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Results for “Randomized controlled trials”

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PubMed2001

Meta-analyses in systematic reviews of randomized controlled trials in perinatal medicine: comparison of fixed and random effects models.

There is a need for empirical work comparing the random effects model with the fixed effects model in the calculation of a pooled relative risk in the meta-analysis in systematic reviews of randomized controlled trials. Such comparisons are particularly important when trial results are heterogeneous. We considered 84 independent meta-analyses in which each trial included a set of different women/newborns. These meta-analyses were included in systematic reviews published in the Cochrane Library's pregnancy and childbirth module. Twenty-one of these 84 meta-analyses demonstrated statistical heterogeneity at p<0.10. The random effects model estimates showed wider confidence intervals, particularly in those meta-analyses showing heterogeneity in the trial results. The summary relative risk for the random effects model tended to show a larger protective treatment effect than the fixed effects model in the heterogeneous meta-analyses. In this set of meta-analyses, statistical evaluation of publication bias cannot be shown to account for heterogeneity. Our empirical conclusion is that there may be opposing effects if the random effects model is used in the meta-analysis of clinical trials showing heterogeneity in the results: stronger treatment effects reflected in the summary relative risk, but wider confidence intervals about this summary measure.

Chi-Square Distribution↗

PubMedDate not supplied

Randomized controlled trials to investigate occupational therapy research questions.

The randomized controlled trial (RCT) has become the most widely accepted research design for testing the efficacy of health care interventions. The purposes of this paper are to (a) introduce the essential elements of RCTs, and (b) discuss some of the special problems faced by occupational therapists in conducting and interpreting RCTs. The CONSORT (Consolidated Standards of Reporting Trials) statement is recommended as an introduction to the components of RCT quality. Problems pertinent to the study of the efficacy of occupational therapy and related interventions include the importance of: theory, background, and rationale; treatment fidelity; theory-based outcomes; management of non-masked (non-blinded) interventionists and participants; and multiplicity of statistical analyses. This paper can help practitioners judge the quality of an RCT, and it can help the profession work toward the development of a cadre of qualified researchers who can adapt the well-established methods of RCTs to the study of occupation-based interventions.

Evidence-Based Medicine↗

PubMed1983

Randomized controlled trial of physiotherapy for postoperative pulmonary complications.

A prospective randomized controlled trial was conducted in patients undergoing elective cholecystectomy to assess the value of routine chest physiotherapy. One hundred and two patients entered the study: 47 patients developed no pulmonary complications, 29 had pulmonary atelectasis and a further 26 developed chest infection. The pattern of changes in arterial oxygen tension in the period after operation supported the clinical allocation of the patients. Of 51 patients not receiving physiotherapy, 11 developed atelectasis and 19 chest infection. Of 51 treated patients, 18 developed atelectasis and seven chest infection. Routine prophylactic postoperative chest physiotherapy decreased significantly the frequency of chest infection (P less than 0.02).

Adult↗

PubMed2003

Effects of a videotape to increase use of poison control centers by low-income and Spanish-speaking families: a randomized, controlled trial.

BACKGROUND: Poison control centers (PCCs) reduce health care costs for childhood poisonings by providing telephone advice for home management of most cases. Past research suggests that PCCs are underutilized by low-income minority and Spanish-speaking parents because of lack of knowledge and misconceptions about the PCC. A videotape intervention was designed to address these barriers to PCC use. OBJECTIVE: To evaluate the effectiveness of a videotape intervention (videotape, PCC pamphlet, and PCC stickers) in improving knowledge, attitudes, behaviors, and behavioral intention regarding use of the PCC in a low-income and predominantly Spanish-speaking population in Northern California. METHODS: Two hundred eighty-nine parents of children <6 years of age, attending educational classes at 2 Women, Infant, and Children (WIC) clinics participated in a randomized, controlled trial. WIC classes were randomized to receive the video intervention (video group) or to attend the regularly scheduled WIC class (control group). Participants completed a baseline questionnaire and 2 to 4 weeks later, a follow-up telephone interview. Changes from baseline to posttest were compared in the treatment and control groups using analysis of variance. RESULTS: Compared with the control group, the video group showed an increase in knowledge about the PCC's function, its hours of operation, and staff qualifications; was more likely to feel confident in speaking with and carrying out recommendations made by the PCC; was less likely to believe the PCC would report a mother for neglect; was more likely to have the correct PCC phone number posted in their homes; and when presented with several hypothetical emergency scenarios, was more likely to correctly answer that calling the PCC was the best action to take in a poisoning situation. CONCLUSIONS: This videotape intervention was highly effective in changing knowledge, attitudes, behaviors, and behavioral intentions concerning the PCC within this population. As a result, use of this video may help increase use of the PCC by low-income and Spanish-speaking families.

Adult↗

PubMed1995

The "optional cross-over design" for randomized controlled trials.

In order to facilitate the performance of randomized controlled trials (RCT) in situations where no "hard" endpoints can be identified and the patient's subjective impressions about success of failure of a given treatment are paramount, the "optional cross-over design" is suggested. In this design, patients are randomised to receive either active medication or placebo during phase I. At its end the patient may choose to change to the other treatment arm, if therapy was felt to be unsuccessful (= optional cross-over). In phase II, treatment continues as in phase I except for those patients who have chosen the "optional cross-over". Further cross-over points may ensue depending on the particularities of the situation, however, two such options may be adequate for most studies. At the end of the trial period, the numbers of patients in each treatment arm are counted and evaluated statistically. If an optimally successful remedy is being tested, close to 100% of the study population could finish up in the active treatment arm. If, as in most instances, the remedy is not optimally successful, this percentage will be proportionally less. If an ineffective remedy is being tested, the distribution of the total sample within the two treatment arms approaches 50:50%. The "optional cross-over design" seems suited for RCT in areas where the complex, unmeasurable and subjective experience of the patient are considered to represent adequate endpoints.

Cross-Over Studies↗

PubMed2006

A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials.

BACKGROUND: The low recruitment rates into surgical randomized controlled trials (RCTs) threaten the validity of their findings. We reviewed the reasons for nonentry of eligible patients into surgical RCTs that would form the basis for future prospective research. METHODS: A systematic review of the English language literature for studies reporting reasons for nonentry of eligible patients into surgical RCTs and of recommendations made to improve the low recruitment rates. RESULTS: We reviewed 401 articles, including 94 articles presenting the results of 62 studies: 23 reports of recruitment into real surgical RCTs, 11 surveys of patients regarding hypothetical surgical RCTs, 10 surveys of clinicians and 18 literature reviews. The most frequently reported patient-related reasons for nonentry into surgical RCTs were preference for one form of treatment, dislike of the idea of randomization, and the potential for increased demands. Distrust of clinicians caused by a struggle to understand, explicit refusal of a no-treatment (placebo) arm, and the mere inability to make a decision were frequently reported in studies of real RCTs and patient surveys, but were not emphasized in surveys of clinicians and review articles. Difficulties with informed consent, the complexity of study protocols, and the clinicians' loss of motivation attributable to lack of recognition were the most commonly reported clinician-related reasons. CONCLUSIONS: There seems to be a discrepancy between real reasons for nonentry of eligible patients into surgical RCTS and those perceived by the clinicians, which require further prospective research. A summary and discussion of main recommendations sighted in the literature is presented.

Health Status↗

PubMed1979

Randomized controlled trial of cefuroxime for established postoperative respiratory infection.

A randomized controlled trial has investigated the value of cefuroxime (a new antibiotic resistant to beta-lactamase) in 80 patients with established postoperative respiratory infection. Although the majority of respiratory isolates were sensitive to cefuroxime, there was no significant advantage in the antibiotic group compared with the controls with respect to duration of fever, radiological abnormality or infected sputum. We conclude that antibiotics are rarely necessary for the majority of patients who develop postoperative respiratory infections.

Cephalosporins↗

PubMed1995

The effect of a 12-month exercise trial on balance, strength, and falls in older women: a randomized controlled trial.

OBJECTIVE: To determine whether a 12-month program of regular exercise can improve balance, reaction time, neuromuscular control, and muscle strength and reduce the rate of falling in older women. DESIGN: A randomized, controlled trial of 12 months duration. SETTING: Conducted as part of the Randwick Falls and Fractures Study in Sydney, Australia. PARTICIPANTS: One hundred ninety-seven women aged 60 to 85 years (mean age 71.6, SD = 5.4) who were randomly recruited from the community. OUTCOME MEASURES: Accidental falls, postural sway, reaction time, neuromuscular control, and lower limb muscle strength. MAIN RESULTS: Exercise and control subjects were tested before, midway through, and at the end of the trial. At initial testing, exercisers and controls performed similarly in all tests and were well matched in relevant health and lifestyle factors. The mean number of classes attended for the 75 exercise subjects who completed the program was 60.0 (range 26-82). At the end of the trial, the exercise subjects showed improved performance in all five strength measures, in reaction time, neuromuscular control, body sway on a firm surface with the eyes open, and body sway on a compliant surface with the eyes open and closed. In contrast, there were no significant improvements in any of the test measures in the controls. In one test measure, hip flexion strength, the exercisers showed continued improvement throughout the study year. There was no significant difference in the proportion of fallers between the exercise and control subjects. Interesting trends were evident, however, between falls frequency and adherence to the exercise program. CONCLUSIONS: These findings show that exercise can produce long-term benefits with regard to improving sensorimotor function in older persons. The findings also suggest that high compliance to an exercise program may reduce falls frequency, although further studies are required to conclusively demonstrate that exercise offers an effective means of preventing falls.

Accidental Falls↗

PubMed2001

Randomized controlled trial of neural mobilization after spinal surgery.

STUDY DESIGN: Randomized controlled trial with 12-month follow-up. OBJECTIVES: To determine whether the addition of neural mobilization to standard postoperative care improved the outcome of lumbar spinal surgery. SUMMARY OF BACKGROUND DATA: It has been suggested that neural mobilization should be performed after spinal surgery to prevent nerve root adhesions and improve outcome. However, to date, there is no convincing evidence of the value of neural mobilization. METHODS: Eighty-one patients undergoing lumbar discectomy, fusion, or laminectomy at a private hospital in Sydney were randomly allocated to standard postoperative care or standard care plus neural mobilization. Neural mobilization included passive movements and active exercises designed to mobilize the lumbosacral nerve roots and sciatic tract. Primary outcome measures were global perceived effect measured on a 7-point scale, pain measured using visual analogue scales and the McGill Pain Questionnaire, and disability measured with the Quebec Disability Scale. RESULTS: All patients received the treatment as allocated with 12-month follow-up data available for 76 patients (94% of those randomized). There were no statistically significant or clinically significant benefits provided by the neural mobilization treatment for any outcome. CONCLUSIONS: The neural mobilization protocol evaluated in this study did not provide an additional benefit to standard postoperative care for patients undergoing spinal surgery. The authors advocate that this protocol not be used in clinical practice.

Analysis of Variance↗

PubMed1985

The Dublin randomized controlled trial of intrapartum fetal heart rate monitoring.

In a randomized controlled trial involving 12,964 women, a policy of continuous electronic intrapartum fetal heart monitoring was compared with an alternative policy of intermittent auscultation, both policies including an option to measure fetal scalp blood pH. Women allocated to electronic fetal heart monitoring had shorter labors and received less analgesia. The caesarean delivery rates were 2.4% for electronic fetal heart monitoring and 2.2% for intermittent auscultation but this small difference arose from the identification of nearly twice as many fetuses with low scalp pH (less than 7.20) in the electronic fetal heart monitoring group. The forceps delivery rate was 8.2% in the electronic fetal heart monitoring group compared with 6.3% in the intermittent auscultation group, and this excess was explained by more instrumental deliveries prompted by fetal heart rate abnormalities. There were 14 stillbirths and neonatal deaths in each group, with a similar distribution of causes. There were no apparent differences in the rates of low Apgar scores, need for resuscitation, or transfer to the special care nursery. Cases of neonatal seizures and persistent abnormal neurological signs followed by survival were twice as frequent in the intermittent auscultation group, and this differential effect was related to duration of labor. Follow-up at 1 year of babies who survived neonatal seizures revealed three clearly abnormal infants in each group. The implications of these findings for both theory and practice are discussed.

Adult↗

PubMed2002

Interventions led by nurse continence advisers in the management of urinary incontinence: a randomized controlled trial.

BACKGROUND: The short-term efficacy of combined lifestyle and behavioural interventions led by nurses in the management of urinary incontinence has not been rigorously evaluated by randomized controlled trial. We conducted a 6-month randomized controlled trial to determine whether a model of service delivery that included lifestyle and behavioural interventions led by "nurse continence advisers" in collaboration with a physician with expertise in continence management could reduce urinary incontinence and pad use in an outpatient population. We also aimed to evaluate the impact of this approach on subjects' knowledge about incontinence and their quality of life. METHODS: We used advertising in the mainstream media, newsletters to family physicians and community information sessions in 1991 to invite volunteers who were 26 years of age or older and suffered from incontinence to participate in a randomized controlled trial. Men and women who met the eligibility criteria were randomly allocated to receive either counselling from specialized nurses to manage incontinence using behavioural and lifestyle modification sessions every 4 weeks for 25 weeks or usual care. Symptoms of incontinence and the use of incontinence pads were the primary outcome measures. RESULTS: Using sealed envelopes, 421 patients were randomly allocated to the treatment or control groups. On average, patients in the treatment group experienced 2.1 "incontinent events" per 24 hours before treatment and 1.0 incontinent event per 24 hours at the end of the study. Control patients had an average of 2.4 incontinent events per 24 hours before the study and 2.2 incontinent events per 24 hours at the end of the study. The mean decrease in events in the treatment group was 1.2 and in the control group 0.2 (p = 0.001). Pad use declined from a mean of 2.2 per 24 hours before randomization in the treatment group to 1.2 per 24 hours at the end of the study, compared with 2.6 pads per 24 hours in the control group at the start of the study and 2.4 per 24 hours at the end. Pad use per 24 hours decreased on average by 0.9 pads in the treatment group and 0.1 in the control group (p = 0.021). INTERPRETATION: Behavioural and lifestyle counselling provided by specialized nurses with training in managing incontinence reduces incontinent events and incontinence pad use.

Adult↗

PubMedDate not supplied

Short-term responsiveness of manual thoracic end-play assessment to spinal manipulation: a randomized controlled trial of construct validity.

OBJECTIVE: To evaluate the short-term responsiveness of rotatory thoracic end-play assessment to spinal manipulation and, thereby, motion palpation construct validity. DESIGN: Prospective, single-blind, randomized, controlled trial (randomized blocks design). SETTING: Laboratory, Center for Technique Research. PARTICIPANTS: Sixty first-year chiropractic college student volunteers; seventy-three possible candidates were screened. INTERVENTIONS: The treatment group received manual high-velocity, low-amplitude rotatory manipulation. The control group received no intervention to minimize nonspecific effects of sham treatment. MAIN OUTCOME MEASURES: End-play response, defined as the change from restricted to normal end play immediately after intervention. Responsiveness, defined as the percentage of the end-play response attributable to spinal manipulation: relative response attributable to the maneuver, RRAM = (treatment group response--control group response)/treatment group response. RESULTS: Ten percent of the tests were positive for restriction of end play in left or right rotation from T3-T4 to T12-L1; the average rate was 2.1 restrictions per subject (SD = 1.4). End-play response was 60% in the treatment group, in contrast to the 37% response in the control group (z = 1.86, p = .04). More than a third of the response in the treatment group was attributable to spinal manipulation (RRAM = 39%). For one examiner, RRAM = 51%. Mild symptomatology did not affect responsiveness. CONCLUSIONS: The data suggest a moderate short-term responsiveness of rotatory thoracic end-play restriction to spinal manipulation, hence it has utility as a posttreatment evaluative test. This study was the first to use an external standard (manipulation) to demonstrate that segmental end-play restriction changes, hence end-play restriction itself, are detectable in human subjects with manual palpation by chiropractors. Further research is required to determine the generalizability of the study findings.

Adult↗

PubMed1998

Zinc gluconate and the common cold. Review of randomized controlled trials.

OBJECTIVE: To examine the evidence of seven randomized controlled trials (RCT) on the therapeutic effectiveness of zinc gluconate lozenges for treating the common cold. DATA SOURCES: Using the MeSH headings common cold and zinc gluconate, MEDLINE was searched from 1966 on for all published RCTs evaluating use of zinc gluconate for treating the common cold. STUDY SELECTION: For this study, only double-blind RCTs were included. SYNTHESIS: Fair evidence suggests that zinc gluconate lozenges have a therapeutic effect in treating the common cold. Starting therapy with zinc gluconate lozenges within 24 to 48 hours of onset of cold symptoms reduces the duration and severity of the cold. Patients must suck lozenges every 2 hours while awake during the cold. Minimum effective dose appears to be 13.3 mg of elemental zinc per lozenge. Evidence suggests that compounds such as citric acid, sorbitol, and mannitol bind the free zinc ion in the mouth, and this could account for variations in therapeutic benefit. Bad taste and nausea are important side effects of zinc lozenges. CONCLUSION: Evidence supports use of zinc gluconate lozenges for reducing the symptoms and duration of the common cold, but the side effects, bad taste, and therapeutic protocol might limit patient compliance.

Adult↗

PubMed2001

Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials.

CONTEXT: When clinicians assess the validity of randomized controlled trials (RCTs), they commonly evaluate the blinding status of individuals in the RCT. The terminology authors often use to convey blinding status (single, double, and triple blinding) may be open to various interpretations. OBJECTIVE: To determine physician interpretations and textbook definitions of RCT blinding terms. DESIGN AND SETTING: Observational study undertaken at 3 Canadian university tertiary care centers between February and May 1999. PARTICIPANTS: Ninety-one internal medicine physicians who responded to a survey. MAIN OUTCOME MEASURES: Respondents identified which of the following groups they thought were blinded in single-, double-, and triple-blinded RCTs: participants, health care providers, data collectors, judicial assessors of outcomes, data analysts, and personnel who write the article. Definitions from 25 systematically identified textbooks published since 1990 providing definitions for single, double, or triple blinding. RESULTS: Physician respondents identified 10, 17, and 15 unique interpretations of single, double, and triple blinding, respectively, and textbooks provided 5, 9, and 7 different definitions of each. The frequencies of the most common physician interpretation and textbook definition were 75% (95% confidence interval [CI], 65%-83%) and 74% (95% CI, 52%-90%) for single blinding, 38% (95% CI, 28%-49%) and 43% (95% CI, 24%-63%) for double blinding, and 18% (95% CI, 10%-28%) and 14% (95% CI, 0%-58%) for triple blinding, respectively. CONCLUSIONS: Our study suggests that both physicians and textbooks vary greatly in their interpretations and definitions of single, double, and triple blinding. Explicit statements about the blinding status of specific groups involved in RCTs should replace the current ambiguous terminology.

Double-Blind Method↗

PubMed2003

Risks of estrogen plus progestin therapy: a sensitivity analysis of findings in the Women's Health Initiative randomized controlled trial.

CONTEXT: The Women's Health Initiative (WHI) randomized controlled trial that compared estrogen plus progestin versus placebo was stopped because of a significantly increased risk of breast cancer in the active treatment group (reason 1), and because a global index supported a finding of overall harm (reason 2). The possibility that the findings could have been accounted for by bias was not considered. OBJECTIVE: The present analysis was undertaken to determine whether detection bias is a plausible alternative to causality as an explanation for those findings that contributed to the reasons for discontinuing the study. DESIGN: setting and participants: This work took the form of a sensitivity analysis of the published WHI data to determine the magnitude of the detection bias required to account for those findings that contributed to the two reasons for stopping the study. MAIN OUTCOME MEASURES: These were differences in incidence rates of breast cancer (reason 1), and breast cancer, coronary heart disease, stroke and pulmonary embolism (reason 2), among estrogen plus progestin and placebo recipients. RESULTS: In the WHI study, 44.4% of the women on active treatment, as against 6.8% of the placebo recipients, had their treatments unblinded (mainly because of vaginal bleeding). Among them, detection bias could not be excluded. For the three cardiovascular outcomes, bias became a strong likelihood after the women were twice cautioned about possible increased risks observed in the interim data among estrogen plus progestin recipients. On the null hypothesis, bias could have accounted for the observed associations if, on average, it augmented the detection of disease that would otherwise have gone undiagnosed by 0.7-0.8/1000 per year. CONCLUSIONS: For differences in incidence of the order of 0.7-0.8/1000 per year, it is not possible to discriminate between causation and detection bias as alternative explanations for the findings.

Bias↗

PubMed2001

Randomized, controlled trial of acetazolamide and furosemide in posthemorrhagic ventricular dilation in infancy: follow-up at 1 year.

OBJECTIVE: Posthemorrhagic ventricular dilation (PHVD) is a complication of intraventricular hemorrhage in preterm infants and is associated with a high risk of long-term disability. Furosemide and acetazolamide are used widely in the treatment of PHVD in the hope of avoiding the need for placement of a ventriculoperitoneal shunt, but these drugs have not been evaluated in a controlled trial. This article reports a multicenter, randomized, controlled trial designed to test the hypothesis that these drugs would reduce the rate of shunt placement (or death) and increase survival to 1 year of age without disability. METHODS: Between 1992 and 1996, 177 infants who were less than 3 months past term and had ventricular width >4 mm above the 97th centile following intraventricular hemorrhage were assigned randomly to either standard therapy or standard therapy plus drug therapy with acetazolamide (100 mg/kg/d) plus furosemide (1 mg/kg/d). Infants who were enrolled in the trial had a median gestational age of 28.6 weeks and were enrolled at a mean postnatal age of 3.6 weeks. Forty-four percent were reported to have a cerebral parenchymal lesion on ultrasound scan at randomization. The primary outcome measure of death or shunt placement (known in all but 1 infant) occurred in 56 of 88 infants who were allocated to drug plus standard therapy compared with 46 of 88 who were allocated to standard therapy. The risk ratio was 1.23 (95% confidence interval: 0.95-1.59). Neurodevelopmental outcome information at a corrected age of 1 year (known in all but 3 of 149 surviving infants) included disability or neuromotor impairment in 54 of 67 infants (81%) who were allocated to drug plus standard therapy and 52 of 69 infants (66%) who were allocated to standard therapy. Seventy-two of 85 infants (85%) who were allocated to drug therapy either died or were disabled or impaired at 1 year compared with 62 of 89 infants (70%) who were treated with standard therapy (risk ratio: 1.22; 95% confidence interval: 1.03-1.4376). The excess risk of these adverse outcomes was greater among infants who did not have a cerebral parenchymal lesion seen on ultrasound examination at trial entry. CONCLUSIONS: These results suggest that the use of acetazolamide and furosemide in preterm infants with PHVD is ineffective in decreasing the rate of shunt placement and is associated with increased neurologic morbidity. This treatment therefore cannot be recommended.

Acetazolamide↗

PubMed1997

A systematic review of randomized controlled trials of pharmacological therapy in osteoarthritis of the knee, with an emphasis on trial methodology.

We systematically reviewed randomized controlled trials (RCTs) of pharmacological therapy in knee osteoarthritis (OA), published between 1966 and August 1994. RCTs were identified by MEDLINE, supplemented by a manual search of reference lists. Qualitative assessment of RCTs was performed using Gotzsche's method; design and analysis features were rated on a scale of 0 (worst) to 8 (best). Heller et al's method was used to compare efficacy of nonsteroidal antiinflammatory drugs (NSAIDs) in comparative trials. A total of 80 RCTs were analyzed (45 involved NSAIDs, 3 analgesics, 5 intraarticular [IA] steroids, 9 biological agents, including IA hyaluronic acid, and 18 mixed modalities, including topical capsaicin). The median design and analysis scores for all 80 RCTs were 2 and 5, respectively. NSAIDs were superior to placebo in all short-term trials, but in the 32 comparative NSAID trials, only five (16%) found significant differences in efficacy. Heller et al's method identified differences in 14 NSAID comparisons; etodolac (600 mg/day) was superior in five of its nine comparisons. Indomethacin and aspirin were the most toxic NSAIDs. IA steroids were superior to placebo in short-term efficacy (< 1 month). Biological agents were superior to placebo and generally well tolerated over a mean follow-up of 48 weeks. Acetaminophen was superior to placebo and was comparably efficacious to low-dose naproxen and ibuprofen (< 2,400 mg/day). The data support the use of acetaminophen, topical capsaicin, IA steroids, IA hyaluronic acid, and NSAIDs in the treatment of patients with knee OA.

Humans↗

PubMed1996

Oral type II collagen treatment in early rheumatoid arthritis. A double-blind, placebo-controlled, randomized trial.

OBJECTIVE: To investigate the efficacy of oral type II collagen in the treatment of early rheumatoid arthritis (RA). METHODS: Ninety patients with RA (disease duration < or = 3 years) were treated for 12 weeks with oral bovine type II collagen at 1 mg/day (n = 30) or 10 mg/day (n = 30) or with placebo (n = 30), in a double-blind randomized study. RESULTS: There were no significant difference between the 3 groups in terms of response to treatment. However, we observed a higher prevalence of responders in the type II collagen-treated groups: 7 responders in the 10-mg type II collagen group and 6 in the 1-mg group, versus 4 in the placebo group. Furthermore, 3 patients in the 10-mg type II collagen group and 1 patient in the 1-mg type II group, but no patients in the placebo group, had very good response. A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy. CONCLUSION: Only a minority of patients responded to treatment with oral type II collagen. These results justify further efforts to identify which patients will have good response to such therapy.

Administration, Oral↗