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Efficacy and Safety of Clearing Heat and Detoxifying Injection in the Treatment of Influenza: a Randomized, Double-Blinded, Placebo-Controlled Trial

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Efficacy and Safety of Clearing Heat and Detoxifying Injection in the Treatment of Influenza: a Randomized, Double-Blinded, Placebo-Controlled Trial Hindawi Publishing Corporation Evidence-Based Complementary and Alternative Medicine Volume 2014, Article ID 151235, 8 pages http://dx.doi.org/10.1155/2014/151235 Research Article Efficacy and Safety of Clearing Heat and Detoxifying Injection in the Treatment of Influenza: A Randomized, Double-Blinded, Placebo-Controlled Trial Yu Liu,1 Yuhong Huang,1 Baolin Wei,1 Xinqiao Liu,2 Yaqing Zhang,3 Xiaomin Huang,4 Yuping Tan,5 and Zengtao Sun1 1 The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, No. 816 Zhenli Road, Hebei District, Tianjin 300150, China 2 The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, No. 314 Anshanxi Road, Naikai District, Tianjin 300193, China 3 JiangsuHospitalofIntegratedTraditionalChineseandWesternMedicine,No.100ShiziStreet,HongshanRoad, Nanjing 210028, China 4 The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine, No. 54 Youdian Road, Shangyou District, Hangzhou 310006, China 5 Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, No. 10 Huadong Road, Nanning 530011, China Correspondence should be addressed to Yuhong Huang; [email protected] and Zengtao Sun; [email protected] Received 22 June 2014; Revised 9 September 2014; Accepted 28 October 2014; Published 25 November 2014 Academic Editor: Hongcai Shang Copyright © 2014 Yu Liu et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objective. To evaluate the efficacy and safety of CHDI in the treatment of influenza infection. Method. A randomized double- blind, double dummy trial was conducted. Influenza patients with a positive influenza A rapid test diagnosis were randomized to receive CHDI or oseltamivir. Primary outcome was assessed by the median fever alleviation time and clearance time, and secondary outcome was total scores of influenza symptoms. Results. One hundred thirty-nine participants were screened and 34 had a RT- PCR laboratory confirmation of influenza virus infection. Fever alleviation time was 2.5 and 5 hours in CHDI and oseltamivir, respectively, and fever clearance time was 32.5 and 49 hours. The HR of fever alleviation and clearance time shows no significant difference between two groups. Total scores of influenza symptoms descended significantly in both groups after treatment and descended more in CHDI than oseltamivir on day 2. Similar to total symptoms severity score, fever severity score descend more significantly in CHDI than oseltamivir on day 2, and there were no differences on other symptoms. Conclusions.CHDIhavea similar effect to oseltamivir in reducing the duration of influenza illness. CHDI was well tolerated, with no serious adverse events noted during the study period. 1. Introduction and confers a considerable burden on health care systems [4– 6], there is a need for effective and well-tolerated treatments The influenza virus is an orthomyxovirus and causes an acute that can reduce the impact of influenza on the individual and respiratory tract disease. Influenza illness is characterized society. by abrupt onset of fever, headache, myalgia, sore throat, Traditional Chinese medicine (TCM) has been used in and nonproductive cough, whose complications often cause China for centuries to treat colds and influenza. Tradi- hospitalization and deaths in elderly and children, including tional Chinese medicine injection is a kind of new TCM bronchitis and pneumonia. Because annual influenza virus preparations, which was mainly used for treatment of acute causes significant morbidity and mortality worldwide [1–3] and severe disease. Clearing heat and detoxifying injection 2 Evidence-Based Complementary and Alternative Medicine Chlorogenic acids Geniposide 1 = 225 8 = \ \ 00001 MWD B, Sig . Ref off (E: SRDN CP- .D) 200 Neochlorogenic acid 175 150 125 Isochlorogenic acid B 100 (mAU) 75 50 25 0 0 10 20 30 40 50 (min) Cryptocholrogenic acid Secoxyloganin Isochlorogenic Isochlorogenic acid A acid C Caffeic acid Figure 1: Liquid quantitative fingerprint of CHDI. CHDI, clearing heat and detoxifying injection. Nine ingredients in CHDI: (1) neochlorogenic acid, (2) chlorogenic acids, (3) cryptochlorogenic acid, (4) caffeic acid, (5) geniposide, (6) secoxyloganin, (7) isochlorogenic acid B, (8) isochlorogenic acid A, and (9) isochlorogenic acid C. (CHDI),whoseChinesepinyinnameiscalledReduning 2.2. Patients. According to “The diagnosis and treatment injection, was approved by CFDA (China Food and Drug guidelines for pandemic influenza” issued by the Ministry Administration) in May 2005 for the treatment of upper of Public Health of China, influenza was defined as oneof respiratory tract infection. To date, CHDI was prescribed the following conditions in epidemic period of influenza. (1) Generally characterized by acute high fever (axillary to nearly 20 million patients in China, and the incidence ∘ of adverse reactions was nearly 0.4%, mainly skin itching. temperature 38 C), chills, headache, dizziness, ache all over, Nine ingredients of CHDI were listed in finger-print for poisoning symptoms such as fatigue, sore throat, dry cough, quality control in Figure 1. CHDI is a key product of Jiangsu and other respiratory symptoms, but catarrhal symptoms are Kangyuan pharmaceutical co., LTD., which locates in Jiangsu often not obvious; (2) a few cases may have loss of appetite, province, east of China. Antiviral activity of extract from abdominal pain, bloating, vomiting and diarrhea, and other three plants that composes CHDI has been reported against gastrointestinal symptoms; (3) A few cases may also be complicated by sinusitis, otitis media, laryngitis, bronchitis, herpes simplex virus, adenovirus, respiratory syncytial virus, pneumonia, respiratory and circulatory failure, and even parainfluenza virus, and influenza A viruses in many vivo death; (4) chest X-ray examination of severe patients may and vitro studies [7–9]. Standardized CHDI has also been show unilateral or bilateral pulmonary parenchymal disease, showntoinactivateorinhibittheproliferationofinfluenza and a few may be associated with pleural effusions; (5) white virus FM, respiratory syncytial virus, and adenovirus in vivo blood cell in peripheral blood is not high or low, accompanied study [10, 11]. Moreover, the mechanism research has reported by relatively increased lymphocytes. that CHDI has a similar role in inhibiting neuraminidase The inclusion criteria were (1) previously healthy adults (NA) as oseltamivir [12]. For influenza-like symptoms, the aged 18 to 65; (2) onset of influenza symptoms within 48 ∘ efficacy of CHDI was also demonstrated in small sample trials hours; (3) axillary temperature that was 38.5 Corhigher; [13, 14]. (4) at least one or more respiratory symptoms (sore throat, We designed the current trial to test the hypothesis that cough, and nasal congestion); (5) at least one or more general CHDI, which is already on the market, would be well- symptoms (headache, fatigue, and myalgia); (6) a positive toleratedandwouldreducethedurationofnaturallyacquired throat rapid test for influenza A performed by the practitioner influenza illness. The study was conducted to determine (Clear view Exact Influenza A&B). safetyandclinicalefficacyofCHDIadministeredfor3days The exclusion criteria were (1) receiving influenza vac- in adults with microbiologically proven influenza. cination 12 months prior to the beginning of the study; (2) routine blood WBC that was greater than the upper limit 2. Method of normal value; (3) having chronic respiratory diseases or pneumonia;(4)havingclinicallysignificantchronicillness 2.1. Study Design and Sites. A prospective, multicentre, dou- or human immunodeficiency virus disease; (5) receiving ble-blinded, double-dummy, randomized trial was con- systemic steroids or other immunosuppressants 3 months ducted according to the revised Declaration of Helsinki and prior to the beginning of the study; (6) women who had a theapprovaloftheethicalcommitteeoftheSecondAffil- positive urine pregnancy test before drug administration. iated Hospital of Tianjin University of Traditional Chinese Prior to inclusion, patients gave informed written con- Medicine in Sep. 2010. The subjects were enrolled from Jan. sent. 2011 to Mar. 2011, when the epidemic of influenza in China was reported by Chinese Center for Disease Control and Pre- 2.3. Treatment. Qualified patients were randomly allocated vention. The registration number is ChiCTR-TRC-10001082. to treatment or control group. In treatment group, patients Evidence-Based Complementary and Alternative Medicine 3 received simulation agent of oseltamivir plus CHDI. In Swabs were taken from enrolled patients’ throat, placed control group, patients were given oseltamivir plus simulation into 3 mL of viral transport medium, and transported at ∘ agent of CHDI. Both oseltamivir and its simulation were 4 C by special courier to the National Influenza Centre administered 75 mg orally twice a day for 5 days. CHDI was (NIC)ofChina.Uponarrival,theswabsampleswere 20 mL added in normal saline 250 mL, and simulation of eluted into 2 mL of transport medium, processed for real- CHDI was saline 250 mL. Both were intravenously admin- time reverse transcription- (RT-) PCR analyses, and inocu- istered by research nurses, once a day for 3 days, and the lated onto MDCK cells for virus isolation and subsequent infusion lasted nearly 90 minutes. On days
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