normal approximations of the type I error probability, and as- sess the performance of different interim analysis strategies. It also presents two computer programs implementing these methods. Reprinted from Controlled Clinical Trials, Volume 20, Gu M, Leung Lai T, Determination of power and sample size in the design of clinical trials with failure-time endpoints and interim analyses, 423-38, 1999, with permisson from El- sevier Science Inc.

Journal of Manipulative and Physiological Therapeutics Volume 23 • Number 5 • June 2000

Journal Abstracts

375

clinically similar to chronic bronchitis, such as cystic fibro- sis. Alternatively, these therapies may be based on clinical observations or in vitro studies that suggest a potential thera- peutic benefit. Establishment of these therapies is likely to require more extensive investigation before their use is rou- tinely recommended. Until such data is available, the clini- cian can only use his or her clinical judgment regarding the likely risk-benefit ratio.

Jackson KG,Taylor GRJ, ClohessyAM,Williams CM. The effect of the daily intake of inulin on fasting lipid, insulin and glucose concentra- tions in middle-aged men and women. Br J Nutri 1999;82:23-30.

ABSTRACT: The present study was carried out to examine the effect of

the daily intake of 10 g inulin on fasting blood lipid, glucose and insulin levels in healthy middle-aged men and women with moderately raised total plasma cholesterol (TC) and tria- cylglycerol (TAG) levels. This study was a double-blind ran- domized placebo-controlled parallel study in which fifty-four middle-aged subjects received either inulin or placebo for a period of 8 weeks. Fasting blood samples were collected be- fore the supplementation period (baseline samples 1 and 2, separated by 1 week) and at weeks 4 and 8, with a follow-up at week 12. Compared with baseline values, insulin concentra- tions were significantly lower at 4 weeks (P < 0.01) in the in- ulin group. There was a trend for TAG values, compared with baseline, to be lower in the inulin group at 8 weeks (P < 0.08) returning to baseline concentrations at week 12. On compari- son of the inulin and placebo groups, the fasting TAG re- sponses ovei" the 8-week test period were shown to be signifi- cantly different (P < 0.05, repeated measures ANOVA), which was largely due to lower plasma TAG levels in the inulin group at week 8. The percentage change in TAG levels in the inulin group during the 8-week study was shown to correlate with the initial TAG level of the subjects (r~--0.499, P = 0.004). We therefore conclude that the daily addition of 10 g inulin to the diet significantly reduced fasting insulin concentrations dur- ing the 8-week test period and resulted in lower plasma TAG levels, particularly in subjects in whom fasting TAG levels were greater than 1.5 mmol/1. These data support findings from animal studies that fructans influence the formation and/or degradation of TAG-rich lipoprotein particles, and the insulin data are also consistent with recent studies showing at- tenuation of insulin levels in fructan-treated rats.

Jones KL, Robbins RA. Alternative therapies for chronic bronchitis.

Am J Med Sci 1999;318:96-8.

ABSTRACT: Alternative therapies for chronic bronchitis are therapies

in which clinical efficacy is not well established. These can be broadly divided into expectorants, mucolytics, mucoki- netics, antiproteases, antioxidants, and immunostimulants. Data supporting these therapies may be present in disorders

Kannus P, NatriA, PaakkalaT, Jiirvinen M, FinlandT. An outcome study of chronic patellofemoral pain syndrome. Seven-year follow-up of pa- tients in a randomized, controlled trial. J Bone Joint SurgAm 1999;81:355-63.

ABSTRACT: Background: We determined prospectively the long-term

outcomes of nonoperative treatment of chronic patello- femoral pain syndrome.

Methods: Of forty-nine patients in a prospective, random- ized, double-blind study of unilateral chronic patellofemoral pain syndrome in the knee, forty-five were reexamined seven years after the initial trial of treatment. In the earlier trial, the short-term (six-month) effects of intra-articular injections of glycosaminoglycan polysulfate combined with intensive quadriceps-muscle exercises were compared with those of injections of a placebo combined with exercises and with those of exercises alone. At seven years, the follow-up consisted of standardized subjective, functional, and clinical assessments and muscle-strength measurements as well as magnetic resonance imaging, radiography, and bone-densi- tometry measurements of the knee.

Results: At six months, complete subjective, functional, and clinical recovery had occurred in almost three-fourths of the patients and, with the numbers available for study, neither significant nor clinically important differences among the three initial treatment groups were detected. The subjective and functional parameters showed few changes between six months and seven years; almost three-fourths of the patients still had full subjective and functional recovery at the time of the latest follow-up. However, according to the physician's clinical evaluation, the number of patients who had no symp- toms on the patellar compression and apprehension tests de- creased over time, from forty-two (93 percent) and forty (89 percent) of forty-five patients at six months to thirty (67 per- cent) and thirty-one (69 percent) at seven years; these changes were significant (p = 0.002 and p = 0.023, respec- tively). The number of patients who had crepitation on the patellar compression test increased over time, from twenty- six (58 percent) at six months to thirty-six (80 percent) at seven years (p = 0.021). The physician's overall assessment showed a similar trend, with thirty-four patients (76 percent) having had complete recovery at six months compared with thirty (67 percent) at seven years; however, with the numbers available, this change was not significant (p = 0.420). Mag- netic resonance imaging, performed for thirty-seven patients, revealed no abnormalities in twenty-four (65 percent), mild abnormalities in four (11 percent), moderate abnormalities fa

376 Journal of Manipulative and Physiological Therapeutics Volume 23 • Number 5 • June 2000 Journal Abstracts

25 to 75 percent decrease in the thickness of the cartilage) in seven (19 percent), and overt patellofemoral osteoarthritis in two (5 percent) at seven years.

Conclusions: The seven-year overall outcome was good in approximately two-thirds of the patients. However, the remaining patients still had symptoms or objective signs of a patellofemoral abnormality.

Kazemi M. Degenerative rotator cuff tear in an elderly athlete: a case report. JCCA 1999;43:104-10.

ABSTRACT: The incidence of rotator cuff tear increases with age.

Degenerative rotator cuff tears are commonly seen in ath- letes above 40 years. These athletes are commonly involved in overhead activities. Repetitive microtrauma is a more important factor in rotator cuff degeneration than acute trau- ma. Conservative treatment is the mainstay treatment for these injuries. A case report of an elderly athlete who sailed competitively is presented. The clinical and radiographic presentations, management and rehabilitation of degenera- tive rotator cuff tears are discussed.

Li B, Marshall D, Roe M,Aspden RM. The electron microscope appearance of the subehondral bone plate in the human femoral head in osteoarthritis and osteoporosis. J Anat 1999; 195:101 - I 0.

ABSTRACT: The subchondral bone plate supports the articular cartilage

in diarthrodial joints. It has a significant mechanical function in transmitting loads from the cartilage into the underlying cancellous bone and has been implicated in the destruction of cartilage in osteoarthritis (OA) and its sparing in osteoporosis (OP), but little is known of its composition, structure or mate- rial properties. This study investigated the microscopic ap- pearance and mineral composition of the subchondral bone plate in femoral heads from patients with OA or OP to deter- mine how these correspond to changes in composition and stiffness found in other studies. Freeze-fractured full-depth samples of the subchondral bone plate from the femoral heads of patients with osteoarthritis, osteoporosis or a matched con- trol group were examined using back scattered and secondary emission scanning electron microscopy. Other samples were embedded and polished and examined using back-scattered electron microscopy and electron probe microanalysis. The appearances of the samples from the normal and osteoporotic patients were very similar, with the subchondral bone plate overlaid by a layer of calcified cartilage. Osteoporotic sam- ples presented a more uniform fracture surface and the rela- tive thicknesses of the layers appeared to be different. In con- Ira,st, the OA bone plate appeared to be porous and have a much more textured surface. There were occasional sites of microtrabecular bone formation between the trabeculae of the underlying cancellous bone, which were not seen in the other groups, and more numerous osteoclast resorption pits. The calcified cartilage layer was almost absent and the bone plate

was apparently thickened. The appearance of the osteo- arthritic subchondral bone plate was, therefore, considerably different from both the normal and the osteoporotic, strongly indicative of abnormal cellular activity. Reprinted with the permission of Cambridge University Press.

Liu PY, LeBlanc M, Desai M. False positive rates for randomized phase II designs. Control Clin Trials 1999;20:343-52.

ABSTRACT: The randomized Phase II design for the purpose of select-

ing a treatment for eventual Phase III testing has recently gained popularity in cancer clinical research. Unfortunately, along with its wider use also come frequent misapplications. The major misuse of the design is the treatment of the Phase II results as ends in themselves without further, definitive evaluation. For binary and censored exponential survival data, we quantify the chance of observing "impressive" between-group differences when underlying distributions are exactly the same in 2-, 3-, and 4-arm selection designs. Depending on one's view of what is impressive, the "false- positive" rates range from 20% to over 40%. We stress that randomized Phase II results are pilots to Phase III evalua- tions. One should not regard them as conclusive. We caution especially against the inclusion of control arms in such designs because of the propensity for erroneous inferences. We also discuss the inappropriate practice of performing post-hoc hypothesis testing and presenting p-values that are less than 0.05. © Elsevier Science Inc. 1999.

Shacklock MO. Case report: the clinical application of central pain mechanisms in manual therapy. Austr J Physiother 1999;45:215-21.

ABSTRACT: Treatment of central pain mechanisms is a new horizon

for manual therapists. This paper presents key points about central pain mechanisms and how they can be treated by the manual therapist. Included are facets of conditioning, mem- ory and learning; some types of central problems and cogni- tive-behavioral and physical techniques for use by manual therapists. The concept of treatment through central pain mechanisms is concluded with a case study illustrating the relevant clinical application. Education of central pain mechanisms and, for that matter, the pain paradigm, should become an integral part of physiotherapy education.

Shuyuan G, Donglan Z, Yanguang X. A comparative study on the treatment of migraine headache with combined distant and local acupuncture points versus conventional drug therapy. Am J Acupunct 1999;27:27-30.

ABSTRACT: According to Chinese medicine, the differential diagnosis

of migraine headache may be classified based on the state of the viscera, channels and collaterals. In this study, acupunc-