Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial
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《英国医生杂志》
1 Pain Treatment Unit, Centro de Salud "Dos Hermanas A" (Distrito Sanitario Sevilla-Sur), 41700 Dos Hermanas, Spain, 2 Distrito Sanitario Sevilla-Sur, Alcalá de Guadaira 41500, Spain, 3 Research Support Unit, Hospital Costa del Sol, 29600 Marbella, Spain, 4 Department of Social Psychology, Universidad de Sevilla, 41018 Sevilla, Spain, 5 Servicio Andaluz de Salud, Servicio de Ordenación Sanitaria, 41001 Sevilla, Spain, 6 Municipal Medical Services, 41927 Mairena del Aljarafe, Spain, 7 Pain Treatment Unit, Centro de Salud "Castilleja de la Cuesta," 41950 Castilleja de la Cuesta, Spain
Correspondence to: J Vas jvas@acmas.com
Abstract
Osteoarthritis is the most common form of joint disease, and its most common location is the knee.1 As the population ages or the disease worsens, osteoarthritis is associated with incapacity and a deteriorating quality of life owing to increased pain, loss of mobility, and the consequent loss of functional independence.2 As a result, osteoarthritis is often treated by medical or surgical intervention. The general increase in life expectancy means that increasing numbers of people present with osteoarthritis of the knee and have a reduced quality of life. Pain relief treatment is therefore a fundamental aspect in dealing with this illness.
In patients in whom standard medical practice (pharmacological treatment) is ineffective and who are not candidates for surgery (or who reject it), other pain management procedures should be considered.3 The role of acupuncture in osteoarthritis of the knee is still a matter of controversy, and few comparative studies of acupuncture and non-steroidal anti-inflammatory drugs (NSAIDs) for its treatment have been conducted.4 A recent systematic review concluded that a moderate degree of evidence exists that the effect of the acupuncture treatment could be due to the placebo,5 and further studies are therefore necessary to determine the true role of acupuncture.
We analysed the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical functioning during treatment; modifications in the consumption of diclofenac during treatment; and changes in patients' quality of life.
Materials and methods
Recruitment took place between January 2001 and December 2002. We selected 97 patients to participate in the study, all of whom agreed to take part. Table 2 lists the baseline characteristics of the patients; we found no clinically relevant differences in the variables that we analysed (total WOMAC, pain visual analogue scale, PQLC) at baseline. Of the nine patients who dropped out of the study, one out of 48 (2.1%) was in the treatment group and abandoned the programme because of fear of the acupuncture process, and eight of 49 (16.3%) were in the control group (six left due to lack of improvement and two for personal reasons; fig 2). The only significant difference between completers and non-completers was their age (they were six years older than non-completers; P = 0.03). Adverse effects after acupuncture treatment were limited to three patients who reported bruising at one of the acupuncture points (SP9).
In the intention to treat analysis, the WOMAC index presented a greater, and significant, reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8; the magnitude of the reduction was greater in the subscale of functional activity (17.5, 11.0 to 24.0). The same result was observed in the pain visual analogue scale (reduction 26.6, 18.5 to 34.8). A reduction of 53.9 was observed in the total accumulated number of diclofenac tablets for the intervention group compared with the control group (24.7 to 83.1). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability and psychological functioning (table 3).
Table 3 Bivariant analysis by intention to treat. Data are mean (SD) scores
Discussion
Creamer P, Hochberg MC. Osteoarthritis. Lancet 1997;350: 503-8.
Felson DT. The epidemiology of knee osteoarthritis: results from the Framingham osteoarthritis study. Semin Arthritis Rheum 1990;20(3 suppl 1): 42-50.
Vas J, Perea-Milla E, Mendez C. Acupuncture and moxibustion as an adjunctive treatment for osteoarthritis of the knee—a large case series. Acupunct Med 2004;22(1): 23-28.
Perrot S, Menkes CJ. Nonpharmacological approaches to pain in osteoarthritis. Available options. Drugs 1996;52(suppl 3): 21-6.
Ferrandez IA, Garcia OL, Gonzalez GA, Meis Meis MJ, Sanchez Rodriguez BM. . Aten Primaria 2002;30(10): 602-8. (In Spanish.)
Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum 1986;29: 1039-49.
Ahlb?ck S. Osteoarthrosis of the knee. A radiographic investigation. Acta Radiol Diagn (Stockh) 1968;(suppl 72).
Silva Ayzaguer LC. Muestreo para la investigación en ciencias de la salud. Madrid: Ediciones Díaz de Santos; 1993.
Cheng XN. Chinese acupuncture and moxibustion. Beijing: Foreign Languages Press, 1987.
Cobos R, Vas J. Manual de Acupuntura y Moxibustión. Beijing: Morning Glory; 2000.
Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet 1998;352: 364-5.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988;15: 1833-40.
Siegrist J, Broer M, Junge A. Profil der Lebensqualit?t Chronischkranker (PLC). G?ttingen: Hogrefe Verlag, 1996.
Brown BW. DSTPLAN calculations for sample sizes and related problems . Version 4.2. Houston: University of Texas, 2000.
Christensen BV, Iuhl IU, Vilbek H, Bulow HH, Dreijer NC, Rasmussen HF. Acupuncture treatment of severe knee osteoarthrosis. A long-term study. Acta Anaesthesiol Scand 1992;36: 519-25.
Berman BM, Singh BB, Lao L, Langenberg P, Li H, Hadhazy V, et al. A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee. Rheumatology (Oxford) 1999;38: 346-54.
Yurtkuran M, Kocagil T. TENS, electroacupuncture and ice massage: comparison of treatment for osteoarthritis of the knee. Am J Acupunct 1999;27(3-4): 133-40.
Takeda W, Wessel J. Acupuncture for the treatment of pain of osteoarthritic knees. Arthritis Care Res 1994;7(3): 118-22.(Jorge Vas, chief medical )
Correspondence to: J Vas jvas@acmas.com
Abstract
Osteoarthritis is the most common form of joint disease, and its most common location is the knee.1 As the population ages or the disease worsens, osteoarthritis is associated with incapacity and a deteriorating quality of life owing to increased pain, loss of mobility, and the consequent loss of functional independence.2 As a result, osteoarthritis is often treated by medical or surgical intervention. The general increase in life expectancy means that increasing numbers of people present with osteoarthritis of the knee and have a reduced quality of life. Pain relief treatment is therefore a fundamental aspect in dealing with this illness.
In patients in whom standard medical practice (pharmacological treatment) is ineffective and who are not candidates for surgery (or who reject it), other pain management procedures should be considered.3 The role of acupuncture in osteoarthritis of the knee is still a matter of controversy, and few comparative studies of acupuncture and non-steroidal anti-inflammatory drugs (NSAIDs) for its treatment have been conducted.4 A recent systematic review concluded that a moderate degree of evidence exists that the effect of the acupuncture treatment could be due to the placebo,5 and further studies are therefore necessary to determine the true role of acupuncture.
We analysed the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical functioning during treatment; modifications in the consumption of diclofenac during treatment; and changes in patients' quality of life.
Materials and methods
Recruitment took place between January 2001 and December 2002. We selected 97 patients to participate in the study, all of whom agreed to take part. Table 2 lists the baseline characteristics of the patients; we found no clinically relevant differences in the variables that we analysed (total WOMAC, pain visual analogue scale, PQLC) at baseline. Of the nine patients who dropped out of the study, one out of 48 (2.1%) was in the treatment group and abandoned the programme because of fear of the acupuncture process, and eight of 49 (16.3%) were in the control group (six left due to lack of improvement and two for personal reasons; fig 2). The only significant difference between completers and non-completers was their age (they were six years older than non-completers; P = 0.03). Adverse effects after acupuncture treatment were limited to three patients who reported bruising at one of the acupuncture points (SP9).
In the intention to treat analysis, the WOMAC index presented a greater, and significant, reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8; the magnitude of the reduction was greater in the subscale of functional activity (17.5, 11.0 to 24.0). The same result was observed in the pain visual analogue scale (reduction 26.6, 18.5 to 34.8). A reduction of 53.9 was observed in the total accumulated number of diclofenac tablets for the intervention group compared with the control group (24.7 to 83.1). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability and psychological functioning (table 3).
Table 3 Bivariant analysis by intention to treat. Data are mean (SD) scores
Discussion
Creamer P, Hochberg MC. Osteoarthritis. Lancet 1997;350: 503-8.
Felson DT. The epidemiology of knee osteoarthritis: results from the Framingham osteoarthritis study. Semin Arthritis Rheum 1990;20(3 suppl 1): 42-50.
Vas J, Perea-Milla E, Mendez C. Acupuncture and moxibustion as an adjunctive treatment for osteoarthritis of the knee—a large case series. Acupunct Med 2004;22(1): 23-28.
Perrot S, Menkes CJ. Nonpharmacological approaches to pain in osteoarthritis. Available options. Drugs 1996;52(suppl 3): 21-6.
Ferrandez IA, Garcia OL, Gonzalez GA, Meis Meis MJ, Sanchez Rodriguez BM. . Aten Primaria 2002;30(10): 602-8. (In Spanish.)
Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum 1986;29: 1039-49.
Ahlb?ck S. Osteoarthrosis of the knee. A radiographic investigation. Acta Radiol Diagn (Stockh) 1968;(suppl 72).
Silva Ayzaguer LC. Muestreo para la investigación en ciencias de la salud. Madrid: Ediciones Díaz de Santos; 1993.
Cheng XN. Chinese acupuncture and moxibustion. Beijing: Foreign Languages Press, 1987.
Cobos R, Vas J. Manual de Acupuntura y Moxibustión. Beijing: Morning Glory; 2000.
Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet 1998;352: 364-5.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988;15: 1833-40.
Siegrist J, Broer M, Junge A. Profil der Lebensqualit?t Chronischkranker (PLC). G?ttingen: Hogrefe Verlag, 1996.
Brown BW. DSTPLAN calculations for sample sizes and related problems . Version 4.2. Houston: University of Texas, 2000.
Christensen BV, Iuhl IU, Vilbek H, Bulow HH, Dreijer NC, Rasmussen HF. Acupuncture treatment of severe knee osteoarthrosis. A long-term study. Acta Anaesthesiol Scand 1992;36: 519-25.
Berman BM, Singh BB, Lao L, Langenberg P, Li H, Hadhazy V, et al. A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee. Rheumatology (Oxford) 1999;38: 346-54.
Yurtkuran M, Kocagil T. TENS, electroacupuncture and ice massage: comparison of treatment for osteoarthritis of the knee. Am J Acupunct 1999;27(3-4): 133-40.
Takeda W, Wessel J. Acupuncture for the treatment of pain of osteoarthritic knees. Arthritis Care Res 1994;7(3): 118-22.(Jorge Vas, chief medical )