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Megan L Martin

4 November 2016

Article Critique:

CITATION

Cornu, C., Remontet, L., Noel-Baron, F., Nicolas, A., Feugier-Favier, N., Roy, P., & ... Kassaï,

B. (2010). A Dietary Supplement to Improve the Quality of Sleep: A Randomized

Placebo Controlled Trial. BMC Complementary & Alternative Medicine, 1029-37. doi:

10.1186/1472-6882-10-29

MY ABSTRACT

The study was developed in order to test the theory that the commercially available

dietary supplement Cyclamax could improve the sleep quality for those affected by insomnia.

The design of the study was to randomize a group of individuals who suffer from insomnia as

identified by medical professionals with the minimal severity of 10 as rated by the Insomnia

Severity Index. Other secondary criteria were used in selecting a study population. The

population was then randomized and a group was given placebo gel tablets containing olive oil.

The second group was given identical gel capsules containing the dietary supplement. The

population was then instructed to take two capsules each night before bed. Some of the

population also volunteered for secondary studies which were conducted to measure the

melatonin levels of the individuals as well as measure the actigraphic movement during sleep.

Various evaluation methods were used including the Leeds sleep evaluation questionnaire and a

personal sleep diary. The results showed an improved quality in sleep in both groups meaning the

supplement did not provide noticeable effects in improving sleep or melatonin secretion.
EVALUATE THE TITLE

The title is as follows, “A dietary supplement to improve the quality of sleep: a

randomized placebo controlled trial”. Overall this title is very clear as to what the article

contains; it explains that there is a dietary supplement that is theorized to improve sleep. One

thing missing from the title is the mention of insomnia. In further reading the article it is clear

that the supplement is being tested as an alternative treatment for the disorder and not just to

review its overall effect on sleep. The secondary title gives a clear explanation of the type of

study that was done.

ABSTRACT

The abstract summarizing the content of the article is divided into the basic parts of what

can be found in the paper later. This is pretty different from most research articles but it

summarized the individual parts effectively. The background section was more of the purpose of

the study and didn’t serve as any true background information on the topic. Labeling information

is this way can be fairly misleading. The abstract next contains a section labeled methods. This

section neatly summarizes the process of the study, giving a breakdown of the placebo group and

the active group and how they were treated. Additionally the methods section described the tools

used to evaluate the results including, “perception of the quality of sleep at the end of treatment

using the LSEQ questionnaire [Leeds sleep evaluation questionnaire], sleep efficiency measured

by one-week actigraphic movement measurement performed before and during the treatment in a

subsample of subjects, night melatonin and 6 sulfatoxymelatonin (aMT6S) urine rates in a

subsample of subjects.” The next subsection within the abstract is a summary of the results.

Placing this information in an abstract is fairly standard and is useful when evaluating the article

for research purposes. The results are reported in an unbiased form, and in all previously
mentioned evaluation methods are reported on in this section. Lastly the abstracts contains a few

short lines of the conclusions made from the study stating that the supplement had no measurable

effect on sleep.

INTRODUCTION

The introduction to the topic at hand was very direct and concise. The authors shared

information in regards to the effects of insomnia and why it is a problem that needs to be

researched. The stated overall problem is that insomnia affects a large portion of the population

(about 10-20%) and has many adverse effects including but not limited to a decreased quality of

daily life and an increase in medical complications. One missing explanation is what the term

“primary insomnia” means, it is used in the first line of the background section and can be

misleading. It is unclear as to whether the term refers to the commonly known disorder or a

different form. Upon further reading however it can be assumed the authors are referring to the

disorder. Within the introduction the authors also explained why previously effective methods are

lacking and why a replacement treatment would be beneficial. The reasoning stated was that the

hypnotic drugs used to treat insomnia often affect that person during the day and can lead to

accidents. Thus the researchers concluded that there is a need for an alternative treatment for this

fairly common sleep disorder and the following study was done in order to test the effectiveness

of the proposed dietary supplement. One thing missing from the introduction was any mention of

other similar studies and their relationship to this particular study. Overall the introduction was

clear, informative, and well prepared the audience for what was to follow.

LITERATURE REVIEW

The literature review within the introduction was lacking in a few aspects. One aspect

lacking was its content. The literature review was quite short and not much outside relevant
information was provided. The review did explain however the make-up of the dietary

supplement being tested. It also explained the expected effects within the body giving the

audience a fairly clear picture of why this product is a viable treatment for the sleep disorder,

insomnia. It appears that all facts were cited from relevant and credible sources. Overall the

literature review was not really a review of any relevant literature other than the workings of

melatonin and the make-up of the proposed dietary supplement.

RESEARCH QUESTION – HYPOTHESIS – OBJECTIVE

The research question being examined is whether the dietary supplement (containing

polyunsaturated fats and humulus lupulus extract) effective in treating the sleeping disorder

insomnia or simply improving sleep overall. Upon evaluation the article keeps this question at its

heart throughout and all information is relevant and goes back to addressing the purpose of the

study. Additionally through close reading it can be concluded that the hypothesis would be that

the supplement is effective in raising natural melatonin levels but it is not forwardly stated in the

formal writing. This study can be concluded as ethical because all proper steps were taken

including obtaining written consent. Additionally, other medical screening was done to prevent

the endangerment of a subject. These criteria are explained in further detail in the methodology

and include circumstances such as a secondary sleep disorders or other possibly effected medical

conditions. Also the protocol was approved by an ethics committee in France as explained in the

methods section.

METHODOLOGY

The methodology section of the paper gives a very detailed look at the study from

beginning to end including all relevant information. It begins with a section depicting the

selection process for participants even going so far as to share the website domain used to recruit
subjects. Within this section is also a figure meant to demonstrate the design of the study and

how it will be conducted and when the various evaluation methods will be administered.

Following this section is a summary of secondary exclusion factors that were considered to help

ensure the safety of the subjects as well as the integrity of the study. From the explanation of the

selection process is appears that all the screening processes were reliable and appropriate to the

study.

Following the study population and exclusion criteria is an explanation of how the study

was randomized. It was explained that a permuted-block algorithm was used ensuring that the

study was a double blind, ensuring the eradication of bias. Also described was the instructions

given to the subjects. The researchers failed to acknowledge that there could be some human

error due to the fact that the supplement/placebo gel capsules were self-administered and there

could be result skewing errors, such as the failure to take the supplement/placebo at the same

time each day or forgetting one night. Another aspect missing from this section of the report is

the discussion of limitations to the study, such as the failure to collect information that could

affect the absorption of the supplement or placebo, such as meal times, meal content, or alcohol

consumption. Also described in this section is the supplement being tested.

Lastly described throughout the rest of the methods section is the evaluation methods and

sub-studies done. Again the researchers don’t discuss limitations to these sub-studies. The

instruments used to collect the data were all described and all methods are valid in their relation

to the purpose of the study. Overall, the methods of this study are valid and were properly used to

evaluate the objective at hand.
SUMMARY OF RESULTS

Overall the results were summarized and failed to show any correlation between use of

the supplement and improved sleep. There was a notable overall improvement in both groups and

this was consistent across all measures of evaluation. The results were reported without

evaluation and were later discussed in the appropriate article section. The article includes a

variety of charts, graphs, and tables all meant to enhance the demonstration of results. The use of

figures and tables was fairly effective, however each one was full of a lot of information and they

could have been narrowed down to be more precise.

TABLE OR FIGURE

Table 1

Baseline Characteristics of the Study Subjects
DISCUSSION AND CONCLUSSION

Within the discussion of results it was concluded that there was no significant effect of

the theorized sleep-improving dietary supplement. In this section limitations to the study that

were missing in previous sections were discussed and various proposed explanations to why the

results turned out the way they did were offered. Additionally there was an acknowledgement for

where further studies could be conducted in relation to what the results showed. The discussion

does not tie back much to the literature review mainly because the review was so lacking to

begin with. There was not much of a proposed explanation as to why the results were different as

what was expected. Although the theory behind why this supplement should be effective was

sound there was no clear evidence as to why it was not effective and a theory was not offered.

Implications for the professional practice include an exclusion of the supplement and others like

it as being a recommended to treat insomnia.

REFERENCES

After evaluation the references all appear to be recent and most are primary sources.

However it is unclear how some of them relate to the study and it was not explained in writing

why these references were included. For example, an article named “A new method for

measuring daytime sleepiness: The Epworth sleepiness scale” was cited but it was never referred

to directly in the article and its scale was not used as an evaluation method.

PERSONAL CONCLUSION

This article is a valid summarization of a fairly interesting study. Insomnia is a disorder

that effects many and research into its treatment is extremely important. There were things

missing from the article, such as more extensive background information. Overall the concise

nature of the article made it easy to read and understand, also it was quite interesting to include
the sub-studies. There wasn’t much new information to be learned from this article mainly due to

its lack of summary of relevant literature, but the findings were interesting. Also notable was the

mention that simply the partaking in some of the evaluation methods, such as keeping a sleep

diary, were actually effective treatment of the insomnia regardless of the placebo or supplement.

It would be interesting to see more research in this area. Perhaps a different dietary supplement

could be effective in the way theorized in this article.

APPLICATION

This research is applicable to me in a variety of ways. One of which is that I believe it is

important for someone pursuing the profession that I am to be aware of some of the claims of

various health related products, especially supplements, and to know what the science is behind

these claims. It also applies to my personal life because I know a variety of people in my life

who suffer from insomnia, thus this research appealed to me. Reading the study was a little

disappointing because it’s never very enjoyable to read about something that didn’t work, but

some of the results were interesting and are things I will recommend to those I know. For

example, the article mentioned that it was noted the keeping of a sleep journal was effective in

promoting healthier sleep patterns.

GRADE AND FEEDBACK

74/75 - Citation- italicize journal title, only capitalize first word in article title. (-1)

**Great summary and evaluation of the article's methods, results, discussion and how this study

contributes to the field. Impressive understanding of the scientific process!