Capsaicin for Osteoarthritis Pain


Study, duration

n

Age (years) Sex (M:F)

OA site

Formulation

Outcomes

Rate of application site burning

Deal 1991 (Deal et al. 1991) 4 weeks

70

61 25M:45F

Knee

0.025 % capsaicin

VAS pain −13.9 %, p = 0.061

23/52 (44 %) capsaicin; 1/49 (0.02 %) placebo patient

Pain (categories) −0.35, p = 0.053

Global evaluation −0.39, p = 0.051

McCarthy 1992 (McCarthy and McCarty 1992) 4 weeks

14

65 ± 2 5M:9F

Hand

0.075 % capsaicin

Pain VAS ~−40 % (p < 0.02)

7/7 capsaicin; 0/7 placebo

Tenderness scores ~ −30 % p < 0.02. No effect on grip strength, joint swelling, duration of morning stiffness or function

Altman 1994 (Altman et al. 1994) 12 weeks

113

62 ± 12¥

Knee

0.025 % capsaicin

Pain VAS Significant differences by week 4, effect size −9 mm at week 12

26/36 (46 %) of capsaicin users

Tenderness Less tenderness in capsaicin group by week 8 (p = 0.03)

Global assessment (physician) significant improvement by week 4 (p = 0.042). Patient assessment by week 4 (p = 0.023)

Pain severity (categorical) and HAQ: no differences

McCleane 2000 (McCleane 2000) 5 weeks

200

~49 ± 14 78M:89F

Hip, knee, shoulder, hand

0.025 % capsaicin ± 1.33 % GTN

VAS pain scores Difference between GTN + capsaicin and GTN or capsaicin alone p < 0.05

Not reported

Analgesic use Difference between any actives and placebo p < 0.05, Adding GTN to capsaicin has additive effect. GTN application reduced burning sensation when combined with capsaicin

Schnitzer 2012 (Schnitzer et al. 2012) 12 weeks + extension

695

61 33 %:67 %

Knee

0.075 % civamide Placebo 0.01 % civamide

Primary outcomes (12 weeks) using TWA WOMAC pain p = 0.009. WOMAC physical function: p ≤ 0.001

35 % in capsaicin group, 11 % in placebo p ≤ 0.001

Subject global evaluation p = 0.008. Pain and physical function effect sizes greater in patients with higher pain scores

Kosuwon 2010 (Deal et al. 1991) 4 weeks treatment

70

61 (44–82) years 0M:61F

Knee

0.025 % capsaicin

VAS pain−0.72, p ≤ 0.05

66.6 % of patients during the capsaicin phase versus 16.6 % patients during placebo phase; p ≤ 0.05

WOMAC pain −3.42, p ≤ 0.05

WOMAC function −8.97, p ≤ 0.05


¥No data on sex ratios in Altman 1994 (3)

Data given only for whole cohort (rheumatoid arthritis and osteoarthritis)

VAS visual analog scale; GTN glycerol trinitrate; IA intra–articular; OA osteoarthritis; NSAIDs non–steroidal anti–inflammatory drugs; ACR American College of Rheumatology criteria; KL Kellgren and Lawrence classification; WOMAC Western Ontario and McMaster University Osteoarthritis Index; HAQ Health Assessment Questionnaire; BMI body mass index; TWA mean time weighted average (area under the curve/days of observation)

KL Kellgren and Lawrence classification

JSW Joint space width



Studies included in Table 11.1 assess the effect of treatment with capsaicin (or capsaicin–like compounds) for 4–12 weeks in older adults with OA of the knee (Deal et al. 1991; Schnitzer et al. 2012; Kosuwon et al. 2010), hand (McCarthy and McCarty 1992), and a mixture of joints (Altman et al. 1994; McCleane 2000). Inclusion and exclusion criteria varied between trials but patients were typically required to have at least moderate pain and either radiological evidence of OA or be clinically diagnosable as having OA, or both.



11.6 Treatment Efficacy Within Placebo–Controlled Trials


Studies described in Table 11.1 show the efficacy of capsaicin (vs. placebo) on a range of outcomes, including pain using a visual analog scale (VAS), either a 0–100 scale or a 0–10 scale, as well as other outcomes including Western Ontario and McMaster Universities Index (WOMAC) pain, function and stiffness scales, patient and physician global evaluation, tenderness, grip strength, joint swelling, duration of morning stiffness, analgesic use, and adverse events.

VAS pain is the most commonly assessed outcome, and therefore we have further summarized the effect of capsaicin on pain intensity as assessed by visual analog scores (VAS) in Table 11.2. VAS scores have been compared using standardized mean differences in studies with available data (Deal et al. 1991; McCarthy and McCarty 1992; Altman et al. 1994; McCleane 2000; Kosuwon et al. 2010), using Review Manager (Revman) version 5.2 (The Cochrane Collaboration, Copenhagen). By convention (Cohen 1988), the standardized mean difference values of 0.2, 0.5, and 0.8 are considered small, medium, and large. Table 11.2 shows that capsaicin has a medium sized effect (SMD = 0.44) on pain intensity in patients with painful OA over 4 weeks of treatment. Results were remarkably consistent across trials with no heterogeneity, suggesting no dose response from different doses of capsaicin, and no difference in the effect of capsaicin on OA of different sites (e.g. hand vs. knee).


Table 11.2
Forest plot comparing changes in VAS pain score over 4 weeks of treatment with capsaicin in patients with painful osteoarthritis








































































































Study or subgroup

Capsaicin

Placebo

Weight (%)

Std. mean difference

Year

Std. mean difference

Mean

SD

Total

Mean

SD

Total

IV random, 95 % CI

IV random, 95 % CI

Deal 1991

33.4

18

36

19.5

23

34

14.3

0.67 [0.19, 1.15]

1991

A312106_1_En_11_Figa_HTML.gif

Mc Carthy 1992

55

31.7

7

19

29.1

7

2.5

1.11 [−0.05, 2.26]

1992

Altman 1994

29

15.1

57

20

18.7

56

23.7

0.53 [0.15, 0.90]

1994

McCleane 2000

0.49

2.37

40

0.08

2.05

40

17.3

0.18 [−0.26, 0.62]

2000

Kosuwon 2010

2.04

1.93

99

1.31

1.97

99

42.2

0.37 [0.09, 0.65]

2010

Total (95 % CI)
   
239
   
236

100.0

0.44 [0.25, 0.62]
 

Heterogeneity Tau2 = 0.00; Chi2 = 3.88, df = 4(P = 0.42); I 2 = 0 %

Test for overall effect Z = 4.69 (P < 0.00001)

Most studies report capsaicin use over 4 weeks, with only, two studies continued treatment beyond 4 weeks (Altman et al. 1994; Schnitzer et al. 2012), both of which reported that continuing use was associated with beneficial effects. The study reported by Altman et al. (1994) demonstrated that the maximum difference between groups occurred at 4 weeks, and differences between groups remained similar between weeks 4 and 12. Schnitzer et al. (2012) report that differences in groups increase over time, even up to 20 weeks. These studies demonstrate that treatment with capsaicin is associated with benefits for treatment periods exceeding 4 weeks but that 4 weeks is probably sufficient for a therapeutic trial.

Two studies reported assessments of how patients reported the overall impression of treatment effectiveness (symptoms better, much better or completely gone) after 4 weeks. Capsaicin treated patients had a 40 % increased likelihood of reporting that their symptoms were at better after 4 weeks of treatment (Table 11.3). Schnitzer’s study reported that after 12 weeks, the Osteoarthritis Research Society International (OARSI) simplified response was 10 % greater in civamide-treated patients (Schnitzer et al. 2012), suggesting that response to treatment continues up until at least 12 weeks.
Mar 4, 2017 | Posted by in PHARMACY | Comments Off on Capsaicin for Osteoarthritis Pain

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