求问恶心生活功能量表（Functional Living Index-Emesis，FLIE）的评分标准是什么？怎么计算得分？_百度知道
提问者采纳
一般标准化评分然后差方计算取均值
表里面分为恶心/呕吐，共18个问题，分为几个功能模块？求大神再指点。
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虽然我没搞懂，但是貌似你说的挺对的。
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Research article
Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial
David Pérol, Jocelyne Proven?al, Anne-claire Hardy-Bessard, David Coeffic, Jean-Phillipe Jacquin, Cécile Agostini, Thomas Bachelot, Jean-Paul Guastalla, Xavier Pivot, Jean-Pierre Martin, Agathe Bajard and Isabelle Ray-Coquard*
Corresponding author:
Ray-Coquard
Centre Léon Bérard, 28 rue Laennec, Lyon Cedex 08, 69373, France
Centre hospitalier de la région d’Annecy, 1 avenue de l’h?pital, Annecy, BP9, France
Clinique armoricaine de Radiologie, 21 rue du Vieux Séminaire, Saint Brieuc, 22 000, France
UMGEC, Service Institut Daniel Hollard, 12 Rue Docteur Calmette, Grenoble, 38028, France
Institut de cancérologie de la Loire, 108, avenue Albert-Raimond, Saint-Priest-en-Jarez, 42270, France
Centre hospitalier Général, Chambéry, BP, France
Centre Hospitalier Universitaire, Boulevard Fleming, Besan?on, 25030, France
H?pital Jean Mermoz, 55 avenue Jean Mermoz, Lyon, 69008, France
Centre Léon Bérard, 28 rue Laennec, Lyon, 69008, France
For all author emails, please .
BMC Cancer 2012, 12:603&
doi:10.07-12-603
The electronic version of this article is the complete one and can be found online at:
Received:11 May 2012
Accepted:5 December 2012
Published:17 December 2012
& 2012 Pé licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
Chemotherapy induced nausea and vomiting (CINV) remains a major problem that seriously
impairs the quality of life (QoL) in cancer patients receiving chemotherapy regimens.
Complementary medicines, including homeopathy, are used by many patients with cancer,
usually alongside with conventional treatment. A randomized, placebo-controlled Phase
III study was conducted to evaluate the efficacy of a complex homeopathic medicine,
Cocculine, in the control of CINV in non-metastatic breast cancer patients treated
by standard chemotherapy regimens.
Chemotherapy-na?ve patients with non-metastatic breast cancer scheduled to receive
6 cycles of chemotherapy including at least three initial cycles of FAC 50, FEC 100
or TAC were randomized to receive standard anti-emetic treatment plus either a complex
homeopathic remedy (Cocculine, registered in France for treatment of nausea and travel sickness) or the matching
placebo (NCT
clinicaltrials.gov). The primary endpoint was nausea score measured after the 1st chemotherapy course using the FLIE questionnaire (Functional Living Index for Emesis)
with 5-day recall. Secondary endpoints were: vomiting measured by the FLIE score,
nausea and vomiting measured by patient self-evaluation (EVA) and investigator recording
(NCI-CTC AE V3.0) and treatment compliance.
From September 2005 to January
patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). Patient characteristics were well-balanced between the
2 arms. Overall, compliance to study treatments was excellent and similar between
the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in
the homeopathy arms) had nausea FLIE scores & 6 indicative of no impact of nausea
on quality of life during the 1st chemotherapy course. There was no difference between the 2 arms when primary endpoint
analysis was performed by
or in the subgroup of patients with
susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting
and global emesis FLIE scores were not statistically different at any time between
the two study arms. The frequencies of severe (Grade ≥ 2) nausea and vomiting were
low in our study (nausea: P: 17.6% vs C: 15.7%, p=0.62; vomiting: P: 10.8% vs C: 12.0%,
p=0.72 during the first course).
Conclusion
This double-blinded, placebo-controlled, randomised Phase III study showed that adding
a complex homeopathic medicine (Cocculine) to standard anti-emetic prophylaxis does
not improve the control of CINV in early breast cancer patients.
Keywords: E A H N Quality of lifeBackground
Chemotherapy induced nausea and vomiting (CINV) are among the most severe and feared
collateral effects of chemotherapy
[-] associated with a significant deterioration in quality of life (QoL) and patients’
ability to carry out daily activities
[,]. Poor QoL can influence the patient’s willingness to continue with and successfully
complete cancer treatment. Therefore, it is essential to prevent and treat these side
effects optimally to maximize QoL and to encourage patient compliance
Over the past few years, selective serotonin type 3 receptor (5-HT3) antagonists and
the neurokinin-1 (NK-1) antagonist aprepitant have substantially improved the management
of acute CINV (occurring within 24 hours of chemotherapy) and to a lesser extent delayed
CINV (occurring more than 24 hours post-chemotherapy)
[-]. Nevertheless, 75% percent of patients with nausea and 50% of those with vomiting
reported a negative impact on the performance of daily living activities when queried
with the Functional Living Index–Emesis (FLIE) questionnaire despite modern prophylactic
anti-emetic treatment
[]. To date, CINV remains a significant problem contributing to patient withdrawal from
potentially curative chemotherapy
In an attempt to alleviate collateral effects of cancer therapies, complementary and
alternative medicines are increasingly used by cancer patients
[,]. In an European survey, 35.9% of cancer patients have reported using some form of
complementary or alternative medicines (CAM) to reduce cancer treatment-related adverse
events (AEs)
[]. Homeopathy was in the top five of the most commonly used CAM in 7 out of 14 European
[]. Overall, homeopathic approaches are used by cancer patients to alleviate their pain
resulting from the disease itself or from conventional anti-cancer treatment
[]. Homeopathic medicines efficacy have been studied in the treatment of adverse effects
of radiotherapy and chemotherapy in breast cancer patients. However, large, randomized,
placebo-controlled trials with powered statistical analysis are needed to generate
evidence-based data on the value of complementary medicine.
Different homeopathic practices coexist: the “classical” or “individualised” homeopathy
using single homeopathic medicine that is prescribed according to the individual’s
condition and history, (ii) the “clinical” homeopathy that uses the same homeopathic
medicine for a group of patients with the same disease and (iii) the “complex” homeopathy
that uses more than one homeopathic medicine, in a fixed combination or concurrently,
for a particular condition. Cocculine is a homeopathic medicinal product registered
in France for treatment of nausea and travel sickness composed of 4 homeopathic components
(Cocculus indicus 4 CH, Tabacum 4 CH, Nux vomica 4 CH, Petroleum 4 CH produced by
Boiron, France, according to European Pharmacopoeia). A recent study has demonstrated
that Cocculine has a potential interest for the management of CINV with a 30% reduction of nausea
under Cocculine treatment compared to placebo in breast cancer patients treated by chemotherapy (overall
n=80: incidence of nausea 61.5% in Cocculine arm versus 87.5% with placebo
[]). The main objective of the present study was to evaluate if this complex homoepathic
medicine can improve the control of CINV in non-metastatic breast cancer patients
in a large, randomized, multicenter Phase III trial.
Eligible women patients were chemotherapy-naive adults with non metastatic, histologically
proven breast cancer and an Eastern Cooperative Oncology Group performance status
(ECOG PS) of ≤ 2, scheduled to receive 6 cycles of standard adjuvant chemotherapy.
The first 3 cycles were required to be FAC50 (5-Fluoruracil 500 mg/m [2] + adriamycin
[doxorubicin] 50 mg/m [2] + cyclophosphamide 500 mg/m [2]), FEC100 (5-Fluoruracil
500 mg/m [2] + epirubicin 100 mg/m [2] + cyclophosphamide 500 mg/m [2]) or TAC (Taxotere
[Docetaxel] 75 mg/m [2] + adriamycine 50 mg/m [2] + cyclophosphamide 500 mg/m [2]).
Patients with previous malignancies (except those in complete remission for more than
5 years), contraindications to corticoids or 5-HT3 receptor antagonists, or prior
treatment with Cocculine or other anti-emetics within the previous 15 days were ineligible.
Pregnant or lactating patients, those who could not be followed up for social, geographical,
familial or psychological reasons or unavailability by phone were also excluded. The
protocol was approved by a French ethical committee (CPP Sud Est IV) and registered
clinicaltrials.gov as NCT. All included patients have signed an inform consent form before study
Randomisation and blinding
Randomisation was conducted centrally via a computer-generated system, using permuted
blocks of four patients (the Jadad/Oxford score was ≥ 3/5). Patients were stratified
by participating centre and type of chemotherapy regimen (FAC50 or FEC100 versus TAC).
Allocation list was generated by the study statistician before the beginning of the
study. Investigators asked the coordinating center by fax for a treatment allocation
number. Both investigator and patient remained blind to the assignment of individuals
to either active treatment or placebo throughout the study.
Study treatments
The trial used a randomized, multicenter, double blind phase III design in which patients
were randomly assigned to receive placebo or Cocculine (Cocculine(R), Boiron- France) plus standard anti emetic treatment. Cocculine is a complex of four
active elements incorporated in the same tablets. The placebo tablets were identical
seemingly in the active tablets (packaging, colour, shape…). The placebo tablets were
inert and contained only (Saccharose (75%), lactose (24%), and Magnesium stearate
(1%)) without any homeopathic components. All patients received a box containing six
* two blister packs of ten tablets corresponding to the treatment number allocated
at randomisation (Cocculine or matching placebo). Patients had to return boxes and
tablet blisters to the investigator at the end of treatment. Two tablets were to be
taken in the evening before chemotherapy, 6 on the day of chemotherapy and 4 tablets
the next day (see Table
). A standard anti-emetic treatment was given to patient: ondansetron 8 mg (or granisetron
3 mg in case of intolerance to ondansetron) and methylpredinosolone 80 mg. While this
trial was being conducted, consensus guidelines were updated to recommend the use
of a three-drug combination of steroids plus 5-HT3 receptor antagonist plus the NK-1
receptor antagonist aprepitant
[,]. At the time of patient enrolment, aprepitant was not recommended and so was not
used during the study. The study flow chart is presented in Table
Study flow-chart (per chemotherapy cycle)
Assessment
The primary objective was to evaluate the efficacy of Cocculine versus Placebo when
added to conventional corticoid plus setron prophylaxis in the control of chemotherapy-induced
nausea during the 1st cycle of chemotherapy. The secondary objectives were to evaluate the efficacy of
Cocculine during the 2nd and 3rd cycles, the contribution of Cocculine in the treatment of nausea and vomiting, and
compliance to Cocculine treatment. To evaluate the impact of homeopathy remedy in
the control of CINV based on patients’ assessment: a self-assessment booklet composed
of the FLIE questionnaire
[,] and a specific diary were given to patients. In addition, CINV were also evaluated
based on investigators’ assessment using the CTCAE V3.0 grading scale.
The self–administered FLIE questionnaire is composed of two dimensions (nausea and
vomiting) each with 9 items. Each item consists of a horizontal Visual Analogical
Scale (VAS) of 100 mm graduated from 1 (a lot) to 7 (not at all). The first question
in each domain asks the patient to rate how much nausea or vomiting she has experienced
over the past 5 days. The remaining eight questions specifically address the impact
of CINV on daily activities (i.e. physical abilities, social and emotional function)
[,]. No or minimal impact on daily life was defined as an average FLIE item score & 6.
Patients completed the FLIE questionnaire on Day 6 of the first 3 chemotherapy cycles.
Patients were also provided with a daily diary to record i) intake of study drug ii)
the occurrence and intensity of nausea during the first 24 hours and over days 2 to
5 following chemotherapy and the number of vomiting episodes, and iii) use of any
rescue antiemetic medications. All patients were contacted by telephone on the day
before the start of chemotherapy and (if they requested this) on day 5 of the first
cycle to ensure that the diary and FLIE questionnaire had been completed accurately.
In addition, the incidence and severity of AEs (NCI-CTCAE v3.0, ctep.cancer.gov/protocolDevelopment/electronic…/docs/ctcaev3.pdf)
including nausea and vomiting were recorded by the investigator at the end of each
chemotherapy cycle. Data were collected until either the cessation of chemotherapy
or the administration of a maximum of 6 cycles of treatment.
Statistical analysis
The study was powered to detect a 0.5 point difference between treatment arms in the
FLIE nausea score after the 1st CT cycle. Accepting a two-sided type I error of 5% and a type II error of 15%, 198
patients were required per group. The statistical analysis was performed by intent-to-treat.
The primary endpoint was the mean of 9 first FLIE items (at least 5 out of 9 items
had to be completed). Scores were compared between the two arms using the non parametric
Mann–Whitney U test. The number of patients with a mean score & 6 versus the number
of patients with a mean score ≤ 6 were compared using Fisher’s exact test.
The emesis score after the 1st, 2nd and 3rd chemotherapy cycles and the nausea score after the 2nd and 3rd chemotherapy cycles were calculated in order to evaluate the efficacy of Cocculine
over the first 3 CT cycles.
Vomiting frequency reported on the VAS during the 1st, 2nd and 3rd CT courses was compared between the two arms by a Pearson’s chi-square test (or a
Fisher’s exact test, if appropriate).
Compliance was compared between the 2 arms using the diary and by counting the amount
of drug that remained in its packaging. AEs were compared between the two arms over
the 6-cycle period with particular attention to nausea or vomiting.
All analyses were performed using the SAS software, version 9.1 (SAS Institute, Cary,
Assignment of patients and treatment compliance
From September 2005 to January
non metastatic breast cancer patients were
enrolled in 8 214 patients were randomly assigned to Cocculine (C) and 217
to placebo (Figure
). A total of 266 patients (61.7%) were in the FAC/FEC stratum and 165 (38.3%) in
the TAC stratum. Major patient characteristics at baseline are detailed in Table
. The two arms were well-balanced, with no statistically significant differences between
them. Median age was 52.8 years (range 20–74); 237 patients (55.6%) were T1 a-b-c
and 258 patients (60.6%) were pN+; and 35.3% of the patients had susceptibility to
nausea or vomiting. Treatment compliance as estimated using patient diary and tablet
count was largely acceptable: according to the diary, 71% of patients had taken the
study drug per protocol, and this figure was 81% according to the count of remaining
tablets (data not shown). Compliance was similar between arms. A total of 263 patients
(63.2%) had taken standard anti-emetic treatment per protocol during cycle 1. A total
of 384 patients (90.8%) had received chemotherapy for the entire study period but
146 patients (34.5%) had to delay CT (mainly due to haematological toxicity) and 34
patients (8.0%) had at least one dose reduction over the 6-cycle period. The number
of delays and/or dose reductions was similar between the two arms (data not shown).
There was no impact of Cocculine treatment on compliance to chemotherapy regimen.
Of note, there was no statistical difference in the use of concomitant anti-emetic
rescue medication between the 2 study arms at any time during the study period (data
not shown).
CONSORT diagram.
Patient characteristic
CINV assessed by patients using FLIE scores [Table
] or daily diaries [Table
Impact of nausea on quality of life during cycle 1 of chemotherapy: nausea dimension
of the FLIE score in ITT population
Patient self -evaluation of nausea and vomiting during the 1stCT cycle (ITT population)
In total, 403 of 431 patients (93.5%) were assessable for the primary endpoint (FLIE
nausea score during 1st CT course): 28 patients were non evaluable, 15 in the placebo and 13 in the Cocculine
arms (Table
). Non-assessable patients were accounted for 7 who withdrew consent, 17 from whom
questionnaires were not received, and 4 who returned questionnaires that were not
evaluable.
Using the FLIE questionnaire, nausea scores after the 1st chemotherapy cycle were 6.02 and 6.07 for placebo and Cocculine arms, respectively
(p = 0.84). A total of 205 patients (50.9%; 103 patients in the placebo and 102 in
the Cocculine arms) had scores & 6 indicative of no impact of nausea on quality of
life. FLIE analysis results are reported in Table
. There was no difference between the 2 arms when analysis was performed by chemotherapy
and there was no difference in the subgroup of patients with known susceptibility
to nausea and vomiting (Table
Nausea, vomiting and global emesis FLIE scores were not statistically different at
any time between the two arms (data not shown).
Based on daily diaries, the intensity of nausea reported by patients over the first
3 cycles of chemotherapy was very low (median nausea severity: 1st cycle: 0.56 [P] vs. 0.58 [C], p = 0.61 [Table
]; 2nd cycle: 0.52 [P] vs. 0.60[C], p=0.36; and 3rd cycle: 0.93 [P] vs. 0.40 [C]; p=0.45, data not shown) with no significant difference
between the two arms. Patient had few vomiting episodes of low intensity (medians
were 0 for the 3 cycles). More patients reported vomiting episodes during the 3rd CT course in the placebo (34.2%) than in the Cocculine arms (23.4%), p = 0.03 (data
not shown). However, these observations were not maintained over the 4, 5 and 6th cycles of CT and had no impact on FLIE vomiting score.
CINV assessed by investigators (NCI –CTCAE V3.0 grading)
Based on investigators assessments using CTCAE V3.0, nausea occurred in 51.1% versus
47.4% of the patients treated with placebo and Cocculine respectively (p = 0.48) during
the 1st CT cycle (Table
), in 42.3% (P) versus 48.9% (C) (p = 0.21) during the 2nd CT and in 43.2% (P) versus 45.8% (C) (p = 0.63) during the 3rd CT cycle (data not shown). No significant differences were noted during cycles 4
Frequency of nausea and vomiting AEs during 1stcycle of chemotherapy
Frequency of vomiting was also similar between the 2 arms: 19.7% versus 21.1% (p =
0.72) for Placebo and Cocculine respectively during the 1st CT cycle (Table
); 13.7% (P) versus 15.2% (C) (p = 0.7) during the 2nd CT and 22.2 (P) versus 16.9% (C) (p = 0.22) during the 3rd CT cycle (data not shown). The incidence of severe nausea and vomiting (i.e. Grade
≥ 2) reported by the investigators during the 1st CT cycle was also similar between the 2 treatment groups (Table
): severe nausea occurred in 17.6% versus 15.7% of patients receiving Placebo versus
Cocculine (p = 0.62) and severe vomiting in 10.8% versus 12.0% of patients receiving
Placebo versus Cocculine (p = 0.72).
Four serious adverse events (SAEs), including 1 cutaneous papular eruption, 2 cases
of anxiety/depression syndrome and 1 cholecystectomy for biliary colic, were reported
but none were related to Cocculine. The overall incidence of AE (any type any grade)
was similar between the 2 arms.
Discussion
This study evaluates the potential clinical benefit of a complex homeopathic medicine
for the control of CINV in a large homogenous randomized population of early breast
cancer patients receiving uniform protocols of chemotherapy. Overall, adding thiscomplex
homeopathic medicine to standard anti-emetic regimen did not improve the control of
CINV in early breast cancer patients under chemotherapy regimen. FLIE nausea scores
after the first chemotherapy course were 6.02 and 6.07 for placebo and Cocculine arms,
respectively (p = 0.84, Table
Our study was initially performed to confirm the efficacy of Cocculine in control
of CINV in early breast cancer patients as reported by Genre et al.,[]. However, our data showed no superiority of Cocculine over placebo. Several aspects
of methodology may explain this discrepancy. Firstly, Genre et al. performed a small, single-centre study whereas more than 400 patients were enrolled
in our multi-center clinical trial. Secondly, our prospective investigation was based
on the FLIE score derived from a validated 18-item, patient-reported questionnaire.
As CINV is frequently underestimated by caregivers, the FLIE questionnaire is an essential
and better patient-reported tool to assess the functional impact of CT on patients’
daily lives. Relevant to our negative results, it should be noted that in the current
study the percentage of patients with no or minimal impact of CINV on their daily
life was particularly high (51% of patients in both placebo and Cocculine arms) and
the incidence of severe nausea and vomiting were low (nausea: 17.6-15.7%, and vomiting
10.8-12%, Table
). In contrast, Genre et al. have reported that 87.5% of patients enrolled in placebo arm have experienced nausea
episodes during the first cycle of chemotherapy
[]. Of note, the emetyogenic properties of the chemotherapy used in our study as well
as the standard anti-emetic treatment were similar. For additional comparison, the
prevalence of CINV in previously reported clinical trials was around 65% (depending
on chemotherapy regimen, and/or anti-emetic treatment used)
[,,]. Of note, one limitation of our study is the absence of data collection related to
patients' belief as to group allocation (Cocculine or placebo), patient’s belief of
homeopathy efficacy, comfort of homeopathy, pre-existing anxiety, history of alcohol
consumption. Therefore, no comparison between groups for such patient-related factors,
which may have influenced the development of CINV, was performed.
Considering that patients’ expectancies are largely influenced by the attention and
information they received from clinicians, and are predictors, and, likely, contributing
factors to the development of treatment-related emesis
[,], we have followed 34 breast cancer patients during their 1st cycle of chemotherapy (FAC50, FEC100 or TAC) in a post-study cohort. In contrast
to patients enrolled in our Phase III, these patients were requested to complete a
FLIE questionnaire without a recall on Day 5. Interestingly, at the end of the 1st cycle, the proportion of patients with no or minimal impact of nausea on QoL (FLIE
score &6) in this post-study cohort was only 31% (data not shown) versus 51 % in our
Phase III population. Therefore, it is possible that extra attention provided to the
patients enrolled in this study (i.e. with 5-day recall) may have change their perception
of may be beneficial in terms of the occurrence and intensity of treatment-related
side effects
Our study has evaluated the effect of a complex homeopathic medicine in a large randomized
study. This strategy was chosen for the following reasons: (i) first of all, the management
of side effects related to conventional treatment need to be integrated in the routine
of daily clinical practice thus not allowing time-consuming individual homeopathic
prescription, (ii) secondly, the use of homeopathy with an individualized remedy is
expensive and required the implication of the same experienced homeopath that is difficult
to set up in multicenter trial and (iii) finally, individualized prescription is not
easily compatible with double-blind randomized trials
Although controversial, homeopathy is increasingly used worldwide as a complementary
medicine and has been largely investigated in clinical trials
[-]. However, no definitive conclusions can be drawn due to the low methodological quality
of clinical trials, the small number of patients involved, lack of replication and
presumed publication bias
[]. More and higher quality clinical trials, unbiased by belief or disbelief in the
principles of homeopathy, need to be performed to assess the potential effect of such
alternative medicines in controlling the side effects of cancer treatment
Conclusions
In conclusion, this double-blinded, placebo-controlled, randomised Phase III study
showed that adding a complex homeopathic treatment to standard anti-emetic prophylaxis
does not improve the control of CINV in early breast cancer patients.
Competing interests
The authors declare that they have no competing interests. The study was partially
funded by Boiron laboratories. The study treatments (Cocculine and placebo) were also
provided by Boiron Laboratories. However, no representative from the funding sources
participated at any stage of the trial, from either design to publication.
Authors’ contributions
JP, AC H-B, TB; DC, J-P J, J-P G, CA, XP, IRC recruited and treated patients. DP,
AB and IRC contributed to the design of the trial. DP and AB did the statistical analysis
of the trial. All authors reviewed the manuscript before submission. All authors read
and approved the final manuscript.
Acknowledgements
We thank Nathalie Girerd-Chambaz, Aurélie Belleville for the monitoring of the study,
Giovanna Barone for the coordination, and all clinical research associates from investigator
sites (Julien Gautier, Thierry Hardy, Nadine Cadoux, Véronique Alcalay and Séverine
Marchand).
We are grateful to all investigators (Drs Thomas Bachelot, Jean-Paul Guastalla, Paul
Rebattu, Laura Zufferey, Jocelyne Proven?al, Laetitia Stephani, Xavier Pivot, Cristian
Villanueva, Cécile Agostini, David Coeffic, Claire Garnier, Cécile Leyronnas, Anne-claire
Hardy-Bessard, Dominique Besson, Jean-Pierre Jacquin, Dominique Mille and Jean-Pierre
Martin) and to all patients whose participation made this study possible.
We thank Boiron France for providing homeopathy and Naoual Boujedaini for fruitful
scientific collaboration.
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