Abstract
Introduction
Psoriasis is a chronic inflammatory skin disease that affects 1% to 3% of the population, in some people causing changes to the nails and joints as well as skin lesions.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-drug (other than ultraviolet light), topical drug, ultraviolet light, and systemic drug treatments for chronic plaque psoriasis? What are the effects of combined treatment with drugs plus ultraviolet light for chronic plaque psoriasis? What are the effects of combined systemic plus topical drug treatments for chronic plaque psoriasis? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2007 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 122 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, adding calcipotriol (topical) to psoralen plus ultraviolet light A or ultraviolet light B, adding oral retinoids to psoralen plus ultraviolet A (PUVA), alefacept, balneotherapy, ciclosporin, dithranol, T cell-targeted therapies, cytokine blocking agents, emollients (alone or plus ultraviolet light B), etanercept, fish oil supplementation, fumaric acid derivatives, Goeckerman treatment, heliotherapy, infliximab, Ingram regimen, keratolytics (salicylic acid, urea), leflunomide, methotrexate, oral pimecrolimus, oral retinoids (alone or with ultraviolet light B), phototherapy plus balneotherapy, psoralen plus ultraviolet A, psychotherapy, systemic drug treatments plus topical vitamin D derivatives, tars, tazarotene, topical corticosteroids (alone or plus oral retinoids), topical Vitamin D derivatives, ultraviolet light A, and ultraviolet light B.
Key Points
Psoriasis affects 1% to 3% of the population, causing changes to the nails and joints in addition to skin lesions in some people.
We don't know whether treatments that might affect possible triggers, such as acupuncture, balneotherapy, fish oil supplementation, or psychotherapy, improve symptoms of psoriasis, as we found few studies.
There is consensus that topical emollients and salicylic acid are effective as initial and adjunctive treatment for people with chronic plaque psoriasis, but we don't know whether tars are effective.
Dithranol may improve lesions compared with placebo. It may be less effective than topical vitamin D derivatives such as calcipotriol.
Topical potent corticosteroids may improve psoriasis compared with placebo, and efficacy may be increased by adding tazarotene, oral retinoids, or vitamin D and derivatives, or by wrapping in occlusive dressings. Short-term, placebo-controlled randomised trials of topical corticosteroids and vitamin D derivatives are still currently performed in psoriasis, mainly for regulatory purposes. From a clinical point of view, there is no need for further trials of this sort; however, there is still a need for additional long-term or comparative trials.
We don't know whether tars are more effective than ultraviolet light or vitamin D derivatives in people with chronic plaque psoriasis.
CAUTION: Tazarotene, vitamin D and derivatives, and oral retinoids are potentially teratogenic and are contraindicated in women who may be pregnant.
Heliotherapy, PUVA, and ultraviolet B (UVB) may improve lesions and reduce relapse, but increase the risks of photo-ageing and skin cancer.
There is consensus that heliotherapy and UVB are beneficial.
Methotrexate and ciclosporin seem similarly effective at clearing lesions and maintaining remission, but both can cause serious adverse effects.
Oral retinoids may improve clearance of lesions, alone or with ultraviolet light, but may be less effective than ciclosporin.
Cytokine inhibitors (etanercept, infliximab, and adalimumab) and T cell-targeted therapies (alefacept, efalizumab) may improve lesions, but long-term effects are unknown.
We don't know whether leflunomide improves psoriasis.
The Ingram regimen is considered effective, but we don't know whether Goeckerman treatment or other combined treatments are beneficial.
Clinical context
About this condition
Definition
Chronic plaque psoriasis, or psoriasis vulgaris, is a chronic inflammatory skin disease characterised by well demarcated, erythematous, scaly plaques on the extensor surfaces of the body and scalp. The lesions may occasionally itch or sting, and may bleed when injured. Dystrophic nail changes or nail pitting are found in more than one third of people with chronic plaque psoriasis, and psoriatic arthropathy occurs in 1% to more than 10%. The condition waxes and wanes, with wide variations in course and severity among individuals. Other varieties of psoriasis include guttate, inverse, pustular, and erythrodermic psoriasis. This review deals only with treatments for chronic plaque psoriasis and does not cover nail involvement or scalp psoriasis.
Incidence/ Prevalence
Psoriasis affects 1% to 3% of the general population. It is believed to be less frequent in people from Africa and Asia, but we found no reliable epidemiological data to support this.
Aetiology/ Risk factors
About one third of people with psoriasis have a family history of the disease, but physical trauma, acute infection, and some medications (e.g., lithium and beta-blockers) are believed to trigger the condition. A few observational studies have linked the onset or relapse of psoriasis with stressful life events, and with personal habits including cigarette smoking and, less consistently, alcohol consumption. Others have found an association between psoriasis and body mass index (BMI), and with a diet low in fruit and vegetables.
Prognosis
We found no long-term prognostic studies. With the exceptions of erythrodermic and acute generalised pustular psoriasis (severe conditions that affect less than 1% of people with psoriasis, and require intensive hospital care), psoriasis is not known to affect mortality. Psoriasis may substantially affect quality of life, by influencing a negative body image and self-image, and by limiting daily activities, social contacts, and work. One systematic review (search date 2000, 17 cohort studies) suggested that severe psoriasis may be associated with lower levels of quality of life than mild psoriasis. At present, there is no cure for psoriasis. However, in many people it can be well controlled with treatment, at least in the short term.
Aims of intervention
To achieve short-term suppression of symptoms, and long-term modulation of disease severity; to improve quality of life, with minimal adverse effects of treatment.
Outcomes
Symptom improvement: Clearance or improvement of lesions over time, often measured by Psoriasis Area and Severity Index (PASI) score; use of routine treatments; maintenance of remission in people with psoriasis clearance or previous response: duration of remission, relapse; quality of life: patient satisfaction and autonomy; disease-related quality of life; adverse effects of treatment on clinical outcomes of interest. Although PASI scores are used to measure outcome in most of the included RCTs, we found no documented evidence that such clinical activity scores are reliable proxies for these symptom improvements. Some trials attempt to overcome score limitations by converting PASI scores into categories of response deemed to be clinically important: for example, at least a 75% reduction in score from baseline (PASI 75) or at least a 90% reduction in score from baseline (PASI 90). Many trials provide no explicit criteria for severity. The effects of placebo treatment have been found to vary across studies in an unpredictable way. Improvements with standardisation of study designs, entry criteria, and outcome measures are needed.
Methods
Clinical Evidence search and appraisal August 2007. The following databases were used to identify studies for this systematic review: Medline 1966 to August 2007, Embase 1980 to August 2007, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2007, Issue 3. Additional searches were carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) — for Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA), Turning Research into Practice (TRIP), and NICE. We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the author for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews and RCTs in any language, at least single-blinded, and containing more than 20 people of whom more than 80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as "open", "open label", or not blinded unless blinding was impossible. Short-term, placebo-controlled randomised trials of topical corticosteroids and vitamin D derivatives are still currently performed in psoriasis, mainly for regulatory purposes. We therefore add only longer-term trials, or trials that compare the effectiveness of these treatments versus other psoriasis treatments. We also searched for cohort, case control, RCT, and meta-analysis studies on specific harms of interventions. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. The contributors identified supplementary references through additional electronic literature searches, contact with other experts in the field, and hand searches of several dermatological and medical journals for the years 1976–2004 as a project of the European Dermatoepidemiology Network. The journals searched were the Journal of Investigative Dermatology, British Journal of Dermatology, Dermatology, Acta Dermo-Venereologica, Archives of Dermatology, Journal of the American Academy of Dermatology, Annales de Dermatologie et de Vénéréologie, Giornale Italiano di Dermatologia e Venereologia, Hautarzt, BMJ, Lancet, Journal of the American Medical Association, and New England Journal of Medicine. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as RRs and ORs. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
Table.
GRADE Evaluation of interventions for Psoriasis (chronic plaque).
| Important outcomes | Adverse effects, Maintenance of remission, Quality of life, Symptom improvement | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of non-drug treatments (other than ultraviolet light) for chronic plaque psoriasis? | |||||||||
| 1 (56) | Symptom improvement | Acupuncture versus sham acupuncture | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (50) | Symptom improvement | Balneotherapy versus placebo | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data. Directness points deducted for uncertainty about disease severity and method of assessing improvement |
| 4 (325) | Symptom improvement | Fish oil versus placebo | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for incomplete reporting of results. Directness points deducted for uncertainty about disease severity and method of assessing improvement |
| 1 (25) | Maintenance of remission | Fish oil versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting. Directness point deducted for unclear assessment of efficacy |
| What are the effects of topical drug treatments for chronic plaque psoriasis? | |||||||||
| 3 (1672) | Symptom improvement | Tazarotene versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 3 (1198) | Symptom improvement | Tazarotene plus topical corticosteroids versus tazarotene plus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (106) | Symptom improvement | Tazarotene plus topical corticosteroids versus vitamin D derivatives | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 16 (2817) | Symptom improvement | Vitamin D derivatives versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for method of assessing improvement |
| 1 (97) | Maintenance of remission | Vitamin D derivatives versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 3 (681) | Symptom improvement | Different vitamin D derivatives versus each other | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for method of assessing improvement |
| 9 (1875) | Symptom improvement | Vitamin D derivatives versus topical corticosteroids | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for statistical heterogeneity between studies. Directness points deducted for uncertainty about disease severity and method of assessing improvement |
| 6 (1143) | Symptom improvement | Vitamin D derivatives versus dithranol | 4 | 0 | 0 | –2 | 0 | Low | Directness points deducted for uncertainty about disease severity and method of assessing improvement |
| 1 (80) | Symptom improvement | Vitamin D derivatives versus dithranol plus coal tar | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 2 (not reported) | Symptom improvement | Vitamin D derivatives versus coal tar | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for incomplete reporting. Directness points deducted for uncertainty about disease severity and method of assessing improvement |
| 1 (46) | Symptom improvement | Vitamin D derivatives plus dithranol versus dithranol alone | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (143) | Symptom improvement | Vitamin D derivatives plus fumaric acid esters versus fumaric acid esters alone | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 3 (not reported) | Symptom improvement | Dithranol versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (not reported) | Symptom improvement | Salicylic acid versus placebo | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for incomplete reporting. Directness points deducted for uncertainty about disease severity and method of assessing improvement |
| 17 (1686) | Symptom improvement | Topical corticosteroids versus placebo | 4 | 0 | 0 | –2 | 0 | Low | Directness points deducted for uncertainty about disease severity and method of assessing improvement |
| 1 (90) | Maintenance of remission | Topical corticosteroids versus placebo | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data. Directness points deducted for uncertainty about disease severity and method of assessing improvement |
| 2 (131) | Symptom improvement | Topical corticosteroids plus occlusive dressings versus topical corticosteroids alone | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and methodological weaknesses. Directness point deducted for uncertainty about method of assessing improvement |
| 8 (less than 4507) | Symptom improvement | Topical corticosteroids plus vitamin D derivatives versus vitamin D derivatives alone | 4 | 0 | –1 | –1 | 0 | Low | Consistency point deducted for conflicting results. Directness point deducted for method of assessing improvement |
| 1 (20) | Adverse effects | Coal tar plus fatty acids versus coal tar alone | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| What are the effects of ultraviolet light treatments for chronic plaque psoriasis? | |||||||||
| 1 (95) | Symptom improvement | Heliotherapy versus no intervention | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (1005) | Maintenance of remission | PUVA versus no treatment | 4 | 0 | 0 | –1 | +1 | High | Directness point deducted for mixed population. Effect-size point added for RR 0.2–0.5 |
| 3 (208) | Symptom improvement | High-dose psoralen in PUVA versus low-dose psoralen in PUVA | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 2 (207) | Symptom improvement | Comparison of different formulations of the same oral psoralen in PUVA regimens | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 2 (137) | Symptom improvement | Oral versus bath psoralen formulations in PUVA | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 2 (157) | Symptom improvement | High-dose versus low-dose PUVA | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (100) | Symptom improvement | PUVA versus PUVB | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (224) | Symptom improvement | PUVA versus other topical or systemic treatments (dithranol, tar, vitamin D analogues, corticosteroids, and fish oil) | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 2 (150) | Maintenance of remission | UVB versus no UVB | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for sparse data, and for methodological weaknesses in one RCT. Consistency point deducted for conflicting results. Directness point deducted for differences in disease severity between groups |
| 1 (100) | Symptom improvement | Narrowband UVB versus broadband UVB | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and inconsistent treatment between groups |
| 1 (113) | Symptom improvement | Twice-weekly versus three times-weekly narrowband UVB | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 3 (371) | Symptom improvement | UVB (broadband or narrowband) versus PUVA | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 1 (71) | Symptom improvement | Phototherapy plus balneotherapy versus either intervention alone | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (38) | Symptom improvement | UVA versus placebo or no treatment | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement. |
| What are the effects of systemic drug treatments for chronic plaque psoriasis? | |||||||||
| 3 (1289) | Symptom improvement | Alefacept versus placebo | 4 | 0 | +1 | –1 | 0 | High | Consistency point added for dose response. Directness point deducted for uncertainty about method of assessing improvement |
| 3 (1289) | Quality of life | Alefacept versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for uncertainty about clinical significance of results |
| 5 (3130) | Symptom improvement | Efalizumab versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for uncertainty about method of assessing improvement |
| 2 (1349) | Quality of life | Efalizumab versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for uncertainty about clinical significance of results |
| 4 (1965) | Symptom improvement | Etanercept versus placebo | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for uncertainty about method of assessing improvement |
| 3 (1853) | Quality of life | Etanercept versus placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 4 (1495) | Symptom improvement | Infliximab versus placebo | 4 | –1 | +1 | –1 | 0 | Moderate | Quality point deducted for not reporting method of randomisation in large study. Consistency point added for dose response. Directness point deducted for uncertainty about method of assessing improvement |
| 2 (627) | Quality of life | Infliximab versus placebo | 4 | –1 | +1 | 0 | 0 | High | Quality point deducted for not reporting method of randomisation in large study. Consistency point added for dose response |
| 1 (148) | Symptom improvement | Adalimumab versus placebo | 4 | 0 | 0 | –1 | +2 | High | Directness point deducted for uncertainty about method of assessing improvement. Effect-size points added for RR >5 |
| 1 (148) | Quality of life | Adalimumab versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 6 (289) | Symptom improvement | Ciclosporin versus placebo | 4 | −1 | 0 | −2 | 0 | Very low | Quality point deducted for heterogeneity in results. Directness points deducted for comparing different doses and uncertainty about method of assessing improvement |
| 2 (not clear) | Maintenance of remission | Ciclosporin versus placebo | 4 | −2 | 0 | −1 | 0 | Very low | Quality points deducted for incomplete reporting of results and no statistical analysis. Directness point deducted for uncertainty about method of assessing improvement |
| 2 (345) | Symptom improvement | Different ciclosporin formulations versus each other | 4 | 0 | 0 | −1 | 0 | Moderate | Directness point deducted for uncertainty about method of assessing improvement |
| 2 (468) | Symptom improvement | Different ciclosporin doses versus each other | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and for lack of blinding. Directness point deducted for uncertainty about method of assessing improvement |
| 4 (203) | Symptom improvement | Fumaric acid derivatives versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (37) | Symptom improvement | Methotrexate versus placebo | 4 | −3 | 0 | −2 | 0 | Very low | Quality points deducted for sparse data and methodological weaknesses. Directness points deducted for inclusion of people with non-plaque psoriasis and uncertainty about method of assessing improvement |
| 1 (88) | Symptom improvement | Methotrexate versus ciclosporin | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (88) | Maintenance of remission | Methotrexate versus ciclosporin | 4 | −1 | 0 | −1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 4 (197) | Symptom improvement | Etretinate versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (36) | Maintenance of remission | Etretinate versus placebo | 4 | −1 | 0 | −2 | 0 | Very low | Quality point deducted for sparse data. Directness points deducted for uncertainty about method of assessing severity and relapse and inclusion of PUVA |
| 2 (118) | Symptom improvement | Acitretin versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Consistency point deducted for conflicting results but added back for dose response. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (80) | Maintenance of remission | Acitretin versus placebo | 4 | –2 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data and incomplete reporting. Directness point deducted for uncertainty about assessing severity and use of corticosteroid allowed |
| 4 (508) | Symptom improvement | Acitretin versus etretinate | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for uncertainty about method of assessing improvement |
| 2 (286) | Symptom improvement | Etretinate versus ciclosporin | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for uncertainty about assessing improvement |
| 1 (190) | Symptom improvement | Leflunomide versus placebo | 4 | −1 | 0 | −2 | 0 | Very low | Quality point deducted for sparse data. Directness points deducted for inclusion of people with non-plaque psoriasis and for uncertainty about method of assessing improvement |
| 1 (143) | Symptom improvement | Pimecrolimus versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| What are the effects of combined treatment with drugs plus ultraviolet light for chronic plaque psoriasis? | |||||||||
| 1 (53) | Symptom improvement | Ingram regimen versus dithranol alone | 4 | −2 | 0 | −1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 6 (305) | Symptom improvement | Oral retinoids plus PUVA versus PUVA alone | 4 | −1 | 0 | 0 | +2 | High | Quality point deducted for incomplete reporting of results. Effect-size points added for RR <0.2 |
| 2 (100) | Symptom improvement | Oral retinoids plus UVB (broadband or narrowband) versus oral retinoids alone or UVB alone | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about method of assessing improvement |
| 9 (552) | Symptom improvement | PUVA or UVB plus calcipotriol versus either PUVA or UVB alone | 4 | −1 | 0 | −1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for uncertainty about disease severity |
| 2 (71) | Symptom improvement | Goeckerman treatment versus UVB alone or UVB plus emollients | 4 | −2 | 0 | −1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (43) | Symptom improvement | UVB radiation plus emollient versus UVB alone | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| What are the effects of combined systemic plus topical drug treatments for chronic plaque psoriasis? | |||||||||
| 3 (296) | Symptom improvement | Retinoids (oral) plus corticosteroids (topical) versus either treatment alone | 4 | −1 | 0 | −1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for uncertainty about method of assessing improvement |
| 1 (135) | Symptom improvement | Oral retinoid plus calcipotriol versus oral retinoid alone | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (69) | Symptom improvement | Calcipotriol plus ciclosporin versus ciclosporin alone | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.
Glossary
- Beck Depression Inventory
Standardised scale to assess depression. This instrument consists of 21 items to assess the intensity of depression. Each item is a list of 4 statements (rated 0, 1, 2, or 3), arranged in increasing severity, about a particular symptom of depression. The range of scores possible are 0 = least severe depression to 63 = most severe depression. It is recommended for people aged 13 to 80 years. Scores of more than 12 or 13 indicate the presence of depression.
- Body mass index (BMI)
A measure of obesity, defined as the weight (in kg) divided by the square of the height (in metres).
- Dermatology Life Quality Index
Validated 10-item questionnaire for assessing quality or life in people with various skin conditions, including psoriasis. Overall score ranges from 0 to 30, with a higher score indicating a lower quality of life.
- Goeckerman treatment
A daily application of coal tar followed by ultraviolet B irradiation.
- Hamilton Depression Rating Scale
a measure of depressive symptoms using 17 items, with total scores from 0 to 54 (higher scores indicate increased severity of depression).
- High-quality evidence
Further research is very unlikely to change our confidence in the estimate of effect.
- Ingram regimen
A daily application of dithranol (sometimes in combination with coal tar bath) plus ultraviolet B irradiation.
- Investigator Assessment of Global Improvement
A measure of overall change in lesion severity from baseline, scored on a 6- or 7-point scale, where the lowest score indicates worsening and the highest score indicates clearing of lesions. May also be referred to as the Physician's Global Assessment.
- Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
- Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
- Physician's Global Assessment
See Investigator assessment of global improvement.
- Psoriasis Area and Severity Index (PASI) score
Composite score grading severity of psoriasis in four body regions according to erythema, scaling, thickness, and the total area of skin affected. Severity of each of erythema, scaling, and thickness is graded from 0–4, and extension in each body region is graded from 1–6. The final composite score ranges from 0–72, with a higher score indicating a greater severity of psoriasis.
- SF-36
A scale that assesses health-related quality of life across 8 domains: limitations in physical activities (physical component); limitations in social activities; limitations in usual role activities owing to physical problems; pain; psychological distress and wellbeing (mental health component); limitations in usual role activities because of emotional problems; energy and fatigue; and general health perceptions.
- Total Severity Score
Assesses signs (redness, scaling, and thickness) and symptoms (itching) of psoriasis on 3- or 4-point scales. The scores for all signs and symptoms are summed to obtain the total severity score, which typically ranges from 0 to 12, where a higher score indicates greater severity.
- Ultraviolet A
315 nm to 400 nm ultraviolet radiation.
- Very low-quality evidence
Any estimate of effect is very uncertain.
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.
Contributor Information
Luigi Naldi, Centro Studi GISED, Bergamo, Italy.
Berthold Rzany, Klinik für Dermatologie Universittsklinikum Mannheim, Mannheim, Germany.
References
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