Documents

Future prospects in rhinosinusitis and postoperative care


MASSEGUR H.
ENT Department. Hospital de la
Santa Creu i Sant Pau. Barcelona.

New Concepts and New Strategies in Rhinosinusitis and Postoperative Care.
57th National Congress of the Spanish Society of Otorhinolaryngology.
Granada, 1 October 2006.

Keywords of 57th National Congress of SPO in Granada - PDF


PAPERS

The level or degree of clinical evidence is a hierarchical system, based on research tests or studies, which helps health professionals determine the strength or robustness of the evidence associated with the results of a treatment strategy. Since the late 90’s, any preventive, diagnostic, therapeutic, prognostic or rehabilitative procedure performed in Medicine must be defined by its level of scientific evidence, and is known as Evidence-Based Medicine (EBM).

Evidence-Based Medicine comprises the rational, explicit, judicious, up-to-date use of the best scientific evidence applied to the care and management of individual patients. EBM requires integrating individual clinical experience with the best external clinical evidence obtained from systematic research studies.


CLASSIFICATION OF THE DEGREE OF EVIDENCE

The levels of evidence currently accepted for classifying treatments’ degree of proven efficacy are structured in four categories. According to the US Agency for Health Care Policy Research, Ia evidence is provided by meta-analyses of well-designed, randomised, controlled trials; Ib evidence is provided by at least one randomised controlled trial; IIa evidence is provided by at least one well-designed, non-randomised, controlled study; IIb evidence is that which comes from at least one well-designed, not entirely experimental study, such as cohort studies (this refers to the situation in which application of an intervention is outside of the investigators’ control but its effect can be evaluated); III evidence is provided by well-designed, non-experimental descriptive studies, such as comparative studies, correlation studies or case-control studies; finally, IV evidence is obtained from the documents or opinions of expert committees or clinical experiences reported by acknowledged authorities, or case series studies. There are basically three degrees of recommendation:

A) requires at least one high-quality, high-consistency, randomised controlled trial on which to base the particular recommendation (levels of evidence Ia and Ib);
B) requires well-performed clinical studies but not randomised clinical trials, on the subject matter of the recommendation (levels of evidence IIa, IIb and III); and
C) requires evidence obtained from the documents or opinions of expert committees or clinical experiences reported by acknowledged authorities and indicates the absence of directly applicable, high-quality clinical studies (level of evidence IV).


APPLICATION TO DIFFERENT TREATMENTS

Taking into account this classification, antibiotics, topical steroids and the combination of both therapies are the treatments associated with the best level of evidence for the management of acute rhinosinusitis (Ia for the antibiotics and Ib for the topical steroids and their combination), with a degree of recommendation A for antibiotics and their association with topical steroids and B for monotherapy with topical steroids. The use of antihistamines in allergic patients has a level of evidence IIb and a degree of recommendation B. There is no consistent clinical evidence for decongestants, mucolytics, nasal irrigations and oral steroids (with a degree of recommendation D). In the case of phytotherapy, the present level of evidence is IIb and the degree of recommendation is B.

For the treatment of chronic rhinosinusitis, topical steroids have a level of evidence IIb and a degree of recommendation A. Other more innovative treatment strategies, and which have a certain degree of backing from scientific evidence, are prescribing antibiotics for 12 weeks and nasal irrigations (level III and degree of recommendation C). The mucolytics, topical antibiotics and antibiotic therapy for less than 2 weeks have a level of evidence III and a degree of recommendation C. The antifungals have a level of evidence Ib but the degree of recommendation is D. In the case of the proton pump inhibitors, the level of evidence is III and the degree of recommendation is C.

Topical steroids and the combination of both therapies are the treatments associated with the best level of evidence for the management of acute rhinosinusitis.

For the treatment of nasal polyps, the treatments of choice may be, in Dr. Massegur’s opinion, “oral antibiotics for 12 weeks (level III, degree C) and topical steroids (Ib, recommendation A)”. There are no reliable data on the use of antibiotics for less than 2 weeks, topical antibiotics or decongestants. Oral steroids and nasal irrigations have a level of evidence III (with degree of recommendation C and D, respectively). Topical antihistamines have a level of evidence III and a degree of recommendation D, while the level of evidence for capsaicin is II and the degree of recommendation is B. Finally, the proton pump inhibitors have a level of evidence II and a degree of recommendation C.


POSTOPERATIVE CARE

The classic postoperative care after sinonasal surgery has followed the recommendations made more than a decade ago by Professor Stammberger. This expert advised using merocel+beclometasone solution for 1-2 days and antibiotic ointment + corticoid (although it has since been shown that this measure does not offer any advantage and that it may even be contraindicated). In addition, during the first three days of the post-operative period, aspiration and removal of clots and secretions were recommended. As with other types of care, the importance of performing non-routine irrigations with saline and soaking with merocel + beclometasone was pointed out. It was considered that at least six weeks were required for re-epithelialisation. The monitoring visits were scheduled for after 1 week and after 4-6 weeks.

For the treatment of chronic rhinosinusitis, topical steroids have a level of evidence IIb and a degree of recommendation A.

Another reference author, Professor Hosemann, established in 2000 a series of basic postoperative care procedures: mechanical cleaning, topical steroids, inhalations and irrigations, use of ointments/gels or solutions, removal of scabs and bone fragments, removal of synechias and aspiration of all the cavities. He recommended not performing nasal suction by hand and reminded that the level of postoperative care depended on the patient’s progress. According to this expert, scabs appeared during the first ten days and, after about 30 days, a lymphatic-obstructive oedema appeared while the mesenchymal reaction is usually detected after 3 months and healing usually occurs any time beyond 90 days after surgery.

For the treatment of nasal polyps, the treatments of choice may be oral antibiotics for 12 weeks (level III, degree C) and topical steroids (Ib, recommendation A).

Quoting another acknowledged expert, Professor Bernal et al. pointed out in 2001 on the subject of postoperative care that dressing changes had to be performed 3-5 times during the first 15 days, 1-2 times/week during the first month, and then once a week until the healing process was complete. Inhalations, irrigations and topical medication were recommended after the operation.


THE EPOS CONSENSUS

More recently, the EPOS consensus has established a series of practical recommendations for postoperative care. In this case, it is the topical steroids that have a higher level of evidence and the best degree of recommendation (Ib, A). Antibiotic therapy for 12 weeks has a level of evidence III and a degree of recommendation C. Nasal irrigation has no scientific data that can confirm its efficacy and the degree of recommendation is D.

The plant extracts have a local effect on the mucous membranes in the nose and paranasal sinuses. According to the experts, such products may provide rapid, safe symptom relief.

The patients’ evolution during the postoperative period varies substantially from one case to another. In some cases, as the speaker explained, “bloody, sticky mucus is observed; other cases have moulds made of scab material and some patients have an oedematous and/or polypous mucosa. In some cases, the appearance of the nasal mucosa rapidly becomes normal.”


NEW OUTLOOK

However, the near future promises to bring new products which, to quote Dr. Massegur, “will enrich our armamentarium and facilitate a natural, safe approach to various sinonasal disorders.”

The most interesting of these are those that contain plant extracts which have a local effect on the mucous membranes in the nose and paranasal sinuses. According to the experts, such products may provide rapid, safe symptom relief.

Plant extracts have been used successfully in traditional Russian medicine. After inhalation, as Dr. Massegur pointed out, “there is a reflex secretion by the mucous membrane lining the nasal passages and paranasal sinuses and this increase in secretion is associated with an intense natural cleansing of the nasal passages and paranasal sinuses.”

Shortly after application, the patient may have a sensation of mild or moderate smarting and irritation of the nose and heavy sneezing bouts. Meanwhile, the product causes an intense reflex secretion that begins a few minutes after application and which may continue for a couple of hours.

The secretion is associated with an intense physiological drainage of the nasal passages and paranasal sinuses, which is very effective in providing symptom relief.

Through the intense secretion, the mucosa is dehydrated virtually instantly, causing diminished tissue oedema, decrease in mucosal inflammation and opening of the ostiomeatal complex. The secretion is associated with an intense physiological drainage of the nasal passages and paranasal sinuses, which is very effective in providing symptom relief. As Dr. Massegur explained, referring to his own personal experience with this product, “expulsion of the mucus secretion into the sinuses and nasal passages and its subsequent drainage could be compared in a way with inserting a sponge inside the nose, causing a marked drying effect.” This effect, as he pointed out, “is caused by activation of the mucociliary clearing processes during administration of the cyclamen extract”.


PERSONAL OBSERVATIONS

In an illustrative series of sequential images, the speaker clearly showed the effect and outcome obtained with administration of this product. Thus, one case was shown with clear signs of hyperaemia and congestion and purulent mucus in the middle meatus. Just 3 minutes after first administration of the cyclamen extract, mucus started to be expelled in large quantities from the nasal cavity and the sinuses through the ostiomeatal complex. By 5-10 minutes after administration, drainage of the mucopurulent secretions from the sinuses to the nasal passages began (for subsequent expulsion and removal).

After 1 hour, the secretions became more abundant. If the patient starts to sneeze, this causes expulsion of large quantities of mucopurulent secretions. After three hours, the secretion’s nature starts to change, taking on a much more seromucous form. After three days, there are mucupurulent secretions in the middle meatus.
By the third day, mucus and pus are drained from the ostiomeatal complex just 5 minutes after applying the product.
Finally, after 5 days, recovery is almost complete. In short, as the speaker concluded, “spraying with these plant extracts has an effect that, above all else, consists of intensifying physiological nasal mechanisms.”

Although experience with this product is still limited, given the little time it has been on the market, Dr. Humbert Massegur reviewed in this forum his personal experience in different sinonasal conditions using one instillation in each nostril, once daily for 7 days, without any concurrent therapy. As a general rule and as his main observation, the expert pointed out that “all patients were symptom-free by the end of the treatment period and no rescue systemic or local therapy was required in any case”.

The symptom results obtained with this product in postoperative care or cleansing are also satisfactory. An improvement is observed in symptoms after the sixth day in the patients treated with the product. The treatment was started in all cases on the third day after surgery (after removing the merocel). One patient reported pain in the forehead area and treatment was stopped.

The plant extracts have been shown to be useful in clearing the surgical cavity, reducing the need for aggressive care, diminishing the number of postoperative dressing changes, and promoting physiological drainage.

Dr. Massegur pointed out “that their use may be associated with smarting after the first sprays. This side effect is variable and may even be absent in postoperative patients. Sneezing, watery rhinorrhoea or isolated pain may also appear in obstructive conditions. In any case, these are mild, passing, rarely seen but expected effects that have a negligible clinical significance.”

This new product is also useful in postoperative care after sinonasal surgery. As Dr. Massegur remarked, “it has been shown to be useful in clearing the surgical cavity; it reduces the need for aggressive care, diminishes the number of postoperative dressing changes (longer time between changes), promotes physiological drainage, may speed up the re-epithelialisation process, and can be used jointly with topical corticoids.”



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