Ear acupressure for perennial allergic rhinitis: A multicenter randomized controlled trial.

BACKGROUND: Perennial allergic rhinitis (PAR) has a high and increasing prevalence worldwide. Ear acupressure (EAP) is a noninvasive semi-self-administered form of acupuncture. Previous studies indicated that EAP could be effective and safe for AR symptom management. However, there was insufficient evidence to confirm this. This study investigated whether EAP, a noninvasive clinical alternative to acupuncture, is effective and safe for PAR. METHODS: This is an international, multicenter, randomized, single-blind, sham-controlled trial. The trial was conducted at two centers: Royal Melbourne Institute of Technology University (Melbourne, Australia) Clinical Trial Clinic and Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. PAR participants were randomized to receive real or sham EAP treatment once a week for 8 weeks and then were followed-up for 12 weeks. Participants were instructed to administer EAP stimulation three times daily. Symptom severity and quality of life (QoL) were evaluated. Adverse events (AEs) were also monitored. Intention-to-treat analysis on change of symptom scores and QoL was applied. RESULTS: Two hundred forty-five participants were randomly assigned to real (n = 124) and sham EAP (n = 121) groups. Twenty-five participants discontinued during treatment and 15 participants dropped out during follow-up. At the end of treatment and follow-up periods, changes of global QoL score were significantly greater in the real EAP group compared with the sham group. At the end of follow-up, scores for total nasal symptom, runny nose, and eye symptoms in the real EAP group had a greater reduction compared with the sham group. Overall, both real and sham EAP were well tolerated. Two severe AEs were reported but were not considered related to the EAP procedures. CONCLUSION: In conclusion, EAP showed short-term and extended benefit for improving PAR symptoms and QoL for PAR patients.

Psychiatric morbidity in chronic respiratory disorders in an Indian service using GMHAT/PC.

OBJECTIVE: The study aimed to assess psychiatric morbidity in stable chronic respiratory disorders and to examine the pattern of psychiatric illness in specific respiratory disorders in Northern India. METHODS: All consecutive patients with stable chronic respiratory illnesses who attended the respiratory disease clinic were recruited in the study. Their healthy attendants were interviewed as a control group. The research clinician, trained in the use of the Global Mental Health Assessment Tool, Primary Care Version (GMHAT/PC), interviewed all the participants. The respiratory consultant made the respiratory illness diagnosis. The data were analyzed comparing the patient and the control group by using relative risk and adjusted odds ratios. RESULTS: Of 391 patients with respiratory illness, 44.8% had a mental illness identified by GMHAT/PC interview compared with 24.3% of 177 attendants (controls). Anxiety (20.6%), depression (13.2%) and obsessive compulsive disorders (4.6%) were the most frequently identified mental disorders in the respiratory disease group. Chronic obstructive pulmonary disease and bronchial asthma when combined with rhinitis had a significantly higher prevalence of comorbid mental illness than those illnesses alone. CONCLUSION: Patients with chronic respiratory illness have high mental health comorbidity. Physicians and practitioners can be trained to identify mental illness using computer-assisted tools such as GMHAT/PC (which is easy to use by clinicians and well accepted by patients). A holistic approach of providing care to such patients may improve their overall outcome and quality of life.

Functional relaxation and guided imagery as complementary therapy in asthma: a randomized controlled clinical trial.

BACKGROUND: Asthma is a frequently disabling and almost invariably distressing disease that has a high overall prevalence. Although relaxation techniques and hypnotherapeutic interventions have proven their effectiveness in numerous trials, relaxation therapies are still not recommended in treatment guidelines due to a lack of methodological quality in many of the trials. Therefore, this study aims to investigate the efficacy of the brief relaxation technique of functional relaxation (FR) and guided imagery (GI) in adult asthmatics in a randomized controlled trial. METHODS: 64 patients with extrinsic bronchial asthma were treated over a 4-week period and assessed at baseline, after treatment and after 4 months, for follow-up. 16 patients completed FR, 14 GI, 15 both FR and GI (FR/GI) and 13 received a placebo relaxation technique as the control intervention (CI). The forced expiratory volume in the first second (FEV(1)) as well as the specific airway resistance (sR(aw)) were employed as primary outcome measures. RESULTS: Participation in FR, GI and FR/GI led to increases in FEV(1) (% predicted) of 7.6 +/- 13.2, 3.3 +/- 9.8, and 8.3 +/- 21.0, respectively, as compared to -1.8 +/- 11.1 in the CI group at the end of the therapy. After follow-up, the increases in FEV(1) were 6.9 +/- 10.3 in the FR group, 4.4 +/- 7.3 in the GI and 4.5 +/- 8.1 in the FR/GI, compared to -2.8 +/- 9.2 in the CI. Improvements in sR(aw) (% predicted) were in keeping with the changes in FEV(1) in all groups. CONCLUSIONS: Our study confirms a positive effect of FR on respiratory parameters and suggests a clinically relevant long-term benefit from FR as a nonpharmacological and complementary therapy treatment option.

Cost-effectiveness of acupuncture in women and men with allergic rhinitis: a randomized controlled study in usual care.

To assess quality of life and cost-effectiveness of additional acupuncture treatment for allergic rhinitis, patients were randomly allocated to 2 groups; both received usual care, but one group received an additional 10 acupuncture sessions. Quality of life (according to the SF-36 Health Survey), and direct and indirect costs, were assessed at baseline and after 3 months, and the incremental cost-effectiveness ratio of acupuncture treatment was calculated. This German study (December 2000-June 2004) involved 981 patients (64% women, mean age 40.9 years (standard deviation, 11.2); 36% men, mean age 43.2 years (standard deviation, 13.0)). At 3 months, quality of life was higher in the acupuncture group than in the control group (mean Physical Component Score 51.99 (standard error (SE), 0.33) vs. 48.25 (SE, 0.33), P < 0.001; mean Mental Component Score 48.55 (SE, 0.42) vs. 45.35 (SE, 0.42), respectively, P < 0.001). Overall costs in the acupuncture group were significantly higher than those in the control group (Euro (euro; 1 euro = US $1.27) 763, 95% confidence interval: 683, 844 vs. 332 euro, 95% confidence interval: 252, 412; mean difference 432 euro, 95% confidence interval: 318, 545). The incremental cost-effectiveness ratio was 17,377 euro per quality-adjusted life year (women, 10,155 euro; men, 44,871 euro) and was robust in sensitivity analyses. Acupuncture, supplementary to routine care, was beneficial and, according to international benchmarks, cost-effective. However, because of the study design, it remains unclear whether the effects are acupuncture specific.

Behavioral conditioning of antihistamine effects in patients with allergic rhinitis.

BACKGROUND: Allergic symptoms can be induced by behavioral conditioning. However, the conditionability of antiallergic effects has not yet been studied. Thus, we investigated whether the effects of a histamine 1 (H(1)) receptor antagonist are inducible in patients suffering from house-dust mite allergy using a behavioral conditioning procedure. METHODS: During the association phase, 30 patients with allergic house-dust mite rhinitis received a novel-tasting drink once daily, followed by a standard dose of the H(1) receptor antagonist, desloratadine, on 5 consecutive days. After 9 days of drug washout, the evocation trial commenced: 10 patients received water together with an identically looking placebo pill (water group), 11 patients were re-exposed to the novel-tasting drink and received a placebo pill [conditioned stimulus (CS); CS group] and 9 patients received water and desloratadine (drug group). RESULTS: During the association phase, desloratadine treatment decreased the subjective total symptom scores, attenuated the effects of the skin prick test for histamine and reduced basophil activation ex vivo in all groups. During the evocation trial, the water group, in which subjects were not re-exposed to the gustatory stimulus, showed a reduction in subjective total symptom scores and skin prick test results, but no inhibition of basophil activation. In contrast, re-exposure to the novel-tasting drink decreased basophil activation, the skin prick test result and the subjective symptom score in the CS group to a degree that was similar to the effects of desloratadine in the drug group. CONCLUSIONS: These data show that behaviorally conditioned effects are not only able to relieve subjective rhinitis symptoms and allergic skin reactions, but also to induce changes in effector immune functions.

Concerns of patients with allergic rhinitis: the Allergic Rhinitis Care Programme in South Africa.

BACKGROUND: The major reason for treating chronic rhinitis is to improve quality of life. Although primary symptoms cause morbidity in their own right, these symptoms are significantly aggravated by the impact of cognitive dysfunction and quality of life. OBJECTIVE: The Allergic Rhinitis Care Programme was initiated by the South African Allergic Rhinitis Working Group. An important task of this programme was to document health-related quality of life impairment amongst allergic rhinitis patients in South Africa. METHODS: A questionnaire, appropriate to South Africa, was distributed to patients. The questionnaire inquired about symptoms, quality of life, complications, trigger factors, associated allergic conditions, medication preference, medication adherence and concerns about the condition. RESULTS: 1181 people completed the questionnaire and returned the survey. Nasal congestion was identified as a common and frequent problem, while seasonality of symptoms was uncommon. Symptoms affected sleep in 76.6% of sufferers, and in at least a third this was every night. Over 1000 respondents felt miserable due to allergic rhinitis (85.2%). 63.1% indicated that they always followed instructions for taking rhinitis medication. A variety of perceived concerns around having and being treated for allergic rhinitis were identified, suggesting multiple reasons for non-adherence. CONCLUSIONS: We report symptom frequency and quality of life impairment for respondents who identify themselves as having allergic rhinitis. Since allergic rhinitis is, in the main, a doctor-diagnosed condition, this would suggest a significant problem with inappropriate, insufficient or incorrect therapy.

Skin test results and self-reported symptom severity in allergic rhinitis: The role of psychological factors.

BACKGROUND: In allergic conditions, the degree of skin test reactivity does not always correlate with the severity of clinical symptoms. Additional factors may contribute to the reported symptom severity. OBJECTIVES: To investigate the association between the magnitude of the skin prick test (SPT) response and the reported symptom severity in patients with allergic rhinitis and the possible modifying role of psychological factors. METHODS: One hundred four patients with allergic rhinitis and 23 with non-allergic rhinitis, classified according to their SPT response to 19 aeroallergens, were asked to rate the severity of five symptoms and to indicate whether their symptoms intensified on exposure to five common aeroallergens. They also completed a psychological questionnaire. Results Reported symptom severity of allergic rhinitis did not correlate with weal size for any of the aeroallergens tested or with the number of positive responses on SPT. It was not related to patient age, sex, or education. The reported symptoms severity correlated positively (0.29, P < 0.01) with reported symptom intensification on exposure to allergens. Moreover, both outcomes were positively associated with the psychological factors of hypochondriasis (0.20, P < 0.05 and 0.18, P < 0.05, respectively), and somatic awareness (0.24, P < 0.05 and 0.33, P < 0.01, respectively), but not with neuroticism. CONCLUSIONS: The severity of symptoms experienced by patients with allergic rhinitis is apparently not related to the magnitude of SPT response, but rather to psychological factors of hypochondriasis and somatic awareness. Physicians should be aware of the contribution of psychological factors to patient perceptions of the intensity of symptoms and of the intensification of symptoms on their exposure to allergens.

Quality of life improvement with soy sauce ingredients, Shoyu polysaccharides, in perennial allergic rhinitis: a double-blind placebo-controlled clinical study.

Soy sauce (Shoyu) is a traditional fermented seasoning of East Asian countries and available throughout the world. We obtained polysaccharides from raw soy sauce, and showed the anti-allergic activities of these Shoyu polysaccharides (SPS) in vitro and in vivo. The present study determined whether oral supplementation of SPS is an effective intervention for patients with perennial allergic rhinitis. In a 4-week randomized, double-blind, placebo-controlled parallel group study, patients with mild perennial allergic rhinitis were treated with 600 mg of SPS (n=11) or placebo (n=10) each day. After 4 weeks of treatment with SPS, a reduction in symptom scores for runny nose, sore throat, and itchy eyes were significantly changed from the baseline within the group (p<0.05), but no change in these scores was observed over 4 weeks of treatment in the placebo group. However, differences in the symptom scores during the study period were not significantly different between the groups. The total symptom score, calculated from the sum of individual scores, showed a significant difference between the 2 groups after 4 weeks of treatment (p<0.05). The efficacy of global symptoms score, which was defined as the adjusted mean change from baseline during 4 weeks of treatment, also showed a significant improvement in the SPS group (p<0.05). An overall evaluation of the medication's effectiveness after 4 weeks treatment showed significant differences between the SPS- and placebo-treated groups (p<0.05). In conclusion, SPS of soy sauce improved the quality of life for patients with perennial allergic rhinitis, and soy sauce would be useful in an anti-allergic therapy utilizing everyday foods.

[Clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis].

The clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis was evaluated. A bipolar radiofrequency system (CelonLab ENT) was used to treat 16 patients suffering from allergic rhinitis between February 2003 and August 2003. The thermotherapy was performed under local anesthesia at the otolaryngology outpatient clinic of St. Marianna University Toyoko Hospital. Data were collected by questionnaire and rhinomanometry preoperatively and 2 months postoperatively. The mean visual analogue scale (VAS) score for intraoperative pain was 31 mm (range, 0-100), and nearly all the patients felt no or a subtle pain during the thermotherapy. Postoperative pain was also well tolerated, with nearly all the patients not requiring analgesic drugs. Postoperative bleeding was minor, and none of the patients required additional treatment for bleeding. Nearly all the patients reported an improvement in their nasal patency, rhinorrhea, headaches, and sleeping. Statistically significant improvements were observed for all the measured VAS scores: nasal patency, rhinorrhea, headache, and olfactory function. Nasal resistance, as measured by anterior rhinomanometry, significantly improved after treatment. The effect of decongestion was also measured using anterior rhinomanometry. The ratio of nasal resistance before and after decongestion was significantly higher after thermotherapy, suggesting that nasal decongestion had a smaller effect on nasal patency after treatment. The current results suggest that the CelonLab ENT device is an effective and safe treatment for allergic rhinitis.

Effects of butterbur treatment in intermittent allergic rhinitis: a placebo-controlled evaluation.

BACKGROUND: Butterbur (Petasites hybridus) contains the active ingredient petasin, which exhibits antileukotriene and antihistamine activity. Previous studies of intermittent allergic rhinitis (IAR) have demonstrated a comparable response to butterbur compared with a histamine H1-receptor antagonist on the 36-Item Short-Form Health Survey quality-of-life score. However, there has been no placebo-controlled study of the effects of butterbur use on objective and subjective outcomes in IAR. OBJECTIVE: To evaluate the effects of treatment with butterbur vs placebo on objective and subjective outcomes in IAR. METHODS: A double-blind, placebo-controlled, crossover study was carried out during the grass pollen season in Tayside, Scotland. Thirty-five patients (14 men and 21 women) with IAR received butterbur, 50 mg twice daily, or placebo for 2 weeks. Domiciliary measurements were taken in the morning and evening for peak nasal inspiratory flow (PNIF) (the primary outcome variable), nasal and eye symptoms, and rhinoconjunctivitis-specific quality-of-life score. RESULTS: Butterbur treatment had no significant effect on PNIF, total nasal symptom score, eye symptom score, or quality of life compared with placebo use. Mean (SEM) morning and evening PNIF values were 107 (6) and 114 (6) L/min, respectively, for butterbur vs 105 (6) and 117 (6) L/min for placebo. Mean (SEM) morning and evening total nasal symptom scores (maximum total score, 12) were 3.4 (0.4) and 3.5 (0.4), respectively, for butterbur vs 3.7 (0.3) and 3.8 (0.4) for placebo. CONCLUSIONS: There was no significant clinical efficacy of butterbur use vs placebo use on objective and subjective outcomes in IAR. Further studies are now indicated to investigate the use of butterbur in persistent allergic rhinitis.

Symptoms of persistent allergic rhinitis during a full calendar year in house dust mite-sensitive subjects.

BACKGROUND: Little is known about the natural course of persistent rhinitis symptoms over a prolonged period. OBJECTIVE: To describe the frequency and severity of nasal symptoms and quality of life (QoL) in house dust mite-sensitive persistent rhinitic subjects and to determine if medication use was related to symptoms. METHODS: Rhinitics and controls were telephoned fortnightly for 1 year to monitor symptoms. QoL was measured every 3 months. RESULTS: Thirty-seven rhinitics and 19 controls completed the study. Total nasal symptom scores (TNSS) were 'high' for 65% (95% CI +/- 6%) of the year in rhinitic subjects. When TNSS increased by 1, the likelihood of nasal medication use increased by 25% (95% CI: 7-46%). General and specific QoL were worse in rhinitic subjects than controls (P < 0.04 and <0.0001). Rhinitics with pollen allergy (n = 21) had seasonal variation in the frequency of high nasal symptom scores (P = 0.02). CONCLUSION: Nasal symptom scores were consistently high in rhinitics, and their QoL was worse than controls, even in general QoL. An increase in nasal symptom score increased the likelihood of nasal medication use. These findings help to characterize the course of persistent rhinitis over a previously unstudied period of 1 year.

Anti-inflammatory activity of an extract of Petasites hybridus in allergic rhinitis.

Previous studies have suggested that histamine and leukotrienes (LTs) play an important pathobiological role in IgE-mediated allergic diseases. In vitro studies suggested that an extract of Petasites hybridus (Ze339) blocks LT synthesis in monocytes and granulocytes. Petasins are considered to be the pharmacologically active fraction within Ze339. Patients suffering from allergic rhinitis received three times a day two tablets of Ze339 standardized to 8 mg petasins within a time period of 1 week. After 5 days of treatment, Ze339 significantly improved primary end points, which were day- and nighttime nasal symptoms. Nasal resistance, which was measured by rhinomanometry, gradually decreased as a consequence of Ze339 treatment reaching normal levels after 5 days (rhinomanometry: from 403.5+/-62.0 to 844.8+/-38.8 ml). Levels of inflammatory mediators in nasal fluids and serum were measured 90 min after drug administration every day in the morning. After 5 days of treatment, a significant reduction of histamine (from 153.7+/-32.1 to 53.0+/-8.4 pg/ml) and LT levels (LTB4: from 313.1+/-46.5 to 180.6+/-32.2 pg/ml; cysteinyl-LT: from 137.0+/-42.2 to 70.1+/-16.5 pg/ml) could be observed. Moreover, quality-of-life scores significantly improved. The drug had no effect on the distribution of lymphocyte subpopulations in the blood as well as on the capacity of blood leukocytes to generate cytokines and lipid mediators. These results suggest that Ze339 is effective in treating allergic rhinitis patients by decreasing levels of nasal inflammatory mediators.