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Aim: To explore the current practice of stakeholder engagement in clinical trials and its evaluation in North America (USA and Canada), DACH countries (Germany, Austria and Switzerland) and China. Participants & methods: We conducted a web-based, anonymous, international, cross-sectional online survey for clinical researchers. Data were analyzed using descriptive and explorative statistical analysis including analysis of variance and analysis of covariance. Results: Stakeholder engagement is more prominent and higher accepted among researchers in North America. Researchers in DACH countries have less knowledge of the stakeholder engagement method and are less likely to apply it. Conclusion: Stakeholder engagement is perceived very differently among participants from DACH countries, North America and China. For a broader acceptance and implementation institutional support and motivational conditions might be needed.

The imagination of tactile stimulation has been shown to activate primary somatosensory cortex (SI) with a somatotopic specificity akin to that seen during the perception of tactile stimuli. Using fMRI and MVPA, we investigate if this recruitment of sensory regions also reflects content-specific activation, i.e. whether the activation in SI is specific to the mental content participants imagined. To this end, healthy volunteers (n=21) either perceived or imagined three types of vibrotactile stimuli (mental content) while fMRI data was acquired. Independent of the content, during tactile mental imagery we found activation of fronto-parietal regions, supplemented with activation in the contralateral BA2 subregion of SI, replicating previous reports. While the imagery of the three different stimuli did not reveal univariate activation differences, using multivariate pattern classification we were able to decode the imagined stimulus type from BA2. Moreover, cross-classification revealed that tactile imagery elicits activation patterns similar to those evoked by the perception of the respective stimuli. These findings promote that mental tactile imagery involves the recruitment of content-specific activation patterns in sensory cortices, namely in SI.Significance StatementIt has been shown previously that mental imagery of sensations in different modalities can activate respective primary sensory cortices (visual/auditory/tactile). However, a relation of such activation to the imagined mental content was mainly shown for the visual system. Here, we generalize this concept to the somatosensory domain by showing that content-specific activation during tactile mental imagery can be found in primary somatosensory cortex subarea BA2. Most importantly, we show that tactile imagery elicits activation patterns similar to those evoked by sensory stimulation. Our results provide further evidence that sensory recruitment is among the brain processes that allow conscious information representation.

Traditional medical practice has suffered from male bias, which can lead to sub-optimal treatment options for female patients and increase the incidence of severe side-effects in this population. Mobile health applications, mHealth apps, represent one essential component of the shift towards consumer-centered self-administered individualized health. To prevent sex-specific bias it is important that trials consider sex and gender when developing mHealth apps. We evaluated the inclusion and reporting of sex and gender at all levels in mHealth randomized controlled trials (RCTs). To this end, we conducted a secondary analysis of a large study database addressing the effectiveness of app interventions on clinical outcomes in patients with chronic medical conditions. We followed the 5 steps described in the framework by Arksey and O’Malley and the guidelines of the PRISMA-ScR. Of the 72 app-based RCTs which reported information about sex overall, 62 included individuals of both sexes. The concept of gender was not addressed in any of the studies. The consideration of sex aspects in the design, execution and reporting of mHealth RCTs was minimal or absent. To adequately address the health and preventative needs of the mHealth user population, sex and gender should be systematically included in the research, development and evaluation of mHealth applications.

Acupuncture is a complementary and nonpharmacological intervention that can be effective for the management of chronic pain in addition to or instead of medication. Various animal models for neuropathic pain, inflammatory pain, cancer-related pain, and visceral pain already exist in acupuncture research. We used a newly validated human pain model and examined whether acupuncture can influence experimentally induced dental pain. For this study, we compared the impact of manual acupuncture (real acupuncture), manual stimulation of a needle inserted at nonacupuncture points (sham acupuncture) and no acupuncture on experimentally induced dental pain in 35 healthy men who were randomized to different sequences of all 3 interventions in a within-subject design. BORG CR10 pain ratings and autonomic responses (electrodermal activity and heart rate variability) were investigated. An initial mixed model with repeated measures included preintervention pain ratings and the trial sequence as covariates. The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (β = -.708, P = .002), corresponding to a medium Cohen's d effect size of .56. The comparison to the sham acupuncture revealed no statistically significant difference. No differences in autonomic responses between real and sham acupuncture were found during the intervention procedures. PERSPECTIVE: This study established a dental pain model for acupuncture research and provided evidence that experimentally induced dental pain can be influenced by either real acupuncture or manual stimulation of needles at nonacupuncture points. The data do not support that acupoint specificity is a significant factor in reducing experimental pain.

BACKGROUND Chronic conditions have a big impact on disability, morbidity, and mortality worldwide. Smartphone health applications (apps) have the potential to improve the health of patients with chronic conditions and to enhance the quality and efficiency of healthcare. The number of randomized controlled trials (RCTs) of smartphone health apps is increasing but a collection of the available evidence in one database is still missing. OBJECTIVE To describe Smartphone-RCCT, which is a database of randomized controlled clinical trials (RCTs) of smartphone apps for chronic conditions. METHODS Smartphone-RCCT is an open-access database collecting bibliographic references and important characteristics of RCTs. For a study to be included, the following criteria had to be met: a) RCT published in a peer-reviewed journal; b) adult study participants with one or several chronic conditions that represent the main health problem addressed by the study intervention. c) Intervention: smartphone health app used by the patient. d) Comparator: any control condition. e) Outcomes: any patient-reported health outcome (studies exclusively measuring the patients’ knowledge about the chronic conditions or their satisfaction with the smartphone app were excluded). f) Sample size: at least 15 participants per study arm. We searched in electronic databases and other resources to identify relevant studies. Two reviewers selected the studies and extracted data independently. RESULTS The database is available in Open Science Framework (OSF): https://osf.io/nxerf/. Annual updates are planned. CONCLUSIONS Smartphone-RCCT is the first systematic open-access database collecting peer-reviewed publications of RCTs of smartphone apps for patients with chronic conditions. The database accelerates the delivery of evidence-based information in a dynamic research field. It represents an essential resource for different stakeholders, such as professionals working in evidence synthesis, meta-epidemiological studies, or planning a RCT. CLINICALTRIAL https://osf.io/nxerf/

Background Clinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions. Objective We aimed to establish practical lessons from the experience of our working group, which might accelerate the development of future mHealth interventions and their evaluation by randomized controlled trials (RCTs). Methods This paper is based on group and expert discussions, and focuses on the researchers’ perspectives after four RCTs on mHealth interventions for chronic pain. Results The following five lessons are presented, which are based on practical application, increase of speed, and sustainability: (1) explore stakeholder opinions, (2) develop the mHealth app and trial simultaneously, (3) minimize complexity, (4) manage necessary resources, and (5) apply behavior change techniques. Conclusions The five lessons developed may lead toward an agile research environment. Agility might be the key factor in the development and research process of a potentially sustainable and evidence-based mHealth intervention.

BACKGROUND Clinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions. OBJECTIVE We aimed to establish practical lessons from the experience of our working group, which might accelerate the development of future mHealth interventions and their evaluation by randomized controlled trials (RCTs). METHODS This paper is based on group and expert discussions, and focuses on the researchers’ perspectives after four RCTs on mHealth interventions for chronic pain. RESULTS The following five lessons are presented, which are based on practical application, increase of speed, and sustainability: (1) explore stakeholder opinions, (2) develop the mHealth app and trial simultaneously, (3) minimize complexity, (4) manage necessary resources, and (5) apply behavior change techniques. CONCLUSIONS The five lessons developed may lead toward an agile research environment. Agility might be the key factor in the development and research process of a potentially sustainable and evidence-based mHealth intervention.

Introduction Fatigue plays an important role in the daily activity of patients with multiple sclerosis (MS) and strongly influences their quality of life. Numerous clinical trials evaluating various interventions for fatigue in MS have shown only minor benefits. The main aim of the present trial is to evaluate whether 1) acupuncture or 2) mindfulness-based stress reduction (MBSR) in addition to usual care are effective in reducing fatigue in MS patients compared to usual care alone. Methods Within a randomized, three-arm, controlled trial we aim to include 141 MS patients aged 18–65 years with fatigue for at least 3 months and an average score of ≥4 on the Fatigue Severity Scale (FSS). Patients will be randomized into three groups: an acupuncture group receiving 12 weeks of acupuncture in addition to usual care, a MBSR group receiving 12 weeks of MBSR in addition to usual care, and a usual care group continuing their previous treatment. Primary outcome is the Fatigue Severity Scale (FSS) after 12 weeks. To assess the trial’s characteristics regarding efficacy and effectiveness we used the pragmatic explanatory continuum summary (PRECIS-2). Discussion This trial addresses new therapeutic approaches for fatigue in MS. The resulting design is a compromise between scientific rigor and pragmatism. Due to difficulties with recruitment we had to scale down our trial to the groups of usual care and acupuncture. The trial's results will give first evidence whether acupuncture is effective in patients with MS associated fatigue. Trial registration ClinicalTrials.gov identifier NCT01864707, registered on 2 April 2013.

Objective: Since recent studies suggested a role of the striatum and prefrontal cortex for multiple sclerosis (MS)-related fatigue, we investigated resting-state functional connectivity alterations of striatal subdivisions and the dorsolateral prefrontal cortex (dlPFC). Methods: Resting-state functional magnetic resonance imaging was acquired in 77 relapsing–remitting MS patients (38 fatigued (F-MS), 39 non-fatigued (NF-MS)) and 41 matched healthy controls (HC). Fatigue severity was assessed using the fatigue severity scale. Seed-based connectivity analyses were performed using subregions of the striatum and the dlPFC as regions of interest applying non-parametric permutation testing. Results: Compared to HC and NF-MS patients, F-MS patients showed reduced caudate nucleus and ventral striatum functional connectivity with the sensorimotor cortex (SMC) and frontal, parietal, and temporal cortex regions. Fatigue severity correlated negatively with functional connectivity of the caudate nucleus and ventral striatum with the SMC and positively with functional connectivity of the dlPFC with the rostral inferior parietal gyrus and SMC. Conclusion: MS-related fatigue is associated with reduced functional connectivity between the striatum and sensorimotor as well as attention and reward networks, in which the ventral striatum might be a key integration hub. Together with increased connectivity between the dlPFC and sensory cortical areas, these connectivity alterations shed light on the mechanisms of MS-related fatigue.

BACKGROUND Primary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain. OBJECTIVE This study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access to the full-featured study app and will be compared with 2 control groups who have access to fewer app features. Here, we report the trial design, app development, user access, and engagement. METHODS On the basis of the practical implications of the previous app-based study, we revised and reengineered the study app and included the ResearchKit (Apple Inc) framework. Behavior change techniques (BCTs) were implemented in the app and validated by expert ratings. User access was estimated by assessing recruitment progress over time. User evolution and baseline survey respondent rate were assessed to evaluate user engagement. RESULTS The development of the study app for a 3-armed randomized controlled trial required a multidisciplinary team. The app is accessible for the target population free of charge via the Apple App Store. In Germany, within 9 months, the app was downloaded 1458 times and 328 study participants were recruited using it without external advertising. A total of 98.27% (5157/5248) of the app-based baseline questions were answered. The correct classification of BCTs used in the app required psychological expertise. CONCLUSIONS Conducting an innovative app study requires multidisciplinary effort. Easy access and engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of user engagement, optimal BCT application, and potential clinical and self-care scenarios for app use. CLINICALTRIAL ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ).

Background Primary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain. Objective This study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access to the full-featured study app and will be compared with 2 control groups who have access to fewer app features. Here, we report the trial design, app development, user access, and engagement. Methods On the basis of the practical implications of the previous app-based study, we revised and reengineered the study app and included the ResearchKit (Apple Inc) framework. Behavior change techniques (BCTs) were implemented in the app and validated by expert ratings. User access was estimated by assessing recruitment progress over time. User evolution and baseline survey respondent rate were assessed to evaluate user engagement. Results The development of the study app for a 3-armed randomized controlled trial required a multidisciplinary team. The app is accessible for the target population free of charge via the Apple App Store. In Germany, within 9 months, the app was downloaded 1458 times and 328 study participants were recruited using it without external advertising. A total of 98.27% (5157/5248) of the app-based baseline questions were answered. The correct classification of BCTs used in the app required psychological expertise. Conclusions Conducting an innovative app study requires multidisciplinary effort. Easy access and engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of user engagement, optimal BCT application, and potential clinical and self-care scenarios for app use. Trial Registration ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ).

To evaluate whether tuina is more effective and cost-effective in reducing pain compared to no intervention in patients with chronic neck pain.Single-center randomized two-armed controlled trial.University outpatient clinic specialized in Integrative Medicine.Outpatients with chronic neck pain were randomly allocated to tuina or no intervention.Six tuina treatments within 3 weeks.The primary outcome was the mean neck pain intensity during the previous 7 days on a visual analogue scale after 4 weeks (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain). Secondary outcomes included Neck Pain and Disability Scale (NPDS), Neck Disability Index (NDI), health-related quality of life (12-item quality-of-life questionnaire [SF-12]), medication intake, and cost-effectiveness after 4 and 12 weeks. Statistical analysis included analysis of covariance adjusted for baseline values and a full economic analysis from a societal perspective.Altogether, 92 outpatients were included (46 in both groups, 87% female, mean age 45.4 [standard deviation ±9.7], and mean VAS 57.7 ± 11.5). Tuina treatment led to a clinically meaningful reduction in neck pain intensity (group differences, 4 weeks: -22.8 mm [95% confidence interval, -31.7 to -13.8]; p 0.001 and 12 weeks: -17.9 mm [-27.1 to -8.8], p 0.001). No serious adverse events were observed. Total costs as well as quality-adjusted life years (QALYs) did not differ significantly between the groups. When taking group differences into account independently from their statistical significance, costs per QALY gained (incremental cost-effectiveness ratio) would range within a cost-effective area from €7,566 (for costs €10.28 per session) to €39,414 (cost €35 per session).An additional treatment with six tuina sessions over 3 weeks was effective, safe and relatively cost-effective for patients with chronic neck pain. A future trial should compare tuina to other best care options.

Background: Primary dysmenorrhea is common among women of reproductive age. Nonsteroidal anti-inflammatory drugs and oral contraceptives are effective treatments, although the failure rate is around 20% to 25%. Therefore additional evidence-based treatments are needed. In recent years, the use of smartphone applications (apps) has increased rapidly and may support individuals in self-management strategies. Objective: We aimed to investigate the effectiveness of app-based self-acupressure in women with menstrual pain. Materials and Methods: A 2-armed, randomized, pragmatic trial was conducted from December 2012 to April 2015 with recruitment until August 2014 in Berlin, Germany, among women aged 18 to 34 years with self-reported cramping pain of 6 or more on a numeric rating scale (NRS) for the worst pain intensity during the previous menstruation. After randomization, women performed either app- based self-acupressure (n = 111) or followed usual care only (n = 110) for 6 consecutive menstruation cycles. The primary outcome was the mean pain intensity (NRS 0−10) on the days with pain during the third menstruation. Secondary outcomes included worst pain intensity during menstruation, duration of pain, 50% responder rates (reduction of mean pain by at least 50%), medication intake, sick leave days, and body efficacy expectation assessed at the first, second, third, and sixth menstruation cycles. Results: We included 221 women (mean age, 24.0 years; standard deviation [SD], 3.6 years). The mean pain intensity difference during the third menstruation was statistically significant in favor of acupressure (acupressure: 4.4; 95% confidence interval [CI], 4.0−4.7; usual care 5.0; 95% CI, 4.6−5.3; mean difference −0.6; 95% CI, − 1.2 to −0.1; P = .026). At the sixth cycle, the mean difference between the groups (−1.4; 95% CI, −2.0 to −0.8; P < .001) reached clinical relevance. At the third and sixth menstruation cycles, responder rates were 37% and 58%, respectively, in the acupressure group, in contrast to 23% and 24% in the usual care group. Moreover, the worst pain intensity (group difference −0.6; 95% CI, −1.2 to −0.02; and −1.4; 95% CI, −2.0 to −0.7), the number of days with pain (−0.4; 95% CI, −0.9 to −0.01; and −1.2; 95% CI, −1.6 to −0.7) and the proportion of women with pain medication at the third and sixth menstruation cycles (odds ratio [OR], 0.5; 95% CI, 0.3−0.9] and 0.3 (95% CI, 0.2−0.5) were lower in the acupressure group. At the third cycle, hormonal contraceptive use was more common in the usual care group than in the acupressure group (OR, 0.5; 95% CI, 0.3−0.97) but not statistically significantly different at the sixth cycle (OR, 0.6; 95% CI, 0.3−1.1]). The number of sick leave days and body efficacy expectation (self-efficacy scale) did not differ between groups. On a scale of 0 to 6, mean satisfaction with the intervention at the third cycle was 3.7 (SD 1.3), recommendation of the intervention to others 4.3 (1.5), appropriateness of acupressure for menstrual pain 3.9 (1.4), and application of acupressure for other pain 4.3 (1.5). The intervention was safe, and after the sixth cycle, two-thirds of the women (67.6%) still applied acupressure on all days with pain. Conclusion: Smartphone app−delivered self-acupressure resulted in a reduction of menstrual pain compared to usual care only. Effects were increasing over time, and adherence was good. Future trials should include comparisons with other active treatment options.

Background The value of qigong in the treatment of chronic low back pain is unclear. In a randomized controlled trial, we evaluated whether qigong is non-inferior to exercise therapy in patients with chronic low back pain. Methods German outpatients (aged 46.7 ± 10.4) with chronic low back pain [mean visual analogue scale (VAS), 53.9 ± 12.5 mm] were enrolled and randomly allocated in a 1:1 ratio to receive either qigong (64 patients, 12 sessions with 1 × 90 min/week over 3 months) or exercise therapy (63 patients, 12 sessions 1 × 60 min/week). The primary outcome measure was the average pain intensity over the last 7 days on a VAS (0–100 mm, 0 = no pain, 100 = worst imaginable pain, non-inferiority margin = 5 mm) after 3 months. Follow-up was measured after 6 and 12 months. Results The mean adjusted low back pain intensity after 3 months was 34.8 mm [95% confidence interval (CI) 29.5; 40.2] in the qigong group and 33.1 mm (95% CI 27.7; 38.4) in the exercise group. Non-inferiority of the qigong group compared with the exercise group failed to show statistical significance (p = 0.204). In both groups, 10 patients reported suspected adverse reactions (e.g., muscle soreness, dizziness, pain) the total number was comparable in both groups (qigong n = 40, exercise n = 44). Conclusions Qigong was not proven to be non-inferior to exercise therapy in the treatment of chronic low back pain. Its role in the prevention of chronic low back pain might be addressed in further studies.

The existence of point specificity in acupuncture is still controversial (Choi et al., 2012). Therefore, a thoughtful choice of control points is very important when evaluating point specific effects in acupuncture research.

Background To investigate the effects of stimulated and non-stimulated manual acupuncture at ST36 and PC6 on gastric myoelectrical activity and autonomic function. Methods A total of 65 healthy volunteers were randomly assigned to a 1: 1: 2 ratio to receive either 15 min of verum acupuncture (VA) with stimulation followed by 15 min of VA without stimulation (nsVA), or 15 min of nsVA followed by 15 min of VA with stimulation (sVA), or 30 min of sham acupuncture (SA). Measures of autonomic function included electrogastrogram, electrocardiogram, impedance cardiography and assessment of blood pressure, breathing frequency, and electrodermal activity. Outcome parameters were compared between VA and SA, and between sVA and nsVA. The percentage of regular gastric slow waves (normogastria) was defined as the primary outcome. Key Results The percentage of normogastria was not significantly different between VA and SA. Differences in secondary outcomes such as power spectrum of gastric slow waves and heart rate variability parameters were pronounced in the comparison of sVA and nsVA. During sVA, the percentage of normogastria was lower (P = 0.005), the percentage of bradygastria was higher (P = 0.003) and power ratio was higher (P

The aim was to investigate the frequency of adverse effects due to acupuncture treatment, the need for treatment and the costs in patients with chronic low back or neck pain. This prospective observational study included patients who received acupuncture for chronic low back pain or chronic neck pain. After treatment all patients documented adverse events associated with acupuncture (defined as adverse effects) and provided details e.g. on treatment. Cost data was provided by the health insurance companies. We used a societal perspective including direct health care costs related to the acupuncture and the indirect costs caused through lost workdays. From 73,406 patients, 5440 patients (7.4% [95% CI 7.2%; 7.6%] reported experiencing at least one adverse effect and 1422 patients (1.9% [1.8%; 2.0%]) required treatment. The subsequent treatments reported were either self-treatment (1.2% [1.09%; 1.25%]), treatment with medication and/or by a physician (0.6% [0.57%; 0.68%]), or treatment in a hospital (0.03% [0.02%; 0.04%]). Patients reporting adverse effects that required treatment had higher costs compared to patients without adverse effects (at 3 months €1265 [1179; 1351] vs. €1140 [1128; 1153] and at 12 months € 3534 [3256; 3812] vs. € 3249 [3209; 3289]. The difference was caused through the expense of visiting physicians and higher indirect costs (difference at 3 months: €125 [38; 211], p = 0.005 and at 12 months: €285 [4; 566], p = 0.047). Adverse effects from acupuncture occur in about 7% of patients and were mainly treated by themselves. When these effects needed treatment by a health professional additional expenses were the consequence.

To create a German version of the Southampton Needle Sensation Questionnaire (SNSQ) in order to measure deqi (needling sensation) in subjects receiving different forms of acupuncture and to evaluate the translated questionnaire in an acupuncture study.A forward and backward translation procedure was applied to create a German version of the SNSQ. Discrepancies between translations were resolved by consensus. Healthy participants from an experimental acupuncture trial were asked to fill in the resulting questionnaire comprising of 17 items (none (0) to intense (3)) and a visual analogue scale (VAS) for pain (0-100 mm) after receiving either sham or real acupuncture with or without stimulation. The questionnaire was validated using factor analysis and correlation analysis.Questionnaires from 63 subjects (mean 27.1 years; 69.8% female) were included in the analysis. Participants tended to score toward the low end of each of the 17 items (mean sum score (± SD): 8.9 ± 7.0). Four factors with eigenvalues1 were identified using exploratory factor analysis. Both of the original subscales, aching deqi (AD) and tingling deqi (TD), showed good internal consistency (Cronbach's α: AD: 0.71; TD: 0.78) and medium test-retest reliability (AD: r = 0.538, p = 0.002; TD: r = 0.603, p0.001). AD feeling (r = 0.574, p0.001) and TD feeling (r = 0.496, p0.001) correlated with the VAS for pain.Factor structure of the original questionnaire could not be reproduced with the German version of the SNSQ in an experimental setting. The questionnaire could not discriminate between pain and deqi. Further research is needed to create a German tool which is more suitable to measure deqi.

Objective: To compare the efficacy of applying hot dry air versus dry air at room temperature to the throat of patients with a newly acquired common cold using a symptom severity score. Design, setting and participants: A randomised single-blind controlled trial with a treatment duration of 3 days and a follow-up period of 4 days was conducted at a sauna in Berlin, Germany. Between November 2007 and March 2008 and between September 2008 and April 2009, 157 patients with symptoms of the common cold were randomly assigned to an intervention group (n = 80) and a control group (n =7 7). Interventions: Participants in the intervention group inhaled hot dry air within a hot sauna, dressed in a winter coat, whereas participants in the control group inhaled dry air at room temperature within a hot sauna, also dressed in a winter coat. Main outcome measures: Area under the curve (AUC) summarising symptom severity over time (Days 2, 3, 5 and 7), symptom severity scores for individual days, intake of medication for the common cold and general ill feeling. Results: No significant difference between groups was observed for AUC representing symptom severity over time (intervention group mean, 31.2 [SEM, 1.8]; control group mean, 35.1 [SEM, 2.3]; group difference, − 3.9 [95% CI, − 9.7 to 1.9]; P = 0.19). However, significant differences between groups were found for medication use on Day 1 (P = 0.01), symptom severity score on Day 2 (P = 0.04), and participants’ ratings of the effectiveness of the therapy on Day 7 (P =0 .03). Conclusion: Inhaling hot air while in a sauna has no significant impact on overall symptom severity of the common cold. Trial registration