Write an AMA narrative essay (550-600 words) considering these questions: How does each article compare experimental and control arms? Were significant results found in both papers? How was significance determined, if at all. What statistical analysis was performed? Which of the two papers had a more developed statistical analysis? Which was the stronger paper? The paper should be a formal AMA paper with a title page and references.
The goal of this assignment is to examine the statistical methods of a pilot study Berman BM, Lao L, Greene M, et al. Efficacy of traditional Chinese acupuncture in the treatment of symptomatic knee osteoarthritis: a pilot study. Osteoarthritis Cartilage. 1995;3(2):139-142. doi:10.1016/S1063-4584(05)80046-9 and a larger and better funded paper Witt C, Brinkhaus B, Jena S, et al. Acupuncture in patients with osteoarthritis of the knee: a randomized trial. The Lancet. 2005;366(9480):136-143. doi:10.1016/S0140-6736(05)66871-7 Write an AMA narrative essay (550-600 words) considering these questions: How does each article compare experimental and control arms? Were significant results found in both papers? How was significance determined, if at all. What statistical analysis was performed? Which of the two papers had a more developed statistical analysis? Which was the stronger paper? The paper should be a formal AMA paper with a title page and references. PII: S1063-4584(05)80046-9 Osteoarthritis and Cartilage (1995) 3, 139-142 © 1995 Osteoarthritis Research Society 1063-4584/95/020139 + 04 $08.00)0 OSTEOARTHRITIS and CARTILAGE SHORT COMMUNICATION Eff icacy o f t rad i t iona l Chinese a c u p u n c t u r e in the t r e a t m e n t of s y m p t o m a t i c k n e e os teoar thr i t i s : a pi lot s tudy Introduction/Summary ALTHOUGH OSTEOARTHRITIS (OA) of the knee is a common and frequently disabling disease among the elderly, there is current ly neither any specific nor curative therapy for this condition. Current medical management emphasizes the use of patient education, acetaminophen, non- steroidal anti-inflammatory drugs, physical and occupational therapy, and, occasionally, intra- ar t icular steroid injections. Additional therapies include topical capsaicin cream, tidal joint lavage, injections of hyaluronic acid and arthro- scopic debridement [1]. There has recently been renewed interest in unconvent ional medicine in- cluding acupuncture; indeed, arthri t is is the third most common condition for which people seek al ternative care in the United States [2]. The percentage of patients with arthri t is who have visited an al ternat ive practi t ioner has been reported to range from 25-54% in the United Kingdom [3]. Acupuncture is an accepted treat- ment for arthri t is in Asian countries, and OA has been recognized by the World Heal th Organ- ization as an indication for acupuncture treat- ment [4]. Although acupuncture has been practised for thousands of years, studies of its efficacy in patients with OA have given conflict- ing results [5, 6]. In planning a randomized con- trolled trial of acupuncture, w e conducted a pilot study using validated outcome measures to obtain preliminary data on efficacy and tolerabil- i ty in 12 patients with symptomatic knee OA. These data suggest tha t t radit ional Chinese acu- puncture may be effective in relieving symptoms Submitted 27 June 1994; accepted 9 September 1994. This work was supported by the Maurice Laing Foundation and Thera Trust. Address reprint requests to: Dr B. M. Berman, University of Maryland School of Medicine, 419 W. Redwood St, Suite 470B, Baltimore, MD 21201, U.S.A. and improving function in patients with knee OA. Methods Twelve patients, 10 African-Americans (nine women and one man) and two Caucasians (one woman and one man) with a mean _+ s tandard devi- at ion (S.D.) age of 69 __ 8 years and mean dura t ion of disease of 11 _+ 10.6 years were enrolled in the study (Table I). All had a clinical diagnosis of knee OA and symptoms which were not adequately controlled on standard medical therapy. All patients fulfilled the American College of Rheuma- tology criteria for OA of the knee [7] and had at least moderate pain in one or both knees for most days in the past month, a global assessment by the pat ient of at least moderate severity, and Kellgren and Lawrence grade 2 or higher changes on stand- ing bilateral knee radiographs [8]. Pat ients were excluded from part icipation for the following: (1) intra-art icular corticosteroids within 4 weeks prior to acupuncture therapy; (2) history of bleeding diathesis, including current use of oral anticoagu- lants; (3) any severe chronic or uncontro l led comorbid disease; and (4) use of any investiga- t ional drug within 4 weeks. All patients underwent a standardized baseline assessment including a detailed examination of the knees, the Western Ontario McMaster (WOMAC) Osteoarthri t is Index [9], the Lequesne Algofunctional Index [10], global assessments of severity by both patient and phys- ician, and a timed 50-foot walk. A single unblinded physician (MKG) performed all examinations and assessments. Patients were instructed not to make any changes in their background therapies during the study. Each patient was then evaluated and treated by an experienced, registered acupuncturis t (LL). Patients received treatments twice a week for 8 weeks; all symptomatic knees were treated. Each 139 140 Berman et al.: Efficacy of acupuncture in knee OA t r ea tment involved s tandard cleansing of the skin with alcohol and inser t ion of disposable, sterile, 2.5 cm, 34-gauge, 0.22 mm diameter needles to a convent ional depth of 1-1.5cm [11]. The acupuncture point selection was based on t radi t ional Chinese medicine theory which specifies the use of points both local and distal on meridians which t raverse the area of pain [4]. The following points were used; local: Yangl inquan (GB 34), Yinl inquan (Sp 9), Zhusanli (St 36), Dub± (St 35) and extra point Xiyan; and distal: Kun lan (UB 60), Xuanzhong (GB 39), Sanyinj iao (Sp 6) and Taixi (Kid 3) (Fig. 1). The 'De-Q±' sensation, a local sensation of heaviness, numbness, soreness, or paresthesia tha t accompanies the insert ion of needles during acupuncture , was achieved in all patients at all nine points. Electr ical s t imulat ion (Electro-Stimulator 4C) with low frequency, 2.5- 4 Hz, was applied only at points Dub± (St 35) and Xiyan; these points were chosen because of the i r location in the infrapate l lar area. All needles were left in place for 20 min. No o ther manipula t ion of needles was performed. After 4 and 8 weeks of t r ea tment and then again at 12 weeks, the pat ients completed both the WOMAC and Lequesne questionnaires, a t imed 50-foot walk and evaluated their global change from baseline as e i ther worse, unchanged, a li t t le (25%) better, moderate ly (50%) bet ter or markedly (75%) better. In addition, the physician indepen- dently assessed thei r global change from baseline using the same five-point scale. The change in individual scores on the WOMAC and Lequesne Indices and change in 50-foot walk time between baseline (week 0) and weeks 4, 8 and 12 for each par t ic ipant were analyzed using Wilcoxon's signed rank test for paired data with 2-tailed P values. R e s u l t s / D i s c u s s i o n At entry, these patients had moderate-to-severe symptomatic OA of the knee with a mean WOMAC score of 54 ± 14 units (possible range 0-96) and a mean Lequesne score of 16 _+ 3 units (possible range 1-24); the mean time to walk 50 feet was 13.9 +_ 4.4 s (Table I). All pat ients re tu rned for the 4 week assessment. At week 4, there was a significant decline in the Lequesne score of 3 + 2 units (P 4 0.01), in the WOMAC score of 8 + 13 units (P ~< 0.05),="" and="" in="" the="" 50-foot="" walk="" time="" of="" 1.4="" ±="" 2.0="" s="" (p="" 4="" 0.02)="" (table="" ii).="" two="" pat="" ients="" did="" not="" r="" e="" tu="" rn="" at="" week="" 8;="" one="" dropped="" ou="" t="" for="" lack="" of="" efficacy="" while="" the="" other="" claimed="" sufficient="" efficacy="" and="" re="" tu="" rned="" for="" the="" 12="" week="" evaluat="" ion.="" among="" the="" 10="" pat="" ients="" examined="" at="" week="" 8,="" the="" improve-="" ment="" in="" all="" outcome="" measures="" was="" greater;="" the="" decline="" in="" the="" lequesne="" index="" was="" 6="" +="" 3="" units="" (p="" ~="" 0.01),="" in="" the="" 50-foot="" walk="" time="" was="" 3.0="" +__="" 2.3="" s="" (p="">< 0.01),="" and="" in="" the="" womac="" index="" was="" 14="" +="" 20="" units="" (table="" h).="" at="" week="" 12,="" the="" improvement="" in="" all="" the="" outcome="" measures="" was="" significant;="" the="" decline="" in="" the="" lequesne="" index="" was="" 4="" +="" 3="" units="" (p="">< 0.01),="" in="" the="" 50-foot="" walk="" time="" was="" 3.2="" +="" 2.7="" s="" (p="">< 0.01), and in the womac index was 10 ± 15 units (p ~ 0.05) (table ii). the percentage of pat ients ra t ing their global improvement as moderate or marked was 33% at 4 weeks, 60% at 8 weeks and 73°//0 at 12 weeks. the physician independent ly ra ted their global improvement as moderate or marked in 42% at 4 weeks, 70% at 8 weeks and 64~/o at 12 weeks. there were no significant adverse side effects and all pat ients tolerated the t rea tments well. these pilot data suggest tha t acupuncture is well to lera ted and associated with significant improve- ment in both self-reported pain and funct ion and table i demographic and baseline data on patients with oa of the knee treated with acupuncture disease body mass kellgren- patient age duration 0.01),="" and="" in="" the="" womac="" index="" was="" 10="" ±="" 15="" units="" (p="" ~="" 0.05)="" (table="" ii).="" the="" percentage="" of="" pat="" ients="" ra="" t="" ing="" their="" global="" improvement="" as="" moderate="" or="" marked="" was="" 33%="" at="" 4="" weeks,="" 60%="" at="" 8="" weeks="" and="" 73°//0="" at="" 12="" weeks.="" the="" physician="" independent="" ly="" ra="" ted="" their="" global="" improvement="" as="" moderate="" or="" marked="" in="" 42%="" at="" 4="" weeks,="" 70%="" at="" 8="" weeks="" and="" 64~/o="" at="" 12="" weeks.="" there="" were="" no="" significant="" adverse="" side="" effects="" and="" all="" pat="" ients="" tolerated="" the="" t="" rea="" tments="" well.="" these="" pilot="" data="" suggest="" tha="" t="" acupuncture="" is="" well="" to="" lera="" ted="" and="" associated="" with="" significant="" improve-="" ment="" in="" both="" self-reported="" pain="" and="" funct="" ion="" and="" table="" i="" demographic="" and="" baseline="" data="" on="" patients="" with="" oa="" of="" the="" knee="" treated="" with="" acupuncture="" disease="" body="" mass="" kellgren-="" patient="" age="">