Incidence rate, risk factors, and management of Bell's palsy in the Qurayyat region of Saudi Arabia.

Background: Bell's palsy is an idiopathic facial nerve dysfunction causing temporary paralysis of muscles of facial expression. This study aimed to determine the incidence rate, common risk factors, and preferred treatment by the Saudi patients with Bell's palsy. Method: This cross-sectional study was carried out in the Qurayyat region of Saudi Arabia. The retrospective medical records were searched from 2015-2020 of patients diagnosed with Bell's palsy at Qurayyat General Hospital and King Fahad hospital. A 28-item questionnaire was developed by a team of experts and pre-tested among patients with Bell's palsy before being sent to the eligible participants. The data were analyzed using summary statistics, Chi-square test, Fisher exact test and Likelihood ratio test. Results: We identified 279 cases of Bell's palsy from the medical records of the hospitals from the years 2015 to 2020, accounting for 46.5 cases per year and an incidence rate of 25.7 per 100,000 per year. Out of 279 patients with Bell's palsy, only 171 returned the questionnaire accounting for a response rate of 61.2%. Out of 171 patients with Bell's palsy, females (n = 147, 86.0%) accounted for the majority of cases. The most affected age group among participants with Bell's palsy was 21-30 years (n = 76, 44.4%). There were 153 (89.5%) cases who reported Bell's palsy for the first time. The majority of the participants experienced right-sided facial paralysis (n = 96, 56.1%). Likelihood ratio test revealed significant relationship between exposure to cold air and common cold with age groups (χ 2(6, N = 171) = 14.92, p = 0.021), χ 2(6, N = 171) = 16.35, pp = 0.012 respectively. The post hoc analyses revealed that participants in the age group of 20-31-years were mostly affected due to exposure to cold air and common cold than the other age groups. The main therapeutic approach preferred was physiotherapy (n = 149, 87.1%), followed by corticosteroids and antivirals medications (n = 61, 35.7%), acupressure (n = 35, 20.5%), traditional Saudi herb medicine (n = 32, 18.7%), cauterization by hot iron rod (n = 23, 13.5%), supplementary therapy (n = 2, 1.2%), facial cosmetic surgery (n = 1, 0.6%) and no treatment (n = 1, 0.6%). The most preferred combined therapy was physiotherapy (87.6%) with corticosteroid and antiviral drugs (35.9%), and acupressure (17.6%). Conclusion: The rate of Bell's palsy was approximately 25.7 per 100,000 per year in the Qurayyat region of Saudi Arabia. Exposure to cold air and common cold were the significant risk factors associated with Bell's palsy. Females were predominantly affected by Bell's palsy in the Qurayyat region of Saudi Arabia. Bell's palsy most commonly occurred in the age group 21-30 years. The most favored treatment was physiotherapy following Bell's palsy.

The efficacy of a compounded micronutrient supplement on the incidence, duration, and severity of the common cold: A pilot randomized, double-blinded, placebo-controlled trial.

PURPOSE: Viral upper respiratory infections are associated with significant health and economic impact. This study sought to determine the efficacy of routine immune system micronutrient supplementation on the incidence, duration and severity of common cold symptoms. METHODS: This pilot study was a randomized, double-blinded, placebo-controlled trial of N = 259 with asymptomatic participants aged 18 to 65 in two cold seasons of 2016 and 2017. The treatment group received an immune system targeted micronutrient caplet, while the placebo group received a micronized cellulose caplet externally identical to the treatment caplet. Weekly surveys were sent electronically to participants to document common cold incidence, duration and severity. Primary statistical results were obtained using mixed-effects logistic regressions to account for longitudinal measurements for participants. RESULTS: The odds of acquiring an upper respiratory infection, adjusted for potential confounders, was estimated to be 0.74 times lower in the treatment group (p = 0.14). The odds of reporting specific symptoms were statistically lower in the treatment arm compared to the placebo arm for runny nose (OR = 0.53, p = 0.01) and cough (OR = 0.51, p = 0.04). Shorter durations of runny nose and cough were also observed in the treatment arm compared to placebo (both p < 0.05). There was no significant difference in severity of symptoms in either group. The observed proportion of reported cold symptoms in the treatment group was lower compared to the placebo group between late January and February in two consecutive cold seasons. Given the physical, workplace and economic impact of upper respiratory infections, this low cost and low risk intervention should be further studied with more robust investigation and meticulous experimental design.

Black elderberry (Sambucus nigra) supplementation effectively treats upper respiratory symptoms: A meta-analysis of randomized, controlled clinical trials.

Upper respiratory symptoms are often treated with over the counter drugs, antibiotics, and antiviral medications. Due to concerns about safety and efficacy, there is a demand for an alternative solution. Black elderberry (Sambucus nigra) has been used to treat cold and flu symptoms, but there are no large-scale studies or meta-analyses. This meta-analysis quantifies the effects of elderberry supplementation and evaluates moderators including vaccination status and the underlying pathology. This analysis included a total of 180 participants and evaluates moderators such as vaccination status and cause of the upper respiratory symptoms. Supplementation with elderberry was found to substantially reduce upper respiratory symptoms. The quantitative synthesis of the effects yielded a large mean effect size. These findings present an alternative to antibiotic misuse for upper respiratory symptoms due to viral infections, and a potentially safer alternative to prescription drugs for routine cases of the common cold and influenza.

Pharmacologic and Nonpharmacologic Treatment for Acute Cough Associated With the Common Cold: CHEST Expert Panel Report.

BACKGROUND: Acute cough associated with the common cold (CACC) causes significant impairment in quality of life. Effective treatment approaches are needed for CACC. We conducted a systematic review on the management of CACC to update the recommendations and suggestions of the CHEST 2006 guideline on this topic. METHODS: This systematic review of randomized controlled trials (RCTs) asked the question: Is there evidence of clinically relevant treatment effects for pharmacologic or nonpharmacologic therapies in reducing the duration/severity of acute CACC? Studies of adults and pediatric patients with CACC were included and assessed for relevance and quality. Based on the systematic review, guideline suggestions were developed and voted on using the American College of Chest Physicians organization methodology. RESULTS: Six systematic reviews and four primary studies identified from updated literature searches for each of the reviews or from hand searching were included and reported data on 6,496 participants with CACC who received one or more of a variety of interventions. The studies used an assortment of descriptors and assessments to identify CACC. CONCLUSIONS: The evidence supporting the management of CACC is overall of low quality. This document provides treatment suggestions based on the best currently available evidence and identifies gaps in our knowledge and areas for future research.

Characterization of urge to cough and cough symptoms associated with the common cold: results of a US internet survey.

OBJECTIVES: Our knowledge of cough physiology is limited despite years of study. Even less is known about the sensation of urge to cough. Given that limited clinical data are available about urge to cough and cough attributes during a common cold, we sought to gain insights into experiences and perceptions related to these symptoms. METHODS: An internet survey consisting of 51 questions was fielded in the United States. Eligible survey participants included men and women aged 18 years and older who had suffered from a cold with cough within the three months preceding the survey. Participants who confirmed suffering from recurrent cough, asthma, chronic bronchitis, chronic obstructive pulmonary disease, cystic fibrosis, or gastrointestinal reflux were excluded. RESULTS: Of 19,530 initial respondents, 8011 had a cold in the past three months. Of these, 6484 (81%) had experienced cough symptoms; 2708 respondents with cough due to cold and no exclusionary condition made up the analysis sample. Most respondents (62%) reported that cough developed one to two days after the onset of cold symptoms, and 45% felt that cough worsened their other cold symptoms. In 69% of respondents, cough outlasted other cold symptoms. Urge to cough was reported by 98% of respondents, and among these respondents, 64% described it as uncontrollable and 65% rated severity as moderate. More than half of respondents (57%) considered the sensation of urge to cough and the act of coughing as equally bothersome. Although urge to cough and inability to control cough were the most bothersome aspects of cough due to cold, few (<20%) respondents asked healthcare providers for treatment recommendations. CONCLUSION: Symptoms of urge to cough and cough are common and have a significant impact on cold sufferers. Understanding attributes of these symptoms may provide insights for effective management and the development of novel treatment strategies.

[Randomized, double-blind, multi-center, positive parallel control clinical trial of compound Wuzhigan capsules on anemopyretic cold].

Compound Wuzhigan capsules is a compound preparation composed of Wuzhigan, Shidagonglao, Gangmei, Shanzhima. A Randomized, double-blind, multi-center, positive parallel control designed to evaluate the clinical efficacy and safety of compound Wuzhigan capsules on anemopyretic cold. One hundred and twenty anemopyretic cold patients were given compound Wuzhigan capsules (test group), 2 capsules one time, three times a day, 119 patients were given compound Wuzhigan tablets (control group) ,4 tablets one time, three times a day; three days of treatment The study showed, the markedly effective rate and total effective rate respectively were 63. 3% and 80% of the test group. For the control group, the markedly effective rate and total effective rate respectively were 72. 5% and 80. 7%. The difference was not statistically significant. Compound Wuzhigan capsules can reduce the dosage, and get better patient compliance.

RANDOMISED DOUBLE BLIND STUDY TO COMPARE EFFECTIVENESS OF HONEY, SALBUTAMOL AND PLACEBO IN TREATMENT OF COUGH IN CHILDREN WITH COMMON COLD.

BACKGROUND: Acute upper respiratory infection is the most common childhood illness and presents with cough, coryza and fever. Available evidence suggests that cough medicines may be no more effective than honey-based cough remedies. OBJECTIVE: To compare effectiveness of honey, salbutamol and placebo in the treatment of cough in children with acute onset cough. DESIGN: Randomised control trial. SETTING: Aga Khan University Hospital Paediatric Casualty. SUBJECTS: Children between ages one to twelve years presenting with a common cold between December 2010 and February 2012 were enrolled. OUTCOME MEASURES: Frequency, severity and extent to which cough bothered and disturbed child and parental sleep were assessed at baseline and over the subsequent five days through telephone interview using a validated scoring tool. RESULTS: One hundred and forty five children were enrolled in the study (45- placebo, 57 -honey, 43 -salbutamol). Of the 145 children 51% were male. Honey significantly reduced the total mean symptom score by day three (p < 0.001). Total mean difference in scores between day zero to five demonstrated a significant difference of honey's efficacy over placebo (p < 0.002) however no difference was noted when compared to salbutamol (p < 0.478). Significant differences in both total as well as each individual symptom score was detected with honey consistently scoring the best whilst placebo and salbutamol scored the worst. In paired comparisons honey was superior to placebo but not salbutamol, whilst salbutamol was not superior to placebo. CONCLUSION: Honey was most effective in symptomatic relief of symptoms associated with the common cold whilst salbutamol or placebo offered no benefit.

Micronutrients and oral clefts: a case-control study.

Little is known about oral clefts in developing countries. We aimed to identify micronutrient-related and environmental risk factors for oral clefts in Thailand. We tested hypotheses that maternal exposure during the periconceptional period to multivitamins or liver consumption would decrease cleft lip with or without cleft palate (CL ± P) risk and that menstrual regulation supplements would increase CL ± P risk. We conducted a multisite hospital-based case-control study in Thailand. We enrolled cases with CL ± P and 2 live births as controls at birth from the same hospital. Mothers completed a questionnaire. Conditional logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs). Eighty-six cases and 172 controls were enrolled. Mothers who took a vitamin (adjusted OR, 0.39; 95% CI: 0.16, 0.94) or ate liver (adjusted OR, 0.26; 95% CI: 0.12, 0.57) were less likely than those who did not to have an affected child. Mothers who took a menstrual regulation supplement were more likely than mothers who did not to have an affected child. Findings did not differ for infants with a family history of other anomalies or with isolated CL ± P. If replicated, our finding that liver decreases CL ± P risk could offer a low-cost primary prevention strategy.

Baker's yeast beta glucan supplementation increases salivary IgA and decreases cold/flu symptomatic days after intense exercise.

Strenuous exercise, such as running a marathon, is known to suppress mucosal immunity for up to 24 hr, which can increase the risk of developing an upper respiratory tract infection (URTI) and reduced performance capacity (Allgrove JE, Geneen L, Latif S, Gleeson M. Influence of a fed or fasted state on the s-IgA response to prolonged cycling in active men and women. Int J Sport Nutr Exerc Metab. 2009;19(3):209-221; Barrett B, Locken K, Maberry R, Schwamman J, Brown R, Bobula J, Stauffacher EA. The Wisconsin Upper Respiratory Symptom Survey (WURSS): a new research instrument for assessing the common cold. J Fam Pract. 2002;51(3):265; Carpenter KC, Breslin WL, Davidson T, Adams A, McFarlin BK. Baker's yeast beta glucan supplementation increases monocytes and cytokines post-exercise: implications for infection risk? Br J Nutr. 2012;1-9). While many dietary interventions have been used to combat postexercise immune suppression, most have been ineffective. The key purpose of this study was to determine if baker's yeast ß-glucan (BG) could positively affect the immune system of individuals undergoing intense exercise stress using two experiments. In the first (E1; N = 182 men and women), BG was compared to placebo supplementation for the incidence of URTI symptoms for 28 days postmarathon. In the second (E2; N = 60 men and women) changes in salivary immunoglobulin A (IgA) were evaluated after 50-min of strenuous cycling when participants had been supplemented for 10 days with either BG (250 mg/day) or placebo (rice flour). For E1, subjects reported URTI symptoms using a daily health log. For E2, saliva was collected prior to, immediately, and 2-hr postexercise using a salivette. Data for E1 and E2 were analyzed using separate analyses of variance (ANOVAs) with repeated measures (p < .05). In E1, BG was associated with a 37% reduction in the number of cold/flu symptom days postmarathon compared to placebo (p = .026). In E2, BG was associated with a 32% increase in salivary IgA (p = .048) at 2 hr after exercise compared to placebo. In summary, the present study demonstrates that BG may reduce URTI symptomatic days and improve mucosal immunity (salivary IgA) postexercise.

Honey plus coffee versus systemic steroid in the treatment of persistent post-infectious cough: a randomised controlled trial.

BACKGROUND: Persistent post-infectious cough (PPC) is a cough that remains after a common cold or an upper respiratory tract infection for more than three weeks or perhaps for many months. Two of the suggested treatments for PPC are systemic steroid and honey plus coffee. AIMS: The aim of this study was to evaluate and compare scientifically the therapeutic effects of these two regimens. METHODS: A double-blind randomised controlled trial was conducted from 2008 to 2011 at the Baqiyatallah University Hospital, Tehran, Iran. Included in the study were 97 adults who had experienced PPC for more than three weeks. Patients with other causes of chronic cough, systemic disease, or abnormal routine laboratory tests were excluded. The participants were distributed into three groups. A jam like paste was prepared which consisted of honey plus coffee for the first group ('HC'), prednisolone for the second group (steroid, 'S'), and guaifenesin for the third group (control, 'C'). The participants were told to dissolve a specified amount of their product in warm water and to drink the solution every eight hours for one week. All the participants were evaluated before treatment and one week after completion of treatment to measure the severity of their cough. The main outcome measure was the mean cough frequency before and after one week's treatment calculated by a validated visual analogue cough questionnaire score. RESULTS: There were 97 adult patients (55 men) enrolled in this study with the mean of age of 40.1 years. The mean (+/- SD) cough scores pre- and post-treatment were: HC group 2.9 (0.3) pre-treatment and 0.2 (0.5) post-treatment (p < 0.001); steroid ('S') group 3.0 (0.0) pre-treatment and 2.4 (0.6) post-treatment (p < 0.05); control ('C') group 2.8 (0.4) pre-treatment and 2.7 (0.5) post-treatment (p > 0.05). Analysis of variance showed a significant difference between the mean cough frequency before and after treatment in the HC group versus the S group (p< 0.001). Honey plus coffee was found to be the most effective treatment modality for PPC. CONCLUSIONS: A combination of honey and coffee can be used as an alternative medicine in the treatment of PPC.

The clinical efficacy of a bovine lactoferrin/whey protein Ig-rich fraction (Lf/IgF) for the common cold: a double blind randomized study.

OBJECTIVE: The aim of the study was to determine if a bovine lactoferrin/whey protein Ig-rich fraction (Lf/IgF) combination was effective in reducing the number of colds and in turn improving symptom recovery in a cohort of males and females that reported frequently contracting a cold. DESIGN: A double blind randomized placebo-controlled clinical trial. SETTING: One-hundred and twenty-six participants matched by age, BMI, dietary and physical parameters with self-reported frequent upper respiratory tract symptoms and infections were randomly assigned to receive 600 mg of Lf/IgF or a placebo daily for 90 days. MAIN OUTCOME MEASURES AND RESULTS: A total of 90 participants (47 receiving the active and 43 placebo) completed the 90 day trial and 15 completed 45 days participation (6 in the active and 9 in the placebo group). The total number of colds recorded over the study period was 48 for the treatment group versus 112 for the placebo group (p < 0.001). The significant trend was retained when the data was corrected for medications returned (p < 0.001) and for guessing treatment allocations (p < 0.001). Non-parametric analysis demonstrated that the total number of cold-associated symptoms reported by participants that received Lf/IgF was significantly less than those in the placebo group (p < 0.05). Also, total days sick with a cold and cold severity were reduced over the clinical trial period for Lf/IgF over placebo, but the trend was not significant. CONCLUSIONS: These findings demonstrate that the Lf/IgF combination significantly decreased the incidence of colds and the cumulative number of cold-related symptoms over placebo. This therapeutic combination may be indicated for the prevention of colds and its most common symptoms in the general population when administered as a preventative supplement.

Lessons learned from a double-blind randomised placebo-controlled study with a iota-carrageenan nasal spray as medical device in children with acute symptoms of common cold.

BACKGROUND: Common cold is caused by a variety of respiratory viruses. The prevalence in children is high, and it potentially contributes to significant morbidity. Iota-carragenan, a polymer derived from red seaweed, has reduced viral load in nasal secretions and alleviated symptoms in adults with common cold. METHODS: We have assessed the antiviral and therapeutic activity of a nasal spray containing iota-carrageenan in children with acute symptoms of common cold. A cohort of 153 children between 1-18 years (mean age 5 years), displaying acute symptoms of common cold were randomly assigned to treatment with a nasal spray containing iota-carrageenan (0.12%) as verum or 0.9% sodium chloride solution as placebo for seven days. Symptoms of common cold were recorded and the viral load of respiratory viruses in nasal secretions was determined at two consecutive visits. RESULTS: The results of the present study showed no significant difference between the iota carrageenan and the placebo group on the mean of TSS between study days 2-7. Secondary endpoints, such as reduced time to clearance of disease (7.6 vs 9.4 days; p = 0.038), reduction of viral load (p = 0.026), and lower incidence of secondary infections with other respiratory viruses (p = 0.046) indicated beneficial effects of iota-carrageenan in this population. The treatment was safe and well tolerated, with less side effects observed in the verum group compared to placebo. CONCLUSION: In this study iota-carrageenan did not alleviate symptoms in children with acute symptoms of common cold, but significantly reduced viral load in nasal secretions that may have important implications for future studies. TRIAL REGISTRATION: ISRCTN52519535, http://www.controlled-trials.com/ISRCTN52519535/

Hypovolemic shock due to severe gastrointestinal bleeding in a child taking an herbal syrup.

We report the case of a 4-years-old boy who was admitted with hypovolemic shock due to a severe gastrointestinal bleeding. The esophagogastroduodenoscopy (EGDS) showed hiatus hernia, erosions and ulcerations of the lower esophagus, possibly due to a gastroesophageal reflux, and a small duodenal erosion. The child was previously healthy and he had never shown any symptoms related to this condition. The only product taken by the child in the previous days was a syrup containing several herbs, among which Filipendula ulmaria (L.) Maxim. and Salix spp. (known to contain salicylates), marketed as food and prescribed by his paediatrician to treat a mild cold accompanied by fever. Quali-quantitative analysis confirmed the presence of salicylates in the syrup. Naranjo algorithm showed a probable correlation between the onset of symptoms and the consumption of the herbal remedy. The child recovered after receiving intensive care. The product was withdrawn from Italian market.

Observational study on the tolerability and safety of film-coated tablets containing ivy extract (Prospan® Cough Tablets) in the treatment of colds accompanied by coughing.

The only saponin drug currently prescribed in any significant amount in monotherapy medicines is ivy. This post-marketing surveillance study (PMSS) aimed at investigating the tolerability and safety of film-coated tablets containing ivy leaves dry extract (extracting medium: ethanol 30%, DER 5-7.5:1 [Prospan® Cough Tablets]) under practice conditions. Adults and children aged 11-85 years of both genders were included. A total of 330 patients suffering from colds accompanied by coughing or from chronic, inflammatory bronchial diseases were scheduled to undergo treatment for a period of at least seven days. The tolerability of the tablets was rated by means of questionnaires. The results of this PMSS reflect the good to very good tolerability of the tablets in the global assessment by both, the practitioner (98.5%) and by the patient (96.4%). This is one of the reasons for the high acceptance and compliance (rated as 'good' in 98.8% of all cases). The safety not only regarding the administration form but also regarding the active substance is thus underlined once again.

Reduction of common cold symptoms by encapsulated juice powder concentrate of fruits and vegetables: a randomised, double-blind, placebo-controlled trial.

Dietary supplements have been suggested in the prevention of the common cold, but previous investigations have been inconsistent. The present study was designed to determine the preventive effect of a dietary supplement from fruits and vegetables on common cold symptoms. In a randomised, double-blind, placebo-controlled trial, healthcare professionals (mainly nursing staff aged 18-65 years) from a university hospital in Berlin, Germany, were randomised to four capsules of dietary supplement (Juice Plus+®) or matching placebo daily for 8 months, including a 2-month run-in period. The number of days with moderate or severe common cold symptoms within 6 months (primary outcome) was assessed by diary self-reports. We determined means and 95 % CI, and differences between the two groups were analysed by ANOVA. A total of 529 subjects were included into the primary analysis (Juice Plus+®: 263, placebo: 266). The mean age of the participants was 39·9 (sd 10·3) years, and 80 % of the participants were female. The mean number of days with moderate or severe common cold symptoms was 7·6 (95 % CI 6·5, 8·8) in the Juice Plus+® group and 9·5 (8·4, 10·6) in the placebo group (P = 0·023). The mean number of total days with any common cold symptoms was similar in the Juice Plus+® and in the placebo groups (29·4 (25·8, 33·0) v. 30·7 (27·1, 34·3), P = 0·616). Intake of a dietary supplement from fruits and vegetables was associated with a 20 % reduction of moderate or severe common cold symptom days in healthcare professionals particularly exposed to patient contact.

Inhibition of cough-reflex sensitivity by benzonatate and guaifenesin in acute viral cough.

Acute cough due to viral upper respiratory tract infection (URI) is the most common form of cough and accounts for tremendous expenditure on prescription and non-prescription cough products worldwide. However, few agents have been shown in properly conducted clinical trials to be effective for cough due to URI. The present study evaluated the effect of benzonatate 200mg (B), guaifenesin 600 mg (G), their combination (B+G), and placebo (P) on capsaicin-induced cough in 30 adult nonsmokers with acute URI. On 3 separate days within a 7-day period, 1h after ingesting randomly assigned study drug in a double-blind fashion, subjects underwent capsaicin cough challenge testing, which involved inhalation of incremental doubling concentrations of capsaicin until the concentration of capsaicin inducing 5 or more coughs (C(5)) was attained. Each subject received 3 of 4 possible study drugs. G (p=0.01) but not B (p=NS) inhibited cough-reflex sensitivity (log C(5)) relative to P. The combination of B+G suppressed capsaicin-induced cough to a greater degree than B alone (p<0.001) or G alone (p=0.008). The mechanism by which the combination of B+G causes a potentiation of antitussive effect remains to be elucidated. Our results suggest that B+G may be an effective therapy for acute cough due to the common cold (URI).

[Randomized controlled study on suhuang zhike capsule for treatment of post-cold cough].

OBJECTIVE: To observe the effect and safety of Suhuang Zhike Capsule (SZC) on post-cold cough. METHODS: The multi-centered randomized double-blinded clinical trial was adopted, and Zhike Ningsuo Capsule (ZNC) as the positive control drug, 280 patients were enrolled and assigned to two groups, the 210 patients (2 dropped out) in the treatment group were treated with SZC, and the 70 (1 dropped out) in the control group treated with ZNC, both at the daily dose of 3 capsules for three times, and the course for all patients was 7 days. The frequency, degree of cough as well as the condition of throat itching and expectoration were observed. RESULTS: The program was completed in 204 patients of the treatment group and 67 in the control group. per-protocol (PP) analysis on cough showed the total effective rate and the cured-effective rate was 87.75 % and 58.82% in the treatment group respectively, which was superior to that in the control group, 76.12% and 34.33%, respectively (P < 0.05). intention-to-treat (ITT) analysis on cough also showed the similar results 87.02 % vs 75.36% for total effective rate, 57.42% vs 35.71% for the cured-effective rate (P < 0.05). The two indexes of effectiveness on disease analyzed by PP were 92.16 % and 60.29% in the treatment group, and 86.57% and 31.34% in the control group respectively (P < 0.05), and by ITT were 91.35 % and 59.62%, 85.51% and 30.43%, respectively (P < 0.05), both showed significant difference between groups only in cured-effective rate but not in the total effective rate (P > 0.05). CONCLUSION: SZC is effective and safe in treating post-cold cough.

Randomized controlled trial on treatment of bronchial asthma of qi-deficiency cold syndrome type by pingchuan yiqi granule.

OBJECTIVE: To evaluate the effect and safety of Pingchuan Yiqi Granule in treating bronchial asthma of qi-deficiency cold syndrome type (BS-QDC). METHODS: With the randomized, positive agent parallel controlled design adopted, the 80 subjects enrolled were assigned in the ratio of 3:1 to two groups, the 60 patients in the trial group were treated with PYG and the 20 in the control group treated with Ruyi Dingchuan Pill (RDP), with the therapeutic course consisting of 7 days for both groups. The clinical effects, effects on TCM syndrome and the changes of lung function after treatment were observed. RESULTS: The effect of the treatment on asthma in the trial group: clinically controlled rate was 6.67%, markedly effective rate 51.67%, improved rate 33.33% and ineffective rate 8.33%; and the corresponding rates in the control group were 5.00%, 50.00%, 30.00%, and 15.00% respectively. Comparison between the two groups showed insignificant difference (P>0.05). The effect on TCM syndrome in the treated group: clinically controlled rate was 11.67%, markedly effective rate 58.33%, effective rate 21.67% and ineffective rate 8.33%; and those in the control group were 10.00%, 50.00%, 30.00% and 10.00% respectively, also showing insignificant difference between the two groups (P>0.05). Lung function test showed that the change on forced expiratory volume in 1 second (FEV1) after treatment in the trial group was of statistical significance (P<0.05), but no significant difference was shown in the change of peak expiratory flow (PEF, P>0.05); while the changes in the control group were just the opposite, showing insignificance in FEV1 (P>0.05) but significance in PEF (P<0.05). Comparison of the therapeutic effect on lung function between the two groups showed no significant difference (P>0.05). No adverse reaction was found in either group in the course of treatment. CONCLUSION: PYG used to treat BS-QDC is effective and safe, it's effect is similar to that of RDP.