Blinding protects against bias but the success of blinding is seldom assessed and reported in clinical trials including studies of acupuncture where blinding represents a major challenge. Recently, needles with the potential for double-blinding were developed, so we tested if acupuncture can be double-blinded in a randomized study of sixty-seven patients with acute pain ≥ 3 (0-10 scale following third molar removal) who received active acupuncture with a penetrating needle or placebo acupuncture with a non-penetrating needle. To test if acupuncture was administered double-blind, patients and acupuncturists were asked about perceived treatment allocation at the end of the study. To test if there were clues which led to identification of the treatment, deep dull pain associated with needle application and rotation (termed “de qi” in East Asian medicine), and patients’ pain levels were assessed. Perceived treatment allocation depended on actual group allocation (p < 0.015) for both patients and acupuncturists, indicating that the needles were not successful in double-blinding. Up to 68% of patients and 83% of acupuncturists correctly identified the treatment, but for patients the distribution was not far from 50/50. Also, there was a significant interaction between actual or perceived treatment and the experience of de qi (p = 0.027), suggesting that the experience of de qi and possible non-verbal clues contributed to correct identification of the treatment. Yet, of the patients who perceived the treatment as active or placebo, 50% and 23%, respectively, reported de qi. Patients’ acute pain levels did not influence the perceived treatment. In conclusion, acupuncture treatment was not fully double-blinded which is similar to observations in pharmacological studies. Still, the non-penetrating needle is the only needle that allows some degree of practitioner blinding. The study raises questions about alternatives to double-blind randomized clinical trials in the assessment of acupuncture treatment.

neurodegenerative disease with loss of dopaminergic neurons in the substantia nigra of the brain. It is a multisystem disorder clinically characterised by motor and non-motor (NM) symptoms. 1 The motor symptoms of PD include four cardinal features: bradykinesia (slowness of movements), rest tremor, rigidity and postural instability or gait impairment. 2 The NM symptoms include autonomic disturbances and neuropsychiatric dysfunctions such as depression, dementia and apathy. Most therapies are oriented towards symptomatic relief and do not have significant effect on the underlying disease process with respect Abstract Background: Parkinson's disease (PD) is a progressive neurodegenerative disorder.It is associated with reduced oral health and impaired oro-facial function, but besides recommendations of dental visits and drooling treatment, there are little documented odontological treatment options. Objectives:To evaluate the effect of standardised home exercise jaw opening and chewing programmes, as well as home oral hygiene measures instructed and controlled by a trained dentist.Methods: Twenty-nine patients (median 65 years) with moderate to advanced PD participated in the project after informed consent. They were followed at a Neurology Department, were able to cooperate, and had stable medical treatment and nine also deep brain stimulation. The interventions were individual dental hygiene instruction, training of jaw opening (JawTrainer), and lip and chewing exercises (Ulmer Oral Screen and Proxident Fluoride Gum). The study was performed as a randomised controlled study. The treatment effect was evaluated after 2 and 4 months. The primary outcome was maximum unassisted jaw opening capacity, chewing time of a standardised apple slice, and the Simplified Debris Index. Results were analysed with Wilcoxon matched pairs test and Mann-Whitney U test (significance level P < .05).Results: Jaw opening, chewing time and hygiene were significantly improved 2 months from the start of the invention, respectively, 6%, 49%, and 25%, and the improvement was still significant after 4 months. No significant changes were found after the 2-month control period without intervention. Conclusion:The simple measures had a substantial and significant clinical effect which is promising despite the progressive nature of the PD.

It is well known that acupuncture has pain-relieving effects, but the contribution of specific and especially non-specific factors to acupuncture analgesia is less clear. One hundred and one patients who developed pain ≥ 3 on a visual analog scale (VAS, 0-10) following third molar surgery were randomized to receive active acupuncture, placebo acupuncture, or no treatment for 30 min with acupuncture needles with potential for double-blinding. Patients’ perception of the treatment (active or placebo), and expected pain levels (VAS) were assessed prior to and halfway through the treatment. Looking at actual treatment allocation, there was no specific effect of active acupuncture (P = 0.240), but a large and significant non-specific effect of placebo acupuncture (P < 0.001), which increased over time. Interestingly, however, looking at perceived treatment allocation, there was a significant effect of acupuncture (P < 0.001) indicating that patients who believed they received active acupuncture had significantly lower pain levels than those who believed they received placebo acupuncture. Expected pain levels accounted for significant and progressively larger amounts of the variance in pain ratings following both active and placebo acupuncture (up to 69.8%), This is the first study to show that under optimized blinding conditions non-specific factors such as patients’ perception of and expectations toward treatment are central to the efficacy of acupuncture analgesia and that these factors may contribute to self-reinforcing effects in acupuncture treatment To obtain an effect of acupuncture in clinical practice it may, therefore, be important to incorporate and optimize these factors.

Summary Background Oromandibular dystonia (OMD) with involuntary jaw and tongue movements may be misdiagnosed as temporomandibular disorders (TMD) and because of the complex muscle activity and involvement of several small muscles, OMD is also considered difficult to treat. Objectives The aim was to evaluate OMD in patients 8‐10 years after start of treatment with botulinum toxin (BoNT) by self‐reported and standardised global scales and questionnaires. Methods Of 21 previously reported patients with OMD, 14 responded to a mail health questionnaire to describe the disease course and treatment effect as well as the overall impact of OMD by a visual analogue scale (VAS), the Patient Health Questionnaire (PHQ) for depression and anxiety, and the Jaw Functional Limitation Scale (JFLS). The results were analysed with non‐parametric statistical analysis (Wilcoxon matched‐pairs test and Spearman's rank‐order correlations). Results The OMD was still present in 13 patients. In nine patients, the BoNT treatment had continued as monotherapy or combined with oral medication. VAS for OMD was significantly reduced (P < 0.04) over the years, and most patients felt improvement from the treatment. However, the patients had still some functional limitations, typically regarding jaw mobility and communication, and both JFLS and mental distress (PHQ) were significantly correlated with the OMD VAS (rS 0.77 and 0.74). Conclusion The results showed marked reduction of the experienced OMD with treatment and over time, and also stressed similarities between OMD and TMD. Both dentists and neurologists should be aware of this overlap and reduce misdiagnosis by applying an interdisciplinary approach.

It is well known that acupuncture has pain-relieving effects, but the contribution of specific and especially non-specific factors to acupuncture analgesia is less clear. One hundred and one patients who developed pain ≥ 3 on a visual analog scale (VAS, 0-10) following third molar surgery were randomized to receive active acupuncture, placebo acupuncture, or no treatment for 30 min with acupuncture needles with potential for double-blinding. Patients' perception of the treatment (active or placebo), and expected pain levels (VAS) were assessed prior to and halfway through the treatment. Looking at actual treatment allocation, there was no specific effect of active acupuncture (P = 0.240), but a large and significant non-specific effect of placebo acupuncture (P < 0.001), which increased over time. Interestingly, however, looking at perceived treatment allocation, there was a significant effect of acupuncture (P < 0.001) indicating that patients who believed they received active acupuncture had significantly lower pain levels than those who believed they received placebo acupuncture. Expected pain levels accounted for significant and progressively larger amounts of the variance in pain ratings following both active and placebo acupuncture (up to 69.8%), This is the first study to show that under optimized blinding conditions non-specific factors such as patients' perception of and expectations toward treatment are central to the efficacy of acupuncture analgesia and that these factors may contribute to self-reinforcing effects in acupuncture treatment To obtain an effect of acupuncture in clinical practice it may, therefore, be important to incorporate and optimize these factors.