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

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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