BACKGROUND: Nasal congestion is one of the most common complaints dealt with in otorhinolaryngology. Side effects of decongestants are frequently seen in patients with chronic nasal congestion. This leads to an increasing demand of alternative treatments such as acupuncture. Future studies on acupuncture should aim at objectifying effects by both physical measuring and double blinding. Therefore, we were interested in whether these effects can potentially be measured as increase in nasal airflow (NAF) in ventus ("wind") disease of traditional Chinese medicine (TCM). METHODS: Twenty-four patients with a history of nasal congestion due to hypertrophic inferior turbinates or chronic sinusitis without polyposis were additionally diagnosed according to the Heidelberg model of TCM. They were asked to score the severity of their nasal congestion on a visual analog scale (VAS). The acupuncturist was blinded according to the Heidelberg blinding assay. NAF was measured by using active anterior rhinomanometry (ARM). Specific verum acupoints according to the Chinese medical diagnosis were tested against nonspecific control acupoints. VAS and NAF were scored and measured before and 15 and 30 minutes after acupuncture. RESULTS: Control acupuncture showed a significant improvement in VAS and a deterioration of NAF. Verum acupuncture showed highly significant improvements in VAS and NAF. In addition, verum acupuncture improved NAF and VAS significantly over time. CONCLUSION: Our control and verum acupoints fulfill the condition of a control and verum treatment, respectively. Measuring NAF by RRM and scoring VAS are possible and reflect acupuncture effects in vivo.

BACKGROUND: Nasal congestion is one of the most common complaints dealt with in otorhinolaryngology. Side effects of decongestants are frequently seen in patients with chronic nasal congestion. This leads to an increasing demand of alternative treatments such as acupuncture. Future studies on acupuncture should aim at objectifying effects by both physical measuring and double blinding. Therefore, we were interested in whether these effects can potentially be measured as increase in nasal airflow (NAF) in ventus ("wind") disease of traditional Chinese medicine (TCM). METHODS: Twenty-four patients with a history of nasal congestion due to hypertrophic inferior turbinates or chronic sinusitis without polyposis were additionally diagnosed according to the Heidelberg model of TCM. They were asked to score the severity of their nasal congestion on a visual analog scale (VAS). The acupuncturist was blinded according to the Heidelberg blinding assay. NAF was measured by using active anterior rhinomanometry (ARM). Specific verum acupoints according to the Chinese medical diagnosis were tested against nonspecific control acupoints. VAS and NAF were scored and measured before and 15 and 30 minutes after acupuncture. RESULTS: Control acupuncture showed a significant improvement in VAS and a deterioration of NAF. Verum acupuncture showed highly significant improvements in VAS and NAF. In addition, verum acupuncture improved NAF and VAS significantly over time. CONCLUSION: Our control and verum acupoints fulfill the condition of a control and verum treatment, respectively. Measuring NAF by RRM and scoring VAS are possible and reflect acupuncture effects in vivo.

BACKGROUND:There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the treatment of acute maxillary sinusitis (AMS).

OBJECTIVE:The objective of this clinical trial was to demonstrate the efficacy of a complex homeopathic medication (Sinfrontal) compared with placebo in patients with AMS confirmed by sinus radiography.

DESIGN:A prospective, randomized, double-blind, placebo-controlled, phase III clinical trial was conducted for a treatment period of 22 days, followed by an eight-week posttreatment observational phase.

SETTING:The clinical trial was conducted at six trial sites in the Ukraine.

PARTICIPANTS:One hundred thirteen patients with radiography-confirmed AMS participated in the trial.

INTERVENTIONS:Fifty-seven patients received Sinfrontal and 56 patients received placebo. Additionally, patients were allowed saline inhalations, paracetamol, and over-the-counter medications, but treatment with antibiotics or other treatment for sinusitis was not permitted.

MAIN OUTCOME MEASURES:Primary outcome criterion was change of the sinusitis severity score (SSS) from day zero to day seven. Other efficacy assessments included radiographic and clinical cure, improvement in health state, ability to work or to follow usual activities, and treatment outcome.

RESULTS:From day zero to day seven, Sinfrontal caused a significant reduction in the SSS total score compared with placebo (5.8 +/- 2.3 [6.0] points vs 2.3 +/- 1.8 [2.0] points; P<.0001). On day 21, 39 (68.4%) patients on active medication had a complete remission of AMS symptoms compared with five (8.9%) placebo patients. All secondary outcome criteria displayed similar trends. Eight adverse events were reported that were assessed as being mild or moderate in intensity. No recurrence of AMS symptoms occurred by the end of the eight-week posttreatment observational phase.

CONCLUSION:This complex homeopathic medication is safe and appears to be an effective treatment for acute maxillary sinusitis.

OBJECTIVES: To test whether daily hypertonic saline nasal irrigation improves sinus symptoms and quality of life and decreases medication use in adult subjects with a history of sinusitis. STUDY DESIGN: Randomized controlled trial. Experimental subjects used nasal irrigation daily for 6 months. POPULATION: Seventy-six subjects from primary care (n=70) and otolaryngology (n=6) clinics with histories of frequent sinusitis were randomized to experimental (n=52) and control (n=24) groups. OUTCOMES MEASURED: Primary outcome measures included the Medical Outcomes Survey Short Form (SF-12), the Rhinosinusitis Disability Index (RSDI), and a Single-Item Sinus-Symptom Severity Assessment (SIA); all 3 were completed at baseline, 1.5, 3, and 6 months. Secondary outcomes included daily assessment of compliance and biweekly assessment of symptoms and medication use. At 6 months, subjects reported on side effects, satisfaction with nasal irrigation, and the percentage of change in their sinus-related quality of life. RESULTS: No significant baseline differences existed between the 2 groups. Sixty-nine subjects (90.8%) completed the study. Compliance averaged 87%. Experimental group RSDI scores improved from 58.4 -/+ 2.0 to 72.8 -/+ 2.2 (P

ABSTRACT: BACKGROUND: Acupuncture is commonly used to treat chronic sinusitis, though there is little documentation on the effect. This study presents the health-related quality of life (HRQoL) outcomes in a trial comparing traditional Chinese acupuncture, sham acupuncture, and conventional treatment for chronic sinusitis. FINDINGS: In a three-armed single blind randomized controlled study, we recruited 65 patients with symptoms of sinusitis >3 months and signs of sinusitis on computed tomography (CT). Patients were randomized to one of three study arms: (1) 2-4 weeks of medication with antibiotics, corticosteroids, 0.9% sodium chloride solution, and local decongestants (n = 21), (2) ten treatments with traditional Chinese acupuncture (n = 25), or (3) ten treatments with minimal acupuncture at non-acupoints (n = 19). Change in HRQoL was assessed over 12 weeks using the Chronic Sinusitis Survey (CSS) and Short form 36 (SF-36) questionnaires.In the study, we found only a non-significant difference on the CSS symptom scale between conventional medical therapy and traditional Chinese acupuncture. On the SF-36 scale role-physical the change was larger in the conventional group than in the sham group (p = 0.02), and on the mental health scale the change in the conventional therapy arm was larger than in the traditional Chinese acupuncture group (p = 0.03). There was no difference in effect on HRQoL on any scale between the sham and traditional Chinese acupuncture groups. CONCLUSION: There was no clear evidence of the superiority of one treatment over another on short-term HRQoL outcomes, although there was a statistically non-significant advantage of conventional therapy in a few dimensions.

ABSTRACT: BACKGROUND: Acupuncture is commonly used to treat chronic sinusitis, though there is little documentation on the effect. This study presents the health-related quality of life (HRQoL) outcomes in a trial comparing traditional Chinese acupuncture, sham acupuncture, and conventional treatment for chronic sinusitis. FINDINGS: In a three-armed single blind randomized controlled study, we recruited 65 patients with symptoms of sinusitis >3 months and signs of sinusitis on computed tomography (CT). Patients were randomized to one of three study arms: (1) 2-4 weeks of medication with antibiotics, corticosteroids, 0.9% sodium chloride solution, and local decongestants (n = 21), (2) ten treatments with traditional Chinese acupuncture (n = 25), or (3) ten treatments with minimal acupuncture at non-acupoints (n = 19). Change in HRQoL was assessed over 12 weeks using the Chronic Sinusitis Survey (CSS) and Short form 36 (SF-36) questionnaires.In the study, we found only a non-significant difference on the CSS symptom scale between conventional medical therapy and traditional Chinese acupuncture. On the SF-36 scale role-physical the change was larger in the conventional group than in the sham group (p = 0.02), and on the mental health scale the change in the conventional therapy arm was larger than in the traditional Chinese acupuncture group (p = 0.03). There was no difference in effect on HRQoL on any scale between the sham and traditional Chinese acupuncture groups. CONCLUSION: There was no clear evidence of the superiority of one treatment over another on short-term HRQoL outcomes, although there was a statistically non-significant advantage of conventional therapy in a few dimensions.

ABSTRACT: BACKGROUND: An evaluation of homeopathic treatment and the outcomes in patients suffering from sinusitis for >/=12 weeks in a usual care situation. METHODS: Subgroup analysis including all patients with chronic sinusitis (ICD-9: 473.9; >/=12 weeks duration) of a large prospective multicentre observational study population. Consecutive patients presenting for homeopathic treatment were followed-up for 2 years, and complaint severity, health-related quality of life (QoL), and medication use were regularly recorded. We also present here patient-reported health status 8 years post initial treatment. RESULTS: The study included 134 adults (mean age 39.8 +/- 10.4 years, 76.1% women), treated by 62 physicians. Patients had suffered from chronic sinusitis for 10.7 +/- 9.8 years. Almost all patients (97.0%) had previously been treated with conventional medicine. For sinusitis, effect size (effect divided by standard deviation at baseline) of complaint severity was 1.58 (95% CI 1.77; 1.40), 2.15 (2.38; 1.92), and 2.43 (2.68; 2.18) at 3, 12, and 24 months respectively. QoL improved accordingly, with SF-36 changes in physical component score 0.27 (0.15; 0.39), 0.35 (0.19; 0.52), 0.44 (0.23; 0.65) and mental component score 0.66 (0.49; 0.84), 0.71 (0.50; 0.92), 0.65 (0.39; 0.92), 0.74 (0.49; 1.00) at these points. The effects were still present after 8 years with SF-36 physical component score 0.38 (0.10; 0.65) and mental component score 0.74 (0.49; 1.00). CONCLUSION: This observational study showed relevant improvements that persisted for 8 years in patients seeking homeopathic treatment because of sinusitis. The extent to which the observed effects are due to the life-style regulation and placebo or context effects associated with the treatment needs clarification in future explanatory studies.

OBJECTIVE: To determine if isotonic sodium chloride (hereinafter "saline") nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays at improving quality of life and decreasing medication use. DESIGN: A prospective, randomized controlled trial. SETTING: Community. PARTICIPANTS: A total of 127 adults with chronic nasal and sinus symptoms. INTERVENTIONS: Patients were randomly assigned to irrigation performed with large volume and delivered with low positive pressure (n = 64) or spray (n = 63) for 8 weeks. MAIN OUTCOME MEASURES: Change in symptom severity measured by mean 20-Item Sino-Nasal Outcome Test (SNOT-20) score; change in symptom frequency measured with a global question; and change in medication use. RESULTS: A total of 121 patients were evaluable. The irrigation group achieved lower SNOT-20 scores than the spray group at all 3 time points: 4.4 points lower at 2 weeks (P = .02); 8.2 points lower at 4 weeks (P < .001); and 6.4 points lower at 8 weeks (P = .002). When symptom frequency was analyzed, 40% of subjects in the irrigation group reported symptoms "often or always" at 8 weeks compared with 61% in the spray group (absolute risk reduction, 0.2; 95% confidence interval, 0.02-0.38 (P = .01). No significant differences in sinus medication use were seen between groups. CONCLUSION: Nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays for treatment of chronic nasal and sinus symptoms in a community-based population.

Rhinosinusitis is an inflammation or infection of the nose and air pockets (sinuses) above, below and between the eyes which connect with the back of the nose through tiny openings (ostia). Rhinosinusitis can be caused by bacteria, viruses, fungi (molds) and possibly by allergies. Chronic rhinosinusitis (CRS) is an immune disorder caused by fungi. The immune response produced by eosinophils causes the fungi to be attacked, which leads to damage of the sinus membranes, resulting in full-blown rhinosinusitis symptoms. Gaseous nitric oxide (NO) is naturally released in the human respiratory tract. The major part of NO found in exhaled air originates in the nasal airways, although significant production of NO also takes place in the paranasal sinuses. Proper ventilation is essential for maintenance of sinus integrity, and blockage of the ostium is a central event in pathogenesis of sinusitis. Concentrations of NO in the healthy sinuses are high. Nasal NO is known to be increased 15- to 20-fold by humming compared with quiet exhalation. NO is known to be broadly antifungal, antiviral and antibacterial. This case report shows that a subject hummed strongly at a low pitch ( approximately 130 Hz) for 1h (18 hums per minute) at bedtime the first night, and hummed 60-120 times 4 times a day for the following 4 days as treatment for severe CRS. The humming technique was described as being one that maximally increased intranasal vibrations, but less than that required to produce dizziness. The morning after the first 1-h humming session, the subject awoke with a clear nose and found himself breathing easily through his nose for the first time in over 1 month. During the following 4 days, CRS symptoms slightly reoccurred, but with much less intensity each day. By humming 60-120 times four times per day (with a session at bedtime), CRS symptoms were essentially eliminated in 4 days. Coincidentally, the subject's cardiac arrhythmias (PACs) were greatly lessened. It is hypothesized that strong, prolonged humming increased endogenous nasal NO production, thus eliminating CRS by antifungal means.

OBJECTIVE: To assess quality of life (QOL) in patients with sinonasal symptoms in response to hypertonic saline nasal irrigation (HSNI), and to assess HSNI use patterns. STUDY DESIGN AND SETTING: The study was an uncontrolled 12-month follow-up to a randomized controlled trial (RCT) and used HSNI in a community setting. We included 54 participants with recurrent or chronic sinonasal symptoms. Forty participants had been in the intervention group of a previous study; 14 had been control participants. Primary outcome measures were the Rhinosinusitis Disability Index (RSDI), a sinus-symptom severity assessment (SIA), and the Sino-Nasal Outcomes Test (SNOT-20). Secondary outcome measures were frequency and pattern of HSNI use, side effects and satisfaction. RESULTS: Among participants using HSNI in the prior RCT, RSDI scores continued to improve, from 73.2 +/- 2.6 points to 80.6 +/- 2.4 points (P<0.001). SIA and SNOT-20 scores remained stable. Former control participants reported QOL improvement similar to that of HSNI users in the prior RCT. RSDI scores improved from 62.0 +/- 3.9 points to 79.7 +/- 3.7 points (P<0.05), SNOT-20 scores improved from 43.5 +/- 5.7 points to 28.4 +/- 4.8 points, and SIA scores improved from 4.2 +/- 0.3 points to 2.6 +/- 0.3 points (P<0.01). Mean HSNI use for all participants was 2.4 irrigations per week; 33% of participants used HSNI regularly, 55% when symptomatic. Side effects were minor; satisfaction was high. CONCLUSIONS: Participants with chronic sinonasal symptoms reported improved QOL and frequent, satisfying use of HSNI. SIGNIFICANCE: HSNI is an effective adjunctive treatment of chronic sinonasal symptoms.

The therapeutic efficiency and safety of the proteolytic enzyme bromelaine obtained from pineapple (Bromelain-POS, Ursapharm GmbH, Saarbrücken, Germany) was evaluated in children under the age of 11 years diagnosed with acute sinusitis. Data from 116 patients from 19 centres located across Germany were analysed in a pharmacoepidemiological cohort study. Patient cohorts were either treated with Bromelain-POS (N = 62), in combination with Bromelain-POS and standard therapies (N = 34), or with standard therapies (N = 20). The primary parameter measuring effectiveness of the different treatment groups was the duration of symptoms. The shortest mean period of symptoms was observed in patients treated with Bromelain-POS alone (6.66 days), followed by the standard therapy (7.95 days) and those treated with a combination of Bromelain-POS and the standard therapy (9.06 days). Patients of the Bromelain-POS monotherapy group showed a statistically significant faster recovery from symptoms (p = 0.005) compared to the other treatment groups. One 10-year-old male patient, with a known pineapple allergy, showed a self-limiting mild allergic reaction. No other unwanted side-effects were reported. This trial documents that the proteolytic pineapple enzyme Bromelain-POS is widely used in the treatment of young children diagnosed with acute sinusitis in Germany and that the use of proteolytic enzymes can benefit such patients.