scholarly journals P188 Secukinumab provides significant improvement of spinal pain and lowers disease activity in patients with axial spondyloarthritis: 24-week results from a randomised controlled Phase 3b trial

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Helena Marzo-Ortega ◽  
Chiara Perella ◽  
Denis Poddubnyy ◽  
Effie Pournara ◽  
Agnieszka Zielińska ◽  
...  
Keyword(s):  
Disease Activity ◽  
Primary Endpoint ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Spinal Pain ◽  
Stock Ownership ◽  
Double Blind ◽  
Low Disease Activity ◽  
Numerical Rating ◽  
Randomised Controlled

Abstract Background/Aims  SKIPPAIN (NCT03136861) is the first randomised controlled study involving a biological disease-modifying anti-rheumatic drug, with a primary endpoint of spinal pain at Week 8 in patients with axial spondyloarthritis (axSpA; ankylosing spondylitis [AS] and non-radiographic [nr]-axSpA). We present the 24-week results of secukinumab in reducing spinal pain and disease activity following step-up dosing. Methods  This double-blind, placebo-controlled Phase 3b study enrolled patients (aged ≥18 years) with active disease (BASDAI ≥4; average spinal pain numerical rating scale [NRS] score >4 at baseline; inadequate response to ≥ 2 non-steroidal anti-inflammatory drugs ≥4 weeks). Patients were randomised (3:1) to subcutaneous secukinumab 150 mg or placebo weekly followed by every 4 weeks (Q4W) from Week 4. At Week 8, placebo patients were re-randomised to secukinumab 150 or 300 mg Q4W. Patients originally randomised to secukinumab 150 mg were classified as responders or non-responders (spinal pain NRS score <4 or ≥ 4, respectively) at Week 8. Responders were re-assigned to continue doubleblind secukinumab 150 mg Q4W (Arm A1). Non-responders were re-randomised to double-blind secukinumab 150 mg (Arm A2) or a step-up dose of 300 mg (Arm A3) Q4W. Treatment was up to Week 24. Primary endpoint: proportion of patients achieving an average spinal pain score <4 on a 0-10 NRS with secukinumab vs placebo at Week 8. Results  380 axSpA patients (269/380 [70.8%] AS; 111/380 [29.2%] nr-axSpA) were randomised to secukinumab 150 mg (N = 285) or placebo (N = 95). The primary endpoint was met (proportion of spinal pain NRS [average] score responders: 32% vs 20%; odds ratio [95% confidence interval] 1.9 [1.1-3.3] favouring secukinumab vs placebo; P < 0.05). Further reductions in spinal pain occurred at Week 24, especially in those initially randomised to placebo and switched to active drug. Pronounced improvements were observed in other disease activity measurements (Table 1). Numerically, more patients achieved ASDAS low disease activity at Week 24 post-secukinumab dose escalation (Arm A3) vs those remaining on the same dose (Arm A2). Conclusion  Secukinumab provided rapid, significant improvement in spinal pain and led to low disease activity in axSpA patients. Secukinumab dose escalation might be beneficial for patients not responding fully to the starting dose. P188 Table 1:Spinal pain and ASDAS-CRP scores at Weeks 8 and 24Week 8SEC 150 mg (N = 285)PBO (N = 95)Change from baseline in spinal pain NRS score (total), mean (SD) [n]-2.6 (2.5) [279]-1.5 (2.2) [92]Change from baseline in ASDAS-CRP score, mean (SD) [n]-1.2 (1.0) [271]-0.5 (0.8) [89]Week 24Active treatment group (SEC treatment starting at baseline)PBO switchers group (SEC treatment starting at Week 8)Arm A1 (SEC 150 R-150) N = 90Arm A2 (SEC 150 NR-150) N = 94Arm A3 (SEC 150 NR-300) N = 94Arm B1 (PBO-SEC 150) N = 45Arm B2 (PBO-SEC 300) N = 44Change from Week 8 in spinal pain NRS score (total), mean (SD) [n]-0.4 (1.5) [88]-2.1 (2.2) [93]-1.9 (2.2) [91]-2.5 (2.6) [45]-2.9 (2.6) [43]Change from baseline in ASDAS-CRP score, mean (SD) [n]-2.2 (1.0) [86]-1.2 (1.0) [93]-1.5 (1.0) [92]-1.5 (1.1) [44]-1.8 (0.9) [43]Arm A1=SEC responder to SEC 150 mg at Week 8 (SEC 150 R-150); Arm A2=SEC non-responder to SEC 150 mg at Week 8 (SEC 150 NR-150); Arm A3=SEC non-responder to SEC 300 mg at Week 8 (SEC 150 NR-300); Arm B1=Placebo patients to SEC 150 mg (PBO-SEC 150); Arm B2=Placebo patients to SEC 300 mg (PBO-SEC 300). ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score using C-reactive protein; N, total number of patients randomised; n, number of evaluable patients; NR, non-responders; NRS, numerical rating scale; PBO, placebo; R, responders; SD, standard deviation; SEC, secukinumab. Disclosure  H. Marzo-Ortega: Consultancies; AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer, Takeda, UCB. Grants/research support; Janssen, Novartis. C. Perella: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis Stock. D. Poddubnyy: Consultancies; Consultant/speaker for: AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, UCB. Grants/research support; AbbVie, MSD, Novartis, Pfizer. E. Pournara: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis Stock. A. Zielińska: Consultancies; Novartis, Pfizer. A. Baranauskaite: Consultancies; AbbVie. Member of speakers’ bureau; Novartis, AbbVie, Amgen, Roche, KRKA. S. Sadhu: Corporate appointments; Employee of Novartis. B. Schulz: Corporate appointments; Employee of Novartis. M. Rissler: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis Stock.

Meta-analysis of the efficacy and safety of Sativex (nabiximols), on spasticity in people with multiple sclerosis

2010 ◽  
Vol 16 (6) ◽  
pp. 707-714 ◽  
Author(s):  
Derick T Wade ◽  
Christine Collin ◽  
Colin Stott ◽  
Paul Duncombe
Keyword(s):  
Multiple Sclerosis ◽  
Odds Ratio ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Meta Analysis ◽  
Treated Group ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Numerical Rating ◽  
Global Impression Of Change

Objective: To determine the efficacy of Sativex (USAN: nabiximols) in the alleviation of spasticity in people with multiple sclerosis. Methods: The results from three randomized, placebo-controlled, double-blind parallel group studies were combined for analysis. Patients: 666 patients with multiple sclerosis and spasticity. Measures: A 0—100 mm Visual Analogue Scale (VAS, transformed to a 0—10 scale) or a 0—10 Numerical Rating Scale (0—10 NRS) was used to measure spasticity. Patients achieving a ≥30% improvement from baseline in their spasticity score were defined as ‘responders’. Global impression of change (GIC) at the end of treatment was also recorded. Results: The patient populations were similar. The adjusted mean change of the numerical rating scale from baseline in the treated group was —1.30 compared with —0.97 for placebo. Using a linear model, the treatment difference was —0.32 (95% CI —0.61, —0.04, p = 0.026). A statistically significant greater proportion of treated patients were responders (odds ratio (OR) = 1.62, 95% CI 1.15, 2.28; p = 0.0073) and treated patients also reported greater improvement: odds ratio 1.67 (95% CI 1.05, 2.65; p = 0.030). High numbers of subjects experienced at least one adverse event, but most were mild to moderate in severity and all drug-related serious adverse events resolved. Conclusion: The meta-analysis demonstrates that nabiximols is well tolerated and reduces spasticity.

Acupuncture for Insomnia in Pregnancy – a Prospective, Quasi-Randomised, Controlled Study

2005 ◽  
Vol 23 (2) ◽  
pp. 47-51 ◽  
Author(s):  
João Bosco Guerreiro da Silva ◽  
Mary Uchiyama Nakamura ◽  
José Antonio Cordeiro ◽  
Luiz Kulay
Keyword(s):  
Pregnant Women ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Randomised Controlled Study ◽  
Numerical Rating ◽  
Randomised Controlled

Objective This study was undertaken to test the effects of acupuncture on insomnia in a group of pregnant women under real life conditions, and to compare the results with a group of patients undergoing conventional treatment alone (sleep hygiene). Methods A total of 30 conventionally treated pregnant women were allocated at random into groups with or without acupuncture. Seventeen patients formed the study group and 13 the control group. The pregnant women scored the severity of insomnia using a Numerical Rating Scale from 0 to 10. Women were followed up for eight weeks and interviewed five times, at two-week intervals. Results Eight women dropped out, five in the study group and three in the control group. The study group reported a larger reduction on insomnia rating (5.1) than the control group (0.0), a difference which was statistically significant (P=0.0028). Average insomnia scores decreased by at least 50% over time in nine (75%) patients in the study group and in three (30%) of the control group. Conclusion The results of this study suggest that acupuncture alleviates insomnia during pregnancy and further research is justified.

Ea versus Sham Acupuncture and no Acupuncture for the Control of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting: A Pilot Study

2015 ◽  
Vol 33 (4) ◽  
pp. 277-283 ◽  
Author(s):  
Chris McKeon ◽  
Caroline A Smith ◽  
Kristen Gibbons ◽  
Janet Hardy ◽  
Corrine Haugstetter ◽  
...  
Keyword(s):  
Standard Care ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Sham Acupuncture ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Acupuncture Points ◽  
Numerical Rating ◽  
Randomised Controlled ◽  
Oncology Unit

Objective To assess the feasibility of undertaking a high-quality randomised controlled study to determine whether EA gives better control of delayed chemotherapy-induced nausea and vomiting (CINV) than sham EA or standard antiemetic treatment alone. Methods Patients having their first cycle of moderately or highly emetogenic chemotherapy were randomised to EA, sham EA or standard care. EA was given for 30 min on day 1 at the time of chemotherapy and on day 3 using standard acupuncture points bilaterally. Sham EA was given to points adjacent to true EA points. All patients received usual care, comprising antiemetics, according to hospital guidelines. The primary outcomes related to study feasibility, and the clinical outcome measure was the change in Functional Living Index Emesis (FLIE) score captured on days 1 and 7. Results 153 participants were screened between April 2009 and May 2011. Eighteen patients did not meet the inclusion criteria, 37 declined to participate and the absence of an acupuncturist or lack of consent from the treating oncologist excluded a further 38 patients; 60 patients were recruited. The FLIE was completed on day 7 by 49 participants; 33 of 40 patients returned on day 3 for treatment. The nausea and vomiting scores were low in all three arms. Adverse events were generally mild and infrequent. Conclusions It was feasible to undertake a randomised EA trial on a busy day oncology unit. As few patients experienced nausea with their first cycle of chemotherapy, it was not possible to determine whether EA improves CINV over standard care. An enriched enrolment strategy is indicated for future studies. A simple numerical rating scale may prove a better objective nausea measure than the FLIE. Trial Registration Number ACTRN12609001054202.

scholarly journals Comparing the visual analogue scale (VAS) and the numerical rating scale (NRS) in patient reported outcomes in psoriatic arthritis

2020 ◽  
pp. jrheum.200928
Author(s):  
Weiyu Ye ◽  
Simon Hackett ◽  
Claire Vandevelde ◽  
Sarah Twigg ◽  
Philip S. Helliwell ◽  
...  
Keyword(s):  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Correlation Coefficients ◽  
Patient Reported ◽  
Life Impact ◽  
Numerical Rating ◽  
Global Disease Activity ◽  
Test Retest Reliability

Objective Patient self-report scales are invaluable in psoriatic arthritis (PsA), as they allow physicians to rapidly assess patient perspectives of disease activity. We aimed to assess the agreement of the visual analogue scale (VAS), a 100 mm horizontal line, and the numerical rating scale (NRS), a 21-point scale ranging from 0 to 10 in increments of 0.5, in patients with PsA. Methods Data were collected prospectively across three UK hospital trusts from 2018-2019. All patients completed the VAS and NRS for pain, arthritis, skin psoriasis, and global disease activity. A subset completed an identical pack one week later. Demographic and clinical data were also collected. Agreement was assessed using medians and the Bland-Altman method. Intraclass correlation coefficients (ICC) were used to assess test-retest reliability. Spearman’s rank correlation coefficients were used to assess dependency between scale scores and clinical parameters. Results 210 patients completed the study; one withdrew consent, thus 209 were analysed. For pain, arthritis, skin psoriasis and global disease activity, the difference between the VAS and NRS mostly lay within 1.96 SD of the mean, suggesting reasonable agreement between the two scales. 64.1% patients preferred the NRS. The ICCs demonstrate excellent test-retest reliability for both VAS and NRS. Higher VAS and NRS scores were associated with increased tender/swollen joint count, poorer functional status and greater life impact. Conclusion The VAS and NRS show reasonable agreement in key patient reported outcomes in PsA. Results from both scales are correlated with disease severity and life impact.

scholarly journals Neurokinin-1 antagonist orvepitant for EGFRI-induced pruritus in patients with cancer: a randomised, placebo-controlled phase II trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e030114 ◽  
Author(s):  
Bruno Vincenzi ◽  
Mike Trower ◽  
Ajay Duggal ◽  
Pamela Guglielmini ◽  
Peter Harris ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Primary Endpoint ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Once Daily ◽  
Intense Pruritus ◽  
Neurokinin 1

ObjectiveTo evaluate the efficacy of orvepitant (10 or 30 mg given once daily, orally for 4 weeks), a neurokinin-1 receptor antagonist, compared with placebo in reducing the intensity of epidermal growth factor receptor inhibitor (EGFRI)-induced intense pruritus.DesignRandomised, double-blind, placebo-controlled clinical trial.Setting15 hospitals in Italy and five hospitals in the UK.Participants44 patients aged ≥18 years receiving an EGFRI for a histologically confirmed malignant solid tumour and experiencing moderate or intense pruritus after EGFRI treatment.Intervention30 or 10 mg orvepitant or placebo tablets once daily for 4 weeks (randomised 1:1:1).Primary and secondary outcome measuresThe primary endpoint was change from baseline in mean patient-recorded numerical rating scale (NRS) score (over the last three recordings) at week 4. Secondary outcome measures were NRS score, verbal rating scale score, Skindex-16 and Leeds Sleep Evaluation Questionnaire at each study visit (baseline, weeks 1, 4, 8); rescue medication use; EGFRI dose reduction; and study withdrawal because of intense uncontrolled pruritus.ResultsThe trial was terminated early because of recruitment challenges; only 44 of the planned 90 patients were randomised. All patients were analysed for efficacy and safety. Mean NRS score change from baseline to week 4 was −2.78 (SD: 2.64) points in the 30 mg group, −3.04 (SD: 3.06) points in the 10 mg group and −3.21 (SD: 1.77) points in the placebo group; the difference between orvepitant and placebo was not statistically significant. No safety signal was detected. Adverse events related to orvepitant (asthenia, dizziness, dry mouth, hyperhidrosis) were all of mild or moderate severity.ConclusionsOrvepitant was safe and well tolerated. No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint. A number of explanations for this outcome are possible.Trial registration numberEudraCT2013-002763-25.

scholarly journals Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT)

2019 ◽  
Vol 78 (4) ◽  
pp. 465-472 ◽  
Author(s):  
Sarah Hewlett ◽  
Celia Almeida ◽  
Nicholas Ambler ◽  
Peter S Blair ◽  
Ernest H Choy ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Cognitive Behavioural ◽  
Numerical Rating ◽  
Randomised Controlled ◽  
Group Programme

ObjectivesTo see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone.MethodsMulticentre, 2-year randomised controlled trial in RA adults (fatigue severity>6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0–10). Intention-to-treat regression analysis adjusted for baseline scores and centre.Results308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect −0.59, 95% CI –1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total −3.42 (95% CI –6.44 to -0.39), Living with Fatigue −1.19 (95% CI –2.17 to -0.21), Emotional Fatigue −0.91 (95% CI –1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect −0.49 (95% CI −0.83 to -0.14), BRAF MDQ Total −2.98 (95% CI −5.39 to -0.57), Living with Fatigue −0.93 (95% CI −1.75 to -0.10), Emotional Fatigue −0.90 (95% CI −1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored > 8/10 vs 54% controls rating usual care booklet (p<0.0001).ConclusionMultiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches.Trial registration numberISRCTN52709998.

scholarly journals Acupuncture for Cancer Related Pain: Protocol for a Pragmatic Randomised Wait-List Controlled Trial

2020 ◽  
Vol 19 ◽  
pp. 153473542097657
Author(s):  
Qi Zhao ◽  
Suyang Zheng ◽  
Geoff P. Delaney ◽  
Eugene Moylan ◽  
Meera R. Agar ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Post Treatment ◽  
Local Health ◽  
Wait List ◽  
Clinical Trial Registry ◽  
Numerical Rating ◽  
Randomised Controlled

Background: Acupuncture has been proved effective for cancer related pain (CRP) in China, America and some other countries. However, there is relative lack of evidence to support the use of acupuncture for CRP in Australia. Objectives: To assess the effectiveness and safety of acupuncture for management of CRP in a real-world setting and to understand cancer patients’ experience of undergoing acupuncture for CRP. Methods: A pragmatic randomised controlled trial will be conducted in South Western Sydney Local Health District (SWSLHD) in NSW, Australia. Adults with cancer related pain (n = 106) will be randomised in a 1:1 ratio to receive the acupuncture intervention up front versus after a wait list period of 4 weeks. Pain level (by Numerical Rating Scale), analgesic use, auricular acupressure frequency and adverse events will be assessed at baseline, mid-treatment and post-treatment. Expectancy on trial outcome (by Credibility and Expectancy questionnaire) will be assessed at baseline. The perspective of the participants (by an interview) will be recorded after the last intervention. Expected outcomes: We hypothesise that acupuncture will relieve cancer related pain at mid-treatment and post-treatment. We also hypothesise that few adverse events will be provoked by acupuncture. Trial registration: Australia New-Zealand Clinical Trial Registry (ACTRN12620000325909).

scholarly journals Safety and efficacy of naldemedine in cancer patients with opioid-induced constipation: a pooled, subgroup analysis of two randomised controlled studies

ESMO Open ◽  
2019 ◽  
Vol 4 (4) ◽  
pp. e000527 ◽  
Author(s):  
Iwao Osaka ◽  
Hiroto Ishiki ◽  
Takaaki Yokota ◽  
Yukio Tada ◽  
Hiroki Sato ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Phase Iii ◽  
Spontaneous Bowel Movement ◽  
Numerical Rating ◽  
Baseline Characteristics ◽  
Randomised Controlled ◽  
Post Hoc ◽  
Phase Iii Studies

ObjectiveThis post hoc, pooled, subgroup analysis of two randomised studies evaluated baseline characteristics that may influence the efficacy and safety of naldemedine in patients with opioid-induced constipation (OIC) and cancer.MethodsData for patients who received 0.2 mg naldemedine or placebo were pooled from randomised, placebo-controlled, phase IIb and phase III studies. Proportions of spontaneous bowel movement (SBM) responders and patients with diarrhoea were assessed for each treatment group. For the patient subgroups with or without possible blood–brain barrier (BBB) disruptions, changes in Numerical Rating Scale (NRS) and Clinical Opioid Withdrawal Scale (COWS) scores were assessed.ResultsA total of 307 patients were included in this analysis (naldemedine: n=155; placebo: n=152). The pooled proportion of SBM responders was 73.5% with naldemedine versus 35.5% with placebo. There was a significant increase in the proportion of SBM responders with naldemedine versus placebo (38.0% (95% CI 27.6% to 48.4%); p<0.0001). Greater proportions of SBM responders and patients who experienced diarrhoea were observed with naldemedine versus placebo in all subgroups. Changes from baseline in NRS and COWS scores were similar with naldemedine or placebo in patients with or without brain metastases.ConclusionsAlthough not powered to detect statistically significant differences in treatment effect among subgroups, this study demonstrated that naldemedine appeared to benefit patients with OIC and cancer, irrespective of baseline characteristics, and did not seem to affect analgesia or withdrawal–even in patients with potential BBB disruptions. Baseline characteristics did not appear to affect the incidence of diarrhoea in patients who received naldemedine.Trial registration numbersJapicCTI-111510 and JapicCTI-132340.

scholarly journals Rating of four different foods in women with hyperemesis gravidarum: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e046528
Author(s):  
Gi Ni Tan ◽  
Peng Chiong Tan ◽  
Jesrine Gek Shan Hong ◽  
Balaraman Kartik ◽  
Siti Zawiah Omar
Keyword(s):  
Rating Scale ◽  
Hyperemesis Gravidarum ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Random Order ◽  
University Hospital ◽  
White Bread ◽  
Significant Difference ◽  
Numerical Rating ◽  
Randomised Controlled

ObjectiveTo evaluate four foods in women with hyperemesis gravidarum (HG) on their agreeability and tolerability.DesignProspective, randomised, within-subject cross-over trial.SettingSingle-centre, tertiary, university hospital in Malaysia.Participants72 women within 24-hour of first admission for HG who were 18 years or above, with confirmed clinical pregnancy of less than 16 weeks’ gestation were recruited and analysed. Women unable to consume food due to extreme symptoms, known taste or swallowing disorder were excluded.InterventionsEach participant chewed and swallowed a small piece of apple, watermelon, cream cracker and white bread in random order and was observed for 10 min after each tasting followed by a 2 min washout for mouth rinsing and data collection.Outcome measuresPrimary outcome was food agreeability scored after 10 min using an 11-point 0–10 Visual Numerical Rating Scale (VNRS). Nausea was scored at baseline (prior to tasting) and 2 and 10 min using an 11-point VNRS. Intolerant responses of gagging, heaving and vomiting were recorded.ResultsOn agreeability scoring, apple (mean±SD 7.2±2.4) ranked highest followed by watermelon (7.0±2.7) and crackers (6.5±2.6), with white bread ranked lowest (6.0±2.7); Kruskal-Wallis H test, p=0.019. Apple had the lowest mean nausea score and mean rank score, while white bread had the highest at both 2 and 10 min; the Kruskal-Wallis H test showed a significant difference only at 10 min (p=0.019) but not at 2 min (p=0.29) in the ranking analyses. The intolerant (gagged, heaved or vomited) response rates within the 10 min study period were apple 3/72 (4%), watermelon 7/72 (10%), crackers 8/72 (11%) and white bread 12/72 (17%): χ2 test for trend p=0.02.ConclusionSweet apple had the highest agreeability score, the lowest nausea severity and intolerance–emesis response rate when tasted by women with HG. White bread consistently performed worst.

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