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Complementary Therapies in Medicine (2009) 17, 257—261 available at www.sciencedirect.com journal homepage: www.elsevierhealth.com/journals/ctim Autologous blood therapy for common cold—–A randomized, double-blind, placebo-controlled trial S. Hensler a,∗, P.W. Guendling a,b, M. Schmidt a, K. Jork a a Institute of General Practice, University of Frankfurt, Theodor-Stern-Kai 7, D-60596 Frankfurt, Germany b Master Course Complementary Medicine, Fresenius University of Applied Sciences, Idstein, Germany Available online 29 July 2009 KEYWORDS Summary Autologous blood Background: In Germany autologous blood therapy (ABT) is a widespread therapy for infectious therapy; diseases in complementary medicine. Clinical data for its use for common cold is lacking. Common cold; Methods: In a double-blind randomized controlled trial 139 patients with common cold were Primary care enrolled either to ABT (gluteal intramuscular reinjection of venous blood three times a week) or to placebo (sterile sodium chloride solution). Main criterion was time period of illness after initiation of treatment, measured by a modified symptom diary adapted from Jackson. Results: 58 and 56 patients completed therapy. In both groups illness duration was 7 days (5.0—10.0 for verum and 5.25—9.0 for placebo). Conclusions: This trial found no effect of ABT as treatment for common cold. Because of a rather highly selected patient sample another RCT on this topic is reasonable. Further research to analyse the effect of other doses or of autologous blood therapy in addition to homeopathic preparations or vitamin preparations is needed. © 2009 Elsevier Ltd. All rights reserved. Background revealed only one randomized controlled trial (RCT) testing autologous blood therapy to prevent common cold in case In Europe particularly in Germany autologous blood therapy of elevated susceptibility to infection. This study found no is a widespread and well established therapy for infectious significant effect, possibly due to an undersized sample.2 and allergic diseases in complementary medicine. It is used The role of autologous blood therapy for other indica- as treatment of allergic diseases (e.g. pollinosis), inflamma- tions has been subject to limited clinical trials. Schirmer tory and degenerative arthropathia or skin diseases1 and in et al.3 tested autologous blood therapy in combination with order to cure and prevent acute common cold especially in Formica rufa D6 for ankylosing spondilytis in a RCT and found case of elevated susceptibility to infection. However, clini- no statistical difference between treatment and placebo cal data for this use is rare. A detailed literature research in group. In another RCT treating atopic dermatitis Pittler et Medline and special databases for complementary medicine al.4 were able to show a positive effect of autologous blood (Cambase, RCCM) resulted in no clinical trial for autolo- therapy vs. placebo. A further RCT conducted by McGrath et gous blood therapy medicating acute common cold. It also al.5 found an effect of ultraviolet radiated autologous blood on walking distance of patients with intermittent claudica- tion. A clinical study by Olwin et al.6 found an effect in the ∗ Corresponding author. Tel.: +49 69 6667031; fax: +49 69 6667031. treatment of herpes zoster. Pfeiffer et al.7 found an effect E-mail address: [email protected] (S. Hensler). in the treatment of recurrent spontaneous abortion. 0965-2299/$ — see front matter © 2009 Elsevier Ltd. All rights reserved. doi:10.1016/j.ctim.2009.06.003 258 S. Hensler et al. Despite the lack of clinical data about the effectivity of practice with symptoms of common cold (cough, rhinitis, autologous blood therapy for common cold, there are only sore throat, fever etc.) which lasted not longer than 7 days few alternative therapy options in the treatment of com- and resulted in at least four points on a modified Jackson- mon cold with some evidence for effectivity. According to a Score (s.a.). Exclusion criteria were illness duration before review by Smith et al.8 there is no evidence for effectiveness treatment longer than 7 days, severe forms of respiratory of unspecific symptomatic therapy options such as antitus- infections (exacerbation of chronic obstructive pulmonary sives, mucolytics, expectorants and histamine antagonists. disease by infection, exacerbation of asthma by infection, Available results on effectiveness of zinc,9,10 echinacea11—13 streptococcal tonsillitis, peritonsillar infection, pneumonia, and inhalations with steam14 are too inconsistent to relay on. mastoiditis, etc.), other diseases with similar symptoms Only for Vitamin C does there seem to be some evidence for (e.g. allergic rhinitis), immunosuppressing diseases (e.g. a declining duration of illness. Simasek and Blendino15 and AIDS) or medication (e.g. Cyclosporin), dementia, and coag- the Cochrane-Review of Douglas et al.16 found that Vitamin ulopathy. C prophylaxis may modestly reduce the duration and sever- ity of the common cold in the general population and may Randomisation reduce the incidence of the illness in persons exposed to physical and environmental stresses. After enrolling in the study, patients were allocated to Specific therapy with antibiotics is probably due to mostly intervention (autologous blood therapy) and control group viral etiology only marginally effective (common cold,17 (placebo) by a specially instructed practice nurse, who acute otitis,18 acute bronchitis,19 acute laryngitis,20 and contacted the study centre (Institute of General Practice, acute sinusitis21). Side effects of antibiotics outweigh the university of Frankfurt/Main) in order to ask the sequence benefit, especially for primary care a prudent use of antibi- of randomisation. In order to avoid an unbalanced allocation otics is strictly recommended.22 Exception is the acute of samples inside a practice, for each practice a blocked pharyngitis caused by Streptococcus pyogenes.23 From a randomisation list was prepared. Although effects on the public health point of view the widespread use of antibiotics effectiveness of autologous blood therapy are not known, gives rise to a growing number of resistant bacteria strains. an influence of illness duration before initiation of treat- Because on the one hand there is no really effective ther- ment is theoretically possible. Therefore randomisation was apy for the common cold and on the other hand there are stratified for 72 h and 4—7 days as illness duration before no sufficient data on the effectiveness of autologous blood initiation of treatment. therapy for the common cold, a need for a prospective study on this matter is evident. An effective therapy option could Test treatment be an alternative to the use of antibiotics in this indication. Considering the burden of illness (high rate of incidence and After randomisation patients were asked for three appoint- sick leave) an effective reduction of illness duration is rele- ments within one week to conduct the test treatment, vant for patient and employer. In order to provide basic data preferably on days 1, 2, and 4. Due to weekends and banking we aimed to test autologous blood therapy vs. placebo. holidays variations in sequence were allowed. Autologous blood therapy was realised by a venous blood sample (2 ml) Methods from a cubital vein and gluteal intramuscular reinjection. There were no homeopathic additives or vitamin prepara- tions. The control group received 2 ml of sterile sodium Design and setting chloride solution instead of the blood sample. At each appointment the doctor was expected to monitor participat- A randomized double-blinded placebo-controlled study was ing patients for complications arising from original infection conducted in a primary care setting. Twenty practices of or test treatment. general practitioners (11 of them specialized in complemen- tary medicine) in two cities (Frankfurt and Wetzlar) and Blinding their rural surrounding areas were involved in the study from 20 November 2003 until 28 February 2007 (four winter The doctors recruited and monitored patients but were seasons). blind to the therapy, because conduction of the blood ther- Medical practices were recruited out of a practice apy and separate documentation was the task of a picked network belonging to the university department of Frank- nurse in each practice. The nurses were specially instructed furt/Main (Institute of General Practice) and of a physician on site by two of the authors (SH + MS). In order to blind organisation (Hessian society of physicians for Naturopathy). treatment to the patient the placebo injection had to be Practices were not randomly selected. Some doctors were conducted slowly and with sodium chloride solution at room- practising as doctor of naturopathic medicine and experi- temperature. The syringe was prepared with tape or with enced in autologous blood therapy. The majority of doctors a paper cover in a separate practice room. Patients were were interested in naturopathy but were practising as usual required to turn around before applying intramuscular injec- general practitioners. tion of either verum or placebo. Eligibility criteria for participants Finding of data Patients (18—75 years of age) were asked by the practice The main criterion was time period of illness after initi- doctor to take part in the study when they consulted the ation of treatment. Illness was measured by a subjective Autologous blood therapy for common cold 259 rating scale adapted from Jackson.24 In this symptom diary, should be continued in case of injection-related complica- usually used for studies for common cold, patients moni- tion with harmless course (e.g. streptococcal tonsillitis, light tored the severity (0—3 points: absent, mild, moderate, or pneumonia) beside an antibiotic therapy. severe) of eight common cold symptoms (nasal discharge, nasal congestion, sneezing, cough, malaise, throat discom- Statistics fort, fever/chills, and headache). We modified the score adding the symptom ‘‘pain in the limbs’’. A score below Null-hypothesis was that the primary endpoint time period 3 points on three consecutive days was the cut-off crite- of illness after initiation of treatment was the same in the rion for illness.

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