CUPPING THERAPY

HEALTH TECHNOLOGY ASSESSMENT SECTION MEDICAL DEVELOPMENT DIVISION MINISTRY OF HEALTH MALAYSIA 010/2012
i

DISCLAIMER Technology review is a brief report, prepared on an urgent basis, which draws on restricted reviews from analysis of pertinent literature, on expert opinion and / or regulatory status where appropriate. It has not been subjected to an external review process. While effort has been made to do so, this document may not fully reflect all scientific research available. Additionally, other relevant scientific findings may have been reported since completion of this review. Please contact: htamalaysia@moh.gov.my, if you would like further information.

Health Technology Assessment Section (MaHTAS), Medical Development Division Ministry of Health Malaysia Level 4, Block E1, Precinct 1 Government Office Complex 62590 Putrajaya Tel Fax : 603 88831246 : 603 8883 1230

Available at the following website: http://www.moh.gov.my

ii

Prepared by: Dr. Hanin Farhana Kamaruzaman Assistant Director Health Technology Assessment Section (MaHTAS) Ministry of Health Malaysia Reviewed by: Datin Dr Rugayah Bakri Deputy Director Health Technology Assessment Section (MaHTAS) Ministry of Health Malaysia

DISCLOSURE The author of this report has no competing interest in this subject and the preparation of this report is totally funded by the Ministry of Health, Malaysia.

iii

EXECUTIVE SUMMARY Introduction Cupping therapy is a physical treatment which refers to a technique that uses small glass cups or bamboo jars as suction devices that are placed on the skin. This method is mostly used in Asian and Middle Eastern countries. Cupping is believed to have potential benefit in treating myriad types of disease and conditions. The most common conditions were pain related such as chronic muscle pain, low back pain, neuralgia pain, fibromyalgia and headache. This technology review was requested by the Director of Traditional and Complementary Medicine (TCM), Ministry of Health Malaysia to evaluate the therapeutic effect of cupping therapy on certain diseases or conditions. Objective/aim To assess the efficacy, effectiveness and safety of cupping therapy in treating diseases or medical conditions such as herpes zoster, facial paralysis, back pain, spondylosis, cerebrovascular accident, hypertension, fibromyalgia, bronchitis, asthma and headache. Results and conclusions Three full text articles (one systematic review and two systematic reviews with meta-analysis) were included in this technology review discussing the efficacy and effectiveness of cupping therapy, with or without comparative treatments. As for safety issues, 2 articles discussed on the adverse effects of cupping therapy. This review showed that there is insufficient high quality evidence to support the effectiveness of cupping therapy in treating diseases or medical conditions such as herpes zoster, facial paralysis, back pain, spondylosis, cerebrovascular accident, hypertension, fibromyalgia, bronchitis, asthma and headache. Although cupping therapy is considered relatively safe and no major adverse effects were reported directly on the therapy itself, it is very important to ensure that the practitioners are properly trained and aware of the dangers involved in the cupping therapy.

Methods Electronic databases were searched through the MEDLINE(R) In-process and other Non-Indexed Citations and Ovid MEDLINE(R) 1948 to present, EBM Reviews - Cochrane Central Register of Controlled Trials and EBM Reviews Health Technology Assessment. Other database was PubMed, Cochrane Library, Australia & New Zealand Horizon Scanning Network (ANZHSN) and US Food & Drugs Administration (US FDA).

iv

1.

INTRODUCTION Cupping therapy is a physical treatment which refers to a technique that uses small glass cups or bamboo jars as suction devices that are placed on the skin.1 It has been used for thousands of years, said to be as early as 3000 BC. However, the earliest recorded evidence of cupping is in Ebers Papyrus, one of the oldest medical textbooks in the world which described that in 1550 BC, Egyptians used cupping as one of the treatment method. In ancient Greece, Hippocrates used cupping for internal disease and structural problems. This method is mostly used in Asian and Middle Eastern countries and has been claimed to reduce pain and other symptoms.2 Originally, practitioners would use hollowed-out animal horns for cups and place them over particular points or meridians on the body, especially the back part of the torso.2 Today, most therapists use cups made of thick glass or plastic, although bamboo, iron and pottery cups are still being used in some countries. Glass cups are the preferred method of therapy because they do not break as easily as pottery or deteriorate like bamboo, and they allow the therapists to see the skin and evaluate the effects of treatment. 1 In general, there are two types of cupping therapy, dry cupping and wet cupping. Dry cupping is the process using vacuum on different areas of the body in order to accumulate blood in that area without any incisions made. Olive oil may be applied to the cupping area to allow easy movements of the cups and create a massaging effect. In wet cupping, small incisions or puncture are made on the skin using small razor or needle before treatment. When the cup is applied and the skin is drawn up using vacuum, a small amount of blood may flow from the puncture sites, which are believed to help removing harmful substances and toxins from the body.1 Cupping is believed to have potential benefit in treating myriad types of disease and conditions. The most common conditions were pain related, including chronic muscle pain, low back pain, neuralgia pain, fibromyalgia, headache and migraine.3 Other common diseases that were also treated with cupping therapy are cough, common cold, facial paralysis, herpes zoster, stroke rehabilitation, hypertension, sinusitis, acne and others. 3 In oriental countries such as China and Korea, cupping therapy has been applied as a formal modality in hospitals and act as a complementary therapy to the current modern medicine.4 This technology review was requested by the Director of Traditional and Complementary Medicine (TCM), Ministry of Health Malaysia to evaluate the therapeutic effect of cupping therapy on certain diseases or conditions.

2.

OBJECTIVE/AIM To assess the efficacy, effectiveness and safety of cupping therapy in treating diseases or medical conditions such as herpes zoster, facial paralysis, back pain, spondylosis, cerebrovascular accident, hypertension, fibromyalgia, bronchitis, asthma and headache.

3.

TECHNICAL FEATURES There are several ways used by acupuncturists or other traditional complementary therapists to create the suction in the cups. Conventionally, therapists swab alcohol onto the bottom of the cup, or using a cotton ball soaked in alcohol, then lighting it and applied the cup immediately against the skin.1 This method utilized the flaming heating power to achieve suction through negative pressure inside the cups and apply them on the desired part of the body. This type of vacuum method is still in use today, although most current modern therapists who use vacuum technology therapeutically rely on machines that pull the air out of the cupped part of the patients skin. Vacuum machine can be set so that the pressure inside the chamber is at a specific strength. Depending on the conditions being treated, the cups will be left in place for 5 to 30 minutes. Several cups may be placed on a patients body at the same time. . Some practitioners will also apply small amounts of medicated oils or herbal oils to the skin just before the cupping procedure, which allow them to move the cups. Apart from dry cupping and wet cupping, there are some other methods of cupping being practiced worldwide such as:

a) Moving / massage cupping Prior to applying the cups, oil is administered to the skin to facilitate smooth movements of the cups, giving a massage effect. b) Needle/ acupuncture cupping Acupuncture and cupping are done in the same place, by applying acupuncture needle first then cupping over the needle. c) Flash cupping Cupping are performed several times in quick succession along the area being treated to promote blood circulation. d) Water cupping This technique involves filling a glass or bamboo cup one-third full with warm water and pursuing the cupping process quickly without spilling the water.

e) Medicinal / herbal cupping Bamboo cups and herbs prescribed by traditional medicine practitioner were immersed in water, boiled and simmered for 30 minutes before applying. The steam from boiled herbs will provide vacuum as well as therapeutic effect.

3.1

Mechanisms of Action The mechanisms of action of cupping therapy and its curative process are not yet discovered by modern science like in the case of acupuncture. The postulated modes of actions include the interruption of blood circulation and congestion as well as stopping the inflammatory extravasations from the tissues.5 Others have postulated that cupping could affect the autonomic nervous system and help to reduce pain .5 However, none of these theories are proven and established in scientific view.

Figure 1 : Three types of cups glass, bamboo and pottery Figure 2 : Method in creating vacuum by flaming the alcohol-swabbed cup and apply it to the skin

Figure 3 : Modern cupping set. Image available at :

http://img06.taobaocdn.com/imgextra/i6/120484/T2t6haXjRaXXXXXXXX_!!120484.jpg

Figure 4 : Wet / Bleeding cupping. Image available at:

http://www.thejakartapost.com/files/images/p19-b-1_17.jpg

4. 4.1.

METHODS Searching Electronic databases were searched through the MEDLINE(R) In-process and other Non-Indexed Citations and Ovid MEDLINE(R) 1948 to present, EBM Reviews - Cochrane Central Register of Controlled Trials and EBM Reviews - Health Technology Assessment. Other database was PubMed, Cochrane Library, Australia & New Zealand Horizon Scanning Network (ANZHSN) and US Food & Drugs Administration (US FDA). The search terms used can be referred in Appendix 1.

4.2.

Selection A reviewer screened the titles and abstracts against the inclusion and exclusion criteria and then evaluated the selected full-text articles for final article selection. The inclusion and exclusion criteria were: Inclusion criteria Population Herpes zoster, facial paralysis, Bells palsy, back pain, spondylosis, stroke, cerebrovascular accident, cerebral stroke, brain vascular accident, hypertension, fibromyalgia, bronchitis, asthma, headache Interventions Cupping therapy alone or cupping therapy combined with other therapies (other traditional complementary therapy such as acupuncture, or conventional therapy) Comparators Conventional therapy, medicines, placebo Outcomes Efficacy/effectiveness and safety of cupping therapy Study design Randomized control trials, systematic reviews, metaanalysis, case control, cohort and descriptive studies Type of English publication Exclusion criteria Study design Abstract, animal study Type of Other language than English publication Relevant articles were critically appraised using Critical Appraisal Skills Programme (CASP) and evidence graded according to the US / Canadian Preventive Services Task Force (Appendix 2).

5.

RESULTS AND DISCUSSION Three full text articles were included in this technology review discussing the efficacy and effectiveness of cupping therapy, with or without comparative treatments. As for safety issues, 2 articles discussed on the adverse effects of cupping therapy.

5.1

EFFICACY / EFFECTIVENESS OF CUPPING THERAPY The three studies included in this technology review were one systematic review and two systematic reviews with meta-analysis. Cao et al conducted a systematic review and meta-analysis to evaluate the therapeutic effect of cupping therapy for specific disease or conditions. The eligible studies were randomized controlled trials (RCT) that examined the effectiveness of cupping therapy, including one or more types of cupping methods, compared with no treatment, placebo, or conventional medication. Cupping combined with other interventions and compared with other interventions alone were also included. However, studies that assessing the effectiveness of cupping therapy combined with other traditional complementary (TCM) therapies, such as acupuncture, compared with nonTCM therapies were excluded. As the result, 135 studies were included in the review and different types of cupping methods were used in the trials that were selected. The six most common diseases or conditions for which cupping was applied were herpes zoster, facial paralysis (Bells plasy), , acne, cervical spondylosis, lumbar disc herniation and also cough and dyspnea. Meta-analyses were conducted on the first four of the above listed conditions and due to the heterogeneity of the RCTs of the remaining two diseases- lumbar disc herniation and cough and dyspnea- meta-analyses could not be completed. 4, level I Among the limitations in this study were the inconsistency of the outcome measures that has been used by each and every single RCTs that were included in this systematic review. The included trials used composite non-standardized outcome measures, which categorized treatment efficacy into four grades: cure, markedly effective, effective and ineffective. This classification was not internationally recognized and the exact meaning is open to various interpretations. Fifteen RCTs were included to evaluate the efficacy of wet cupping therapy in treating herpes zoster. Wet cupping therapy was found to be superior to pharmaceutical medications, such as antiviral, in providing cure (RR 2.07, CI 1.77 to 2.43, p<0.0001, 5 trials, random model) and in lowering the incidence rate of post-herpetic neuralgia (RR 0.12, CI 0.06 to 0.28, p<0.0001, 4 trials, fixed model). But no difference was identified in the number of patients with improved symptoms (RR 1.11, CI 1.00 to 1.23, p = 0.06, 5 trials, random model). Wet cupping in combination with pharmaceutical medications was significantly better than medications alone

in effecting a cure (RR 1.93, CI 1.23 to 3.04, p= 0.005, 5 trials, random model), but no difference in symptom improvement was observed (RR 1.00, CI 0.97 to 1.03, p= 0.99, 4 trials, random model). Wet cupping combined with acupuncture was superior to acupuncture alone both in providing cure (RR 1.65, CI 1.08 to 2.53, p= 0.02, 3 trials, random model) and in improving symptoms (RR 1.13, CI 1.02 to 1.25, p= 0.02, 3 trials, random model). 4 In the same review, the authors included 17 RCTs that assessed the therapeutic effect of cupping therapy for facial paralysis. However, two of the trials were excluded from meta-analysis due to the incomparability between treatment and control groups. Meta-analysis showed that flash cupping combined with acupuncture (RR 1.51, CI 1.29 to 1.76, p< 0.00001, 5 trials, fixed model) and wet cupping combined with acupuncture (RR 1.60, CI 1.33 to 1.93, p< 0.00001, 6 trials, fixed model) were markedly better than acupuncture alone in providing cure. In addition, cupping in combination with medications, such as neurotrophic drugs, was superior to medications alone in reducing average cure time (MD -6.05, CI -9.83 to -2.27, p= 0.002, 2 trials, random model).4 The review also included 6 trials in evaluating the efficacy of cupping therapy for acne. In improving the cure rate, wet cupping therapy was significantly better than medications, such as tanshinone, tetracycline and ketoconazole (RR 2.14, CI 1.42 to 3.22, p= 0.0003, 3 trials, fixed model). Furthermore, cupping therapy combined with other interventions was superior to other interventions alone (RR 1.93, CI 1.40 to 2.65, p< 0.0001, 3 trials, fixed model).4 For cervical spondylosis, 6 trials evaluated the efficacy of cupping therapy on the condition were included in the review. Cupping therapy especially wet cupping, combined with other treatment, including acupuncture and traction, was better than other treatments alone in effecting a cure (RR 1.52, CI 1.20 to 1.92, p= 0.0005, 5 trials, fixed model) and in relieving symptoms (RR 1.52, CI 1.20 to 1.92, p< 0.00001, 6 trials, fixed model). One trial compared wet cupping with flunarizine for symptom improvement, and found no difference between the two groups (RR 1.18, CI 0.60 to 2.32, p=0.63, 1 trial).4 The authors concluded that despite the large number of studies on cupping therapy, there was still lack of well-designed investigations. Of the 135 RCTs included in this review, 84.44% were categorized as having high risk of bias based on criteria from the Cochrane Handbook for Systematic Reviews of Interventions. The meta-analysis also revealed that cupping therapy combined with other treatments, be it acupuncture or medications, showed significant benefit over other treatments alone in effecting a cure for herpes zoster, facial paralysis, acne and cervical spondylosis. This appears to support the common practice in the authors country, China, of combining

TCM therapeutic modalities, either TCM with TCM, or TCM with routine modern medicine and practice, to enhance efficacy. However, due to the limitations especially high risk of bias of the studies that were included in this review, the authors suggested that it is necessary to conduct further RCTs that are of high quality and larger sample sizes in order to draw a definitive conclusion.4 From another oriental country, Republic of Korea, Kim et al conducted a systematic review to summarize and evaluate the effectiveness of cupping therapy as a singular treatment of pain. The authors included 7 RCTs that met the inclusion criteria of their review. All of the included trials adopted a two-armed parallel group design. The treated pain-related conditions were low back pain, cancer pain, trigerminal neuralgia, brachialgia paraesthetica nocturna (BPN) and herpes zoster. One RCT compared the effects of dry cupping on cancer pain with conventional drug therapy and reported favourable effects for cupping after 3-day intervention (response rate: 67% versus 43%, p<0.05). Another RCT compared dry cupping with nonsteroidal anti-inflammatory drugs in non-specific low back pain and suggested a significant difference in pain relief on Visual Analogue Scale (VAS) after treatment duration (MD 22.8 of 100mm VAS, CI 11.4 to 34.2, p< 0.001). The third RCT suggested that wet cupping reduced pain compared with analgesics in acute trigerminal neuralgia after the intervention period (response rate 93% versus 47%, p< 0.01). The fourth RCT tested wet cupping plus usual care for pain reduction compared with usual care in nonspecific low back pain and suggested significant differences in pain relief using McGill Pain Questionnaire at 3 months after 3 treatment sessions (MD 2.2 of 6 points present pain intensity; CI 1.7 to 2.6, p< 0.01). The fifth RCT reported that one session of wet cupping plus usual care significantly reduced pain during a week compared with usual care alone in patients with BPN (MD 1.6 of 10 points score, CI 0.13 to 3.07, p= 0.03). The sixth RCT showed favourable effects of one session of wet cupping on pain reduction compared with a heat pad in patients with BPN at 7 days after treatment (MD 22.9 of 100mm VAS, CI 10.5 to 35.3, p< 0.001). A further RCT of wet cupping plus conventional drugs on pain reduction compared with conventional drugs alone in patients with herpes zoster failed to show significant effects of wet cupping after interventions (response rate 100% versus 88%, p= 0.065). In conclusion, the results of this systematic review provide some suggestive evidence for the effectiveness of cupping in the management of pain conditions. However, the total number of RCTs included in the analysis and the methodological quality were too low to draw firm conclusions. Furthermore, the studies with negative outcomes or effects of cupping therapy remained unpublished thus may obscure the overall picture. 5, level 1

Cao et al conducted a systematic review and meta-analysis to evaluate the therapeutic effect and safety of traditional Chinese medicine, including Chinese herbal medicine for treatment of fibromyalgia which is characterised by chronic widespread pain multiple tender points over the body. A total of 25 RCTs were included in this review. The effects of traditional Chinese therapies in providing pain relief and restoring functionality as well as improving quality of life of the patients were studied. Three of the RCTs compared acupuncture plus cupping therapy with medications alone. However, only 2 trials were chosen for meta-analysis because of low risk of bias. The analysis on the 2 RCTs showed that a combination of acupuncture and cupping therapy plus medications was significantly better than conventional medications alone in reducing pain (pain reduction assessed using 10mm Visual Analogue Scale, MD -1.66, CI 2.14 to -1.19, p< 0.00001, I2= 0%) and reducing depression symptoms (assessment of depression symptoms using Hamilton Depression Scale (HAMD) scores, MD -4.92, CI -6.49 to -3.34, p< 0.0001, I2= 32%). The authors concluded that patients with fibromyalgia might benefit from traditional Chinese therapies however, more rigorously designed trials with larger number of patients were warranted in demonstrating the effectiveness and long term effects of these therapies.6, level 1

5.2

SAFETY OF CUPPING THERAPY Cupping therapy is considered relatively safe with no major side effects. However, it can cause some swelling and bruising on the skin. These bruises are usually painless and disappear within a few days posttreatment.1 There are several instances where cupping should not be performed. Patients with inflamed skin and those who bleed easily are not suitable candidates for cupping. Pregnant women or menstruating women and patients with bone fracture or muscle spasms are also believed to be contra-indicated.2 Cupping therapy also cannot be applied to a site of Deep Vein Thrombosis (DVT), where there are ulcers, arteries or places where pulses can be felt.2 The adverse effects of cupping therapy was briefly described in a systematic review done by Cao et al as the secondary outcomes of the review. One of the trials included in the review reported that a patient had mild scalding on the skin after having cupping therapy. However, the authors did not discussed in detail regarding that incident.6 A case study reported by Iblher et al described a significant thermal injury following cupping therapy that warranted plastic surgery assessment and management. A 59 year old Greek woman arrived at the Emergency Department of Freiburg University Hospital, Germany by ambulance and was found to have extensive truncal and upper extremity burns. The patient

reported receiving cupping treatment from her husband due to chronic back pain. Six to eight cups were heated by a burning cloth which had been soaked in petrol before ignition. The heated cups were then applied to the skin of her back. During the treatment, the petrol container fell, spilling the contents over the patient and she was subsequently caught on fire. The accident had resulted in superficial to deep partial-thickness burns to the back, abdomen, chest and right arm, involving a total body surface area of 15%. There were also rounded hematomas caused by cupping therapy itself. The patient needed debridement and silicon-collagen foil burn dressing, which required 10-day of hospital stay. No specific details whether her husband is a recognized cupping therapist. 7, level III Eventhough the incident was rare and more of the caution during the treatment process, it is important to create awareness among the public and the therapists on the risk of the injuries related to cupping therapy. 5.3 LIMITATIONS This technology review has several limitations. The selection of studies was done by one reviewer. Although there was no restriction in language during the search but only English full text articles were included in this report. Any abstracts without a full text articles were also excluded.

6. 6.1

CONCLUSION EFFICACY/EFFECTIVENESS This review suggested that there is insufficient high quality evidence to support the use of cupping therapy in treating diseases or medical conditions such as herpes zoster, facial paralysis, back pain, spondylosis, cerebrovascular accident, hypertension, fibromyalgia, bronchitis, asthma and headache. There was fair level of evidence to show the effectiveness of cupping therapy in treatment of certain disease or medical conditions, especially pain-related conditions. However, most of the trials combined cupping therapy with other traditional complementary (TCM) treatment or with conventional medications and standard therapeutic modalities that are available in the hospitals. No retrievable evidence to prove that cupping therapy as a single treatment is effective in treating any medical conditions. Another drawback that has been identified is most of the articles that reported positive effects of cupping therapy are from Chinese literature and there are hardly any studies reported in Western literature, thus, the possibility of publication bias is undeniable. The long term effect of cupping therapy is not known.

10

6.2

SAFETY Although cupping therapy is considered relatively safe and no major adverse effects reported directly on the therapy itself, it is very important to ensure that the practitioners are properly trained and aware of the dangers involved in the cupping therapy. The burns are preventable, and therefore the first step is to increase the awareness of the public and healthcare professionals on the risk of these injuries. The long term complications and adverse events related to cupping therapy is not known.

7.

REFERENCES 1. The Many Benefits of Chinese Cupping. Available http://www.itmonline.org/arts/cupping (retrieved on 14/5/2012) at :

2. Evaluation of the effects of traditional cupping on the biochemical, hematological and immunological factors of human venous blood. Available at: cdn.intechweb.org/pdfs/26488.pdf. 3. Cao H, Han M, Li X, et al. Clinical research evidence of cupping therapy in China: a systematic literature review. BMC Complement Altern Med. 2010 Nov 16;10:70. 4. Cao H, Li X, Liu J. An updated review of the efficacy of cupping therapy. PLoSOne. 2012;7(2):e31793. 5. Kim JI, Lee MS, Lee DH et al. Cupping for treating pain: a systematic review. Evid Based Complement Alternat Med. 2011;2011:467014. 6. Cao H, Liu J, Lewith GT. Traditional Chinese Medicine for treatment of fibromyalgia: a systematic review of randomized controlled trials. J Altern Complement Med. 2010 Apr;16(4):397-409. 7. Iblher N, Stark B. Cupping treatment and associated burn risk: a plastic surgeon's perspective. J Burn Care Res. 2007 Mar-Apr;28(2):355-8.

11

8. 8.1.

APPENDIX Appendix 1: LITERATURE SEARCH STRATEGY

Ovid MEDLINE In-process & other Non-Indexed citations and OvidMEDLINE 1948 to present 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. exp herpes zoster/ herpes zoster.tw. exp facial/ adj1 paralysis/ facial paralysis.tw. Bells palsy.tw. exp back pain/ back pain.tw. exp spondylosis/ spondylosis.tw. exp stroke/ stroke.tw. cerebrovascular accident$.tw. brain vascular accident$.tw. cerebral stroke.tw. exp hypertension/ hypertension.tw. exp fibromyalgia/ fibromyalgia.tw. exp bronchitis/ bronchitis.tw. exp asthma/ asthma.tw. exp headache/ headache.tw. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 Bloodletting/ or cupping therapy.mp. cupping.tw. cupping therap$.tw. (cupping adj1 therap$).tw. 26 or 27 or 28 or 29 25 AND 30

12

OTHER DATABASES EBM Reviews - Cochrane Central Register of Controlled Trials EBM Reviews - Database of Abstracts of Review of Effects EBM Reviews - Cochrane database of systematic reviews EBM Reviews Health Technology Assessment PubMed NHS economic database INAHTA FDA evaluation

Same MeSH, keywords, limits used as per MEDLINE search

13

8.2.

Appendix 2

HIERARCHY OF EVIDENCE FOR EFFECTIVENESS STUDIES DESIGNATION OF LEVELS OF EVIDENCE I Evidence obtained from at least one properly designed randomized controlled trial. Evidence obtained randomization. from well-designed controlled trials without

II-I

II-2

Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or research group. Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence. Opinions or respected authorities, based on clinical experience; descriptive studies and case reports; or reports of expert committees.

II-3

III

SOURCE:

US/CANADIAN PREVENTIVE SERVICES TASK FORCE (Harris 2001)

14