting, especially if you have other health conditions.\u003c\/p\u003e\n\u003ch3\u003eHow long did any benefit last?\u003c\/h3\u003e\n\u003cp\u003eIn the trial, any improvement in dry mouth symptoms or resting salivary flow rate was seen only at week 8. By week 12, no differences remained between the laser and sham groups for any outcome. This suggests that even if laser acupuncture helps, its effects may be short-lived. Longer trials are needed to confirm whether repeated sessions could extend benefits.\u003c\/p\u003e\n\u003ch3\u003eI have Sjögren's Disease and my doctor suggested laser acupuncture for my dry mouth — should I get a second opinion before trying it?\u003c\/h3\u003e\n\u003cp\u003eLaser acupuncture for Sjögren's-related dry mouth has only marginal, short-lived evidence: at week 8, 64.29% of treated patients improved on a dry-mouth scale versus 33.33% with sham treatment, but this did not reach statistical significance (p = 0.0974), and no differences remained by week 12. The trial was small, single-center, and all-female, with substantial dropout. A second opinion can help you weigh this preliminary option against proven therapies and clarify whether it belongs alongside your current care. Diagnostic Detectives Network provides independent expert second opinions.\u003c\/p\u003e\n\u003c!-- ddn:faq:end --\u003e\n\n\u003ch2 id=\"source\"\u003eSource Information\u003c\/h2\u003e\n\n\u003cp\u003e\u003cstrong\u003eOriginal article title:\u003c\/strong\u003e Laser Acupuncture on the Management of Xerostomia in Sjögren's Disease: A Randomized Clinical Trial.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eAuthors:\u003c\/strong\u003e Linares MF, Dos Santos França TD, Ferreira MCBM, do Nascimento MG, Duarte ALBP, Gueiros LA.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eAuthor affiliations:\u003c\/strong\u003e Department of Oral Diagnosis, Semiology and Pathology Areas, Piracicaba Dental School, University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil; Private Office, Recife, Pernambuco, Brazil; Department of Pediatric Dentistry, University of Pernambuco, Recife, Pernambuco, Brazil; Rheumatology Unit, Hospital das Clínicas, Universidade Federal de Pernambuco, Recife, Pernambuco, Brazil; Department of Clinic and Preventive Dentistry, Oral Medicine Unit, Federal University of Pernambuco (UFPE), School of Dentistry, Recife, Pernambuco, Brazil\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eCorresponding author:\u003c\/strong\u003e Luiz Alcino Gueiros (luiz.mgueiros@ufpe.br)\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eJournal:\u003c\/strong\u003e Oral Diseases, 2026; 32:1912–1922\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003ePublication details:\u003c\/strong\u003e Received 4 May 2025; Revised 6 January 2026; Accepted 1 February 2026\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eDOI:\u003c\/strong\u003e https:\/\/doi.org\/10.1111\/odi.70241\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c\/strong\u003e Brazilian Registry of Clinical Trials (U1111-1298-9891)\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eKeywords:\u003c\/strong\u003e acupuncture, photobiomodulation, Sjögren's syndrome, xerostomia\u003c\/p\u003e\n\n\u003cp\u003e\u003cem\u003eThis patient-friendly article is based on peer-reviewed research. It is intended for educational purposes and should not replace consultation with a qualified healthcare professional. Patients should discuss any treatment decisions with their doctor.\u003c\/em\u003e\u003c\/p\u003e","brand":"DiagnosticDetectives.Com","offers":[{"title":"Default Title","offer_id":47816828879004,"sku":null,"price":0.0,"currency_code":"KRW","in_stock":true}],"url":"https:\/\/diagnosticdetectives.kr\/products\/laser-acupuncture-for-dry-mouth-in-sjogrens-disease-what-a-new-randomized-trial-found","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}